COVID-19 Vaccination and Testing; Emergency Temporary Standard

CourtOccupational Safety And Health Administration
Citation86 FR 61402
Record Number2021-23643
Published date05 November 2021
Federal Register, Volume 86 Issue 212 (Friday, November 5, 2021)
[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
                [Rules and Regulations]
                [Pages 61402-61555]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-23643]
                [[Page 61401]]
                Vol. 86
                Friday,
                No. 212
                November 5, 2021
                Part IIDepartment of Labor-----------------------------------------------------------------------Occupational Safety and Health AdministrationDepartment of Health and Human Services-----------------------------------------------------------------------Centers for Medicare & Medicaid Services-----------------------------------------------------------------------29 CFR Parts 1910, 1915, 1917, et al.
                42 Parts 416, 418, 441, et al.-----------------------------------------------------------------------COVID-19 Vaccination and Testing; Emergency Temporary Standard;
                Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff
                Vaccination; Interim Final Rules
                Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 /
                Rules and Regulations
                [[Page 61402]]
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                DEPARTMENT OF LABOR
                Occupational Safety and Health Administration
                29 CFR Parts 1910, 1915, 1917, 1918, 1926, and 1928
                [Docket No. OSHA-2021-0007]
                RIN 1218-AD42
                COVID-19 Vaccination and Testing; Emergency Temporary Standard
                AGENCY: Occupational Safety and Health Administration (OSHA),
                Department of Labor.
                ACTION: Interim final rule; request for comments.
                -----------------------------------------------------------------------
                SUMMARY: The Occupational Safety and Health Administration (OSHA) is
                issuing an emergency temporary standard (ETS) to protect unvaccinated
                employees of large employers (100 or more employees) from the risk of
                contracting COVID-19 by strongly encouraging vaccination. Covered
                employers must develop, implement, and enforce a mandatory COVID-19
                vaccination policy, with an exception for employers that instead adopt
                a policy requiring employees to either get vaccinated or elect to
                undergo regular COVID-19 testing and wear a face covering at work in
                lieu of vaccination.
                DATES: The rule is effective November 5, 2021. The incorporation by
                reference of certain publications listed in the rule is approved by the
                Director of the Federal Register as of November 5, 2021.
                 Compliance dates: Compliance dates for specific provisions are in
                29 CFR 1910.501(m).
                 Comments: Written comments, including comments on any aspect of
                this ETS and whether this ETS should become a final rule, must be
                submitted by December 6, 2021 in Docket No. OSHA-2021-0007. Comments on
                the information collection determination described in Additional
                Requirements (Section V.K. of this preamble) (OMB review under the
                Paperwork Reduction Act of 1995) may be submitted by January 4, 2022 in
                Docket No. OSHA-2021-0008.
                ADDRESSES: In accordance with 28 U.S.C. 2112(a), the Agency designates
                Edmund C. Baird, the Associate Solicitor for Occupational Safety and
                Health, Office of the Solicitor, U.S. Department of Labor, to receive
                petitions for review of the ETS. Service can be accomplished by email
                to zzSOL-Covid19-[email protected].
                 Written comments. You may submit comments and attachments,
                identified by Docket No. OSHA-2021-0007, electronically at
                www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
                the online instructions for making electronic submissions.
                 Instructions: All submissions must include the agency's name and
                the docket number for this rulemaking (Docket No. OSHA-2021-0007). All
                comments, including any personal information you provide, are placed in
                the public docket without change and may be made available online at
                www.regulations.gov. Therefore, OSHA cautions commenters about
                submitting information they do not want made available to the public,
                or submitting materials that contain personal information (either about
                themselves or others), such as Social Security Numbers and birthdates.
                 Docket: To read or download comments or other material in the
                docket, go to Docket No. OSHA-2021-0007 at www.regulations.gov. All
                comments and submissions are listed in the www.regulations.gov index;
                however, some information (e.g., copyrighted material) is not publicly
                available to read or download through that website. All comments and
                submissions, including copyrighted material, are available for
                inspection through the OSHA Docket Office. Documents submitted to the
                docket by OSHA or stakeholders are assigned document identification
                numbers (Document ID) for easy identification and retrieval. The full
                Document ID is the docket number plus a unique four-digit code. OSHA is
                identifying supporting information in this ETS by author name and
                publication year, when appropriate. This information can be used to
                search for a supporting document in the docket at http://www.regulations.gov. Contact the OSHA Docket Office at 202-693-2350
                (TTY number: 877-889-5627) for assistance in locating docket
                submissions.
                FOR FURTHER INFORMATION CONTACT:
                 General information and press inquiries: Contact Frank Meilinger,
                OSHA Office of Communications, U.S. Department of Labor; telephone
                (202) 693-1999; email [email protected].
                 For technical inquiries: Contact Andrew Levinson, OSHA Directorate
                of Standards and Guidance, U.S. Department of Labor; telephone (202)
                693-1950; email [email protected].
                SUPPLEMENTARY INFORMATION: The preamble to the ETS on COVID-19
                vaccination and testing follows this outline:
                Table of Contents
                I. Executive Summary and Request for Comment
                 A. Executive Summary
                 B. Request for Comment
                II. Pertinent Legal Authority
                III. Rationale for the ETS
                 A. Grave Danger
                 B. Need for the ETS
                IV. Feasibility
                 A. Technological Feasibility
                 B. Economic Analysis
                V. Additional Requirements
                VI. Summary and Explanation
                 A. Purpose
                 B. Scope and Application
                 C. Definitions
                 D. Employer Policy on Vaccination
                 E. Determination of Employee Vaccination Status
                 F. Employer Support for Employee Vaccination
                 G. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
                 H. Employee Notification to Employer of a Positive COVID-19 Test
                and Removal
                 I. Face Coverings
                 J. Information Provided to Employees
                 K. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
                 L. Availability of Records
                 M. Dates
                 N. Severability
                 O. Incorporation by Reference
                VII. Authority and Signature
                I. Executive Summary and Request for Comment
                A. Executive Summary
                 This ETS is based on the requirements of the Occupational Safety
                and Health Act (OSH Act or Act) and legal precedent arising under the
                Act. Under section 6(c)(1) of the OSH Act, 29 U.S.C. 655(c)(1), OSHA
                shall issue an ETS if the agency determines that employees are subject
                to grave danger from exposure to substances or agents determined to be
                toxic or physically harmful or from new hazards, and an ETS is
                necessary to protect employees from such danger. These legal
                requirements are more fully discussed in Pertinent Legal Authority
                (Section II. of this preamble). This ETS does not apply to workplaces
                subject to E.O. 14042 on Requiring Coronavirus Disease 2019 Vaccination
                for Federal Contractors. In addition, OSHA will treat federal agencies'
                compliance with E.O. 14043, and the Safer Federal Workforce Task Force
                guidance issued under section 4(e) of Executive Order 13991 and section
                2 of Executive Order 14043, as sufficient to meet their obligations
                under the OSH Act and E.O. 12196.
                 COVID-19 has killed over 725,000 people in the United States in
                less than two years, and infected millions more (CDC, October 18,
                2021--Cumulative US Deaths). The pandemic continues to affect workers
                and workplaces. While COVID-19 vaccines authorized or
                [[Page 61403]]
                approved by the U.S. Food and Drug Administration (FDA) effectively
                protect vaccinated individuals against severe illness and death from
                COVID-19, unvaccinated individuals remain at much higher risk of severe
                health outcomes from COVID-19. Further, unvaccinated workers are much
                more likely to contract and transmit COVID-19 in the workplace than
                vaccinated workers. OSHA has determined that many employees in the U.S.
                who are not fully vaccinated against COVID-19 face grave danger from
                exposure to SARS-CoV-2 in the workplace. This finding of grave danger
                is based on the severe health consequences associated with exposure to
                the virus along with evidence demonstrating the transmissibility of the
                virus in the workplace and the prevalence of infections in employee
                populations, as discussed in Grave Danger (Section III.A. of this
                preamble).
                 OSHA has also determined that an ETS is necessary to protect
                unvaccinated workers from the risk of contracting COVID-19 at work, as
                discussed in Need for the ETS (Section III.B. of this preamble). At the
                present time, workers are becoming seriously ill and dying as a result
                of occupational exposures to COVID-19, when a simple measure,
                vaccination, can largely prevent those deaths and illnesses. The ETS
                protects these workers through the most effective and efficient control
                available--vaccination--and further protects workers who remain
                unvaccinated through required regular testing, use of face coverings,
                and removal of all infected employees from the workplace. OSHA also
                concludes, based on its enforcement experience during the pandemic to
                date, that continued reliance on existing standards and regulations,
                the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1), and
                workplace guidance, in lieu of an ETS, is not adequate to protect
                unvaccinated employees from the grave danger of being infected by, and
                suffering death or serious health consequences from, COVID-19.
                 OSHA will continue to monitor trends in COVID-19 infections and
                death as more of the workforce and the general population become fully
                vaccinated against COVID-19 and the pandemic continues to evolve. Where
                OSHA finds a grave danger from the virus no longer exists for the
                covered workforce (or some portion thereof), or new information
                indicates a change in measures necessary to address the grave danger,
                OSHA will update this ETS, as appropriate.
                 This ETS applies to employers with a total of 100 or more employees
                at any time the standard is in effect. In light of the unique
                occupational safety and health dangers presented by COVID-19, and
                against the backdrop of the uncertain economic environment of a
                pandemic, OSHA is proceeding in a stepwise fashion in addressing the
                emergency this rule covers. OSHA is confident that employers with 100
                or more employees have the administrative capacity to implement the
                standard's requirements promptly, but is less confident that smaller
                employers can do so without undue disruption. OSHA needs additional
                time to assess the capacity of smaller employers, and is seeking
                comment to help the agency make that determination. Nonetheless, the
                agency is acting to protect workers now in adopting a standard that
                will reach two-thirds of all private-sector workers in the nation,
                including those working in the largest facilities, where the most
                deadly outbreaks of COVID-19 can occur.
                 The agency has also evaluated the feasibility of this ETS and has
                determined that the requirements of the ETS are both economically and
                technologically feasible, as outlined in Feasibility (Section IV. of
                this preamble). The specific requirements of the ETS are outlined and
                described in Summary and Explanation (Section VI. of this preamble).
                B. Request for Comment
                 Although this ETS takes effect immediately, it also serves as a
                proposal under Section 6(b) of the OSH Act (29 U.S.C. 655(b)) for a
                final standard. Accordingly, OSHA seeks comment on all aspects of this
                ETS and whether it should be adopted as a final standard. OSHA
                encourages commenters to explain why they prefer or disfavor particular
                policy choices, and include any relevant studies, experiences,
                anecdotes or other information that may help support the comment. In
                particular, OSHA seeks comments on the following topics:
                 1. Employers with fewer than 100 employees. As noted above and
                fully discussed in the Summary and Explanation for Scope and
                Application (Section VI.B. of this preamble), OSHA has implemented a
                100-employee threshold for the requirements of this standard to focus
                the ETS on companies that OSHA is confident will have sufficient
                administrative systems in place to comply quickly with the ETS. The
                agency is moving in a stepwise fashion on the short timeline
                necessitated by the danger presented by COVID-19 while soliciting
                stakeholder comment and additional information to determine whether to
                adjust the scope of the ETS to address smaller employers in the future.
                OSHA seeks information about the ability of employers with fewer than
                100 employees to implement COVID-19 vaccination and/or testing
                programs. Have you instituted vaccination mandates (with or without
                alternatives), or requirements for regular COVID-19 testing or face
                covering use? What have been the benefits of your approach? What
                challenges have you had or could you foresee in implementing such
                programs? Is there anything specific to your industry, or the size of
                your business, that poses particular obstacles in implementing the
                requirements in this standard? How much time would it take, what types
                of costs would you incur, and how much would it cost for you to
                implement such requirements?
                 2. Significant Risk. If OSHA were to finalize a rule based on this
                ETS, it would be a standard adopted under 6(b) of the OSH Act, which
                requires a finding of significant risk from exposure to COVID-19. As
                discussed more fully in Pertinent Legal Authority (Section II. of this
                preamble), this is a lower showing of risk than grave danger, the
                finding required to issue a 6(c) emergency temporary standard. How
                should the scope of the rule change to address the significant risk
                posed by COVID-19 in the workplace? Should portions of the rule, such
                as face coverings, apply to fully vaccinated persons?
                 3. Prior COVID-19 infections. OSHA determined that workers who have
                been infected with COVID-19 but have not been fully vaccinated still
                face a grave danger from workplace exposure to SARS-CoV-2. This is an
                area of ongoing scientific inquiry. Given scientific uncertainty and
                limitations in testing for infection and immunity, OSHA is concerned
                that it would be infeasible for employers to operationalize a standard
                that would permit or require an exception from vaccination or testing
                and face covering based on prior infection with COVID-19. Is there
                additional scientific information on this topic that OSHA should
                consider as it determines whether to proceed with a permanent rule?
                 In particular, what scientific criteria can be used to determine
                whether a given employee is sufficiently protected against reinfection?
                Are there any temporal limits associated with this criteria to account
                for potential reductions in immunity over time? Do you require
                employees to provide verification of infection with COVID-19? If so,
                what kinds of verification do you accept (i.e., PCR testing, antigen
                testing, etc.)? What challenges have you
                [[Page 61404]]
                experienced, if any, in operationalizing such an exception?
                 4. Experience with COVID-19 vaccination policies. Should OSHA
                impose a strict vaccination mandate (i.e., all employers required to
                implement mandatory vaccination policies as defined in this ETS) with
                no alternative compliance option? OSHA seeks information on COVID-19
                vaccination policies that employers have implemented to protect
                workers. If you have implemented a COVID-19 vaccination policy:
                 (a) When did you implement it, and what does your policy require?
                Was vaccination mandatory or voluntary under the policy? Do you offer
                vaccinations on site? What costs associated with vaccination did you
                cover under the policy? What percentage of your workforce was
                vaccinated as a result? Do you offer paid leave for receiving a
                vaccination? If vaccination is mandatory, have employees been resistant
                and if so what steps were required to enforce the policy?
                 (b) How did you verify that employees were vaccinated? Are there
                other reliable means of vaccination verification not addressed by the
                ETS that should be included? Did you allow attestation where the
                employee could not find other proof, and if so, have you experienced
                any difficulties with this approach? Have you experienced any issues
                with falsified records of vaccination, and if so, how did you deal with
                them?
                 (c) Have you experienced a decrease in infection rates or outbreaks
                after implementing this policy?
                 (d) If you have received any requests for reasonable accommodation
                from vaccination, what strategies did you implement to address the
                accommodation and ensure worker safety (e.g., telework, working in
                isolation, regular testing and the use of face coverings)?
                 5. COVID-19 testing and removal. OSHA seeks information on COVID-19
                testing and removal practices implemented to protect workers.
                 (a) Do you have a testing and removal policy in your workplace and,
                if so, what does it require? How often do you require testing and what
                types of testing do you use (e.g., at-home tests, tests performed at
                laboratories, tests performed at your worksites)? What costs have you
                incurred as part of your testing and removal policies? Do you have
                difficulty in finding adequate availability of tests? How often? Have
                you experienced any issues with falsified test results, and if so, how
                did you deal with them? Have you experienced other difficulties in
                implementing a testing and removal scheme, including the length of time
                to obtain COVID-19 test results? Do you offer paid leave for testing?
                 (b) How often have you detected and removed COVID-19 positive
                employees from the workplace under this policy? Do you provide paid
                leave and job protection to employees you remove for this reason?
                 (c) Should OSHA require testing more often than on a weekly basis?
                 6. Face coverings. As discussed in the Summary and Explanation for
                Face Coverings (Section VI.I. of this preamble), ASTM released a
                specification standard on February 15, 2021, to establish a national
                standard baseline for barrier face coverings (ASTM F3502-21). Should
                OSHA require the use of face coverings meeting the ASTM F3502-21
                standard instead of the face coverings specified by the ETS? If so,
                should OSHA also require that such face coverings meet the NIOSH
                Workplace Performance or Workplace Performance Plus criteria (see CDC,
                September 23, 2021)? Are there particular workplace settings in which
                face coverings meeting one standard should be favored over another? Are
                there alternative criteria OSHA should consider for face coverings
                instead of the F3502-21 standard or NIOSH Workplace Performance or
                Workplace Performance Plus criteria? Is there sufficient capacity to
                supply face coverings meeting F3502-01 and/or NIOSH Workplace
                Performance or Workplace Performance Plus criteria to all employees
                covered by the ETS? What costs have you incurred as part of supplying
                employees with face coverings meeting the appropriate criteria?
                 7. Other controls. This ETS requires employees to either be fully
                vaccinated against COVID-19 or be tested weekly and wear face
                coverings, based on the type of policy their employer adopts. It stops
                short of requiring the full suite of workplace controls against SARS-
                CoV-2 transmission recommended by OSHA and the CDC, including
                distancing, barriers, ventilation, and sanitation. As OSHA explained in
                Need for the ETS (Section III.B. of this preamble), OSHA has determined
                that it needs more information before imposing these requirements on
                the entire scope of industries and employers covered by the standard.
                OSHA is interested in hearing from employers about their experience in
                implementing a full suite of workplace controls against COVID-19.
                 What measures have you taken to protect employees against COVID-19
                in your workplace? Are there controls that you attempted to employ but
                found ineffective or infeasible? What are they? Why did you conclude
                that they were they ineffective or infeasible; for example, are there
                particular aspects of your workplace or industry that make certain
                controls infeasible? Do you require both fully vaccinated and
                unvaccinated employees to comply with these controls? Have you
                experienced a reduction in infection rates or outbreaks since
                implementing these controls?
                 8. Educational materials. Have you implemented any policies or
                provided any information that has been helpful in encouraging an
                employee to be vaccinated?
                 9. Feasibility and health impacts. Do you have any experience or
                data that would inform OSHA's estimates in its economic feasibility
                analysis or any of the assumptions or estimates used in OSHA's
                identification of the number of hospitalizations prevented and lives
                saved from its health impacts analysis (see OSHA, October 2021c)?
                References
                Centers for Disease Control and Prevention (CDC). (2021, October
                18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
                (CDC, October 18, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, September
                23). Types of Masks and Respirators. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html.
                (CDC, September 23, 2021)
                Occupational Safety and Health Administration (OSHA). (2021c,
                October). Health Impacts of the COVID-19 Vaccination and Testing
                ETS. (OSHA, October 2021c)
                II. Pertinent Legal Authority
                 The purpose of the Occupational Safety and Health Act of 1970 (OSH
                Act), 29 U.S.C. 651 et seq., is ``to assure so far as possible every
                working man and woman in the Nation safe and healthful working
                conditions and to preserve our human resources.'' 29 U.S.C. 651(b). To
                this end, Congress authorized the Secretary of Labor (Secretary) to
                promulgate and enforce occupational safety and health standards under
                sections 6(b) and (c) of the OSH Act.\1\ 29 U.S.C. 655(b). These
                provisions provide bases for issuing occupational safety and health
                standards under the Act. Once OSHA has established as a threshold
                matter that a health standard is necessary under section 6(b) or (c)--
                i.e., to reduce
                [[Page 61405]]
                a significant risk of material health impairment, or a grave danger to
                employee health--the Act gives the Secretary ``almost unlimited
                discretion to devise means to achieve the congressionally mandated
                goal'' of protecting employee health, subject to the constraints of
                feasibility. See United Steelworkers of Am. v. Marshall, 647 F.2d 1189,
                1230 (D.C. Cir. 1981). A standard's individual requirements need only
                be ``reasonably related'' to the purpose of ensuring a safe and
                healthful working environment. Id. at 1237, 1241; see also Forging
                Indus. Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1447 (4th Cir. 1985).
                OSHA's authority to regulate employers is hedged by constitutional
                considerations and, pursuant to section 4(b)(1) of the OSH Act, the
                regulations and enforcement policies of other federal agencies. See,
                e.g., Chao v. Mallard Bay Drilling, Inc., 534 U.S. 235, 241 (2002).
                ---------------------------------------------------------------------------
                 \1\ The Secretary has delegated most of his duties under the OSH
                Act to the Assistant Secretary of Labor for Occupational Safety and
                Health. Secretary's Order 08-2020, 85 FR 58393 (Sept. 18, 2020).
                This section uses the terms Secretary and OSHA interchangeably.
                ---------------------------------------------------------------------------
                 The OSH Act in section 6(c)(1) states that the Secretary ``shall''
                issue an emergency temporary standard (ETS) upon a finding that the ETS
                is necessary to address a grave danger to workers. See 29 U.S.C.
                655(c). In particular, the Secretary shall provide, without regard to
                the requirements of chapter 5, title 5, United States Code, for an
                emergency temporary standard to take immediate effect upon publication
                in the Federal Register if the Secretary makes two determinations: That
                employees are exposed to grave danger from exposure to substances or
                agents determined to be toxic or physically harmful or from new
                hazards, and that such emergency standard is necessary to protect
                employees from such danger. 29 U.S.C. 655(c)(1). A separate section of
                the OSH Act, section 8(c), authorizes the Secretary to prescribe
                regulations requiring employers to make, keep, and preserve records
                that are necessary or appropriate for the enforcement of the Act. 29
                U.S.C. 657(c)(1). Section 8(c) also provides that the Secretary shall
                require employers to keep records of, and report, work-related deaths
                and illnesses. 29 U.S.C. 657(c)(2).
                 The ETS provision, section 6(c)(1), exempts the Secretary from
                procedural requirements contained in the OSH Act and the Administrative
                Procedure Act, including those for public notice, comments, and a
                rulemaking hearing. See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C. 552, 553.
                 The Secretary must issue an ETS in situations where employees are
                exposed to a ``grave danger'' and immediate action is necessary to
                protect those employees from such danger. 29 U.S.C. 655(c)(1); Pub.
                Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156 (D.C. Cir.
                1983). The determination of what exact level of risk constitutes a
                ``grave danger'' is a ``policy consideration that belongs, in the first
                instance, to the Agency.'' Asbestos Info. Ass'n, 727 F.2d at 425
                (accepting OSHA's determination that eighty lives at risk over six
                months was a grave danger); Indus. Union Dep't, AFL-CIO v. Am.
                Petroleum Inst., 448 U.S. 607, 655 n.62 (1980). However, a ``grave
                danger'' represents a risk greater than the ``significant risk'' that
                OSHA must show in order to promulgate a permanent standard under
                section 6(b) of the OSH Act, 29 U.S.C. 655(b). Int'l Union, United
                Auto., Aerospace, & Agr. Implement Workers of Am., UAW v. Donovan, 590
                F. Supp. 747, 755-56 (D.D.C. 1984), adopted, 756 F.2d 162 (D.C. Cir.
                1985); see also Indus. Union Dep't, AFL-CIO, 448 U.S. at 640 n.45
                (noting the distinction between the standard for risk findings in
                permanent standards and ETSs).
                 In determining the type of health effects that may constitute a
                ``grave danger'' under the OSH Act, the Fifth Circuit emphasized ``the
                danger of incurable, permanent, or fatal consequences to workers, as
                opposed to easily curable and fleeting effects on their health.'' Fla.
                Peach Growers Ass'n, Inc. v. U. S. Dep't of Labor, 489 F.2d 120, 132
                (5th Cir. 1974). Although the findings of grave danger and necessity
                must be based on evidence of ``actual, prevailing industrial
                conditions,'' see Int'l Union, 590 F. Supp. at 751, when OSHA
                determines that exposure to a particular hazard would pose a grave
                danger to workers, OSHA can assume an exposure to a grave danger
                wherever that hazard is present in a workplace. Dry Color Mfrs. Ass'n,
                Inc. v. Dep't of Labor, 486 F.2d 98, 102 n.3 (3d Cir. 1973).
                 In demonstrating whether OSHA had shown that an ETS is necessary,
                the Fifth Circuit considered whether OSHA had another available means
                of addressing the risk that would not require an ETS. Asbestos Info.
                Ass'n, 727 F.2d at 426 (holding that necessity had not been proven
                where OSHA could have increased enforcement of already-existing
                standards to address the grave risk to workers from asbestos exposure).
                Additionally, a standard must be both economically and technologically
                feasible in order to be ``reasonably necessary and appropriate'' under
                section 3(8) and, by inference, ``necessary'' under section 6(c)(1)(B)
                of the Act. Cf. Am. Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490,
                513 n.31 (1981) (noting ``any standard that was not economically or
                technologically feasible would a fortiori not be `reasonably necessary
                or appropriate' '' as required by the OSH Act's definition of
                ``occupational safety and health standard'' in section 3(8)); see also
                Florida Peach Growers, 489 F.2d at 130 (recognizing that the
                promulgation of any standard, including an ETS, must account for its
                economic effect). However, given that section 6(c) is aimed at enabling
                OSHA to protect workers in emergency situations, the agency is not
                required to make a feasibility showing with the same rigor as in
                ordinary section 6(b) rulemaking. Asbestos Info. Ass'n, 727 F.2d at 424
                n.18.
                 On judicial review of an ETS, OSHA is entitled to great deference
                on the determinations of grave danger and necessity required under
                section 6(c)(1). See, e.g., Pub. Citizen Health Research Grp., 702 F.2d
                at 1156; Asbestos Info. Ass'n, 727 F.2d at 422 (judicial review of
                these legislative determinations requires deference to the agency); cf.
                Am. Dental Ass'n v. Martin, 984 F.2d 823, 831 (7th Cir. 1993) (``the
                duty of a reviewing court of generalist judges is merely to patrol the
                boundary of reasonableness''). These determinations are ``essentially
                legislative and rooted in inferences from complex scientific and
                factual data.'' Pub. Citizen Health Research Grp., 702 F.2d at 1156.
                The agency is not required to support its conclusions ``with anything
                approaching scientific certainty,'' Indus. Union Dep't, AFL-CIO, 448
                U.S. at 656, and has the ``prerogative to choose between conflicting
                evidence.'' Asbestos Info. Ass'n, 727 F.2d at 425.
                 The determinations of the Secretary in issuing standards under
                section 6 of the OSH Act, including ETSs, must be affirmed if supported
                by ``substantial evidence in the record considered as a whole.'' 29
                U.S.C. 655(f). The Supreme Court described substantial evidence as
                ``such relevant evidence as a reasonable mind might accept as adequate
                to support a conclusion.'' Am. Textile Mfrs. Inst., 452 U.S. at 522-23
                (quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951)). The
                Court also noted that ``the possibility of drawing two inconsistent
                conclusions from the evidence does not prevent an administrative
                agency's finding from being supported by substantial evidence.'' Id. at
                523 (quoting Consolo v. FMC, 383 U.S. 607, 620 (1966)). The Fifth
                Circuit, recognizing the size and complexity of the rulemaking record
                before it in the case of OSHA's ETS for organophosphorus pesticides,
                stated that a court's function in reviewing an ETS to determine whether
                it meets the substantial evidence standard is ``basically [to]
                determine whether the
                [[Page 61406]]
                Secretary carried out his essentially legislative task in a manner
                reasonable under the state of the record before him.'' Fla Peach
                Growers Ass'n, 489 F.2d at 129.
                 Although Congress waived the ordinary rulemaking procedures in the
                interest of ``permitting rapid action to meet emergencies,'' section
                6(e) of the OSH Act, 29 U.S.C. 655(e), requires OSHA to include a
                statement of reasons for its action when it issues any standard. Dry
                Color Mfrs., 486 F.2d at 105-06 (finding OSHA's statement of reasons
                inadequate). By requiring the agency to articulate its reasons for
                issuing an ETS, the requirement acts as ``an essential safeguard to
                emergency temporary standard-setting.'' Id. at 106. However, the Third
                Circuit noted that it did not require justification of ``every
                substance, type of use or production technique,'' but rather a
                ``general explanation'' of why the standard is necessary. Id. at 107.
                 ETSs are, by design, temporary in nature. Under section 6(c)(3), an
                ETS serves as a proposal for a permanent standard in accordance with
                section 6(b) of the OSH Act (permanent standards), and the Act calls
                for the permanent standard to be finalized within six months after
                publication of the ETS. 29 U.S.C. 655(c)(3); see Fla. Peach Growers
                Ass'n, 489 F.2d at 124. The ETS is effective ``until superseded by a
                standard promulgated in accordance with'' section 6(c)(3). 29 U.S.C.
                655(c)(2).
                 Section 6(c)(1) states that the Secretary ``shall'' provide for an
                ETS when OSHA makes the prerequisite findings of grave danger and
                necessity. See Pub. Citizen Health Research Grp., 702 F.2d at 1156
                (noting the mandatory language of section 6(c)). OSHA is entitled to
                great deference in its determinations, and it must also account for
                ``the fact that `the interests at stake are not merely economic
                interests in a license or a rate structure, but personal interests in
                life and health.' '' Id. (quoting Wellford v. Ruckelshaus, 439 F.2d
                598, 601 (D.C. Cir. 1971)).
                 When OSHA issues a standard pursuant to section 6--whether
                permanent or an ETS--section 18 of the OSH Act provides that OSHA's
                standard preempts any state occupational safety or health standard
                ``relating to [the same] occupational safety or health issue'' as the
                Federal standard. 29 U.S.C. 667(b); see also Gade v. Nat'l Solid Wastes
                Mgmt. Ass'n, 505 U.S. 88, 97 (1992). A state can avoid preemption only
                if it submits, and receives Federal approval for, a state plan for the
                development and enforcement of standards pursuant to section 18 of the
                Act, which must be ``at least as effective'' as the Federal standards.
                29 U.S.C. 667; Indus. Truck Ass'n v. Henry, 125 F.3d 1305, 1311 (9th
                Cir. 1997). However, the OSH Act does not preempt state laws of
                ``general applicability'' that regulate workers and non-workers alike,
                so long as they do not conflict with an OSHA standard. Gade, 505 U.S.
                at 107.
                 As discussed in detail elsewhere in this preamble, OSHA has
                determined that a grave danger exists necessitating a new ETS (see
                Grave Danger and Need for the ETS, Sections III.A. and III.B. of this
                preamble), and that compliance with this ETS is feasible for covered
                employers (see Feasibility, Section IV. of this preamble). OSHA has
                also provided a more detailed explanation of each provision of this ETS
                in Summary and Explanation (Section VI. of this preamble). In addition,
                OSHA wishes to provide here some general guidance on its legal
                authority to regulate COVID-19 hazards, and for particular provisions
                of this ETS.
                 As a threshold matter, OSHA's authority to regulate workplace
                exposure to biological hazards like SARS-CoV-2 is well-established.
                Section 6(b)(5) of the OSH Act uses similar language to section
                6(c)(1)(A): The former sets forth requirements for promulgating
                permanent standards addressing ``toxic materials or harmful physical
                agents,'' and the latter authorizes OSHA to promulgate an ETS
                addressing ``substances or agents determined to be toxic or physically
                harmful'' (as well as ``new hazards''). OSHA has consistently
                identified biological hazards similar to SARS-CoV-2, as well as SARS-
                CoV-2 itself, to be ``toxic materials or harmful physical agents''
                under the Act. Indeed, in its exposure and medical records access
                regulation, OSHA has defined ``toxic materials or harmful physical
                agents'' to include ``any . . . biological agent (bacteria, virus,
                fungus, etc.)'' for which there is evidence that it poses a chronic or
                acute health hazard. 29 CFR 1910.1020(c)(13). And in addition to
                previously regulating exposure to SARS-CoV-2 as a new and physically
                harmful agent in the Healthcare ETS (see, e.g., 86 FR at 32381), OSHA
                has also previously regulated biological hazards like SARS-CoV-2 as
                health hazards under section 6(b)(5), for example in the Bloodborne
                Pathogens (BBP) standard, 29 CFR 1910.1030, which addresses workplace
                exposure to HIV and Hepatitis B. The BBP standard was upheld (except as
                to application in certain limited industries) in American Dental
                Association, which observed that ``the infectious character'' of the
                regulated bloodborne diseases might warrant ``more regulation than
                would be necessary in the case of a noncommunicable disease.'' 984 F.2d
                at 826. In addition, in the preamble to the respiratory protection
                standard, 29 CFR 1910.134, which was also promulgated under section
                6(b)(5), ``OSHA emphasize[d] that [the] respiratory protection standard
                does apply to biological hazards.'' Respiratory Protection, 63 FR 1152-
                01, 1180 (Jan. 8, 1998) (citing Mahone Grain Corp., 10 BNA OSHC 1275
                (No. 77-3041, 1981)).
                 In addition to being a physically harmful agent covered by section
                6(c)(1)(A), SARS-CoV-2 is also, without question, a ``new hazard''
                covered by this provision, as discussed in more detail in Grave Danger
                (Section III.A. of this preamble). SARS-CoV-2 was not known to exist
                until January 2020, and since then more than 725,000 people have died
                from COVID-19 in the U.S. alone (CDC, October 18, 2021--Cumulative US
                Deaths).
                 Turning to specific provisions of this standard, the vaccination
                requirements in this ETS are also well within the bounds of OSHA's
                authority. Vaccination can be a critical tool in the pursuit of health
                and safety goals, particularly in response to an infectious and highly
                communicable disease. See, e.g., Jacobson v. Commonwealth of Mass., 197
                U.S. 11, 27-28 (1905) (recognizing use of smallpox vaccine as a
                reasonable measure to protect public health and safety); Klaassen v.
                Trustees of Ind. Univ., 7 F.4th 592, 593 (7th Cir. 2021) (citing
                Jacobson and noting that vaccination may be an appropriate safety
                measure against SARS-CoV-2 as ``[v]accination protects not only the
                vaccinated persons but also those who come in contact with them''). And
                the OSH Act itself explicitly acknowledges that such treatments might
                be necessary, in some circumstances. 29 U.S.C. 669(a)(5) (providing in
                the Act's provisions on research and related activities conducted by
                the Secretary of Health and Human Services to aid OSHA in its
                formulation of health and safety standards that ``[n]othing in this or
                any other provision of this Act shall be deemed to authorize or require
                medical examination, immunization, or treatment for those who object
                thereto on religious grounds, except where such is necessary for the
                protection of the health or safety of others.'' (emphasis added)). In
                recognition of the health and safety benefits provided by vaccination,
                OSHA has previously exercised its authority to promulgate vaccine-
                related requirements in the COVID-19 Healthcare ETS (29 CFR
                1910.502(m))
                [[Page 61407]]
                and the BBP standard (29 CFR 1910.1030(f)). The BBP standard
                illustrates congressional understanding that the statutory delegation
                of authority to OSHA to issue standards includes authority for vaccine
                provisions, where appropriate. See Public Law 102-170, Title I, Section
                100, 105 Stat. 1107 (1991) (directing OSHA to complete the BBP
                rulemaking by a date certain, and providing that if OSHA did not do so,
                the proposed rule, which included a vaccine provision, would become the
                final standard).
                 Additionally, OSHA's authority to require employers to bear the
                costs of particular provisions of a standard is solidly grounded in the
                OSH Act. The Act reflects Congress's determination that the costs of
                compliance with the Act and OSHA standards are part of the cost of
                doing business and OSHA may foreclose employers from shifting those
                costs to employees. See Am. Textile Mfrs. Inst., 452 U.S. at 514;
                Phelps Dodge Corp. v. OSHRC, 725 F.2d 1237, 1239-40 (9th Cir. 1984);
                see also Sec'y of Labor v. Beverly Healthcare-Hillview, 541 F.3d 193
                (3d Cir. 2008). Consistent with this authority, OSHA has largely
                required employers to bear the costs of the provisions of this ETS,
                including the typical costs associated with vaccination. The allocation
                of vaccination costs to employers in this ETS is similar to OSHA's
                treatment of vaccine-related costs in the COVID-19 Healthcare ETS and
                the BBP standards. See 29 CFR 1910.502(m), (p); 29 CFR
                1910.1030(f)(1)(ii)(A).
                 The OSH Act provides OSHA with discretion, however, to decide
                whether to impose certain costs--such as those related to medical
                examinations or other tests--on employers ``[w]here [it determines that
                such costs are] appropriate.'' 29 U.S.C. 655(b)(7). OSHA has determined
                that for purposes of this ETS, it would not be ``appropriate'' to
                impose on employers any costs associated with COVID-19 testing for
                employees who choose not to be vaccinated. For most of the agency's
                existing standards containing medical testing and removal provisions,
                OSHA has found it necessary to impose the costs of such provisions on
                employers in order to remove barriers to employee participation in
                medical examinations that are critical to effectuating the standards'
                safety and health protections. See United Steelworkers of Am., 647 F.2d
                at 1229-31, 1237-38. However, as explained in greater detail elsewhere
                in this preamble (see Need for the ETS, Section III.B. of this
                preamble), the ETS's safety and health protections are best effectuated
                by employee vaccination, not testing. Accordingly, OSHA only requires
                employers to bear the costs of employee compliance with the preferred,
                and more protective, vaccination provision, but not costs associated
                with testing. The agency does not believe it appropriate to impose the
                costs of testing on an employer where an employee has made an
                individual choice to pursue a less protective option. For the same
                reasons, OSHA has also determined that it is not appropriate to require
                employers to pay for face coverings for employees who choose not to be
                vaccinated.\2\
                ---------------------------------------------------------------------------
                 \2\ OSHA notes that while the ETS does not impose these testing
                or face covering costs on employers, in some circumstances employers
                may be required to pay for the costs related to testing and/or face
                coverings by other laws, regulations, or collectively negotiated
                agreements. OSHA has no authority under the OSH Act to determine
                whether such obligations under other laws, regulations, or
                agreements might exist.
                ---------------------------------------------------------------------------
                 Finally, the Act and its legislative history ``both demonstrate
                unmistakably'' OSHA's authority to require employers to temporarily
                remove workers from the workplace to prevent exposure to a health
                hazard. United Steelworkers of Am., 647 F.2d at 1230. And again, this
                is an authority OSHA has repeatedly exercised in prior standards,
                including in: COVID-19 Healthcare ETS (29 CFR 1910.502); Lead (29 CFR
                1910.1025); Cadmium (29 CFR 1910.1027); Benzene (29 CFR 1910.1028);
                Formaldehyde (29 CFR 1910.1048); Methylenedianiline (29 CFR 1910.1050);
                Methylene Chloride (29 CFR 1910.1052); and Beryllium (29 CFR
                1910.1024). It is equally appropriate to impose that obligation here.
                 For all of these reasons, as well as those explained more fully in
                other areas of this preamble, OSHA has the authority--and obligation--
                to promulgate this ETS.
                References
                Centers for Disease Control and Prevention (CDC). (2021, October
                18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
                (CDC, October 18, 2021)
                III. Rationale for the ETS
                A. Grave Danger
                I. Introduction
                 Section 6(c)(1) of the OSH Act requires the Secretary to issue an
                ETS in situations where employees are exposed to a ``grave danger'' and
                immediate action is necessary to protect those employees from such
                danger (29 U.S.C. 655(c)(1)). Consistent with its legal duties, OSHA is
                issuing this ETS to address the grave danger posed by occupational
                exposure to SARS-CoV-2, the virus that causes COVID-19.\3\ OSHA has
                determined that occupational exposure to SARS-CoV-2, including the
                Delta variant (B.1.617.2 and AY lineages), presents a grave danger to
                unvaccinated workers in the U.S., with several exceptions explained
                below.\4\ This finding of grave danger is based on the science of how
                the virus spreads, the transmissibility of the disease in workplaces,
                and the serious adverse health effects, including death, that can be
                suffered by those who are diagnosed with COVID-19. The protections of
                this ETS--which will apply, with some limitations, to a broad range of
                workplace settings where exposure to SARS-CoV-2 may occur--are designed
                to protect employees from infection with SARS-CoV-2 and from the dire,
                sometimes fatal, consequences of such infection.
                ---------------------------------------------------------------------------
                 \3\ OSHA is defining the grave danger as workplace exposure to
                SARS-CoV-2, the virus that causes the development of COVID-19.
                COVID-19 is the disease that can occur in people exposed to SARS-
                CoV-2, and that leads to the health effects described in this
                section. This distinction applies despite OSHA's use of the terms
                SARS-CoV-2 and COVID-19 interchangeably in some parts of this
                preamble.
                 \4\ OSHA refers to the grave danger from occupational exposure
                to SARS-CoV-2 throughout this document. Those references are
                intended to encompass exposure to SARS-CoV-2 and all variants of
                SARS-CoV-2, including the Delta variant.
                ---------------------------------------------------------------------------
                 The fact that COVID-19 is not a uniquely work-related hazard does
                not change the determination that it is a grave danger to which
                employees are exposed, nor does it excuse employers from their duty to
                protect employees from the occupational transmission of SARS-CoV-2. The
                OSH Act is intended to ``assure so far as possible every working man
                and woman in the Nation safe and healthful working conditions'' (29
                U.S.C. 651(b)), and there is nothing in the Act to suggest that its
                protections do not extend to hazards which might occur outside of the
                workplace as well as within. Indeed, COVID-19 is not the first hazard
                that OSHA has regulated that occurs both inside and outside the
                workplace. For example, the hazard of noise is not unique to the
                workplace, but the Fourth Circuit has upheld OSHA's Occupational Noise
                Exposure standard (29 CFR 1910.95) (Forging Industry Ass'n v. Sec' of
                Labor, 773 F.2d 1437, 1444 (4th Cir. 1985)). Diseases caused by
                bloodborne pathogens, including HIV/AIDS and hepatitis B, are also not
                unique to the workplace, but the Seventh Circuit upheld the majority of
                OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) (Am. Dental
                Ass'n v. Martin, 984 F.2d 823 (7th Cir. 1993)). OSHA's Sanitation
                [[Page 61408]]
                standard, 29 CFR 1910.141, which requires measures such as cleaning,
                waste disposal, potable water, toilets, and washing facilities,
                addresses hazards that exist everywhere--both within and outside of
                workplaces. Moreover, employees have more freedom to control their
                environment outside of work, and to make decisions about their behavior
                and their contact with others to better minimize their risk of
                exposure. However, during the workday, while under the control of their
                employer, workers may have little ability to limit contact with
                coworkers, clients, members of the public, patients, and others, any
                one of whom could represent a source of exposure to SARS-CoV-2. OSHA
                has a mandate to protect employees from hazards they are exposed to at
                work, even if they may be exposed to similar hazards outside of work.
                 As described above in Pertinent Legal Authority (Section II. of
                this preamble), ``grave danger'' indicates a risk that is more than
                ``significant'' (Int'l Union, United Auto., Aerospace, & Agr. Implement
                Workers of Am., UAW v. Donovan, 590 F. Supp. 747, 755-56 (D.D.C. 1984);
                Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 640
                n.45, 655 (1980) (stating that a rate of 1 worker in 1,000 workers
                suffering a given health effect constitutes a ``significant'' risk)).
                ``Grave danger,'' according to one court, refers to ``the danger of
                incurable, permanent, or fatal consequences to workers, as opposed to
                easily curable and fleeting effects on their health'' (Fla. Peach
                Growers Ass'n, Inc. v. U.S. Dep't of Labor, 489 F.2d 120, 132 (5th Cir.
                1974)). Fleeting effects were described as nausea, excessive
                salivation, perspiration, or blurred vision and were considered so
                minor that they often went unreported; these effects are in stark
                contrast with the adverse health effects of COVID-19 infections, which
                are formally referenced as ranging from ``mild'' to ``critical,'' \5\
                but which can involve significant illness, hospital stays, ICU care,
                death, and long-term health complications for survivors. Beyond this,
                however, ``the determination of what constitutes a risk worthy of
                Agency action is a policy consideration that belongs, in the first
                instance, to the Agency'' (Asbestos Info. Ass'n/N. Am. v. OSHA, 727
                F.2d 415, 425 (5th Cir. 1984)).
                ---------------------------------------------------------------------------
                 \5\ See the definitions for the different levels of severity of
                COVID-19 illness in the National Institutes of Health's COVID-19
                treatment guidelines (NIH, October 12, 2021).
                ---------------------------------------------------------------------------
                 In the context of ordinary 6(b) rulemaking, the Supreme Court has
                said that the OSH Act is not a ``mathematical straitjacket,'' nor does
                it require the agency to support its findings ``with anything
                approaching scientific certainty,'' particularly when operating on the
                ``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
                Am. Petroleum Inst., 448 U.S. 607, 655-56 (1980)). Courts reviewing
                OSHA's determination of grave danger do so with ``great deference''
                (Pub. Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156
                (D.C. Cir. 1983)). In one case, the Fifth Circuit, in reviewing an OSHA
                ETS for asbestos, declined to question the agency's finding that 80
                worker lives at risk nationwide over six months constituted a grave
                danger (Asbestos Info. Ass'n/N. Am., 727 F.2d at 424). OSHA estimates
                that this ETS would save over 6,500 worker lives and prevent over
                250,000 hospitalizations over the course of the next six months (OSHA,
                October 2021c). Here, the mortality and morbidity risk to employees
                from COVID-19 is so dire that the grave danger from exposures to SARS-
                CoV-2 is clear.
                 SARS-CoV-2 is both a physically harmful agent and a new hazard (see
                29 U.S.C. 655(c)(1)(A)). The majority of OSHA's previous ETSs addressed
                toxic substances that had been familiar to the agency for many years
                prior to issuance of the ETS. OSHA's Healthcare ETS, issued in response
                to COVID-19 earlier this year, is one notable exception. In most cases,
                OSHA's ETSs were issued in response to new information about substances
                that had been used in workplaces for decades (e.g., Vinyl Chloride (39
                FR 12342 (April 5, 1974)); Benzene (42 FR 22516 (May 3, 1977)); 1,2-
                Dibromo-3-chloropropane (42 FR 45536 (Sept. 9, 1977))). In some cases,
                the hazards of the toxic substance were already so well established
                that OSHA promulgated an ETS simply to update an existing standard
                (e.g., Vinyl cyanide (43 FR 2586 (Jan. 17, 1978))). The COVID-19
                Healthcare ETS, which was issued in June 2021, was the sole instance in
                which OSHA issued an ETS to address a grave danger from a substance
                that had only recently come into existence. Although that action by the
                agency was challenged, the case has not gone to briefing (see United
                Food & Commercial Workers Int'l Union, AFL-CIO, CLC and AFL-CIO v.
                OSHA, Dep't of Labor, D.C. Circuit No. 21-1143). Thus, no court has had
                occasion to examine OSHA's authority under section (6)(c) of the OSH
                Act (29 U.S.C. 655(c)) to address a grave danger from a ``new hazard.''
                Yet by any measure, SARS-CoV-2 is a new hazard. Unlike any of the
                hazards addressed in previous ETSs, there were no documented cases of
                SARS-CoV-2 infections in the United States until January 2020. Since
                then, more than 725,000 people have died in the U.S. alone (CDC,
                October 18, 2021--Cumulative US Deaths). The pandemic continues to
                affect workers and workplaces, with workplace exposures leading to
                further exposures among workers' families and communities. Clearly,
                SARS-CoV-2 is both a physically harmful agent and a new hazard that
                presents a grave danger to workers in the U.S.
                 Published on June 21, 2021, OSHA's Healthcare ETS (86 FR 32376) was
                written in response to the grave danger posed to healthcare workers in
                the United States who faced a heightened risk of infection from COVID-
                19. In the healthcare ETS, OSHA described its finding of grave danger
                for healthcare and healthcare support service workers (see 86 FR 32381-
                32412). OSHA now finds that all unvaccinated workers, with some
                exceptions, face a grave danger from the SARS-CoV-2 virus.\6\
                ---------------------------------------------------------------------------
                 \6\ When OSHA refers to ``unvaccinated'' individuals in its
                grave danger finding, it means all individuals who are not fully
                vaccinated against COVID-19, i.e., those who are completely
                unvaccinated and those who are partially vaccinated.
                ---------------------------------------------------------------------------
                II. Nature of the Disease
                 The health effects of symptomatic COVID-19 illness can range from
                mild disease consisting of fever or chills, cough, and shortness of
                breath to severe disease. Severe cases can involve respiratory failure,
                blood clots, long-term cardiovascular and neurological effects, and
                organ damage, which can lead to hospitalization, ICU admission, and
                death (see 86 FR 32383-32388; NINDS, September 2, 2021). Even in the
                short time since the Healthcare ETS's publication in June 2021, the
                risk posed by COVID-19 has changed meaningfully. Since OSHA considered
                the impact of COVID-19 when promulgating the Healthcare ETS, over
                135,000 additional Americans have died from COVID-19, and over 933,000
                have been hospitalized, (CDC, October 18, 2021--Cumulative US Deaths;
                CDC, May 28, 2021; CDC, October 18, 2021--Weekly Review). In August
                2021, COVID-19 was the third leading cause of death in the United
                States, trailing only heart disease and cancer (Ortaliza et al., August
                27, 2021). By September 20, 2021, COVID-19 had killed as many Americans
                as the 1918-1919 flu pandemic (Johnson, September 20, 2021).
                 While the Healthcare ETS addresses the risk of illness and death
                from
                [[Page 61409]]
                COVID-19 as the SARS-CoV-2 virus continues to change over time, it does
                not specifically address the increases in infectiousness and
                transmission, and the potentially more severe health effects, related
                to the Delta variant. The rapid rise to predominance of the Delta
                variant in the U.S. occurred shortly after the ETS was published. At
                this time, the widespread prevalence of the Delta variant and its
                increased transmissibility have resulted in increased risk of exposure
                and disease relative to the previously-dominant strains of the SARS-
                CoV-2 virus. Adding to the information covered in the Healthcare ETS,
                the following sections provide a brief review of SARS-CoV-2 and
                describe the characteristics of the Delta variant that are different
                from previous versions of SARS-CoV-2 and have changed the risks posed
                by COVID-19. The agency specifically references the material presented
                in the Healthcare ETS, which is still relevant to this analysis, to
                support OSHA's finding of grave danger. Taken together, the information
                available to OSHA demonstrates that SARS-CoV-2 poses a grave danger to
                unvaccinated workers across all industry sectors.
                a. Variants of SARS-CoV-2
                 Viral mutations have been a serious concern of scientists, public
                health experts, and policymakers from the beginning of the COVID-19
                pandemic. Viral mutations can affect how a virus interacts with a
                cell--altering the virus's transmissibility, infection severity, and
                sensitivity to vaccines. The U.S. government's SARS-CoV-2 Interagency
                Group has a variant classification scheme that defines four classes of
                SARS-CoV-2 variants: Variants Being Monitored (VBM), Variants of
                Interest (VOI), Variants of Concern (VOC), and Variants of High
                Consequence (VOHC). These variant designations are based on their
                ``proportions at the national and regional levels and the potential or
                known impact of the constellation of mutations on the effectiveness of
                medical countermeasures, severity of disease, and ability to spread
                from person to person'' (CDC, October 4, 2021), with VOIs considered
                less serious than VOCs and VOCs considered less serious than VOHCs. As
                of early October 2021, the CDC was monitoring 10 VBMs--Alpha (B.1.1.7,
                Q.1-Q.8), Beta (B.1.351, B.1.351.2, B.1.351.3), Gamma (P.1, P.1.1,
                P.1.2), Epsilon (B.1.427 and B.1.429), Eta (B.1.525), Iota (B.1.526),
                Kappa (B.1.617.1), B.1.617.3, Mu (B.1.621, B.1.621.1), and Zeta (P.2)--
                and one VOC--Delta (B.1.617.2 and AY.1 sublineages)--in the U.S. (CDC,
                October 4, 2021). CDC defines a VOC as ``[a] variant for which there is
                evidence of an increase in transmissibility, more severe disease (e.g.,
                increased hospitalizations or deaths), significant reduction in
                neutralization by antibodies generated during previous infection or
                vaccination, reduced effectiveness of treatments or vaccines, or
                diagnostic detection failures'' (CDC, October 4, 2021).
                 While the proportions of SARS-CoV-2 variants in the United States
                have shifted over time (CDC, May 24, 2021c; CDC, October 18, 2021--
                Variant Proportions, July through October 2021), the primary variant
                that drove COVID-19 transmission in the late Winter and Spring of 2021
                was the Alpha variant. The CDC noted that Alpha is associated with an
                increase in transmission, as well as potentially increased incidences
                of hospitalization and death, compared to the predominant variants
                before its emergence (CDC, October 4, 2021; Pascall et al., August 24,
                2021; Julin et al., September 22, 2021). As Alpha transmission subsided
                in the United States during the late Spring and early Summer of 2021,
                Delta emerged and quickly became the predominant variant in the U.S. by
                July 3, 2021 (CDC, October 18, 2021--Variant Proportions, July through
                October 2021). Delta now accounts for more than 99% of circulating
                virus nationwide (CDC, October 18, 2021--Variant Proportions, July
                through October 2021).
                 FDA authorized and approved COVID-19 vaccines currently work well
                against all of these variants; however, there are differences in
                various variants' ability to spread and the likelihood of infection to
                cause severe illness. Data on the Beta and Gamma variants do not
                indicate that infections from these variants caused more severe illness
                or death than other VOCs. Data on the Alpha variant does indicate its
                ability to cause more severe illness and death in infected individuals.
                And some data on the Delta variant suggests that the Delta variant may
                cause more severe illness than previous variants, including Alpha, in
                unvaccinated individuals (CDC, October 4, 2021).
                 The emergence of the Delta variant, along with other VOCs, has
                resulted in a more deadly pandemic (Fisman and Tuite, July 12, 2021).
                While the Delta variant is the most transmissible SARS-CoV-2 variant to
                date, the possibility remains for the rise of future VOCs, and even
                more dangerous VOHCs, as the virus continues to spread and mutate.
                Inadequate vaccination rates and the abundance of transmission create
                an environment that can foster the development of new variants that
                could be similarly, or even more, disruptive (Liu and Rocklov, August,
                4, 2021). In this context, it is critical that OSHA address the grave
                danger from COVID-19 that unvaccinated workers are currently facing by
                requiring vaccination and the other measures included in this rule, in
                order to significantly slow the transmission of COVID-19 in workers and
                workplaces and mitigate the rise of future variants.
                b. Transmission
                 SARS-CoV-2 is a highly transmissible virus, regardless of variant.
                Since the first case was detected in the U.S., there have been close to
                45 million reported cases of COVID-19, affecting every state and
                territory, with thousands more infected each day (CDC, October 18,
                2021--Cumulative US Cases), and some indication that these numbers
                continue to underestimate the full burden of disease (CDC, July 27,
                2021). According to the CDC, the primary way the SARS-CoV-2 virus
                spreads from an infected person to others is through the respiratory
                droplets that are produced when an infected person coughs, sneezes,
                sings, talks, or breathes (CDC, May 7, 2021). Infection could then
                occur when another person breathes in the virus. Most commonly this
                occurs when people are in close contact with one another in indoor
                spaces (within approximately six feet for at least fifteen minutes)
                (CDC, August 13, 2021). Additionally, airborne transmission may occur
                in indoor spaces without adequate ventilation where small respiratory
                particles are able to remain suspended in the air and accumulate (CDC,
                May 7, 2021; Fennelly, July 24, 2020). While scientists' understanding
                of the Delta variant's virology is evolving and remains at the frontier
                of science, current data shows that the routes of transmission remain
                the same for all currently-identified SARS-CoV-2 variants. In addition,
                all variants can be transmitted by people who are pre-symptomatic
                (i.e., people who are infected but do not yet feel sick) or
                asymptomatic (i.e., people who are infected but never feel any symptoms
                of COVID-19), as well as those who are symptomatic. Pre-symptomatic and
                asymptomatic transmission continue to pose serious challenges to
                containing the spread of COVID-19. For more extensive information on
                transmission routes, as well as pre-symptomatic and asymptomatic
                transmission, see the preamble to the Healthcare ETS (86 FR
                [[Page 61410]]
                32392-32396), which is hereby included in the record of this ETS.\7\
                ---------------------------------------------------------------------------
                 \7\ This adoption includes the citations in the referenced
                section of the Healthcare ETS, which are also included in the docket
                for this ETS.
                ---------------------------------------------------------------------------
                 The Delta variant is transmitted from infectious individuals via
                the same routes as previous variants, but is much more transmissible.
                Specifically, Delta differs from previous dominant variants of SARS-
                CoV-2 in terms of the amplification of viral particles expelled from
                infected individuals. Testing of Delta-infected individuals indicates
                that their viral loads are--on average--approximately 1,000x greater
                than those of the SARS-CoV-2 variants from the first COVID-19 wave in
                early 2020. This finding suggests much faster replication of viral
                particles during early infection with the Delta variant, resulting in
                greater infectiousness (contagiousness) when compared to earlier
                versions of SARS-CoV-2 (Li et al., July 12, 2021).
                 The transmissibility of viruses is measured in part by the average
                number of subsequently-infected people (or secondary cases) that are
                expected to occur from each existing case (often referred to as
                R0). Several comparisons of the transmissibility of the
                initial SARS-CoV-2 variants to the Delta variant have shown that Delta
                is approximately twice as transmissible (contagious) as previous
                versions of SARS-CoV-2 (CDC, August 26, 2021; Riou and Althaus, January
                30, 2020; Li et al., July 12, 2021; Liu and Rocklov, August, 4, 2021),
                likely the result of higher initial viral loads during the pre-
                symptomatic phase (Li et al., July 12, 2021). In addition, as described
                further below, data on Delta shows that both unvaccinated and
                vaccinated individuals are more likely to transmit Delta than previous
                variants (Liu and Rocklov, August, 4, 2021; Eyre et al., September 29,
                2021), making it especially dangerous to those who remain unvaccinated.
                c. Health Effects
                 COVID-19 infections can lead to death. As reported in the
                Healthcare ETS, by May 24, 2021, there had been 587,432 deaths and
                32,947,548 million infections in the U.S. alone (CDC, May 24, 2021a;
                CDC, May 24, 2021b). At that point in the pandemic, 1.8 out of every
                1,000 people in the U.S. had died from COVID-19 (CDC, May 24, 2021a).
                Since then, reported cases have increased to 44,857,861 and the number
                of deaths has increased to 723,205 (CDC, October 18, 2021- Cumulative
                US Cases; Cumulative US Deaths). By September 2021, an astounding 1 in
                500 Americans had died from COVID-19 (Keating, September 15, 2021).
                Updated mortality data \8\ currently indicate that people of working
                age (18-64 years old) now have a 1 in 202 chance of dying when they
                contract the disease, with the risk much higher (1 in 72) for those
                aged 50-64 (CDC, October 18, 2021--Demographic Trends, Cases by Age
                Group; CDC, October 18, 2021--Demographic Trends, Deaths by Age Group).
                For a more in-depth description of the health effects resulting from
                SARS-CoV-2 infection, see the preamble to the Healthcare ETS (86 FR
                32383-32392), which is hereby included in the record of this ETS.\9\
                ---------------------------------------------------------------------------
                 \8\ Risk of death is based on averages from reported CDC data.
                Risks of hospitalization and death are much higher in unvaccinated
                individuals, as discussed further in Grave Danger, Section III.A.IV.
                Vaccines Effectively Reduce Severe Health Outcomes from and
                Transmission of SARS-CoV-2.
                 \9\ This adoption includes the citations in the referenced
                section of the Healthcare ETS, which are also included in the docket
                for this ETS.
                ---------------------------------------------------------------------------
                 Apart from fatal cases, COVID-19 can cause serious illness,
                including long-lasting effects on health. Many patients who become ill
                with COVID-19 require hospitalization. Indeed, updated CDC
                hospitalization and mortality data indicate that working age Americans
                (18-64 years old) now have a 1 in 14 chance of hospitalization when
                infected with COVID-19 (CDC, October 18, 2021--Demographic Trends,
                Cases by Age; Total Hospitalizations, by Age). Those who are
                hospitalized frequently need supplemental oxygen and treatment for the
                disease's most common complications, which include pneumonia,
                respiratory failure, acute respiratory distress syndrome (ARDS), acute
                kidney injury, sepsis, myocardial injury, arrhythmias, and blood clots.
                One study, which included 35,502 inpatients nationwide, determined that
                the median length of hospital stay was 6 days, unless the cases
                required ICU treatment. For those cases, ICU stays were on median 5
                days in addition to the time spent hospitalized outside of the ICU
                (Rosenthal et al., December 10, 2020). Another study that assessed
                hospital length of stay for COVID-19 patients in England estimated that
                a non-ICU hospital stay averaged between 8 and 9 days, but those
                estimates ranged from approximately 12 to 18 days when patients were
                admitted to the ICU (Vekaria et al., July 22, 2021). Moreover, given
                that SARS-CoV-2 is still a novel virus, the severity of long-term
                health effects--such as ``post-COVID conditions''--are not yet fully
                understood.
                 Many members of the workforce are at increased risk of death and
                severe disease from COVID-19 because of their age or pre-existing
                health conditions. The comorbidities that further exacerbate COVID-19
                infections are common among adults of working age in the U.S. For
                instance, 46.1% of individuals with cancer are in the 20-64 year old
                age range (NCI, April 29, 2015), and over 40% of working age adults are
                obese (Hales et al., February 2020). Disease severity is also likely
                exacerbated by long-standing healthcare inequities experienced by
                members of many racial and economic demographics (CDC, April 19, 2021).
                 Recent data suggests that Delta variant infections may result in
                even more severe illness and a higher frequency of death than previous
                COVID-19 variants due to Delta's increased transmissibility, virulence,
                and immune escape (Fisman and Tuite, July 12, 2021). Symptomatic Delta
                variant infections do occur in fully vaccinated people (Mlcochova et
                al., June 22, 2021; Musser et al., July 22, 2021); however, as reported
                by the CDC (CDC, August 26, 2021), the vast majority of the continuing
                instances of severe and fatal COVID-19 infections are occurring in
                unvaccinated persons (discussed further in Grave Danger, Section
                III.A.IV. Vaccines Effectively Reduce Severe Outcomes from and
                Transmission of SARS-CoV-2). An assessment of Delta-related hospital
                admissions in Scotland found that hospitalizations were approximately
                doubled in patients with the Delta variant when compared to the Alpha
                variant (Sheikh et al., June 4, 2021). A similar study conducted using
                a retrospective cohort in Ontario, Canada compared the virulence of
                novel SARS-CoV-2 variants and found that the incidences of
                hospitalization, ICU admission, and death were more pronounced with the
                Delta variant than any other SARS-CoV-2 variant (Fisman and Tuite, July
                12, 2021). A large national cohort study that included all Alpha and
                Delta SARS-CoV-2 patients in England between March 29 and May 23, 2021
                found a ``higher hospital admission or emergency care attendance risk
                for patients with COVID-19 infected with the Delta variant compared
                with the Alpha variant,'' suggesting that Delta outbreaks--especially
                amongst unvaccinated populations--may lead to more severe health
                consequences and an equivalent or greater burden on healthcare services
                than the Alpha variant (Twohig et al., August 27, 2021). However, one
                more recent study examining data from several U.S. states demonstrated
                a significant increase in hospitalization from the pre-Delta to the
                Delta period, which may be related to increased transmissibility of
                Delta rather than
                [[Page 61411]]
                more severe health outcomes (Taylor et al., October 22, 2021).
                III. Impact on the Workplace
                 SARS-CoV-2 is readily transmissible in workplaces because they are
                areas where multiple people come into contact with one another, often
                for extended periods of time. When employees report to their workplace,
                they may regularly come into contact with co-workers, the public,
                delivery people, patients, and any other people who enter the
                workplace. Workplace factors that exacerbate the risk of transmission
                of SARS-CoV-2 include working in indoor settings, working in poorly-
                ventilated areas, and spending hours in close proximity with others.
                Full-time employees typically spend 8 hours or more at work each shift,
                more time than they spend anywhere else but where they live. Employees
                work in proximity to others in workplaces that were not originally
                designed to keep people six feet away from other people and that may
                make it difficult for employees to perform work tasks while maintaining
                a six-foot distance from others. Even in the cases where workers can do
                most of their work from, for example, a private office within a
                workplace, they share common areas like hallways, restrooms, lunch
                rooms and meeting rooms. Furthermore, many work areas are poorly
                ventilated (Allen and Ibrahim, May 25, 2021; Lewis, March 30, 2021). An
                additional factor that exacerbates the risk of transmission of SARS-
                CoV-2 is interacting with or caring for people with suspected or
                confirmed COVID-19; this was a primary driver of OSHA's determination
                of grave danger for healthcare workers in the Healthcare ETS (see 86 FR
                32381-32383). In recent weeks, the majority of states in the U.S. have
                experienced what CDC defines as ``high or substantial community
                transmission,'' indicating that there is a clear risk of the virus
                being introduced into and circulating in workplaces (CDC, October 18,
                2021--Community Transmission Rates).
                 Although COVID-19 is not exclusively an occupational disease, it is
                evident from research accrued since the beginning of the pandemic that
                SARS-CoV-2 transmission can and does occur in workplaces, affecting
                employees and their lives, health, and livelihoods. This continues to
                be true for the Delta variant, with its increased transmissibility and
                potentially more severe health effects. This section describes some of
                the clusters, outbreaks, and other occurrences of workplace COVID-19
                cases that government agencies, researchers, and journalists have
                described, and the widespread effects of SARS-CoV-2 in industry sectors
                across the national economy. While the focus is on more recent data
                reflecting the impact of the Delta variant, evidence of workplace
                transmission that occurred prior to the emergence of the Delta variant
                is also presented.
                 The workplace-based clusters described below provide evidence that
                workplaces in a wide range of industries have been affected by COVID-
                19, that many employees face exposure to infected people in their
                workspaces, and that SARS-CoV-2 transmission is occurring in the
                workplace, including during the recent period where the Delta variant
                has predominated. Although the presence of a cluster on its own does
                not necessarily establish that the cluster is work-related (i.e., a
                result of transmission at the worksite), many state investigation
                reports and published studies provide evidence that transmission is
                work related by documenting that infections at a workplace occurred
                within 14-days (the incubation period for the virus) of each other and
                ruling out the possibility that transmission occurred outside the
                workplace. In addition, the information below demonstrates that
                exposures to SARS-CoV-2 happen regularly in a wide variety of different
                types of workplaces.
                 The basis for OSHA's grave danger finding is that employees can be
                exposed to the virus in almost any work setting; that exposure to SARS-
                CoV-2 can lead to infection (CDC, September 21, 2021); and that
                infection in turn can cause death or serious impairment of health,
                especially in those who are unvaccinated (see Section III.A.IV.
                Vaccines Effectively Reduce Severe Health Outcomes from and
                Transmission of SARS-CoV-2). The information described in this section
                supports OSHA's finding that employees who work in spaces shared by
                others are at risk of exposure to SARS-CoV-2. The degree of risk from
                droplet-based transmission may vary based on the duration of close
                proximity to a person infected with SARS-CoV-2, including the Delta
                variant, but the simple and brief act of sneezing, coughing, talking,
                or even breathing can significantly increase the risk of transmission
                if controls are not in place. SARS-CoV-2, including the Delta variant,
                might also be spread through airborne particles under certain
                conditions, particularly in enclosed settings with inadequate
                ventilation, which are common characteristics of some workplaces.
                 The peer-reviewed scientific journal articles, government reports,
                and news articles described below establish the widespread prevalence
                of COVID-19 among employees, beginning with a description of the recent
                impact from the Delta variant. OSHA's findings are based primarily on
                the evidence from peer-reviewed scientific journal articles and
                government reports. However, peer review for scientific journal
                articles and the assembly of information for government reports and
                other official sources of information take time, and therefore those
                sources do not always reflect the most up-to-date information (Chan et
                al., December 14, 2010). In addition, while state and local health
                departments can report workplace outbreaks to CDC, the agency does not
                provide summary statistics by workplace so that those outbreaks can be
                tracked on a national level. In the context of the COVID-19 pandemic,
                given the recent impacts due to the Delta variant and the emergence of
                new information on a daily basis, it is critical for OSHA to rely on
                the most up-to-date information available. Therefore, OSHA has
                occasionally supplemented peer-reviewed data and government reports
                with additional information on occupational outbreaks contained in
                other sources of media (e.g., newspapers, digital media, and
                information submitted to or obtained by private organizations).\10\ The
                reported information from other sources can provide further evidence of
                the impact of an emerging and changing disease, especially for
                industries that are not well represented in the peer-reviewed
                scientific literature. Together, these sources of information represent
                the best available evidence of the impact on employees of the pandemic
                thus far.
                ---------------------------------------------------------------------------
                 \10\ OSHA did not make findings based solely on non-peer-
                reviewed sources such as news articles, but the agency found that
                those sources can sometimes provide useful information when
                considered with more robust sources.
                ---------------------------------------------------------------------------
                 The information described herein illustrates a significant number
                of infections among employees in a variety of industries, with
                virtually every state continuing to experience what CDC defines as high
                or substantial community transmission related to the recent surge of
                the Delta variant. The industries and types of workplaces described are
                not the only ones in which a grave danger exists. The science of
                transmission does not vary by industry or by type of workplace. OSHA
                therefore expects transmission to occur in diverse workplaces all
                across the country (see Dry Color Mfrs. Ass'n, Inc. v. Dep't of Labor,
                486 F.2d 98, 102 n.3 (3d Cir. 1973) (holding that when OSHA determines
                a substance poses a grave
                [[Page 61412]]
                danger to workers, OSHA can assume an exposure to a grave danger exists
                wherever that substance is present in a workplace)). In addition, the
                severity of COVID-19 does not depend on where an employee is infected;
                an employee exposed to SARS-CoV-2 might die whether exposed while
                working at a meat packing facility, a retail establishment, or an
                office (see Grave Danger, Section III.A.V.b. Employees Who Work
                Exclusively Outside, below, for a discussion of the risk of exposure in
                outdoor workplaces).
                a. General Impact on Workers
                 Data on SARS-CoV-2 infections, illnesses, and deaths among
                employees in general industry, agriculture, construction, and maritime
                support OSHA's finding that COVID-19 poses a grave danger to employees
                in these sectors across the U.S. economy. This section summarizes
                studies and reports of COVID-19 illness and fatalities in a wide range
                of workplaces across those industry sectors. Not all workplace settings
                are discussed; nor is the data available to do so. However, the
                characteristics of the various affected workplaces--such as indoor work
                settings; contact with coworkers, clients, or members of the public;
                and sharing space with others for prolonged periods of time--indicate
                that exposures to SARS-CoV-2 are occurring in a wide variety of work
                settings across all industries. Therefore, most employees who work in
                the presence of other people (e.g., co-workers, customers, visitors)
                need to be protected.
                 While there is no comprehensive source of nationwide workplace
                infection data, reports from states and communities on outbreaks
                related to workplaces provide key, up-to-date data that illustrate the
                likelihood of employee exposure to SARS-CoV-2 at workplaces throughout
                the U.S. OSHA identified a number of recent reports from various
                regions of the country that together demonstrate the impact that SARS-
                CoV-2 can have on a variety of workplaces, including in service
                industries (e.g., restaurants, grocery and other retail stores, fitness
                centers, hospitality, casinos, salons), corrections, warehousing,
                childcare, schools, offices, homeless shelters, transportation, mail/
                shipping/delivery services, cleaning services, emergency services/
                response, waste management, construction, agriculture, food packaging/
                processing, and healthcare. Deaths are reported in many studies
                performed prior to the emergence of the Delta variant but, because the
                Delta outbreak is so recent and deaths can occur weeks after infection,
                the number of deaths from recent infections might be underestimated.
                Some of the reports include cumulative data representing various phases
                of the pandemic, beginning prior to the availability of vaccines and
                continuing through the recent surge of the Delta variant. In addition,
                some studies report investigations of recent outbreaks, which provide
                insight on the impact of the Delta variant as well as impacts
                associated with the current vaccination status of workers.
                 The Washington State Department of Health (WSDH) reports outbreaks
                occurring in non-healthcare workplaces (WSDH, September 8, 2021). In
                non-healthcare workplaces, outbreaks are defined as two or more
                laboratory confirmed cases of COVID-19, with at least two cases
                reporting symptom onset within 14 days of each other, and plausible
                epidemiological evidence of transmission in a shared location other
                than a household. As of September 4, 2021, WSDH reported 5,247
                outbreaks in approximately 40 different types of non-healthcare work
                settings. During the week of August 29 through September 4, 2021, WSDH
                identified 137 separate workplace outbreaks. The types of non-medical
                workplace settings that represented more than 5% of the total outbreaks
                during that week included food service/restaurants, childcare, schools,
                retail, grocery, and shelter/homeless services. Other types of non-
                healthcare settings where outbreaks occurred recently included non-food
                and food manufacturing, construction, professional services/office
                based, agriculture/produce packing, transportation/shipping delivery,
                government agencies/facilities, leisure hospitality/recreation,
                corrections, utilities, warehousing, facility/domestic cleaning
                services, youth sports/activities, camps, and public safety. Over the
                course of the pandemic, outbreaks have also been observed at bars/
                nightclubs, hotels, and fishing/commercial seafood vessels.
                 The Oregon Health Authority (OHA) publishes a weekly report
                detailing outbreaks directly related to work settings. OHA
                epidemiologists consider cases to be part of a workplace outbreak when
                clusters form with respect to space and time, within a plausible
                incubation period for the virus, and their investigation does not
                uncover an alternative source for the outbreak. For privacy reasons,
                OHA only reports outbreaks with 5 or more cases in workplaces with 30
                or more people. OHA reported a total of 26,013 cases and 135 deaths
                related to workplace outbreaks as of September 1, 2021. As of September
                1, 2021, OHA was investigating more than 124 active workplace outbreaks
                (OHA, September 1, 2021). Those outbreaks occurred in a wide variety of
                industries including correctional facilities, emergency services, waste
                management, schools and child care, retail and grocery stores,
                restaurants, warehousing, agriculture, food processing/packaging,
                construction, healthcare, mail and delivery services, office locations,
                utilities, transportation, and others.
                 Tennessee Department of Health was investigating 557 active COVID-
                19 clusters as of September 8, 2021 (TDH, September 8, 2021). Clusters
                are defined as two or more laboratory confirmed COVID-19 cases linked
                to the same location or event that is not a household exposure. The
                clusters occurred in 13 types of settings, 10 of which were workplace
                settings. Outbreaks at workplaces represented more than half of the
                total active outbreaks in the state at that time. Settings comprising
                more than 5% of total clusters included assisted care living
                facilities, nursing homes, and correctional facilities. Other types of
                workplaces where outbreaks occurred included bars, construction, farms,
                homeless shelters, and industrial settings.
                 The North Carolina Department of Health and Human Services reports
                cumulative numbers of clusters, cases, and deaths for workers in
                poultry processing facilities (beginning in April of 2020) and other
                types of workplaces (beginning in May of 2020) (NCDHHS, August 30,
                2021). Clusters are defined as a minimum of 5 cases with illness onset
                or initial positive results within a 14-day period and plausible
                epidemiological linkage between the cases. Plausible epidemiological
                linkage means that multiple cases were in the same general setting
                during the same time period (e.g., same shift, same physical area) and
                that a more likely source of exposure is not identified (e.g.,
                household contact or close contact to a confirmed case in another
                setting). During that time period of April/May 2020 through August 30,
                2021, workplaces \11\ were associated with nearly 80% of the 1,969
                clusters and 27,097 cases observed and nearly 40% of the 167 deaths
                related to the clusters. Cumulative numbers of cluster-associated
                deaths were highest in meat and poultry processing (25 of 5,351 cases),
                followed by healthcare (10 of 1,036 cases), government services and
                manufacturing (5 of 1,048 cases and 5 of
                [[Page 61413]]
                1,856 cases, respectively), and restaurants and childcare (3 of 421
                cases and 3 of 1,943 cases, respectively). Recently, in July of 2021,
                the number of cases associated with workplace clusters began increasing
                in several different types of work settings, including meat processing,
                manufacturing, retail, restaurants, childcare, schools, and higher
                education.
                ---------------------------------------------------------------------------
                 \11\ NCDHHS identifies a ``workplace'' category in their report
                (e.g., agriculture, construction), but OSHA includes other settings
                where employees would be present (e.g., retail, restaurants,
                childcare, healthcare).
                ---------------------------------------------------------------------------
                 Colorado Department of Public Health & Environment/Colorado State
                Emergency Operations Center (CDPHE/CSEOC, September 8, 2021) reported
                5,584 resolved workplace-related outbreaks involving 40,156 employee
                cases and 79 employee deaths since May of 2020. The agency's current
                investigations, as of September 8, 2021 included 291 active outbreaks
                (not defined), with 2,865 staff cases (assumed to be cases in
                employees). The majority of active outbreaks were reported in
                childcare, schools, healthcare, and corrections. Active outbreaks were
                also reported in construction, retail, homeless shelters, casinos,
                restaurants, hotels, offices, law enforcement, manufacturing, delivery
                services, and warehouses. Other types of work settings that were
                affected in resolved outbreaks included warehouses, bars, government
                locations, waste management, utilities, salons, emergency services,
                meat processing/packaging, and postal services. From June 21, 2021 (the
                date the healthcare ETS was published) through September 8, 2021, 1,469
                staff cases associated with outbreaks were reported, for an average of
                approximately 19 cases per day.
                 Similar reporting is available from Louisiana's Department of
                Health (LDH, August 24, 2021), with 1,347 outbreaks and 9,130 cases
                reported as of August 24, 2021. LDH defines an outbreak as 2 or more
                cases among unrelated individuals who visited a site within a 14-day
                period. More than three quarters of outbreaks through that date were
                associated with workplaces. Workplace settings in Louisiana that
                experienced more than 5% of outbreaks included day care facilities,
                bars, restaurants, retail settings, industrial settings, and office
                spaces. Other types of workplace settings or industries where outbreaks
                occurred included casinos, gyms/fitness centers, banks, automotive
                services, construction, and ships/boats.
                 In addition to the state data above, some published studies and
                government reports provide information on recent workplaces outbreaks.
                For example, 47 people, including 3 of 11 staff members, 23 gymnasts,
                and 21 household contacts, contracted COVID-19 from an outbreak linked
                to an Oklahoma gymnastics facility during April 15 through May 3, 2021
                (Dougherty et al., July 16, 2021). All 21 of the virus samples
                sequenced were determined to be the Delta variant. The majority of the
                infected individuals (85%) were unvaccinated. Infections were reported
                in 16 adults aged 20 years or older; two adults were hospitalized and
                one required intensive care.
                 The state of Hawaii defines clusters as three or more confirmed or
                probable cases linked to a site or event within 14 days, with no
                outside exposure of cases to each other (Hawaii State, August 19,
                2021). The state reported a COVID-19 cluster in July associated with a
                concert at a bar that affected 16 people, including employees, band
                members, and concert attendees; infections also spread to 7 household
                members. Band members had performed while sick. Four of the initial 16
                people and none of the household members who tested positive for COVID-
                19 were fully vaccinated. The concert cluster was linked to clusters at
                another workplace and another concert. The report lists additional
                clusters investigated in the two weeks prior to the report; those
                clusters were observed in workplace locations such as correctional
                facilities, bars and nightclubs, restaurants, construction/industrial
                sites, travel/lodging/tourism, schools, food suppliers, and gyms.
                 Additional evidence that employees are at risk of exposure to SARS-
                CoV-2 in the workplace is available from published, peer-reviewed
                studies that were conducted before the Delta variant emerged. Those
                studies demonstrate that employees have been at risk of infection,
                illness, and death throughout the COVID-19 pandemic. Because the Delta
                variant is more transmissible and likely causes more severe disease
                than previous variants, there is even greater potential for
                unvaccinated employees to become seriously ill or die as a result of
                exposure to the Delta variant.
                 Contreras et al. (July, 2021) examined workplace outbreaks
                (excluding healthcare settings, homelessness services, and emergency
                medical services) in Los Angeles county from March 19 through September
                30, 2020. Workplace outbreaks were defined as 5 or more suspected or
                laboratory confirmed COVID-19 cases (prior to May 29) or 3 or more
                laboratory confirmed cases (after May 29) occurring within 14 days.
                Nearly 60% of the 698 identified outbreaks occurred in three sectors--
                manufacturing (184, 26.4%), retail trade (137, 19.6%), and
                transportation and warehousing (73, 10.5%). Also notable were the 71
                outbreaks in the accommodation and food services industry, which
                represented 10.2% of the outbreaks. The study authors concluded that
                outbreaks were larger and lasted longer at facilities with more onsite
                staff.
                 Outbreaks in Wisconsin from March 4 through November 16, 2020 were
                also examined (Pray et al., January 29, 2021). Non-household outbreaks
                were defined as two or more confirmed COVID-19 cases that occurred
                within 14 days in persons who attended the same facility or event and
                did not share a household. During the period from March 4 through
                November 16, 2020, the largest percentages of cases were associated
                with outbreaks in long-term care facilities (26.8% of cases),
                correctional facilities (14.9% of cases), and colleges or universities
                (15% of cases). Also notable were the substantial number of cases
                associated with outbreaks in food production or manufacturing
                facilities (including meat processing and warehousing; 14.5% of cases)
                and schools and childcare facilities (10.6% of cases).
                 Bui et al. (August 17, 2020) analyzed data from the Utah Department
                of Health's COVID-19 case surveillance system, which included data on
                workplace outbreaks. Outbreaks were defined as two or more laboratory
                confirmed cases occurring within a 14 day period among coworkers in a
                common workplace (e.g., same facility). During the time period between
                March 6 and June 5, 2020, 277 COVID-19 outbreaks were reported, of
                which 210 (76%) occurred in workplaces. The 210 workplace outbreaks
                occurred in 15 of 20 industry sectors, and the industry sectors of
                manufacturing (43 outbreaks, 20%), construction (32 outbreaks, 15%),
                and wholesale trade (29 outbreaks, 14%) together represented nearly
                half of workplace outbreaks. Other sectors that represented more than
                10% of total outbreaks were retail trade (28 outbreaks, 13%) and
                accommodation and food services (25 outbreaks, 12%). Incidence rates of
                COVID-19 over the period of March 6 through June 5, 2020 were 339/
                100,000 workers in manufacturing, 122/100,000 workers in construction,
                377/100,000 workers in wholesale trade, 68/100,000 workers for retail
                trade, and 78/100,000 workers for accommodation and food services. For
                COVID-19 cases associated with workplace outbreaks in which
                hospitalization and severity status were known (1,382 and 1,155,
                respectively), the number in all sectors who were admitted to the
                hospital was 85 (6%) and the number with severe outcomes (intensive
                care unit admission, mechanical ventilation, or death) was 40 (3%).
                [[Page 61414]]
                 The impact of SARS-CoV-2 exposures on employee infection, illness,
                and death has also been demonstrated in studies focusing on specific
                types of industries, such as those where employees have frequent
                contact with each other and the public (e.g., grocery stores, bars,
                fitness facilities, schools, and law enforcement/corrections). For
                example, a study by Lan et al. (September 26, 2020) demonstrates the
                risk of infection in service industries. The cross-sectional study
                examined the risks of SARS-CoV-2 exposure and infection for employees
                in a Boston, Massachusetts-area retail grocery store market. The study
                tested 104 grocery store employees, of whom 20% (21 employees) were
                positive for COVID-19; 76% of confirmed cases did not have symptoms.
                After adjusting for gender, smoking, age, and the prevalence of COVID-
                19 in the employees' residential communities, employees who had direct
                customer exposure (e.g., cashiers, sales associates, cart attendants)
                were 5.1 times more likely to have a positive test for COVID-19 than
                employees without direct face-to-face customer exposure (e.g.,
                stockers, backroom, receiving and maintenance). The infection rate of
                20% among all employees was significantly higher than the rate in the
                surrounding community.
                 In February of 2021, an event at an Illinois bar that accommodates
                approximately 100 people resulted in a COVID-19 outbreak that affected
                46 people, including 3 (10%) staff members, 26 (90%) patrons, and 17
                secondary cases (Sami et al., April 9, 2021). People at the event
                included an asymptomatic person diagnosed with COVID-19 on the previous
                day and 4 symptomatic people who were later diagnosed with COVID-19.
                The outbreak resulted in a school closure and the hospitalization of a
                resident at a long-term care facility.
                 In Minnesota, 47 COVID-19 outbreaks were detected at fitness
                facilities from August through November of 2020 (Suhs et al., July 23,
                2021). One outbreak at a fitness facility during October through
                November of 2020 resulted in 23 COVID-19 cases including 5 (22%)
                employees and 18 (78%) members. A genetic analysis of specimens from 3
                employees and 10 members identified 2 distinct genetic subclusters,
                indicating two distinct chains of transmission among members and
                employees.
                 School-related outbreaks were examined from December 1, 2020
                through January 22, 2021 in eight public elementary schools of a
                Georgia school district (Gold et al., February 26, 2021). A COVID-19
                case was determined to be school-related if (1) symptom onset or a
                positive test was consistent with the incubation period of the virus
                following contact with an index case or a school-associated case, (2)
                close contact occurred with the index case or school-associated case
                while that person was infected, and (3) no known contact occurred with
                an infected community or household contact in the two weeks prior to a
                positive test for COVID-19. The investigators identified nine clusters
                of three or more epidemiologically linked COVID-19 cases that involved
                13 educators and 32 students in six of the eight elementary schools.
                Approximately half of the school-associated cases involved two clusters
                that began with probable transmission between educators, followed by
                educator to student transmission. Eighteen of 69 household members
                tested received positive results.
                 A number of studies demonstrate the impact of COVID-19 in law
                enforcement and related fields such as corrections. For example, a
                study examining COVID-19 antibodies in employees from public service
                agencies in the New York City area from May through July of 2020, found
                that 22.5% of participants had COVID-19 antibodies (Sami et al., March,
                2021). The percentage of correctional officers found to have COVID-19
                antibodies (39.2%) was the highest observed among all the occupations.
                The percentages of police dispatchers, traffic officers, security
                guards, and dispatchers found to have COVID-19 antibodies (29.8 to
                37.3%) were among the highest levels observed in all the occupations.
                The study authors noted that those jobs involve frequent or close
                contact with the public or are done in places where employees work in
                close proximity to their coworkers.
                 Wallace et al. (May 15, 2020) evaluated data on COVID-19 cases and
                deaths among correctional facility employees and inmates from January
                21 to April 21, 2020. Data were reported to CDC by 37 (69%) of 54 state
                and territorial health department jurisdictions. Of these 37
                jurisdictions, 32 (86%) reported at least one COVID-19 case from a
                correctional facility. Of the 420 facilities with a case, 221 (53%)
                reported cases only among staff members. In total, 4,893 COVID-19 cases
                among incarcerated or detained persons and 2,778 cases among staff
                members were reported (total tested not provided). Among staff member
                cases, 79 hospitalizations (3%) and 15 deaths (1%) were reported. The
                study authors noted that ``correctional and detention facilities face
                challenges in controlling the spread of infectious diseases because of
                crowded, shared environments and potential introductions by staff
                members and new intakes.''
                 Ward et al. (June 2021) analyzed COVID-19 prevalence among
                prisoners and staff in 45 states from March 31, 2020 through November
                4, 2020. During that time period, COVID-19 cases in staff were 3 to 5
                times higher compared to the U.S. population. Average daily increases
                in cases were 42 per 100,000 prison employees, 61 per 100,000
                prisoners, and 13 per 100,000 U.S. residents. On November 4, 2020,
                COVID-19 prevalence for prison staff was 9,316 cases per 100,000
                employees, which was 3.2 times greater than prevalence in the U.S.
                population (2,900 cases per 100,000).
                 Kirbiyik et al. (November 6, 2020) analyzed movement through a
                network-informed approach to identify likely high points of
                transmission within the Cook County Jail in Chicago, IL. At that
                facility, over 900 COVID-19 cases were reported across 10 housing
                divisions in 13 buildings from March 1-April 30, 2020. Staff members
                were required to report symptoms of COVID-19 (probable cases) or
                receipt of a positive test result (confirmed cases). A total of 2,041
                staff members (77% of staff) were included in the network analysis
                because information was available about their shift and division
                assignments, and 198 (9.7%) of those staff members had COVID-19 during
                the two-month study period. Connections between staff members who had
                COVID-19 were higher than expected, suggesting likely transmission
                among staff members. Fewer connections than expected were observed
                among detained persons with SARS-CoV-2 infections, suggesting the
                effectiveness of medical isolation at reducing transmission.
                 The Officer Down Memorial Page, which tracks police officer
                fatalities determined to be occupationally related, reported that the
                majority of officer deaths for 2021 (157 of 269) were related to COVID-
                19 (ODMP, September 14, 2021). For the 269 officers who died, causes of
                death were not reported for each month, but the highest numbers of
                monthly deaths, 52 in January and 65 in August (compared to 16 to 34
                deaths on other reported months), were consistent with the winter surge
                of COVID-19 and, more recently, the surge caused by the Delta variant.
                 The risk of COVID-19 has also been examined in industries where
                employees have little contact with the public, such as construction,
                and food processing, and where most exposure to
                [[Page 61415]]
                SARS-CoV-2 likely comes from other workers. Pasco et al. (October 29,
                2020) examined the association between construction work during the
                COVID-19 pandemic and community transmission and construction worker
                hospitalization rates in Austin, Texas from March 13 to August 20,
                2020. A ``Stay Home-Work Safe'' order enacted on March 24, 2020,
                limited construction to only critical infrastructure and excluded
                commercial and residential work. One week later, the Texas governor
                lifted the restriction for essential workers and allowed all types of
                construction work to resume, while keeping the order in place for other
                workers. The authors found that resuming construction during the
                shelter-in-place order led to an increase in community transmission, an
                increase in hospitalizations among community members, and an increase
                in hospitalizations of construction workers. By mid-July, Austin Public
                Health identified at least 42 clusters (not defined) of COVID-19 cases
                in the construction industry; 515 individuals were hospitalized for
                COVID-19 illnesses acquired as part of these clusters, and 77 of those
                reported working in construction. The study found that construction
                workers had a nearly 5-fold increased risk of hospitalization in
                central Texas compared with workers in other occupations. The authors'
                model predicted that allowing unrestricted construction work would be
                associated with an increase in COVID-19 hospitalization rates from 0.38
                per 1,000 residents to 1.5 per 1,000 residents overall, and from 0.22
                per 1,000 construction workers to 9.3 per 1,000 construction workers
                for the construction industry specifically. The authors concluded that
                stringent workplace safety measures could significantly mitigate risks
                related to COVID-19 in the industry.
                 The meat packing and processing industries and related agricultural
                and food processing sectors have also been impacted by COVID-19.
                Waltenburg et al. (January, 2021) reported COVID-19 cases in employees
                from meat and poultry processing facilities in 31 states from March 1
                through May 31, 2020. As reported in Table 2 of that report, 28,364
                employees in those facilities were confirmed to have COVID-19 by
                laboratory testing and 132 died. Among the 20 states that reported
                total numbers of employees, 11.4% of the workers were diagnosed with
                COVID-19 (with a range of 3.1 to 27.7% of workers in individual
                states). For states that reported at least one COVID-19-related death,
                the percentages of employees who died in each state ranged from 0.1 to
                2.4% of those with COVID-19. The authors found a high burden of disease
                in persons employed at these facilities who were racial or ethnic
                minorities. Higher incidence in these populations might be due to the
                likelihood of these employees working in areas in the plant where
                transmission risk is higher. Steinberg et al. (August 7, 2020) reported
                that attack rates (i.e., the number of individuals who are infected in
                comparison to the total number at risk) among production employees in
                the Cut (30.2%), Conversion (30.1%), and Harvest (29.4%) departments of
                a meat processing plant (where spacing between employees is less than 6
                feet) were double that of salaried employees (14.8%) whose workstations
                had been modified to increase physical distancing from others.
                 Waltenburg et al. (January, 2021) also evaluated COVID-19 incidence
                in food manufacturing and agricultural settings (e.g., manufacturing or
                farming involving fruits, vegetables, dairy, baked goods, eggs,
                prepared foods), as reported in 30 states from March through May 2020.
                In food manufacturing and farming of fruits, vegetables, dairy, and
                other items, 742 workplaces were affected, including 8,978 infections
                and 55 fatalities. For states that reported total numbers of employees,
                the proportion of employees who developed COVID-19 in each state ranged
                from 2.0 to 43.5%. For states that reported at least one death, the
                percentages of deaths among cases ranged from 0.1 to 3.8%.
                 Porter et al. (April 30, 2021) reported that 13 COVID-19 outbreaks
                occurred at Alaska seafood processing facilities and vessels (both of
                which were described as high density workplaces) during the Summer and
                early Fall of 2020. The 13 outbreaks involved 539 COVID-19 cases, with
                2-168 cases per outbreak. Attack rates in facilities and offshore
                vessels ranged from less than 5% to 75%. Outbreaks were also reported
                in entry quarantine groups. Because of these outbreaks, it was
                determined that vaccination of these essential workers is important and
                requirements for COVID-19 prevention were updated to include smaller
                quarantine groups, serial testing, and testing before transfers from
                one facility or vessel to another.
                 Finally, two published studies analyzed death records to determine
                how mortality rates among individuals in various types of workplaces
                had changed during the pandemic. Chen et al. (June 4, 2021) analyzed
                records of deaths occurring on or after January 1, 2016 in California
                and found that mortality rates in working aged adults (18-65 years)
                increased 22% during the COVID-19 pandemic period of March through
                November 2020 compared to pre-pandemic periods. Relative to pre-
                pandemic periods, the groups of employees experiencing the highest,
                statistically significant increases in relative excess mortality were
                those in food/agriculture (39% increase), transportation/logistics (31%
                increase), facilities (23% increase), and manufacturing (24% increase).
                Other groups that also experienced excess, statistically significant
                mortality compared to pre-pandemic periods were health or emergency
                workers (17% increase), retail workers (21% increase), and government
                and community workers (17% increase). The study authors concluded that
                certain occupational sectors were impacted disproportionally by
                mortality during the pandemic and that essential work conducted in-
                person is a likely avenue of infection transmission.
                 Hawkins et al. (January 10, 2021) examined death certificates of
                individuals who died in Massachusetts between March 1 and July 31,
                2020. An age-adjusted mortality rate of 16.4 per 100,000 employees was
                determined from 555 death certificates that had useable occupation
                information. Employees in 11 occupational groups had particularly high
                mortality rates: healthcare support; transportation and material
                moving; food preparation and serving; building and grounds cleaning and
                maintenance; production, construction and extraction; installation/
                maintenance/repair; protective services; personal care services; arts/
                design/entertainment; sports/media; and community and social services.
                The study authors noted that occupational groups expected to have
                frequent contact with sick people, close contact with the public, and
                jobs that are not practical to do from home had particularly elevated
                mortality rates.
                b. Healthcare Workers
                 As explained in the Healthcare ETS, COVID-19 presents a grave
                danger to workers in all U.S. healthcare settings where people with
                COVID-19 are reasonably expected to be present (86 FR 32381).
                Healthcare settings covered by the Healthcare ETS primarily include
                settings where people with suspected or confirmed COVID-19 are treated,
                exacerbating the risk present in most workplaces. To control the higher
                level of risk in those settings, OSHA determined that a suite of
                workplace controls was necessary to protect all employees, whether they
                are vaccinated or unvaccinated. As explained further
                [[Page 61416]]
                below, OSHA now finds that unvaccinated healthcare workers in
                healthcare settings not covered by the Healthcare ETS are also at grave
                danger from exposure to SARS-CoV-2, just like unvaccinated workers in
                other industries. Data continue to be collected and reported for
                healthcare workers, and a small number of peer-reviewed studies
                demonstrate the potential impact of the Delta variant on healthcare
                workers.
                 CDC continues to provide updates for COVID-19 cases and deaths
                among healthcare personnel. However, information on healthcare
                personnel status continues to be reported for only a fraction (18.91%)
                of total reported cases, and death status was reported for only 82.16%
                of healthcare personnel cases as of October 18, 2021 (CDC, October 18,
                2021--Healthcare Personnel). Given incomplete reporting, the data from
                this source represent only a fraction of actual healthcare cases and
                deaths. Nevertheless, CDC reported 666,707 healthcare personnel cases
                among the 6,754,306 reported cases that included information on
                healthcare personnel status (9.9%) and 2,229 fatalities among the
                547,769 cases that included death status (0.4%) for healthcare
                employees as of October 18, 2021. This is a 26% increase in the number
                of cases and a 27% increase in the number of deaths since the May 24,
                2021 data reported in the ETS (CDC, October 18, 2021--Healthcare
                Personnel). The Delta variant is likely responsible for the majority of
                those deaths. No healthcare worker deaths were reported by CDC during
                the weeks of May 30 through June 13, 2021; however, as the Delta
                variant's prevalence rose after June 20, healthcare worker deaths began
                increasing; they peaked during the period of August 15 through
                September 12, 2021, when 34 to 36 healthcare worker deaths were
                reported per week (CDC October 18, 2021--Healthcare Personnel, Deaths
                by Week). Independent reporting by Kaiser Health News and The Guardian
                reported more than 3,600 fatalities in health care workers as of April
                2021 (Spencer and Jewett, April 8, 2021). That number is expected to be
                higher at this time since the earlier figure did not include the most
                recent 5 months of the pandemic, which includes the period of Delta
                variant predominance.
                 Published studies also demonstrate that healthcare workers,
                especially those who are unvaccinated, remain at risk of being infected
                with SARS-CoV-2 (see Section III.A.IV. Vaccines Effectively Reduce
                Severe Health Outcomes from and Transmission of SARS-CoV-2). Routine
                testing of health care personnel, first responders, and other frontline
                workers in eight U.S. locations in six states from December 14, 2020
                through August 14, 2021 revealed 194 infections in 4,136 unvaccinated
                participants (89.7% symptomatic) and 34 infections in 2,976 fully
                vaccinated participants (80.6% symptomatic) (Fowlkes et al., August 27,
                2021). During time periods when the Delta variant represented more than
                50% of viruses sequenced, 19 infections were detected in 488
                unvaccinated participants (94.7% symptomatic) and 24 infections were
                detected in 2,352 vaccinated participants (75% symptomatic).
                 Monthly COVID-19 cases in healthcare workers were reported during
                the period from March 1 to July 31, 2021 at the University of
                California San Diego (UCSD) health system, which is a healthcare
                provider that includes primary care services such as family medicine
                and pediatrics (Keehner et al., September 1, 2021; UCSD, 2021). During
                that time period, a total of 227 health care workers tested positive
                for COVID-19. One hundred and nine of 130 fully vaccinated workers who
                tested positive (83.8%) were symptomatic and 80 of 90 unvaccinated
                workers (88.9%) were symptomatic; one unvaccinated person was
                hospitalized for COVID-19 symptoms. By July of 2021, after the end of
                California's mask mandate on June 15 and after the Delta variant became
                dominant, the number of cases detected dramatically increased; the
                Delta variant accounted for more than 95% of SARS-CoV-2 viruses
                sequenced by the end of that month. During July of 2021, symptomatic
                infections were detected in 94 of 16,492 fully vaccinated workers and
                31 of 1,895 unvaccinated workers. Attack rates in July of 2021 were 5.7
                per 1,000 fully vaccinated workers and 16.4 per 1,000 unvaccinated
                workers.
                 In Finland, a Delta variant infection from a hospitalized patient
                spread throughout the hospital and to three primary care facilities,
                infecting 103 individuals, including 45 healthcare workers
                (Hetem[auml]ki et al., July 29, 2021). Twenty-six of the healthcare
                workers were infected at the hospital and 19 were infected at primary
                care facilities. The affected health care workers included 28 with
                direct patient contact (11 who were not fully vaccinated), 8
                unvaccinated healthcare worker students, and 9 other staff, including
                hospital cleaners and secretaries (of whom 6 were not fully
                vaccinated). According to study authors, ``There was high vaccine
                coverage among permanent staff in the central hospital, but lower for
                HCW in primary healthcare facilities. . .'' Study authors estimated
                that vaccine effectiveness against the Delta variant in healthcare
                workers was approximately 88-91%, suggesting how much more extensive
                the outbreak could have been if a high percentage of healthcare workers
                were not fully vaccinated.
                 In the UK, a Delta variant infection in a healthcare worker
                resulted in an outbreak in a care home that affected 16 of 21 residents
                and 8 of 21 staff (Williams et al., July 8, 2021). One staff member was
                hospitalized. Attack rates were 35.7% in staff who were partially
                vaccinated (i.e., received their second dose of vaccine on the day that
                the index case was diagnosed with COVID-19 or had only received one
                vaccine dose) and 40% in staff who were not vaccinated.
                 Recent news stories demonstrate that outbreaks affecting staff
                members are still occurring in U.S. healthcare facilities. An outbreak
                that began in August, 2021 at a Washington State nursing center
                resulted in infections in 22 staff members and 52 residents. In an
                unrelated outbreak, a nursing facility in Hawaii reported infections in
                24 employees and 54 patients (Wingate, September 24, 2021). Vaccination
                rates were reported at 64.5% of residents and 37.1% of staff in the
                Washington State facility and 91% of staff and more than 80% of
                patients at the Hawaii facility.
                 COVID-19 cases were also observed in staff at ambulatory care
                settings prior to emergence of the Delta variant. Over an 11-week
                period beginning on March 20, 2020, 254 tests for SARS-CoV-2 were
                performed on employees who had potential exposures at an outpatient
                urology center in New York State (Kapoor et al., 2020). Positive test
                rates in employees correlated with rates in New York State, declining
                over time, from 26.1% in the early stage to 7.3% in the late stage of
                the study. According to study authors, the positive test results
                coincided with the implementation of infection control procedures
                (e.g., symptom screening, masking, distancing, and hygiene). Positivity
                rates were similar in administrative and clinical staff and the study
                authors concluded that ``administrative staff in an outpatient setting
                were equally--if not more--vulnerable to SARS-CoV-2 transmission when
                compared with clinical staff who were more directly exposed to
                patients.'' The study authors speculated that possible reasons for the
                findings were that clinical staff were more familiar with PPE and that
                administrative staff, especially in check-in and check-out points, tend
                to work close to each other.
                [[Page 61417]]
                c. Conclusion for Employee Impact
                 The evidence described above provides examples of the impact that
                exposures from SARS-CoV-2, including those involving the Delta variant,
                have had on employees in general industry, agriculture, construction,
                maritime, and healthcare settings. It demonstrates that SARS-CoV-2 has
                spread to employees in these industries and, in many cases, infection
                was linked to exposure to infected persons at the worksite (WSDH,
                September 8, 2021; OHA, September 1, 2021; TDH, September 8, 2021;
                NCDHHS, August 30, 2021; Hawaii State, August 19, 2021; Pray et al.,
                January 29, 2021; Sami et al., April 9, 2021; Suhs et al., July 23,
                2021; Gold et al., February 26, 2021; Porter et al., April 30, 2021;
                Hetem[auml]ki et al., July 29, 2021; Williams et al., July 8, 2021).
                The documentation of so many workplace clusters suggests that exposures
                to SARS-CoV-2 occur regularly in workplaces where employees come into
                contact with others. This prevalence of clusters, combined with some
                evidence that many infections occurred within the 14-day incubation
                period for SARS-CoV-2 and that exposures to infected persons outside
                the workplace were frequently ruled out, supports the proposition that
                exposures to and transmission of SARS-CoV-2 occur frequently at work.
                Multiple studies demonstrate high rates of COVID infections, illnesses,
                and fatalities in the wide range of occupations that require frequent
                or prolonged close contact with other people, indoor work, and work in
                crowded and/or poorly ventilated areas The large numbers of infected
                employees suggest that SARS-CoV-2 is likely to be present in a wide
                variety of workplaces, placing unvaccinated workers at risk of serious
                and potentially fatal health effects.
                IV. Vaccines Effectively Reduce Severe Health Outcomes From and
                Transmission of SARS-CoV-2
                 During the course of the SARS-CoV-2 pandemic, different variants
                have emerged with different characteristics that better enable
                transmission and potentially cause more severe outcomes. However,
                vaccines remain very effective at reducing the occurrence of COVID-19-
                related severe illness, disability and death.\12\ The Delta variant is
                more transmissible than previous variants, might cause more severe
                illness than previous variants in unvaccinated people, and has led to
                hospitalization of individuals in numbers similar to those of the
                November 2020 to February 2021 surge. These changes in characteristics
                have provided a clearer realization of the continuing capacity for
                SARS-CoV-2 to present a grave danger to workers. However, it is well
                evident that even given these changed characteristics of Delta, serious
                disease and death continue to occur overwhelmingly in unvaccinated
                individuals while the vaccinated are afforded great protection.\13\
                ---------------------------------------------------------------------------
                 \12\ A discussion of vaccination rates, as well as OSHA's
                rationale for why vaccination is a critical means of protecting
                workers from the grave danger described in this section, can be
                found in Need for the ETS (Section III.B. of this preamble).
                 \13\ While mild cases of COVID-19 are included in the grave
                danger presented by COVID-19, as stated in the Healthcare ETS (see
                86 FR 32382), OSHA is focusing on the most severe health effects,
                i.e., cases requiring hospitalization and cases resulting in death,
                in this new rulemaking effort in order to prevent the gravest of
                consequences to workers.
                ---------------------------------------------------------------------------
                a. Impact of Vaccination on Severe Health Outcomes
                 There are currently three vaccines that are approved or authorized
                for the prevention of COVID-19 in the U.S.: The Pfizer-BioNTech COVID-
                19 vaccine (FDA approved for ages 16 and above; authorized for ages 12
                and above), the FDA-authorized Moderna COVID-19 vaccine (authorized for
                ages 18 and above), and the FDA-authorized Janssen COVID-19 vaccine
                (also known as the Johnson & Johnson vaccine; authorized for ages 18
                and above.) Pfizer-BioNTech and Moderna are mRNA vaccines that require
                two primary series doses administered three weeks and one month apart,
                respectively. Janssen is a viral vector vaccine administered as a
                single primary vaccination dose (CDC, September 15, 2021). The vaccines
                were shown to greatly exceed minimum efficacy thresholds in preventing
                COVID-19 in clinical trial participants (FDA, December 11, 2020; FDA,
                December 18, 2020; FDA, February 26, 2021). Data from clinical trials
                for all three vaccines and observational studies for the two mRNA
                vaccines clearly establish that fully vaccinated persons have a greatly
                reduced risk of SARS-CoV-2 infection compared to unvaccinated
                individuals. This includes severe infections requiring hospitalization
                and those resulting in death. For more information about the
                effectiveness of vaccines as of late Spring 2021, see 86 FR 32397,
                which OSHA hereby includes in the record for this ETS.\14\
                ---------------------------------------------------------------------------
                 \14\ This adoption includes the citations in the referenced
                section of the Healthcare ETS, which are also included in the docket
                for this ETS.
                ---------------------------------------------------------------------------
                 Vaccines remain highly effective against hospitalization and death.
                A study evaluating vaccine effectiveness at preventing hospitalization
                among those with SARS-CoV-2 infections in New York found that
                effectiveness did not change from May 3 to July 25, 2021 as the Alpha
                variant gave way to the Delta variant (91.9-96.2% range; Rosenberg et
                al., August 27, 2021). Grannis et al. used data from 187 hospitals in
                nine states from June to August 2021 to evaluate the efficacy of
                vaccines against hospitalization when Delta had emerged as the
                predominant variant causing SARS-CoV-2 infections (September 17, 2021).
                This study found that vaccines were 89% effective at preventing
                hospitalization in individuals aged 18 to 74. Similarly, vaccines were
                also found to be 89% effective in preventing hospitalization in a study
                collecting data from five Veteran Affairs Medical Centers from July 1
                to August 6, 2021, a time when most transmission was attributed to the
                Delta variant (Bajema et al., September 10, 2021).
                 Two other studies found that, although the level of protection
                provided by vaccination has decreased somewhat with the emergence of
                the Delta variant, vaccines continue to provide high levels of
                protection against hospitalization. In a U.S. study, researchers found
                that while the Moderna and Janssen vaccines mostly maintained their
                effectiveness at preventing hospitalization (going from 93% to 92%
                after more than 120 days post-vaccination and 71% to 68% after more
                than 28 days post-vaccination, respectively) from March to August 2021,
                the effectiveness of the Pfizer-BioNTech vaccine at preventing those
                severe outcomes decreased from 91% to 77% after more than 120 days
                post-vaccination (Self et al., September 17, 2021). An Israeli study on
                infections documented between July 11 and July 31, 2021 found a
                significant decrease in vaccine efficacy for the Pfizer-BioNTech
                vaccine against severe outcomes in relation to when an individual was
                vaccinated, but the absolute difference was much less than what was
                observed in the U.S. study (e.g., 98% effective for 40-59 year olds
                vaccinated in March versus 94% effective for those in the same age
                group who were vaccinated in January) (Goldberg et al., August 30,
                2021).
                 Vaccines also remain extremely effective at preventing death. A UK
                study evaluated the effectiveness of the Pfizer-BioNTech vaccine
                against death and found it to be 96.3% effective against the Alpha
                strain and 95.2% protective against the Delta strain (Andrews et al.,
                September 21, 2021). Two Israeli studies, Haas et al. and Saciuk et
                al., performed during time periods where Alpha was predominant, found
                the Pfizer-BioNTech vaccine to be 96.7% and 91.1% effective,
                [[Page 61418]]
                respectively, against death (Haas et al., May 15, 2021; Saciuk et al.,
                June 25, 2021). A California study found that the Moderna vaccine was
                97.9% effective against death (Bruxvoort et al., September 2, 2021). A
                study on patients served by the Veterans Health Administration found
                that Pfizer-BioNTech and Moderna vaccines provided 99% effectiveness
                against death (Young-Xu et al., July 14, 2021).
                 The risks of hospitalization and death appear to have increased for
                unvaccinated individuals since the Delta variant became a common source
                of infections. A study of Los Angeles County SARS-CoV-2 infections
                found that vaccinations reduced hospitalization risk by a factor of 10
                on May 1, 2021, when the Alpha variant was dominant, but that the risk
                of hospitalization was even more greatly reduced (by a factor of 29.2)
                on July 25, 2021, when the Delta variant was dominant (Griffin et al.,
                August 27, 2021). This difference suggests both that vaccines continue
                to provide a high level of protection against disease that results in
                hospitalization and that risk has increased for those who are
                unvaccinated. Similar increased risk for unvaccinated individuals was
                reported in a study that evaluated hospitalization and death data from
                13 U.S. jurisdictions between June 20 and July 17, 2021, a period when
                the Delta variant gained prominence (Scobie et al., September 17,
                2021). For unvaccinated 18 to 49 year olds, the risk of hospitalization
                was 15.2 times greater, and the risk of death was 17.2 times greater,
                than the risks for vaccinated people in the same age range. For
                unvaccinated 50 to 64 year olds, the risk of hospitalization was 10.9
                times greater, and the risk of death was 17.9 times greater, than for
                those who are vaccinated. These studies illustrate that vaccination is
                an extremely effective control measure to minimize severe outcomes
                resulting from Delta variant infections.
                b. Impact of Vaccination on Infection and Transmission
                 Vaccines continue to provide robust protection for vaccinated
                individuals against SARS-CoV-2 infections, even though several studies
                indicate that vaccine efficacy against infection may have decreased
                somewhat with the emergence of the Delta variant (Fowlkes et al.,
                August 27, 2021; Rosenberg et al., August 27, 2021; Nanduri et al.,
                August 27, 2021; Seppala et al., September 2, 2021; Bernal et al.,
                August 12, 2021). For example, vaccination was observed to reduce the
                risk of infection by a factor of 8.4 on May 1, 2021, when the Alpha
                variant was predominant in Los Angeles county (Griffin et al., August
                27, 2021). However, the level of protection had fallen to a factor of
                4.9 by July 25, 2021, when Delta made up 88% of infections in the
                county. The findings from this study indicate that while vaccines
                maintain robust protection against severe outcomes, protection against
                infection has fallen with the increased circulation of the Delta
                variant. A broader study using data from 13 U.S. jurisdictions had
                similar findings, observing that the protection vaccines afforded
                against infection decreased from a factor of 11.1 (i.e., vaccinated
                people were 11.1 times less likely than unvaccinated people to become
                infected) between April 4 and June 19, 2021, to a factor of 4.6 between
                June 20 and July 17, 2021 (Scobie et al., September 17, 2021). An
                additional study noted, however, that the decrease in vaccine
                protectiveness against symptomatic infection from the Delta variant
                could be due to the waning of immunity specifically in older
                populations. Andrews et al. (September 21, 2021) found that while the
                Pfizer-BioNTech vaccine effectiveness decreased from 94.1% to 67.4% in
                those 65 years old and older, vaccine effectiveness for those 40 to 64
                years old only decreased from 92.9% to 80.6%.
                 While infections themselves do not normally result in serious
                illness for those who are vaccinated, evidence shows that vaccinated
                individuals who become infected with the Delta variant can transmit the
                disease more easily to others than with previous variants. This
                development poses a great concern for the unvaccinated, who generally
                do not have the protections against severe outcomes that vaccination
                affords. Before Delta, vaccinated individuals were shown to have lower
                estimated viral loads when infected than those who were unvaccinated,
                which suggested that infected vaccinated individuals were likely not a
                major concern for transmission (Levine-Tiefenbrun et al., March 29,
                2021). Transmission studies prior to the emergence of Delta appear to
                bear this out. A Scottish study performed during a time period when the
                Alpha variant was predominant in the region, showed that a fully
                vaccinated individual was 3.2 times less likely than an unvaccinated
                individual to transmit the virus to unvaccinated family members (Shah
                et al., September 10, 2021; supplementary appendix). A population-based
                study from the Netherlands found that vaccination decreased secondary
                transmission to household members from 31% to 11% (de Gier et al.,
                August 5, 2021). Additionally, a study from the UK found that household
                transmission decreased by as much as 50% when the infected individual
                was vaccinated (Harris et al., June 23, 2021).
                 More recent research suggests that the Delta variant may have
                reduced the level of protection vaccination affords against
                transmission of the virus to others, but still significantly reduces
                transmission risk in comparison to infected unvaccinated individuals. A
                UK study found that fully vaccinated individuals infected by the Delta
                variant are able to transmit the virus to both vaccinated and, to a
                greater degree, unvaccinated persons (Singanayagam et al., September 6,
                2021). Still, the rate at which transmission to unvaccinated
                individuals occurred was nearly double the rate of transmission to
                vaccinated individuals (35.7% compared to 19.7%). Similarly, Eyre et
                al., (September 29, 2021) found that during the predominance of Alpha,
                full vaccination with the Pfizer-BioNTech vaccines resulted in a
                significant reduction in transmission to others (an adjusted Odds Ratio
                (aOR) of 0.18, meaning that being unvaccinated increased the odds of
                transmission by over five times). With the rise of the Delta variant,
                that reduction in transmission to others was less than with the Alpha
                variant, but still significantly more than for unvaccinated individuals
                (aOR of 0.35, meaning that being unvaccinated increased the odds of
                transmission by almost three times).
                 The greater ability for vaccinated individuals to transmit the
                Delta variant of SARS-CoV-2 to others (compared to previous variants)
                appears to be linked to the generation of similar viral loads (as
                estimated by Ct threshold) in the vaccinated compared to the
                unvaccinated (Ct threshold is the number of RT-PCR cycles that need to
                be run in order to amplify the RNA enough to be detected--fewer cycles
                means a greater initial amount of virus was collected) (Singanayagam et
                al., September 6, 2021). This observation has been made in several
                studies. A study from Israel observed that viral loads among those
                infected with the Delta variant were only decreased in people who had
                been vaccinated recently (within the past two months) or in those who
                had recently received a booster dose (Levine-Tiefenbrun et al.,
                September 1, 2021). In a study of SARS-CoV-2 infections in Los Angeles
                County, performed when the Delta variant was predominant, vaccination
                status did not appear to affect the estimated viral loads, suggesting
                that infected individuals who are vaccinated
                [[Page 61419]]
                may be just as likely to transmit the virus (Griffin et al., August 27,
                2021). Additionally, estimated viral loads did not appear to be
                significantly different with respect to vaccination status in a
                Wisconsin study (Riemersma et al., July 31, 2021). Regardless of viral
                loads in vaccinated and unvaccinated individuals, the fact remains
                clear that unvaccinated people pose a higher risk of transmission to
                others than vaccinated people, simply because they are much more likely
                to get COVID-19 in the first place.
                 These studies, however, appear to overstate increases in
                transmission risk from vaccinated individuals related to the Delta
                variant. From May to July 2021, UK researchers tested individuals at
                random to better characterize viral load estimates in people with
                asymptomatic as well as symptomatic infections; they found that
                vaccination was associated with a significantly lower estimated viral
                load (Elliott et al., September 10, 2021). This more comprehensive
                study (i.e., Elliott et al., September 10, 2021) may have been able to
                better characterize the course of infection and to incorporate
                vaccinated individuals whose viral loads were decreasing quickly. The
                findings in Elliott et al. are consistent with studies observing that
                viral load may fall more quickly in vaccinated individuals, resulting
                in a shorter infectious period and possibly fewer transmission events
                (Chia et al., July 31, 2021; Eyre et al., September 29, 2021).
                c. Conclusion for the Impact of Vaccines
                 The studies discussed above indicate that vaccines continue to
                effectively protect vaccinated individuals against SARS-CoV-2
                infections, while the risk of infection, hospitalization, and death
                increased among unvaccinated people as the Delta variant became
                predominant in the U.S. The Delta variant is even more dangerous to
                unvaccinated individuals than previous variants because of the higher
                transmission potential from both unvaccinated and vaccinated people.
                Because unvaccinated individuals are at much higher risk of severe
                health outcomes from infection with SARS-CoV-2, and also pose a greater
                transmission risk to those around them, it is critical to assure that
                as many people as possible are fully vaccinated in order to prevent
                transmission at work.
                V. Coverage of OSHA's Grave Danger Finding
                 Based on the information discussed above, OSHA finds that many
                unvaccinated workers across the U.S. economy are facing a grave danger
                of severe health effects or death from exposure to SARS-CoV-2. Fully
                vaccinated workers are not included in this grave danger finding
                because, as described throughout this section, those who are fully
                vaccinated are much better protected from the effects of SARS-CoV-2
                and, in particular, the most severe effects, than are those who are
                unvaccinated.\15\ Beyond that, OSHA's grave danger determination
                exempts several categories of workers based on characteristics of their
                work or workplace: (1) Workers who do not report to a workplace where
                other individuals are present or who telework from home; and (2)
                workers who perform their work exclusively outdoors. The basis for
                these exemptions is explained below. In this section, OSHA also
                addresses the basis for OSHA's grave danger finding for workers who are
                unvaccinated yet had a prior COVID-19 infection, and explains the
                Agency's more nuanced grave danger finding in the healthcare industry.
                ---------------------------------------------------------------------------
                 \15\ The exclusion of vaccinated workers from this grave danger
                finding does not mean that vaccinated workers face no risk from
                exposure to SARS-CoV-2. The best available evidence clearly shows
                that vaccination provides great protection from infection and severe
                outcomes, but breakthrough infections do occur and vaccinated
                individuals can still transmit the virus to others. In some cases,
                the level of risk to vaccinated workers may even rise to the level
                of a significant risk, the standard OSHA must meet for promulgation
                of a permanent standard under section 6(b)(5) of the OSH Act (29
                U.S.C. 655(b)(5)).
                ---------------------------------------------------------------------------
                a. Employees Who Telework and Employees Who Do Not Report to a
                Workplace Where Other People Are Present.
                 Employees who report to workplaces where no other people are
                present face no grave danger from occupational exposure to COVID-19
                because such exposure requires the presence of other people. For those
                who work from their homes, or from workplaces where no other people are
                present (such as a remote worksite), the chances of being exposed to
                SARS-CoV-2 through a work activity are negligible. Therefore, OSHA is
                exempting those workers who do not come into contact with others for
                work purposes from its grave danger finding as well as the scope of the
                ETS (for more information, see the Summary and Explanation for Scope
                and Application, Section VI.B. of this preamble).
                b. Employees Who Work Exclusively Outside
                 Employees who work exclusively outside face a much lower risk of
                exposure to SARS-CoV-2 at work, because their workplaces typically do
                not include any of the characteristics that normally enable
                transmission to occur (e.g., indoors, lack of ventilation, crowding).
                Bulfone et al. attributed the lower risk of transmission in outdoor
                settings (i.e., open air or structures with one wall) to increased
                ventilation with fresh air and a greater ability to maintain physical
                distancing (November 29, 2020). While the best available evidence
                firmly establishes a grave danger in indoor settings, the CDC has
                stated that the risk of outdoor transmission is ``low'' (CDC, September
                1, 2021) and OSHA is unable to establish a grave danger in outdoor
                settings from exposure during normal work activities.
                 OSHA recognizes that outdoor transmission has been identified in a
                few specific incidents (e.g., 2 of 7,324 cases, Qian et al., October
                27, 2020). However, general reviews of transmission studies that
                include large-scale and high-density outdoor gatherings indicate that
                indoor transmission overwhelmingly is responsible for SARS-CoV-2
                transmission. Additionally, the lack of evidence tied to specific case
                studies illustrating outdoor transmission in comparison to the bevy of
                case studies on indoor transmission makes it difficult to support a
                conclusion that outdoor transmission rises to the level of a grave
                danger.
                 Bulfone et al. reviewed a collection of SARS-CoV-2 studies that
                evaluated infections in outdoor and indoor settings (November 29,
                2020), and found that transmission is significantly less likely to
                occur in outdoor settings than in indoor settings. The studies overall
                found that the risk of outdoor transmission was less than 10% of the
                risk of transmission in indoor settings, with three of the studies
                concluding risk was 5% or less of the risk of transmission in indoor
                settings. While acknowledging significant gaps in knowledge, the
                authors of a different study suggested that increases in transmission
                related to large events such as the Sturgis motorcycle rally may be
                related to lack of local efforts to prevent transmission indoors (e.g.,
                requiring the wearing of masks, closing indoor dining), rather than the
                outdoor setting for the rally (Dave et al., December 2, 2020). In
                contrast, transmission rates did not increase as expected following the
                Summer 2020 protests on racial injustice. This outcome was attributed,
                in part, to participants having been less likely to enter indoor
                commercial establishments.
                [[Page 61420]]
                 Weed and Foad (September 10, 2020) found that transmission of SARS-
                CoV-2 related to large scale outdoor gatherings could be largely
                attributed to individual behaviors related to that event, such as
                communal travel and indoor congregation at other facilities (e.g.,
                restaurants, shared accommodations), rather than to the time spent
                outdoors at those gatherings. Similarly, a Public Health England
                evaluation of the literature on SARS-CoV-2 and surrogate respiratory
                viruses (December 18, 2020) also concluded that when transmission does
                occur at outdoor events, outdoor activities were mixed with indoor
                setting use. Public Health England concluded that the vast majority of
                transmission happens in indoor settings, with very little evidence for
                outdoor transmission.
                 A systemic review of SARS-CoV-2 clusters identified 201 events
                through May 26, 2020 (Leclerc et al., April 28, 2021), only 4 of which
                occurred at predominantly outdoor settings. For those 4 clusters, the
                authors noted that they were not able to evaluate specific transmission
                events and attributed it to local health agencies being overwhelmed by
                the pandemic. OSHA notes that the designations of settings in this
                study are somewhat generic, as outdoor construction sites will often
                have indoor locations, such as mobile offices, or locations with
                reduced airflow, such as areas with a roof or ceiling and two or more
                walls. Regardless, this study illustrates the comparable abundance of
                evidence available to evaluate SARS-CoV-2 transmission in indoor
                settings versus outdoor settings.
                 Cevik et al. (August 1, 2021) reviewed studies on the transmission
                dynamics of SARS-CoV-2 infections from large scale, contact-tracing
                studies. The authors recommended that, based on the evidence that
                outdoor transmission dynamics resulted in significantly fewer
                infections than in indoor settings, public health entities should
                greatly encourage use of outdoor settings. The researchers highlighted
                a study by Nishiura et al. (April 16, 2020), who evaluated 110 cases in
                Japan at the beginning of the pandemic and found that outdoor settings
                reduced transmission risk by 18.7 times and reduced the risk of super-
                spreader events by 32.5 times.
                 Agricultural workplace settings have experienced significant SARS-
                CoV-2 infections. However, transmission in these settings is difficult
                to characterize because many jobs in this sector include both outdoor
                and indoor activities. Miller et al. (April 30, 2021) evaluated an
                outbreak among farmworkers in Washington State. The researchers found
                that 28% of workers with predominantly indoor tasks where they were
                unable to maintain physical distance were infected, compared to 6% of
                workers who performed predominantly outdoors tasks in the orchards.
                Conversely, a study on farmworkers in Monterey County, California found
                a significant correlation between evidence of infection and individuals
                who worked in the fields as opposed to indoor work (Mora et al.,
                September 15, 2021). The paper noted that infections were predominant
                in individuals who lived in crowded conditions, commuted together to
                the fields, and spoke at home in indigenous languages, which is
                important as written health messages are often not available in all
                worker languages. These papers cannot identify where or when infections
                occurred in order to discern causation. The associations observed may
                indicate that SARS-CoV-2 infections may be more related to aspects
                related to indoor exposures outside of the work activities (e.g.,
                crowded living conditions) or potentially overlooked indoor aspects
                connected to outdoor work (e.g., shared commuting).
                 Several studies discussed below in more detail have evaluated
                outdoors on-field transmission from infected participants during
                football, soccer, and rugby matches. These events include repeated
                close physical contact between players, without PPE or physical
                distancing, over the course of fairly long events, with increased
                exertion leading to greater respiratory effort and production of
                respiratory droplets. These events also include opposing cohorts who
                only interact during on-field activities. Therefore, these studies
                provide some evidence for the low likelihood of outdoor transmission in
                other workplace activities greatly impacted by the pandemic, such as in
                construction.
                 Mack et al. (January 29, 2021) detailed the National Football
                League's complex program to assess and prevent transmission, which
                included devices that recorded distance and duration of interactions
                with others, for the purpose of improving identification of individuals
                with high-risk exposures. Although 329 positive cases were identified
                among roughly 11,400 players and staff, there were no reported cases of
                on-field transmission by infected players. The results led the NFL to
                focus more on reducing transmission in indoor settings, including
                transportation.
                 Egger et al. (March 18, 2021) reviewed three soccer matches
                involving 18 players who had SARS-CoV-2; one match involved a team
                where 44% of the players were infected. Video analysis was used to
                determine the type of contact between players, such as contact to face
                or hand slaps. None of the existing cases were associated with on-field
                play and no secondary transmission from on-the-field contacts was
                observed. Jones et al. (February 11, 2021), evaluated four rugby Super
                League matches involving eight players who were found to be infected
                with SARS-CoV-2. Using video footage and global positioning data, the
                researchers were able to identify 28 players as high-risk contacts with
                the infected players. These high-risk players together had as many as
                32 tackles and were within two meters of infected players as often as
                121 times during the four matches. Of the 28 players noted as high-risk
                contacts, one became infected with SARS-CoV-2. However, researchers
                determined that the transmission resulted from internal team outbreaks
                and not from exposure on the field.
                 OSHA acknowledges that the risk of transmission of SARS-CoV-2 in
                outdoor settings is not zero, and that there may be some low risk to
                workers performing general tasks exclusively in outdoor settings.
                However, where studies have been able to differentiate between indoor
                and outdoor exposures, they indicate that indoor exposures are the much
                more significant drivers of SARS-CoV-2 infections. Therefore, the best
                available evidence at this time does not provide OSHA with the
                information needed to establish SARS-CoV-2 as a grave danger for
                general work activities in outdoor settings (see Int'l Union, United
                Auto., Aerospace, & Agr. Implement Workers of Am., UAW, 590 F. Supp. at
                755-56, describing a ``grave danger'' as a risk that is more than
                ``significant''). Therefore, OSHA has excluded employees who work
                exclusively outdoors from the scope of this ETS (see the Summary and
                Explanation for Scope and Application, Section VI.B. of this preamble).
                c. Employees in Healthcare
                 Because OSHA issued a separate grave danger determination several
                months ago for some healthcare workers, some explanation of how its
                current finding applies to healthcare workers is necessary. In June
                2021, OSHA issued its Healthcare ETS (86 FR 32376) after determining
                that some healthcare workers faced a grave danger of infection from
                SARS-CoV-2. This grave danger determination, along with the protections
                of the Healthcare ETS, applied to healthcare and healthcare support
                workers in settings where
                [[Page 61421]]
                people with suspected or confirmed cases of COVID-19 are treated, and
                was based on the increased potential for transmission of the virus in
                such settings (see 86 FR 32411-32412). These workers are currently
                covered by the protections of the Healthcare ETS (29 CFR 1910.502).
                OSHA does not have data to demonstrate that unvaccinated workers in
                settings covered by the Healthcare ETS face a grave danger from SARS-
                CoV-2 when the requirements of that standard are followed. However, if
                the Healthcare ETS were no longer in effect, OSHA would consider the
                workers who were covered by it, and who remain unvaccinated, to be at
                grave danger for the reasons described in this ETS.
                 OSHA's new finding of grave danger applies to healthcare and
                healthcare support workers who are not covered by the Healthcare ETS,
                to the extent they remain unvaccinated. In this ETS, as discussed in
                this section, OSHA has made a broader determination of grave danger
                that applies to most unvaccinated workers, regardless of industry.
                OSHA's current finding of grave danger supporting this ETS does not
                depend on whether a workplace is one where people with suspected or
                confirmed COVID-19 are expected to be present. Therefore, the finding
                of grave danger applies to unvaccinated workers in healthcare settings
                that are not covered by 29 CFR 1910.502 to the same extent it applies
                to unvaccinated workers in all other industry sectors.
                d. Employees Who Were Previously Infected With SARS-CoV-2
                 OSHA has carefully evaluated the effectiveness of previous SARS-
                CoV-2 infections in providing protection against reinfection. This
                section provides a detailed description of the current scientific
                information in order to ascertain what the best available scientific
                evidence on this topic indicates regarding the risk to individuals with
                previous COVID-19 infections from exposure to SARS-CoV-2. While the
                agency acknowledges that the science is evolving, OSHA finds that there
                is insufficient evidence to allow the agency to consider infection-
                acquired immunity to allay the grave danger of exposure to, and
                reinfection from, SARS-CoV-2.
                 To determine whether employees with infection-induced immunity from
                SARS-CoV-2 (i.e., those who were infected with SARS-CoV-2 but have not
                been vaccinated) face a grave danger, OSHA reviewed the scientific
                evidence on the protective effects of vaccine-induced SARS-CoV-2
                immunity versus infection-induced immunity. Individual immunity to any
                infectious disease, including SARS-CoV-2, is achieved through a complex
                response to exposure by the immune system. This response consists of
                disease-specific antibody production guided and augmented by certain
                types of immune cells, such as T and B cells, which work together to
                neutralize or destroy the disease-causing agent. Immune responses to
                viruses like SARS-CoV-2 can be measured in several ways. For instance,
                blood serum can be taken and exposed to specific proteins found on the
                SARS-CoV-2 virus, in order to measure the presence of antibodies in the
                blood. Another antibody test, the neutralization test, measures the
                ability of the antibodies present in a serum to neutralize infectivity
                and prevent cells from being infected. T cell immunity can be measured
                using techniques that target a specific biomolecule that is specific to
                SARS-CoV-2.
                 A considerable number of individuals who were previously infected
                with SARS-CoV-2 do not appear to have acquired effective immunity to
                the virus (Psichogiou et al., September 13, 2021; Wei et al., July 5,
                2021; Cavanaugh et al., August 13, 2021). The level of protection
                afforded by infection-induced immunity appears to depend on the
                severity of individuals' infections. In a study from Greece,
                immunogenicity was compared between healthcare workers who were
                vaccinated with Pfizer-BioNTech and unvaccinated patients who acquired
                a natural infection (Psichogiou et al., September 13, 2021). The
                researchers found that the immune response in unvaccinated individuals
                correlated to the severity of their disease. Fully vaccinated
                healthcare workers had immune responses (measured as antibody levels
                specific to SARS-CoV-2) that were 1.3 times greater than patients who
                had critical cases of COVID-19 cases, 2.5 times greater than patients
                who had moderate to severe cases, and 10.5 times greater than patients
                who had asymptomatic/mild illnesses. Similarly, another study found
                that 24.0% (1,742 of 7,256) of individuals who had a previous SARS-CoV-
                2 infection were seronegative (i.e., did not produce antibodies in
                response to the virus), suggesting that the previous infection provided
                insufficient protection against future infection (Wei et al., July 5,
                2021). Individuals who were seronegative were typically older, had
                lower viral burdens when infected, and were more likely to be
                asymptomatic. The authors posited that the immunity of those who were
                seropositive (i.e., did produce antibodies in response to the virus)
                would provide some measure of protection, but that these individuals
                would benefit from a vaccination booster. This position appears to be
                validated by a study that compared the reinfection rates of individuals
                in Kentucky based on their post-recovery vaccination status (Cavanaugh
                et al., August 13, 2021). Unvaccinated individuals with previous
                infection were found to be 2.3 times more likely to be reinfected than
                those who were vaccinated after their prior infection. These studies
                demonstrate not only that those with milder infections may not be
                protected against future infection, but that it is difficult to tell,
                on an individual level, which individuals might have had prior
                infections that conveyed protection equivalent to that provided by
                vaccination.
                 A number of other studies indicate that fully vaccinated
                individuals may be better protected against future infection than those
                with previous infections. A study in Massachusetts concluded that the
                immunity conveyed from a previous SARS-CoV-2 infection was effectively
                equivalent to the immunity of an uninfected individual who has had only
                one dose of an mRNA vaccine (Naranbhai et al., October 13, 2021). The
                authors found that fully vaccinated individuals have an immune response
                (i.e., antibodies and neutralization) well above the levels observed in
                unvaccinated, previously-infected individuals. German researchers found
                that individuals who were fully vaccinated with Pfizer-BioNTech had a
                significantly greater immune response (as measured by antibody levels)
                than unvaccinated individuals who had infections, concluding that
                vaccination would be needed for those unvaccinated individuals to have
                similar protection against infection (Herzberg et al., June 13, 2021).
                Similarly, a Dutch study observed that vaccination greatly improved the
                immune response (as measured by antibodies and virus-specific T cells)
                of individuals who had recovered from COVID-19 (Geers et al., May 25,
                2021). Planas et al. (August 12, 2021) also noted that immune response
                (as measured by neutralization) to the Alpha, Beta, and Delta
                (B.1.617.2) variants in unvaccinated, previously-infected individuals
                was considerably less than the immune response in individuals five
                weeks after their second Pfizer-BioNTech dose. When unvaccinated,
                previously-infected individuals were vaccinated, their immune response
                (as measured by neutralization) increased by more than an order of
                magnitude. Likewise, Wang
                [[Page 61422]]
                et al. (July 15, 2021) found that the immune response (as measured by
                neutralization) of those with previous SARS-CoV-2 infection increased
                by more than an order of magnitude against Alpha (B.1.1.7), Beta
                (B.1.351), Iota (B.1.526), and Gamma (P.1) variants when they were
                vaccinated. These studies show that infection-induced immunity may not
                equal the protection afforded by vaccination and that vaccination
                greatly improves the immune response of those who were previously
                infected.
                 The aforementioned studies indicate that immunity acquired through
                infection appears to be less protective than vaccination. There are
                also a number of epidemiological studies that provide some evidence
                that infection-acquired immunity has the potential to provide a
                significant level of protection against reinfection. As OSHA discusses
                in greater detail below, these studies suffer from methodological
                limitations that render them inconclusive about the level of immunity
                conferred by infection, and therefore OSHA is unable to establish that
                such immunity eliminates grave danger. This determination is based in
                three parts.
                 First, the epidemiological literature OSHA reviewed generally
                suffers from selection bias to a degree that it serves as an unreliable
                basis on which to reach a robust conclusion on whether previous
                infection removes workers from grave danger. In general, the studies
                described below do not account for people who had mild COVID-19
                infections, leading to study findings regarding the level of protection
                afforded by prior infection that are not generally applicable. Second,
                the tests employed in the studies are being used in ways that they were
                not originally designed to be employed. These tests are powerful tools,
                but there are limitations to their use in determining if a specific
                individual is, in fact, protected from the grave danger of SARS-CoV-2.
                Particularly problematic is the lack of established thresholds to
                determine full protection from reinfection or even a standardized
                methodology to determine infection severity or immune response. Thus,
                while these studies broadly establish some increase in protectiveness
                against SARS-CoV-2 among the studied populations, they as yet are
                unable to provide a reasonable degree of certainty on whether the
                degree of protection afforded any particular individual from their
                prior infection is sufficient to eliminate the grave danger from
                reinfection (see Milne, et al., October 21, 2021.) Third, while the
                research methodology itself creates difficulties in the context of
                OSHA's grave danger inquiry, the implications of trying to apply
                investigative research methodology to clinical practice are even more
                challenging. The need for the development of standardized methods and
                criteria for establishing sufficient immunity preclude the application
                of the studies' findings to robust and reliable clinical practice.
                These three rationales for OSHA's finding are described in more detail
                below.
                 Several epidemiological studies used previous RT-PCR positive cases
                to define previous infections (Hansen et al., March 27, 2021; Pilz et
                al., February 11, 2021; Vitale et al., May 28, 2021; Pouwels et al.,
                October 14, 2021; Braeye et al., September 15, 2021; Hall et al., April
                17, 2021). RT-PCR tests, particularly in the beginning of the pandemic,
                were given high priority to discern who seeking medical care was, in
                fact, infected. For instance, the progression of testing from medical
                needs to more of a community perspective is illustrated in Denmark
                (Vrangbaek et al., April 29, 2021). Denmark, considered one of the gold
                standard countries for its comprehensive testing program, missed five
                infections for every one it identified in the spring of 2020 (Espenhaim
                et al., August 22, 2021). Hansen et al. (March 27, 2021) depended
                greatly on these first surge infection definitions to determine that
                survivors had protection of 80.5% effectiveness during the second surge
                in Denmark from September through December, 2020. By only noting RT-PCR
                positives from the spring when testing was limited and highly focused
                on health care needs, it seems apparent that the study excluded many
                less severe cases (which are less likely to result in an effective
                immune response against reinfection), leading to results that may
                suggest greater protection is afforded by infection than in actuality.
                Even by December of 2020, it appears Denmark's gold standard
                comprehensive testing approach was only able to capture roughly half of
                all infections. Similar systemic undercounts have also been determined
                to be true in the United States where approximately three out of four
                infections have never been reported (CDC, July 27, 2021b).
                 It is important to recognize that RT-PCR testing was not
                implemented to find every infection, but was used instead to assist in
                determining when medical and community interventions were necessary.
                Infections without symptoms or with mild symptoms likely would not
                require medical intervention and, therefore, would likely not be
                identified via testing. The absence of this population that is more
                vulnerable to reinfection, in these studies, undercuts their usefulness
                in OSHA's grave danger analysis, because they may overestimate the
                protectiveness of immunity acquired through infection.
                 Several other studies in regions less known for their sampling
                approach than Denmark also were heavily dependent on early, limited
                pandemic RT-PCR testing. An Austrian study found a roughly ten-fold
                decrease in reinfection in survivors of reported infections from
                February to April 30, 2020 in comparison with the general public (Pilz
                et al., February 11, 2021). The authors noted that ``infections in the
                first wave are likely to have been far more common than the documented
                ones'' and referred to their results as a ``rough estimate.''
                Researchers at the Cleveland Clinic also found a reduced rate of
                reinfection in those who had a reported previous infection compared
                with those with no prior infection (13.8% infection rate for those
                previously uninfected and 4.9% infection rate for those previously
                infected), but noted that testing was limited in that the ``Cleveland
                Clinic did not test asymptomatic patients unless they were admitted to
                hospital or undergoing a procedure/surgery'' (Sheehan et al., March 15,
                2021). These criteria for testing create uncertainty in determining the
                level of effectiveness previous infection provides against SARS-CoV-2
                because many individuals with asymptomatic infections would not have
                been tested. Similar issues are also found in studies on populations in
                Italy, Belgium, and the UK (Vitale et al., May 28, 2021; Braeye et al.,
                September 15, 2021; Pouwels et al., October 14, 2021).
                 To avoid the well-known problems with RT-PCRs defining previous
                infection, other studies have defined previous infection as testing
                positive for antibodies specific for SARS-CoV-2 (Lumley et al.,
                February 11, 2021; Abu-Raddad et al., April 28, 2021; Hall et al.,
                April 17, 2021). As noted above, previous infection does not
                necessarily result in a seropositive outcome; one study indicated that
                nearly a quarter (24%) of those infected with SARS-CoV-2 subsequently
                showed no sign of an immune response in SARS-CoV-2-specific antibody
                testing (Wei et al., July 5, 2021). Therefore, studies only considering
                seropositive individuals are in essence studying only the individuals
                most likely to have protection from reinfection. Lumley et al.
                (February 11, 2021) found that those having a seropositive response had
                almost an order of magnitude fewer infections (e.g., 0.11 adjusted
                incidence rate ratio). Likewise, Abu-Raddad et al. (April 28,
                [[Page 61423]]
                2021) found that seropositive individuals were reinfected less (0.7%)
                during their study period in comparison to seronegative individuals
                (3.09%). In addition to the bias associated with using antibodies to
                determine previous infection, the authors also noted that there may
                have been issues with being able to document cases with mild or no
                symptoms.
                 Hall et al. (April 17, 2021) cast a wider net by defining previous
                infection to include both positive RT-PCR tests and seropositivity. The
                researchers found that those who were considered previously infected
                had an 84% lower risk of infection compared to those who were
                unvaccinated with no record of infection. While the study does attempt
                to capture as many previously-infected individuals as possible, this
                does not actually address the weaknesses of each method. Those with
                less severe infections were less likely to have sought out or been able
                to get an RT-PCR test during the first surge, which is when an
                overwhelming number of the previous infections were recorded in this
                study (March through May, 2020). Additionally, the less severe
                infections that are most likely underrepresented in the study appear to
                be the ones that are less likely to produce seropositivity. Shenai et
                al. (September 21, 2021) pooled several studies with the above issues
                and concluded that immunity acquired through a previous infection from
                SARS-CoV-2 may be as protective as, or more protective than, the
                immunity afforded by vaccination to an individual without previous
                infection. However, authors of several of those underlying studies used
                in the analysis noted that their studies were limited by not having the
                capability to fully account for asymptomatic infections (the
                aforementioned Lumley et al., July 3, 2021; Gazit et al., August 25,
                2021; Shrestha et al., June 19, 2021). As noted earlier, infection
                severity appears to be correlated with the robustness of immunity
                acquired through that infection, so the failure to account for
                asymptomatic infections may mean that this finding is related to the
                protection afforded by more severe disease. While pooled analyses can
                be utilized to make powerful observations, those observations are
                highly dependent upon the underlying studies not sharing the same
                methodological weakness which, in this case, was the studies' exclusion
                of asymptomatic infections.
                 Moreover, while the evidence suggests that severe infection may
                provide significant protection against reinfection in some cases (Milne
                et al., October 21, 2021), the level of protection cannot be determined
                on an individual basis. The studies discussed above are based on tests
                that show only whether a person was or was not infected and provide no
                information about the severity of the infection. Because the studies
                are likely biased towards those who had a relatively serious infection,
                their findings cannot be generalized to all individuals with prior
                infections.
                 RT-PCR and antibody testing are powerful tools with many clinical
                and research applications. However, the application of these tools
                cannot determine what degree of protection a particular individual has
                against SARS-CoV-2 without a great deal of additional study concerning
                thresholds establishing individual immunity. Therefore, these tools are
                not yet able to assist OSHA in making more nuanced findings about which
                workers who had COVID-19 previously are at grave danger. There is no
                established threshold to determine full protection from reinfection or
                a standardized methodology to determine infection severity or immune
                response. Studies use Ct threshold to approximate viral loads and infer
                disease severity, but that metric depends on many variables (e.g. time
                of collection during infection, quality of collection, handling of
                sample, specifics of the test protocol and materials, precision in
                performing the protocol) that are often of far less importance when it
                is used as a crude diagnostic to determine the presence of an
                infection. In other words, it is reasonable to say that the lower the
                Ct count, the greater the likelihood that an individual is at a lower
                reinfection risk; however, the Ct count is greatly dependent on the RT-
                PCR test used, and how different laboratories may run that test, which
                cannot be discerned. Similarly, research needs to be done to better
                identify the minimum protective threshold of anti-SARS-CoV-2 serum
                neutralizing antibodies (Milne et al., October 21, 2021). Thus, these
                studies currently do not allow OSHA to determine, with a reasonable
                degree of certainty, how much protection employees with prior
                infections have against reinfection.
                 Furthermore, while the research methodology itself raises
                challenges in making the grave danger determination, the implications
                of trying to apply investigative research methodology to clinical
                practice are even more difficult. The lack of standardized methods and
                standardized measures for immunity preclude their application to robust
                and reliable clinical practice. One major drawback discussed above is
                that, in contrast to vaccine studies where researchers know who was
                vaccinated with a standardized dosing regime, scientific inquiries
                likely will not be able to identify most individuals who were infected,
                the degree of disease experienced for those with a confirmed infection,
                and the immunity against reinfection. As of October 18, 2021, several
                RT-PCR assays have been authorized without standardization or
                assessment with respect to measuring disease severity (FDA, October 18,
                2021). As noted above, the use of the Ct threshold to approximate viral
                loads and infer disease severity is unreliable. As the FDA notes, the
                same is true about antibody tests, which are considered to be poor
                indicators for individuals to use to determine whether they are
                protected from reinfection (FDA, May 19, 2021). There are many
                different SARS-CoV-2-specific antibody tests that focus on different
                specificity. Not only are the outcomes of these tests not directly
                comparable to each other, but the specificity of these tests is not
                related to any notion of protection against reinfection. It can be
                reasonably said that a greater antibody response means a greater
                likelihood of protection against infection, but, again, the science is
                not clear what those thresholds are and whether a threshold would be
                comparable between laboratories. At this point in time, even if OSHA
                determined that some individuals with prior infections are not at grave
                danger from exposure to SARS-CoV-2, there is no agreement on what
                indicators of infection might be sufficient to confer this level of
                immunity or how a healthcare provider or employer could document that a
                certain level of immunity had been achieved.
                 Based on the best available evidence described above, OSHA
                concludes that while some individuals who were infected with SARS-CoV-2
                may have significant protection from subsequent infections, the level
                of protection afforded by infection may be significantly impacted by
                the severity of the infection and some previously infected individuals
                may have no future protection at all. In addition, given the
                limitations of the studies described above, there is considerable
                uncertainty as to whether any given individual is adequately protected
                against reinfection. Furthermore, the level of protection, if any,
                provided by a given person's SARS-CoV-2 infection cannot be ascertained
                based on currently-available testing methods. Therefore, OSHA finds
                that the requirements of this ETS are necessary to protect unvaccinated
                individuals who had prior SARS-CoV-2 infections from the grave danger
                from exposure to SARS-CoV-2.
                [[Page 61424]]
                 OSHA recognizes that its finding regarding infection-induced
                immunity is being made in an area of inquiry that is currently on the
                ``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
                Am. Petroleum Inst., 448 U.S. 607, 656 (1980)). For these reasons, OSHA
                finds that those who have previously been infected with SARS-CoV-2 and
                are not yet fully vaccinated are at grave danger from SARS-CoV-2
                exposure and that it is necessary to protect these workers via
                vaccination, or testing and the use of face coverings, under this
                standard. OSHA will continue to follow developments on this issue,
                however, and make appropriate adjustments to this ETS if the evidence
                warrants.
                VI. Conclusion.
                 OSHA finds that many employees in the U.S. who are not fully
                vaccinated against COVID-19 face a grave danger from exposure to SARS-
                CoV-2 in the workplace. OSHA's determination is based on the severe
                health consequences of exposure to the virus, including death; powerful
                lines of evidence demonstrating the transmissibility of the virus in
                the workplace; and the prevalence of infections in employee
                populations.
                 With respect to the grave health consequences of exposure to SARS-
                CoV-2, OSHA has found that regardless of where and how exposure occurs,
                COVID-19 can result in death. Even for those who survive a SARS-CoV-2
                infection, the virus can cause serious, long-lasting, and potentially
                permanent health effects. Serious cases of COVID-19 require
                hospitalization and dramatic medical interventions, and might leave
                employees with permanent and disabling health effects. Both death and
                serious cases of COVID-19 requiring hospitalization provide independent
                bases for OSHA's finding of grave danger. The evidence is clear that
                the safe and effective vaccines authorized and/or approved for use in
                the United States greatly reduce the likelihood of these severe
                outcomes.
                 The best available evidence on the science of transmission of the
                virus makes clear that SARS-CoV-2 is transmissible from person to
                person in shared workplace settings. The likelihood of transmission can
                be exacerbated by common characteristics of many workplaces, including
                working indoors, working with others for extended periods of time, poor
                ventilation, and close contact with potentially infectious individuals.
                The likelihood of transmission in the workplace is also exacerbated by
                the presence of unvaccinated workers, who are more likely than those
                who are vaccinated to be infected and transmit the virus to others.
                Every workplace SARS-CoV-2 exposure or transmission has the potential
                to cause severe illness or even death, particularly in unvaccinated
                workers. Taken together, the severe health consequences of COVID-19 and
                the evidence of its transmission in environments characteristic of the
                workplaces covered by this ETS demonstrate that exposure to SARS-CoV-2
                represents a grave danger to unvaccinated employees in many workplaces
                throughout the country.
                 The existence of a grave danger to employees from SARS-CoV-2 is
                further supported by the toll the pandemic has already taken on the
                nation as a whole and the number of workers who remain unvaccinated.
                Although OSHA cannot state with precision the total number of workers
                in our nation who have contracted COVID-19 at work and became sick or
                died, COVID-19 has killed 723,205 people in the United States as of
                October 18, 2021 (CDC, October 18, 2021--Cumulative US Deaths). That
                death toll includes 131,478 people who were 18 to 64 years old, prime
                working age (CDC, October 18, 2021--Demographic Trends, Deaths by Age
                Group). OSHA estimates that there are over 26 million workers subject
                to the rule who remain unvaccinated at present and therefore are in
                grave danger. As a result of this ETS, the agency estimates that 72% of
                them will be vaccinated (see OSHA, October 2021c).
                 Current mortality data shows that unvaccinated people of working
                age have a 1 in 202 chance of dying when they contract COVID-19 (CDC,
                October 18, 2021--Demographic Trends, Cases by Age Group; Demographic
                Trends, Deaths by Age Group). As of October 18, 2021, close to 45
                million people in the United States have been reported to have
                infections, and thousands of new cases were being identified daily
                (CDC, October 18, 2021--Daily Cases).One in 14 reported cases of COVID-
                19 in people ages 18 to 64 becomes severe and requires hospitalization
                (CDC, October 18, 2021--Demographic Trends, Cases by Age; Total
                Hospitalizations, by Age). Moreover, public health officials agree that
                these numbers fail to show the full extent of the deaths and illnesses
                from this disease, and racial and ethnic minority groups are
                disproportionately represented among COVID-19 cases, hospitalizations,
                and deaths (CDC, December 10, 2020; CDC, May 26, 2021; Escobar et al.,
                February 9, 2021; Gross et al., October 2020; McLaren, June 2020; CDC,
                October 6, 2021). Given this context, OSHA is confident in its finding
                that exposure to SARS-CoV-2 poses a grave danger to the employees
                covered by this ETS.
                 The above analysis fully satisfies the OSH Act's requirements for
                finding a grave danger. Although OSHA usually performs a quantitative
                risk assessment based on extrapolations among exposure levels before
                promulgating a health standard under section 6(b)(5) of the OSH Act (29
                U.S.C. 655(b)(5)), that type of analysis is not necessary in this
                situation. OSHA has most often invoked section 6(b)(5) authority to
                regulate exposures to chemical hazards involving much smaller
                populations, many fewer cases, extrapolations from animal evidence,
                long-term exposure, and delayed effects. In those situations,
                mathematical modelling is necessary to evaluate the extent of the risk
                at different exposure levels. The gravity of the danger presented by a
                disease with acute effects like COVID-19, on the other hand, is made
                obvious by a straightforward count of deaths and illnesses caused by
                the disease, which reach sums not seen in at least a century. The
                evidence compiled above amply supports OSHA's finding that SARS-CoV-2
                presents a grave danger in American workplaces. In the context of
                ordinary 6(b) rulemaking, the Supreme Court has said that the OSH Act
                is not a ``mathematical straitjacket,'' nor does it require the agency
                to support its findings ``with anything approaching scientific
                certainty,'' particularly when operating on the ``frontiers of
                scientific knowledge'' (Indus. Union Dep't, AFL-CIO v. Am. Petroleum
                Inst., 448 U.S. 607, 655-56 (1980)). This is true a fortiori in the
                current national crisis, where OSHA must act to ensure employees are
                adequately protected from the hazard presented by the COVID-19 pandemic
                (see 29 U.S.C 655(c)(1)).The grave danger from SARS-CoV-2 represents
                the biggest threat to employees in OSHA's more than 50-year history.
                The threat applies to employees in all sectors covered by OSHA,
                including general industry, construction, maritime, agriculture, and
                healthcare. Having made the determination of grave danger, as well as
                the determination that an ETS is necessary to protect employees from
                exposure to SARS-CoV-2 (see Need for the ETS, Section III.B. of this
                preamble), OSHA is required to issue this standard to protect employees
                from getting sick or dying from COVID-19 acquired at work (see 29
                U.S.C. 655(c)(1)).
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                COVID's first year. https://khn.org/news/article/us-health-workers-deaths-covid-lost-on-the-frontline/. (Spencer and Jewett, April 8,
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                Steinberg J et al. (2020, August 7). COVID-19 Outbreak among
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                Suhs T et al. (2021, July 23). COVID-19 Outbreak Associated with a
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                Taylor et al. (2021, October 22). Severity of Disease Among Adults
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                Tennessee Department of Health (TDH). (2021, September 8). COVID-19
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                Twohig K et al. (2021, August 27). Hospital admission and emergency
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                alpha (B.1.1.7) variants of concern: A cohort study. The Lancet
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                (Twohig et al., August 27, 2021)
                University of California San Diego (UCSD). (2021). Better Primary
                Care for You and Your Family. https://health.ucsd.edu/specialties/primary-care/Pages/default.aspx. (UCSD, 2021)
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                Vitale J et al. (2021, May 28). Assessment of SARS-CoV-2
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                B. Need for the ETS
                 This ETS is necessary to protect unvaccinated workers from the risk
                of contracting COVID-19, including its more contagious variants, such
                as the B.1.617.2 (Delta), at work. The rule protects workers through
                the most effective and efficient workplace control available:
                Vaccination. Additionally, this ETS is necessary to protect workers who
                remain unvaccinated through required regular testing, use of face
                coverings, and removal of infected employees from the workplace.
                I. Events Leading to the ETS
                 This section describes the evolution of OSHA's actions to protect
                employees from the grave danger posed by COVID-19 and the agency's
                reasons for issuing this ETS at this time.
                a. OSHA's 2020 Actions Regarding COVID-19
                 Beginning in early 2020, OSHA began to monitor the growing cases of
                the SARS-CoV-2 virus that were occurring around the country. Because
                scientific information about the disease, its potential duration, and
                ways to mitigate it were undeveloped, OSHA decided to monitor the
                situation. As noted below, OSHA subsequently issued numerous guidance
                documents advising interested employers of steps they could take to
                mitigate the hazard arising from the virus.
                 Also beginning in early 2020, OSHA received numerous petitions and
                supporting letters from members of Congress, unions, advocacy groups,
                and one group of large employers urging the agency to take immediate
                action by issuing an ETS to protect employees from exposure to the
                virus that causes COVID-19 (Scott and Adams, January 30, 2020; NNU,
                March 4, 2020; AFL-CIO, March 6, 2020; Menendez et al., March 9, 2020;
                Wellington, March 12, 2020; DeVito, March 12, 2020; Carome, March 13,
                2020; SMART, March 30, 2020; Blumenthal et al., April 8, 2020; Murray
                et al., April 29, 2020; Luong, April 30, 2020; Novoa, June 24, 2020;
                Solt, April 28, 2020; Castro et al., April 29, 2020; Talbott and Adely,
                May 4, 2020; Public Citizen, March 13, 2020;
                [[Page 61430]]
                LULAC, March 31, 2020; Meuser, May 1, 2020; Raskin, April 29, 2020;
                Cartwright et al., May 7, 2020; Frosh et al., May 12, 2020; Pellerin,
                March 19, 2020; Yborra, March 19, 2020; Owen, March 19, 2020; Brown et
                al., April 30, 2020; Price et al., May 1, 2020; ORCHSE, October 9,
                2020). These petitions and supporting letters argued that many
                employees had been infected because of workplace exposures to the virus
                that causes COVID-19, and that immediate, legally enforceable action is
                necessary for protection. OSHA quickly began issuing detailed guidance
                documents and alerts beginning in March 2020 that helped employers to
                determine employee risk levels of COVID-19 exposure and made
                recommendations for appropriate controls. As explained in detail in
                Section IV. of the Healthcare ETS, 86 FR 32376, 32412-13 (June 21,
                2021) and hereby included in the record for this ETS,\16\ at the time,
                OSHA leadership believed that implementing a combination of enforcement
                tools, including guidance, existing OSHA standards, and the General
                Duty Clause, would provide the necessary protection for workers. OSHA
                also expressed concern that an ETS might unintentionally enshrine
                requirements that are subsequently proven ineffective in reducing
                transmission.
                ---------------------------------------------------------------------------
                 \16\ This adoption includes the citations in the referenced
                section of the Healthcare ETS, which are also included in the docket
                for this ETS.
                ---------------------------------------------------------------------------
                 When it decided not to issue an ETS in the spring of 2020, OSHA
                determined that the agency could provide sufficient employee protection
                against COVID-19 through enforcing existing workplace standards and the
                General Duty Clause of the OSH Act, coupled with issuing industry-
                specific, non-mandatory guidance. However, in doing so OSHA indicated
                that its conclusion that an ETS was not necessary was specific to that
                time, and that the agency would continue to monitor the situation and
                take additional steps as appropriate (see, e.g., OSHA, March 18, 2020
                Letter to Congressman Scott (stating ``[W]e currently see no additional
                benefit from an ETS in the current circumstances relating to COVID-19.
                OSHA is continuing to monitor this quickly evolving situation and will
                take the appropriate steps to protect workers from COVID-19 in
                coordination with the overall U.S. government response effort.''
                (emphasis supplied); DOL May 29, 2020 at 20 (stating ``OSHA has
                determined this steep threshold [of necessity] is not met here, at
                least not at this time.'' (emphasis supplied))).
                 In addition to the various petitions for rulemaking that were
                submitted to OSHA, the AFL-CIO filed a petition for a writ of mandamus
                with the U.S. Court of Appeals for the D.C. Circuit, requesting that
                the court compel OSHA to issue an ETS. (AFL-CIO, May 18, 2020). In its
                administrative decision and filing in that case, OSHA explained that
                the determination not to issue an ETS was based on the conditions and
                information available to the agency at that time and was subject to
                change as additional information indicated the need for an ETS. On June
                11, 2020, the U.S. Court of Appeals for the D.C. Circuit issued a one
                paragraph per curiam order denying the AFL-CIO's petition to require
                OSHA to issue an ETS. To be clear, nothing in OSHA's prior position or
                the D.C. Circuit's decision in In re Am. Fed'n of Labor & Cong. of
                Indus. Orgs., No. 20-1158, 2020 WL 3125324 (D.C. Cir. June 11, 2020);
                rehearing en banc denied (July 28, 2020) precludes OSHA's decision to
                promulgate an ETS now. To the contrary, at an early phase of the
                pandemic, when vaccines were not yet available and when it was not yet
                known how extensive the impact would be on illness and death, the court
                decided not to second-guess OSHA's decision to hold off on regulation
                in order to see if its nonregulatory enforcement tools could be used to
                provide adequate protection against the virus. ``OSHA's decision not to
                issue an ETS is entitled to considerable deference,'' the court
                explained, noting ``the unprecedented nature of the COVID-19 pandemic''
                and concluding merely that ``OSHA reasonably determined that an ETS is
                not necessary at this time.'' (Id., with emphasis added).
                 Employers do not have a reliance interest in OSHA's prior decision
                not to issue an ETS on May 29, 2020, which did not alter the status quo
                or require employers to change their behavior. See Dep't of Homeland
                Security v. Regents of the Univ. of California, 140 S. Ct. 1891, 1913-
                14 (2020). As OSHA indicated when it made the decision, the
                determination was based on the conditions and information available to
                the agency at that time and was subject to change as additional
                information indicated the need for an ETS. In light of the agency's
                express qualifications and the surrounding context, any employer
                reliance would have been unjustified and cannot outweigh the
                countervailing urgent need to protect workers covered by this ETS from
                the grave danger posed by COVID-19.
                b. OSHA's Decision To Promulgate a Healthcare ETS
                 OSHA subsequently issued the Healthcare ETS to protect healthcare
                workers. 86 FR 32376. (June 21, 2021), codified at 29 CFR 1910.502.
                Looking back on a year of experience, OSHA found that its enforcement
                efforts had encountered significant obstacles, demonstrating that
                existing standards, regulations, and the General Duty Clause were
                inadequate to address the grave danger faced by healthcare employees.
                86 FR 32415. In promulgating that ETS, OSHA recognized that ``the
                impact of [COVID-19] has been borne disproportionately by the
                healthcare and healthcare support workers tasked with caring for those
                infected by this disease.'' 86 FR 32377. Furthermore, states and
                localities had taken increasingly divergent approaches to workplace
                protections against COVID-19, making it clear that a federal standard
                was needed to ensure sufficient protection in all states. 86 FR 32377.
                Therefore, OSHA focused on the unique situation experienced by
                healthcare industry workers as the frontline caregivers and support
                workers for those suffering from COVID-19. See 86 FR 32376, 32411-12.
                 The Healthcare ETS requires employers to institute a suite of
                engineering controls, administrative controls, work practices, and
                personal protective equipment to combat the COVID-19 hazard. In the
                Preamble to the Healthcare ETS, OSHA observed that the development of
                safe and highly effective vaccines is a critical milestone in the
                nation's response to COVID-19, and that fully vaccinated persons have a
                greatly reduced risk of death, hospitalization and other health
                consequences. 86 FR 32396. The Healthcare ETS therefore includes
                provisions intended to encourage employees to become vaccinated,
                including a requirement for employers to provide reasonable paid leave
                for vaccination and recovery from any side effects. 86 FR 32415, 29 CFR
                1910.502(m).
                 In the Healthcare ETS OSHA found that employees who work in covered
                healthcare workplaces are exposed to grave danger. 86 FR 32411. The
                agency also stated that in light of the effectiveness of vaccines,
                there was ``insufficient evidence in the record to support a grave
                danger finding for non-healthcare workplaces where all employees are
                vaccinated.'' 86 FR 32396 (emphasis supplied). OSHA made no finding at
                that time regarding unvaccinated workers in non-healthcare workplaces.
                [[Page 61431]]
                 No employer challenged the Healthcare ETS in court. The United Food
                and Commercial Workers Union (UFCW) together with the AFL-CIO filed a
                petition for review asserting that the rule should have gone further
                and included more industries in its scope (UFCW and AFL-CIO, June 24,
                2021). That case is being held in abeyance pending the issuance of this
                ETS.
                c. Subsequent Developments
                 The preamble to the Healthcare ETS notes that new COVID-19 variants
                might emerge that are more transmissible and cause more severe illness,
                but does not specifically mention the Delta Variant. See 86 FR 32384.
                Since publication of the Healthcare ETS, the Delta Variant has become
                the dominant form of the virus in the United States, causing large
                spikes in transmission, and surges of hospitalizations, and deaths,
                overwhelmingly among the unvaccinated (CDC, August 26, 2021; CDC,
                October 18, 2021--Variant Proportions, July Through October, 2021). As
                discussed in more detail in Grave Danger (Section III.A. of this
                preamble), the Delta Variant is at least twice as contagious as
                previous COVID-19 variants, and research suggests that it also causes
                more severe illness in the unvaccinated population (CDC, August 26,
                2021). More infections mean more potential for exposures, including in
                workplaces (see Grave Danger, Section III.A. of this preamble, for
                further discussion on workplace outbreaks, clusters, and the general
                impact of transmission in the workplace.). More infections also mean
                more opportunities for the virus to undergo mutations to its genetic
                code, resulting in genetic variants with the potential to infect or re-
                infect people.
                 Some variability in infection rates in a pandemic is to be
                expected. While the curves of new infections and deaths can bend down
                after peaks, they often reverse course only to reach additional peaks
                in the future (Moore et al., April 30, 2020). Last year experts
                expressed concern that one or more subsequent waves of COVID-19 were
                possible in 2021 (Moore et al., April 30, 2020), especially with new
                variants of COVID-19 in circulation (Doughton, February 9, 2021). That
                potential tragically became a reality with the spread of the Delta
                Variant.
                 In June 2021, when the Healthcare ETS was published, COVID-19
                transmission rates in the United States were at a low point, with the
                7-day moving average of reported cases to be about 12,000. (CDC, August
                26, 2021) However, by the end of July, the 7-day moving average reached
                over 60,000 as the Delta Variant spread across the country. (CDC,
                August 26, 2021). The 7-day moving average of reported cases at the
                beginning of September, 2021 exceeded 161,000 (CDC, October 18, 2021--
                Daily Cases). The most recent 7-day moving average of reported cases,
                while lower than the peak in late August and early September, is still
                over 85,000. (CDC, October 18, 2021--Daily Cases). These rates are also
                far higher than the rate when OSHA first declined to issue an ETS.
                (CDC, August 27, 2020 (20,401 confirmed cases per day on May 29,
                2020)). The jump in infections has resulted in increased
                hospitalizations and deaths for unvaccinated workers, as discussed in
                detail in Grave Danger (Section III.A. of this preamble). While the
                most current data reflect a decline in new cases from the peak, the
                level of new cases remains high. CDC data shows that, as of October 18,
                2021, approximately 85% of U.S. counties were experiencing ``high''
                rates of community transmission, and another 10% were experiencing
                ``substantial'' community transmission (CDC, October 18, 2021--Daily
                Cases). Although the number of new detected cases is currently
                declining nationwide (see CDC, October 18, 2021--Community Transmission
                Rates), the agency cannot assume based on past experience that
                nationwide case levels will not increase again. Indeed, many northern
                states are currently experiencing increases in their rate of new cases
                (see CDC, October 18, 2021--Cases, Deaths, and Laboratory Testing
                (NAATS) by State; Slotnik, October 18, 2021), including Vermont, which
                set a new record for new COVID-19 cases in mid-October 2021 (Murray,
                October 18, 2021). Unless vaccination rates increase, the experience of
                northern states during this fall could presage a greater resurgence in
                cases this winter as colder weather drives more individuals indoors
                (see Firozi and Dupree, October 18, 2021).
                 While it is important to recognize that the Delta Variant has
                caused a spike in hospitalization and death in the United States, the
                SARS-CoV-2 virus, and not just a particular variant of that virus, is
                the hazard that workers face (see Grave Danger, Section III.A. of this
                preamble). Like any virus, SARS-CoV-2 has the ability to mutate over
                time and produce variants that may be more or less severe. Indeed, the
                World Health Organization and the CDC both track new variants that have
                continued to arise, such as the Lamda and Mu Variants (WHO, October 12,
                2021; CDC, October 4, 2021). At this time, the CDC is tracking 11
                different variants of COVID-19 (CDC, October 4, 2021). The World Health
                Organization has classified the Lambda and Mu variants as ``variants of
                interest,'' meaning that they have genetic changes that affect
                transmissibility, disease severity, immune escape, diagnostic or
                therapeutic escape; and have been identified to cause significant
                community transmission or multiple COVID-19 clusters, in multiple
                countries with increasing relative prevalence alongside increasing
                number of cases over time, or other apparent epidemiological impacts to
                suggest an emerging risk to global public health (WHO, October 12,
                2021). Medical experts have also explained that vaccination reduces the
                opportunities for the virus to continue to mutate by reducing
                transmission and length of infection. And, there is no indication that
                future variants of COVID-19 will not be equally or even more dangerous
                than Delta without a higher rate of vaccination (Bollinger and Ray,
                July 23, 2021).
                 Meanwhile, evidence on the power of vaccines to safely protect
                individuals from infection and especially from serious disease has
                continued to accumulate. (CDC, May 21, 2021). For example, as explained
                in more detail in Grave Danger (Section III.A. of this preamble),
                multiple studies have demonstrated that vaccines are highly effective
                at reducing instances of hospitalization and death. In September the
                CDC compiled data from various studies that demonstrated overall
                authorized vaccines reduced death and severe case rates by 91 and 92%
                respectively in the population studied between April and July (Scobie
                et al., September 17, 2021, Table 1.). Additionally, the FDA granted
                approval to the Pfizer-BioNTech COVID-19 Vaccine for individuals 16
                years of age and older on August 23, 2021 (FDA, August 23, 2021). In
                announcing the decision, the FDA Commissioner explained that ``[w]hile
                this and other vaccines have met the FDA's rigorous, scientific
                standards for emergency use authorization, as the first FDA-approved
                COVID-19 vaccine, the public can be very confident that this vaccine
                meets the high standards for safety, effectiveness, and manufacturing
                quality the FDA requires of an approved product.'' (FDA, August 23,
                2021.)
                 Despite this important milestone, and the demonstrated
                effectiveness of the approved and authorized vaccines available to the
                public, millions of employees remain unvaccinated, approximately 39% of
                workers who are covered by this ETS (See Economic Analysis, Section
                IV.B. of this ETS). The rate of vaccination in the United States
                [[Page 61432]]
                has slowed significantly from its peak in April, when the daily number
                of vaccination doses administered exceeded three million at one point.
                In recent months, daily vaccination rates have hovered around one
                million doses administered, or lower (CDC, October 18, 2021--Daily
                Vaccination Rate). The shortfall in vaccination leaves the nation's
                working population vulnerable to sickness, hospitalization and death,
                whether today under the Delta Variant, or under future variants that
                may arise (CDC, October 18, 2021--Daily Vaccination Rate); see also
                Grave Danger (Section III.A. of this preamble).
                 Moreover, in recent months, an increasing number of states have
                promulgated Executive Orders or statutes that prohibit workplace
                vaccination policies that require vaccination or proof of vaccination
                status, thus attempting to prevent employers from implementing the most
                efficient and effective method for protecting workers from the hazard
                of COVID-19 (see, e.g., Texas Executive Order GA-40, October 11, 2021;
                Montana H.B. 702, July 1, 2021; Arkansas S.B. 739, October 4, 2021 and
                Arkansas H.B. 1977, October 1, 2021; AZ Executive Order 2021-18, August
                16, 2021). While some States' bans have focused on preventing local
                governments from requiring their public employees to be vaccinated or
                show proof of vaccination, the Texas, Montana, and Arkansas
                requirements apply to private employers as well. Other states have
                banned local ordinances that require employers to ensure that customers
                who enter their premises wear masks, thus endangering the employees who
                work there, particularly those who are unvaccinated (see, e.g., Florida
                Executive Order 21-102, May 3, 2021; Texas Executive Order GA-34, March
                2, 2021).
                 In short, at the present time, workers are becoming sick and dying
                unnecessarily as a result of occupational exposures, when there is a
                simple and effective measure, vaccination, that can largely prevent
                those deaths and illnesses (see Grave Danger, Section III.A. of this
                preamble). Congress charged OSHA with responsibility for issuing
                emergency standards when they are necessary to protect employees from
                grave danger. 29 U.S.C. 655(c). In light of the current situation, OSHA
                is issuing this emergency rule.
                References
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                Organizations (AFL-CIO). (2020, March 6). ``To Address the Outbreak
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                American Federation of Labor and Congress of Industrial
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                Writ Of Mandamus, and Request For Expedited Briefing And
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                Delta Variant: What We Know About the Science. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11512:cdc%20delta%20variant:sem.ga:p:RG:GM:gen:PTN:FY21. (CDC, August 26, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, October 4).
                SARS-CoV-2 Variant Classifications and Definitions. https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html. (CDC,
                October 4, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, October
                18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
                (CDC, October 18, 2021)
                DeVito J. (2020, March 12). ``Grant OSHA emergency standard for
                COVID-19 to protect frontline workers.'' (DeVito, March 12, 2020)
                Doughton S. (2021, February 9). Can a fourth wave of COVID-19 be
                prevented? Not likely, says Fred Hutch model--but the curve could be
                flattened. The Seattle Times. https://www.seattletimes.com/seattle-news/health/can-a-fourth-wave-of-covid-19-be-prevented-not-likely-says-fred-hutch-model-but-the-curve-could-be-flattened/. (Doughton,
                February 9, 2021)
                Firozee P and Dupree J. (2021, October 18). Coronavirus numbers are
                dropping. More vaccinations can prevent a winter surge, Fauci says.
                The Washington Post. https://www.washingtonpost.com/health/2021/10/18/faucis-americans-can-prevent-winter-pandemic-surge/. (Firozee and
                Dupree, October 18, 2021)
                Florida Executive Order 21-102. (2021, May 3). https://www.flgov.com/wp-content/uploads/orders/2021/EO_21-102.pdf. (Florida
                Executive Order 21-102, May 3, 2021)
                Food and Drug Administration (FDA) (2021, August 23). FDA Approves
                First COVID-19 Vaccine. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine. (FDA, August 23,
                2021)
                Frosh BE, Becerra X, Weiser PJ, Jennings K, Racine KA, Raoul K.,
                Frey AM, Healey M., Nessel D, Ellison K, Ford AD, Grewal GS,
                Balderas H, James L, Rosenblum EF, Shapiro J, Neronha P, Herring MP,
                Ferguson B, Kaul JL. (2020, May 12).
                [[Page 61433]]
                ``COVID-19 ETS Petition.'' (Frosh et al., May 12, 2020)
                League of United Latin American Citizens (LULAC). (2020, March 31).
                ``COVID-19 ETS Petition.'' (LULAC, March 31, 2020)
                Luong M. (2020, April 30). ``Petition for an OSHA Emergency
                Temporary Standard for Airborne Infectious Diseases.'' (Luong, April
                30, 2020)
                Menendez R, Murray P, Baldwin T, Brown S, Duckworth T, Booker CA,
                Warren E. (2020). ``Urge DOL to Direct OSHA to Issue Comprehensive
                Emergency Temporary Standard (ETS) To Protect Workers Against COVID-
                19.'' (Menendez et al., March 9, 2020)
                Meuser D. (2020, May 1). ``COVID-19 ETS Petition.'' (Meuser, May 1,
                2020)
                Moore KA et al. (2020, April 30). COVID-19: The CIDRAP Viewpoint.
                Part 1: The Future of the COVID-19 Pandemic: Lessons Learned from
                Pandemic Influenza. University of Minnesota Center for Infectious
                Disease Research and Policy. https://www.cidrap.umn.edu/sites/default/files/public/downloads/cidrap-covid19-viewpoint-part1_0.pdf.
                (Moore et al., April 30, 2020)
                Murray E. (2021, October 18). Vermont sets new positive COVID daily
                case record as delta surge continues. Burlington Free Press. https://www.burlingtonfreepress.com/story/news/local/2021/10/18/covid-vermont-new-daily-positive-case-record-set/8505021002/. (Murray,
                October 18, 2021)
                Murray P, Brown S, Heinrich M, Brown S, Blumenthal R., Markey EJ,
                Van Hollen C, Durbin RJ, Smith T, Whitehouse S, Wyden R, King Jr.
                AS, Kaine T, Reed J, Menedez R, Gillibrand K, Duckworth T, Warren E,
                Hassan MW, Casey Jr. RP, Sanders B, Udall T, Hirono MK, Harris KD,
                Feinstein D, Klobuchar A, Booker CA, Shaheen J, Cardin B. (2020,
                April 29). ``COVID-19 ETS Petition.'' (Murray et al., April 29,
                2020)
                National Nurses United (NNU). (2020, March 4). ``National Nurses
                United Petitions OSHA for an Emergency Temporary Standard on
                Emerging Infectious Diseases in Response to COVID-19.'' (NNU, March
                4, 2020)
                Novoa M. (2020, June 24). ``Direct OSHA to issue an emergency
                temporary standard to protect all workers from COVID-19 now!''
                (Novoa, June 24, 2020)
                Occupational Safety and Health Administration (OSHA). Letter from
                Loren Sweatt to Congressman Robert C. ``Bobby'' Scott. (OSHA, March
                18, 2020)
                ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
                Department of Labor--Occupational Safety and Health Administration
                (OSHA) for an Emergency Temporary Standard (ETS) for Infectious
                Disease.'' (ORCHSE, October 9, 2020)
                Owen M. (2020, March 19). ``Grant OSHA emergency standard to protect
                frontline workers from COVID-19.'' (Owen, March 19, 2020)
                Pellerin C. (2020, March 19). ``Grant OSHA emergency standard to
                protect frontline workers from COVID-19.'' (Pellerin, March 19,
                2020)
                Price D, Pocan M, Schakowsky J, DeLauro RL. (2020, May 1). ``COVID-
                19 ETS Petition.'' (Price et al., May 1, 2020)
                Public Citizen. (2020, March 13). ``Support for AFL-CIO's Petition
                for an OSHA Emergency Temporary Standard for Infectious Disease to
                Address the Epidemic of Novel Coronavirus Disease.'' (Public
                Citizen, March 13, 2020)
                Raskin J. (2020, April 29). ``COVID-19 ETS Petition.'' (Raskin,
                April 29, 2020)
                Scobie HM et al. (2021, September 17). Monitoring Incidence of
                COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination
                Status--13 U.S. Jurisdictions, April 4-July 17, 2021. MMWR Morb
                Mortal Wkly Rep 2021; 70: early release. https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm. (Scobie et al., September 17, 2021)
                Scott RC and Adams AS. (2020, January 30). ``Prioritize OSHA's Work
                on Infectious Diseases Standard/Immediate Issue of Temporary
                Standard.'' (Scott and Adams, January 30, 2020)
                Slotnik D. (2021, October 18). Coronavirus cases rise in the
                northern U.S. amid lower temperatures. The New York Times. https://www.nytimes.com/live/2021/10/18/world/covid-delta-variant-vaccine#covid-cases-us-winter. (Slotnik, October 18, 2021)
                International Association of Sheet Metal, Air, Rail and
                Transportation Workers (SMART). (2020, March 30). ``Petition for
                Emergency Standards.'' (SMART, March 30, 2020)
                Solt BE. (2020, April 28). ``COVID-19 ETS Petition'' (Solt, April
                28, 2020)
                Talbott R and Adely R. (2020, May 4). ``Rulemaking Petition to the
                United States Department of Labor Occupational Safety and Health
                Administration.'' (Talbott and Adely, May 4, 2020)
                Texas Executive Order GA-34. (2021, March 2). https://open.texas.gov/uploads/files/organization/opentexas/EO-GA-34-opening-Texas-response-to-COVID-disaster-IMAGE-03-02-2021.pdf.
                (Texas Executive Order GA-34, March 2, 2021)
                Texas Executive Order GA-40. (2021, October 11). https://gov.texas.gov/uploads/files/press/EO-GA-40_prohibiting_vaccine_mandates_legislative_action_IMAGE_10-11-2021.pdf. (Texas Executive Order GA-40, October 11, 2021)
                United Food and Commercial Workers International Union (UFCW) and
                American Federation of Labor and Congress of Industrial
                Organizations (AFL-CIO). (2021, June 24). ``Petition for Review,
                filed with the D.C. Circuit on June 24, 2021.'' (UFCW and AFL-CIO,
                June 24, 2021)
                Wellington M. (2020, March 12). ``Grant OSHA emergency standard for
                COVID-19 to protect front-line workers'' (Wellington, March 12,
                2020)
                World Health Organization (WHO). (2021, October 12). Tracking SARS-
                CoV-2 variants. https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/. (WHO, October 12, 2021)
                Yborra G. (2020, March 19). ``Grant OSHA emergency standard to
                protect frontline workers from COVID-19.'' (Yborra, March 19, 2020)
                II. This ETS Is Necessary To Protect Unvaccinated Employees From Grave
                Danger
                 As explained at length in the preceding section (Grave Danger,
                Section III.A. of this preamble), OSHA has determined that most
                unvaccinated workers across the U.S. economy are facing a grave danger
                posed by the COVID-19 hazard.\17\ This new hazard has taken the lives
                of more than 725,000 people--many of them workers--in the United States
                since it was first detected in this country in early 2020. As the
                federal agency tasked with protecting the safety and health of workers
                in the United States, OSHA is required to act when it finds that
                workers are exposed to a grave danger. 29 U.S.C. 655(c)(1). OSHA now
                finds that this emergency temporary standard is necessary to protect
                employees who are unvaccinated. Asbestos Info. Ass'n, 727 F.2d at 423
                (``failure to act does not conclusively establish that a situation is
                not an emergency . . . [when there is a grave danger to workers,] to
                hold that because OSHA did not act previously it cannot do so now only
                compounds the consequences of the Agency's failure to act.''). As
                explained in detail below, OSHA has determined that vaccination is the
                most effective control for abating the grave danger that unvaccinated
                employees face from the COVID-19 hazard. And, for workers who are not
                vaccinated, the use of testing, face coverings, and removal from the
                workplace, while not as effective as vaccination, is still effective
                and necessary.
                ---------------------------------------------------------------------------
                 \17\ As explained in the Grave Danger section, this ETS focuses
                on protecting unvaccinated workers from the grave danger that COVID-
                19 poses in the workplace. OSHA did not include fully vaccinated
                workers in its finding of grave danger because such workers are
                generally much better protected from the effects of COVID-19, and,
                in particular, the most severe effects, than workers who are
                unvaccinated. OSHA's action in adopting this ETS for unvaccinated
                workers does not mean that vaccinated workers do not face a
                significant risk from COVID-19, or that the OSH Act's general duty
                clause poses no obligation on employers to protect their vaccinated
                workers from COVID-19. Indeed, symptomatic infections can occur in
                fully vaccinated people, and COVID-19 therefore poses at least some
                risk to vaccinated workers. OSHA has requested comment on the risks
                faced by vaccinated workers from COVID-19, and what additional
                measures, if any, should be taken to protect both vaccinated and
                unvaccinated workers (see Request for Comments, Section I.B. of this
                preamble).
                ---------------------------------------------------------------------------
                 OSHA has determined that the best method for addressing the grave
                danger that COVID-19 poses to unvaccinated workers is to strongly
                encourage the use of the single most effective and efficient protection
                available: Vaccination. OSHA
                [[Page 61434]]
                has long recognized the importance of vaccinating workers against
                preventable illnesses to which they may be exposed on the job. See 56
                FR 64004, 64152 (Dec. 6, 1991) (discussing requirement in Bloodborne
                Pathogens standard for employer to make hepatitis B vaccine available
                to any employees with occupational exposure to blood and other
                potentially infectious materials). As explained in Grave Danger
                (Section III.A. of this preamble), COVID-19 vaccines do not completely
                eliminate the potential for infection, but significantly reduce the
                likelihood of infection, and in turn, transmission of the virus to
                others. Data from clinical trials for all three vaccines and
                observational studies for the two mRNA vaccines clearly establish that
                fully vaccinated persons have a greatly reduced risk of SARS-CoV-2
                infection compared to unvaccinated individuals (see FDA, December 11,
                2020; FDA, December 18, 2020; FDA, February 26, 2021).
                 More importantly, vaccination is the single most effective method
                for protecting workers from the most serious consequences of a COVID-19
                infection: Hospitalization and death. Although symptomatic infections
                can occur in fully vaccinated people, they are less likely to occur,
                and are far less likely to result in severe health outcomes or death.
                As discussed in Grave Danger (Section III.A. of this preamble), studies
                have established that the available COVID-19 vaccines are highly
                effective at preventing hospitalization, and even more effective at
                preventing death. For example, one study found that unvaccinated adults
                age 18 to 49 were 15.2 times more likely to be hospitalized and 17.2
                times more likely to die of COVID-19 than fully vaccinated people in
                the same age range, and unvaccinated adults age 50 to 64 were 10.9
                times more likely to be hospitalized and 17.9 times more likely to die
                than their fully vaccinated peers (Scobie et al., September 17, 2021).
                The New York Times reported on October 1, 2021, that of the
                approximately 100,000 individuals who died of COVID-19 since mid-June
                2021, less than 3% had been identified by the CDC as vaccinated
                individuals (Boseman and Leatherby, October 1, 2021).
                 Vaccines are also uniquely effective when compared to non-
                pharmaceutical methods for controlling exposure to COVID-19 at the
                workplace. To be sure, non-pharmaceutical controls play an important
                role in employers' efforts to prevent exposure to the virus; as
                discussed in detail earlier, OSHA has, throughout the pandemic, advised
                employers to implement various administrative, engineering, and other
                controls to reduce workplace exposure to the virus. And, for certain
                work settings in the healthcare industry where people with COVID-19 are
                reasonably expected to be present, OSHA both encouraged vaccination and
                mandated a suite of protections, many of which involve physical
                controls (see 29 CFR 1910.502). Indeed, workers who work indoors and
                near others are best protected from COVID-19 when they are fully
                vaccinated and their exposure to COVID-19 is reduced (to the extent
                possible) by non-pharmaceutical controls.
                 Non-pharmaceutical controls, however, focus on preventing employee
                exposure to the virus, and do not directly affect an employee's immune
                response if exposure to the virus does occur. Additionally, non-
                pharmaceutical controls often rely on the actions of individuals and/or
                the integrity of equipment to be effective; for example, to use PPE to
                control exposure, a worker must correctly don appropriate PPE each time
                there is potential exposure, must properly clean, store, and maintain
                the PPE between uses, and must replace the PPE when it is no longer
                effective (see, e.g., 29 CFR 1910.132 (general PPE requirements in
                general industry workplaces)). Accordingly, OSHA standards have always
                followed the principle of the hierarchy of controls, under which
                employers must control hazards by means other than PPE whenever
                feasible, and PPE is a supplementary control. See e.g., 29 CFR
                1910.134(a); 29 CFR 1910.1030(d)(2).
                 Physical distancing requires workers to maintain constant awareness
                of their environment in order to avoid coming into close proximity with
                colleagues, customers, or other individuals, even though the realities
                of their jobs and/or the design of the workplace may be unaccommodating
                to that effort. Requiring employees to examine themselves for signs and
                symptoms consistent with SARS-CoV-2 infection before reporting to work
                is prone to human error and entirely ineffective when the employee is
                infected but asymptomatic or pre-symptomatic.
                 In contrast, a worker is considered fully vaccinated after
                completing primary vaccination with a COVID-19 vaccine, or the second
                dose of any combination of two doses of a COVID-19 vaccine that is
                approved, authorized, or listed as a two-dose primary vaccination by
                the FDA or WHO (see the Summary and Explanation for paragraph (c),
                Section VI.C. of this preamble). Once fully vaccinated, a worker enjoys
                automatic and long-lasting benefits; namely, a drastic reduction in the
                risk of severe health effects or death. The vaccine works by bolstering
                the worker's immune system and does not depend on the worker's acumen
                or actions to afford its protection. Moreover, where an employer
                implements one or more non-pharmaceutical controls at the workplace,
                vaccination provides workers with a backstop of protection that greatly
                reduces their risk of serious health effects if they are exposed to the
                virus despite the presence of other controls. Vaccination thus ensures
                that workers need not rely on other factors, be it the workplace
                environment, the effectiveness of equipment, or the actions of other
                individuals, to be substantially protected from the worst potential
                outcomes of a COVID-19 infection.
                 This ETS focuses on encouraging vaccination because it is the most
                efficient and effective method for addressing the grave danger.
                Vaccination is patently appropriate and feasible for almost every
                worker in all industries, and will drastically reduce the risk that
                unvaccinated workers will suffer the serious health outcomes associated
                with SARS-CoV-2 infection. As described in Section III.A. of this
                preamble (Grave Danger), employees who are unvaccinated are in grave
                danger from the SARS-CoV-2 virus, but employees who are fully
                vaccinated are not. Since it is the lack of vaccination that results in
                grave danger, vaccination will best allay the grave danger. This ETS,
                which is designed to strongly encourage vaccination, is thus
                ``necessary to protect employees'' from a grave danger. 29 U.S.C.
                655(c).
                 OSHA continues to encourage employers to implement additional
                controls that may be appropriate to eliminate exposure to the SARS-CoV-
                2 virus at their workplace, but, as discussed further below, OSHA has
                not required employers to implement a comprehensive and multilayered
                set of COVID-19 exposure controls in this ETS. This decision reflects
                the extraordinary and exigent circumstances have required OSHA to
                immediately promulgate this emergency temporary standard. Although OSHA
                was able to design a comprehensive infection prevention program for the
                specific healthcare settings to which the June 2021 Healthcare ETS
                applied, this rule encompasses all industries covered by the OSH Act,
                and targets unvaccinated workers in any indoor work setting not covered
                by the Healthcare ETS where more than one person is present. Crafting a
                multi-layered standard that is comprehensive and feasible for all
                [[Page 61435]]
                covered work settings, including mixed settings of vaccinated and
                unvaccinated workers, is an extraordinarily challenging and complicated
                undertaking, yet the grave danger that COVID-19 poses to unvaccinated
                workers obliges the agency to act as quickly possible. As discussed
                above, OSHA has identified vaccination as the single most efficient and
                effective means for removing an unvaccinated worker from the grave
                danger.
                 Given the urgency of the rulemaking, and the singular effectiveness
                of vaccination in removing unvaccinated workers from the grave danger,
                OSHA is promulgating this ETS to immediately address the grave danger
                that COVID-19 poses to unvaccinated workers by strongly encouraging
                vaccination. As discussed in Pertinent Legal Authority (Section II. of
                this preamble), a ``grave danger'' represents a risk greater than the
                ``significant risk'' that OSHA must show in order to promulgate a
                permanent standard under section 6(b) of the OSH Act, 29 U.S.C. 655(b).
                OSHA will consider whether it is necessary to require additional
                controls to avert a significant risk of harm in the rulemaking
                proceedings that follow this ETS. OSHA directs employers to its
                website, www.osha.gov/coronavirus, and the CDC's website, www.cdc.gov/coronavirus, for guidance on the engineering, administrative, and other
                exposure controls that may be effective and appropriate for their
                workplace.
                 OSHA expects that, by strongly encouraging vaccination, this ETS
                will have a positive impact on worker health. As discussed above,
                millions of workers remain unvaccinated and are presently exposed to
                risks of hospitalization and death many times higher than their
                vaccinated coworkers. Although predicting the health impact of this ETS
                is particularly challenging, given the ever-changing nature of the
                pandemic and the many factors that may motivate workers to become fully
                vaccinated, OSHA has attempted to quantify the potential number of
                hospitalizations and fatalities that this ETS could avert by increasing
                workforce vaccination rates (see OSHA, October 2021c). OSHA has
                estimated that, as a result of the ETS, over 6,500 fewer currently
                unvaccinated workers will die from COVID-19 over the next six months.
                OSHA also estimates that this ETS will prevent over 250,000 currently
                unvaccinated workers from being hospitalized during that same time
                period. Even if OSHA's estimate does not prove to be precisely
                accurate, OSHA is confident that this ETS will save hundreds of lives
                and prevent thousands of workers from becoming severely ill.
                a. OSHA Finds It Necessary To Strongly Encourage Vaccination
                 Despite the proven safety and efficacy of the available COVID-19
                vaccines, many workers remain unvaccinated and are currently exposed to
                a grave danger. As discussed in Grave Danger (Section III.A. of this
                preamble), countless COVID-19 outbreaks have occurred in myriad work
                settings where employees come into contact with others, and in recent
                weeks, the majority of states in the U.S. have experienced what CDC
                defines as high or substantial community transmission, indicating that
                there is a clear risk of the virus being introduced into and
                circulating in workplaces (CDC, October 18, 2021--Community
                Transmission Rates). As of October 18, 2021, more than 184 million
                people in the United States have been fully vaccinated, but only 68.5%
                of people ages 18 years or older are fully vaccinated (CDC, October 18,
                2021--Fully Vaccinated). OSHA has estimated that approximately 62.4%
                percent of adults aged 18-74 within the scope of this ETS are either
                fully vaccinated or received their first vaccine dose during the
                previous two weeks, leaving approximately 31.7 million unvaccinated
                (i.e., not fully vaccinated and did not receive a first dose with in
                the past two weeks) (see Economic Analysis, Section IV.B. of this
                preamble, Table IV.B.7). Meanwhile, the rate of new vaccinations has
                slowed considerably; on October 15, 2021, the 7-day moving average
                number of administered vaccine doses reported to the CDC per day was
                841,731 doses, a steep reduction from the peak 3,448,156 dose average
                that the CDC reported on April 11, 2021 (CDC, October 18, 2021--Weekly
                Review).
                 Given the pervasiveness of the virus in workplaces across the
                country and the unparalleled efficacy of vaccines at preventing serious
                health effects, OSHA finds it necessary to strongly encourage
                vaccination. Encouraging vaccination is principally necessary to reduce
                the likelihood that workers who are infected by the SARS-CoV-2 virus
                will suffer the worst outcomes of an infection (hospitalization and
                death). Put simply, the single best method for protecting an
                unvaccinated worker from the serious health consequences of a COVID-19
                infection is for that worker to become fully vaccinated.
                 Additionally, encouraging vaccination is necessary to reduce the
                overall prevalence of the SARS-CoV-2 virus at workplaces. Because
                vaccinated workers are less likely than unvaccinated workers to be
                infected by the virus, they are less likely to spread the virus to
                others at their workplace, including to unvaccinated coworkers.
                Increasing workforce vaccination rates will therefore reduce the risk
                that unvaccinated workers will be infected by a coworker.
                 Evidence shows that mandating vaccination has proven to be an
                effective method for increasing vaccination rates, and that vaccination
                mandates have generally been more effective than merely encouraging
                vaccination. Significant numbers of workers would get vaccinated if
                their employers required it, and many workers who were vaccinated over
                the last four months were motivated by their employer requiring
                vaccination. The Kaiser Family Foundation (KFF) vaccine monitor, an
                ongoing research project tracking the public's attitudes and
                experiences with COVID-19 vaccinations, conducted a survey from
                September 13 to September 22, 2021, among a nationally representative
                random digit dial telephone sample of 1,519 adults ages 18 and older,
                and found that those who received their first dose of a COVID-19
                vaccine after June 1, 2021 were motivated by mandates of various sorts,
                including one in five (19%) who say a major reason was that their
                employer required it (KFF, September 2021). A survey conducted by
                Change Research from August 30 to September 2, 2021 regarding
                Americans' views on COVID-19 vaccines found that among the 1,775
                respondents, ``one of the things that was most likely to lead someone
                to get vaccinated was if their employer required it'' (Towey, September
                27, 2021).
                 Vaccine mandates imposed by state governments and large employers
                have also demonstrated the effectiveness of mandates in increasing
                vaccination rates. For example, when Tyson Foods announced its
                vaccination requirement in early August 2021, only 45% of its workforce
                had received a vaccination dose, but as of September 30, 2021, the New
                York Times reported that has increased to 91% (White House, October 7,
                2021; Hirsch, September 30, 2021). Similarly, United Airlines reported
                that 97% of its U.S.-based employees were fully vaccinated against
                COVID-19 within a week of the deadline of the company's vaccination
                mandate, and the 3% who were not fully vaccinated included several
                employees who sought a medical or religious exemption from vaccination
                (The Associated Press, September 22, 2021). In Washington State, the
                weekly vaccination rate increased 34% after the Governor announced
                vaccine requirements for
                [[Page 61436]]
                state workers (White House, October 7, 2021). The success of these
                COVID-19 vaccination mandates comports with the National Safety
                Council's recent finding that employers that instituted a COVID-19
                vaccination mandate produced a 35% increase in employee vaccination
                (NSC, September 2021). Similarly, the White House recently reported
                that its analysis of vaccination requirements imposed by healthcare
                systems, educational institutions, public-sector agencies, and private
                businesses demonstrated that such requirements increased their
                vaccination rates by more than 20 percentage points and have routinely
                seen their share of fully vaccinated workers rise above 90 percent
                (White House, October 7, 2021).
                 Given the effectiveness of vaccination mandates in increasing
                vaccination rates, OSHA expects that, in most instances, an employer
                implementing a policy that requires all employees to be vaccinated will
                be the most effective approach for increasing the vaccination rate of
                its employees and ensuring that they have the best protection available
                against the worst consequences of a COVID-19 infection. Although OSHA
                may well have the authority to impose a vaccination mandate, OSHA has
                decided against pursuing strict vaccination requirement and has instead
                crafted the ETS to strongly encourage vaccination. Employers are in the
                best position to understand their workforces and the approach that will
                work most effectively with them to secure employee cooperation and
                protection. OSHA's traditional practice when including medical
                procedures, such as medical surveillance testing and vaccinations, in
                its health standards has been to require the employer to make the
                medical procedure available to employees, and has viewed mandating
                those procedures as a measure to avoid if possible. For example, when
                the agency promulgated its standard regulating occupational exposure to
                lead, OSHA considered mandating that employees participate in physical
                examinations and biological monitoring, but ultimately required
                employers to make them available to employees (see 43 FR 54354, 54450
                (Nov. 21, 1978)). OSHA decided against mandating those procedures in
                part because it believed a voluntary approach would elicit more
                effective employee participation in the medical program and in part
                because of the agency's concerns about the Government intruding into a
                private and sensitive area of workers' lives (43 FR at 54450-51). OSHA
                has followed that same approach of requiring employers to ``provide''
                or ``make available'' medical procedures to employees in numerous
                subsequent standards, such as the standards for asbestos (29 CFR
                1910.1001), benzene (1910.1028), cotton dust (1910.1043), and
                formaldehyde (1910.1048).
                 OSHA adhered to this approach when it promulgated the Bloodborne
                Pathogens standard. The agency considered mandating a Hepatitis B
                vaccination, but instead required employers to make the Hepatitis B
                vaccination available to employees. 56 FR 64004, 64155 (Dec. 6, 1991);
                29 CFR 1910.1030(f)(1)(i), (f)(2)(i). OSHA explained that the agency
                may have the legal authority to mandate vaccination, but believed that,
                under the circumstances, a voluntary vaccination program would ``foster
                greater employee cooperation and trust in the system'' and ``enhance [
                ] compliance while respecting individuals' beliefs and rights to
                privacy.'' 56 FR at 64155.
                 In keeping with this traditional practice, the agency has stopped
                short of including a strict vaccination mandate with no alternative
                compliance option in this ETS. OSHA has never done so, and if it were
                to take that step, OSHA believes it more prudent to do so where the
                agency has ample time to fully assess the potential ramifications of
                imposing a vaccination mandate on covered employers and employees.
                Here, exigent circumstances demand that OSHA take immediate action to
                protect workers from the grave danger posed by COVID-19, but OSHA has
                not had a full opportunity to study the potential spectrum of impacts
                on employers and employees, including the economic and health impacts,
                that would occur if OSHA imposed a strict vaccination mandate with no
                alternative compliance option. Moreover, employers in their unique
                workplace settings may be best situated to understand their workforce
                and the strategies that will maximize worker protection while
                minimizing workplace disruptions. These considerations persuade the
                agency that this ETS should afford employers some flexibility in the
                form of an alternative option to strictly mandating vaccination. In
                light of the unique and grave danger posed by COVID-19, OSHA has
                requested comment on whether a strict vaccination mandate is warranted
                and the agency will consider all the information it receives as it
                determines how to proceed with this rulemaking (see Request for
                Comment, Section I.B. of this preamble).
                 Although this ETS does not impose a strict vaccination mandate,
                OSHA has determined that, to adequately address the grave danger that
                COVID-19 poses to unvaccinated workers, a more proactive approach is
                necessary than simply requiring employers to make vaccination available
                to employees. None of the standards that OSHA promulgated prior to this
                year concerned an infectious agent as readily transmissible as COVID-
                19. Standards like the Lead standard do not concern infectious agents
                that can be transmitted between individuals at a workplace;
                accordingly, the medical procedures that employers are required to make
                available under those standards are solely aimed at protecting the
                health of the worker who is undergoing the procedure. The Bloodborne
                Pathogens standard concerned exposure to infectious biological agents
                (Hepatitis B and HIV) that can be transmitted between individuals, but
                the potential for those agents to be transmitted between workers is
                minimal in comparison to the SARS-CoV-2 virus; Hepatitis B and HIV are
                transmitted through blood and certain body fluids, whereas the SARS-
                CoV-2 virus spreads through respiratory droplets that can travel
                through the air from worker-to-worker (see Grave Danger, Section III.A.
                of this preamble). Vaccination against COVID-19 is thus particularly
                important in reducing the potential for workers to become infected and
                spread the virus to others at the workplace, in addition to protecting
                the worker from severe health outcomes if they are infected. Moreover,
                the ease with which the SARS-CoV-2 virus spreads between workers makes
                it more urgent for workers to be vaccinated, and this urgency
                contributes to the agency's decision to strongly encourage vaccination.
                 Accordingly, to further the goal of increasing workforce
                vaccination rates, this ETS requires employers to implement a mandatory
                vaccination policy unless they adopt a policy in which employees may
                either be fully vaccinated or regularly tested for COVID-19 and wear a
                face covering in most situations when they work near other individuals.
                Employers have the duty under the OSH Act to provide safe workplaces to
                their employees, including protecting employees from known hazards by
                complying with occupational safety and health standards (see 29 U.S.C.
                654), and this ETS therefore provides employers with two compliance
                options for protecting unvaccinated workers from the grave danger posed
                by COVID-19. But while this ETS offers employers a choice in how to
                comply, OSHA has presented implementation of a vaccination mandate as
                the preferred compliance
                [[Page 61437]]
                option; as discussed above, vaccine mandates have proven to be
                effective in increasing vaccination rates, and OSHA expects that, in
                most instances, implementing a vaccination mandate will be the most
                effective method for increasing a workforce's vaccination rate. As
                discussed below, OSHA also recognizes that requiring that all employees
                be vaccinated provides more protection to vaccinated workers than
                regularly testing unvaccinated workers for COVID-19 and requiring them
                to wear face coverings when they work near others. This ETS will
                preempt inconsistent state and local requirements, including
                requirements that ban or limit employers' authority to require
                vaccination (see the Summary and Explanation for paragraph (a), Section
                VI.A. of this preamble), and will therefore provide the necessary legal
                authorization to covered employers to implement mandatory vaccination
                policies, if they choose to comply in this preferred manner.
                 Although the ETS does not require all covered employers to
                implement a mandatory vaccination policy, OSHA expects that employers
                that choose that compliance option will enjoy advantages that employers
                that opt out of the vaccination mandate option will not. Most
                obviously, employers with a mandatory vaccination policy will enjoy a
                dramatically reduced risk that their employees will become severely ill
                or die of a COVID-19 infection. In addition, employers who implement a
                vaccination mandate will likely have fewer workers temporarily removed
                from the workplace due to a COVID-19 positive test; this rule requires
                all covered employers to remove from the workplace any employee who
                tests positive for COVID-19 or receives a diagnosis of COVID-19 (see
                the Summary and Explanation for paragraph (h), Section VI.H. of this
                preamble), and because vaccinated workers are less likely than
                unvaccinated workers to be infected by the virus, OSHA expects
                employers with a mandatory vaccination policy will be statistically
                less likely to be obliged to remove a COVID-positive employee from the
                workplace in accordance with paragraph (h)(2). Additionally, only
                employers who decline to implement a mandatory vaccination program are
                required by the rule to assume the administrative burden necessary to
                ensure that unvaccinated workers are regularly tested for COVID-19 and
                wear face coverings when they work near others.
                 Where employers opt out of implementing a mandatory vaccination
                program, the ETS encourages employees to elect to be fully vaccinated.
                As discussed in the Summary and Explanation for paragraph (f) (Section
                VI.F. of this preamble), the ETS requires all covered employers to
                support vaccination by providing employees with reasonable time,
                including up to four hours of paid time, to receive each vaccination
                dose, and reasonable time and paid sick leave to recover from
                vaccination side effects. Many workers have been deterred from
                receiving vaccination by fears of missing work and/or losing pay to
                obtain vaccination and/or recover from side effects (see Section VI.F.
                of this preamble; see, e.g., KFF, May 6, 2021; KFF, May 17, 2021), and
                OSHA finds that this employer support is necessary to ensure that
                employees can become fully vaccinated without concern that they will be
                sacrificing pay or their jobs to do so.
                 All covered employers are required by the ETS to bear the cost of
                providing up to four hours of paid time and reasonable paid sick leave
                needed to support vaccination, but where an employee chooses to remain
                unvaccinated, the ETS does not require employers to pay for the costs
                associated with regular COVID-19 testing or the use of face coverings
                (see the Summary and Explanation for paragraphs (g) and (i), Sections
                VI.G. and VI.I. of this preamble). In some cases, employers may be
                required to pay testing and/or face covering costs under other federal
                or state laws or collective bargaining obligations, and some may choose
                to do so even without such a mandate, but otherwise employees will be
                required to bear the costs if they choose to be regularly tested and
                wear a face covering in lieu of vaccination.
                 This ETS more strongly encourages vaccination than the June 2021
                Healthcare ETS. OSHA designed the Healthcare ETS, which addresses the
                grave danger that COVID-19 poses workers in specific health care
                settings where COVID-19-positive individuals are reasonably likely to
                be present, to encourage vaccination (see 86 FR at 32415, 32423, 32565,
                32597). Specifically, the Healthcare ETS encourages vaccination by
                requiring employers to provide employees reasonable and paid time to
                receive vaccination doses and recover from side effects (29 CFR
                1910.502(m)), and by exempting from its scope ``well-defined hospital
                ambulatory care settings where all employees are fully vaccinated'' and
                all non-employees are screened and denied entry if they are suspected
                or confirmed to have COVID-19 (1910.502(a)(2)(iv)) and ``home
                healthcare settings where all employees are fully vaccinated'' and all
                nonemployees at that location are screened prior to employee entry so
                that people with suspected or confirmed COVID-19 are not present
                (1910.502 (a)(2)(v)).
                 Similar to the Healthcare ETS, this ETS requires employers to
                support vaccination by providing employees with reasonable time,
                including up to four hours of paid time, to receive vaccination, and
                reasonable time and paid sick leave to recover from vaccination side
                effects (see discussion above and the Summary and Explanation for
                paragraph (f), Section VI.F. of this preamble). However, as discussed
                above, this ETS goes further and expressly requires the implementation
                of a mandatory vaccination policy, unless the employer implements an
                alternative policy that requires unvaccinated workers to be regularly
                tested for COVID-19 and to wear face coverings in most situations when
                they work near others. While nothing in the Healthcare ETS prohibits
                covered employers from implementing a mandatory vaccination policy,
                this ETS presents the implementation of a mandatory vaccination policy
                as a preferred compliance option, and will preempt inconsistent state
                and local requirements that ban or limit employers' authority to
                require vaccination. Additionally, where the employer opts out of
                implementing a mandatory vaccination policy, and the employee opts out
                of vaccination, this ETS places no obligation on the employer to pay
                for costs associated with the regular testing of unvaccinated workers
                for COVID-19 or their use of face coverings, which will provide a
                financial incentive for some employees to be fully vaccinated.
                 OSHA finds it necessary to more strongly encourage vaccination in
                this ETS than in the Healthcare ETS in the manner described above. The
                Healthcare ETS's provisions that encouraged vaccination were packaged
                with a comprehensive infection prevention program that was tailored to
                the specific healthcare work settings to which the ETS applied,
                including a suite of layered and overlapping controls. In contrast,
                OSHA is promulgating this ETS to address the grave danger that COVID-19
                now poses to all unvaccinated workers who work indoors and in the
                presence of others. As mentioned above, crafting a comprehensive and
                multi-layered standard that is comprehensive and feasible for the
                myriad work settings to which this ETS will apply, including workplaces
                as diverse as schools, restaurants, retail settings, offices, prisons,
                and factories, is an
                [[Page 61438]]
                extraordinarily challenging and complicated undertaking.
                 Exigent circumstances require OSHA to immediately promulgate this
                ETS to protect unvaccinated workers, and vaccination is the single most
                efficient and effective method for removing unvaccinated workers from
                the grave danger. Given the urgency of the rulemaking and the singular
                efficacy of vaccination, OSHA has decided against including
                comprehensive and multilayered exposure controls in this ETS, and is
                instead focusing the ETS on strongly encouraging vaccination. Strongly
                encouraging vaccination is thus critical to the effectiveness of this
                ETS at protecting unvaccinated workers from the grave danger. In
                Request for Comment (Section I.B. of this preamble), OSHA seeks
                information on what additional measures, if any, should be required to
                protect employees against COVID-19.
                 Moreover, stronger encouragement of vaccination is needed in this
                ETS than in the Healthcare ETS because workers who are protected by the
                Healthcare ETS are more likely to be vaccinated and/or subject to a
                vaccination mandate. The Healthcare ETS, 29 CFR 1910.502, focused on
                healthcare work settings where COVID-19 is reasonably expected to be
                present, and, this ETS does not apply in settings where any employee
                provides healthcare services or healthcare support services while they
                are covered by the requirements of 29 CFR 1910.502 (see the Summary and
                Explanation for paragraph (b), Section VI.B. of this preamble).
                Evidence shows that workers in settings covered by Sec. 1910.502
                already have a high rate of vaccination. As of July 2021, healthcare
                workers had a higher rate of vaccination than non-healthcare workers
                (Lazer et al., August, 2021), and many healthcare workers are currently
                subject to vaccination mandates. Twenty-two states and the District of
                Columbia have instituted vaccination mandates that are applicable to
                healthcare workers (NASHP, October 1, 2021), and nearly 300 hospitals
                and broader health systems have implemented vaccine mandates for their
                employees (Renton et al., October 14, 2021). The White House reported
                that almost 2,500 hospitals, 40% of all U.S. hospitals, across all 50
                states, the District of Columbia, and Puerto Rico, have announced
                vaccination requirements for their workforce, and noted numerous
                examples of highly successful mandates in those workplaces (White
                House, October 7, 2021). News reports attest that many of these
                vaccination mandates have had great success in increasing the
                vaccination rate of the targeted healthcare workers (Goldberg, July 9,
                2021; Otterman and Goldstein, September 28, 2021; Hubler, September 30,
                2021; Beer, October 4, 2021). Even more healthcare workers covered by
                29 CFR 1910.502 will be subject to a vaccination mandate under the
                Centers for Medicare & Medicaid Services (CMS) rule published elsewhere
                in this issue of the Federal Register that requires COVID-19
                vaccinations for workers in most healthcare settings that receive
                Medicare or Medicaid reimbursement, including but not limited to
                hospitals, dialysis facilities, ambulatory surgical settings, and home
                health agencies. This CMS rule applies to at least 76,000 providers
                (i.e., employers) and covers a majority of healthcare workers across
                the country. OSHA expects that the combination of incentives to
                vaccination in the Healthcare ETS and vaccination mandates applicable
                to healthcare workers will leave few healthcare workers within the
                scope of the Healthcare ETS unvaccinated.
                b. Unvaccinated Workers Must Be Regularly Tested for COVID-19 and Use
                Face Coverings
                 As discussed above, this ETS presumptively requires employers to
                implement a mandatory vaccination policy, but permits employers to opt
                out of that requirement. Nonetheless, the grave danger that COVID-19
                poses to unvaccinated workers demands that alternative protective
                measures be taken at workplaces where the employer does not implement a
                mandatory vaccination policy. Given that the SARS-CoV-2 virus is highly
                contagious, transmitted easily through the air, and can lead to severe
                and/or fatal outcomes in unvaccinated workers, it is critical that
                employers who do not require their employees to be vaccinated implement
                controls to mitigate the potential for COVID-19 outbreaks to occur. As
                discussed above, and in Grave Danger (Section III.A. of this preamble),
                unvaccinated workers are more likely than vaccinated workers to be
                infected with COVID-19 and transmit the virus to others, and thus pose
                a heightened risk of spreading the virus at the workplace, including to
                other unvaccinated workers.
                 To reduce the risk that unvaccinated workers will spread COVID-19
                at the workplace, this rule requires employers that do not implement a
                mandatory vaccination policy to ensure that unvaccinated workers who
                report to a workplace where others are present are tested at least once
                a week for COVID-19. As discussed in the Summary and Explanation for
                paragraph (g) (Section VI.G. of this preamble), it is well-established
                that, by identifying and isolating infected individuals, regularly
                testing individuals for COVID-19 infection can be an effective method
                for reducing virus transmission. Regularly testing unvaccinated workers
                is essential because SARS-CoV-2 infection is often attributable to
                asymptomatic or presymptomatic transmission (Bender et al., February
                18, 2021; Byambasuren et al., December 11, 2020; Johansson et al.,
                January 7, 2021; Klompas et al., September 2021). In accordance with
                the CDC's recommendations, OSHA has set the minimum frequency of
                testing at 7 days because the agency expects that it will be effective
                in slowing the spread of COVID-19, while taking into account associated
                cost considerations (see the Summary and Explanation for paragraph (g),
                Section VI.G. of this preamble). As noted in the Request for Comment
                (Section I.B. of this preamble), OSHA is gathering additional
                information about whether OSHA should require testing more often than
                on a weekly basis.
                 The requirement for unvaccinated workers to be regularly tested for
                COVID-19 operates in tandem with paragraph (h)(2), which requires that
                all employers remove from the workplace any employee who receives a
                positive COVID-19 test, or a COVID-19 diagnosis (see the Summary and
                Explanation for paragraph (h), Section VI.H. of this preamble).
                Paragraph (h)(2) ensures that the COVID-19-positive employee will be
                isolated from the workplace until it is safe for the employee to
                return, and also allows the employee to seek medical care sooner and
                reduce the likelihood that they will suffer the most severe
                consequences of an infection (e.g., by seeking monoclonal antibody
                treatment). The combination of the testing and medical removal
                provisions will reduce the likelihood that an unvaccinated worker who
                has been infected with COVID-19, including those who are not
                experiencing symptoms of infection, will be permitted to spread the
                virus to others at the workplace, including unvaccinated coworkers.
                 Additionally, OSHA finds it necessary to require employers that do
                not implement a mandatory vaccination policy to ensure that
                unvaccinated workers wear face coverings in most situations when they
                are working near others. This reflects OSHA's recognition that
                regularly testing unvaccinated workers for COVID-19 will not be 100%
                effective in identifying infected workers before they enter the
                workplace. Most obviously, testing employees once a week will not
                prevent an unvaccinated
                [[Page 61439]]
                worker from exposing others at the workplace if the worker becomes
                infected and reports to the workplace in between their weekly tests.
                And, even if the rule required unvaccinated workers to be tested more
                frequently than once a week, infected persons may still be missed,
                particularly in areas with high community spread (Chin et al.,
                September 9, 2020).
                 Accordingly, requiring unvaccinated workers to wear face coverings
                in most situations when they are working near others will further
                mitigate the potential for unvaccinated workers to spread the virus at
                the workplace. As discussed in the Summary and Explanation for
                paragraph (i) (Section VI.I. of this preamble), it is well-established
                that face coverings provide effective source control; that is, they
                largely prevent respiratory droplets emitted by the wearer of the face
                covering from spreading to others, and thus make it significantly less
                likely that the person wearing the mask will transmit the virus, if
                they are infected. Face coverings are also believed to provide the
                wearer some limited protection from exposure to the respiratory
                droplets of co-workers and others (e.g., customers) (CDC, May 7, 2021),
                but the principal benefit of face coverings is to significantly reduce
                the wearer's ability to spread the virus. By requiring unvaccinated
                workers to wear face coverings, this rule significantly reduces the
                likelihood that an infected unvaccinated worker who enters the
                workplace despite the testing requirements will spread the virus to
                others, including unvaccinated coworkers.
                 OSHA acknowledges that regularly testing unvaccinated workers for
                COVID-19 and requiring them to wear face coverings when they work near
                others is less protective of unvaccinated workers than simply requiring
                all workers to be vaccinated. To be sure, OSHA strongly prefers that
                employers adopt a mandatory vaccination policy, as vaccination is
                singularly effective at protecting workers from the severe consequences
                that can result from a COVID-19 infection. And, where employers do not
                adopt a mandatory vaccination policy, employers may also consider
                alternative feasible measures that would remove employees who remain
                unvaccinated from the scope of this ETS, such as increasing telework
                (see the Summary and Explanation for paragraph (b), Section VI.B. of
                this preamble). Nonetheless, as discussed above, OSHA has not imposed a
                strict vaccination mandate on all covered employees who work in the
                presence of others and not exclusively outdoors, given that the agency
                has never previously used its authority to strictly mandate
                vaccination, and the exigent and extraordinary circumstances driving
                this emergency rulemaking have not afforded OSHA a full opportunity to
                assess the potential ramifications of including a strict vaccination
                mandate in this rule. Given these circumstances, and employers' unique
                understanding of the compliance approaches that will best increase
                vaccination rates among their workforce, OSHA has designed a rule that
                preserves a limited degree of employer flexibility, and strongly
                encourages, but does not strictly require, vaccination. OSHA has
                requested comment in this ETS on whether a strict vaccination mandate
                would be appropriate and the agency will consider those comments as it
                determines how to proceed with this rulemaking.
                References
                Beer T. (2021, October 4). COVID-19 Vaccine Mandates Are Working--
                Here's The Proof. Forbes. https://www.forbes.com/sites/tommybeer/2021/10/04/covid-19-vaccine-mandates-are-working-heres-the-proof/?sh=1a08d2e72305. (Beer, October 4, 2021)
                Bender JK et al. (2021, February 18). Analysis of asymptomatic and
                presymptomatic transmission in SARS-CoV-2 outbreak, Germany, 2020.
                Emerging Infectious Diseases. 27(4). https://doi.org/10.3201/eid2704.204576. (Bender et al., February 18, 2021)
                Boseman J and Leatherby L. (2021, October 1). U.S. Coronavirus Death
                Toll Surpasses 700,000 Despite Wide Availability of Vaccines. The
                New York Times. https://www.nytimes.com/2021/10/01/us/us-covid-deaths-700k.html. (Boseman and Leatherby, October 1, 2021)
                Byambasuren O et al., (2020, December 11). Estimating the extent of
                asymptomatic COVID-19 and its potential for community transmission:
                Systematic review and meta-analysis. Official Journal of the
                Association of Medical Microbiology and Infectious Disease Canada.
                5(4): 223-234 doi:10.3138/jammi-2020-0030. (Byambasuren et al.,
                December 11, 2020)
                Centers for Disease Control and Prevention (CDC). (2021, May 7).
                Science brief: Community use of cloth masks to control the spread of
                SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/masking-science-SARS-cov2.html. (CDC, May 7, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, October
                18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
                (CDC, October 18, 2021)
                Chin E et al. (2020, September 9). Frequency of routine testing for
                COVID-19 in high-risk healthcare environments to reduce outbreaks.
                https://doi.org/10.1101/2020.04.30.20087015. (Chin et al., September
                9, 2020)
                Food and Drug Administration (FDA). (2020, December 11). Emergency
                use authorization for an unapproved product review memorandum
                (Pfizer-BioNTech COVID-19 vaccine/BNT 162b2 mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. (FDA, December 11,
                2020)
                Food and Drug Administration (FDA). (2020, December 18). Emergency
                use authorization for an unapproved product review memorandum
                (Moderna COVID-19 vaccine/mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine. (FDA, December 18, 2020)
                Food and Drug Administration (FDA). (2021, February 26). Janssen
                COVID-19 vaccine. Vaccines and Related Biological Products Advisory
                Committee February 26, 2021 Meeting Briefing Document. https://www.fda.gov/media/146219/download. (FDA, February 26, 2021)
                Goldberg C. (2021, July 9). Hospital Vaccine Mandates Suggest
                Success in Boosting U.S. Shots. Bloomberg News. https://www.bloomberg.com/news/articles/2021-07-09/early-mandates-boost-worker-vaccine-rates-prompt-few-to-quit. (Goldberg, July 9, 2021)
                Hirsch L. (2021, September 30). After Mandate, 91% of Tyson Workers
                Are Vaccinated. https://www.nytimes.com/2021/09/30/business/tyson-foods-vaccination-mandate-rate.html. (Hirsch, September 30, 2021)
                Hubler S. (2021, September 30). `Mandates Are Working': Employer
                Ultimatums Life Vaccination Rates, So Far. The New York Times.
                https://www.nytimes.com/2021/09/30/us/california-vaccine-mandate-health-care.html. (Hubler, September 30, 2021)
                Johansson MA et al., (2021, January 7). SARS-CoV-2 transmission from
                people without COVID-19 symptoms. JAMA Network Open. 4(1): e2035057.
                doi:10.1001/jamanetworkopen.2020.35057. (Johansson et al., January
                7, 2021)
                Kaiser Family Foundation (KFF). (2021, May 6). KFF COVID-19 Vaccine
                Monitor: April 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/. (KFF, May 6, 2021)
                Kaiser Family Foundation (KFF). (2021, May 17). How employer actions
                could facilitate equity in COVID-19 vaccinations. https://www.kff.org/policy-watch/how-employer-actions-could-facilitate-equity-in-covid-19-vaccinations/. (KFF, May 17, 2021)
                Kaiser Family Foundation (KFF). (2021, September). Does The Public
                Want To Get A COVID-19 Vaccine? When? https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/?utm_source=web&utm_medium=trending&utm_campaign=COVID-19-vaccine-monitor#messagesandinformation. (KFF, September 2021)
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                Klompas M et al. (2021, September). The case for mandating COVID-19
                vaccines for health care workers. Annals of Internal Medicine.
                https://doi.org/10.7326/M21-2366. (Klompas et al., September 2021)
                Lazer D et al. (2021, August). The COVID States Project: A 50-State
                COVID-19 Survey Report #62: COVID-19 Vaccine Attitudes Among
                Healthcare Workers. http://news.northeastern.edu/uploads/COVID19%20CONSORTIUM%20REPORT%2062%20HCW%20August%202021.pdf. (Lazer
                et al., August, 2021)
                National Academy for State Health Policy (NASHP). (2021, October 1).
                State Efforts to Ban or Enforce COVID-19 Vaccine Mandates and
                Passports. https://www.nashp.org/state-lawmakers-submit-bills-to-ban-employer-vaccine-mandates/. (NASHP, October 1, 2021)
                National Safety Council (NSC). (2021, September). A Year in Review,
                and What's Next: COVID-19 Employer Approaches and Worker
                Experiences. https://www.nsc.org/faforms/safer-year-one-final-report. (NSC, September 2021)
                Occupational Safety and Health Administration (OSHA). (2021c,
                October). Health Impacts of the COVID-19 Vaccination and Testing
                ETS. (OSHA, October 2021c)
                Otterman S and Goldstein J. (2021, September 28). Thousands of N.Y.
                Health Care Workers Get Vaccinated Ahead of Deadline. The New York
                Times. https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html. (Otterman and Goldstein, September 28,
                2021)
                Renton B et al. (2021, October 14). New: Hospital Vaccine Mandate
                Tracker. Global Epidemics, Brown School of Public Health. https://globalepidemics.org/2021/07/24/new-hospital-vaccine-mandate-tracker/
                . (Renton et al., October 14, 2021)
                Scobie HM et al. (2021, September 17). Monitoring Incidence of
                COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination
                Status--13 U.S. Jurisdictions, April 4-July 17, 2021. MMWR Morb
                Mortal Wkly Rep 2021; 70: early release. https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm. (Scobie et al., September 17, 2021)
                The Associated Press. (2021, September 22). United Airlines says 97%
                of US employees have been vaccinated. https://www.wifr.com/2021/09/22/united-airlines-say-97-us-employees-have-been-vaccinated/. (The
                Associated Press, September 22, 2021)
                Towey R. (2021, September 27). CNBC poll shows very little will
                persuade unvaccinated Americans to get Covid shots. https://www.cnbc.com/2021/09/10/cnbc-poll-shows-very-little-will-persuade-unvaccinated-americans-to-get-covid-shots.html. (Towey, September
                27, 2021)
                White House. (2021, October 7). White House Report: Vaccination
                Requirements Are Helping Vaccinate More People, Protect Americans
                from COVID-19, and Strengthen the Economy. https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf. (White House, October 7, 2021)
                III. No Other Agency Action is Adequate To Protect Employees Against
                Grave Danger
                 OSHA's experience to date shows that the agency's existing tools
                are inadequate to meet the grave danger posed by COVID-19 to
                unvaccinated workers not covered by the Healthcare ETS. OSHA has
                determined that its existing standards, regulations, the OSH Act's
                General Duty Clause, and non-mandatory guidance will not adequately
                promote the most effective means to protect these workers: Vaccination.
                The agency has determined that this ETS is necessary to address these
                inadequacies. Multiple developments support this change in approach.
                First, large numbers of employees are continuing to contract COVID-19
                and die. (See Grave Danger, Section III.A. of this preamble). Further,
                based on a thorough review of its existing approach to protecting
                employees from COVID-19 and the current state of the pandemic, OSHA
                finds that existing OSHA standards, regulations, the General Duty
                Clause, and non-mandatory guidance are not adequate to protect
                employees outside healthcare from COVID-19. The Preamble to the
                Healthcare ETS includes a detailed analysis demonstrating the
                inadequacy of existing tools in the healthcare industry. See 86 FR
                32414-32423. In general, the same analysis applies here. The reasons
                existing tools were inadequate to protect healthcare workers apply in
                other industry sectors as well. The Healthcare ETS itself, while
                necessary to protect healthcare workers, of course applies only to that
                industry. Finally, the numerous guidance products published by other
                entities, such as CDC, are not adequate to protect employees because
                they are not enforceable; there is no penalty for noncompliance. 86 FR
                at 32415. Even as the CDC has increasingly recommended vaccination to
                protect from the dangers of transmission and severe illness related to
                the SARS-CoV-2 virus, vaccination rates remain uneven around the
                country. (CDC, September 9, 2021; Leonhardt, September 7, 2021; KFF,
                October 6, 2021; McPhillips and Cohen, May 19, 2021).
                 The need for this ETS is also reflected in the number of states and
                localities that have issued their own mandatory standards in
                recognition that OSHA's existing measures (including non-mandatory
                guidance, compliance assistance, and enforcement of existing standards)
                have failed to prevent the spread of the virus in workplaces.
                Additionally, as mentioned previously, other states have banned certain
                employers from implementing workplace vaccination mandates or from
                verifying an employee's vaccination status or from requiring face
                coverings. A national standard is necessary to establish clear
                requirements regarding vaccination, testing and face coverings that
                will protect employees in all states and preempt state or local
                ordinances that prevent employers from implementing necessary
                protections.
                a. The Current Standards and Regulations Are Inadequate
                 In the Healthcare ETS, OSHA considered its enforcement efforts with
                regard to existing standards and regulations that OSHA had identified
                as potentially applicable to occupational exposure to SARS-CoV-2.
                OSHA's analysis in Section IV of the Healthcare ETS, 86 FR 32376,
                32416-17 and hereby included in the record of this ETS,\18\ is
                applicable here in considering the need for this ETS, which covers a
                much broader set of employers in all industries. There OSHA found that
                none of the existing OSHA standards could sufficiently abate the hazard
                posed by COVID-19 in healthcare settings. Here again OSHA concludes
                that the potentially applicable existing standards are insufficient to
                address the grave danger faced by workers covered by this ETS. None of
                the current standards, even if more rigorously enforced, can
                sufficiently address this cross-industry hazard of national proportions
                to abate the grave danger posed by COVID-19 or lead to the same
                benefits that this ETS will achieve. See Asbestos Info. Ass'n/N. Am. v.
                Occupational Safety & Health Admin., 727 F.2d 415, 427 (5th Cir. 1984)
                (``[M]uch of the claimed benefit could be obtained simply by enforcing
                the current standard.'').
                ---------------------------------------------------------------------------
                 \18\ This adoption includes the citations in the referenced
                section of the Healthcare ETS, which are also included in the docket
                for this ETS.
                ---------------------------------------------------------------------------
                 Through its enforcement guidance, OSHA identified a number of
                current standards and regulations that might apply when workers have
                occupational exposure to SARS-CoV-2, most of which are the same
                standards OSHA considered in the Healthcare ETS. (Updated Interim
                Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19))
                (OSHA, July 7, 2021). OSHA has also cited the Hazard communication
                standard (29 CFR 1910.1200) during COVID-19 investigations.
                Accordingly, a list of
                [[Page 61441]]
                potentially applicable standards and regulations follows:
                 29 CFR part 1904, Recording and Reporting Occupational
                Injuries and Illnesses. This regulation requires certain employers to
                keep records of work-related fatalities, injuries, and illnesses and
                report them to the government in specific circumstances.
                 29 CFR 1910.132, General requirements--Personal Protective
                Equipment (PPE). This standard requires that appropriate PPE, including
                PPE for eyes, face, head, and extremities, protective clothing,
                respiratory devices, and protective shields and barriers, be provided,
                used, and maintained in a sanitary and reliable condition.
                 29 CFR 1910.134, Respiratory protection. This standard
                requires that employers provide, and ensure the use of, appropriate
                respiratory protection when necessary to protect employee health.
                 29 CFR 1910.141, Sanitation. This standard applies to
                permanent places of employment and contains, among other requirements,
                general housekeeping and waste disposal requirements.
                 29 CFR 1910.145, Specification for accident prevention
                signs and tags. This standard requires the use of biological hazard
                signs and tags, in addition to other types of accident prevention signs
                and tags.
                 29 CFR Subpart U--COVID-19 Emergency Temporary Standard.
                The Healthcare ETS, promulgated on June 21, 2021 includes various
                controls (patient screening and management, respirators and other PPE,
                limiting exposure to aerosol-generating procedures, physical
                distancing, physical barriers, cleaning, disinfection, ventilation,
                health screening and medical management, access to vaccination, anti-
                retaliation provisions, and medical removal protection) to address the
                grave danger posed by COVID-19 to healthcare workers.
                 29 CFR 1910.1020, Access to employee exposure and medical
                records. This standard requires that employers provide employees and
                their designated representatives access to relevant exposure and
                medical records.
                 29 CFR 1910.1200, Hazard communication. This standard
                requires employers to keep Safety Data Sheets (SDS) for chemical
                hazards, provide SDSs to employees and their representatives when
                requested, and train employees about those hazards. The standard does
                not apply to biological hazards, but hazard communication becomes an
                issue for the SARS-CoV-2 virus when chemicals are used to disinfect
                surfaces.
                 OSHA again finds that none of these existing standards provide for
                the types of workplace controls that are necessary to combat the grave
                danger addressed by this ETS. First, none of the listed potentially
                applicable standards require vaccination against SARS-CoV-2, the most
                efficient and effective control to combat the grave danger posed by the
                virus. (The Bloodborne Pathogen Standard requires that the hepatitis B
                vaccine be made available to certain employees, but that is not that is
                not relevant here, since the hepatitis vaccine provides no protection
                against COVID-19). Nor are the additional safety measures included in
                this ETS--vaccination verification, screening testing, face coverings,
                and medical removal of COVID-19 positive workers-- required by existing
                standards other than OSHA's Healthcare ETS (covering employees exempted
                from this new ETS while the Healthcare ETS is in effect).
                 Second, because existing standards do not contain provisions
                specifically targeted at the COVID-19 hazard, it may be difficult for
                employers and employees to determine what particular COVID-19 safety
                measures are required by existing standards, or how the separate
                standards are expected to work together as applied to COVID-19. An ETS
                that contains provisions specifically addressing COVID-19 hazards in
                covered workplaces will provide clear instructions. More certainty will
                lead to more compliance, and more compliance will lead to improved
                protection of employees covered by this standard.
                 Third, requirements in some standards may be appropriate for other
                situations but simply do not contemplate COVID-19 and fail to address
                important aspects of the hazard. For example, the general sanitation
                standard requires employers to provide warm water, soap, and towels
                that can be used in hand washing, but does not require disinfection or
                provision of hand sanitizer where handwashing facilities cannot be made
                readily available. See 86 FR 32417. Although the sanitation standard
                might appear at first glance to be relevant here, it simply does not
                require the types of controls that would, even if more rigorously
                enforced, sufficiently reduce the threat of COVID-19 in the workplace.
                As such, OSHA affirms its previous determination that some of the
                above-listed standards--including the sanitation standard--are in
                practice too difficult to apply to the COVID-19 hazard and have never
                been cited in COVID enforcement. 86 FR 32416.
                 Fourth, existing recordkeeping and reporting regulations do not
                adequately allow the employer or the agency to assess the full scope of
                COVID-19 workplace exposures and protection. OSHA's general
                recordkeeping regulations were not written with the nature of COVID-19
                transmission or illness in mind. In order to adequately understand and
                thereby control the spread of COVID-19 in the workforce, it is critical
                that the employer has records of employees' vaccination status, and of
                the testing undergone by employees who do not receive vaccination, and
                that it knows of all cases of COVID-19 occurring among employees.
                However, such information is outside of the scope of OSHA's existing
                recordkeeping requirements, which are limited to injuries or illnesses
                that the employer knows to be work-related.
                 Moreover, existing reporting regulations do not adequately ensure
                that OSHA has the full picture of the impact of COVID-19 because those
                regulations only require employers to report in-patient
                hospitalizations that occur within 24 hours of the work-related
                incident and to report fatalities that occur within thirty days of the
                work-related incident. 86 FR at 32417. Many COVID-19 infections will
                not result in hospitalization or death until well after these limited
                reporting periods. Under existing regulations, such cases are not
                required to be reported to OSHA, which limits the agency's ability to
                fully understand the impact of COVID-19 on the workforce. 86 FR 32417.
                This ETS includes a provision, paragraph (k), that removes the time
                limitation on reporting for COVID-19 cases.
                 In conclusion, OSHA's experience has demonstrated that existing
                standards and regulations are inadequate to address the current COVID-
                19 hazard.
                b. The General Duty Clause Is Inadequate To Meet the Current Crisis
                 Section 5(a)(1) of the OSH Act, or the General Duty Clause,
                provides the general mandate that each employer ``furnish to each of
                [its] employees employment and a place of employment which are free
                from recognized hazards that are causing or are likely to cause death
                or serious physical harm to [its] employees.'' 29 U.S.C. 654(a)(1). For
                General Duty Clause citations to be upheld, OSHA must demonstrate
                elements of proof that are supplementary to, and can be more difficult
                to show than, the elements of proof required for violations of specific
                standards, where a hazard is presumed. Specifically, to prove a
                violation of the General Duty Clause, OSHA needs to
                [[Page 61442]]
                establish--in each individual case--that: (1) An activity or condition
                in the employer's workplace presented a hazard to an employee; (2) the
                hazard was recognized; (3) the hazard was causing or was likely to
                cause death or serious physical harm; and (4) feasible means to
                eliminate or materially reduce the hazard existed. BHC Nw. Psychiatric
                Hosp., LLC v. Sec'y of Labor, 951 F.3d 558, 563 (D.C. Cir. 2020). OSHA
                often relies on the General Duty Clause to fill gaps where specific
                standards do not address a hazard and OSHA enforces it through case-by-
                case adjudicative proceedings. See United States v. Strum, 84 F.3d 1, 5
                (1st Cir. 1996).
                 OSHA has previously found the General Duty Clause to be inadequate
                to protect employees from dangers posed by infectious agents. In
                promulgating the bloodborne pathogens standard, OSHA explained that
                enforcement under the General Duty Clause was insufficient to protect
                employees from the serious hazards those pathogens present. 56 FR 64007
                (December 6, 1991). In the recently promulgated Healthcare ETS, OSHA
                found that the General Duty Clause was insufficient to protect
                healthcare workers from the grave danger they faced as well. 86 FR
                32418. While OSHA initially attempted to use the General Duty Clause to
                protect employees across all industries from COVID-19-related hazards,
                OSHA's experience has demonstrated that the Clause is grossly
                inadequate to protect employees covered by this ETS from the grave
                danger posed by COVID-19 in the workplace. As explained more fully
                below, OSHA finds this ETS is necessary to protect employees from the
                hazards of COVID-19.
                 As an initial matter, the General Duty Clause does not provide
                employers with specific requirements to follow or a roadmap for
                implementing appropriate abatement measures. The ETS, however, provides
                a clear statement of what OSHA expects employers to do to protect
                workers, thus facilitating better compliance. The General Duty Clause
                is so named because it imposes a general duty to keep the workplace
                free of recognized serious hazards; the ETS, in contrast, lays out
                clear requirements for employers to implement vaccination policies
                including vaccination verification, support for employee vaccination,
                screening testing and face coverings for unvaccinated workers, and
                medical removal of COVID-19 positive employees. Conveying obligations
                as clearly and specifically as possible makes it much more likely that
                employers will comply with those obligations and thereby protect
                workers from COVID-19 hazards. See, e.g., Integra Health Mgmt., Inc.,
                2019 WL 1142920, at *7 n.10 (No. 13-1124, 2019) (noting that standards
                ``give clear notice of what is required of the regulated community'');
                56 FR 64007 (``because the standard is much more specific than the
                current requirements [general standards and the general duty clause],
                employers and employees are given more guidance in carrying out the
                goal of reducing the risks of occupational exposure to bloodborne
                pathogens'').
                 Moreover, several characteristics of General Duty Clause
                enforcement actions make them an inadequate means to address hazards
                associated with COVID-19. First, it would be virtually impossible for
                OSHA to require and enforce the most important worker-protective
                elements of the ETS (such as vaccination and testing) under the General
                Duty Clause. Second, OSHA's burden of proof for establishing a General
                Duty Clause violation is heavier than for standards violations. Third,
                promulgating an ETS will enable OSHA to issue more meaningful penalties
                for willful and egregious violations, thus creating effective
                deterrence against employers who intentionally disregard their
                obligations under the Act or demonstrate plain indifference to employee
                safety. As discussed in more detail below, all of these considerations
                demonstrate OSHA's need to promulgate this ETS in order to protect
                unvaccinated workers covered by this standard from hazards posed by
                COVID-19.
                The General Duty Clause is ill-suited to requiring employers to adopt
                vaccination and testing policies, like those required by the ETS
                 Because the General Duty Clause requires OSHA to establish the
                existence and feasibility of abatement measures that can materially
                reduce a hazard, it is difficult for OSHA to use the clause to require
                specific control measures where an employer is doing something, but not
                what the Secretary has determined is needed to fully address the
                serious hazard. See, e.g., Waldon Health Care Center, 16 BNA OSHC 1052,
                1993 WL 119662 at * (No. 89-2804, 1993) (vacating OSHA citation
                requiring pre-exposure hepatitis B vaccination under General Duty
                Clause by finding that although vaccination would more fully reduce the
                hazard, the employer's chosen means of abatement were sufficient);
                Brown & Root, Inc., Power Plant Div., 8 BNA OSHC 2140, 1980 WL 10668 at
                *5 (No. 76-1296, 1980) (``[T]he employer may defend against a section
                5(a)(1) citation by asserting that it was using a method of abatement
                other than the one suggested by the Secretary.'').
                 Further, even where OSHA establishes a violation of the General
                Duty Clause, the employer is under no obligation to implement the
                feasible means of abatement proven by OSHA as part of its prima facie
                case. Cyrus Mines Corp., 11 OSH Cas. (BNA) 1063, 1982 WL 22717, at *4
                (No. 76-616, 1983) (``[The employer] is not required to adopt the
                abatement method suggested by the Secretary, even one found feasible by
                the Commission; it may satisfy its duty to comply with the standard by
                using any feasible method that is appropriate to abate the
                violation.''); Brown & Root, Inc., Power Plant Div., 1980 WL 10668 at
                *5. Thus, even in cases where OSHA prevails, the employer need not
                necessarily implement the specific abatement measure(s) OSHA
                established would materially reduce the hazard. The employer could
                select alternative controls and then it would be up to OSHA, if it
                wished to cite the employer again, to establish that the recognized
                hazard continued to exist and that its preferred controls could
                materially reduce the hazard even further.
                 Given the severity and pervasiveness of the COVID-19 hazard, OSHA
                has determined that the specific abatement measures provided in this
                ETS are necessary to protect workers from grave danger. Under the
                General Duty Clause alone, it would be nearly impossible to require
                employers to provide these specific measures, and even then, it could
                only be on a case-by-case enforcement basis. Considering the magnitude
                and ubiquity of the danger that SARS-CoV-2 poses to workers across the
                country, the case-by-case adjudicatory regime set up through the
                General Duty Clause is simply not adequate to combat the risk of severe
                illness and death caused by the virus.
                General Duty Clause Citations Impose a Heavy Litigation Burden on OSHA
                 Under the General Duty Clause OSHA must prove that there is a
                recognized hazard, i.e., a workplace condition or practice to which
                employees are exposed, creating the potential for death or serious
                physical harm to employees. See SeaWorld of Florida LLC v. Perez, 748
                F.3d 1202, 1207 (D.C. Cir. 2014); Integra Health Management, 2019 WL
                1142920, at *5. Whether a particular workplace condition or practice is
                a ``recognized hazard'' under the General Duty Clause is a question of
                fact that must be decided in each individual case. See SeaWorld of
                Florida LLC, 748 F.3d at 1208. In the case of a COVID-19-related
                citation, this means showing
                [[Page 61443]]
                not just that the virus is a hazard as a general matter--a fairly
                indisputable point--but also that the specific conditions in the cited
                workplace, such as unvaccinated, unmasked employees working in close
                proximity to other employees for extended periods, create a COVID-19-
                related hazard.
                 In contrast, an OSHA standard that requires or prohibits specific
                conditions or practices establishes the existence of a hazard. See
                Harry C. Crooker & Sons, Inc. v. Occupational Safety & Health Rev.
                Comm'n, 537 F.3d 79, 85 (1st Cir. 2008); Bunge Corp. v. Sec'y of Labor,
                638 F.2d 831, 834 (5th Cir. 1981). Thus, in enforcement proceedings
                under OSHA standards, as opposed to the General Duty Clause, ``the
                Secretary need not prove that the violative conditions are actually
                hazardous.'' Modern Drop Forge Co. v. Sec'y of Labor, 683 F.2d 1105,
                1114 (7th Cir. 1982). With OSHA's finding that the hazard of exposure
                to COVID-19 can exist for unvaccinated workers in all covered
                workplaces (see Grave Danger, Section III.A. of this preamble), the ETS
                will eliminate the burden to repeatedly prove, workplace by workplace,
                the existence of a COVID-19 hazard under the General Duty Clause.
                 One of the most significant advantages to standards like the ETS
                that establish the existence of the hazard at the rulemaking stage is
                that the Secretary can require specific abatement measures without
                having to prove that a specific cited workplace is already
                hazardous.\19\ In contrast, as discussed above, under the General Duty
                Clause the Secretary cannot require abatement before proving in the
                enforcement proceeding that an existing condition at the workplace is
                hazardous. For example, in a challenge to OSHA's Grain Handling
                Standard, which was promulgated in part to protect employees from the
                risk of fire and explosion from accumulations of grain dust, the Fifth
                Circuit acknowledged OSHA's inability to effectively protect employees
                from these hazards under the General Duty Clause in upholding, in large
                part, the standard. See Nat'l Grain & Feed Ass'n v. Occupational Safety
                & Health Admin., 866 F.2d 717, 721 (5th Cir. 1988) (noting Secretary's
                difficulty in proving explosion hazards of grain handling under General
                Duty Clause). Although OSHA had attempted to address fire and explosion
                hazards in the grain handling industry under the General Duty Clause,
                ``employers generally were successful in arguing that OSHA had not
                proved that the specific condition cited could cause a fire or
                explosion.'' Id. at 721 & n.6 (citing cases holding that OSHA failed to
                establish a fire or explosion hazard under the General Duty Clause).
                The Grain Handling Standard, in contrast, established specific limits
                on accumulations of grain dust based on its combustible and explosive
                nature, and the standard allowed OSHA to cite employers for exceeding
                those limits without the need to prove at the enforcement stage that
                each cited accumulation was likely to cause a fire or explosion. See
                id. at 725-26.
                ---------------------------------------------------------------------------
                 \19\ ``The Act does not wait for an employee to die or become
                injured. It authorizes the promulgation of health and safety
                standards and the issuance of citations in the hope that these will
                act to prevent deaths and injuries from ever occurring.'' Whirlpool
                Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also Arkansas-Best
                Freight Sys., Inc. v. Occupational Safety & Health Rev. Comm'n, 529
                F.2d 649, 653 (8th Cir. 1976) (noting that the ``[OSH] Act is
                intended to prevent the first injury'').
                ---------------------------------------------------------------------------
                 The same logic applies to COVID-19 hazards. Given OSHA's burden
                under the General Duty Clause to prove that conditions at the cited
                workplace are hazardous, it is difficult for OSHA to ensure necessary
                abatement before individual employee lives and health are unnecessarily
                endangered by exposure to COVID-19, despite widespread evidence of the
                grave danger posed by worker exposure to COVID-19. Indeed, despite
                publishing a voluminous collection of COVID-19 guidance online and
                receiving and investigating thousands of complaints, OSHA did not
                believe it could justify the issuance of more than 20 COVID-19 related
                General Duty Clause citations over the entire span of the pandemic so
                far, because of the quantum of proof the Secretary must amass under the
                General Duty Clause. Unlike enforcement under the General Duty Clause,
                this ETS allows OSHA to cite employers for each protective requirement
                they fail to implement without the need to wait for employee infection
                or death to prove in an enforcement proceeding that the particular
                cited workplace was hazardous without that particular measure in place.
                Thus, this ETS, which covers millions of workers nation-wide, is
                significantly preferable to the General Duty Clause with respect to
                such a highly transmissible virus because the inability to prevent a
                single exposure can quickly result in an exponential increase in
                exposures and illnesses or fatalities even at a single worksite.
                 An additional limitation of the General Duty Clause is that proving
                that there are feasible means to materially reduce a recognized hazard
                typically requires testimony from an expert witness in each separate
                case, which limits OSHA's ability to prosecute these cases as broadly
                as needed to protect workers, in light of the expense involved. See,
                e.g., Integra Health Management, 2019 WL 1142920, at *13 (requiring
                expert witness to prove proposed abatement measures would materially
                reduce hazard). In contrast, where an OSHA standard specifies the means
                of compliance, the agency has already made the necessary technical
                determinations in the rulemaking and therefore does not need to
                establish feasibility of compliance as part of its prima facie case in
                an enforcement proceeding. See, e.g., A.J. McNulty & Co. v. Sec'y of
                Labor, 283 F.3d 328, 334 (D.C. Cir. 2002); S. Colorado Prestress Co. v.
                Occupational Safety & Health Rev. Comm'n, 586 F.2d 1342, 1351 (10th
                Cir. 1978). Preventing the initial exposure and protecting as many
                workers as quickly as possible is especially critical in the context of
                COVID-19 because, as explained in Grave Danger, Section III.A. of this
                preamble, it can spread so easily in workplaces.
                The ETS will also permit OSHA to achieve meaningful deterrence when
                necessary to address willful or egregious failures to protect employees
                against the COVID-19 hazard
                 As described above, in contrast to the broad language of the
                General Duty Clause, this ETS will prescribe specific measures
                employers covered by this standard must implement. This specificity
                will make it easier for OSHA to determine whether an employer has
                intentionally disregarded its obligations or exhibited a plain
                indifference to employee safety or health. In such instances, OSHA can
                classify the citations as ``willful,'' allowing it to propose higher
                penalties, with increased deterrent effects. In promulgating the
                Healthcare ETS, OSHA noted that early in the pandemic, shifting
                guidance on the safety measures employers should take to protect their
                employees from COVID-19 created ambiguity regarding employers' specific
                obligations. Thus, OSHA could not readily determine whether a
                particular employer had ``intentionally'' disregarded obligations that
                were not yet clear. And, even as the guidance began to stabilize,
                OSHA's ability to determine ``intentional disregard'' or ``plain
                indifference'' was difficult, for example, when an employer took some
                steps address the COVID-19 hazard. 86 FR 32420. The Healthcare ETS
                largely resolved this issue for employers covered by that standard, by
                laying out clearly what parameters to put in place to protect
                healthcare workers. However, this general challenge persists in OSHA's
                [[Page 61444]]
                attempts at enforcement in other industries.
                 Further, OSHA has adopted its ``egregious violation'' policy to
                impose sufficiently large penalties that achieve appropriate deterrence
                against bad actor employers who willfully disregard their obligation to
                protect their employees when certain aggravating circumstances are
                present, such as a large number of injuries or illnesses, bad faith, or
                an extensive history of noncompliance (OSHA Directive CPL 02-00-080
                (October 21, 1990)). Its purpose is to increase the deterrent impact of
                OSHA's enforcement activity. This policy utilizes OSHA's authority to
                issue a separate penalty for each instance of noncompliance with an
                OSHA standard, such as each employee lacking the same required
                protections, or each workstation lacking the same required controls. It
                can be more difficult to use this policy under the General Duty Clause
                because the Fifth Circuit and the Occupational Safety and Health Review
                Commission have held that, under the General Duty Clause, OSHA may only
                cite a hazardous condition once, regardless of its scope or the number
                of workers affected. Reich v. Arcadian Corp., 110 F.3d 1192, 1199 (5th
                Cir. 1997). Thus, even where OSHA finds that an employer willfully
                failed to protect a large number of employees from a COVID-19 hazard,
                OSHA might not be able to cite the employer on a per-instance basis for
                failing to protect each of its employees. The provisions of this ETS
                have been intentionally drafted to make clear OSHA's authority to
                separately cite employers for each instance of the employer's failure
                to protect employees and for each affected employee, where appropriate.
                 By providing needed clarity, the ETS will facilitate ``willful''
                and ``egregious'' determinations that are critical enforcement tools
                OSHA can use to adequately address violations by employers who have
                shown a conscious disregard for the health and safety of their workers
                in response to the pandemic. Without the necessary clarity, OSHA has
                been limited in its ability to impose penalties high enough to motivate
                the very large employers who are unlikely to be deterred by penalty
                assessments of tens of thousands of dollars, but whose noncompliance
                can endanger thousands of workers. Indeed, OSHA has only been able to
                issue two COVID-19-related ``willful'' citations and no ``egregious''
                citations since the start of the pandemic because of the challenges
                described above.
                 For all of the reasons described above, and after over a year of
                attempting to use the General Duty Clause to address this widespread
                hazard, OSHA finds that the General Duty Clause is not an adequate
                enforcement tool to protect employees covered by this standard from the
                grave danger posed by COVID-19.
                c. OSHA and Other Entity Guidance Is Insufficient
                 OSHA has issued numerous non-mandatory guidance products to advise
                employers on how to protect workers from SARS-CoV-2 infection (see
                https://www.osha.gov/coronavirus). Even the most comprehensive guidance
                makes clear, as it must, that the guidance itself imposes no new legal
                obligations, and that its recommendations are ``advisory in nature.''
                (See OSHA's online guidance, Protecting Workers: Guidance on Mitigating
                and Preventing the Spread of COVID-19 in the Workplace (OSHA, Updated
                August 13, 2021); and OSHA's earlier 35-page booklet, Guidance on
                Preparing Workplaces for COVID-19, (OSHA, March 9, 2020)). This
                guidance, as well as guidance products issued by other government
                agencies and organizations, including the CDC, the Centers for Medicare
                & Medicaid Services (CMS), the Institute of Medicine (IOM), and the
                World Health Organization (WHO), help protect employees to the extent
                that employers voluntarily choose to implement the practices they
                recommend. Unfortunately, OSHA's experience and the continued spread of
                COVID-19 throughout the country shows that does not happen consistently
                or rigorously enough, resulting in inadequate protection for employees.
                For example, the CDC has strongly recommended vaccination since
                vaccines became widely available earlier in the year, but many
                employees have yet to take this simple step, which would protect
                themselves and their co-workers from the danger of COVID-19.
                 As documented in numerous peer-reviewed scientific publications,
                CDC, IOM, and WHO have recognized a lack of compliance with non-
                mandatory recommended infection-control practices (Siegel et al., 2007;
                IOM, 2009; WHO, 2009). As noted in the preamble to the Healthcare ETS,
                OSHA was aware of these findings when it previously concluded that an
                ETS was not necessary, but at the time of that conclusion, the agency
                erroneously believed that it would be able to effectively use the non-
                mandatory guidance as a basis for establishing the mandatory
                requirements of the General Duty Clause, and informing employers of
                their compliance obligations under existing standards. 86 FR 32421. As
                explained above, that has not proven to be an effective strategy.
                Moreover, when OSHA made its initial necessity determination at the
                beginning of the pandemic, it made an assumption that given the
                unprecedented nature of the COVID-19 pandemic, there would be an
                unusual level of widespread voluntary compliance by the regulated
                community with COVID-19-related safety guidelines. (See, e.g., DOL, May
                29, 2020 at 20 (observing that ``[n]ever in the last century have the
                American people been as mindful, wary, and cautious about a health risk
                as they are now with respect to COVID-19,'' and that many ``protective
                measures are being implemented voluntarily, as reflected in a plethora
                of industry guidelines, company-specific plans, and other sources'')).
                 Since that time, however, developments have led OSHA to conclude
                that the same uneven compliance documented by CDC, IOM, and WHO is also
                occurring for the COVID-19 guidance issued by OSHA and other agencies.
                For example, rising ``COVID fatigue'' or ``pandemic fatigue'' has been
                reported for nearly a year already--i.e., a decrease in voluntary use
                of COVID-19 mitigation measures over time (Meichtry et al., October 26,
                2020; Silva and Martin, November 14, 2020; Belanger and Leander,
                December 9, 2020; Millard, February 18, 2021). Other reasons that
                people have not followed COVID-19 guidance include fear of financial
                loss; skepticism about the danger posed by COVID-19; and even a simple
                human tendency, called ``psychological reactance,'' to resist curbs on
                personal freedoms, i.e., an urge to do the opposite of what somebody
                tells you to do (Belanger and Leander, December 9, 2020; Markman, April
                20, 2020). OSHA is seeing evidence of these trends in its COVID-19
                enforcement. For example, although OSHA has issued guidance since the
                spring of 2020 encouraging the use of physical distancing and barriers
                as a means of protecting employees at fixed work locations, there have
                been a number of news reports indicating that employers ignore that
                guidance (Romo, November 19, 2020; Richards, May 5, 2020; Lynch, July
                9, 2020). This was evidenced by a cross-sectional study performed from
                late summer to early fall of 2020 in New York and New Jersey that found
                non-compliance and widespread inconsistencies in COVID-19 response
                programs (Koshy et al., February 4, 2021). Indeed, OSHA continues to
                receive complaints and referrals attesting to such workplace practices.
                [[Page 61445]]
                (OSHA, October 17, 2021). Worse, some employers must now deal with
                employees who not only have yet to be vaccinated but compound the
                danger by hiding their unvaccinated status and declining to wear source
                protection that would identify them as unvaccinated, even though it
                could provide some protection to their coworkers, in workplaces where
                there is a stigma attached to being unvaccinated. (Ember and Murphy
                Marcos, August 7, 2021). This ETS contains notification and vaccine
                verification requirements that address these avoidant behaviors and
                mitigate the hazard of undisclosed exposure and transmission (see the
                Summary and Explanation for paragraphs (e), (g), and (h), Sections
                VI.E., VI.G., and VI.H. of this preamble).
                 OSHA's more recent guidance update encourages employers to
                facilitate employee vaccination by providing paid time off and
                encourages testing and masks for unvaccinated workers. However, as
                discussed previously, vaccination rates remain inconsistent across the
                country and have slowed significantly since the spring of 2021. And
                infection rates remain high, especially among the unvaccinated. It is
                clear, as discussed previously, that voluntary self-regulation by
                employers will not sufficiently reduce the danger that COVID-19 poses
                in workplaces covered by this standard. As noted in the White House
                Report on vaccination requirements released on October 7, at this time
                only 25% of businesses have vaccine mandates in place (White House,
                October 7, 2021). Since this ETS and other federal efforts to require
                vaccination were announced more private and public sector institutions
                have begun to prepare to implement vaccination requirements, further
                demonstrating the need for this rule as an impetus for employer action
                (White House, October 7, 2021).
                 The high number of COVID-19-related complaints and reports that
                OSHA continues to receive on a regular basis suggests a lack of
                widespread compliance with existing voluntary guidance: From March 2020
                to October 2021, OSHA has continued to receive hundreds of COVID-19-
                related complaints every month, including over 400 complaints during
                the month of August 2021, and over 450 complaints to date in the month
                of September (OSHA, October 11, 2021). And, as of October 17, OSHA has
                received 223 additional COVID-19-related complaints. (OSHA, October 17,
                2021). If guidance were followed more strictly, or if there were enough
                voluntary compliance with steps to prevent illness, OSHA would expect
                to see a significant reduction in COVID-19-related complaints from
                employees.
                 The dramatic increases in the percentage of the population that
                contracted the virus during the summer of 2021 indicates a continued
                risk of COVID-19 transmission in workplace settings (for more
                information on the prevalence of COVID-19 see Grave Danger, Section
                III.A. of this preamble) despite OSHA's publication of numerous
                specific and comprehensive guidance documents. OSHA has found that
                neither reliance on voluntary action by employers nor OSHA non-
                mandatory guidance is an adequate substitute for specific, mandatory
                workplace standards at the federal level. Public Citizen v. Auchter,
                702 F.2d 1150 at 1153 (voluntary action by employers ``alerted and
                responsive'' to new health data is not an adequate substitute for
                government action).
                d. A Uniform Nationwide Response to the Pandemic Is Necessary To
                Protect Workers
                 As the pandemic has continued in the United States, there has been
                increasing recognition of the need for a more consistent national
                approach (GAO, September, 2020; Budryk, November 17, 2020; Horsley, May
                1, 2020; DOL OIG, February 25, 2021). Many employers have advised OSHA
                that they would welcome a nationwide ETS. For example, in its October
                9, 2020 petition for a COVID-19 ETS, ORCHSE Strategies, LLC explained
                that it is ``imperative'' that OSHA issue an ETS to provide employers
                one standardized set of requirements to address safety and health for
                their workers (ORCHSE, October 9, 2020). This group of prominent
                business representatives explained that an ETS would eliminate
                confusion and unnecessary burden on workplaces that are struggling to
                understand how best to protect their employees in the face of confusing
                and differing requirements across states and localities.
                 The lack of a national standard on this hazard has led to
                increasing imbalance in state and local regulation, a problem that OSHA
                already identified as concerning in its Healthcare ETS. See 86 FR 32413
                (``The resulting patchwork of state and local regulations led to
                inadequate and varying levels of protection for workers across the
                country, and has caused problems for many employees and businesses.'')
                Since the Healthcare ETS was published, states and localities have
                taken increasingly more divergent approaches to COVID-19 vaccination,
                vaccination verification, screening testing, and the use of face
                coverings in the workplace. Currently, the spectrum ranges from states
                and localities requiring vaccine mandates and face coverings to states
                prohibiting or restricting them, with many states falling somewhere in
                between. Due to uneven approaches to vaccination across the country,
                states with the lowest rates of vaccination have COVID-19 infection
                rates four times as high as in states with the highest vaccine rates.
                (Leonhardt, September 7, 2021). Given that thousands of working age
                people continue to be infected with COVID-19 each week, many of whom
                will become hospitalized or die, OSHA recognizes that a patchwork
                approach to worker safety has not been successful in mitigating this
                infectious disease outbreak (CDC, October 18, 2021--Cases, By Age). It
                has become clear that a Federal standard, by way of this ETS, is
                necessary to provide clear and consistent protection to employees
                across the country. As explained in Pertinent Legal Authority (Section
                II. of this preamble) and the Summary and Explanation for paragraph (a)
                (Section VI.A. of this preamble), OSHA has the authority to
                comprehensively address the issue(s) described in this ETS, and the
                standard is intended to preempt conflicting state and local laws.
                 In sum, based on its enforcement experience during the pandemic to
                date, OSHA concludes that continued reliance on existing standards and
                regulations, the General Duty Clause, and guidance, in lieu of an ETS,
                is not adequate to protect unvaccinated employees from the grave danger
                of being infected by, and suffering death or serious health
                consequences from, COVID-19.
                References
                Belanger J and Leander P. (2020, December 9). What Motivates COVID
                Rule Breakers? Scientific American. https://www.scientificamerican.com/article/what-motivates-covid-rule-breakers/. (Belanger and Leander, December 9, 2020)
                Budryk Z. (2020, November 17). Fauci calls for `a uniform approach'
                to coronavirus pandemic. The Hill. https://thehill.com/policy/healthcare/526378-fauci-calls-for-a-uniform-approach-to-the-coronavirus-pandemic?rl=1. (Budryk, November 17, 2020)
                Centers for Disease Control and Prevention (CDC). (2021, September
                9). Your COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/your-vaccination.html. (CDC, September 9, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, October
                18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
                (CDC, October 18, 2021)
                [[Page 61446]]
                Ember S and Murphy Marcos C. (2021, August 7). They Don't Want the
                Shot. They Don't Want Colleagues to Know. The New York Times.
                https://www.nytimes.com/2021/08/07/business/workplace-vaccinations-coronavirus-reopenings.html. (Ember and Murphy Marcos, August 7,
                2021)
                Government Accountability Office (GAO). (2020, September). COVID-19:
                Federal Efforts Could Be Strengthened by Timely and Concerted
                Actions. https://www.gao.gov/assets/710/709934.pdf. (GAO, September
                2020)
                Horsley S. (2020, May 1). U.S. Workplace Safety Rules Missing in the
                Pandemic. National Public Radio. https://www.npr.org/2020/05/01/849212026/it-s-the-wild-west-u-s-workplace-safety-rules-missing-in-the-pandemic. (Horsley, May 1, 2020)
                Institute of Medicine (IOM). (2009). Respiratory Protection for
                Healthcare Workers in a Workplace Against Novel H1N1 Influenza A: A
                letter report. The National Academies Press. http://www.nap.edu/catalog/12748.html. (IOM, 2009)
                Kaiser Family Foundation (KFF). (2021, October 6). Latest Data on
                COVID-19 Vaccinations by Race/Ethnicity. https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-by-race-ethnicity/. (KFF, October 6, 2021)
                Koshy K et al., (February 4, 2021). Perspectives of region II OSHA
                authorized safety and health trainers about initial COVID-19
                response programs. Safety Science 138. https://doi.org/10.1016/j.ssci.2021.105193. (Koshy et al., February 4, 2021)
                Leonhardt D. (2021, September 7). One in 5,000. The New York Times.
                https://www.nytimes.com/2021/09/07/briefing/risk-breakthrough-infections-delta.html. (Leonhardt, September 7, 2021)
                Lynch R. (2020, July 9). Orange County to crack down on gyms that
                ignore Covid-19 safety guidelines. Orlando Business Journal. https://www.bizjournals.com/orlando/news/2020/07/09/orange-county-gyms-could-face-scrutiny-for-not.html. (Lynch, July 9, 2020)
                Markman A. (2020, April 20). Why are there still so many coronavirus
                skeptics? Fast Company. https://www.fastcompany.com/90492518/why-are-there-still-so-many-coronavirus-skeptics. (Markman, April 20,
                2020)
                McPhillips D and Cohen E. (2021, May 19). Uneven vaccination rates
                across the US linked to COVID-19 case trends, worry experts. CNN
                Health. https://www.cnn.com/2021/05/19/health/uneven-vaccination-rates-covid-19-trends/index.html. (McPhillips and Cohen, May 19,
                2021)
                Meichtry S et al. (2020, October 26). Pandemic Fatigue is Real--And
                It's Spreading; Collective exhaustion with coronavirus restrictions
                has emerged as a formidable adversary for governments. The Wall
                Street Journal. https://www.wsj.com/articles/pandemic-fatigue-is-realand-its-spreading-11603704601. (Meichtry et al., October 26,
                2020)
                Millard E. (2021, February 18). How to not let pandemic fatigue turn
                into pandemic burnout. Everyday Health. https://www.everydayhealth.com/coronavirus/how-to-not-let-pandemic-fatigue-turn-into-pandemic-burnout/. (Millard, February 18, 2021)
                Occupational Safety and Health Administration (OSHA). (2020, March
                9). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
                March 9, 2020
                Occupational Safety and Health Administration (OSHA). (2021, July
                7). Updated Interim Enforcement Response Plan for Coronavirus
                Disease 2019 (COVID-19). https://www.osha.gov/laws-regs/standardinterpretations/2021-07-07. (OSHA, July 7, 2021)
                Occupational Safety and Health Administration (OSHA). (2021, August
                13). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
                August 13, 2021)
                Occupational Safety and Health Administration (OSHA). (2021, August
                13). Protecting Workers: Guidance on Mitigating and Preventing the
                Spread of COVID-19 in the Workplace. https://www.osha.gov/coronavirus/safework. (OSHA, Updated August 13, 2021)
                Occupational Safety and Health Administration (OSHA). (2021, October
                17). Summary Data for Federal and State Programs--Enforcement.
                https://www.osha.gov/enforcement/covid-19-data#complaints_referrals.
                (OSHA, October 17, 2021)
                ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
                Department of Labor--Occupational Safety and Health Administration
                (OSHA) for an Emergency Temporary Standard (ETS) for Infectious
                Disease.'' (ORCHSE, October 9, 2020)
                Richards C. (2020, May 5). 2 Utah County businesses told staff to
                ignore COVID-19 guidelines, resulting in 68 positive cases. Daily
                Herald. https://www.heraldextra.com/news/local/2-utah-county-businesses-told-staff-to-ignore-covid-19-guidelines-resulting-in-68-positive/article_d8426991-a693-5879-9d88-f9e094aef5b5.html.
                (Richards, May 5, 2020)
                Romo V. (2020, November 19). Tyson managers suspended after
                allegedly betting if workers would contract COVID. National Public
                Radio. https://www.npr.org/2020/11/19/936905707/tyson-managers-suspended-after-allegedly-betting-if-workers-would-contract-covid.
                (Romo, November 19, 2020)
                Siegel J, Rhinehart E, Jackson M, Chiarello L, and the Healthcare
                Infection Control Practices Advisory Committee. (2007). 2007
                Guideline for isolation precautions: Preventing transmission of
                infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
                et al., 2007)
                Silva C and Martin M. (2020, November 14). U.S. Surgeon General
                Blames ``Pandemic Fatigue'' for Recent COVID-19 Surge. NPR. https://www.npr.org/sections/coronavirus-live-updates/2020/11/14/934986232/u-s-surgeon-general-blames-pandemic-fatigue-for-recent-covid-19-surge. (Silva and Martin, November 14, 2020)
                United States Department of Labor (DOL) and Office of the Inspector
                General (OIG). (2021, February 25). COVID-19: Increased Worksite
                Complaints and Reduced OSHA Inspections Leave U.S. Workers' Safety
                at Increased Risk. http://www.oig.dol.gov/public/reports/oa/2021/19-21-003-10-105.pdf. (DOL OIG, February 25, 2021)
                United States Department of Labor (DOL). (2020, May 29). In Re:
                American Federation Of Labor And Congress Of Industrial
                Organizations. Department Of Labor's Response to the Emergency
                Petition for a Writ of Mandamus, No. 20-1158 (D.C. Cir., May 29,
                2020). (DOL, May 29, 2020)
                White House. (2021, October 7). White House Report: Vaccination
                requirements are helping vaccinate more people, protect Americans
                from COVID-19, and strengthen the economy. https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf. (White House, October 7, 2021)
                World Health Organization (WHO). (2009). WHO Guidelines on Hand
                Hygiene in Health Care: A Summary--First Global Patient Safety
                Challenge Clean Care is Safer Care. https://www.ncbi.nlm.nih.gov/books/NBK144013/pdf/Bookshelf_NBK144013.pdf. (WHO, 2009)
                IV. Conclusion
                 This pandemic continues to take a massive toll on American society,
                and addressing it requires a comprehensive national response. This ETS
                is part of that response. OSHA shares the nation's hope for the promise
                of recovery created by the vaccines. But in the meantime, it recognizes
                that we have not yet succeeded in defeating the virus, and that many
                workers across the country are in grave danger. Therefore, this ETS,
                with mitigation measures emphasizing worker vaccination, is necessary.
                Although OSHA finds it necessary to institute specific mitigation
                measures for the immediate future, the agency can adjust as conditions
                change. Even after issuing an ETS, OSHA retains the flexibility to
                update the ETS to adjust to the subsequent evolution of CDC workplace
                guidance. This ETS addresses (and incorporates as a main component) the
                major development in infection control over the last year--the
                development and growing implementation of COVID-19 vaccines. Going
                forward, further developments can be addressed through OSHA's
                [[Page 61447]]
                authority to modify the ETS if needed, or to terminate it entirely if
                vaccination and other efforts end the current emergency. However, at
                this point in time, the available evidence indicates that the ETS is
                necessary to protect unvaccinated employees across the country from the
                grave danger of COVID-19.
                IV. Feasibility
                A. Technological Feasibility
                 This section presents an overview of the technological feasibility
                assessment for OSHA's Emergency Temporary Standard (ETS) for COVID-19
                that requires all employers with 100 or more employees to ensure that
                all employees are fully vaccinated unless they implement a policy
                requiring employees to undergo testing for COVID-19 at least once every
                seven days and wear face coverings.
                 Technological feasibility has been interpreted broadly to mean
                ``capable of being done'' (Am. Textile Mfrs. Inst. v. Donovan, 452 U.S.
                490, 509-510 (1981)). A standard is technologically feasible if the
                protective measures it requires already exist, can be brought into
                existence with available technology, or can be created with technology
                that can reasonably be expected to be developed, i.e., technology that
                ``looms on today's horizon'' (United Steelworkers of Am., AFL-CIO-CLC
                v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980) (Lead I)); Amer. Iron
                & Steel Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (Lead II);
                American Iron and Steel Inst. v. OSHA, 577 F.2d 825 (3d Cir. 1978)).
                Courts have also interpreted technological feasibility to mean that a
                typical firm in each affected industry or application group will
                reasonably be able to implement the requirements of the standard in
                most operations most of the time (see Public Citizen v. OSHA, 557 F.3d
                165 (3d Cir. 2009); Lead I, 647 F.2d at 1272; Lead II, 939 F.2d at
                990).
                 OSHA issued an ETS in June 2021 to protect healthcare and
                healthcare support employees in covered healthcare settings from
                exposure to SARS-CoV-2. See 86 FR 32376 (June 21, 2021) (Healthcare
                ETS). OSHA found the requirements in that ETS to be technologically
                feasible, including a requirement for employers to pay for vaccination
                of employees that is very similar to the requirement in this new ETS.
                OSHA's finding that the Healthcare ETS was technologically feasible was
                primarily based on available evidence showing that most healthcare
                employers, and employers across all industry sectors, had already
                implemented, or were in process of implementing, procedures similar to
                those required by the Healthcare ETS. Similarly, OSHA's feasibility
                findings for this ETS are based on evidence that vaccination and
                testing policies, along with the use of face coverings consistent with
                recommendations from the CDC, have been implemented in multiple
                industry sectors as testing and vaccinations were made more widely
                available during the course of the pandemic.
                 As discussed in Summary and Explanation (Section VI. of this
                preamble), this ETS for vaccination and testing applies to all
                employers with 100 or more employees, except as noted here. It does not
                apply to workplaces covered under the Safer Federal Workforce Task
                Force COVID-19 Workplace Safety: Guidance for Federal Contractors and
                Subcontractors or settings where any employee provides healthcare
                services or healthcare support services when subject to the
                requirements of the Healthcare ETS (29 CFR 1910.502). It also does not
                apply to employees who do not report to a workplace where other
                individuals such as coworkers or customers are present, employees while
                they are working from home, or employees who work exclusively outdoors.
                 As noted above, OSHA has the legal duty to demonstrate that the
                average employer covered by this ETS can comply with that standard in
                most operations most of the time. This legal analysis is therefore
                focused solely on whether employers with 100 or more employees can
                comply with the standard. OSHA's rationale for that scope threshold of
                100 or more employees is explained in the Summary and Explanation for
                paragraph (b), Section VI.B. of this preamble.
                 As discussed below, OSHA finds no technological feasibility
                barriers related to compliance with the requirements in the ETS. These
                requirements include establishing and implementing a written mandatory
                COVID-19 vaccination policy or alternative policy requiring testing and
                face coverings; determining employee vaccination status; supporting
                employee vaccination by providing paid time for vaccination and time
                off for recovery; ensuring that employees who are not fully vaccinated
                are tested for COVID-19 at least once every seven days and wear face
                coverings; and recordkeeping for employee vaccination status and
                testing.
                 OSHA reviewed numerous large-scale employer surveys and vaccination
                and testing policies developed by employers, public health
                organizations, trade association, and local, state, and federal
                governmental bodies. While OSHA discusses several examples of these
                plans and policies below,\20\ OSHA's feasibility determination is based
                on all evidence in the rulemaking record. The majority of the survey
                data and other publicly available material that OSHA reviewed pertains
                to large employers with 100 or more employees.
                ---------------------------------------------------------------------------
                 \20\ While OSHA references several employers' policies, this is
                not intended to serve as an endorsement of those plans or an
                indication that those plans comply with the ETS. Rather, the plans
                and best practice documents show that developing and implementing
                policies to address employee COVID-19 vaccination in various
                workplaces is capable of being done in a variety of industries, and
                therefore, compliance with the ETS is technologically feasible.
                ---------------------------------------------------------------------------
                 Additionally, OSHA thoroughly reviewed current and future
                projections of the availability of COVID-19 tests, testing supplies,
                and laboratory capacity. Based on a review of vaccination and testing
                policies among large employers, OSHA has determined that most employers
                covered by this standard across a wide range of industries have either
                already implemented vaccination and testing programs and require
                unvaccinated employees to wear face coverings, or are capable of
                implementing programs that comply with the requirements in the ETS most
                of the time. OSHA therefore finds that the standard is technologically
                feasible.
                I. Employer Policy on Vaccination
                 Paragraph (d)(1) of the ETS requires each covered employer to
                establish and implement a written mandatory vaccination policy unless
                the employer adopts an alternative policy requiring COVID-19 testing
                and face coverings for unvaccinated employees, which is discussed
                later. To meet the definition of ``mandatory vaccination policy'' under
                paragraph (c), the policy must require: Vaccination of all employees,
                including all new employees as soon as practicable, other than those
                employees (1) for whom a vaccine is medically contraindicated, (2) for
                whom medical necessity requires a delay in vaccination, or (3) those
                legally entitled to a reasonable accommodation under federal civil
                rights laws because they have a disability or sincerely-held religious
                beliefs, practices, or observances that conflict with the vaccination
                requirement.
                 OSHA requires employers to implement a mandatory vaccination
                requirement, but provides an exemption for an alternative policy that
                allows employees to choose either to be fully vaccinated or to be
                regularly tested and wear a face covering. This compliance options mean
                that the ETS is
                [[Page 61448]]
                technologically feasible if employers across various industries are
                capable of implementing either policy, but nevertheless OSHA analyzes
                both employer policy options to demonstrate that there are no
                significant technological barriers to either approach.
                 OSHA reviewed several large-scale employer surveys related to
                vaccination policies across the country covering a wide range of
                industry sectors. Surveys conducted by Arizona State University (ASU)
                and the World Economic Forum (WEF), called COVID-19 Workplace Commons--
                Keeping Workers Well, show that most employers already have some type
                of vaccination policy, with more than 60 percent of surveyed employers
                requiring vaccinations for some or all employees. These survey results
                further support OSHA's determination that the vaccination policy
                requirement is feasible.
                 The ASU WEF workplace COVID-19 surveys collected information from
                employers across industry sectors about their response to the COVID-19
                pandemic. The results and responses from more than 1,400 companies are
                publicly available through the ASU College of Health Solutions web page
                COVID-19 Diagnostics Commons (ASU, October 5, 2021). Case studies from
                employers are also available within the interactive dashboard on that
                web page. The surveys consisted of numerous questions about workplace
                pandemic response, including questions related to vaccination policies
                and testing unvaccinated employees.
                 The most recent COVID-19 survey data was collected between August
                2, 2021 and August 20, 2021 and reported in September 2021 (accessible
                through the COVID-19 Workplace Commons). More than 1,400 companies
                operating 1143 facilities in 23 industry sectors were part of the
                survey, the majority of which are companies of the size covered by the
                ETS. Ninety percent of facilities surveyed had 100 or more employees at
                their facilities, and 56% had more than 100 but less than 1,000
                employees at their facilities. The industry sectors surveyed include:
                Technology and software; business and professional services;
                manufacturing; construction; healthcare, hospitals, and clinics; retail
                stores; retail food stores; consumer retail service; energy and
                utilities; nonprofit organizations; education (colleges and
                universities); education (pre-K to 12); real estate and property
                management; agriculture and food production; healthcare services; media
                and entertainment; government and quasi-public; biotech,
                pharmaceuticals, and diagnostics; restaurants and food service; hotels
                and casinos; transportation, distribution, and logistics; consumer
                transportation; and recreation (ASU WEF, September 2021).
                 The survey responses related to vaccination policies support OSHA's
                determination that it is feasible for covered employers to implement
                mandatory COVID-19 vaccination policies. The survey results showed that
                45% of employers surveyed require all employees to be vaccinated
                against COVID-19, and an additional 16% require some of its employees
                to be vaccinated against COVID-19. (ASU WEF, September 2021). Only
                three percent of employers surveyed did not have a vaccination policy
                at the time (ASU WEF, September 2021). While this survey covers a wide
                range of industries it may not represent the percentage of companies
                implementing mandatory vaccination policies in general populations but
                for the feasibility purposes it demonstrates that it has and can be
                done.
                 OSHA also reviewed slightly older survey data, which, even though
                it shows somewhat lower rates of employer vaccination mandates, still
                supports OSHA's finding that such vaccination polices are feasible. In
                late June 2021, the National Safety Council (NSC) conducted three
                national surveys, one organizational and two workforce, of private
                companies, nonprofits, legal experts, public health professionals,
                medical professionals and government agencies that have addressed
                workforce COVID-19 vaccinations based on best practices and proven
                workplace safety strategies. The survey results show that many
                employers and organizations are currently requiring employees to be
                vaccinated.
                 The three surveys were distributed to 300 employers and
                organizations across the country and from a wide range of industries to
                collect data on pandemic response, including implementation of COVID-19
                vaccine policies and testing among their workforce. Of the employers
                and organizations surveyed in June 2021, the NSC found that 20% were
                implementing some form of a worker vaccination requirement. While OSHA
                believes that the ASU WEF surveys (which included more employers and
                are more recent) are better indicators of current employer vaccination
                policies, the NSC surveys also support the feasibility of employer
                vaccination mandates (NSC, September 2021)
                 The NSC, in partnership with the Health Action Alliance (HAA) and
                the Centers for Disease Control and Prevention (CDC), have developed a
                multifaceted, comprehensive effort called SAFER, aimed at helping
                employers prioritize health and safety as they develop plans and
                polices for their employees to return to the workplace (NSC, May 17,
                2021). Through SAFER, the NSC and HAA developed a web-based decision
                tool to guide employers on health, legal, and other considerations to
                prioritize the health and safety of workers. Due to the Delta Variant
                surge of new COVID-19 cases across the United States, the NSC and HAA
                revised the SAFER resources, including the online tool, to include
                information about employer requirements for COVID-19 vaccinations.
                These include guides for developing plans and policies to support
                employee vaccination through mandates and incentives; the collection
                and maintenance of COVID-19 vaccination records; and various
                considerations for testing unvaccinated workers. (HAA and NSC,
                September 17, 2021). The availability of these publicly-accessible
                tools to help employers develop vaccination policies further reduces
                any potential barriers for covered employers to establish and implement
                a written policy requiring each employee to be fully vaccinated against
                COVID-19, or alternatively to establish a policy allowing employees to
                choose whether to be fully vaccinated or tested for COVID-19 at least
                every seven days and wear face coverings.
                 The HAA maintains an online list of large companies requiring
                vaccinations for all or part of their workforce or customers. OSHA
                reviewed the list of companies, drawn from news reports and employer
                websites, with requirements for COVID-19 vaccination. Most of the
                companies listed require some or all employees to be vaccinated against
                COVID-19 while allowing medical exemptions or reasonable accommodations
                for disability or religious reasons. There are currently 188 listed
                companies across numerous industry sectors, including Amtrak, Deloitte,
                Google, The Walt Disney Company, Walmart, and the U.S. Chamber of
                Commerce.\21\
                ---------------------------------------------------------------------------
                 \21\ https://www.healthaction.org/resources/vaccines/covid-19-vaccines-employer-requirements-health-action-alliance?0405d6f4_page=1 (last visited October 2, 2021).
                ---------------------------------------------------------------------------
                 While healthcare employers subject to 29 CFR 1910.502 are not
                covered by this ETS, a number of large healthcare employers have
                implemented mandatory vaccine policies. This also shows the feasibility
                of the employers implementing mandatory vaccination requirements, often
                on large scales. According to the American Hospital Association (AHA),
                over 1,800 hospitals
                [[Page 61449]]
                have one or more vaccination requirements in place (Becker's Hospital
                Review, October 11, 2021). Large healthcare employers mandating that
                their employees be vaccinated include Kaiser Permanente, the nation's
                largest integrated, nonprofit health care organization with more than
                216,000 employees and more than 23,000 physicians (Kaiser Permanente,
                August 2, 2021); Trinity Health, one of the largest multi-institutional
                Catholic health care delivery systems in the nation, with more than
                123,000 employees and 90 hospitals in 22 states (Trinity Health, July
                8, 2021); Sanford Health, which operates in 26 states and employs
                nearly 50,000 people (Sanford Health, July 22, 2021); and Genesis
                Health Care, a large U.S. nursing home chain with over 40,000 employees
                working in more than 250 centers across 23 states (Genesis Health Care,
                September 29, 2021).
                 Under paragraph (d)(2), if employers do not establish and implement
                a written mandatory vaccination policy, the employer must establish and
                implement a written policy allowing any employees not subject to a
                mandatory vaccination policy to either choose to be fully vaccinated or
                regularly tested for COVID-19 and wear a face covering. A substantial
                number of employers already have such policies in place. For example,
                the ASU WEF survey shows that 30% of employers surveyed require
                unvaccinated employees to participate in mandatory COVID-19 testing and
                30% of employers require face coverings for unvaccinated employees (ASU
                WEF, September 2021).
                 OSHA also notes a number of state COVID-19 vaccination
                requirements. In response to the Delta Variant surge, 19 states have
                implemented written COVID-19 vaccination and testing policies for state
                employees and 23 states have done so for healthcare employees (NASHP,
                October 1, 2021). For example, on September 20, 2021, the Colorado
                Department of Public Health and Environment (CDPHE) implemented
                policies requiring state employees and personnel at health care
                facilities and hospitals to be fully vaccinated against COVID-19. All
                state employees must either be fully vaccinated against COVID-19 or
                participate in twice-weekly testing. Employees are allowed work time to
                get tested and administrative or Public Health Emergency Leave to get
                vaccinated. Employees who are not fully vaccinated must wear masks
                inside state facilities when they are around others. On August 30,
                2021, the State Board of Health approved a vaccine requirement for
                personnel in health care settings with high-risk patients. All
                personnel affected by this rule needed to receive their first dose of
                COVID-19 vaccine by September 30, 2021, and must be fully vaccinated by
                October 31, 2021 (CDPHE, September 17, 2021).
                 A number of local governments have also implemented policies
                requiring COVID-19 vaccination or testing for employees. For example,
                the Fulton County Board of Commissioners in Georgia recently approved a
                ``Vax or Test'' policy requiring employees to get vaccinated or tested
                for COVID-19 each week. Since September 6, 2021, Fulton County has
                required all County employees, as a condition of employment, to either
                be vaccinated against COVID-19 or be tested weekly for COVID-19 unless
                an employee is granted a reasonable accommodation (Fulton County
                Government, September 03, 2021). The multitude of local, state, and
                employer vaccination or testing mandates across the country support
                OSHA's finding that such policies are feasible.
                II. Determining Employee Vaccination Status
                 Paragraph (e) of the ETS requires employers to determine the
                vaccination status of each employee. Employers must require employees
                to provide an acceptable proof of vaccination status, including whether
                they are fully or partially vaccinated. As discussed in Summary and
                Explanation (Section VI. of this preamble), acceptable proof of
                vaccination status is: (i) The record of immunization from a health
                care provider or pharmacy; (ii) a copy of the COVID-19 Vaccination
                Record Card; (iii) a copy of medical records documenting the
                vaccination; (iv) a copy of immunization records from a public health,
                state, or tribal immunization information system; or a copy of any
                other official documentation that contains the type of vaccine
                administered, date(s) of administration, and the name of the health
                care professional(s) or clinic site(s) administering the vaccine(s). A
                signed and dated employee attestation is acceptable in instances when
                an employee is unable to produce proof of vaccination. Given the
                attestation option, there are no technological barriers to the
                provision for proof of vaccination status. As discussed below, many
                employers requiring proof of vaccination have successfully implemented
                such policies even without allowing the flexibility of the attestation
                option.
                 The employer must maintain a record and a roster of each employee's
                vaccination status. This information is subject to applicable legal
                requirements for confidentiality of medical information. These records
                must be preserved while the ETS is in effect. OSHA is not aware of any
                technological challenges that the large employers covered by this ETS
                would face with respect to collecting and maintaining records. This is
                a performance-based requirement, meaning that employers have the
                flexibility to structure their systems to fit within current systems,
                such as those relating to personnel records, tax records, and other
                sensitive or confidential records gathered and maintained by large
                employers.
                 A number of the surveys discussed above also show that most
                employers with vaccine mandates require proof of vaccination. For
                example, ASU WEF workplace COVID-19 survey from fall 2021 found that
                60% of employers that required vaccinations also required proof of
                vaccination from employees. The NSC study from June 2021 found that 45%
                of employers with COVID-19 vaccination requirements required proof of
                vaccination, such as submitting a copy of the COVID-19 vaccination
                card. An additional 30% of employers surveyed verify employee
                vaccination status through self-reporting based on the honor system.
                 Additionally, a large-scale survey conducted by the Willis Towers
                Watson consulting firm between August 18 and 25, 2021, showed that a
                majority of employers currently track their employees' vaccination
                status. Nearly one thousand employers responded to this survey, and
                they collectively employ 9.7 million workers from industries across the
                public and private sectors including manufacturing, general services,
                wholesale and retail, IT and telecom, healthcare, financial services,
                energy and utilities, and public sector and education (Willis Towers
                Watson, June 23, 2021). Nearly six in 10 (59%) currently track their
                workers' vaccination status and another 19% are planning or considering
                doing so later this year. A majority (62%) of those employers who
                currently track their workers' vaccination status require proof of
                vaccination, such as CDC vaccination cards, while 36% rely on employees
                to self-report (Willis Towers Watson, September 1, 2021).
                 Other evidence in the record also supports the feasibility both of
                gathering proof of vaccination and determining employees' vaccination
                status. Many large employers with vaccination policies require
                employees to submit proof of vaccination. For example, Tyson Foods
                requires employees to submit proof of vaccination to Tyson
                [[Page 61450]]
                Foods Vaccination Verification Program in order to qualify for the
                company's vaccination incentive (Tyson Foods, August 3, 2021).
                Similarly, Capital One bank requires all employees, contractors,
                vendors, and visitors to Capital One facilities to show proof of
                vaccination. (Capital One, August 11, 2021). The International Union of
                Painters and Allied Trades (IUPAT), which represents 140,000
                craftspeople in the U.S. and Canada and has implemented vaccine
                requirements for its members, also requires all of its own non-
                bargaining unit office and field employees to show proof of
                vaccination. (IUPAT, May 10, 2021).
                 CVS Health, a health conglomerate with more than 300,000 employees,
                including more than 40,000 physicians, pharmacists, nurses and nurse
                practitioners, has mandated COVID-19 vaccination for its nurses,
                pharmacists and other employees who interact with patients and requires
                proof of vaccination for those employees (CVS Health, August 23, 2021).
                 The surveys and employer policies reviewed by OSHA all support the
                agency's finding that it is feasible for employers to determine their
                employees' vaccination status and collect proof of vaccination.
                III. Providing Support for Vaccination
                 Paragraph (f) of the ETS requires employers to support COVID-19
                vaccination for each employee by providing a reasonable amount of time
                to each employee for vaccination and reasonable time and paid sick
                leave to each employee for side effects experienced following
                vaccination. The feasibility of paying for the time is addressed in
                OSHA's economic analysis.
                 This technological feasibility determination focuses on whether
                employers would encounter obstacles in implementing payment policies
                that would make this requirement infeasible for the large employers
                covered by this ETS. OSHA has determined that there are no such
                obstacles. Most significantly, OSHA has already required this type of
                system for employers covered by the Healthcare ETS and nearly four
                months after that ETS took effect, OSHA is not aware that employers
                covered by that ETS experienced any technological compliance
                difficulties with respect to that requirement. In addition, many
                employers have already implemented policies such as those required to
                comply with this new ETS as a way of incentivizing employee
                vaccination. For example, the ASU WEF workplace COVID-19 survey from
                fall 2021 found that 60% of employers surveyed offered incentives for
                employees to be vaccinated. These incentives ranged from additional
                paid time off, cash, the ability to bypass regular testing and/or daily
                health screening requirements, and gifts. Eighteen percent of surveyed
                employers already provide additional time off for COVID-19 vaccination.
                Moreover, the NSC survey found that 86% of surveyed organizations had
                implemented policies such as paid time off, assistance with scheduling
                and transportation, and/or onsite vaccination.
                 OSHA's review of plans and best practice documents from the HAA
                registry and from other publicly-available sources also inform OSHA's
                finding that it is feasible for large employers to support employee
                vaccination (HAA, October 10, 2021). As part of this review, OSHA
                analyzed the ways that employers are currently supporting employee
                vaccination. One employer in the restaurant industry, the Fifty/50
                Group, a Chicago-based restaurant group comprised of 14 establishments
                that requires employees to be fully vaccinated, offers paid time off
                for anyone getting a vaccine or feeling the mild after-effects. (Fifty/
                50 Group, May 18, 2021). Another employer in the animal slaughtering
                and processing industry, Tyson Foods, requires COVID-19 vaccinations
                for its U.S. workforce and also offers $200 and up to four hours of
                regular pay if employees are vaccinated outside of their normal shift
                or through an external source (Tyson Foods, August 3, 2021). In
                addition, Tyson Foods supports onsite vaccination events in
                collaboration with local health departments and healthcare providers to
                improve accessibility to vaccination. Tyson Foods has hosted more than
                100 vaccination events at its locations across the country.
                 The evidence in the record demonstrates that many employers are
                already offering the types of vaccination support required by paragraph
                (f). Combined with OSHA's previous finding for a similar provision in
                the Healthcare ETS and the lack of compliance difficulties reported
                while that ETS has been in effect, OSHA therefore finds this
                requirement is technologically feasible.
                IV. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
                 Paragraph (g) of the ETS requires employers to ensure that
                employees who are not fully vaccinated and who report at least once
                every seven days to a workplace where other individuals such as
                coworkers or customers are present are: (1) Tested for COVID-19 at
                least once every seven days; and (2) provide documentation of the most
                recent COVID-19 test result to the employer no later than the seventh
                day following the date the employee last provided a test result.
                Employers must also ensure that employees who are not fully vaccinated
                and do not report during a period of seven or more days to a workplace
                where other individuals are present are: (1) Tested for COVID-19 within
                seven days prior to returning to the workplace; and (2) provide
                documentation of that test result upon return to the workplace.
                 Employees who are not fully vaccinated must be tested with a COVID-
                19 test, which is a test for SARS-CoV-2 that is: (i) Cleared, approved,
                or authorized, including in an Emergency Use Authorization (EUA) by the
                U.S. Food and Drug Administration (FDA) to detect current infection
                with the SARS-CoV-2 virus (e.g., a viral test); (ii) administered in
                accordance with the authorized instructions; and (iii) not both self-
                administered and self-read unless observed by the employer or an
                authorized telehealth proctor. Examples of tests that satisfy this
                requirement include tests with specimens that are processed by a
                laboratory (including home or on-site collected specimens which are
                processed either individually or as pooled specimens), proctored over-
                the-counter tests, point of care tests, and tests where specimen
                collection is either done or observed by an employer.
                 COVID-19 testing has become more widely available throughout the
                pandemic and as of September 2021, the FDA has authorized approximately
                250 tests and collection kits that diagnose current infection with the
                SARS- CoV-2 virus and may be acceptable under the ETS (FDA, September
                10, 2021), and by October 1, 2021, the number of EUAs issued had grown
                to 324 (FDA, October 1, 2021). The ETS permits compliance through use
                of a wide range of FDA-authorized tests that are readily available, so
                there is little doubt that testing itself is technologically feasible.
                 This technological feasibility analysis therefore focuses on
                whether testing will continue to be readily available in quantities
                sufficient to meet the potential increase in testing demand while this
                ETS is in place. Given the wide variety of tests that can be used to
                comply with this ETS and OSHA's review of information about the
                existing manufacturing and distribution capabilities of test
                manufacturers, the agency does not anticipate feasibility issues
                related to ensuring that
                [[Page 61451]]
                employees can get access to one of the acceptable tests within the time
                frames required by the ETS.
                a. Brief Overview of Testing and Administration
                 COVID-19 tests that are cleared, approved, or authorized, including
                in an Emergency Use Authorization (EUA), by the FDA to detect current
                infection with the SARS-CoV-2 virus (e.g., a viral test) satisfy the
                ETS. FDA-cleared, approved, or authorized molecular diagnostic tests
                and antigen tests are permitted under the ETS when used as authorized
                by the FDA and with a Clinical Laboratory Improvement Amendments of
                1988 (CLIA) certification when appropriate. As described in the Summary
                and Explanation for paragraph (g) (Section VI.G. of this preamble),
                NAATs are a type of molecular test that detect genetic material. As of
                October 14, 2021, the FDA had issued EUAs for 264 molecular COVID-19
                tests including tests specified to be used ``with certain conditions of
                authorization required of the manufacturer and authorized
                laboratories'', 81 of which are authorized for home collection.
                Additionally, the FDA has issued EUAs for 2 OTC molecular COVID-19 test
                kits available without a prescription (FDA, October 14, 2021b).
                 NAATs, such as real-time reverse transcription-polymerase chain
                reaction (RT-PCR), have greater accuracy than antigen tests. However,
                most FDA-authorized NAATs need to be processed in a laboratory
                certified under the Clinical Laboratory Improvement Amendments of 1988
                (referred to as a ``CLIA-certified laboratory'') with variable time to
                results (~1-2 days). While the NAAT test is a more reliable test, the
                antigen test is faster and less expensive.
                 An antigen test is an in vitro diagnostic test used to detect
                active SARS-CoV-2 infection. As of October 14, 2021, the FDA had issued
                37 EUAs for COVID-19 antigen tests, including eight EUAs for over-the-
                counter (OTC) antigen tests that can be used without a prescription
                (FDA, October 14, 2021a).
                 Administration of an antigen test that meets the definition of
                COVID-19 test under this ETS falls into one of several categories: OTC
                employee self-tests that are observed by employers or authorized
                telehealth proctors; point-of-care (POC) or OTC tests performed by
                employers with a CLIA certificate of waiver; and other FDA cleared,
                approved, or authorized antigen tests that are analyzed in a CLIA
                certified laboratory setting (FDA, October 14, 2021a). The FDA has
                authorized POC tests that can be used at a place of employment when the
                facility is operating under a CLIA certificate of waiver. A CLIA
                certificate of waiver can be issued by CMS and may, when consistent
                with FDA's authorization, allow a laboratory to run a SARS-CoV-2 test
                outside a high or moderate complexity traditional clinical laboratory
                setting (CDC, September 9, 2021). In accordance with the CLIA
                certificate of waiver, the laboratory or POC testing site must use a
                test authorized for that location, like an FDA EUA POC test, and must
                adhere to the authorized test instructions to avoid human error.
                Certain COVID-19 antigen diagnostic tests can be analyzed on-site
                (where the person took the nasal swab) when that facility is operating
                under a CLIA certificate of waiver, while others must be analyzed in a
                CLIA certified high or moderate complexity laboratory setting. Some
                COVID-19 antigen diagnostic tests are authorized for use at home,
                without the need to send a sample to a laboratory. Antigen tests
                generally return results in approximately 15-30 minutes. The CDC
                provides training materials created by test manufacturers for POC
                antigen testing and reading of results for SARS-CoV-2 (CDC, July 8,
                2021).
                 COVID-19 antigen diagnostic tests are found at physician offices;
                urgent care facilities; pharmacies, such as CVS or Walgreens; school
                health clinics; long-term care facilities and nursing homes; temporary
                locations, such as drive-through sites managed by local organizations;
                and other locations across the country (CDC, July 8, 2021; CVS Health,
                October 2021; Walgreens, October 8, 2021). The availability of
                government-offered antigen tests varies by state, and may be free or
                subsidized and accessible without a prescription or physician note
                (RiteAid, October 2021; Walgreens, October 2021; HHS, June 11, 2021).
                The Department of Health and Human Services (HHS) provides a publicly-
                available list of community-based testing locations in each state that
                offer free COVID-19 testing for insured and uninsured residents (HHS,
                August 17, 2021). Pharmacies and other locations often provide antigen
                tests by appointment, although some will allow testing for walk-ins
                (CVS Health, September 2021; Walgreens, October 8, 2021). COVID test
                kits are currently available from several on-line retailers (Amazon,
                October 12, 2021).
                b. Testing Frequency
                 The ASU WEF survey data also supports OSHA's finding that the
                requirement for employees who are not fully vaccinated to be tested at
                least every seven days is feasible. The ASU WEF found that 73% of
                survey surveyed employers (797 employers) had testing policies for
                their workforce, and 76% of those employers had implemented mandatory
                testing requirements. Additionally, 25% of employers with testing
                polices had implemented requirements for routine testing of a portion
                of or the entire workforce, and 41% no longer require testing for fully
                vaccinated employees. Of the employers that test employees, 27% of
                those perform viral testing daily and 46% perform viral test once a
                week. Finally, 38% of companies exclusively administer polymerase chain
                reaction (PCR) tests (PCR tests are a type of NAAT), 17% exclusively
                administer antigen tests, and 45% administer both. Companies administer
                a range of COVID-19 tests and conduct testing at a variety of locations
                (some companies use more than one location). Forty-two percent of
                companies test workers at health testing laboratories, 35% test onsite
                at work, 28% test at hospitals, 23% test at retail pharmacies, 13% test
                at universities, 9% test at home to be sent a lab for evaluation, and
                5% test at home for immediate results (ASU WEF, September 2021).
                 OSHA also evaluated evidence of employers' current testing efforts
                by reviewing existing COVID-19 practices developed by employers, trade
                associations, and other organizations. Based on its review, OSHA
                concludes that it is feasible for most covered employees (and therefore
                their employers) to be tested in compliance with the ETS requirements
                for frequency of testing.
                 OSHA notes that there are several options for large employers to
                consider if they want to help facilitate testing for employees who are
                not vaccinated. Delta Airlines, for example, currently requires weekly
                COVID-19 testing for all of its employees who are not vaccinated, and
                the company has engaged the Mayo Clinic Laboratories to help design the
                employee testing program, assist in administering diagnostic and
                serology tests, and analyze the results to determine broader trends and
                provide recommendations to Delta's existing policies and procedures
                (Mayo Clinic Laboratories, June 30, 2020). Delta Airlines also operates
                onsite testing in cities with large employee populations including
                Atlanta, Minneapolis, and New York. It recently extended an at-home
                specimen collection option to all U.S. employees, through which Quest
                Diagnostics will send self-collection kits directly to an employee's
                doorstep upon request and support complete laboratory confirmation for
                results (Delta, August 25, 2021).
                [[Page 61452]]
                c. Availability of COVID-19 Tests
                 In the spring and early summer months of 2021, demand for tests
                decreased as vaccinations began to increase and the number of COVID-19
                cases declined before the Delta surge and some manufacturers slowed
                production of COVID-19 tests. However, the number of tests performed
                daily has grown considerably over the summer due to the Delta Variant
                surge and re-openings of workplaces and schools. In parallel with the
                Delta surge, COVID-19 testing has increased from a daily average of
                about 450,000 in early July 2021 to about 1.8 million by mid-September
                2021, or roughly 12.6 million per week (JHU, October 8, 2021). This
                data does not include any self-administered OTC tests, which will be
                discussed below.
                 OSHA's review of the evidence shows that the increasing rate of
                production of COVID-19 tests is more than adequate to meet rising
                demand related to compliance with the ETS testing option before the 60-
                day delayed testing compliance date (see paragraph (m)(2)(ii)). This
                determination is largely based on the number of tests with FDA EUAs
                actively being produced through the National Institutes of Health (NIH)
                Rapid Acceleration of Diagnostics (RADx) initiative described below.
                 According to the Johns Hopkins University of Medicine Coronavirus
                Resource Center, the total tests administered in August 2021 was
                approximately 44.4 million (or approximately 11.1 million per week).
                Id. During that same month, the total tests produced by the NIH RADx
                contracts was approximately 121 million (which would average to 30.25
                million per week), resulting in a substantial surplus of available
                tests (NIBIB, September 28, 2021). As discussed in Economic Analysis,
                Section IV.B. of this preamble, Table IV.B.8, OSHA estimates that as
                many as 7.2 million tests may be administered weekly under this
                standard; however, 7.2 million is almost certainly an overestimate
                because it does not exclude employees who are already required to be
                tested by their employers and would continue to be tested at the same
                frequency after the ETS. Even if testing is increased by 7.2 million
                tests per week because of the ETS, that would still mean a surplus of
                nearly 12 million tests per week beyond what would be need to continue
                at current testing levels with the addition of ETS-related tests (30.25
                - 11.1 - 7.2 = 11.95 million surplus per week).
                 The total number of tests administered during June, July, and
                August 2021, the period of the summer including the Delta Variant surge
                and other reasons for substantial testing increases such as re-opening
                of schools, was approximately 87 million tests, an average of
                approximately 6.7 million per week (JHU, October 8, 2021). During that
                period, more than 400 million COVID-19 tests were produced through the
                NIH RADx initiative, or roughly 33 million per week. OSHA anticipates
                that this surplus of tests will continue to increase the availability
                of tests that can be used to comply with the ETS.
                 The data from the Johns Hopkins Coronavirus Resource Center is
                collected from state and county government sources, so it does not
                include any self-administered OTC tests. Additionally, while all states
                report PCR testing, not all states report antigen testing.
                Nevertheless, the data from Johns Hopkins Coronavirus Resource Center
                is the best available evidence from which to estimate the total number
                of tests administered during a given period of time. Even though the
                number of administered tests reported through the Johns Hopkins
                Coronavirus Resource Center does not include unreported OTC tests, the
                NIH RADx program data shows a large surplus and sufficient additional
                COVID-19 test capacity relative to the number of administered tests
                reported. Additionally, the NIH RADx program will further allow for
                increased test distribution through retail markets and will address any
                increase in demand due to companies that may stockpile tests. This
                increased availability will strengthen test capacity, further enabling
                compliance with the ETS testing provision (NIBIB, September 28, 2021).
                OSHA has determined that even with an estimated additional 7.2 million
                tests administered weekly due to the ETS (see Economic Analysis
                (Section IV.B. of this preamble)), there are sufficient COVID-19 tests
                available to allow for both employers and employees to obtain COVID-19
                tests through a variety of retail sources (e.g., local pharmacies, on-
                line purchasing as discussed above).
                 Determinations of testing capacity are aggregate measures of
                domestic and global market and supply chains. Throughout the pandemic,
                diagnostic testing capacity has been stressed by the increased demand,
                as some products that are part of a global market cannot adapt by
                simply increasing manufacturing in one country (e.g., laboratory
                instruments), and other products manufactured domestically require
                capital investments to address rising demands (e.g., extraction kits)
                (CRS, February 25, 2021). As discussed below, because of the
                substantial investments made, OSHA projects that the diagnostic testing
                capacity can meet the increased demand due to this ETS.
                 OSHA evaluated multiple projections of current and future testing
                capacity and determined that projections related to the NIH initiatives
                discussed below are the most reliable estimates of current and future
                testing capacity for its technological feasibility assessment. Test
                manufacturers receiving NIH, FDA, and Biomedical Advanced Research and
                Development Authority (BARDA) (a component of HHS) funding as part of
                these programs undergo a submission and authorization process where
                their production capacity and pipeline are assessed and production
                quantities are validated. As explained below, as of August 2021, the
                NIH data indicates testing capacity stands at about 30 million tests
                per week, and capacity continues to grow (NIBIB, September 28, 2021).
                OSHA notes that this number underestimates the total number of tests
                available each week, as it only includes companies that have received
                funding for tests and testing supplies through the NIH initiatives
                described below.
                 The NIH has identified constraints on testing capacity as an area
                of focus and investment since the beginning of the COVID-19 pandemic,
                and OSHA examined potential constraints on testing capacity as part of
                its feasibility analysis. As described below, massive investments in
                testing capabilities, particularly in underserved areas, have largely
                mitigated issues with the availability of COVID-19 tests. Further,
                testing capacity continues to grow as new tests are developed and
                brought to market and manufacturers can ramp up supply to meet any
                future testing demands if need be.
                 The FDA has authorized more than 320 tests and collection kits that
                diagnose current infection with the SARS-CoV-2 virus and may be
                acceptable under the ETS (FDA, October 1, 2021). Among other criteria,
                the standard allows for the use of tests with specimens that are
                processed by a CLIA certified laboratory (including home or on-site
                collected specimens which are processed either individually or as
                pooled specimens), proctored over-the-counter tests, point of care
                tests, and tests where specimen collection and processing is either
                done or observed by an employer. As explained above, many employers
                across various industry sectors have already implemented policies for
                onsite testing. The use of FDA-authorized POC tests by these employers
                would be compliant with the testing provision of the ETS if the entity
                administering the test holds a CLIA
                [[Page 61453]]
                certificate as required by the EUA. COVID-19 OTC tests that are both
                self-administered and self-read by employees do not satisfy the testing
                requirement unless observed by the employer or an authorized telehealth
                proctor. In the event that the employer is merely observing the
                employee conduct a test, a CLIA certificate would not be needed.
                 There have been extensive investments, including by the federal
                government, to help ensure that COVID-19 tests are widely available.
                Section 2401 of the American Rescue Plan appropriated $47,800,000 to
                the Secretary of the HHS, to remain available until expended, to carry
                out activities to detect, diagnose, trace, and monitor SARS-CoV-2 and
                COVID-19 infections and related strategies to mitigate the spread of
                COVID-19. Funds were made available to implement a national testing
                strategy; provide technical assistance, guidance, support, and awards
                grants or cooperative agreements to State, local, and territorial
                public health departments; and support the development, manufacturing,
                procurement, distribution, and administration of tests to detect or
                diagnose SARS-CoV-2 and COVID-19; and establish federal, state, local
                and territorial testing capabilities.
                 On April 29, 2020, the NIH established the RADx initiative with a
                $1.5 billion investment. The RADx initiative has used this funding to
                speed development of rapid and widely-accessible COVID-19 testing (NIH,
                April 29, 2020). On October 6, 2020, the NIH and BARDA established the
                RADx Technology (RADx-Tech) and RADx Advanced Technology Platforms
                (RADx-ATP) programs to speed innovation in the development,
                commercialization, and implementation of technologies for COVID-19
                testing specifically for late-stage scale-up projects. Through the RADx
                Tech and RADx-ATP programs, the NIH and BARDA have awarded a total of
                $476.4 million in manufacturing expansion contracts supporting a
                combined portfolio of 22 companies in the U.S. (NIH, October 6, 2020).
                 These programs have significantly increased testing capacity
                throughout the country. Since being established, RADx has worked
                closely with the FDA, the CDC, and BARDA to move more advanced
                diagnostic technologies swiftly through the development pipeline toward
                commercialization and broad availability. On April 28, 2021, the
                Institute of Electrical and Electronic Engineers (IEEE) dedicated a
                special issue in the Journal of Engineering in Medicine and Biology
                exploring the innovative structure and operation of the RADx Tech
                program and determined that the initiatives had succeeded in
                dramatically increasing COVID-19 testing capacity in the United States.
                The IEEE report found that the RADx Tech/ATP programs, in conjunction
                with BARDA and the FDA, had streamlined and bolstered the national
                COVID-19 testing capacity. At the time of the report, the RADx Tech/ATP
                programs had increased the number of testing makers to 150 companies
                that, as a result of the NIH/BARDA investments, had the capacity to
                produce up to 1.9 million tests per day (IEEE, April 28, 2021).
                 The NIH RADx-TECH/ATP initiative entered its second phase on
                September 28, 2021, and at that time the supported companies had
                collectively produced over 500 million tests, received 27 FDA
                authorizations, and developed the first OTC COVID-19 test for use at
                home. These September 2021 investments are supporting late stage
                development of innovative point-of-care and home-based tests, as well
                as improved clinical laboratory tests that will increase the capacity
                of testing in the U.S. A full list of active contracts and supported
                U.S. COVID-19 testing manufacturers can be found on the NIH RADx-TECH/
                ATP programs: Phase 2 awards (NIBIB, October 14, 2021).
                 The following example shows the NIH RADx EUA pipeline process. On
                May 9, 2020, the FDA authorized the first EUA for a COVID-19 antigen
                test, a new category of tests for use in the ongoing pandemic. Quidel
                was awarded a contract under the NIH RADx TECH/ATP phase 1 initiative
                for the Sofia 2 SARS Antigen FIA for use in high and moderate
                complexity laboratories certified by CLIA, as well as for point-of-care
                testing by facilities operating under a CLIA certificate of waiver
                (FDA, May 9, 2020). On July 31, 2020, Quidel announced that it had
                received a contract for $71 million under the NIH RADx TECH/ATP
                program, phase 1, to accelerate the expansion of its manufacturing
                capacity for production of the SARS-CoV-2 rapid antigen test and
                quickly exceeded that capacity (Quidel Corp., July 31, 2020). On March
                31, 2021, the FDA then authorized a second EUA from Quidel under
                contract with the NIH RADx initiative for the QuickVue At-Home OTC
                COVID-19 Test, another antigen test where certain individuals can
                rapidly collect and test their sample at home, without needing to send
                a sample to a CLIA certifed laboratory for analysis (FDA, March 31,
                2021). Furthermore, based on the success of the Quidel for the Sofia 2
                SARS Antigen FIA increasing production capacity, the NIH granted
                another $70 million contract for manufacturing Capacity Scale-Up for
                Sofia SARS Antigen and Sofia Influenza A+B/SARS FIAs on June 11, 2021
                (FDA, June 11, 2021).
                 The RADx-TECH/ATP initiative maintains a dashboard of manufacturer
                testing data from supported U.S. firms. OSHA reviewed the data
                available on the dashboard as part of its determination of feasibility.
                In August 2021, the data showed that U.S. manufacturers supported by
                the NIH RADx-TECH/ATP were producing approximately 30 million tests per
                week (NIBIB, September 28, 2021).
                 While consumers in some parts of the country have encountered
                difficulty obtaining rapid at-home tests, on October 4, 2021, the FDA
                granted EUA for the ACON Laboratories Flowflex COVID-19 Home Test,
                which is anticipated to double rapid at-home testing capacity in the
                United States within weeks (and well before compliance dates for
                testing required by this ETS) (FDA, October 4, 2021). By the end of the
                2021 (ahead of the paragraph (g) compliance date), the manufacturer
                plans to produce more than 100 million tests per month and plans to
                produce more than 200 million tests per month by February 2022 (FDA,
                October 4, 2021). On October 6, 2021, the Administration announced a
                plan to buy $1 billion worth of rapid at-home COVID-19 tests; this
                purchase, coupled with the October 4 authorization of the Flowflex
                COVID-19 test, is expected to increase the number of available at-home
                COVID-19 tests to 200 million per month by December 2021 (Washington
                Post, October 6, 2021).
                 These investments have had a pronounced impact on the availability
                of testing and employers' use of testing in the workplace. ASU's recent
                report, How Work has Changed: The Lasting Impact of COVID-19 on the
                Workplace, ascribed the jump in the percentage of employers that test
                their employees from 17% in the fall of 2020 to 70% in the fall of 2021
                in large part to the increased availability of testing. In particular,
                the report noted that by the spring of 2021, ``it became relatively
                easy to acquire tests and hire testing service providers. There are
                more labs and companies with EUA's and most have enough capacity that
                there are few shortages.'' (ASU WEF, September 2021).
                 Moreover, to ensure a broad, sustained capacity for COVID-19 test
                production, multiple COVID-19 test manufacturers have been mobilized by
                authority of the Defense Production Act. Under the Administration's
                plan to increase COVID-19 testing, the federal
                [[Page 61454]]
                government will directly purchase and distribute 280 million- rapid
                point-of-care and over-the-counter at-home COVID-19 tests, sending 25
                million free at-home rapid tests to community health centers and food
                banks. These actions will provide tests for use by communities to build
                adequate stockpiles, as well as the sustained production to be able to
                scale up production as needed in the future. Additionally, to ensure
                convenient access to free testing, 10,000 pharmacies will be added to
                the Department of Health and Human Services free testing program.
                 In response to rising demands for testing, U.S. manufacturers have
                increased production of COVID-19 test kit, reagents, and supplies.
                Advanced Medical Technology Association (AdvaMed), a trade group for
                testing manufacturers, reported that its members are ramping up
                production of rapid point-of-care test supplies to meet demand and that
                laboratory-based testing capacity for test confirmation is strong.
                AdvaMed has created a national COVID-19 Diagnostic Supply Registry of
                COVID-19 test manufacturers that support state and federal governments
                in their pandemic responses. Registry participants are thirteen leading
                diagnostic manufacturers whose tests together comprise approximately
                75-80% of the COVID-19 in vitro diagnostic devices (IVD) on the market
                in the U.S. While these manufacturers produce a majority of molecular
                COVID-19 tests, they do not produce a majority of the total COVID-19
                tests manufactured. These COVID-19 test manufacturers collectively
                shipped approximately 3.8 million tests in July 2021, 8.2 million tests
                in August 2021, and 9.4 million molecular tests for the week ending
                September 4th, 2021 (AdvaMed, September 10, 2021). While these figures
                are not representative of the total weekly testing capacity in the
                U.S., this data demonstrates that testing capacity has grown
                significantly over the past few months and reflects the success
                manufacturers have had in ramping up production of tests.
                 While current test availability is sufficient to meet the increased
                testing demands due to the ETS, OSHA is also confident that the RADx-
                TECH/ATP initiatives will continue to spur testing capacity and growth.
                The RADx-TECH/ATP initiatives have focused on moving test makers'
                products through the late stage pipeline and securing FDA authorization
                for entry into the market. So far, there have been 27 such
                authorizations. As of September 2021, there were 824 eligible late-
                stage scale up proposals from various test makers up for review for
                NIH/BARDA funding. Furthermore, 517 of these submissions are for the
                authorization and production of multiple types of COVID-19 tests
                including one or more of the following: Blood, sputum, nasal swab, oral
                swab, fecal, saliva, or other types. OSHA considers this to be further
                support for its determination that testing capacity will continue to
                grow and that increased COVID-19 testing supplies are on the horizon
                (NIBIB, September 28, 2021).
                 Based on data from the Johns Hopkins Coronavirus Resource Center,
                which examined publicly-available data from multiple sources,
                approximately 12.4 million tests were conducted during the week of
                August 26-September 2, 2021. As noted earlier, in the economic analysis
                of this ETS, OSHA projects testing rates to increase by approximately
                7.2 million tests per week starting 60 days after publication of the
                ETS. As described above, many employers are currently testing their
                workforce. This 7.2 million is almost certainly an overestimate because
                it does not exclude employees who are already required to be tested by
                their employers and would continue to be tested at the same frequency
                after the ETS. The data reviewed by OSHA on the RADx-TECH/ATP Dashboard
                shows that the manufacturers supported by the initiative are producing
                approximately 30 million tests per week, and capacity continues to
                grow. As explained above, it is expected that roughly 50 million at-
                home COVID-19 tests will be available each week by December 2021. OSHA
                therefore finds that there are (and will continue to be) sufficient
                COVID-19 tests available to meet the anticipated demand related to
                compliance with paragraph (g) by the 60-day delayed compliance date.
                d. Availability of COVID-19 Test Supplies
                 OSHA has also analyzed the availability of COVID-19 test supplies
                for use by COVID-19 test kit manufacturers, diagnostic laboratories,
                and determined that there are sufficient supplies to allow compliance
                with the ETS testing option. The COVID-19 pandemic and recent Delta
                Variant surge have caused some disruptions in the availability of
                testing supplies such as swabs, viral transport medium, RNA extraction
                kits, serology consumables, diagnostic reagents, plastic consumables,
                and diagnostic instruments. The COVID-19 testing supply market is
                driven by the need to rapidly screen large segments of the population
                and deliver test results. The data presented throughout this assessment
                has shown demand for laboratory COVID-19 tests is rising across the
                country.
                 Testing for COVID-19 involves many different components that are
                manufactured, transported, and used independently (e.g., bulk solvents,
                extracting reagents, packaging) or semi-independently (e.g., test
                kits). Most of the supplies used in COVID-19 testing are disposable,
                requiring a constant sustained capacity for new supplies. Some
                distribution channels move supplies directly to medical and laboratory
                end-users and others move supplies through distributors. In either
                case, the combination of increased testing demand and the established
                supply chains indicate that testing kits will be available in
                sufficient quantities throughout the country, including in rural areas
                where large employers may be located.
                 There have been substantial investments from federal and state
                programs and private industry to stimulate the production and
                distribution of testing supplies to bolster testing capacity across the
                country. Many products, such as swabs and reagents for RNA extraction
                kits, exhibited rising demand and, at some point during the pandemic,
                were subject to shortages that threatened continued testing capacity.
                For example, there was only one domestic manufacturer of medical grade
                flocked swabs, Puritan Medical Products Company of Guilford, Maine, and
                the company's pre-pandemic capacity was insufficient to meet demand of
                increased testing in the early period of the COVID-19 pandemic (Puritan
                Products, April 20, 2020). On July 29, 2020, the Department of Defense
                (DOD), in coordination with the Department of Health and Human
                Services, awarded $51.15 million to Puritan to expand industrial
                production capacity of flock tip testing swabs (DOD, July 31, 2020). On
                March 26, 2021, Puritan was awarded another $146.77 million to increase
                the company's total production capacity to 250 million foam tip swabs
                per month at its Tennessee facility by February 2022 (DOD, March 29,
                2021).
                 Other private sector companies were mobilized to change the
                products they manufactured to accelerate production of COVID-19 test
                components, such as swabs, reagents, and solvents for RNA extraction
                kits. For example, Microbrush, a U.S.-based manufacturer of sterile
                applicators for the dental industry, began production of a
                nasopharyngeal test swab to meet the growing demand for COVID-19
                testing requirements in July 2020. The Microbrush test swabs are
                sterilized and individually packaged in a medical-
                [[Page 61455]]
                grade pouch intended for nasopharyngeal sample collection such as in
                dental procedures and also COVID-19 testing (Microbrush, July 1, 2020).
                 RNA extraction kits are used by the majority of NAAT protocols.
                These kits are sets of consumable plastic laboratory materials (small
                centrifuge tubes, filters, and collection vials) and chemical reagents
                (solutions for breaking the virus apart and purification) assembled by
                a manufacturer. Each kit has enough materials to process several dozen
                samples. The use of RNA extraction kits is not exclusive to COVID-19
                testing, meaning that a market existed pre-COVID-19, and manufacturers
                were able to adapt to fluctuations in demand spurred by the pandemic.
                 There are multiple companies with facilities in the United States
                that produce RNA extraction kits for the domestic market that have been
                awarded federal grants to increase the supply of COVID-19 test kits and
                reagent supplies. For example, in December 2020, the DOD and HHS
                identified several key reagents with the potential for supply chain
                bottlenecks and awarded a $4.8 million Indefinite Delivery/Indefinite
                Quantity contract to Anatrace Products, LLC to support increased
                production of key reagents for sample processing; Polyadenylic Acid
                (Poly A), Guanidinium Thiocyanate (GTC), and Proteinase K (Pro K) to
                process samples (DOD, December 21, 2020). Additionally, QIAGEN (based
                in Germany with U.S. manufacturing in Germantown, Maryland) produces
                extraction kits for authorized COVID-19 tests and has responded to the
                pandemic by scaling their production to around the clock production to
                strengthen testing kit capacity (Qiagen, October 2, 2021). On August
                23, 2021, DOD, on behalf of and in coordination with HHS, awarded a
                $600,000 contract to QIAGEN to expand manufacturing capacity of
                enzymatic reagents and reagent kits used in COVID-19 molecular
                diagnostic tests, thereby allowing QIAGEN to increase its monthly
                production of reagent kits by 7,000 and enzymes by 5,100 milligrams by
                the end of February 2022 to support domestic laboratory testing for
                COVID-19 (DOD, August 23, 2021).
                 Additionally, manufacturers of raw materials and solvents for
                COVID-19 test kits have implemented strategies to strengthen their
                portions of the COVID-19 test supply chain. Millipore Sigma, a large
                producer of solvents and raw materials for tests, has created a global
                task force to actively evaluate the overall supply chain of products
                and key raw material suppliers to mitigate any potential disruption of
                COVID-19 testing capacity (Millipore Sigma, October 2021). In light of
                the foregoing, OSHA believes that there is sufficient--and increasing--
                availability of COVID-19 testing supplies to enable compliance with the
                ETS testing option.
                e. Sufficiency of Laboratory Capacity
                 As noted above, a wide range of tests are acceptable under the ETS,
                including those that can be observed by employers without laboratory
                processing. Moreover, there has been rapid growth in the availability
                of OTC tests that do not require laboratory processing. Authorized OTC
                tests self-administered by employees and proctored by the employer do
                not require a CLIA certificate of waiver.
                 The Association of Public Health Laboratories (APHL) has conducted
                weekly surveys of its membership to monitor their current and projected
                capability and capacity to test for COVID-19. Data from this survey is
                used to inform HHS, FEMA, CDC, and other federal partners to support
                public health laboratory supply and reagent needs. OSHA reviewed the
                weekly COVID-19 survey results through the APHL COVID-19 Lab Testing
                Capacity and Capability Data Dashboard. The data comes from voluntary
                participation in the weekly surveys collected from approximately 100
                state, local and territorial public health laboratories (PHLs) and
                reported to the CDC. The APHL weekly survey data supports OSHA's
                feasibility determination and demonstrates that COVID-19 testing demand
                will be met. For example, from August 15, 2021 to September 12, 2021,
                the APHL weekly survey data found that 96-100% of PHLs are meeting
                their current testing demand since the Delta Variant surge began (APHL,
                September 27, 2021).
                 Laboratory capacity for processing and confirmation of at-home
                COVID-19 rapid tests provided by manufacturer retailers such as Walmart
                has also increased. Laboratory and diagnostic service providers have
                implemented parallel strategies to strengthen laboratory capacity for
                confirmation of at-home COVID-19 rapid tests available on the market
                for employers and employees to utilize. For example, Quest Diagnostics,
                which is the laboratory processing the samples and delivering results
                to those tested at Walmart's drive-through and curbside testing sites,
                has scaled up laboratory testing capacity and rapid antigen test
                inventory should demand increase (Walmart, July 9, 2021). Quest
                Diagnostics has added COVID-19 testing platforms in laboratories in
                regions where demand is comparatively high and has implemented an
                online consumer-initiated test service for individuals and small
                businesses to request COVID-19 testing. In August 2021, Quest
                Diagnostics began to offer clinician-guided rapid COVID-19 antigen
                testing to employers through a guided telehealth visit using a self-
                administered, nasal swab antigen test that provides results in 15
                minutes that is then shipped to a Quest Diagnostics lab for
                confirmation (Quest Diagnostics, September 28, 2021).
                 Based on the evidence reviewed, OSHA has determined that there is
                adequate laboratory capacity to enable compliance with the ETS testing
                option.
                f. Access to Testing in Underserved Communities
                 Individuals in underserved communities (including Black, Latino,
                and Indigenous and Native American persons, Asian Americans and Pacific
                Islanders and other persons of color; members of religious minorities;
                lesbian, gay, bisexual, transgender, and queer persons; persons with
                disabilities; persons who live in rural areas; and persons otherwise
                adversely affected by persistent poverty or inequality) are
                disproportionately burdened by the COVID-19 pandemic as many
                individuals in these communities are essential workers who cannot work
                from home, increasing their risk of being exposed to the virus. Access
                to COVID-19 testing in these communities has been identified as
                contributing factor to COVID-19 related health disparities in these
                communities. For example, the NSC June 2021 survey found that the most
                common barrier to testing for rural employers and workers is access to
                vaccination and testing sites (NSC, September 2021).
                 Several federal efforts have recently been implemented to
                strengthen testing capabilities in underserved communities. The NIH has
                invested heavily to improve COVID-19 testing in underserved communities
                throughout the COVID-19 pandemic. On September 30, 2020, the NIH
                received nearly $234 million to improve COVID-19 testing for
                underserved and vulnerable populations that have been
                disproportionately affected by this pandemic and launched the RADx
                Underserved Populations (RADx-UP) program (NIH, September 30, 2020).
                 The RADx-UP program has primary components supported by these NIH
                grants to increase availability, accessibility, and acceptance of
                testing among underserved and vulnerable populations. The RADx-UP
                program also provides overarching support and
                [[Page 61456]]
                guidance on administrative operations and logistics, facilitating
                effective use of COVID-19 testing technologies, supporting community
                and health system engagement, and providing overall infrastructure for
                data collection, integration, and sharing from a coordination and data
                collection center (NIH, September 30, 2021). Through the RADx-UP
                program, the NIH has continued to support the needs of underserved
                populations and is currently funding 70 community-based projects across
                the country (NIH, September 30, 2021).
                 The CDC has also focused its efforts to improve COVID-19 testing in
                underserved communities throughout the COVID-19 pandemic. For example,
                on September 20, 2021, Maine Health, the largest health care
                organization in Maine and also serving northern New Hampshire, was
                awarded nearly $1 million for COVID-19 testing in higher risk
                communities (Maine Health, September 20, 2021). In March 2021, the CDC
                implemented a plan to invest $2.25 billion over two years to address
                COVID-19 related health disparities and advance health equity among
                populations that are at high-risk and underserved, including racial and
                ethnic minority groups and people living in rural areas. Since that
                time, the CDC has awarded grants to public health departments to
                improve testing capabilities; improve data collection and reporting;
                and build, leverage, and expand infrastructure support for testing
                (CDC, March 17, 2021). On September 30, 2021, the CDC awarded an $8.1
                million grant to the Arizona Center for Rural Health (ACRH) to address
                COVID-19 disparities across Arizona by improving the delivery of COVID-
                19 testing to rural and underserved communities (ASU CRH, September 30,
                2021). A number of other federal and state government agencies have
                been expanding support for COVID-19 testing in underserved communities
                as well. On June 11, 2021, HHS through the Health Resources and
                Services Administration (HRSA) provided $424.7 million in American
                Rescue Plan funding to over 4,200 Rural Health Clinics (RHCs) for
                COVID-19 testing (HHS, June 11, 2021).
                 Private industry has also mobilized considerably to increase access
                and testing capacity in rural and other underserved communities. The
                NSC June 2021 survey found that a common barrier to employers and
                employees in rural and other underserved communities is transportation
                and access to vaccination and testing sites (NSC, September 2021). In
                its final report, the NSC recommended employers in these communities
                host on-site vaccinations to increase worker access. Applications for
                mobile vaccination are available on most local and state health
                department websites (NSC, September 2021; ASU WEF, September 2021).
                 CVS has collaborated with several organizations, including the
                National Medical Association, to increase access to testing in
                underserved communities and has developed mobile solutions that allow
                health care professionals to bring testing capabilities to businesses
                in these communities as they re-open (CVS Health, September 2021).
                Walgreens has implemented efforts to increase access in underserved
                communities such as rural and/or lower socioeconomic communities as
                well, with now more than half of Walgreens testing sites currently
                located in areas the CDC has identified as socially vulnerable and
                underserved (Walgreens, October 2021). Because of these investments,
                OSHA concludes that employers and their employees in underserved
                communities, including those in rural areas, will have sufficient
                access to COVID-19 tests and will be able to comply with the ETS's
                testing requirements for employees who are not fully vaccinated.
                V. Management of Confidential Medical Records, Including Employee
                COVID-19 Vaccination and Testing Records
                 The ETS requires employers to maintain a record of each employee's
                vaccination status. Employers must also maintain a record of each test
                result provided by each employee. These records must be maintained as
                confidential medical records and must not be disclosed except as
                required or authorized by this ETS or other federal law. The records
                are not subject to the retention requirements of 29 CFR
                1910.1020(d)(1)(i) but must be maintained and preserved while the ETS
                is in effect.
                 Other OSHA rules have a similar requirement to maintain employee
                medical records, which could include vaccination records. See, e.g.,
                Bloodborne Pathogens (29 CFR 1910.1030), Respiratory Protection (29 CFR
                1910.134), Respirable Crystalline Silica (29 CFR 1910.1053), Beryllium
                (29 CFR 1910.1024), Lead (29 CFR 1910.1025), and OSHA's requirements
                for employee access to medical and exposure records (29 CFR 1910.1020).
                OSHA is not aware of any potential technological feasibility issues
                related to recordkeeping.
                 The requirement under this ETS to maintain records of employees'
                COVID-19 vaccination status and COVID-19 test results is similar to
                requirements in the aforementioned OSHA standards, and OSHA therefore
                concludes that compliance is feasible. Employers subject to the ETS
                will be able to comply with the provisions in the ETS using
                straightforward recordkeeping systems that are already widely used by
                large employers as part of their usual and customary business
                practices. OSHA concludes that it is feasible for such employers to
                comply with the requirements in the ETS for maintaining records related
                to COVID-19 vaccination status and COVID-19 test results.
                VI. Other Provisions
                 There are no technological feasibility barriers related to
                compliance with other requirements in the ETS (e.g., face coverings,
                employee notification). As explained above, many of the employer plans
                and best practice documents reviewed by OSHA indicate that employers
                have implemented the measures in these provisions across industry
                sectors. OSHA highlights two of the ETS's other requirements below,
                which are explored in more depth in other sections of this preamble.
                 Face Coverings. Paragraph (i) of the ETS requires the
                employer to ensure that all employees who are not fully vaccinated wear
                a face covering when indoors and when occupying a vehicle with another
                person for work purposes, except: (i) When an employee is alone in a
                room with floor to ceiling walls and a closed door; (ii) for a limited
                time while the employee is eating or drinking at the workplace or for
                identification purposes in compliance with safety and security
                requirements; (iii) when employees are wearing respirators or face
                masks; or (iv) where the employer can show that the use of face
                coverings is infeasible or creates a greater hazard. The definition of
                face covering allows various different types of masks, including clear
                face coverings or cloth face coverings with a clear plastic panel which
                may be used to facilitate communication with people who are deaf or
                hard-of-hearing or others who need to see a speaker's mouth or facial
                expressions to understand speech or sign language respectively. The
                types of face coverings permitted under this ETS are widely used and
                readily available. The results of the ASU WEF June 2021 survey found
                that 30% of employers required face coverings for unvaccinated
                employees, which demonstrates that this provision of the ETS is
                currently being implemented by a substantial number of employers and is
                ``capable of being done.'' (ASU WEF, September 2021). OSHA identifies
                no technological
                [[Page 61457]]
                feasibility issues with this provision of the ETS.
                 Notification. Paragraph (h) of the ETS contains COVID-19
                notification requirements for both the employer and the employee. Under
                this provision, the employer must require each employee to promptly
                notify the employer if they receive a positive COVID-19 test or are
                diagnosed with COVID-19 by a licensed healthcare provider and must
                immediately remove any employee from the workplace who receives a
                positive COVID-19 test or is diagnosed with COVID-19 by a licensed
                healthcare provider. OSHA identifies no technological feasibility
                issues in connection with the ETS's notification requirements. It is
                the employer's responsibility to ensure that appropriate instructions
                and procedures are in place so that designated representatives of the
                employer (e.g., managers, supervisors) and employees conform to the
                rule's requirements.
                VII. Conclusion
                 OSHA has determined that complying with this ETS is technologically
                feasible for typical firms covered by this standard, at least most of
                the time (see Public Citizen v. OSHA, 557 F.3d 165 (3d Cir. 2009); Lead
                I, 647 F.2d at 1272; Lead II, 939 F.2d at 990). OSHA reviewed extensive
                evidence across industries and did not identify any industry-specific
                compliance barriers. Evidence in the record that shows that the written
                workplace COVID-19 vaccination policy requiring each employee to be
                fully vaccinated against COVID-19 unless they establish and implement a
                written policy that permits an employee to choose to be tested for
                COVID-19 at least every seven days and wear a face covering is
                feasible. In fact, such policies have already been implemented by
                hundreds of large companies across industry sectors. OSHA has also
                determined that there are sufficient COVID-19 tests available and
                adequate laboratory capacity to meet the anticipated increased testing
                demand related to compliance with the ETS testing option.
                 Additionally, the ETS's requirements to determine employee
                vaccination status, support employee vaccination by providing time off
                for vaccination and time off for recovery, and maintain records of
                employee COVID-19 vaccination status and COVID-19 test results are also
                technologically feasible. As discussed above, that many employers and
                organizations have already implemented such requirements demonstrates
                that they are ``capable of being done.'' Moreover, the recordkeeping
                requirements in this ETS largely mirror the requirements for the
                collection and maintenance of similar employee medical records in
                OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) and the
                Respiratory Protection standard (29 CFR 1910.134). The ETS provides a
                flexible compliance option for employers to tailor their procedures and
                practices to the needs of their workplace. OSHA finds that employers in
                typical firms in all industry sectors can comply with the requirements
                of the ETS, and compliance with the ETS is therefore technologically
                feasible.
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                CVS Health. (2021, September). COVID-19: Testing information.
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                Delta Airlines. (2021, August 25). Bastian memo to employees
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                Fifty/50 Group. (2021, May 18). Employee Vaccination Requirement
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                Food and Drug Administration (FDA). (2020, May 9). Coronavirus
                (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the
                Rapid Detection of the Virus that Causes COVID-19 in Patients.
                https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid-detection-virus-causes. (FDA, May 9, 2020)
                Food and Drug Administration (FDA). (2021, March 31). Emergency Use
                Authorization QuickVue At-Home OTC COVID-19 Test. https://www.fda.gov/media/147247/download. (FDA, March 31, 2021)
                Food and Drug Administration (FDA). (2021, June 11). Emergency Use
                Authorization Sofia SARS Antigen FIA OTC COVID-19 Test. https://www.fda.gov/media/137886/download. (FDA, June 11, 2021)
                Food and Drug Administration (FDA). (2021, September 10). COVID-19
                Tests and Collection Kits Authorized by the FDA: Infographic.
                https://www.fda.gov/
                [[Page 61458]]
                medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-
                tests-and-collection-kits-authorized-fda-infographic. (FDA,
                September 10, 2021)
                Food and Drug Administration (FDA). (2021, September 22).
                Coronavirus Disease 2019 Testing Basics. https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics.
                (FDA, September 22, 2021)
                Food and Drug Administration (FDA). (2021, October 1). Coronavirus
                (COVID-19) Update: October 1, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-october-1-2021.
                (FDA, October 1, 2021)
                Food and Drug Administration (FDA). (2021, October 4). Coronavirus
                (COVID-19) Update: FDA Authorizes Additional OTC Home Test to
                Increase Access to Rapid Testing for Consumers. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-otc-home-test-increase-access-rapid-testing.
                (FDA, October 4, 2021)
                Food and Drug Administration (FDA). (2021a, October 14). In Vitro
                Diagnostics EUAs--Antigen Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021a)
                Food and Drug Administration (FDA). (2021b, October 14). In Vitro
                Diagnostics EUAs--Molecular Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021b)
                Fulton County, Georgia. (2021, September 3). Fulton Commissioners
                Approve Employee Vaccine Protocols. https://www.fultoncountyga.gov/news/2021/09/03/fulton-commissioners-approve-employee-vaccine-protocols. (Fulton County Government, September 3, 2021)
                Genesis Health Care. (2021, September 29). Coronavirus Updates.
                https://www.genesishcc.com/coronavirus-updates. (Genesis Health
                Care, September 29, 2021)
                Health Action Alliance (HAA). (2021, October 10). COVID-19 Vaccines:
                Employers & Requirements. A list of companies requiring vaccinations
                for all or part of their workforce or customers. https://www.healthaction.org/resources/vaccines/covid-19-vaccines-employer-requirements-health-action-alliance. (HAA, October 10, 2021)
                Health Action Alliance (HAA) and the National Safety Council (NSC).
                (2021, September 17). COVID-19 Employer Policies: A Decision Tool
                for Business Leaders. https://www.healthaction.org/reopening-questions#Q. (HAA and NSC, September 17, 2021)
                Institutes of Electrical and Electronics Engineers. (IEEE). (2021,
                April 28). RADxSM Tech: A New Paradigm for MedTech Development
                Overview of This Special Section. https://ieeexplore.ieee.org/document/9418526. (IEEE, April 28, 2021)
                International Union of Painters and Allied Trades (IUPAT). (2021,
                May 10). IUPAT Supports Vaccine Mandates. https://www.iupat.org/press-room/vaccine-policy/. (IUPAT, May 10, 2021)
                Johns Hopkins University. (2021, October 8). Coronavirus Resource
                Center: Testing Hub. https://coronavirus.jhu.edu/testing/individual-states. (JHU, October 8, 2021)
                Kaiser Permanente. (2021, August 2). Protecting health and safety
                through vaccination. https://about.kaiserpermanente.org/our-story/news/announcements/protecting-health-and-safety-through-vaccination.
                (Kaiser Permanente, August 2, 2021)
                MaineHealth. (2021, September 20). MaineHealth awarded nearly $1M by
                National Institutes of Health to study COVID-19 testing in higher
                risk communities. https://www.mainehealth.org/News/2021/09/MaineHealth-awarded-nearly-1M-by-NIH-to-study-COVID19-testing.
                (Maine Health, September 20, 2021)
                Mayo Clinic Laboratories. (2020, June 30). Mayo Clinic experts to
                help guide Delta Air Lines COVID-19 safety measures. https://newsnetwork.mayoclinic.org/discussion/delta-engages-mayo-clinic-experts-to-advise-on-making-travel-even-safer/. (Mayo Clinic
                Laboratories, June 30, 2020)
                Microbrush. (2020, July 1). Microbrush Introduces New Nasopharyngeal
                Test Swabs. https://www.prnewswire.com/news-releases/microbrush-introduces-new-nasopharyngeal-test-swabs-301087276.html.
                (Microbrush, July 1, 2020)
                Millipore Sigma. (2021, October). Coronavirus COVID-19 (SARS-CoV-2)
                Detection, Characterization, Vaccine and Therapy Production. https://www.sigmaaldrich.com/US/en/life-science/covid. (Millipore Sigma,
                October 2021)
                National Academy for State Health Policy (NASHP). (2021, October 1).
                State Efforts to Ban or Enforce COVID-19 Vaccine Mandates and
                Passports. https://www.nashp.org/state-lawmakers-submit-bills-to-ban-employer-vaccine-mandates/. (NASHP, October 1, 2021)
                National Institutes of Health (NIH) National Institute of Biomedical
                Imaging and Bioengineering (NIBIB). (2021, September 28). RADx Tech/
                ATP Dashboard. https://www.nibib.nih.gov/covid-19/radx-tech-program/radx-tech-dashboard. (NIBIB, September 28, 2021)
                National Institutes of Health (NIH) National Institute of Biomedical
                Imaging and Bioengineering (NIBIB). (2021, October 14). RADxSM Tech
                and ATP Programs: Phase 2 Awards. https://www.nibib.nih.gov/covid-19/radx-tech-program/radx-tech-phase2-awards. (NBIB, October14,
                2021)
                National Institutes of Health (NIH). (2020, October 6). NIH RADx
                initiative advances six new COVID-19 testing technologies. https://www.nih.gov/news-events/news-releases/nih-radx-initiative-advances-six-new-covid-19-testing-technologies. (NIH, October 6, 2020)
                National Institutes of Health (NIH). (2020, September 30). NIH to
                assess and expand COVID-19 testing for underserved communities.
                https://www.nih.gov/news-events/news-releases/nih-assess-expand-covid-19-testing-underserved-communities. (NIH, September 30, 2020)
                National Institutes of Health (NIH). (2020, April 29). NIH mobilizes
                national innovation initiative for COVID-19 diagnostics. https://www.nih.gov/news-events/news-releases/nih-mobilizes-national-innovation-initiative-covid-19-diagnostics. (NIH, April 29, 2020)
                National Safety Council (NSC). (2021, May 17). SAFER: Safe Actions
                For Employee Returns. https://www.nsc.org/getmedia/f5dfd05d-83bf-4753-8903-538a24157725/safer-framework-summary.pdf. (NSC, May 17,
                2021)
                National Safety Council (NSC). (2021, September). SAFER Report: A
                Year in Review, and What's Next. https://www.nsc.org/workplace/safety-topics/safer/state-of-the-response-state-actions-to-address-the. (NSC, September 2021)
                Puritan Products. (2020, April 20). Puritan Blog: Puritan at the
                Epicenter of COVID-19 Testing. https://blog.puritanmedproducts.com/puritan-at-epicenter-of-covid-19-testing. (Puritan Products, April
                20, 2020)
                Qiagen. (2021, October 2). COVID-19 Latest News. https://www.qiagen.com/us/customer-stories/latest-news-on-the-fight-against-coronavirus. (Qiagen, October 2, 2021)
                Quest Diagnostics. (2021, September 28). Quest Diagnostics Media
                Statement about COVID-19 Testing. https://newsroom.questdiagnostics.com/COVIDTestingUpdates. (Quest
                Diagnostics, September 28, 2021)
                Quidel Corporation. (2020, July 31). Press release, Quidel Corp.
                https://ir.quidel.com/news/news-release-details/2020/Quidel-Receives-Preliminary-Contract-Leading-to-Definitive-Agreement-for-71-Million-Under-NIHs-RADx-ATP-Program-to-Accelerate-the-Expansion-of-Its-Manufacturing-Capacity-for-Sofia-SARS-CoV-2-Antigen-Detection-Test-for-Rapid-Diagnosis-of-COVID-19/default.aspx. (Quidel
                Corp., July 31, 2020)
                RiteAid. (2021, October). Free* COVID-19 Testing. https://www.riteaid.com/pharmacy/services/covid-19-testing. (RiteAid,
                October 2021)
                Sanford Health. (2021, July 22). Sanford Health to require COVID-19
                vaccine for employees. https://news.sanfordhealth.org/news-release/sanford-to-require-covid-19-vaccine-for-employees/. (Sanford Health,
                July 22, 2021)
                Trinity Health. (2021, July 8). Trinity Health Announces COVID-19
                Vaccine Requirement for All Colleagues. https://www.trinity-
                health.org/news/trinity-health-announces-covid-19-vaccine-
                [[Page 61459]]
                requirement-for-all-colleagues. (Trinity Health, July 8, 2021)
                Tyson Foods. (2021, August 3) Tyson Foods to Require COVID-19
                Vaccinations for its U.S. Workforce. https://www.tysonfoods.com/news/news-releases/2021/8/tyson-foods-require-covid-19-vaccinations-its-us-workforce. (Tyson Foods, August 3, 2021)
                University of Arizona Center for Rural Health (ASU CRH). (2021,
                September 30). ADHS-CDC COVID Disparities Initiative. https://crh.arizona.edu/programs/covid-disparities-initiative. (ASU CRH,
                September 30, 2021)
                U.S. Department of Defense (DOD). (2021, March 29) DOD Awards
                $146.77 Million Contract to Puritan Medical Products to Increase
                Domestic Production Capacity of Foam Tip Swabs. https://www.defense.gov/News/Releases/Release/Article/2554073/dod-awards-14677-million-contract-to-puritan-medical-products-to-increase-domes/. (DOD, March 29, 2021)
                U.S. Department of Defense (DOD). (2021, July 31). DOD Awards $51.15
                Million Undefinitized Contract Action to Puritan Medical Products
                Company LLC to Increase Domestic Production Capacity of Flock Tip
                Testing Swabs. https://www.defense.gov/News/Releases/Release/Article/2295387/dod-awards-5115-million-undefinitized-contract-action-to-puritan-medical-produc/. (DOD, July 31, 2021)
                U.S. Department of Defense (DOD). (2021, August 23). DOD Awards $0.6
                Million Contract to QIAGEN to Increase Domestic Production Capacity
                of COVID-19 Diagnostic Test Kits and Reagents. https://www.defense.gov/News/Releases/Release/Article/2742967/dod-awards-06-million-contract-to-qiagen-to-increase-domestic-production-capaci/.
                (DOD, August 23, 2021)
                U.S. Department of Defense (DOD). (2021, December 21). DOD Awards
                $4.8 Million Indefinite Delivery/Indefinite Quantity to a Calibre
                Scientific Subsidiary, Anatrace, to Increase Domestic Production
                Capacity of COVID-19 Testing Reagents. https://www.defense.gov/News/Releases/Release/Article/2454163/dod-awards-48-million-indefinite-deliveryindefinite-quantity-to-a-calibre-scien/. (DOD, December 21,
                2020)
                U.S. Department of Health and Human Services. (HHS). (2021, June
                11). HHS Provides $424.7 Million to Rural Health Clinics for COVID-
                19 Testing and Mitigation in Rural Communities. https://www.hhs.gov/about/news/2021/06/11/hhs-provides-424-million-to-rural-health-clinics-for-covid-19-testing.html. (HHS, June 11, 2021)
                U.S. Department of Health and Human Services (HHS). (2021, August
                17). Community based testing sites. https://www.hhs.gov/coronavirus/community-based-testing-sites/index.html. (HHS, August 17, 2021)
                Walgreens. (2021, October). Free Drive-Thru COVID-19 Testing for
                Ages 3+. https://www.walgreens.com/findcare/covid19/testing?ban=covid_hp_cause2. (Walgreens, October 2021)
                Walgreens. (2021, October 8). COVID-19 FAQs. https://news.walgreens.com/our-stories/covid-19-stories/covid-19-faq.htm#testinghome. (Walgreens, October 8, 2021)
                Walmart. (2021, July 9). Supporting COVID-19 Testing. https://corporate.walmart.com/covid19testing. (Walmart, July 9, 2021)
                Washington Post. (2021, October 6). White House announces $1 billion
                purchase of rapid, at-home coronavirus tests. https://www.washingtonpost.com/health/2021/10/06/biden-rapid-at-home-covid-tests/. (Washington Post, October 6, 2021)
                Willis Towers Watson. (2021, June 23) COVID-19 Vaccination and
                Reopening the Workplace Survey press release. https://www.willistowerswatson.com/en-US/News/2021/09/workplace-vaccine-mandates-expected-to-accelerate-wtw-survey-finds. (Willis Towers
                Watson, June 23, 2021)
                Willis Towers Watson. (2021, September 1) Workplace vaccine mandates
                expected to accelerate, Willis Towers Watson survey finds. https://www.willistowerswatson.com/en-US/News/2021/09/workplace-vaccine-mandates-expected-to-accelerate-wtw-survey-finds. (Willis Towers
                Watson, September 1, 2021)
                B. Economic Analysis
                I. Introduction
                 This section presents OSHA's estimates of the costs and impacts,
                anticipated to result from the COVID-19 Vaccination and Testing ETS, 29
                CFR 1910.501. The purpose of this ETS is to address the grave danger of
                COVID-19 in the workplace by promoting vaccination, while allowing an
                alternative for face covering and testing requirements, and also to
                remove COVID-19 positive workers from the workplace regardless of
                vaccination status. The estimated costs are based on employers
                achieving full compliance with the requirements of the ETS. They do not
                include prior costs associated with firms whose current practices are
                already in compliance with the ETS requirements. The purpose of this
                analysis is to:
                 Identify the entities/establishments and industries
                affected by the ETS;
                 Estimate and evaluate the costs and economic impacts that
                regulated entities/establishments will incur to achieve compliance with
                the ETS; and
                 Evaluate the economic feasibility of the rule for affected
                industries.
                 In this analysis, OSHA is fulfilling the requirement under the OSH
                Act to show the economic feasibility of this ETS. This analysis is
                different from the cost portion of a regulatory impact analysis
                prepared in accordance with Executive Order 12866 in that the agency is
                focused only on costs to employers when evaluating economic
                feasibility. In a regulatory impact analysis, the costs to all parties
                (e.g., employers, employees, and governments) are included. While this
                is not the case for an economic feasibility analysis, it does not
                necessarily mean that the ETS imposes no costs or burdens on parties
                other than employers. For example, the rule imposes certain costs on
                employees who choose not to become vaccinated (e.g., for face coverings
                and testing. While these costs are not relevant for the purpose of
                establishing economic feasibility, these costs would be attributable to
                the ETS in a regulatory impact analysis. In addition, these costs are
                not mandatory because any employee who does not wish to pay them may
                choose to become vaccinated or leave employment (see discussion below
                on turnover), after which the costs would not be incurred. Some
                employees may also be entitled to a reasonable accommodation that may
                avoid additional cost (e.g., telework).
                 ``[T]he Supreme Court has conclusively ruled that economic
                feasibility [under the OSH Act] does not involve a cost-benefit
                analysis.'' Pub. Citizen Health Research Grp. v. U.S. Dept. of Labor,
                557 F.3d 165, 177 (3d Cir. 2009); see also Asbestos Info. Ass'n, 727
                F.2d at 424 n.18 (noting that formal cost benefit is not required for
                an ETS, and indeed may be impossible in an emergency). The OSH Act
                ``place[s] the `benefit' of worker health above all other
                considerations save those making attainment of this `benefit'
                unachievable.'' Cotton Dust, 452 U.S. at 509. Therefore, ``[a]ny
                standard based on a balancing of costs and benefits by the Secretary
                that strikes a different balance than that struck by Congress would be
                inconsistent with the command set forth in'' the statute. Id. While
                this case law arose with respect to health standards issued under
                section 6(b)(5) of the Act, which specifically require feasibility,
                OSHA finds the same concerns applicable to emergency temporary
                standards issued under section 6(c) of the Act. An ETS ``serve[s] as a
                proposed rule'' for a section 6(b)(5) standard, and therefore the same
                limits on any requirement for cost-benefit analysis should apply.
                Indeed, OSHA has also rejected the use of formal cost benefit analysis
                for safety standards, which are not governed by section 6(b)(5). See 58
                FR 16,612, 16,622-23 (Mar. 30, 1993) (``in OSHA's judgment, its
                statutory mandate to achieve safe and healthful workplaces for the
                nation's employees limits the role monetization of benefits and
                analysis of extra-
                [[Page 61460]]
                workplace effects can play in setting safety standards.'').\22\ A
                standard must be economically feasible in order to be ``reasonably
                necessary and appropriate'' under section 3(8) and, by inference,
                ``necessary'' under section 6(c)(1)(B) of the OSH Act. Cf. Am. Textile
                Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490, 513 n.31 (1981) (noting
                ``any standard that was not economically . . . feasible would a
                fortiori not be `reasonably necessary or appropriate' '' as required by
                the OSH Act's definition of ``occupational safety and health standard''
                in section 3(8)); see also Florida Peach Growers, 489 F.2d at 130
                (recognizing that the promulgation of any standard, including an ETS,
                must account for its economic effect). A standard is economically
                feasible when industries can absorb or pass on the costs of compliance
                without threatening industry's long-term profitability or competitive
                structure, Cotton Dust, 452 U.S. at 530 n.55, or ``threaten[ing]
                massive dislocation to, or imperil[ing] the existence of, the
                industry.'' United Steelworkers of Am. v. Marshall, 647 F.2d 1189, 1272
                (D.C. Cir. 1981) (Lead I). Given that section 6(c) is aimed at enabling
                OSHA to protect workers in emergency situations, the agency is not
                required to make the showing with the same rigor as in ordinary section
                6(b) rulemaking. Asbestos Info. Ass'n/N. Am. v. OSHA, 727 F.2d 415, 424
                n.18 (5th Cir. 1984). In Asbestos Information Association, the Fifth
                Circuit concluded that the costs of compliance were not unreasonable to
                address a grave danger where the costs of the ETS did not exceed 7.2%
                of revenues in any affected industry. Id. at 424.
                ---------------------------------------------------------------------------
                 \22\ To support its Asbestos ETS, OSHA conducted an economic
                feasibility analysis on these terms. 48 FR 51086, 51136-38 (Nov. 4,
                1983). In upholding that analysis, the Fifth Circuit said that OSHA
                was required to show that the balance of costs to benefits was not
                unreasonable. Asbestos Info. Ass'n, 727 F.2d at 423. As explained
                above, OSHA does not believe that is a correct statement of the
                economic feasibility test. However, even under that approach this
                ETS easily passes muster.
                ---------------------------------------------------------------------------
                 The scope of judicial review of OSHA's determinations regarding
                feasibility (both technological and economic) ``is narrowly
                circumscribed.'' N. Am.'s Bldg. Trades Unions v. OSHA, 878 F.3d 271,
                296 (D.C. Cir. 2017) (Silica). ``OSHA is not required to prove economic
                feasibility with certainty, but is required to use the best available
                evidence and to support its conclusions with substantial evidence.''
                Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 980-81 (D.C. Cir. 1991)
                (Lead II); 29 U.S.C. 655(b)(5), (f). ``Courts, [moreover], `cannot
                expect hard and precise estimates of costs.' '' Silica, 878 F.3d at 296
                (quoting Lead II, 939 F.2d at 1006). Rather, OSHA's estimates must
                represent ``a reasonable assessment of the likely range of costs of its
                standard, and the likely effects of those costs on the industry.'' Lead
                I, 647 F.2d at 1266. The ``mere `possibility of drawing two
                inconsistent conclusions from the evidence,' or deriving two divergent
                cost models from the data `does not prevent [the] agency's finding from
                being supported by substantial evidence.' '' Silica, 878 F.3d at 296
                (quoting Cotton Dust, 452 U.S. at 523).
                 Executive Orders 12866 and 13563 direct agencies to assess the
                costs and benefits of the intended regulation and, if regulation is
                necessary, to select regulatory approaches that maximize net benefits
                (including potential economic, environmental, and public health and
                safety effects; distributive impacts; and equity). Executive Order
                13563 emphasized the importance of quantifying both costs and benefits,
                of reducing costs, of harmonizing rules, and of promoting flexibility.
                Because of the continued impact of the pandemic on occupational safety
                and health, OSHA has prepared this ETS and the accompanying economic
                analysis on an extremely condensed timeline. Thus, in light of the
                Secretary's conclusion that the COVID-19 pandemic constitutes an
                emergency situation, the Secretary has notified OIRA that it is
                necessary for OSHA to promulgate this regulation more quickly than
                normal review procedures allow, pursuant to E.O. 12866 Sec. 6
                (a)(3)(D). OIRA has waived compliance with Sec. 6(a)(3)(B) and (C) for
                this economically significant rule.
                II. COVID-19 ETS Industry Profile
                a. Introduction
                 In this section, OSHA provides estimates of the number of affected
                entities, establishments, and employees for the industries that have
                settings covered by this ETS. The term ``entity'' describes a legal
                for-profit business, a non-profit organization, or a local governmental
                unit, whereas the term ``establishment'' describes a particular
                physical site of economic activity. Some entities own and operate more
                than one establishment.
                 Throughout this analysis, where estimates were derived from
                available data those sources have been noted in the text. Estimates
                without sources noted in the text are based on agency expertise.
                b. Scope of the COVID-19 ETS
                 This ETS applies to all employers with a total of 100 or more
                employees at any time this ETS is in effect. However, the requirements
                of this ETS do not apply to: (1) Workplaces covered under the Safer
                Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for
                Federal Contractors and Subcontractors (Contractor Guidance); or (2)
                settings where any employee provides healthcare services or healthcare
                support services when subject to the requirements of 29 CFR 1910.502
                (i.e., the Healthcare ETS). Furthermore, the requirements of this ETS
                do not apply to the employees of covered employers: (1) Who do not
                report to a workplace where other individuals, such as coworkers or
                customers, are present; or (2) while working from home; or (3) who work
                exclusively outdoors. Based on this scope, employers in nearly every
                sector are expected to be covered by this ETS.
                 OSHA's assumptions may result in an overestimate of the number of
                employees affected by the ETS. First, OSHA is not estimating the number
                and type of workplaces covered by the Safer Federal Workforce Task
                Force COVID-19 Workplace Safety: Guidance for Federal Contractors and
                Subcontractors or removing them from the profile of employers affected
                by this ETS. OSHA assumes for the purpose of this analysis that
                employers covered under the Contractor Guidance will also have
                contracts to perform work in workplaces where they are not covered
                under that Guidance (i.e., where the employer contracts with an entity
                other than the federal government), and so those employers are included
                in the scope here.
                 Second, OSHA estimates that all employers in all private sector
                industries are affected by this ETS to some extent. Although this ETS
                imposes no compliance burden on employers whose employees work remotely
                100 percent of the time, in OSHA's analysis, no employers with 100 or
                more employees have all of their employees working remotely 100 percent
                of the time (i.e., at least some employees in each affected firm do not
                work remotely). Moreover, OSHA's analysis does not take into account
                that some employees may engage in part-time telework (i.e., it assumes
                that employees either work remotely full-time or do not work remotely
                at all). Finally, OSHA's analysis does not fully take into account the
                exemption for employees who do not report to a workplace where other
                individuals are present, meaning that this analysis may overestimate
                the number of employees affected by the rule.
                 As stated, the requirements of this ETS do not apply to the
                employees of covered employers who work
                [[Page 61461]]
                exclusively outdoors. To determine the percentage of employees in
                occupations for which the exception is relevant, the agency uses data
                from the BLS's 2020 Occupational Requirements Survey (ORS) (BLS, 2020).
                This survey looks at various aspects of job requirements. In
                particular, the survey lists occupations where workers are outdoors
                ``constantly,'' which OSHA interprets as being nearly continuously
                outdoors. Because the majority of workers who work outdoors
                ``constantly'' likely work indoors at least some of the time, the
                agency judges that no more than 10 percent of the workers who are
                primarily outdoors are actually there exclusively. See Table IV.B.1 for
                the occupations, the ORS percentages, and final percentages for workers
                OSHA estimates are exempt from the scope of this ETS based on the
                outdoor work exemption.
                [GRAPHIC] [TIFF OMITTED] TR05NO21.000
                 OSHA's estimate of employees who work exclusively outdoors does not
                account for employers who only need to make slight adjustments to their
                current work practices to ensure that their employees qualify for the
                outdoor exemption, such as by holding tool box talks outdoors instead
                of in a traditional indoor location. This may result in more employees
                falling within the exemption than estimated by OSHA; therefore, OSHA's
                cost analysis likely overestimates costs.
                 The requirements of the ETS also do not apply to settings where any
                employee provides healthcare services or healthcare support services
                when subject to the requirements of 29 CFR 1910.502 (the Healthcare
                ETS). The Healthcare ETS is a temporary standard that may not remain in
                effect for the entire period that 29 CFR 1910.501 remains in effect.
                This means that some employers or employees covered by the Healthcare
                ETS, those in firms that have 100 or more employees, may ultimately be
                covered by 29 CFR 1910.501 (because the exception in 29 CFR 1910.501 is
                limited to when employers are subject to the requirements of the
                Healthcare ETS). This potentially impacts two types of costs: Employer-
                based costs (e.g., employer policy on vaccination) and employee-based
                (periodic) costs (e.g., recordkeeping).
                 Employer-Based Costs: For the purpose of the economic analysis
                only, OSHA treats the Healthcare ETS as though it will no longer be in
                effect after December, 2021, because at that point the Healthcare ETS
                will have been in effect for the six months that OSHA had calculated
                costs for that ETS. Therefore, OSHA estimates that some employers
                including those with 100 or more employees subject to the 29 CFR
                1910.502 exemption, will need to take employer-based costs because all
                these employers will ultimately be subject to 29 CFR 1910.501 under
                this assumption.
                 Employee-Based Costs: OSHA's estimates incorporate two assumptions
                for the purposes of this analysis only. First, for the purposes of
                assumptions for this analysis only, Sec. 1910.501 will remain in
                effect for 6 months. Second, many employers and employees currently
                covered only by the Healthcare ETS will be subject to the requirements
                of 29 CFR 1910.501 for approximately 4 months (4 months of the 6 month
                estimated lifespan of 29 CFR 1910.501). OSHA's estimate of those
                employees exempted by the Healthcare ETS was based on the Industry
                Profile of employees in firms with 100 employees or more covered by the
                Healthcare ETS, as estimated in Table VI.B.3 in the economic analysis
                for that rulemaking (see 86 FR 32488).
                 OSHA notes that some employees currently covered by the Healthcare
                ETS might also be currently covered by 29 CFR 1910.501 (albeit at
                different times or in different locations) because the Healthcare ETS
                is settings-based. For example, a pharmacist would normally not need to
                comply with the requirements of Sec. 1910.502 when just filling
                prescriptions in a retail pharmacy store (see 29 CFR
                1910.502(a)(2)(ii)), but would need to comply when administering
                vaccinations within an embedded clinic inside that retail pharmacy.
                Thus, there are a number of variables that could impact the extent to
                which the pharmacist's employer might
                [[Page 61462]]
                incur any costs. However, even to the extent that such costs might
                occur (e.g., recordkeeping for testing if the pharmacist works for an
                employer covered by 29 CFR 1910.501 and is unvaccinated), OSHA judges
                that they would be de minimis for several reasons. First, this pool of
                workers is likely to be very small, especially when compared to the
                population of workers covered by the Healthcare ETS. Second, most
                employees subject to both standards will have been fully vaccinated
                before OSHA takes costs for these employees under 29 CFR 1910.501 by
                operation of the CMS rule mandating vaccination or as a result of the
                voluntary vaccination incentives promoted by OSHA's Healthcare ETS
                (therefore negating most of the costs associated with vaccination and
                testing under 29 CFR 1910.501). Third, any underestimate of periodic
                costs will only apply during the first two months after 29 CFR 1910.501
                goes into effect and the standard has a delayed compliance date of 30
                days after the effective date for most provisions, except for testing,
                which has a delayed compliance date of 60 days. This will further
                lessen the periodic costs associated with any potential underestimate.
                 In all respects (other than the \4/6\ share of employee-based
                costs), OSHA is taking the same approach in the Industry Profile and
                Cost Estimates for employers and employees currently covered by the
                Healthcare ETS as it does for all other industries. These employers and
                employees are fully integrated into Table IV.B.5, below, which contains
                a summary of covered entities and employees. Moreover, the same
                assumptions on outdoor work and other scope exemptions that OSHA
                explains earlier holds for these employers and employees. In addition,
                OSHA makes the same downward adjustment in telework for these employers
                and employees in accordance with the methodology it sets out below.
                Thus, the Healthcare ETS profile used in this ETS to account for
                employees exempted by the Healthcare ETS into the Profile in the event
                the Healthcare ETS expires (i.e., in Table IV.B.5, below) is an updated
                version of Table VI.B.3 in the Healthcare ETS (see 86 FR 32488).\23\
                OSHA notes that some firms may decide to proactively comply with
                certain 29 CFR 1910.501 requirements (such as mandating vaccination for
                all employees that were removed from the Industry Profile) before the
                end date of the Healthcare ETS based on the conclusion that 29 CFR
                1910.501 will ultimately apply in full to them. Since these costs still
                occur due to 29 CFR 1910.501, OSHA is appropriately including them in
                this cost analysis.
                ---------------------------------------------------------------------------
                 \23\ The CMS rule published elsewhere in this issue of the
                Federal Register mandates vaccination for employees in facilities
                that receive Medicare or Medicaid. OSHA is ignoring this for the
                purpose of its cost analysis and taking costs into account as if the
                CMS rule were not promulgated. This creates a substantial
                overestimate.
                ---------------------------------------------------------------------------
                 There are 9.9 million employees who will newly be covered by 29 CFR
                1910.501 starting in December whose employers will incur an additional
                $318 million in costs. These costs are integrated into the agency's
                main cost analysis, which is described later in this economic analysis.
                 Only some state- and local-government entities are included in this
                analysis. State- and local-government entities are specifically
                excluded from coverage under the OSH Act (29 U.S.C. 652(5)). Workers
                employed by these entities only have OSH Act protections if they work
                in states that have an OSHA-approved State Plan. (29 U.S.C. 667).
                Consequently, this analysis excludes public entities in states that do
                not have OSHA-approved State Plans. Table IV.B.2 presents the states
                that have OSHA-approved State Plans and their public entities are
                included in the analysis.
                [GRAPHIC] [TIFF OMITTED] TR05NO21.001
                 OSHA notes, finally, that the percentage of employers mandating
                vaccination, and hence the employee vaccination rate, would likely rise
                to some degree absent this ETS due to other federal actions, such as
                the vaccination mandate for federal contractors, the CMS rule published
                elsewhere in this issue of the Federal Register, and as a result of
                vaccination mandates that have been adopted at state and local levels.
                This analysis does not account for increases in vaccination that would
                occur absent the standard, resulting in a likely overestimate of the
                costs.
                c. Teleworking
                Dingel-Neiman Approach for Estimating Who Can Work Remotely
                 OSHA uses the estimates in a paper by J.I. Dingel and B. Neiman,
                ``How Many Jobs Can be Done at Home?,'' published in July 2020, as a
                starting point to determine the percentage of employees, by occupation,
                who are not expected to work remotely (i.e., the percentage of workers
                for whom employers have employee-based costs under this ETS) (Dingel
                and Neiman, July 2020).
                 In Dingel and Neiman's paper, the authors estimate the number of
                jobs in the U.S. economy that workers can feasibly perform remotely.
                The authors use two different surveys from the
                [[Page 61463]]
                Occupational Information Network (O*Net) \24\ to evaluate which
                occupations can be performed remotely and combine the O*Net estimates
                with the Bureau of Labor Statistics' (BLS) Occupational Employment and
                Wage Statistics (OEWS) data on employment by occupation to estimate the
                total number of workers nationally who can work remotely.
                ---------------------------------------------------------------------------
                 \24\ 24 The O*Net Program is a major source of occupational
                information for the U.S. The O*NET database surveys ask both
                specific occupational experts and workers in those occupations
                questions covering multiple aspects of almost 1,000 occupations
                covering the entire U.S. economy. See https://www.onetonline.org/
                for more information. The occupation definitions in the O*NET data
                are Standard Occupation Codes--the same definitions that are used in
                the BLS OEWS data. Dingel and Neiman use the responses to two
                surveys included in release 24.2 of the database administered by
                O*NET, the Worker Context Questionnaire and the Generalized Work
                Activities Questionnaire. The occupation with the median number of
                respondents had 26 respondents for each work context question and 25
                respondents for each generalized work activities question per
                detailed-level SOC occupation code.
                 In the O*Net Questionnaires, survey respondents responded to
                statements about the nature and requirements of the daily tasks
                associated with their job on a 1-5 ordinal scale, where 5 represents
                the strongest agreement and 1 represents the strongest disagreement
                (see Table IV.B.3). The O*Net data contain the average response to
                each question for each occupation code. For instance, for occupation
                ``Chief Executives'' (SOC 11-1011), the average response to the
                prompt ``Performing General Physical Activities is very important''
                was 1.39, indicating that performing general physical activity is
                not, on average, critical to the work of chief executives. The
                average responses by occupation for other prompts in the relevant
                surveys utilized by Dingel and Neiman are contained in those
                surveys.
                ---------------------------------------------------------------------------
                 To evaluate the survey responses, Dingel and Neiman first
                determined the occupations for which the average response to a given
                prompt met a preset threshold. Table IV.B.3 presents the Dingel and
                Neiman response threshold for each survey question as well as the
                percent of occupations that meet each respective predetermined
                threshold. For example, in 10.8 percent of occupations, the average
                response to the ``Performing general physical activities'' (4.A.3.a.1)
                question met the threshold, falling in the range of 4 to 5.
                 Dingel and Neiman determined that employees in a given occupation
                can telework full time if they did not meet the predetermined threshold
                for any of the questions highlighted in grey and denoted with a ``Yes''
                in the column that reports whether that activity is used in determining
                whether a job can be done remotely in Table IV.B.3.
                [[Page 61464]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.002
                Source: (Dingel and Neiman, July 2020).
                [[Page 61465]]
                Adjusting Dingel and Neiman To Reflect Current Conditions
                 While many employees can and are working remotely, many have
                returned to their places of employment. This conclusion is borne out by
                BLS's Current Population Survey (CPS) (BLS, 2021c). To address the
                tendency toward employees returning to work on site and more accurately
                reflect current remote work conditions, OSHA made two adjustments to
                Dingel and Neiman's estimates. In the COVID-19 Healthcare ETS, OSHA
                also used Dingel and Neiman's paper to estimate the number of workers
                who teleworked in response to the pandemic and the ETS under the
                assumption that anyone who could work remotely would do so in response
                to the pandemic and the Healthcare ETS. Dingel and Neiman's estimates
                are therefore framed as the upper-bound of potential teleworking.
                 The adjustments OSHA made reflect changing circumstances. First,
                based on agency expertise, OSHA changed the status of certain
                occupations in its occupational list from working remotely to not
                working remotely. For example, when Dingel and Neiman published their
                study, many schools were operating virtually so the Dingel and Neiman
                finding that teachers were able to work remotely lined up with the
                situation where teachers were working remotely. At this point in the
                pandemic, on the other hand, in-person learning has mostly recommenced.
                To this end, OSHA changed the status of teachers and other employees in
                the education sector from working remotely to not working remotely in
                this analysis. As another example, many activities that ceased or were
                reduced significantly have now resumed and many locations that were
                closed to the public have reopened (e.g., athletic events, shows, gyms,
                casinos and places of worship), and, since more people have returned to
                the office, there is more need for childcare. Therefore, OSHA also
                changed the status of these employees and others from telework to non-
                telework. This has the ultimate effect of increasing costs estimates
                for the rule.
                 Appendix A (Table A-1), in the accompanying document in the docket,
                ``Vaccination, and Testing ETS: Economic Profile and Cost Chapter
                Appendices'' (OSHA, October 2021b), presents Dingel and Neiman's (July
                2020) unmodified percentages of workers that can work remotely in each
                detailed occupation (based on BLS's Standard Occupation Code
                (SOC)).\25\ Appendix A also presents, in separate columns, percentages
                reflecting the modifications OSHA made in those occupations where OSHA
                changed the results from telework to non-telework for the reasons
                stated, as well as percentages reflecting the modifications made in
                occupations where employees work exclusively outdoors.
                ---------------------------------------------------------------------------
                 \25\ Except for the adjustments to Dingel and Neiman discussed
                above, OSHA used the Dingel and Neiman estimates for telework by
                occupation without change. The agency recognizes that the authors'
                methodology (i.e., the use of 0-1 thresholds) led to a small number
                of results that may appear not to reflect real-world experiences
                within an occupation. However, Dingel and Neiman represents the best
                available evidence for determining the percentage of employees, by
                occupation, who are expected to work remotely. OSHA is aware of no
                other source for this information that contains the level of detail
                necessary to conduct this analysis. Moreover, as explained above,
                OSHA modified the results for individual occupations when it had a
                reasoned basis for doing so. In any event, every NAICS industry is
                comprised of many occupations, so for every occupation where OSHA
                suspects remote work is overestimated in Dingel and Neiman's
                results, there may be another where remote work is underestimated.
                ---------------------------------------------------------------------------
                 According to the OSHA-adjusted Dingel and Neiman estimates, 14
                percent of the jobs in the United States are performed entirely at
                home, with significant variation across cities and industries. It
                should be noted that the Dingel and Neiman analysis does not specify a
                proportion of jobs that can be performed at home part of the time;
                under the analysis, employees are either working remotely full-time or
                are working on site full time.
                 The second adjustment OSHA made used monthly COVID-specific
                teleworking data from telework questions added during the pandemic to
                the CPS to estimate the reduction in teleworking since its peak and
                applied those estimates to further adjust downward the number of
                workers currently teleworking (BLS, 2021c). Specifically, the CPS
                questions asked respondents whether they were teleworking due to COVID-
                19 (as opposed to teleworking for other reasons) and OSHA estimated the
                difference in teleworking from the peak of COVID-related teleworking in
                all industries, which occurred in May 2020, through August 2021 (see
                Table IV.B.4).\26\ The reduction in teleworking was then applied as the
                change in percentage points to the estimated overall level of employees
                covered by the ETS in each NAICS code estimated based on data from
                Dingel and Neiman (July 2020). OSHA's final teleworking estimates are
                provided in Appendix B in the accompanying document in the docket,
                ``Vaccination, and Testing ETS: Economic Profile and Cost Chapter
                Appendices'' (OSHA, October 2021b). Reductions due to employees working
                exclusively outdoors were applied to reduce the percentage of covered
                employees in Appendix B as well.
                ---------------------------------------------------------------------------
                 \26\ The CPS data were available only at the 2-digit NAICS level
                as shown in Table IV.B.4.
                ---------------------------------------------------------------------------
                [[Page 61466]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.003
                Other Teleworking Literature
                 A number of companies have announced plans to allow employees to
                work from home at least through the end of 2021--suggesting that the
                levels of remote work will not be returning to pre pandemic levels in
                the near future. Many technology and internet based companies, such as
                Dropbox, Coinbase, VMWare, and Slack, have announced a complete,
                permanent move to fully remote work (Courtney, September 27, 2021).
                Large employers such as Facebook, Amazon, and Siemens plan to maintain
                some physical workspace but now offer their employees who are telework
                eligible the option to work from home at least part of the time on a
                permanent basis (Id.). Google, Ford, Amazon, Apple and other large
                employers are expecting their telework eligible workers to return to
                on-site work (in some capacity) no earlier than January 2022 with Lyft
                anticipating a February 2022 return (Cerullo, August 31, 2021). As a
                final example, a survey of businesses in Massachusetts found that about
                40 percent of teleworkers anticipate they will not be returning to the
                office in January 2022 or earlier (Chesto, June 22, 2021).
                 Additional studies provide qualitative support for the conclusion
                that a range of employees will ``predictably'' work from home both
                during the pandemic and beyond. In Bick, Blandin, and Martens's paper,
                ``Work from Home Before and After the COVID-19 Outbreak'' the authors
                use the following information to establish the physical location of
                employment (home or workplace) of workers: Data from the Real-Time
                Population Survey (RPS), a
                [[Page 61467]]
                national labor market survey of adults between ages 18-64 that mirrors
                the Current Population Survey (CPS) and collects information used in
                pandemic analysis, such as commuting behavior before and after the
                World Health Organization declared a global pandemic; mobility data on
                commuting; and information from the CPS since May 2020 on `pandemic-
                related' telework (Bick et al., February 2021).
                 Based on these data, Bick et al., found that there was a sudden
                decline in commuting trips in the U.S. after the initial COVID-19
                outbreak, and that even when these trips subsequently began increasing
                back toward the original number of commuting trips, the overall number
                of trips did not return to normal at the end of 2020 because many
                teleworking employees continued working from home. The authors found
                that the surge in work from home came almost entirely from employees
                working from home every workday in the reference week. The authors also
                suggest that, for some occupations, especially those occupations with
                more educated workers, the change to increased work from home appears
                to be a long-term change; the data showed that, as of December 2020,
                12.5 percent of these workers reported they expect to be working from
                home full-time in the future, and 24.5 percent reported they expect to
                be working from home part-time.
                 In ``COVID-19 and Remote Work: An Early Look At U.S. Data,''
                Brynjolfsson et al., noted that some of the shift to working from home
                seems to be a long-term phenomenon (Brynjolfsson et al., June 2020).
                The authors found, using an online survey, that 35.2 percent of workers
                had switched to working from home. Additionally, 15 percent of workers
                reported they were already working from home before COVID-19.
                Therefore, this study finds that about half of workers are now working
                from home--an even greater percentage than estimated by Dingel and
                Neiman.
                 Finally, in ``Why Working from Home Will Stick,'' Barrero et al.
                predict that 22 percent of all full workdays will be performed from
                home after the pandemic ends, compared to 5 percent before (Barrero et
                al., April 2021). The authors highlight five factors contributing
                towards the more permanent shift to telework: Diminished stigma,
                better-than-expected experiences working from home, investments in
                physical and human capital enabling work from home, reluctance to
                return to pre-pandemic activities, and innovation supporting work from
                home.
                d. Affected Entities and Employees
                 OSHA used data from the U.S. Census' 2017 Statistics of U.S.
                Businesses (SUSB) to identify private sector entities and employees
                affected by this section of the ETS (U.S. Census Bureau, 2019), and
                used the BLS 2017 Quarterly Census of Employment and Wages (QCEW) to
                characterize state and local government entities (BLS, 2017). SUSB
                provides estimates of entities and employees by employer size range,
                which OSHA used to exclude employers with fewer than 100 employees.\27\
                ---------------------------------------------------------------------------
                 \27\ SUSB with revenue data is only collected every 5 years.
                While OSHA could attempt to extrapolate these data to more recent
                years, the results would be imprecise because they would change the
                revenue-employee size distributions. Those distributions are crucial
                for measuring impacts so the agency has opted to use the data as is.
                The total number of employees in OSHA's estimate is fairly close to
                that of SUSB. The 2017 SUSB data includes a total of 128.6 million
                employees, while the more recent 2018 SUSB data includes a total of
                130.9 million.
                ---------------------------------------------------------------------------
                 For rail transportation (NAICS 482), which is not included in SUSB
                or QCEW data, OSHA relied on Federal Railroad Administration and
                Association of American Railroads statistics reported in OSHA's 2020
                final rule, Cranes and Derricks in Construction: Railroad Roadway Work.
                See 85 FR 57109 (September 15, 2020). OSHA used these data sources to
                identify public and private railroad employers with more than 100
                employees. For agricultural NAICS (111 and 112), OSHA relies on the
                National Agricultural Statistics Service, 2017 Census of Agriculture
                (NASS, 2017) to obtain estimates of total entities, employees, and
                revenues. Since these data do not indicate the number of entities with
                more than 100 employees, OSHA assumes it is the same as the average
                proportion as the support activity sectors for crop and animal
                production (NAICS 114 and 115). OSHA similarly specifies teleworking
                conditions for NAICS 111 and 112 using the average result for support
                activities for agriculture (NAICS 114 and 115). For the postal service
                industry, NAICS 491110, which is not included in SUSB, OSHA obtains
                total entity and employment data for private postal services from the
                QCEW. Since these data do not indicate the number of entities with more
                than 100 employees, OSHA assumes it is the same as the average
                proportion as the related industries, couriers and express delivery
                (NAICS 492110), and local delivery (NAICS 492120).
                 OSHA used the BLS 2020 Occupational Employment and Wage Statistics
                (OEWS), which provides NAICS-specific estimates of employment and wages
                by occupation, along with the data in Appendix B (discussed earlier),
                to determine the subset of non-teleworking employees affected by the
                ETS.
                 Table IV.B.5 summarizes the set of entities covered by the ETS.
                OSHA estimates a total of approximately 263,879 entities and
                approximately 1.9 million establishments incur costs under the ETS.\28\
                OSHA estimates these entities employ approximately 102.7 million
                employees, and of these, OSHA estimates approximately 84.2 million
                employees are covered by the ETS and are not excluded from coverage by
                working remotely 100 percent of the time or exclusively outside.\29\
                For the purpose of this analysis, OSHA estimates that all employees
                that OSHA estimated will work remotely will continue to do so for the
                duration of this ETS.\30\
                ---------------------------------------------------------------------------
                 \28\ This includes public entities only in states with an
                approved OSHA State Plan. See Table IV.B.2 above for further
                discussion of state plans.
                 \29\ OSHA's estimate of covered employees is based on the
                discussion in the text. For example, as OSHA writes above: OSHA
                assumes for the purpose of its analysis that employers covered under
                the Contractor Guidance will conduct work at least some of the time
                in workplaces not covered under that Guidance and so are fully
                integrated into the scope of the ETS; and the employers and
                employees covered by the Healthcare ETS are also fully integrated
                into the scope of the ETS.
                 \30\ Conditions are changing rapidly, and though many firms are
                planning to keep expanded telework to some extent, as the rate of
                vaccinated workers increases, there may be increased movement back
                to the workplace beyond what OSHA has estimated here.
                ---------------------------------------------------------------------------
                [[Page 61468]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.004
                [[Page 61469]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.005
                [[Page 61470]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.006
                III. Baseline Vaccine Status for Covered Employees
                 To estimate the cost of the ETS, OSHA must first estimate the
                baseline vaccination status for the 84.2m covered employees (those who
                work for employers with 100 or more employees and are not otherwise
                excluded from coverage). OSHA recognizes that employees' current
                vaccination status continues to change on a daily basis. When
                specifying baseline vaccination rates, OSHA used the most recently
                available vaccination data from CDC, reflecting current conditions. For
                the remaining set of unvaccinated employees covered by the ETS, after
                accounting for baseline vaccinations, OSHA estimates the number of
                these employees who will be vaccinated and the number who will test
                under the ETS. OSHA's methodology for this analysis is detailed below.
                a. Estimate the Current Vaccination Rate for Covered Employees
                 To estimate the current vaccinate rate for covered employees, OSHA
                obtained recent vaccination data by age group from the CDC COVID Data
                Tracker (CDC, October 4, 2021a).\31\ For age groups covering 18-74
                years old, these data include the number of people who are fully-
                vaccinated as well as the number of people of who have initiated their
                first shot in the past two weeks (relative to the October 4, 2021
                data).\32\ OSHA estimates the vaccination rate for each group (percent
                of total population in the age group who are vaccinated) based on the
                total number of people who are fully-vaccinated and had their first
                shot in the past two weeks, as a fraction of the population in each age
                group, obtained from the BLS Current Population Survey (CPS) (BLS,
                2021d). Then, to estimate the overall average vaccination rate across
                age groups 18-74 years old, OSHA weighted each group based on the
                distribution of the labor force by age, also obtained from the BLS CPS
                (BLS, 2021d). As shown in Table IV.B.6, OSHA estimates an overall
                vaccination rate of 61.3 percent for covered employees (and 38.7
                percent unvaccinated). The healthcare sector had an earlier push to get
                healthcare workers vaccinated and has a higher current rate, estimated
                to be 70 percent.\33\
                ---------------------------------------------------------------------------
                 \31\ The data from the CDC website was retrieved on October 4,
                2021.
                 \32\ Age groups included: 18-24, 25-39, 40-49, 50-64, and 65-74.
                OSHA had not included the group 65-74 in the economic analysis of
                the Healthcare ETS this past spring because for the healthcare
                sector, using the population wide average of workers in this age
                bracket was felt would overcount the number of such workers in this
                sector. OSHA is including this group now that more of the other age
                populations have been vaccinated and those concerns are no longer as
                relevant. This ETS will therefore indicate that a slightly higher
                percentage of universe of covered employees is vaccinated than if
                that age group of 65-74 was excluded altogether, but it also
                increases the number of employees for which additional compliance
                costs are factored in. OSHA interprets the ultimate result as a more
                accurate reflection of the workplace and notes that more costs are
                included than if the age group had been excluded from the analysis.
                 \33\ The agency takes a recent survey (Lazer et al., August 16,
                2021) which breaks out rates for healthcare vaccination and non-
                healthcare, and rather than replacing the CDC base vaccination rate
                uses the CDC rate to make an adjustment upwards to the healthcare
                rate of 70 percent.
                ---------------------------------------------------------------------------
                [[Page 61471]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.007
                 Based on the above, OSHA estimates that the 84.2m covered employees
                includes 52.5 million (62 percent) vaccinated employees and 31.7
                million unvaccinated employees (38 percent).
                b. Adjust Baseline Vaccination for Continuing Trends
                 OSHA adjusts the current vaccination rate to account for continuing
                trends in vaccinations among covered employees due to employers'
                continued implementation of vaccine mandates and other policies
                (described below), under the ETS. To make this adjustment, OSHA
                requires 1) further characterization of the set of unvaccinated
                employees in terms of their likelihood to receive the vaccine, and 2)
                specification of the extent of employer-mandated and other employer
                vaccination policies.
                 Based on vaccine confidence data from CDC (CDC, October 2021a),
                13.8 percent of the population ``probably or definitely will not'' get
                the vaccine; hereafter referred to as ``vaccine-hesitant''. Since this
                group is by definition part of the currently unvaccinated, OSHA
                characterizes the currently unvaccinated (37.6 percent) as being
                comprised of those who are vaccine--hesitant (13.8 percent) and the
                remainder, who while unvaccinated, are not hesitant because they are
                not in the ``probably or definitely will not'' group (23.8 percent).
                 Among those who are vaccine-hesitant, OSHA estimates that 5 percent
                of covered employees (or about 36 percent of the vaccine-hesitant), are
                hesitant due to a religious (4 percent) or medical (1 percent)
                exemption. The remaining 8.8 percent include those who are vaccine-
                hesitant for other reasons. For the 4 percent estimate for religious
                exemptions, OSHA relies on data from Vermont, which removed its vaccine
                exemption for nonreligious personal beliefs in 2016 and saw the
                proportion of kindergarten students with a religious exemption rise to
                about 4 percent (Graham, September 15, 2021). In analyzing this issue,
                the agency also reviewed other religious exemption data concerning
                state workers in Oregon and Washington; the agency decided not to rely
                on these data because the Vermont data is a more accurate measure of
                the correct religious exemption rate, although the data does represent
                parents deciding on whether to claim an exemption for their child, not
                for themselves. This is because, unlike the Vermont data, the Oregon
                and Washington data contain workers that have applied, but not yet been
                accepted, for a religious exemption (O'Sullivan, September 18, 2021;
                KEZI News, September 25, 2021). In Oregon, 5 percent and in Washington
                8 percent of the employees have requested accommodations though only a
                fraction so far have been accepted. However, the data are not
                inconsistent with the Vermont data even though the process in both
                Oregon and Washington are not yet complete. For the 1 percent estimate
                for medical exemptions, OSHA relied on the Household Pulse Survey (HPS)
                conducted by the U.S. Census (U.S. Census Bureau, 2021). In Table 6a of
                the Health Tables for Week 31, September 1, 2021 through September 13,
                2021, about 1% of the US population said they would not get the vaccine
                because ``Doctor has not recommended it,'' and OSHA uses this response
                as a proxy for all medical conditions.\34\
                ---------------------------------------------------------------------------
                 \34\ Table 6a presents that 3,884,902 of the population will not
                take the vaccine because the ``doctor has not recommended it'' out
                of a total of 38,936,606 who will not get the vaccine for any
                reason. Medical reasons are then about 10% of the general population
                that will not get the vaccine, and the ones who won't get the
                vaccine are about 10% of the whole population, giving 1% (.10 *
                .10).
                ---------------------------------------------------------------------------
                 Table IV.B.7 presents the number of employees in each vaccination
                category, which informs OSHA's subsequent estimates of which currently
                unvaccinated employees may be vaccinated by employer-mandates,
                vaccinated under the ETS, or tested under the ETS.
                [[Page 61472]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.008
                 Next, OSHA estimates the number of currently unvaccinated employees
                that are likely to become vaccinated while the ETS is in effect, based
                on their employers' policies. Based on limited data on current vaccine
                mandate implementation and forecasts for future implementation (Mishra
                and Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons,
                October 6, 2021), OSHA estimates that 25 percent of firms in scope
                currently have a mandate, and assumes that this will rise to 60 percent
                of employers after the ETS is in place. The baseline of 25 percent is
                based on recent surveys showing a range of approximately 13-45 percent
                of employers currently requiring or planning to require vaccination
                among employees (see Willis Towers Watson, June 23, 2021; Mishra and
                Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons, October 6,
                2021). Absent the ETS, OSHA assumes that the percentage of firms would
                remain 25 percent (with some measure of upward adjustment due to other
                federal vaccine mandates affecting select populations, as discussed
                above). To the extent more firms than OSHA estimates would mandate
                vaccination independent of the ETS and thereby increase the vaccination
                rate (again because of factors such as other federal vaccine mandates),
                then the agency's costs are overestimated because the agency's baseline
                vaccination rate is too low. The assumption of an increase from 25 to
                60 percent is based on the same set of surveys that indicate that the
                share of employers who will mandate vaccinations after the ETS
                (including those that already mandate vaccinations) range from 25-75
                percent, see above references. The agency also assumes that employees
                are distributed in the same proportion across employers with and
                without a vaccine mandate (e.g., if 60 percent of firms mandate
                vaccination, 60 percent of employees will be vaccinated due to the
                mandate (less those who remain unvaccinated due to religious or medical
                exemptions).
                 OSHA assumes that all unvaccinated employees subject to an employer
                mandate will be vaccinated under that employer mandate, except for
                those seeking a medical or religious exemption. For unvaccinated
                employees not subject to an employer mandate, OSHA assumes that they
                will also be vaccinated at their employer's request, except for
                employees who are vaccine-hesitant, which includes not only those who
                remain unvaccinated for medical and religious reasons, but also those
                who are hesitant for any other reason. OSHA carries through its
                assumptions and estimates into its total cost estimates. For example,
                OSHA estimates that the 25 percent of firms in scope that currently
                have a vaccination mandate will not need to implement a new written
                policy on vaccination in response to the ETS since they will already
                have implemented a policy that meets the requirements of the ETS.
                 In total, OSHA estimates that 27 percent of covered employees (22.7
                million) will be vaccinated based on employer policies under the ETS;
                or 72 percent of covered employees who are currently unvaccinated. The
                resulting vaccination rate, adjusted for the ETS, is estimated based on
                the total of those who are currently vaccinated and those who will be
                vaccinated under employer policies, 89.4 percent as shown in Table
                IV.B.8. Calculations of this nature, while not discussed in more detail
                in this analysis, are contained fully in the spreadsheets supporting
                this analysis (OSHA, October 2021a).\35\
                ---------------------------------------------------------------------------
                 \35\ OSHA notes that these estimates differ for employees
                covered by the Healthcare ETS. OSHA calculated these estimates
                separately because, as stated above, OSHA is only taking costs for
                these employees in the last four months of the assumed 6-month
                period while the ETS remains in effect. While OSHA does not describe
                in detail how it derived estimates for employees covered by the
                Healthcare ETS in this analysis, the derivation of those estimates
                run parallel to those described above. For more information, please
                see the spreadsheets supporting this analysis. (OSHA, October
                2021a).
                ---------------------------------------------------------------------------
                [[Page 61473]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.009
                 From Table IV.B.8, OSHA estimates that approximately 75.3 million
                (89.4 percent) of covered employees will be vaccinated when the ETS is
                in full effect, and that approximately 8.9 million employees (10.6
                percent, made up of approximately 6.3 million covered employees who
                will be tested for COVID under the ETS and approximately 2.6 million
                employees who return to telework (see next paragraph)) will remain
                unvaccinated. This final set of unvaccinated employees includes all
                employees not vaccinated because of religious or medical accommodations
                or medical contraindication, plus the portion of those who are vaccine-
                hesitant for any other reason, who were not vaccinated because their
                employer has opted for a voluntary vaccination policy.
                 From the above, OSHA estimates that about 5 percent of all covered
                employees will seek and receive religious or medical accommodations or
                exemption for medical contraindication. While the agency encourages
                employers to consider the most protective accommodations such as
                telework, which would prevent the employee from being exposed at work
                or from transmitting the virus at work, for cost analysis purposes the
                agency assumes these workers will largely be tested in order for their
                employers to comply with the ETS. Consistent with the overall average
                22 percent of those who returned to work after teleworking earlier in
                the pandemic (see teleworking discussion above), OSHA assumes for this
                cost analysis that only 22 percent of workers needing a reasonable
                accommodation will return to full time telework as a reasonable
                accommodation. OSHA also assumes that the 78 percent remainder will
                follow the testing/masking protocols in the ETS as a reasonable
                accommodation.
                 For hesitant employees who will not seek a religious or medical
                accommodation, and who work in a firm with a testing option, the agency
                assumes as above that those who were teleworking before (again on
                average 22 percent) will return to telework rather than being tested.
                c. Cost of Absenteeism to Employers
                 Even mild cases of Covid-19 can be costly to employers as they can
                induce productivity losses due to work absences, both among those
                infected and their close contacts who may be subject to quarantine
                requirements. While many workers were able to engage in telework in
                March-April 2020, several occupational groups deemed essential,
                including childcare workers, personal care aids, healthcare support
                occupations, and food processing workers, exhibited significantly
                higher rates of absenteeism during that period, which the authors
                attributed to some workers contracting COVID-19 (Groenewold et al.,
                July 10, 2020). Absenteeism can also affect the productivity of workers
                who are present, similar to how turnover can impose costs on incumbent
                workers (Kuhn and Yu, April 2021).
                 In aggregate, productivity losses from absences can be costly, as
                evidenced by the economic losses from seasonal influenza. One estimate
                found that the United States loses 20.1 million days of economic
                productivity every year due to influenza, an ongoing loss equivalent to
                80,400 full-time worker-years (Putri et al., June 22, 2018). Another
                recent study found that higher influenza vaccination rates result in
                both fewer deaths and significantly reduced illness-related work
                absences (White, 2021).
                 OSHA recognizes that absenteeism has been a problem. However, as
                explained in other sections of the preamble, the ETS vaccination and
                testing and face covering requirements are necessary to reduce the
                spread of COVID-19 in the workplace, which may in part reduce
                absenteeism. The ETS might in a limited sense also increase absenteeism
                because the rule requires employers to temporarily remove from the
                workplace any employee who receives a positive COVID-19 test or is
                diagnosed with COVID-19 by a licensed healthcare provider. However,
                this provision will also help to further reduce absenteeism because,
                when an
                [[Page 61474]]
                infected employee is promptly removed from the workplace, that can
                prevent one employee from infecting other employees in the workplace
                and potentially causing an outbreak or a super-spreader event. Thus,
                OSHA concludes that the ETS may, on net, help ameliorate absenteeism by
                reducing illnesses, but in any event will not increase absenteeism (see
                OSHA, October 2021c).
                d. The Effect of Employee Turnover
                 One of the primary concerns among employers in imposing vaccination
                mandates is loss of staff, with 60 percent of employers selecting it as
                a concern with regard to mandating COVID-19 vaccination, according to
                one survey (Mishra and Hartstein, August 23, 2021).\36\ To this end,
                employer vaccination mandates could lead to employee turnover;
                employees could either leave on their own volition or employers who
                have instituted strict vaccination policies may fire workers who are
                not vaccinated, or place them on unpaid leave.
                ---------------------------------------------------------------------------
                 \36\ This survey done in August, 2021, has 1,630 responses,
                reported by HR staff, attorneys, and executives. Described as being
                ``from a variety of industries,'' 83 percent of respondents were
                from companies with more than 100 employees.
                ---------------------------------------------------------------------------
                 On the other hand, there is countervailing evidence to suggest that
                employers who implement a vaccine mandate will be met with an influx of
                potential workers. Many employees would prefer a mandate in place, and
                would be more likely to stay with, or apply to, a firm that had a
                vaccine mandate in place. For example, although Inova health system in
                Northern Virginia, lost 89 workers for noncompliance with the system's
                vaccination mandate, that loss amounted to less than 0.5 percent of its
                workforce, (Portnoy, October 3, 2021), and, in any event, Inova's CEO
                stated that the vaccine mandate has helped with recruitment, and that
                its workers are concerned for their own safety and want to know they
                are working with vaccinated colleagues. This same article listed some
                other Virginia healthcare systems with higher rates of loss in
                connection with vaccine mandates. Valley Health terminated 1 percent of
                its employees, while Luminis Health had about 2 percent of its workers
                still unvaccinated at the time of its mandate deadline. As another
                example, although United Airlines had 593 employees (out of the
                company's 67,000 U.S. employees) who had not complied with the
                company's vaccination mandate at the end of September (a number that
                dropped below 240 employees by October 1), the company reported it has
                received 20,000 applications for 2,000 flight attendant positions, a
                much higher ratio than before the pandemic (Chokshi and Scheiber,
                October 2, 2021). In addition, one survey reports that among employee
                resignations due to COVID-19 workplace policies, 42 percent reported
                lack of workplace safety policies, 17 percent reported that existing
                workplace policies were not stringent enough, and only 39 percent
                reported overly restrictive workplace policies, suggesting that many
                employees will welcome vaccine mandates (ASU COVID-19 Diagnostic
                Commons, October 6, 2021).\37\
                ---------------------------------------------------------------------------
                 \37\ This August 2021 global survey (all results presented here
                are for the US only) has 1,143 responses. It covers 28 industries,
                including: Technology and Software, Business and Professional
                Services, Manufacturing, Construction, and Healthcare. Ninety
                percent of respondents were from companies with more than 100
                employees.
                ---------------------------------------------------------------------------
                 While employee turnover is a natural part of business in any
                industry, higher employee turnover rate than normal can have a direct
                impact on profit and revenue. The normal range of employee turnover
                differs widely by industry, with an average turnover rate of about 50
                percent per year overall for the private sector.\38\ For example,
                between 2016 and 2020, employee turnover ranged from 55 percent to 70
                percent in the retail industry and from 40 percent to 60 percent in the
                transportation industry (the industry sectors with the highest
                employment).\39\
                ---------------------------------------------------------------------------
                 \38\ BLS (March 11, 2021).
                 \39\ Id.
                ---------------------------------------------------------------------------
                 OSHA acknowledges that a vaccine mandate may result in increased
                employee turnover, but one recent survey \40\ suggests it is very
                unlikely that this potential increase in employee turnover will exceed
                the ranges that industries have experienced over time. The survey,
                though limited because many respondents did not have mandates in place
                at that time, shows that there was no impact on turnover for 71 percent
                of those with mandates in place. Only 25 percent saw a slight increase
                in turnover (1 percent to 5 percent above normal) and only 4 percent
                saw a significant increase (more than 5 percent above normal). As such,
                OSHA does not anticipate that the potentially increased employee
                turnover attributable to vaccine mandates will be substantial enough to
                negate normal profit and revenue.
                ---------------------------------------------------------------------------
                 \40\ Umland, October 13, 2021. This October 2021 survey has
                1,059 total respondents, though only 365 have implemented a
                vaccination mandate and answered this turnover question.
                ---------------------------------------------------------------------------
                 To this end, an important factor to consider in examining turnover
                in connection with vaccine mandates is the unquantified cost savings
                and other positive economic impacts accruing to employers that
                institute vaccine mandates. These include reduced absenteeism due to
                fewer COVID-19 illnesses and quarantines, as discussed above. Other
                positive economic impacts of a vaccine mandate are increased retail
                trade from customers that feel less at risk and better relations with
                suppliers and other business partners. These all would contribute to
                improved business and increased profits.
                 The existence of these cost savings and other positive economic
                impacts accruing to employers that comply with the ETS suggests that
                the actual net costs of the ETS could be much lower than the costs
                reported in this section of the economic analysis. As OSHA discusses
                above, OSHA has provided evidence to support its estimate that 25
                percent of covered employers already voluntarily require that their
                employees be vaccinated and a much larger percentage are considering a
                vaccine mandate. This supports the conclusion that these businesses
                agree that doing so will ultimately save costs.
                 In addition, under the ETS, employers may implement a policy that
                allows for testing and face covering instead. Firms will have a
                tendency to self-select: If a large proportion of its work force has
                indicated concern about a vaccine mandate, the firm is more likely to
                choose the testing option to retain their workers. This is one factor
                that led the agency to estimate that approximately 40 percent of
                employers will allow employees to choose testing and face coverings in
                lieu of vaccination. To the extent employers are concerned about
                employee testing costs, employers can generally absorb testing costs or
                help employees reduce those costs through low-cost assistance such as
                employer proctoring of tests (even though that is not required by this
                ETS). Departure of personnel because of vaccine mandates is also likely
                to be less common when vaccine mandates are more prevalent across
                employers in a region or industry. One survey reports that 65 percent
                of employers state that actions of other companies in their industry
                are very, or at least moderately, important in deciding to mandate
                vaccination (Mishra and Hartstein, August 23, 2021).
                 Mandatory vaccinations for COVID-19 are still relatively new
                because vaccines only became available in quantities sufficient to
                support such mandates only about 6 months ago, and the FDA has only
                recently moved past emergency clearance to final clearance. While there
                is not an abundance of evidence about whether employees have actually
                left or joined an employer based on a vaccine mandate,
                [[Page 61475]]
                particularly one with an alternative allowing for testing in lieu of
                vaccination, OSHA has examined the best available evidence it could
                locate in the timeline necessary to respond with urgency to the grave
                danger addressed in this ETS. Based on that, OSHA is persuaded that the
                net effect of the OSHA ETS on employee turnover will be relatively
                small, given the option for employers to implement a testing and face
                covering policy and the countervailing forces surrounding turnover that
                will limit those effects, as discussed above.
                 Finally, OSHA finds one line of evidence particularly persuasive
                because it involves data instead of polls: While different surveys may
                suggest different levels of worker intentions (joining or remaining
                with a safer employer versus leaving an employer to avoid
                vaccination),\41\ the data suggests that the number of employees who
                actually leave an employer is much lower than the number who claimed
                they might: 1% to 3% or less actually leave, compared to the 48-50% who
                claimed they would.\42\ As discussed earlier, this turnover number is
                well below the average turnover rate in most industries. Thus, OSHA
                concludes that whether or not the ETS proves helpful to recruitment
                efforts for some employers, it will not, on balance, add significant
                new costs to covered employers or threaten the economic feasibility of
                any industry during a six month period.
                ---------------------------------------------------------------------------
                 \41\ Two polls from June 2021, when the number of COVID-19 cases
                had dropped dramatically just before the Delta Variant led to a
                surge in cases, indicated that 50% of unvaccinated employees
                surveyed said that they would leave their job rather than accept a
                vaccination mandate from their employer. (KFF et al., June 30, 2021)
                (the same percentage also responded that ``The number of cases is so
                low that there is no need for more people to get the vaccine.''). A
                separate poll from the same time also stated that 48% of ``vaccine
                hesitant'' employees claimed they would quit their jobs rather than
                be vaccinated. (Barry et al., September 24, 2021--citing yet
                unpublished June 2021 poll). In a more recent poll, about 44% of
                workers said that they would consider leaving their jobs if they
                were forced to get vaccinated, while around 38% of workers would
                consider leaving their current employer if the organization did not
                enact a vaccine mandate. (Kelly August 12, 2021). Interestingly, in
                that survey there was a direct correlation between the age of the
                worker and the desire to have a vaccinated workplace: Younger
                workers, usually the most mobile portion of the workforce, had a
                much higher desire for a vaccinated workforce (50% of Generation Z
                employees, as compared to 33% of Baby Boomers).
                 \42\ An article titled ``Unvaccinated Workers Say They'd Rather
                Quit Than Get a Shot, but Data Suggest Otherwise'' noted the 48%-50%
                threat to leave, but included hard data showing nothing close to
                those levels actually occurred: Houston Methodist Hospital required
                its 25,000 workers (including its 3,580 unvaccinated employees) to
                get a vaccine by June 7, and only 153 resigned or were fired (4% of
                the 3,580 unvaccinated employees; 0.6% of the total number of
                employees); other examples of the numbers of employees who left in
                response to their employers' mandatory vaccine policy involved 5 out
                of 527 (0.9%), 2 out of 250 (0.8%), 6 out of 260 (3%), and 125 out
                of 35,800 (0.3%). (Barry et al., September 24, 2021).
                ---------------------------------------------------------------------------
                 OSHA seeks comments on these estimates and conclusions, as well as
                further data that it could use to refine its estimates.
                IV. Cost Analysis for COVID-19 Vaccination and Testing ETS, Sec.
                1910.501
                 In this section, OSHA provides estimates of the per-entity and
                total costs for the requirements of this ETS. Section 6(c)(3) of the
                OSH Act states that the Secretary will publish a final standard ``no
                later than six months after publication of the emergency standard.''
                Costs are therefore estimated over a six-month time period. Note that
                the estimates are presented in this section at the 3-digit NAICS level,
                but the analysis was conducted at the 6-digit NAICS level and
                aggregated to the 3-digit level for presentation purposes. The 6-digit
                NAICS level data is accessible in the supporting spreadsheet. It should
                be noted that this analysis deals strictly with averages. For any given
                entity, actual costs may be higher or lower than the point estimate
                shown here, but using an average allows OSHA to evaluate feasibility by
                industry as required by the OSH Act. In addition, OSHA has limited data
                on many of the parameters needed in this analysis and has estimated
                them based on the available data, estimates for similar requirements
                for other OSHA standards, consultation with experts in other government
                agencies, and internal agency judgment where necessary. OSHA's
                estimates are therefore based on the best evidence available to the
                agency at the time this analysis of costs and feasibility was
                performed.
                 As mentioned above, OSHA estimates that approximately 264,000
                entities have employees who will be subject to the requirements of the
                ETS, including approximately 84.2 million employees. Many ETS
                requirements result in labor burdens that are monetized using the labor
                rates described next.
                a. Wage Rates
                 OSHA used occupation-specific wage rates from BLS 2020 OEWS data
                (BLS, 2021a). Within each affected 6-digit NAICS industry, OSHA
                calculated the employee-weighted average wage to be used in the
                analysis. OSHA estimated loaded wages using the BLS' Employer Cost for
                Employee Compensation data (BLS, 2021b), as well as OSHA's standard
                estimate for overhead of 17 percent times the base wage.
                 Costs are estimated using three labor rates for each NAICS
                industry: The average labor rate for all employees, the labor rate for
                General and Operations Managers (SOC code 11-1021), and the labor rate
                for Office Clerks, General (SOC 43-9060). Industry-specific wage rates
                are presented in Appendix C in the accompanying document in the docket,
                ``Vaccination and Testing ETS: Economic Profile and Cost Chapter
                Appendices (OSHA, October, 2021b).''
                b. Rule Familiarization, Employer Policy on Vaccination, and
                Information Provided to Employees
                ETS Requirements
                 Section 1910.501(d)(1) of the ETS specifies that the employer must
                establish and implement a written mandatory vaccination policy. The
                employer is exempted from the requirement in paragraph (d)(1) only if
                the employer establishes and implements a written policy allowing any
                employee not subject to a mandatory vaccination policy to either choose
                to be fully vaccinated against COVID-19 or to provide proof of regular
                testing for COVID-19 in accordance with paragraph (g) of the ETS and to
                wear a face covering in accordance with paragraph (i) of the ETS.\43\
                ---------------------------------------------------------------------------
                 \43\ Note to paragraph (d): Under federal law, including the
                Americans with Disabilities Act (ADA) and Title VII of the Civil
                Rights Act of 1964, some workers may be entitled to a reasonable
                accommodation from their employer, absent undue hardship. If the
                worker requesting a reasonable accommodation cannot be vaccinated
                against COVID-19 and/or wear a face covering because of a
                disability, as defined by the ADA, or if the vaccination, testing,
                and/or wearing a face covering conflicts with the worker's sincerely
                held religious belief, practice or observance, the worker may be
                entitled to a reasonable accommodation. For more information about
                evaluating requests for these types of reasonable accommodations for
                disability or sincerely held religious belief, employers should
                consult the Equal Employment Opportunity Commission's regulations,
                guidance, and technical assistance including at: https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
                ---------------------------------------------------------------------------
                 In addition, under Sec. 1910.501(j), information provided to
                employees, the ETS requires the employer to inform each employee, in a
                language and at a literacy level the employee understand about: (1) The
                requirements of the ETS as well as any employer policies and procedures
                established to implement the ETS; (2) COVID-19 vaccine efficacy,
                safety, and the benefits of being vaccinated; (3) the requirements of
                29 CFR 1904.35(b)(1)(iv) and Section 11(c) of the OSH Act; and (4) the
                prohibitions of 18 U.S.C. 1001 and Section 17(g) of the OSH Act.
                 As stated, the ETS face covering requirements are contained in
                paragraph
                [[Page 61476]]
                (i) of the ETS. Under that paragraph, the employer, with certain
                exceptions specified in the ETS, must ensure that each employee who is
                not fully vaccinated wears a face covering when indoors and when
                occupying a vehicle with another person for work purposes. The ETS does
                not require, nor does it prohibit, the employer to pay for any costs
                associated with face coverings (although employer payment for face
                coverings may be required by other laws, regulations, or collective
                bargaining agreements or other collectively negotiated agreements).
                However, the employer must permit the employee to wear a respirator
                instead of a face covering whether required or not. In addition, the
                employer may provide respirators or face coverings to the employee,
                even if not required. In such circumstances, where the employer
                provides respirators, the employer must also comply with Sec.
                1910.504, Mini respiratory protection program.
                 OSHA estimates no costs associated with an employee voluntarily
                bringing in their own respirator to use instead of a face covering
                other than those costs that OSHA is estimating below in connection with
                29 CFR 1910.501(j), information provided to employees. That section
                provides, again, that the employer must inform each employee, in a
                language and at a literacy level the employee understands about the
                requirements of the ETS as well as any employer policies and procedures
                established to implement the ETS. One policy the employer would need to
                establish to implement the ETS is a policy to comply with the
                requirements of 29 CFR 1910.504 when an employee voluntarily brings in
                their own respirator. Those requirements require only that the employer
                provide certain information to the employee (see 29 CFR 1910.504(c)).
                 OSHA is also estimating no costs in connection with the employer
                providing respirators to the employee. The ETS does not require the
                employer to provide respirators to employees. Therefore, any such
                provision is voluntary and not relevant to economic feasibility of this
                rule.
                 The face covering provisions in paragraph (i) contain several other
                requirements, none of which have costs associated with them.
                Cost Analysis Assumptions
                 In this section, OSHA estimates the cost for establishing the
                employer policy on vaccination, providing required information to
                employees, and rule familiarization. OSHA assumes each entity will
                require an average one-time labor burden of 1 hour of management labor
                for rule familiarization. OSHA based this unit cost on that taken for
                rule familiarization in the Healthcare ETS (86 FR at 32496), but
                adjusted the time downward by a half-hour because this ETS is a simpler
                standard than the Healthcare ETS.
                 To establish a written policy in accordance with paragraph (d) of
                the ETS, OSHA assumes a one-time average labor burden of 5 hours of
                manager time per firm. OSHA bases this estimate on its cost estimates
                in the Healthcare ETS, where OSHA estimated that development of the
                COVID-19 Plan required by that standard would take between 5 and 40
                hours (see 86 FR at 32496-32497). OSHA concludes that 5 hours is a
                reasonable estimate because the development of a written policy on
                vaccination will be much simpler than the development of the written
                COVID-19 Plan required by the Healthcare ETS (see 29 CFR
                1910.502(c)).\44\ OSHA notes, that like the Healthcare ETS (id.), the
                cost of implementing the plan for this ETS are included in the costs of
                implementing the corresponding requirements in the ETS, which are
                discussed below.
                ---------------------------------------------------------------------------
                 \44\ The estimates for the time to create the written vaccine
                policy plan under this ETS may differ from the time to create the
                various processes under the CMS rule published elsewhere in this
                issue of the Federal Register since the requirements of what is
                needed to be included in the plans differ. For example, the CMS plan
                requires a process for ensuring the implementation of additional
                precautions to mitigate the transmission and spread of COVID-19
                while OSHA's vaccination policy requirements do not include this
                requirement.
                ---------------------------------------------------------------------------
                 To provide information to employees in accordance with paragraph
                (j) of the ETS, OSHA assumes a one-time average labor burden per firm
                of 10 minutes of manager time. The agency expects activities like
                posting the information on a community board, mass emailing, etc., will
                satisfy this requirement.
                 The total cost for rule familiarization, establishing an employer
                policy on vaccination and providing required information to employees
                is calculated as the product of:
                 One-time labor burden for rule familiarization and
                establishing a policy (a total of 6 hours of manager time per entity)
                plus a one-time labor burden for providing information to employees (10
                minutes of manager time per entity);
                 The labor rate for General and Operations Managers (SOC
                code 11-1021, NAICS-specific wages); and,
                 The total number of covered entities.
                Cost for Employer Policy on Vaccination and Information Provided to
                Employees
                Costs per entity and total costs for employer policy on vaccination and
                information provided to employees are shown below in Table IV.B.9.
                BILLING CODE 4120-01-P
                [[Page 61477]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.010
                [[Page 61478]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.011
                BILLING CODE 4120-01-C
                c. Determining Employee Vaccination Status
                ETS Requirements
                 Under Sec. 1910.501(e):
                 Paragraph (e)(1). The employer must determine the vaccination
                status of each employee. This determination must include whether the
                employee is fully vaccinated, which is 2 weeks after the full required
                vaccine course is completed.
                 Paragraph (e)(2). The employer must require each vaccinated
                employee to provide acceptable proof of vaccination status, including
                whether they are fully or partially vaccinated. Acceptable proof of
                vaccination status is:
                 The record of immunization from a health care provider or
                pharmacy;
                 A copy of the COVID-19 Vaccination Record Card;
                 A copy of medical records documenting the vaccination;
                 A copy of immunization records from a public health,
                state, or tribal immunization information system; or
                [[Page 61479]]
                 A copy of any other official documentation that contains
                the type of vaccine administered, date(s) of administration, and the
                name of the health care professional(s) or clinic site(s) administering
                the vaccine(s).
                 In instances where an employee is unable to produce acceptable
                proof of vaccination, per above, a signed and dated statement by the
                employee, subject to criminal penalties for knowingly providing false
                information:
                 Attesting to their vaccination status (fully vaccinated or
                partially vaccinated); and
                 Attesting that they have lost and are otherwise unable to
                produce proof required by the ETS.
                 Paragraph (e)(3). Any employee who does not provide one of the
                acceptable forms of proof of vaccination status in paragraph (e)(2) of
                the ETS to the employer must be treated as not fully vaccinated for the
                purpose of the ETS.
                 Paragraph (e)(4). The employer must maintain a record of each
                employee's vaccination status and must preserve acceptable proof of
                vaccination for each employee who is fully or partially vaccinated. The
                employer must maintain a roster of each employee's vaccination status.
                These records and roster are considered to be employee medical records
                and must be maintained as such records in accordance with 29 CFR
                1910.1020 and must not be disclosed except as required or authorized by
                the ETS or other federal law. These records and roster are not subject
                to the retention requirements of 29 CFR 1910.1020(d)(1)(i) but must be
                maintained and preserved while the ETS remains in effect.
                 Paragraph (e)(5). Finally, when an employer has ascertained
                employee vaccination status prior to the effective date of this section
                through another form of attestation or proof, and retained records of
                that ascertainment, the employer is exempt from the requirements in
                paragraphs (e)(1)-(e)(3) only for each employee whose fully vaccinated
                status has been documented prior to the effective date of this section.
                For purposes of paragraph (e)(4), the employer's records of
                ascertainment of vaccination status for each such person constitute
                acceptable proof of vaccination.
                 The full costs for these provisions are taken under the costs for
                recordkeeping, discussed below, because determining vaccination status,
                providing acceptable proof of vaccination status, and creating and
                maintaining a roster of each employee's vaccination status will be part
                and parcel of the recordkeeping process.
                d. Employer Support for Employee Vaccination
                ETS Requirements
                 Under 29 CFR 1910.501(f):
                 The employer must support COVID-19 vaccination by providing:
                 Time for vaccination. The employer must: (i) Provide a
                reasonable amount of time to each employee for each of their primary
                vaccination series dose(s); and (ii) provide up to 4 hours paid time,
                including travel time, at the employee's regular rate of pay for this
                purpose.
                 Time for recovery. The employer must provide reasonable
                time and paid sick leave to recover from side effects experienced
                following any primary vaccination series dose to each employee for each
                dose.
                 Under the ETS, fully vaccinated means (i) a person's status 2 weeks
                after completing primary vaccination with a COVID-19 vaccine with, if
                applicable, at least the minimum recommended interval between doses in
                accordance with the approval, authorization, or listing that is: (A)
                Approved or authorized for emergency use by the FDA; (B) listed for
                emergency use by the World Health Organization (WHO); or (C)
                administered as part of a clinical trial at a U.S. site, if the
                recipient is documented to have primary vaccination with the ``active''
                (not placebo) COVID-19 vaccine candidate, for which vaccine efficacy
                has been independently confirmed (e.g., by a data and safety monitoring
                board), or if the clinical trial participant from the U.S. site had
                received a COVID-19 vaccine that is neither approved nor authorized for
                use by FDA but is listed for emergency use by WHO; or (ii) a person's
                status 2 weeks after receiving the second dose of any combination of
                two doses of a COVID-19 vaccine that is approved or authorized by the
                FDA, or listed as a two-dose series by the WHO (i.e., heterologous
                primary series of such vaccines, receiving doses of different COVID-19
                vaccines as part of one primary series). The second dose of the series
                must not be received earlier than 17 days (21 days with a 4-day grace
                period) after the first dose.
                Cost Analysis Assumptions
                 OSHA assumes there will be no costs to employers or employees
                associated with the vaccine itself.\45\ However, to provide support for
                vaccination of employees, OSHA estimates that it will take an average
                of 15 minutes of travel time, each way, per employee to travel to a
                vaccination site (for a total of 30 minutes). OSHA then estimates 5
                minutes to wait, fill out any necessary paperwork, and receive the
                shot, and a post-shot wait time of 20 minutes, per employee. Some
                firms, particularly larger ones, will find it cheaper to have vaccines
                administered on site. They may have an on-site health clinic or may
                hire a 3rd party purveyor to come to the facility.\46\ This will
                minimize travel and also allow the companies to mitigate some of the
                logistical issues that may be preventing employees from receiving a
                vaccine (finding a convenient appointment time, etc.). OSHA estimates
                that 10 percent of firms with employees between 100 to 500 employees
                will select this option, while, given decreased average costs
                associated with economies of scale, 25 percent of firms with over 500
                employees will select this option. OSHA was unable to obtain an
                estimate of the cost savings associated with on-site vaccination in the
                time allotted to issue this emergency standard, so it is assuming that
                the costs for off-site vaccination are the same as the costs for on-
                site vaccination. This results in a likely over-estimate of costs given
                that the entities that choose the on-site option will do so as a cost-
                saving measure.
                ---------------------------------------------------------------------------
                 \45\ While there may be some administrative costs borne by the
                government, such costs are not germane to this analysis of whether
                the ETS is economically feasible for covered employers.
                 \46\ Prior to the effective date of this rule, some companies
                offered on-site vaccination according to a limited survey. (Willis
                Towers Watson, June 23, 2021). See also CDC on creating an on-site
                program (CDC, March 25, 2021; CDC, October 4, 2021b).
                ---------------------------------------------------------------------------
                 In OSHA's cost analysis, OSHA assumes that all employees will be
                vaccinated during working hours and employers would adjust the employee
                work schedule to ensure that the employee would not become eligible for
                overtime pay as a result of the vaccination time. However, it should be
                noted that, if an employee chooses to receive the vaccine outside of
                work hours, OSHA does not require employers to grant paid time to the
                employee for the time spent receiving the vaccine during non-work hours
                (although other laws may include additional requirements for employers,
                such as those addressing reasonable accommodations or exemptions).
                OSHA's analysis may be an overestimate as it reflects an assumption
                that all vaccinations are received during work hours.
                 CDC data indicated that 5 percent of employees vaccinated have
                received the Johnson & Johnson vaccine, and 95 percent have received
                either Pfizer or Moderna (CDC, October 2021b). OSHA applies the same
                allocation to employees being vaccinated under the ETS. For those
                receiving Pfizer or Moderna, the labor burden outlined
                [[Page 61480]]
                above occurs twice, since vaccination requires two shots.
                 The employer must provide reasonable time and paid sick leave to
                recover from side effects experienced following any vaccination dose to
                each employee for each vaccination dose. Employers may require
                employees to use paid sick leave benefits otherwise provided by the
                employer to offset these costs, if available. The average amount of
                time off an employee may need for side effects while receiving the
                vaccine doses necessary to achieve full vaccination (one or two doses,
                depending on the vaccine) depends on several factors. First, the
                percentage of people who will have side effects that are severe enough
                to require time. Second, the average time duration for those who have
                such a severe reaction. For estimates of these parameters OSHA is using
                a recent study (Levi et al., September 29, 2021) which surveyed workers
                at a state-wide health care system who had been vaccinated. The study
                found that, for the first dose, 4.9% needed administrative leave, with
                an average length of absence of 1.66 days. For the second dose, 19.79%
                needed leave and their average length of absence was 1.39 days.
                Together, the average time on leave is .36 days (.049 * 1.66 + .1979 *
                1.39) for a person receiving two doses, which reflects the fact that
                many people who receive the vaccine do not have any side effects for
                either dose while others have more severe side effects.
                 In order to determine the amount of paid sick leave that would be
                available to employees, OSHA relied on data from BLS (BLS, 2021e). BLS
                estimates that for civilian workers in establishments with 100+
                employees, 88% have access to paid sick leave (Table 33). BLS states
                that the average number of paid sick leave available is 9 days (Table
                36). Because there is the same number of days across all levels of
                employee tenure (1 year, 5 years, 10 years, and 20 years), OSHA used 9
                days for all covered employees. The agency assumes that 75% of the
                available paid sick leave has been used by the current 4th quarter of
                the calendar year. So the average number of days available is 1.98
                days: 9 (days) * 88% (employees with available paid sick leave) * 25%
                (amount of leave remaining in the year) = 1.98 days available. Given
                that the average overall time out due to side effects is 0.36 days (see
                above), OSHA concludes that, on average, employees should have
                sufficient existing paid sick leave available to cover the time needed
                as a result of vaccine-related side effects. As a result, OSHA is
                taking no costs to employers in connection with the ETS's requirement
                to provide time for recovery from vaccination (except as provided
                below), as these costs will have been incurred by the employer
                independent of the ETS.
                 While this analysis is entirely consistent with OSHA's standard
                procedure of strictly using averages in cost analysis, it nonetheless
                masks some significant effects resulting from the time for recovery
                requirements. From the BLS data, OSHA knows there are 12% of
                establishments that have 100+ employees and do not provide paid sick
                leave. Correspondingly, there is a group of entities with no paid sick
                leave that will obviously incur costs that result directly from these
                requirements. In addition, some employees may not have, or some other
                entities may not offer, sufficient paid sick leave to cover these
                costs.
                 To account for the 12 percent of firms that do not offer paid sick
                leave, the agency uses the above estimate of average days for two
                doses, 0.36 days, and multiplies the average employee wage by NAICS to
                calculate the cost per employee. Since OSHA does not know which firms
                make up the 12 percent, the agency spreads this total cost across all
                firms by employee. Since firms without any sick leave are likely to be
                lower-wage firms, this will likely lead to a cost overestimate.
                 Therefore, the total cost for paid time off for vaccination is
                based on the costs for providing paid sick leave for the 12 percent of
                firms that do not offer paid sick leave and:
                 Travel time per employee of covered firms of 15 minutes
                each way per vaccination dose (total of 30 minutes).
                 Pre-shot wait time per employee of covered firms of 5
                minutes per vaccination dose.
                 Post-shot wait time per employee of covered firms of 20
                minutes per vaccination dose.\47\
                ---------------------------------------------------------------------------
                 \47\ According to the CDC, people with allergies require a wait
                time of 30 minutes, but they are a small group, and, in any event,
                the CDC recommends that routine wait time is 15 minutes, so the
                agency considers that its average of 20 minutes is probably an
                overestimate. (See CDC, October 4, 2021a; CDC, March 3,2021.)
                ---------------------------------------------------------------------------
                 The average labor rate for employees (NAICS-specific
                wages).
                 Total number of employees at covered firms getting
                vaccinated due to the ETS with the Johnson & Johnson vaccine.
                 Total number of employees at covered firms getting
                vaccinated due to the ETS with the Pfizer and Moderna vaccines,
                multiplied by two to account for two shots.
                Cost for Support for Employee Vaccination
                 Costs per firm and total costs for vaccination are shown below in
                Table IV.B.10.
                BILLING CODE 4120-01-P
                [[Page 61481]]
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                [[Page 61482]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.013
                [[Page 61483]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.014
                [[Page 61484]]
                BILLING CODE 4120-01-C
                e. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
                ETS Requirements
                 Section 1910.501(g)(1) of the ETS requires the employer to ensure
                that each employee who is not fully vaccinated do the following:
                 An employee who reports at least once every 7 days to a workplace
                where other individuals, such as coworkers or customers, are present:
                 Must be tested for COVID-19 at least once every 7 days;
                and
                 Must provide documentation of the most recent COVID-19
                test result to the employer no later than the 7th day following the
                date on which the employee last provided a test result.
                 An employee who does not report during a period of 7 or more days
                to a workplace where other individuals, such as coworkers or customers,
                are present (e.g., teleworking for two weeks prior to reporting to a
                workplace with others):
                 Must be tested for COVID-19 within 7 days prior to
                returning to the workplace; and
                 Must provide documentation of that test result to the
                employer upon return to the workplace.
                 Furthermore, if an employee does not provide documentation of a
                COVID-19 test result as required by paragraph (g)(1) of the ETS, the
                employer must keep that employee removed from the workplace until they
                provide a test result. In addition, when an employee has received a
                positive COVID-19 test, or has been diagnosed with COVID-19 by a
                licensed healthcare provider, the employer must not require that
                employee to undergo COVID-19 testing as required under paragraph (g) of
                this section for 90 days following the date of their positive test or
                diagnosis. Finally, the employer must maintain a record of each test
                result provided by each employee under paragraph (g)(1) of this section
                or obtained during tests conducted by the employer. These records are
                considered to be employee medical records and must be maintained as
                such records in accordance with 29 CFR 1910.1020 and must not be
                disclosed except as required or authorized by this section or other
                federal law. These records are not subject to the retention
                requirements of 29 CFR 1910.1020(d)(1)(i) but must be maintained and
                preserved while this section remains in effect.
                 OSHA addresses the costs associated with testing in the next
                section. The remaining costs required by paragraph (g) are taken under
                the costs for recordkeeping, discussed below, because providing
                documentation of test results to the employer will be part and parcel
                of the recordkeeping process.
                 Employees who are partially vaccinated are also required to be
                tested weekly until they are fully vaccinated. Those receiving the J&J
                vaccine will require two weeks of testing after the single shot,
                employees who received the Pfizer-BioNTech Vaccine will require 5 weeks
                of testing (3 weeks between shots and 2 weeks following the second
                shot), and Moderna recipients require 6 weeks of testing (4 weeks
                between shots and 2 weeks following the second shot) (CDC, October 4,
                2021b). Notwithstanding this, in the agency's total cost estimate OSHA
                accounts for the fact that employers need not comply with the
                requirements of this section in paragraph (g) by 60 days after the
                rule's effective date, and that employees who have completed the entire
                primary vaccination series by that date do not have to be tested, even
                if they have not yet completed the 2 week waiting period.
                 There is no requirement in the rule that the employer pay for this
                testing so these testing-related costs are not included in the main
                analysis (although, as discussed below OSHA takes into account costs
                for testing in connection with the ETS's recordkeeping requirements).
                The agency estimates that 6.3 million weekly tests will need to be
                given due to this ETS (see Table IV.B.8). This 6.3 million is likely an
                overestimate of new costs because it encompasses tests for employees
                who were already required to conduct testing by their employers prior
                to this ETS.
                 OSHA also notes that its cost estimates for testing do not take
                into account the 90-day break in testing that occurs following the date
                of a positive test or diagnosis. OSHA's cost estimates are also
                potentially overcounting costs in that OSHA does not take into account
                that not all employees for whom testing is required will report at
                least once every 7 days to a workplace where other individuals, such as
                coworkers or customers, are present. Thus, OSHA's estimate assumes that
                employees for whom testing is required will need to be tested at least
                once every 7 days and not less frequently as will often be the case.
                 OSHA notes, in addition, that there are no costs associated with
                paragraph (g)'s removal provision. The ETS does not require the
                employer to provide paid time off to any employee for removal as a
                result of the employee's refusal/failure to provide documentation of a
                COVID-19 test result as required by paragraph (g)(1) of the ETS.
                 Finally, OSHA notes that a COVID-19 test under the ETS is a test
                for SARS-CoV-2 that is: (i) Cleared, approved, or authorized, including
                in an Emergency Use Authorization (EUA), by the FDA to detect current
                infection with the SARS-CoV-2 virus (e.g., a viral test); (ii)
                Administered in accordance with the authorized instructions; and (iii)
                Not both self-administered and self-read unless observed by the
                employer or an authorized telehealth proctor. Examples of tests that
                satisfy this requirement include tests with specimens that are
                processed by a laboratory (including home or on-site collected
                specimens which are processed either individually or as pooled
                specimens), proctored over-the-counter tests, point of care tests, and
                tests where specimen collection and processing is either done or
                observed by an employer. Employers may have costs associated with
                doing, observing or proctoring employee testing, if employers choose to
                do so. However, for economic feasibility purposes, OSHA does not
                account for these costs in its estimates because they are not required
                for compliance with the ETS.
                Costs Associated with Reasonable Accommodation: Testing, Face
                Coverings, and Determinations
                 The ETS does not require the employer to pay for any costs
                associated with testing; however employer payment for testing may be
                required by other laws, regulations, or collective bargaining
                agreements. Thus, while OSHA does not include any costs for reasonable
                accommodation requests in its main cost analysis in recognition that
                such costs would result from the application of other laws, OSHA notes
                that even if employers were to agree to pay for COVID-19 testing as
                part of a reasonable accommodation or some other reason required by
                law, such costs would not alter OSHA's findings regarding the economic
                feasibility of the rule.\48\ OSHA reached this conclusion after
                conducting a separate analysis of reasonable accommodation costs that
                an employer might assume if they do not represent an undue hardship for
                the employer. This analysis is available in the docket at OSHA, October
                2021d.
                ---------------------------------------------------------------------------
                 \48\ OSHA notes that while the testing required under this
                standard might be an option for employees who request a reasonable
                accommodation to avoid vaccination, other alternatives such as
                telework would be more protective to the employee by preventing
                COVID-19 exposure. These alternatives may also be available at no
                additional cost to the employer or employee.
                ---------------------------------------------------------------------------
                 OSHA notes that this separate analysis is limited to employees who
                request accommodation, and accounts for costs of reviewing medical and/
                or religious accommodation requests, as
                [[Page 61485]]
                well as costs for COVID-19 testing and face coverings that would
                satisfy the requirements of this ETS. OSHA expects a reasonable
                accommodation request could lead to a review of the employee's request
                by a manager and then a conference between the manager and the
                employee. OSHA concludes that the combination of these costs would not
                alter OSHA's findings regarding the economic feasibility of the ETS.
                f. Employee Notification to Employer of a Positive COVID-19 Test and
                Removal
                ETS Requirements
                 Under Sec. 1910.501(h):
                 Regardless of COVID-19 vaccination status or any COVID-19 testing
                required under paragraph (g) of the ETS, the employer must:
                 Require each employee to promptly notify the employer when
                they receive a positive COVID-19 test or are diagnosed with COVID-19 by
                a licensed healthcare provider; and
                 Immediately remove from the workplace any employee who
                receives a positive COVID-19 test or is diagnosed with COVID-19 by a
                licensed healthcare provider and keep the employee removed until the
                employee: (i) Receives a negative result on a COVID-19 nucleic acid
                amplification test (NAAT) following a positive result on a COVID-19
                antigen test if the employee chooses to seek a NAAT test for
                confirmatory testing; (ii) meets the return to work criteria in CDC's
                ``Isolation Guidance'' (incorporated by reference, Sec. 1910.509); or
                (iii) receives a recommendation to return to work from a licensed
                healthcare provider.
                Costs Analysis Assumptions
                 The ETS does not require employers to provide paid time off to any
                employee for removal from the workplace as a result of a positive
                COVID-19 test or diagnosis of COVID-19; however paid time off may be
                required by other laws, regulations, or collective bargaining
                agreements or other collectively negotiated agreements. Therefore,
                there are no costs associated with paragraph (h)'s removal provision.
                 With respect to notification, to the extent employee notification
                is connected to the ETS's testing and documentation requirements in
                paragraph (g), those costs to the employer are taken under the costs
                for recordkeeping, discussed below, because, as explained above,
                receiving documentation of test results under paragraph (g) will be
                part and parcel of the recordkeeping process.
                 OSHA notes also that the costs associated with employee
                notification by vaccinated employees (not required by this ETS to
                undergo testing) should also be negligible because it will not occur
                with any real frequency. The very low breakthrough rates of infection
                among vaccinated persons suggests that the overwhelming majority of
                COVID-19 cases reported to a covered employer will be in the pool of
                unvaccinated employees.
                g. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
                ETS Requirements
                 Under Sec. 1910.501(j):
                 The employer must report to OSHA:
                 Each work-related COVID-19 fatality within 8 hours of the
                employer learning about the fatality.
                 Each work-related COVID-19 in-patient hospitalization
                within 24 hours of the employer learning about the in-patient
                hospitalization.
                 When reporting COVID-19 fatalities and in-patient hospitalizations
                to OSHA in accordance with paragraph (j)(1) of the ETS, the employer
                must follow the requirements in 29 CFR part 1904.39, except for 29 CFR
                part 1904.39(a)(1) and (2) and (b)(6).
                Cost Analysis Assumptions
                 OSHA estimates a total of 1,464 fatalities and 59,570
                hospitalizations for employees of covered firms.\49\ This analysis is
                broadly consistent, using updated data, with OSHA's analysis of a
                nearly identical provision in 29 CFR 1910.502, the Healthcare ETS. OSHA
                also estimates, based on the Healthcare ETS, that reporting of each
                fatality and hospitalization will require 45 minutes of an employer's
                time (86 FR at 32516). This includes hospitalizations and fatalities
                for employees that remain unvaccinated, as well as a small percentage
                of hospitalizations and fatalities of vaccinated employees due to
                breakthrough cases. Because of the timing requirements in the rule, the
                agency assumes that a hospitalization followed by a death will need two
                reports from the employer (i.e., the agency assumes that reporting for
                hospitalizations will occur within 8 hours, before reporting for
                fatalities occurs, within 24 hours). This will result in a slight over-
                estimate.
                ---------------------------------------------------------------------------
                 \49\ These counts represent hospitalizations and fatalities that
                would occur to the in-scope labor force despite the ETS. The numbers
                are derived using methodology similar to that used in Health Impacts
                to generate hospitalizations and fatalities prevented. An infection
                rate and case fatality rate are multiplied by the number of
                unvaccinated workers to derive a total number of fatalities. That
                number is used to derive hospitalizations. The number of
                hospitalizations and fatalities to vaccinated employees is
                calculated in a similar fashion, but with a lower infection rate
                because vaccination makes it considerably less likely that an
                individual will be tested and found to be infected. See (OSHA,
                October 2021a and OSHA, October 2021c). One difference in
                methodology between these counts and the Health Impacts analysis is
                that these counts use a baseline of the last 19 months of CDC data
                to estimate the case fatality rate (similar to Alternative C in the
                Health Impacts analysis), rather than a baseline of the last 6
                months (which OSHA used for the main Health Impacts analysis). This
                results in an estimate toward the upper bound for these counts
                (i.e., an overestimate of costs).
                ---------------------------------------------------------------------------
                 The total cost for reporting COVID-19 fatalities and
                hospitalizations to OSHA is calculated as the product of:
                 One-time labor burden of 45 minutes per report of
                hospitalization or fatality.
                 Wage range for General and Operations Managers (SOC code
                11-1021, NAICS-specific wages).
                 Total number of fatalities for employees at covered firms.
                 Total number of hospitalizations for employees at covered
                firms.
                Cost for Reporting COVID-19 Fatalities and Hospitalizations to OSHA
                 Costs per entity and total costs for vaccination are shown below in
                Table IV.B.11.
                [[Page 61486]]
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                [[Page 61487]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.016
                h. Recordkeeping
                ETS Requirements
                 As discussed above, the full costs for the requirements in
                paragraph (e) of the ETS are taken under the costs for recordkeeping
                because determining vaccination status, providing acceptable proof of
                vaccination status, and creating and maintaining a roster of each
                employee's vaccination status will be part and parcel of the
                recordkeeping process. Under paragraph (e)(4) of the ETS, the employer
                must maintain a record of each employee's vaccination status and must
                preserve acceptable proof of vaccination for each employee who is fully
                or partially vaccinated. The employer must also maintain a roster of
                each employee's vaccination status. These records and roster are
                considered to be employee medical records and must be maintained in
                accordance with 29 CFR 1910.1020 as such records and must not be
                disclosed except as required or authorized by the ETS or other federal
                law. These records and roster are not subject to the retention
                requirements of 29 CFR 1910.1020(d)(1)(i) but must be maintained and
                preserved while the ETS remains in effect.
                 With respect to vaccination, it should be noted that, under
                paragraph (e)(5) of the ETS, when an employer has ascertained employee
                vaccination status prior to the effective date of this section through
                another form of attestation or proof, and retained records of that
                ascertainment, the employer is exempt from the determination of
                vaccination requirements in paragraphs (e)(1)-(e)(3)
                [[Page 61488]]
                only for each employee whose fully vaccinated status has been
                documented prior to the effective date of this section. For purposes of
                the recordkeeping requirements in paragraph (e)(4), the employer's
                records of ascertainment of vaccination status for each such person
                constitute acceptable proof of vaccination. OSHA estimates, based on
                this provision, that 60% of employees who were vaccinated prior to the
                promulgation of the ETS will not need to document vaccination status in
                connection with paragraph (e) (ASU COVID-19 Diagnostic Commons, October
                6, 2021).
                 As also discussed above, the costs for the requirements for
                documenting test results in paragraph (g), including the timing for
                when recordkeeping costs for testing accrue under the ETS, are taken
                under the costs for recordkeeping because providing documentation of
                test results to the employer will be part and parcel of the
                recordkeeping process. Under paragraph (g)(4) of the ETS, the employer
                must maintain a record of each test result provided by each employee
                under paragraph (g)(1) of the ETS or obtained during tests conducted by
                the employer. These records must be maintained in accordance with 29
                CFR 1910.1020 and must not be disclosed except as required or
                authorized by this section or other federal law. These records are not
                subject to the retention requirements of 29 CFR 1910.1020(d)(1)(i) but
                must be maintained and preserved while this section remains in effect.
                 With respect to testing, it should be noted that, under paragraph
                (m) of the ETS, employers are not required to comply with the
                requirements in paragraph (g) of the ETS until 60 days after the
                effective date of the ETS, meaning that for cost analysis purposes OSHA
                assumes that employers would not receive any testing records until the
                end of that 60-day period.
                 Finally, under paragraph 1910.501(l)(1) of the ETS, availability of
                records, by the end of the next business day after a request, the
                employer must make available, for examination and copying, the
                individual COVID-19 vaccine documentation and any COVID-19 test results
                for a particular employee to that employee and to anyone having written
                authorized consent of that employee. In addition, under paragraph
                1910.501(l)(2) of the ETS, by the end of the next business day after a
                request by an employee or an employee representative, the employer must
                make available to the requester the aggregate number of fully
                vaccinated employees at a workplace along with the total number of
                employees at that workplace. Under paragraph 1910.501(l)(3) of the ETS,
                the employer must also provide to the Assistant Secretary for
                examination and copying: (i) Within 4 business hours of a request, the
                employer's written policy required by paragraph (d) of the ETS, and the
                aggregate numbers described in paragraph (l)(2) of the ETS; and (ii) By
                the end of the next business day after a request, all other records and
                other documents required to be maintained by the ETS.
                Cost Analysis Assumptions
                 To fulfill the recordkeeping requirements in the ETS, OSHA
                estimates that it will take an average of 5 minutes of clerical time
                per employee record. OSHA bases this cost estimate on the estimate for
                recordkeeping in the Healthcare ETS (86 FR at 32515). While OSHA
                estimated an average of 10 minutes of clerical time per employee record
                in the Healthcare ETS, that standard includes more extensive
                recordkeeping requirements than what is being required under this ETS.
                See 29 CFR 1910.502(q)(2)(ii) (Healthcare ETS record must contain, for
                each instance, the employee's name, one form of contact information,
                occupation, location where the employee worked, the date of the
                employee's last day at the workplace, the date of the positive test
                for, or diagnosis of, COVID-19, and the date the employee first had one
                or more COVID-19 symptoms, if any were experienced).
                 In addition, OSHA includes in this estimate 5 minutes of employee
                time to provide documentation of vaccination status or testing, as
                applicable, to the employer. OSHA notes that, for an employee who is
                vaccinated, the employer will determine the vaccination status of that
                employees and obtain acceptable proof of vaccination status at the same
                time, thus negating the need to create two separate records for these
                requirements.
                 OSHA notes that there will be a cost associated with setting up the
                recordkeeping system (e.g., a spreadsheet) used to comply with the ETS.
                OSHA takes these costs in connection with the costs for the employer
                policy on vaccination, which are described above.
                 Given the relative complexity of recordkeeping in the Healthcare
                ETS, OSHA has simplified its assumptions to reflect a variety of small
                costs in a combined estimate. As in the Healthcare ETS, the cost
                estimate of 5 minutes per event is likely much higher than necessary to
                account for just the actions of receiving and maintaining copies of
                records, so retaining this time will yield a tendency toward
                overestimation. However, this cost also reflects a margin to encompass
                additional outlier costs such as a second documentation of vaccination
                status for all employees who need to submit documentation twice (first
                for partial vaccination and then for full vaccination) under the ETS.
                This 5 minutes for recordkeeping also encompasses the marginal time for
                creating and maintaining a roster of each employee's vaccination status
                (paragraph (e)) and making aggregate employee data available (paragraph
                (l)). Since normally the system used for recordkeeping will be
                electronic in businesses with more than 100 employees, the time to
                create an aggregate report and a roster should be de minimis. Finally,
                this inflated recordkeeping cost encompasses time for employee
                notification to the employer of a positive COVID-19 test connected to
                the ETS's testing and documentation requirements in paragraph (g),which
                is a notification under paragraph (h). Finally, the burden of making
                available, for examination and copying, the individual COVID-19 vaccine
                documentation and any COVID-19 test results for a particular employee
                are included in this estimate because this documentation will normally
                be pulled from the electronic recordkeeping system described above.\50\
                ---------------------------------------------------------------------------
                 \50\ The cost of providing to the Assistant Secretary for
                examination and copying the employer's written policy required by
                paragraph (d) of the ETS will be de minimis.
                ---------------------------------------------------------------------------
                [[Page 61489]]
                 The total cost for these requirements is calculated based on:
                 One-time labor burden of 5 minutes of employee labor to
                provide documentation and 5 minutes of clerk labor per employee record
                (one record per test administered and one record per documentation of
                vaccination status).
                 The average labor rate for Office Clerks, General (SOC 43-
                9060, NAICS-specific wages) and employees providing documentation
                (average wage over all employees, NAICS-specific wages)
                 Total number of employees at covered firms getting
                vaccinated due to the ETS with the Johnson & Johnson vaccine, who
                receive one shot.
                 Total number of employees at covered firms getting
                vaccinated due to the ETS with the Pfizer-BioNTech and Moderna
                vaccines, multiplied by two to account for two shots.
                 Total number of tests for employees at covered firms who
                are unvaccinated and will get vaccinated by receiving the Johnson and
                Johnson vaccine.
                 Total number of tests for employees at covered firms who
                are unvaccinated and will get vaccinated by receiving the Pfizer and
                Moderna vaccines.
                 Total number of employees at covered firms who are
                unvaccinated and will be tested weekly.
                Cost for Recordkeeping
                 Costs per entity and total costs for recordkeeping are shown below
                in Table IV.B.12.
                [[Page 61490]]
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                [[Page 61491]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.018
                [[Page 61492]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.019
                i. Summary of Total Cost
                Total Cost and Total Cost per Entity
                [[Page 61493]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.020
                [[Page 61494]]
                [GRAPHIC] [TIFF OMITTED] TR05NO21.021
                j. Sensitivity Analysis
                 As stated above, based on limited data on current vaccine mandate
                implementation and forecasts for future implementation (Mishra and
                Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons, October 6,
                2021), OSHA estimates that 25 percent of firms in scope currently have
                a vaccination mandate, and assumes that this will rise to 60 percent of
                covered employers after the ETS is in place. Because the agency has no
                historic reference on which to base its assumptions regarding vaccine
                mandates, the agency adjusted the percentage of firms that will
                institute a vaccine mandate because of the ETS as part of a sensitivity
                analysis. Along with
                [[Page 61495]]
                the baseline estimate of 60 percent of firms having a mandate, the
                agency looked at a vaccine mandate rate of 40 percent and 80 percent
                for covered firms, which OSHA judged to be a reasonable range based on
                the data available. The total costs associated with a 40 percent
                vaccine mandate are $2.998 billion, and the total costs associated with
                an 80 percent vaccine mandate are $2.964 billion. This compares to the
                baseline costs associated with a 60 percent vaccine mandate of $2.981
                billion. A higher vaccine mandate increases the share of employees who
                get vaccinated while reducing the share that must get weekly testing.
                It is this shift in shares that causes the costs to change because the
                total costs associated with weekly testing (recordkeeping) are more
                expensive than the total costs associated with vaccination under the
                ETS (employer support for vaccination, recordkeeping).
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                Boston Globe. https://www.bostonglobe.com/2021/06/22/business/back-office-not-so-fast/. (Chesto, June 22, 2021)
                Chokshi N and Scheiber N. (2021, October 2). Inside United Airlines'
                Decision to Mandate Coronavirus Vaccines. The New York Times.
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                2021)
                Courtney E. (2021, September 27). 30 Companies Switching to Long-
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                Graham R. (2021, September 15). Vaccine Resistors Seek Exemptions.
                But What Counts as Religious? The New York Times. https://www.nytimes.com/2021/09/11/us/covid-vaccine-religion-exemption.html.
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                Groenewold M et al., (2020, July 10). Increases in Health-Related
                Workplace Absenteeism Among Workers in Essential Critical
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                MMWR Vol. 69, No. 27. https://www.cdc.gov/mmwr/volumes/69/wr/mm6927a1.htm. (Groenewold et al., July 10, 2020)
                Kaiser Family Foundation (KFF). (2021, June 30). KFF COVID-19
                Vaccine Monitor: June 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/. (KFF, June
                30, 2021)
                Kelly J. (2021, August 12) Study Shows That 44% Of Employees Would
                Quit If Ordered To Get Vaccinated. https://www.forbes.com/sites/jackkelly/2021/08/12/study-shows-that-44-of-employees-would-quit-if-ordered-to-get-vaccinated/. (Kelly, August 12, 2021)
                KEZI News. (2021, September 25). Here's How Many Oregon State
                Employees Have Requested a COVID Vaccine Exemption. https://www.kezi.com/content/news/Heres-how-many-Oregon-state-employees-have-requested-a-COVID-vaccine-exemption-575395141.html. (KEZI News,
                September 25, 2021)
                Kuhn P and Yu L. (2021, April). How Costly is Turnover? Evidence
                from Retail. Journal of Labor Economics 39(2), 461-496. https://doi.org/10.1086/710359. (Kuhn and Yu, April, 2021)
                Lazer D et al. (2021, August 16). The COVID States Project: A 50-
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                States Project Report 62. https://covidstates.org/reports. (Lazer et
                al., August 16, 2021)
                Levi M et al. (2021, September 29). COVID-19 mRNA vaccination,
                reactogenicity, work-related absences and the impact on operating
                room staffing: A cross-sectional study. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479312/. (Levi et al.,
                September 29, 2021).
                Mishra D and Hartstein B. (2021, August 23). Littler COVID-19
                Vaccine Employer Survey Report--Delta Variant Update. https://www.littler.com/publication-press/press/littler-survey-employers-increasingly-consider-vaccine-mandates-covid-19. (Mishra and
                Hartstein, August 23, 2021)
                National Agricultural Statistics Service (NASS). (2017). Census of
                Agriculture. https://www.nass.usda.gov/Quick_Stats/CDQT/chapter/1/table/1. (NASS, 2017)
                O'Sullivan J. (2021, September 18). Washington state workers are
                getting exemptions to avoid the COVID-19 vaccine--but will they keep
                their jobs? Seattle Times. https://www.seattletimes.com/seattle-news/politics/washington-state-workers-are-getting-exemptions-to-avoid-the-covid-19-vaccine-but-will-they-keep-their-jobs/.
                (O'Sullivan, September 18, 2021).
                Occupational Safety and Health Administration (OSHA). (2021,
                September 25). State Plans. https://www.osha.gov/stateplans/faqs.
                (OSHA, September 25, 2021)
                Occupational Safety and Health Administration (OSHA). (2021a,
                October). Analytical Spreadsheets in Support of the COVID-19
                Vaccination and Testing ETS. (OSHA, October 2021a)
                Occupational Safety and Health Administration (OSHA). (2021b,
                October). COVID-19 Vaccination and Testing ETS: Economic Profile and
                Cost Chapter Appendices. (OSHA, October 2021b)
                Occupational Safety and Health Administration (OSHA). (2021c,
                October). Health Impacts of the COVID-19 Vaccination and Testing
                ETS. (OSHA, October 2021c)
                Occupational Safety and Health Administration (OSHA). (2021d,
                October). Costs Associated with Reasonable Accommodation: Testing,
                Face Coverings, and Determinations. (OSHA, October 2021d)
                Portnoy J. (2021, October, 3). Several hundred Virginia health-care
                workers have been suspended or fired over coronavirus vaccine
                mandates. The Washington Post. https://www.washingtonpost.com/local/covid-vaccine-mandate-hospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html. (Portnoy, October 3, 2021)
                Putri W et al. (2018, June, 22). Economic burden of seasonal
                influenza in the United States. Vaccine 36(27), 3960-3966. https://www.sciencedirect.com/science/article/pii/S0264410X18306777?via%3Dihub. (Putri et al., June 22, 2018)
                Umland B. (2021, October 13). Survey Looks at Vaccine Mandates and
                Employee Turnover. Mercer. https://www.mercer.us/our-thinking/healthcare/survey-looks-at-vaccine-mandates-and-employee-turnover.html. (Umland, October 13, 2021)
                U.S. Census Bureau. (2019). Statistics of U.S. Businesses (SUSB).
                https://www.census.gov/programs-survey/susb.html. (U.S. Census
                Bureau, 2019)
                U.S. Census Bureau. (2021). Household Pulse Survey (HPS), Week 37
                Table 6A. https://www.census.gov/programs-surveys/household-pulse-survey/data.html. (U.S. Census Bureau, 2021)
                White C. (2021). Measuring Social and Externality Benefits of
                Influenza Vaccination. Journal of Human Resources Vol 56 Number 3,
                pp. 749-785. https://muse.jhu.edu/article/798143. (White, 2021)
                Willis Towers Watson. (2021, June 23). COVID-19 Vaccination and
                Reopening the Workplace Survey. https://www.willistowerswatson.com/en-US/Insights/2021/06/covid-19-vaccination-and-reopening-the-workplace-survey. (Willis Towers Watson, June 23, 2021)
                V. ETS Economic Feasibility Determination
                a. OSHA's Screening Tests for Economic Feasibility
                 As noted in the introduction to the economic analysis, an OSHA
                standard is economically feasible when industries can absorb or pass on
                the costs of compliance without threatening industry's long-term
                profitability or competitive structure, Cotton Dust, 452 U.S. at 530
                n.55, or ``threaten[ing] massive dislocation to, or imperil[ing] the
                existence of, the industry.'' United Steelworkers of Am. v. Marshall
                (Lead I), 647 F.2d 1189, 1272 (D.C. Cir. 1981).
                 To determine whether a rule is economically feasible, OSHA
                typically begins by using two screening tests to determine whether the
                costs of the rule are beneath the threshold level at which the economic
                feasibility of an affected industry might be threatened. The first
                screening test is a revenue test. While there is no hard and fast rule
                on which to base the threshold, OSHA generally considers a standard to
                be economically feasible for an affected industry when the annualized
                costs of compliance are less than one percent of annual revenues. The
                one-percent revenue threshold is intentionally set at a low level so
                that OSHA can confidently assert that the rule is economically feasible
                for industries that are below the threshold (i.e., industries for which
                the costs of compliance are less than one percent of annual revenues).
                To put the one-percent threshold into perspective, OSHA calculated the
                average compounded annual rate of growth or decay in average revenues
                over the 15-year period from 2002 to 2017 (inflated to 2005 to 2020
                dollars) for firms with 100 or more employees in the 479 NAICS (out of
                546) industries covered by this ETS for which Census data were
                available and found that the average annual real rate of change in
                revenues in absolute terms for the average firm was 2.2 percentage
                points a year.\51\ In other words, revenues are generally observed to
                change by well more than one percent per year, on average, for firms
                with 100 or more employees in covered industries, indicating that
                changes of this magnitude are normal in these industries and that
                covered firms are typically able to withstand such changes over the
                course of a year, much less six months. As discussed below, the average
                percentage change due to this ETS for all covered NAICS is a fraction
                of this fluctuation in revenues.
                ---------------------------------------------------------------------------
                 \51\ These results are presented in the Excel ETS Revenue
                Threshold Test Tables available in the Docket for this ETS. The data
                used for six-digit NAICS were from the Bureau of the Census,
                available every five years (2002, 2007, 2012, 2107).
                ---------------------------------------------------------------------------
                 The second screening test that OSHA traditionally uses to consider
                whether a standard is economically feasible for an affected industry is
                if the costs of compliance are less than ten percent of annual profits
                (see, e.g., OSHA's economic analysis of its Silica standard, 81 FR
                16286, 16533 (March 25, 2016); upheld in N. Am.'s Bldg. Trades Unions
                v. OSHA, 878 F.3d 271, 300 (D.C. Cir. 2017)). The ten-percent profit
                test is also intended to be at a sufficiently low level so as to allow
                OSHA to identify industries that might require further examination.
                Specifically, the profit screen is primarily used to alert OSHA to
                potential impacts on industries where the price elasticity of demand
                does not allow for ready absorption of new costs in higher prices
                (e.g., industries with foreign competition where the American firms
                would incur costs that their foreign competitors would not because they
                are not subject to OSHA requirements). In addition, setting the
                threshold for the profit test low permits OSHA to reasonably conclude
                that the rule would be economically feasible for industries below the
                threshold. To put the ten-percent profit threshold test into
                perspective, evidence used by OSHA in its 2016 OSHA silica rule
                indicates that, for the combined affected manufacturing industries in
                general industry and maritime from 2000 through 2012, the average year-
                to-year fluctuation in profit rates (both up and
                [[Page 61497]]
                down) was 138.5 percent (81 FR 16545).\52\
                ---------------------------------------------------------------------------
                 \52\ Profits are subject to the dynamics of the overall economy.
                Many factors, including a national or global recession, a downturn
                in a particular industry, foreign competition, or the increased
                competitiveness of producers of close domestic substitutes are all
                easily capable of causing a decline in profit rates in an industry
                of well in excess of ten percent in one year or for several years in
                succession (See OSHA, March 24, 2016).
                ---------------------------------------------------------------------------
                 When an industry ``passes'' both the ``cost-to-revenue'' and
                ``cost-to-profit'' screening tests, OSHA is assured that the costs of
                compliance with the rule are economically feasible for that industry.
                The vast majority of the industries covered by the ETS fall into this
                category.
                 A rule is not necessarily economically infeasible, however, for the
                industries that do not pass the initial revenue screening test (i.e.,
                those for which the costs of compliance with the rule are one percent
                or more of annual revenues), the initial profit screening test (i.e,
                those for which the costs of compliance are ten percent or more of
                annual profits), or both. Instead, OSHA normally views those industries
                as requiring additional examination as to whether the rule would be
                economically feasible (see N. Am.'s Bldg. Trades Unions v. OSHA, 878
                F.3d at 291). OSHA therefore conducts further analysis of the
                industries that ``fail'' one or both of the screening tests in order to
                evaluate whether the rule would threaten the existence or competitive
                structure of those industries (see United Steelworkers of Am., AFL-CIO-
                CLC v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980)).
                Time Parameters for Analysis
                 OSHA's economic analyses almost always measure the costs of a
                standard on an annual basis, conducting the screening tests by
                measuring the cost of the standard against the annual profits and
                annual revenues for a given industry. One year is typically the minimum
                period for evaluating the status of a business; for example, most
                business filings for tax or financial purposes are annual in nature.
                 Some compliance costs are up-front costs and others are spread over
                the duration of the ETS; regardless, the costs of the rule overall will
                not typically be incurred or absorbed by businesses all at once.
                However, OSHA does not expect that the ETS will require employers to
                incur initial capital costs for equipment to be used over many years
                (which would typically be addressed through installments over a year or
                a longer period to leverage loans or payment options to allow more time
                to marshal revenue and minimize impacts on reserves).
                 The compliance costs for this ETS are for a temporary rule for a
                period of six months (which, again, is the time period that OSHA
                assumes this ETS will last, solely for economic purposes). While OSHA
                believes the most appropriate screens would be based on annual profits
                and revenue, it has followed the more cautious route of basing the
                screens on 6 months of profits and revenues to avoid any potential
                uncertainty about whether the ETS is economically feasible for the
                industries covered by this ETS. Using one year of revenues and profits
                as the denominators in the cost-to-revenue and cost-to-profit ratios
                would have resulted in ratios that are half of the estimated ratios
                presented in this analysis. It is therefore unsurprising that
                businesses in some number of NAICs have edged above the profit-
                thresholds using a 6 month screen (as will be discussed later), and
                OSHA believes that edging above the screening thresholds is less of an
                indicator of economic peril in this context than in the context of a
                permanent rulemaking analysis. Nevertheless, OSHA has examined each of
                the NAICS that did not clear either of these conservative screening
                tests and has concluded that the ETS is economically feasible for each
                one.
                Data Used for the Screening Tests
                 The estimated costs of complying with the ETS, which OSHA relied
                upon to examine feasibility is based on the two tests described above
                (see OSHA, October 2021a). The revenue numbers used to determine cost-
                to-revenue ratios were obtained from the 2017 Economic Census for firms
                with 100 or more employees in covered industries. This is the most
                current information available from this source, which OSHA considers to
                be the best available source of revenue data for U.S. businesses.\53\
                OSHA adjusted these figures to 2020 dollars using the Bureau of
                Economic Analysis's GDP deflator, which is OSHA's standard source for
                inflation and deflation analysis.
                ---------------------------------------------------------------------------
                 \53\ For information regarding the standards and practices used
                by the Census Bureau to ensure the quality and integrity of its
                data, see (US Census Bureau, October 8, 2021a; US Census Bureau,
                October 8, 2021b).
                ---------------------------------------------------------------------------
                 The profit screening test for feasibility (i.e., the cost-to-profit
                ratio) was calculated as ETS costs divided by profits. Profits were
                calculated as profit rates multiplied by revenues. The before-tax
                profit rates that OSHA used were estimated using corporate balance
                sheet data from the Internal Revenue Service (IRS), 2013 Corporation
                Source Book (IRS, 2013). The IRS discontinued the publication of these
                data after 2013, and therefore the most current years available are
                2000-2013.\54\ The most recent version of the Source Book represents
                the best available evidence for these data on profit rates.\55\
                ---------------------------------------------------------------------------
                 \54\ See IRS, 2013.
                 \55\ OSHA also investigated Bizminer and RMA as potential
                sources of profit information and determined that they do not
                represent adequate and random samples of the affected industries.
                ---------------------------------------------------------------------------
                 For each of the years 2000 through 2013, OSHA calculated profit
                rates by dividing the ``net income'' from all firms (both profitable
                and unprofitable) by total receipts from all firms (both profitable and
                unprofitable) for each NAICS.\56\ OSHA then averaged these rates across
                the 14-year (2000 through 2013) period. Since some data provided by the
                IRS were not available at disaggregated levels for all industries and
                profit rates, data at more highly aggregated levels were used for some
                industries; that is, where data were not available for each six-digit
                NAICS code, data for the corresponding four- or five-digit NAICS codes
                were used. Data were used for all firms in the NAICS (as opposed to
                just firms with 100 or more employees) since data disaggregated by
                employment size-class were not available. Profit rates are expressed as
                a percentage (see OSHA, October 2021a). Profits themselves were used to
                calculate the cost-to-profit estimates for all firms contained in a
                particular NAICS code (see OSHA, October 2021a).
                ---------------------------------------------------------------------------
                 \56\ There is one code reported per tax entity and it may not be
                representative to the six-digit level. See Corporation Sourcebook on
                limitations of the industry classification for details. (IRS, 2013).
                ---------------------------------------------------------------------------
                 OSHA has estimated costs over a 6-month timeframe for this ETS. As
                discussed above, OSHA has therefore used six months of revenue to
                conduct the cost-to-revenue tests and six months of profit to conduct
                the cost-to-profit tests.
                General Use of Revenues and Profits To Measure Economic Feasibility
                 As with other OSHA rulemaking efforts, the agency relies on the two
                screening tests (costs less than one percent of revenue and costs less
                than ten percent of profit) as an initial indicator of economic
                feasibility. OSHA has generally found that the cost-to-revenue test is
                a more reliable indicator of feasibility simply because the revenue
                data are more accurate than the profit data. There are several reasons
                for this.
                 First, OSHA has been using corporate balance sheet data from the
                IRS as the best available evidence for estimating
                [[Page 61498]]
                corporate profits for years.\57\ Nevertheless, because firms typically
                have an incentive to minimize their tax burden, it is reasonable to
                expect that some of the reported accounting data may have been
                strategically adjusted to reduce reported profits and their associated
                tax implications. Business profits are much more likely to reflect such
                strategic accounting than business revenues; accordingly, revenues are
                a more accurate measure than profits for evaluating economic
                feasibility for a multitude of reasons.\58\
                ---------------------------------------------------------------------------
                 \57\ OSHA funded and accepted a final report by Contractor Henry
                Beale (Beale Report, 2003) that reviewed alternative financial data
                sources and concluded that the IRS data were the best. Since then
                OSHA has been relying on IRS data to provide the financial data to
                support its rulemaking analyses. See, for example, Occupational
                Safety and Health Administration (OSHA) (2016), Final Economic and
                Regulatory Flexibility Analysis for OSHA's Rule on Occupational
                Exposure to Respirable Crystalline Silica, Chapter VI, pp. VI-2 to
                VI-3, Docket No. OSHA-2010-0034-4247 (OSHA, March 24, 2016), which
                includes a more recent review of data sources for corporate
                financial profit data and further support for OSHA's choice of IRS
                data.
                 \58\ In fact, all other Department of Labor agencies rely solely
                on revenues to assess economic impacts, such as Regulatory
                Flexibility Act certifications, in their rulemakings (see, e.g.,
                Employment and Training Administration, Final Rule on Strengthening
                Wage Protections for the Temporary and Permanent Employment of
                Certain Aliens in the United States, https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00218.pdf; Wage and Hour
                Division, Tip Regulations Under the Fair Labor Standards Act (FLSA),
                https://www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/2020-28555.pdf).
                ---------------------------------------------------------------------------
                 Second, because OSHA is using data from both profitable and
                unprofitable firms, the average profit rate for a small number of
                industries is negative (as described above, using 14 years of data that
                predate the pandemic). This result could have occurred because of the
                way profits are calculated, which unnaturally skews average profit
                rates downward by including firms that have large losses (negative
                profits) or subnormal profits and have already closed or are in the
                process of closing, irrespective of any action by OSHA. The negative
                rates could also be the result of macroeconomic fluctuations during the
                14-year period used to determine the average, a period in which some of
                these industries may have experienced unusually adverse financial
                impacts (see, e.g., the explanation in Chapter VI, pp. VI-20 of the
                Final Economic and Regulatory Flexibility Analysis for OSHA's Rule on
                Occupational Exposure to Respirable Crystalline Silica, Docket No.
                OSHA-2010-0034-4247, which notes the skew from negative impacts during
                recession years (OSHA, March 24, 2016)). Or they could result from tax-
                related incentives, as previously noted.
                 Whatever the reason, the cost-to-profit calculations for NAICS with
                negative profit rates fail to provide reliable information about the
                long-term profitability of these industries, independent of the ETS.
                Companies and industries that consistently lose money do not typically
                stay in business, and would almost certainly not still be in business
                in 2021 if that loss continued at the same level for each of the 8
                years since the profit data was published in 2012. Revenue streams are
                a more dependable measure for those firms because those streams tend to
                be more stable and more indicative of the actual capabilities of
                sustainable firms than reported negative profit margins. As a result,
                for the purposes of this analysis, OSHA has relied more heavily on its
                cost-to-revenue estimates, in lieu of cost-to-profit estimates, as the
                more reliable indicator for economic feasibility for the industries
                with negative profit rates.
                 Third, and similarly, profit rates that are only slightly positive
                (i.e., less than one percent) are inconclusive and not useful for the
                purpose of OSHA's cost-to-profit test. In economics terms, profit
                entails a reasonable rate of return on investment, and long-term
                profits of less than one percent a year are not generally reasonable
                for firms that expect to remain in business. Thus data showing
                industry-wide profits in this range do not measure the true ability of
                companies to pay for the ETS costs. As previously stated, revenue
                streams tend to be more stable and more indicative of the actual
                capabilities of sustainable firms. Therefore, where possible, OSHA
                prefers to rely on the cost-to-revenue test to evaluate economic
                feasibility for industries that have a less than one percent profit
                rate.
                 The qualification, and by far the most important reason for the
                general primacy of revenues versus profits as the appropriate metric
                for determining economic feasibility, for most OSHA rules, is that the
                regulated firms are able to pass on the costs of the rule in the form
                of higher prices. When they cannot, the profit test functions primarily
                as a screen for a limited purpose: Alerting OSHA to potential impacts
                where unregulated competitors can prevent firms from passing costs
                along to customers.
                 To understand this point, some economic background is needed. The
                price elasticity of demand refers to the relationship between the price
                charged for a product or service and the quantity demanded for that
                product or service: The more elastic the relationship, the larger the
                decrease in the quantity demanded for a product when the price goes up.
                When demand is elastic, establishments have less ability to pass
                compliance costs on to customers in the form of a price increase and
                must absorb such costs in the form of reduced profits. In contrast,
                when demand is relatively inelastic, the quantity demanded for the
                product or service will be less affected by a change in price. In such
                cases, establishments can recover most of the variable costs of
                compliance (i.e., costs that are highly correlated with the amount of
                output) by raising the prices they charge; under this scenario, if
                costs are variable rather than fixed, business activity and profit
                rates are largely unchanged for small changes in costs. Ultimately,
                where demand is relatively inelastic, any impacts are primarily borne
                by those customers who purchase the relevant product or service for a
                slightly higher price. Most of the costs of this ETS are variable costs
                because they depend primarily on the level of production or the number
                of employees at an establishment. For example, under the ETS, a firm
                with 500 employees must determine and record the vaccination status of
                500 employees, while a firm with 250 employees need determine and
                record the vaccination status of only 250 employees.\59\
                ---------------------------------------------------------------------------
                 \59\ While fixed cost can be more limiting in terms of options
                for businesses, most of the costs of this rule are not fixed.
                Instead, most of the compliance costs vary with the level of output
                or employment at a facility.
                ---------------------------------------------------------------------------
                 In general, ``[w]hen an industry is subjected to a higher cost, it
                does not simply swallow it; it raises its price and reduces its output,
                and in this way shifts a part of the cost to its consumers and a part
                to its suppliers'' (Am. Dental Ass'n v. Sec'y of Labor, 984 F.2d 823,
                829 (7th Cir. 1993)). A reduction in output could happen in a variety
                of ways: Individual establishments could reduce their levels of service
                (e.g., retail firms) or production (e.g., manufacturing), both of which
                could take the form of a reduction of worker hours; some marginal
                establishments could close; or, in the case of an industry with high
                turnover of establishments, new entry could be delayed until demand
                equals supply. In many cases, a decrease in overall output for an
                industry will be a combination of all three kinds of reductions. The
                primary means of achieving the reduction in output most likely depends
                on the rate of turnover in the industry and on the form that the costs
                of the regulation take. Further, the temporary nature of the ETS and
                its associated
                [[Page 61499]]
                costs suggests that firms may have more flexibility to respond than
                when facing a permanent increase in costs. For example, firms may be
                able to temporarily increase prices or temporarily defer planned
                capital expenditures or other maintenance to cover compliance costs.
                 There are two situations typically mentioned when an industry
                subject to regulatory costs might be unable to pass those costs on: (1)
                Foreign competition not subject to the regulation, or (2) domestic
                competitors in other industries, not subject to the regulation, that
                produce goods or services that are close substitutes. Otherwise, when
                all affected domestic industries are covered by a rule and foreign
                businesses must also comply with the rule or are unable to compete
                effectively, the ability of a competing industry to offer a substitute
                product or service at a lower price is greatly diminished.
                 There is a third situation that is relevant to this ETS--when only
                some firms in a domestic industry (in this case, only employers with
                100 or more employees) are subject to the ETS and its regulatory costs.
                In principle, competition from smaller employers in a NAICS could
                prevent the larger employers from passing on their costs in the form of
                higher prices and instead require them to absorb the costs in the form
                of lost profits. There are, however, several important caveats:
                 1. As a practical matter, it is implausible to expect that covered
                employers (with 100 or more employees) would feel constrained by
                smaller competitors in their industry so as not to pass on costs for a
                rule lasting 6 months that imposes costs equal to 0.02 percent of
                revenues, on average across all NAICS, over that time period (see OSHA,
                October 2021a). This time period would likely be too short for small
                firms to expand to take business away from the larger firms or for new
                firms to form to take advantage of such minor and transitory business
                opportunities. Furthermore, smaller firms (particularly very small
                firms--those with fewer than 20 employees) typically can't compete on
                price with large firms that have cost advantages due to various
                economies of scale; as a result, smaller firms often serve a
                specialized niche market rather than compete directly with larger
                firms. To the extent that this ETS creates new business opportunities
                for these smaller uncovered firms, they would also be covered by the
                ETS as soon as they reached 100 employees.\60\
                ---------------------------------------------------------------------------
                 \60\ This cost advantage may be exaggerated or non-existent in
                many cases (see the discussion directly below in the text in Caveat
                2).
                ---------------------------------------------------------------------------
                 2. An important factor to consider in calculating the costs and
                impacts and economic feasibility of this ETS is the unquantified and
                unmonetized cost savings and other positive economic impacts accruing
                to employers that comply with the ETS. These include reduced
                absenteeism due to COVID-19 illnesses \61\ and quarantine.\62\ Other
                positive economic impacts that compliant employers would enjoy from a
                safer business environment are increased retail trade from customers
                that feel less at risk and better relations with suppliers and other
                business partners. These all would contribute to improved business and
                increased profits.
                ---------------------------------------------------------------------------
                 \61\ Several occupational groups less able to avoid exposure to
                SARS-CoV-2 infection exhibited significantly higher rates of
                absenteeism in March-April 2020 compared to earlier periods
                (Groenewold et al., July 10, 2020).
                 \62\ For a discussion of turnover (i.e. whether the ETS could
                affect the likelihood that an employee will remain with an employer,
                either because the imposition of a vaccine requirement will lead
                some employees to leave and find employment at an establishment not
                subject to the ETS, or, alternatively, to stay due to a preference
                for enhanced COVID-19 safety procedures), please see the cost
                section (Section III.d.) of this economic analysis.
                ---------------------------------------------------------------------------
                 3. The existence of these cost savings and other positive economic
                impacts accruing to employers that comply with the ETS suggests that
                the actual net costs of the ETS will be much lower than the costs
                reported in the supporting economic analysis for this ETS used to
                estimate cost impacts and demonstrate economic feasibility. In fact,
                for some share of covered employers, the net costs of the ETS may well
                be negative. Indeed, this is being confirmed by revealed preference in
                the market. Elsewhere in the economic analysis for this ETS (Cost
                Analysis section 4.2), OSHA has provided evidence to support its
                estimate that 25 percent of covered employers already voluntarily
                require that their employees be vaccinated and a much larger percentage
                are considering a vaccine mandate. This strongly supports the
                conclusion that these businesses agree that doing so will ultimately
                save costs.
                b. Economic Feasibility Analysis and Determination
                 This section summarizes OSHA's feasibility findings for industries
                covered by the ETS. As stated previously, the agency uses two screening
                tests (costs less than one percent of revenue and costs less than ten
                percent of profit) as an initial indicator of economic feasibility. In
                this section, OSHA discusses the industries that fall above the
                threshold level for either screening test.
                 The overall effect of compliance with the general section of the
                ETS on covered industries is very small (see OSHA, October 2021a). The
                vast majority of the covered NAICS have very low cost-to-revenue and
                cost-to-profit ratios, with the overall averages being 0.02 percent of
                revenues and 0.49 percent of profits. To put this into perspective, if
                the average firm decided to raise prices to cover the costs of the ETS,
                the price of a $100 product or service, for example, would have to be
                increased by 2 cents (during the six-month period).
                 Based on the information presented here, the costs of the ETS are
                below both the threshold revenue test (1 percent of revenues) and the
                threshold profit test (10 percent of profits) for the vast majority of
                NAICS industries.\63\ This indicates that the average firm in these
                industries will be able either to raise prices to cover ETS costs or to
                absorb the costs of the ETS out of available profits. In either case,
                OSHA concludes that the ETS is economically feasible for all of these
                industries.
                ---------------------------------------------------------------------------
                 \63\ By OSHA's calculation, 524 out of the 546 six-digit NAICS
                covered by the ETS.
                ---------------------------------------------------------------------------
                 Critically, there are no industries covered by the general section
                of the ETS that are above OSHA's cost-to-revenue threshold level of one
                percent and most are a small fraction of this level. Because OSHA is
                using data from both profitable and unprofitable firms, the average
                profit rate for a small number of industries is negative. There are 14
                NAICS with negative cost-to-profit ratios, resulting from negative
                average profit rates. These industries with negative profit rates are
                domestic service industries that are not subject to international
                competition.
                 There are eight six-digit NAICS industries, covering all
                establishments in those industries covered by the general section of
                the ETS, with cost-to-profit ratios above 10 percent:
                 1. NAICS 221118--Other Electric Power Generation, 23.97 percent;
                 2. NAICS 488119--Other Airport Operations, 18.41 percent;
                 3. NAICS 488410--Motor Vehicle Towing, 15.75 percent;
                 4. NAICS 488490--Other Support Activities for Road Transportation,
                14.32 percent;
                 5. NAICS 713920--Skiing Facilities, 13.16 percent; and
                [[Page 61500]]
                 6. NAICS 713940--Fitness and Recreational Sports Centers, 12.33
                percent;
                 7. NAICS 713120--Amusement Arcades, 11.18 percent; and
                 8. NAICS 488320--Marine Cargo Handling, 10.03 percent.
                 The average profit rate reported over the 14 years for which OSHA
                has profit data for all the NAICS affected by the ETS is 4.2 percent.
                All of the eight NAICS industries with a cost-to-profit ratio above the
                10 percent threshold report an annual profit rate below one percent--75
                percent or more below the overall average for all NAICS covered by the
                ETS. These eight industries all provide domestic services and are not
                subject to international competition.
                 The fact that the covered firms in these 22 NAICS industries (the
                14 with negative cost-to-profit ratios and the 8 with more sustainable
                cost-to-profit ratios) exceeded the profit screen suggests that they
                might in theory have difficulty paying for the costs of the ETS out of
                profits gained over the six-month duration of the ETS if they had no
                savings or access to capital, but even if that were true it would be
                highly unlikely to place the firms in financial jeopardy. OSHA examines
                these industries more closely below, but before even considering the
                reasons in NAICs-specific analysis it is important to consider the
                larger context. For the ETS to threaten the economic solvency of these
                firms, the following 3 conditions must apply:
                 1. These firms must not enjoy certain cost savings and positive
                economic impacts from the ETS that would partially or totally offset
                their costs. This condition is questionable because of the estimated 25
                percent of employers sampled that reported voluntarily imposing a
                vaccine mandate and the substantial number more contemplating the
                voluntary adoption of such a mandate. They can be expected to base
                their decisions, partly or entirely, on anticipated cost savings or
                positive economic impacts (which would reduce or eliminate their risk
                of insolvency due to the ETS).
                 2. These firms (all with 100 or more employees) must not be able to
                raise prices to cover ETS costs because of the threat that smaller
                firms in their NAICS industry, not covered by the ETS, could underprice
                them and take away their business. This condition is unlikely or
                limited because of the economies of scale the larger firms enjoy and
                the fact that the smaller firms out of necessity tend to serve a market
                niche not in direct competition with the larger firms. Also, there is a
                severe limit to the extent that firms with fewer than 100 employees can
                take away significant portions of business from the larger firms
                without becoming subject to the requirements of the rule themselves. If
                the larger firms do not feel threatened by being underpriced by smaller
                firms in these NAICS industries, then they could raise prices an
                average of less than 0.05 percent \64\ to cover the cost of the ETS--a
                small fraction of the 1.0 percent of revenues threshold (beneath which
                OSHA has determined that economic feasibility is not a concern).
                ---------------------------------------------------------------------------
                 \64\ If not underpriced by smaller firms, covered firms in the 8
                NAICS industries reporting ETS costs above 10 percent of profits
                could cover these costs by raising prices an average of 0.08 percent
                (highest, 0.11 percent); covered firms in the 14 NAICS industries
                reporting negative profits could cover ETS costs with a price
                increase of 0.01 percent (highest, 0.02 percent).
                ---------------------------------------------------------------------------
                 3. These firms must not generate sufficient profits or have
                adequate borrowing capacity during the six months the ETS is in force
                to cover the costs of the ETS. There are several reasons to doubt that
                this condition broadly applies. First, the estimates of business
                profits come from corporate balance sheet data that firms report to the
                IRS. But, as previously noted, it is generally the case that firms have
                an incentive to minimize their tax burden, and it is reasonable to
                expect that some of the reported accounting data may have been
                strategically adjusted to reduce reported profits and their associated
                tax implications. Another point concerning the IRS data is that they
                include the negative profits of firms that are going out of business or
                have since gone out of business. To the extent that these points are
                true, many or most of the covered firms in these NAICS industries
                (still in business) actually would generate sufficient profit to cover
                the cost of the ETS. A related point is that for this condition to
                apply, the firms must not be able to borrow the money to pay for the
                costs of the ETS. Recall, however, that these are all large firms with
                100+ employees. It is reasonable to expect that many or most firms of
                this size in the 22 NAICS industries at issue either have available
                funds or could obtain a short-term loan to cover costs equal to the
                0.01 to 0.11 percent of revenues that these firms would incur over the
                six-month period that OSHA assumes the ETS will remain in effect. Firms
                of this size normally have banking relationships and some unencumbered
                assets. They also have access to national and international capital
                markets. If these firms can borrow funds to pay for the ETS, then the
                profit restriction doesn't matter.
                 Finally, OSHA anticipates concern that limiting the scope of the
                ETS to employers with 100 or more employees will somehow put these
                larger firms in economic jeopardy from the smaller firms to which the
                ETS does not currently apply. This is highly improbable for several
                reasons discussed earlier, including the fact that these are large
                employers with advantages of economies of scale and access to capital
                and the fact that this is a temporary standard that would result, at
                most, in marginal impacts over 6 months (on average, equal to costs of
                0.02 percent of revenues, which, again, translates to a cost increase
                of a penny on a fifty dollar item).
                 But even that misses the main point: Economic feasibility refers to
                the industry, not to the firm. OSHA must construct a reasonable
                estimate of compliance costs and demonstrate a reasonable likelihood
                that these costs will not threaten the existence or competitive
                structure of an industry, even if it does portend disaster for some
                marginal firms (Lead I, 647 F.2d at 1272). In the (again) highly
                unlikely event that individual firms exit an industry and are replaced
                by other firms in the industry, then the ETS would preserve the
                economic feasibility of the covered industries. If an employer covered
                by this standard actually had to increase its prices slightly to
                account for the cost of this standard, there are two potential groups
                of smaller businesses that could seek to supplant the covered firms.
                The first group of businesses are much smaller than the covered firms.
                Those businesses, however, will typically have higher costs and prices
                to begin with due to their scale disadvantages to the larger firms. The
                larger firm's small price increases attributable to this ETS would not
                be likely to create an actionable competitive advantage for this group
                of smaller businesses. The second group of businesses are those closer
                in size to the 100-employee cutoff. If the marginal price increases did
                actually cause some of the larger firms to fail and the slightly
                smaller firms to take their place, the industry itself would not suffer
                a massive dislocation or be imperiled. And, of course, if all of the
                firms in an industry are large employers with 100 or more employees, no
                competitive disadvantage from within the industry would exist (even
                hypothetically), and there would be no question that they could cover
                the cost of ETS by raising prices to customers accordingly.
                 Although the preceding discussion demonstrates that the ETS is
                economically feasible, OSHA has provided an additional examination of
                each of the NAICS that have crossed the profit screen (again noting
                that none of
                [[Page 61501]]
                these failed the revenue screen): The eight NAICS industries with
                positive profit ratios but profit rates below 1 percent.
                1. NAICS 221118--Other Electric Power Generation, 23.97 Percent
                 This U.S. industry comprises establishments primarily engaged in
                operating electric power generation facilities (except hydroelectric,
                fossil fuel, nuclear, solar, wind, geothermal, biomass). These
                facilities convert other forms of energy, such as tidal power, into
                electric energy. The electric energy produced in these establishments
                is provided to electric power transmission systems or to electric power
                distribution systems.
                 Using tides to generate power is not yet economically viable,
                according to one source, because ``[t]otal availability of tidal power
                is restricted by its relatively high cost and limited number of sites
                having high flow velocities and tidal ranges,'' although ``with [ ]
                recent advancements in tidal technologies, the total availability of
                tidal power in terms of turbine technology as well as design may be
                higher than before, and the economic costs may be reduced significantly
                to competitive levels.'' In support, in the same article, ``recent
                reports state that the UK, which has the largest tidal and wave
                resource in Europe, is capable of harnessing up to 153GW of tidal power
                capacity with the help of three types of technologies and thus meeting
                20% of current UK electricity demand and reducing carbon emissions.
                Hence it is evident that wave and tidal energy could contribute more to
                the increasing electricity demands across the globe.'' \65\
                ---------------------------------------------------------------------------
                 \65\ See Walker, January 22, 2013.
                ---------------------------------------------------------------------------
                 At the time OSHA obtained the most recent NAICS data, there were 7
                affected entities in this NAICS industry. The entities in this NAICS
                industry include firms like Berkshire Hathaway Energy Company, (with
                annual sales of $19.8 billion, whose ``portfolio consists of locally
                managed business that share a vision for a secure and sustainable
                energy future''); Dominion Energy (with annual sales of $13.4 billion);
                and other leading firms in this industry including some of the largest
                power generation companies in the US (See NAICS Association, 2018a;
                NAICS Association 2018d; and NAICS Association 2018e).
                 As this NAICS industry is not yet viable, (in the United States, at
                least), it is to be expected that revenues and profits would be low. In
                fact, OSHA believes the best way to view this industry is as a series
                of incredibly well-funded start-up companies during the investment
                phase of the business, where short-term losses are expected and offset
                with the anticipation of enormous revenue growth potential (in an
                acknowledged very limited energy market.) Given these factors, OSHA's
                typical revenue and profit screen are a poor predictor of future
                viability with respect to this NAICS industry (although, as pointed
                out, this NAICS industry, like all other NAICS industries, falls well
                below the revenue screen threshold). The estimated cost of this ETS per
                firm is $866 in this NAICS industry, which equals about 11 cents per
                hundred dollars of revenue over a limited six-month duration. OSHA
                concludes that this industry will be able to withstand this small cost
                in order to keep its workers protected during the pandemic.
                2. NAICS 488119--Other Airport Operations, 18.41 Percent 66
                ---------------------------------------------------------------------------
                 \66\ This U.S. industry comprises establishments primarily
                engaged in (1) operating international, national, or regional
                airports, or public flying fields or (2) supporting airport
                operations, such as rental of hangar space, and providing baggage
                handling and/or cargo handling services.
                ---------------------------------------------------------------------------
                 The services this industry offers are integrated into a particular
                geographic location and entail specific tasks, such as parking and
                baggage handling services, that must be done to ensure the proper
                functioning of airports, thus negating the potential for substitution
                during the 6 month period that OSHA is assuming the ETS will be in
                effect for economic purposes. In addition, because these are services
                that need to be done in particular domestic locations (i.e., airports),
                there is no risk of international competition.
                3. NAICS 488410--Motor Vehicle Towing, 15.75 Percent 67
                ---------------------------------------------------------------------------
                 \67\ This industry comprises establishments primarily engaged in
                towing light or heavy motor vehicles, both local and long-distance.
                These establishments may provide incidental services, such as
                storage and emergency road repair services.
                ---------------------------------------------------------------------------
                 The actual cost impacts on this industry are likely significantly
                overstated to the extent that most employees performing towing services
                ride alone in their trucks and their services do not typically require
                exposure to others. In the event that individual large towing firms are
                concerned about economic impacts, it would not be difficult to
                structure their employee interactions with the company and customers to
                take advantage of the scope restrictions. Moreover, the primary
                services this industry offers involve the use of specialized vehicles
                designed uniquely for towing, thus lowering the risk of substitution.
                In addition, because these services are geographically based, there is
                no risk of international competition.
                4. NAICS 488490--Other Support Activities for Road Transportation,
                14.32 Percent 68
                ---------------------------------------------------------------------------
                 \68\ This industry comprises establishments primarily engaged in
                providing services (except motor vehicle towing) to road network
                users.
                ---------------------------------------------------------------------------
                 This industry offers services that must be done to ensure proper
                operation of roadways (for example, bridge, tunnel, and highway
                operations, pilot car services (i.e., wide load warning services),
                driving services (e.g., automobile, truck delivery), and truck or
                weighing station operations), thus negating the potential for
                substitution. In addition, because these services need to be done in
                particular domestic locations (i.e., roadways), there is no risk of
                international competition.
                5. NAICS 713920--Skiing Facilities, 13.16 Percent 69
                ---------------------------------------------------------------------------
                 \69\ This industry comprises establishments engaged in (1)
                operating downhill, cross country, or related skiing areas and/or
                (2) operating equipment, such as ski lifts and tows. These
                establishments often provide food and beverage services, equipment
                rental services, and ski instruction services. Four season resorts
                without accommodations are included in this industry.
                ---------------------------------------------------------------------------
                 This industry caters to a wealthy clientele who ensure an inelastic
                demand easily capable of absorbing any fractional increases
                attributable to this ETS.\70\ In addition, skiing is done outdoors,
                which will incentivize clientele to continue engaging in this
                particular activity in lieu of indoor substitutions, during the
                pandemic. Finally, there is little to no risk of international
                competition from foreign ski resorts because the added and substantial
                costs of international travel outweigh the costs associated with
                marginally higher prices resulting from the ETS.
                ---------------------------------------------------------------------------
                 \70\ See Brown, January 19, 2017, ``[o]f the 9.4 million skiers
                in the U.S., more than half earn a salary higher than $100,000. For
                some context, only 20 percent of American households have a combined
                income of $100K. . . .'')
                ---------------------------------------------------------------------------
                6. NAICS 713940--Fitness and Recreational Sports Centers, 12.33 Percent
                71
                ---------------------------------------------------------------------------
                 \71\ This industry comprises establishments primarily engaged in
                operating fitness and recreational sports facilities featuring
                exercise and other active physical fitness conditioning or
                recreational sports activities, such as swimming, skating, or
                racquet sports.
                ---------------------------------------------------------------------------
                 As these settings are generally located close to where clients live
                or work, there is no risk of international competition. Some of the
                largest employers in this industry have already responded to customer
                feedback by not only requiring employees to be vaccinated, but also
                [[Page 61502]]
                members.\72\ This suggests both that the costs estimates attributed to
                the ETS are overstated for these employers because higher levels of
                compliance may have already occurred than projected in OSHA's analysis,
                and that the ETS requirements reflect more of an industry trend than a
                threat to the existence of the industry.
                ---------------------------------------------------------------------------
                 \72\ See Jackson, August 2, 2021 ``Equinox also noted in the
                press release that `an overwhelming majority of members' have
                expressed support for a vaccination requirement for entry to Equinox
                clubs.''
                ---------------------------------------------------------------------------
                7. NAICS 713120--Amusement Arcades, 11.18 Percent 73
                ---------------------------------------------------------------------------
                 \73\ This industry comprises establishments primarily engaged in
                operating amusement (except gambling, billiard, or pool) arcades and
                parlors.
                ---------------------------------------------------------------------------
                 This industry caters to a select clientele who have chosen to
                engage in leisure activities in the unique settings offered by the
                industry, thus negating the likelihood for substitution. In addition,
                because these settings are localized, there is no risk of international
                competition.
                8. NAICS 488320--Marine Cargo Handling, 10.03 Percent 74
                ---------------------------------------------------------------------------
                 \74\ This industry comprises establishments primarily engaged in
                providing stevedoring and other marine cargo handling services
                (except warehousing).
                ---------------------------------------------------------------------------
                 The services this industry offers are integrated into a particular
                location and entail specific tasks, such as loading and unloading
                services at ports and harbors, longshoremen services, marine cargo
                handling services, ship hold cleaning services, and stevedoring
                services, that must be done to ensure the proper movement of cargo off
                of and onto ships, thus negating the potential for substitution. In
                addition, because these are services that need to be done in particular
                domestic locations (e.g., docks), there is no risk of international
                competition.
                 As with towing, the actual cost impacts on this industry are likely
                significantly overstated to the extent that some of the employees may
                be able to perform their work exclusively outdoors.
                The Fourteen NAICS Industries With Negative Profit Ratios
                1. Air Transportation 75
                ---------------------------------------------------------------------------
                 \75\ NAICS 481111 (Scheduled Passenger Air Transportation)
                provides air transportation of passengers or passengers and freight
                over regular routes and on regular schedules, including commuter and
                helicopter carriers (except scenic and sightseeing). NAICS 481112
                (Scheduled Freight Air Transportation) provides air transportation
                of cargo without transporting passengers over regular routes and on
                regular schedules, including scheduled air transportation of mail on
                a contract basis. NAICS 481211 (Nonscheduled Chartered Passenger Air
                Transportation) provides air transportation of passengers or
                passengers and cargo with no regular routes and regular schedules.
                NAICS 481212 (Nonscheduled Chartered Freight Air Transportation)
                provides air transportation of cargo without transporting passengers
                with no regular routes and regular schedules. NAICS 481219 (Other
                Nonscheduled Air Transportation) provides air transportation with no
                regular routes and regular schedules (except nonscheduled chartered
                passenger and/or cargo air transportation). These establishments
                provide a variety of specialty air transportation or flying services
                based on individual customer needs using general purpose aircraft.
                ---------------------------------------------------------------------------
                 NAICS 481111 (Scheduled Passenger Air Transportation), NAICS 481112
                (Scheduled Freight Air Transportation), NAICS 481211 (Nonscheduled
                Chartered Passenger Air Transportation), NAICS 481212 (Nonscheduled
                Chartered Freight Air Transportation), NAICS 481219 (Other Nonscheduled
                Air Transportation).
                 This group of NAICS industries is comprised of U.S. industries that
                primarily engage in providing air transportation. There is little to no
                risk of substitution for this group of NAICS industries. Air
                transportation provides unique and important benefits that cannot be
                substituted via other forms of transportation (e.g., rail, freight,
                bus). (See ATAG, September 2005). To this end, air transportation is
                often the speediest means of transporting passengers and cargo, giving
                it a unique purpose that cannot be met by other forms of transport. It
                should be noted that the five NAICS in this group of industries are the
                only NAICS in NAICS 4811 (Scheduled Air Transportation) and 4812
                (Nonscheduled Air Transportation). The other industries in NAICS 48
                (Transportation) do not provide air transportation (See NAICS
                Association, 2018b). This further reduces the risk of substitution, as
                all five NAICS at issue have a negative profit ratio and therefore face
                similar challenges that appear to be endemic to air transportation.
                Firms in this industry that have been able to weather the pandemic this
                long are typically highly capitalized or have access to loans, so it is
                highly likely that they could also weather the temporary marginal costs
                of OSHA's ETS.
                 There is also no risk of international competition with respect to
                this group of NAICS industries because any workers, whether they work
                for an international company or not, who are in the US, are subject to
                US laws, including the ETS, and foreign air carriers will need to
                follow the ETS for those workers. In addition, OSHA suspects that any
                smaller foreign air carriers will not have an incentive to expand their
                routes significantly or change their routes to domestic US routes to
                take advantage of the 100-employee cutoff in the ETS in the 6-months
                the ETS is assumed to be in effect.
                2. Telecommunications 76
                ---------------------------------------------------------------------------
                 \76\ NAICS 517311 (Wired Telecommunications Carriers) comprises
                establishments primarily engaged in operating and/or providing
                access to transmission facilities and infrastructure that they own
                and/or lease for the transmission of voice, data, text, sound, and
                video using wired telecommunications networks. Establishments in
                this industry use the wired telecommunications network facilities
                that they operate to provide a variety of services, such as wired
                telephony services, including VoIP services; wired (cable) audio and
                video programming distribution; wired broadband internet services;
                and, by exception, establishments providing satellite television
                distribution services using facilities and infrastructure that they
                operate are included in this industry. NAICS 517312 (Wireless
                Telecommunications Carriers (except Satellite)) comprises
                establishments primarily engaged in operating and maintaining
                switching and transmission facilities to provide communications via
                the airwaves. Establishments in this industry have spectrum licenses
                and provide services using that spectrum, such as cellular phone
                services, paging services, wireless internet access, and wireless
                video services. NAICS 517410 (Satellite Telecommunications)
                comprises establishments primarily engaged in providing
                telecommunications services to other establishments in the
                telecommunications and broadcasting industries by forwarding and
                receiving communications signals via a system of satellites or
                reselling satellite telecommunications. NAICS 517911
                (Telecommunications Resellers) comprises establishments engaged in
                purchasing access and network capacity from owners and operators of
                telecommunications networks and reselling wired and wireless
                telecommunications services (except satellite) to businesses and
                households. Establishments in this industry resell
                telecommunications; they do not operate transmission facilities and
                infrastructure. NAICS 517919 (All Other Telecommunications)
                comprises establishments primarily engaged in providing specialized
                telecommunications services, such as satellite tracking,
                communications telemetry, and radar station operation, and also
                includes establishments primarily engaged in providing satellite
                terminal stations and associated facilities connected with one or
                more terrestrial systems and capable of transmitting
                telecommunications to, and receiving telecommunications from,
                satellite systems, as well as establishments providing internet
                services or Voice over internet protocol (VoIP) services via client-
                supplied telecommunications connections.
                ---------------------------------------------------------------------------
                 NAICS 517311 (Wired Telecommunications Carriers), NAICS 517312
                (Wireless Telecommunications Carriers (except Satellite), NAICS 517410
                (Satellite Telecommunications), NAICS 517911 (Telecommunications
                Resellers), NAICS 517919 (All Other Telecommunications).
                 This group of NAICS industries is entirely comprised of U.S.
                industries, except for NAICS 517410 (Satellite Telecommunications). All
                of these industries provide specialized unique services in the
                telecommunications industry that require specialized unique knowledge
                and are thus resistant to substitution. While it is perhaps
                [[Page 61503]]
                possible that different forms of telecommunications might be
                substituted for one another (e.g., the substitution of wired
                telecommunications carriers for wireless telecommunications carriers),
                the reality is that these different forms exist separately and feed
                different markets and customer needs that are independent of the ETS.
                Moreover, the five NAICS in this group of industries are the only NAICS
                in NAICS 5173 (Wired and Wireless Telecommunications Carriers), NAICS
                5174 (Satellite Telecommunications), and NAICS 5179 (Other
                Telecommunications). The other industries in NAICS 51 (Information) are
                not engaged in telecommunications (NAICS Association, 2018c). This
                further reduces the risk of one industry substituting for the others,
                as all five NAICS at issue have a negative profit ratio and therefore
                face similar challenges that appear to be endemic to
                telecommunications.
                 Moreover, three of the five NAICS industries in this group (NAICS
                517311, 517312, 517410) operate or control the infrastructure needed
                for engaging in the particular type of telecommunications in which
                those industries engage. This not only fully negates the risk of
                substitution, but also negates the risk of international competition
                for these industries.
                 The other two industries in the group apparently do not operate or
                control the infrastructure needed for telecommunications. However, the
                telecommunications industry faces strict state and federal licensing
                requirements, which severely limit the risk of competition both
                internationally and from smaller firms seeking to take advantage of the
                ETS's 100-employee cutoff. (See FCC, 2014; FCC, October 12, 2021a; FCC,
                October 12, 2021b; Caltrans, October 12, 2021; and UTC, October 12,
                2021).
                3. Car and Equipment Rental 77
                ---------------------------------------------------------------------------
                 \77\ NAICS 532111 (Passenger Car Rental) comprises
                establishments primarily engaged in renting passenger cars without
                drivers, generally for short periods of time. NAICS 532112
                (Passenger Car Leasing) comprises establishments primarily engaged
                in leasing passenger cars without drivers, generally for long
                periods of time. NAICS 532120 (Truck, Utility Trailer, and RV
                (Recreational Vehicle) Rental and Leasing comprises establishments
                primarily engaged in renting or leasing, without drivers, one or
                more of the following: Trucks, truck tractors, buses, semi-trailers,
                utility trailers, or RVs (recreational vehicles). NAICS 532310
                (General Rental Centers) comprises establishments primarily engaged
                in renting a range of consumer, commercial, and industrial
                equipment. Establishments in this industry typically operate from
                conveniently located facilities where they maintain inventories of
                goods and equipment that they rent for short periods of time. The
                type of equipment that establishments in this industry provide often
                includes, but is not limited to: Audio visual equipment,
                contractors' and builders' tools and equipment, home repair tools,
                lawn and garden equipment, moving equipment and supplies, and party
                and banquet equipment and supplies.
                ---------------------------------------------------------------------------
                 NAICS 532111 (Passenger Car Rental), NAICS 532112 (Passenger Car
                Leasing), NAICS 532120 (Truck, Utility Trailer), and RV (Recreational
                Vehicle) Rental and Leasing) NAICS 532310 (General Rental Centers).
                 This group of industries rent motor vehicles (NAICS 532111, 532112,
                532120) or equipment (NAICS 532310), for example, audio visual
                equipment, contractors' and builders' tools and equipment, home repair
                tools, lawn and garden equipment, moving equipment and supplies, and
                party and banquet equipment and supplies, to individuals and
                businesses, for personal and professional use. There is no risk of
                substitution with respect to these industries, as these industries rent
                specific items to those who want to use them. There is also no risk of
                foreign competition with respect to these industries, as consumers and
                businesses rent and pick up vehicles, as well as the type of equipment
                offered for rent by NAICS 532310, from specific locations, including
                car rental and other rental centers.
                 These industries have not been hard hit by the pandemic, as many
                consumers have turned from group travel to individual transportation.
                For example, RV rentals and leasing has soared during the pandemic,
                which is not reflected in the pre-pandemic profit and revenue data
                available for this analysis.\78\
                ---------------------------------------------------------------------------
                 \78\ See Park, January 23, 2021.
                ---------------------------------------------------------------------------
                References
                Air Transport Action Group (ATAG). (2005, September). The economic &
                social benefits of air transport. https://www.icao.int/meetings/wrdss2011/documents/jointworkshop2005/atag_socialbenefitsairtransport.pdf. (ATAG, September 2005)
                Beale HBR. (2003). Financial Data Sources. Microeconomic
                Applications Inc. (Beale Report, 2003)
                Brown J. (2017, January 19). Bring More Diversity to Skiing. https://www.powder.com/stories/opinion/extend-the-family/. (Brown, January
                19, 2017)
                Caltrans. (2021, October 12). Wireless Licensing Program, California
                Department of Transportation. https://dot.ca.gov/programs/right-of-way/wireless-licensing-program. (Caltrans, October 12, 2021)
                Federal Communications Commission (FCC). (2021, October 12a)
                Licensing. https://www.fcc.gov/licensing-databases/licensing. (FCC,
                October 12, 2021a)
                Federal Communications Commission (FCC). (2021, October 12b)
                Satellite. https://www.fcc.gov/general/satellite. (FCC, October 12,
                2021b)
                Groenewold M et al., (2020, July 10). Increases in Health-Related
                Workplace Absenteeism Among Workers in Essential Critical
                Infrastructure Occupations During the COVID-19 Pandemic--United
                States, March-April 2020. Centers for Disease Control and Prevention
                MMWR Vol. 69, No. 27. (Groenewold et al., July 10, 2020)
                Internal Revenue Service (IRS). (2013). 2013 Corporation Source
                Book. https://www.irs.gov/statistics/soi-tax-stats-corporation-source-book-us-total-and-sectors-listing. (IRS, 2013)
                Jackson S. (2021, August 2). Gyms like Equinox and SoulCycle will
                soon require members to show proof of vaccination to use their clubs
                and studios. https://www.businessinsider.com/equinox-soulcycle-will-require-covid-19-vaccines-for-members-staff-2021-8. (Jackson, August
                2, 2021)
                NAICS Association. (2018a). NAICS Codes Description, 2018: 221118--
                Other Electric Power Generation. https://www.naics.com/naics-code-description/?code=221118. Last accessed October 12, 2021. (NAICS
                Association, 2018a)
                NAICS Association. (2018b). Six Digit NAICS Codes and Titles, 2018:
                Codes 48-49. https://www.naics.com/six-digit-naics/?code=48-49. Last
                accessed October 12, 2021. (NAICS Association, 2018b)
                NAICS Association. (2018c). Six Digit NAICS Codes and Titles, 2018:
                Code 51. https://www.naics.com/six-digit-naics/?code=51. Last
                accessed October 12, 2021. (NAICS Association, 2018c)
                NAICS Association. (2018d). NAICS Profile Page, 2018: Berkshire
                Hathaway Energy Co. https://www.naics.com/company-profile-page/?co=4973. Last accessed October 12, 2021. (NAICS Association, 2018d)
                NAICS Association. (2018e). NAICS Profile Page, 2018: Dominion
                Energy Inc. https://www.naics.com/company-profile-page/?co=11715.
                Last accessed October 12, 2021. (NAICS Association, 2018e)
                Occupational Safety and Health Administration (OSHA). (2016, March
                24). Final Economic and Regulatory Flexibility Analysis for OSHA's
                Rule on Occupational Exposure to Respirable Crystalline Silica,
                Chapter VI, pp. VI-20. Docket No. OSHA-2010-0034-4247. (OSHA, March
                24, 2016)
                Occupational Safety and Health Administration (OSHA). (2021a,
                October). Analytical Spreadsheets in Support of the COVID-19
                Vaccination and Testing ETS. (OSHA, October 2021a)
                Park S. (2021, January 23). RV sales soar during coronavirus
                pandemic. https://www.foxbusiness.com/lifestyle/rv-sales-soar-during-pandemic-travel-road-trip. (Park, January 23, 2021)
                U.S. Census Bureau. (2021, October 8a). Scientific Integrity.
                https://www.census.gov/about/policies/quality/
                [[Page 61504]]
                scientific_integrity.html. (US Census Bureau, October 8, 2021a)
                U.S. Census Bureau. (2021, October 8b). Statement of Commitment to
                Scientific Integrity by Principal Statistical Agencies. https://www.census.gov/content/dam/Census/about/about-the-bureau/policies_and_notices/scientificintegrity/Scientific_Integrity_Statement_of_the_Principal_Statistical_Agencies.pdf. (US Census Bureau, October 8, 2021b)
                Walker C. (2013, January 22). Is Tidal Power a Viable Source of
                Energy? https://www.azocleantech.com/article.aspx?ArticleID=350.
                (Walker, January 22, 2013)
                Washington Utilities and Transportation Commission (UTC). (2021,
                October 12). Eligible Telecommunications Carriers. https://www.utc.wa.gov/regulated-industries/utilities/telecommunications/federal-universal-service-funds/eligible-telecommunications-carriers. (UTC, October 12, 2021)
                V. Additional Requirements
                A. Regulatory Flexibility Act
                 Whenever an agency is required by the Administrative Procedure Act,
                5 U.S.C. 553, or another law, to publish a general notice of proposed
                rulemaking, the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
                requires the agency to prepare an initial regulatory flexibility
                analysis (IRFA). 5 U.S.C. 601(2), 603(a). Since this ETS ``shall serve
                as a proposed rule'' for a final standard under section 6(c)(3) of the
                OSH Act, it is treated as a general notice of proposed rulemaking under
                the RFA. An agency may waive or defer the IRFA in the event a rule is
                promulgated in response to an emergency that makes compliance with the
                requirements of section 603 impracticable. 5 U.S.C. 608(a). The agency
                hereby certifies that compliance with the IRFA requirement is
                impracticable under the circumstances. OSHA prepared this ETS on an
                expedited basis in response to a national emergency affecting the lives
                and health of the nation's workers; the IRFA is inherently a relatively
                lengthy process that would be impracticable to undertake for a standard
                of such broad applicability in the limited time available. Because OSHA
                is not preparing an IRFA for the ETS, the agency is also not required
                to convene a small entity panel under section 609(b).
                B. Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1501 et seq.
                 Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
                U.S.C. 1532, requires agencies to assess the anticipated costs and
                benefits of a rule before issuing ``any general notice of proposed
                rulemaking'' that includes a Federal mandate that may result in
                expenditures in any one year by state, local, or Tribal governments, or
                by the private sector, of at least $100 million, adjusted annually for
                inflation. The assessment requirement also applies to ``any final rule
                for which a general notice of proposed rulemaking was published.''
                Although no general notice of proposed rulemaking was published, the
                agency has analyzed the ETS's economic feasibility and health impacts
                in Section IV.B. of this preamble (Economic Analysis) and Health
                Impacts Appendix (OSHA, October 2021c).
                C. Executive Order 13175
                 Section 5 of E.O. 13175, on Consultation and Coordination with
                Indian Tribal Governments, requires agencies to consult with tribal
                officials early in the process of developing regulations that: (1) Have
                tribal implications, that impose substantial direct compliance costs on
                Indian governments, and that are not required by statute; or (2) have
                tribal implications and preempt tribal law. 65 FR 67249, 67250 (Nov. 6,
                2000). E.O. 13175 requires that such consultation occur to the extent
                practicable. Given the expedited nature of issuing the ETS, it was not
                practicable for OSHA to consult and incorporate non-federal input prior
                to promulgation of the standard. OSHA commits to meaningful
                consultation with tribal representatives after publication of the ETS
                and during the comment period before finalizing any permanent standard.
                Such consultation will be consistent with the Administrative Procedure
                Act.
                D. National Environmental Policy Act
                 OSHA has reviewed this ETS according to the National Environmental
                Policy Act (NEPA) of 1969, 42 U.S.C. 4321 et seq., the regulations of
                the Council on Environmental Quality, 40 CFR chapter V, subchapter A,
                and the Department of Labor's NEPA procedures, 29 CFR part 11. As a
                result of this review, the agency has determined that the rule will
                have no significant impact on air, water, or soil quality; plant or
                animal life; the use of land; or other aspects of the external
                environment. Although the ETS contains testing requirements, and test
                kits and supplies can generate some additional materials that will
                enter the waste stream, the impact of this ETS will be minimal. As
                discussed in more detail in Technological Feasibility (Section IV.A. of
                this preamble), there is already a surplus of available tests, and
                projected production of COVID-19 tests will be more than sufficient to
                meet demands for testing created as a result of the rule. Therefore,
                tests used for purposes of or for compliance with this ETS are not
                being produced as a result of this standard, and the standard will not
                generate significant new streams of waste beyond what would be
                generated in the absence of the standard.
                E. Congressional Review Act
                 This ETS is considered a major rule under the Congressional Review
                Act (CRA), 5 U.S.C. 801 et seq. Section 801(a)(3) of the CRA normally
                requires a 60-day delay in the effective date of a major rule. 5 U.S.C.
                801(a)(3), 804(2). However, section 808(2) of the CRA allows the
                issuing agency to make a rule effective sooner than otherwise provided
                by the CRA if the agency makes a good cause finding that notice and
                public procedure are impracticable, unnecessary, or contrary to the
                public interest. 5 U.S.C. 808(2). OSHA finds that there is good cause
                to make this rule effective upon publication because notice and public
                procedure with respect to this ETS are both impracticable and contrary
                to the public interest, given the expedited timeline on which this
                standard was developed and the grave danger threatening workers' lives
                and health (see Grave Danger and Need for the ETS, both in Section III.
                of this preamble). Congress authorized OSHA to take swift action in
                promulgating an ETS to address this type of grave danger, and provided
                explicitly that an ETS is effective upon publication, 29 U.S.C.
                655(c)(1); delaying the effective date of such an expedited process
                would thwart that purpose. It is specifically because of the emergency
                nature of this rulemaking that the OSH Act allows for OSHA to proceed
                without the extensive public input the agency normally solicits in
                issuing occupational safety and health standards. 29 U.S.C. 655(c)(1).
                For rules to which section 808(2) applies, the agency may set the
                effective date. In this case, consistent with the OSH Act requirement
                cited above, the ETS takes immediate effect upon publication in the
                Federal Register.
                F. Administrative Procedure Act
                 The Administrative Procedure Act (APA) normally requires notice and
                comment, and a 30-day delay of the effective date of a final rule, for
                recordkeeping and reporting regulations promulgated under section 8(c)
                of the OSH Act. 29 U.S.C. 657(c); 5 U.S.C. 553(b), (d). This ETS
                contains recordkeeping and reporting requirements tailored to address
                COVID-19 illness. To the extent that these requirements are not already
                [[Page 61505]]
                exempt from the APA's requirements for notice and comment under section
                6(c) of the Act (29 U.S.C. 655(c)), OSHA invokes the ``good cause''
                exemption to the APA's notice requirement because the agency finds that
                notice and public procedure are impracticable and contrary to the
                public interest under 5 U.S.C. 553(b)(B). As explained in more detail
                in Grave Danger and Need for the ETS (both in Section III. of this
                preamble), this finding is based on the critical importance of
                implementing the requirements in this ETS, including the recordkeeping
                and reporting provisions, as soon as possible to address the grave
                danger that COVID-19 presents to workers.
                 As noted above, the ETS is required by the OSH Act to take
                immediate effect upon publication. 29 U.S.C. 655(c)(1). For that
                reason, and the underlying public health emergency that prompted this
                ETS as discussed above, OSHA finds good cause to waive the normal 30-
                day delay in the effective date of a final rule from the date of its
                publication in the Federal Register. See 5 U.S.C. 553(d)(3). OSHA
                notes, however, that OSHA does not require compliance with any
                provision of the ETS within the first 30 days after it becomes
                effective.
                G. Consensus Standards
                 OSHA must consider adopting an existing national consensus standard
                that differs substantially from OSHA's standard if the consensus
                standard would better effectuate the purposes of the Act. See section
                12(d)(1) of the National Technology Transfer and Advancement Act of
                1995 (15 U.S.C.A. 272 Note); see also 29 U.S.C. 655(b)(8).
                 OSHA considered incorporation of ASTM F3502-21 in this ETS, as
                required. However, the agency has insufficient evidence to make a
                general finding of feasibility at this time. The agency notes that face
                coverings that meet ASTM F3502-21 criteria also meet the definition of
                ``face coverings'' in this ETS (see the discussion of this issue in
                Summary and Explanation, Section VI. of this preamble). The agency has
                asked questions about this topic to gather additional information.
                H. Executive Order 13045
                 Executive Order 13045, on Protection of Children from Environmental
                Health Risks and Safety Risks, requires that Federal agencies
                submitting covered regulatory actions to OIRA for review pursuant to
                Executive Order 12866 must provide OIRA with (1) an evaluation of the
                environmental health or safety effects that the planned regulation may
                have on children, and (2) an explanation of why the planned regulation
                is preferable to other potentially effective and reasonably feasible
                alternatives considered by the agency (62 FR 19885 (April 23, 1997)).
                Executive Order 13045 defines ``covered regulatory actions'' as rules
                that may (1) be economically significant under Executive Order 12866,
                and (2) concern an environmental health risk or safety risk that an
                agency has reason to believe may disproportionately affect children.
                Because OSHA has no reason to believe that the risk from COVID-19
                disproportionately affects children, the ETS is not a covered
                regulatory action and OSHA is not required to provide OIRA with further
                analysis under section 5 of the executive order. However, to the extent
                children are exposed to COVID-19 either as employees or at home as a
                result of family members' workplace exposures to COVID-19, the ETS
                should provide some protection for children.
                I. Federalism
                 The agency reviewed this ETS according to Executive Order 13132, on
                Federalism, which requires that Federal agencies, to the extent
                possible, refrain from limiting State policy options, consult with
                States before taking actions that would restrict States' policy
                options, and take such actions only when clear constitutional authority
                exists and the problem is of national scope. 64 FR 43255 (August 10,
                1999). The Executive Order generally allows Federal agencies to preempt
                State law only as provided by Congress or where State law conflicts
                with Federal law. In such cases, Federal agencies must limit preemption
                of State law to the extent possible.
                 The Occupational Safety and Health Act is an exercise of Congress's
                Commerce Clause authority, and under Section 18 of the Act, 29 U.S.C.
                667, Congress expressly provided that States may adopt, with Federal
                approval, a plan for the development and enforcement of occupational
                safety and health standards. OSHA refers to States that obtain Federal
                approval for such plans as ``State Plans.'' Occupational safety and
                health standards developed by State Plans must be at least as effective
                in providing safe and healthful employment and places of employment as
                the Federal standards. As discussed below, State Plans must submit to
                Federal OSHA for approval, standards that differ from Federal standards
                addressing the same issues, in order for such standards to become part
                of the OSHA-approved State Plan. Subject to these requirements, State
                Plans are free to develop and enforce their own occupational safety and
                health standards.
                 This ETS complies with E.O. 13132. The problems addressed by this
                ETS for COVID-19 are national in scope. As explained in Grave Danger
                (Section III.A. of this preamble), employees face a grave danger from
                exposure to COVID-19 in the workplace. Employees across the country
                face the danger of exposure to COVID-19 at work, and as explained in
                Need for the ETS (Section III.B. of this preamble), a national standard
                is needed to protect workers from the grave danger of COVID-19 by
                strongly encouraging vaccination and limiting the presence of COVID-19
                positive workers in the workplace through testing and to ensure that a
                clear and consistent baseline approach is taken across the country to
                protect them. The SARS-CoV-2 virus is highly communicable and infects
                workers without regard to state borders, making a national approach
                necessary. Accordingly, the ETS establishes minimum requirements for
                employers in every State to protect employees from the risks of
                exposure to COVID-19.
                 In States without OSHA-approved State Plans, Congress provides for
                OSHA standards to preempt State occupational safety and health
                standards for issues addressed by the Federal standards. In these
                States, this ETS limits State policy options in the same manner as
                every standard promulgated by the agency. Furthermore, as discussed in
                the Summary and Explanation for Purpose, nothing in the ETS is intended
                to limit generally applicable public health measures instituted by
                state or local governments that go beyond, and are not inconsistent
                with, the requirements of the ETS. (See Summary and Explanation for
                Purpose, Section VI.A. of this preamble); Gade v. National Solid Wastes
                Management Ass'n, 505 U.S. 88, 107 (1992). In States with OSHA-approved
                State Plans, this ETS does not significantly limit State policy
                options. Any special workplace problems or conditions in a State with
                an OSHA-approved State Plan may be dealt with by that State's standard,
                provided the standard is at least as effective as this ETS.
                 As discussed in the Summary and Explanation for Purpose in this
                preamble, OSHA has included a provision that states the purpose of this
                ETS, as well as OSHA's intent to preempt all inconsistent State and
                local requirements that relate to the issues addressed by this ETS.
                (See section 1910.501(a); Summary and Explanation for Purpose, Section
                VI.A. of this preamble). This includes State and local
                [[Page 61506]]
                requirements banning or limiting the authority of employers to require
                vaccination, face covering, or testing. As discussed in that section,
                such State and local bans would be preempted by this ETS, even in
                States with OSHA-approved State Plans, because such bans are not
                approved by federal OSHA as part of the State Plan and could not be
                approved, because such bans are clearly not as effective--and, indeed,
                are contrary to--the federal ETS. See Indust. Truck Ass'n v. Henry, 125
                F.3d 1305, 1311 (9th Cir. 1997).
                J. State Plans
                 When Federal OSHA promulgates an emergency temporary standard,
                States and U.S. Territories with their own OSHA-approved occupational
                safety and health plans (``State Plans'') must either amend their
                standards to be identical or ``at least as effective as'' the new
                standard, or show that an existing State Plan standard covering this
                area is ``at least as effective'' as the new Federal standard. 29 CFR
                1953.5(b). This ETS imposes new requirements to protect workers across
                the nation from COVID-19. Adoption of this ETS, or an ETS that is at
                least as effective as this ETS, by State Plans must be completed within
                30 days of the promulgation date of the final Federal rule, and State
                Plans must notify Federal OSHA of the action they will take within 15
                days. The State Plan standard must remain in effect for the duration of
                the Federal ETS. As noted above in Federalism (Section V.I. of this
                preamble), this ETS preempts all State and local requirements,
                including in States with State Plans, that ban or limit the authority
                of employers to require vaccination, face covering, or testing. (See
                also the Summary and Explanation for Purpose, Section VI.A. of this
                preamble). As with all non-identical State Plan standards, OSHA will
                review any comparable State standards to determine whether they are at
                least as effective as this ETS. A State Plan standard that prohibits
                employers from requiring vaccination would not be at least as effective
                as this ETS because OSHA has recognized in this ETS that vaccination is
                the most protective policy choice for employers to adopt to protect
                their workplaces.
                 Of the 28 States and Territories with OSHA-approved State Plans, 22
                cover both public and private-sector employees: Alaska, Arizona,
                California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan,
                Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico,
                South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and
                Wyoming. The remaining six States and Territories cover only state and
                local government employees: Connecticut, Illinois, Maine, New Jersey,
                New York, and the Virgin Islands.
                K. Paperwork Reduction Act
                I. Overview
                 The Emergency Temporary Standard (ETS) for COVID-19 Vaccination and
                Testing contains collection of information requirements that are
                subject to review by the Office of Management and Budget (OMB) under
                the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501, et seq., and
                OMB's regulations at 5 CFR part 1320. The PRA defines a collection of
                information to mean the obtaining, causing to be obtained, soliciting,
                or requiring the disclosure to third parties or the public, of facts or
                opinions by or for an agency, regardless of form or format (44 U.S.C.
                3502(3)(A)). OSHA has determined an ETS is necessary to protect workers
                from the grave danger posed by COVID-19 and is issuing an ETS that
                amends 29 CFR 1910 subpart U to provide COVID-19 protections to workers
                of employers with 100 or more employees. Section 1910.501 contains
                collections of information necessary to effectuate the purpose of the
                ETS. The collections of information appear in paragraphs 1910.501(d),
                (e)(2), (e)(4), (f)(1), (g)(1), (g)(4), (h)(1), (j), (k)(1), (k)(2),
                (l)(1), and (l)(2). For a more comprehensive discussion of these
                provisions, see the sectional analysis earlier in this preamble. These
                information collections are applied by cross reference to other
                industries in regulations 29 CFR 1915.1501 (Shipyard Employment),
                1917.31 (Marine Terminals), 1918.110 (Longshoring), 1926.58
                (Construction), 1928.21 (Agriculture).\79\
                ---------------------------------------------------------------------------
                 \79\ The ETS applies to agricultural establishments with 11 or
                more employees engaged on any day in hand-labor occupations in the
                field and agricultural establishments that maintain a temporary
                labor camp, regardless of how many employees are engaged on any day
                in hand-labor occupations in the field).
                ---------------------------------------------------------------------------
                 Under the PRA, a Federal agency cannot conduct or sponsor a
                collection of information unless OMB approves it and the agency
                displays a currently valid OMB control number (44 U.S.C. 3507).
                Notwithstanding any other provision of law, if a collection of
                information does not display a currently valid control number, an
                employer shall not be subject to penalty for failing to comply with the
                collection of information (44 U.S.C. 3512). The PRA has special
                provisions for emergency situations that are applicable to this ETS.
                OMB may authorize a collection of information without regard to the
                normal clearance procedures if either (a) the relevant agency
                determines that the collection of information is essential to the
                mission of the agency and public harm is reasonably likely to result if
                normal clearance procedures are followed, or (b) the use of normal
                clearance procedures is reasonably likely to cause a statutory or court
                ordered deadline to be missed (44 U.S.C. 3507(j) and 5 CFR 1320.13).
                Because COVID-19 presents an ongoing public health threat to workers
                and American businesses, OSHA has requested the use of these emergency
                procedures for this ETS. In accordance with 44 U.S.C. 3507(j)(1), OMB
                approved the request and assigned this ETS an OMB control number that
                is valid for 180 days. Therefore, the information collection provisions
                contained within this ETS will take effect at the same time as all
                other provisions.
                II. Summary of Information Collection Requirements
                 This information collection is summarized as follows.
                 1. Title: COVID-19 Vaccination and Testing Emergency Temporary
                Standard (29 CFR 1910, subpart U; 1915, subpart Z; 1917, subpart B;
                1918, subpart K; 1926, subpart D; 1928, subpart B).
                 2. Type of Review: Emergency.
                 3. OMB Control Number: 1218-0278.
                 4. Affected Public: This rule applies to employers with a total of
                100 or more employees except where the workplace is covered under the
                Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance
                for Federal Contractors and Subcontractors; or in setting where the
                employee provides healthcare services or healthcare support services
                that falls under the requirements of 29 CFR 1910.502. This rule does
                not apply to employees of covered employers who work from home,
                exclusively outdoors, or who do not report to a workplace where other
                individuals such as coworkers or customers are present.
                 5. Description of the ICR. This ICR contains collections of
                information requirements for employers with 100 or more employees. The
                employer must establish, implement, and enforce a written mandatory
                vaccination policy that requires each employee to be fully vaccinated
                against COVID-19 unless the employer implements a policy that allows
                employees to choose between being fully vaccinated or both tested and
                wearing a face covering. Employers must determine employee vaccination
                status, and must require than any employees who are not vaccinated be
                tested for COVID-19 at least once every
                [[Page 61507]]
                7 days. Employers must provide specified information to employees
                regarding COVID-19 vaccine efficacy, safety, and the benefits of being
                vaccinated, and must maintain a record of the COVID-19 vaccination
                status, proof of vaccination, and copies of employee COVID-19 test
                results, and the aggregate number of fully vaccinated employees at a
                workplace along with the total number of employees at that workplace.
                 6. Number of respondents: 1,858,935.
                 7. Frequency: Varies.
                 8. Number of Responses: 205,262,803.
                 9. Estimated Burden Hours: 79,720,444.
                 10. Estimated Cost (Capital-operation and maintenance):
                $1,383,751,520.
                 These totals are explained and supported in the agency's Supporting
                Statement as required by the PRA.
                III. Request for Comment
                 Although the ETS takes effect immediately, with implementation
                dates specified in the Dates provision of this publication, it also
                serves as a temporary standard that can only be made permanent
                following an opportunity for public notice and comment. OSHA therefore
                invites the public to submit comments to OSHA on the proposed
                collections of information with regard to the following.
                 Whether the proposed collections of information are
                necessary for the proper performance of the Agency's functions,
                including whether the information is useful.
                 The accuracy of OSHA's estimate of the burden (time and
                cost) of the collections of information, including the validity of the
                methodology and assumptions used.
                 The quality, utility, and clarity of the information
                collected.
                 Ways to minimize the compliance burden on employers, for
                example, by using automated or other technological techniques for
                collecting and transmitting information.
                 Please submit comments related to the Paperwork Act analysis to
                OSHA in the PRA docket (Docket Number OSHA-2021-0008). Comments related
                to other parts of the ETS should be submitted to the rulemaking docket
                (Docket Number OSHA-2021-0007). OSHA will accept comments for 60 days
                on the information collection aspects of the rule. For instructions on
                submitting these comments to the rulemaking and/or PRA docket, see the
                sections of this Federal Register notice titled DATES and ADDRESSES.
                References
                Occupational Safety and Health Administration (OSHA). (2021c,
                October). Health Impacts of the COVID-19 Vaccination and Testing
                ETS. (OSHA, October 2021c)
                VI. Summary and Explanation
                A. Purpose
                 The ETS includes a sentence that states the purpose of the rule.
                The first part of the sentence in the paragraph indicates that the
                standard addresses the grave danger of COVID-19 in the workplace by
                establishing workplace vaccination, vaccination verification, face
                covering and testing requirements.
                 The second part of the sentence addresses the preemption of State
                and local laws, regulations, executive orders, and other requirements,
                by this Federal standard. It indicates OSHA's intention that the ETS
                address comprehensively the occupational safety and health issues of
                vaccination, wearing face coverings, and testing for COVID-19, and thus
                that the standard is intended to preempt States, and political
                subdivisions of States, from adopting and enforcing workplace
                requirements relating to these issues, except under the authority of a
                Federally-approved State Plan. In particular, OSHA intends to preempt
                any State or local requirements that ban or limit an employer's
                authority to require vaccination, face covering, or testing.
                 Preemption of such State and local requirements derives from
                section 18 of OSH Act and general principles of conflict preemption.
                See Gade v. National Solid Wastes Management Ass'n, 505 U.S. 88
                (1992).\80\ Gade clarified two important principles. First, section 18
                expresses Congress' intent to preempt State workplace safety or health
                laws relating to issues on which Federal OSHA has promulgated
                occupational safety and health standards. Under section 18, a State can
                avoid preemption of such laws only if it submits and receives Federal
                approval for a State Plan for the development and enforcement of
                standards. OSHA-approved State Plans operate under authority of State
                law and must adopt occupational safety and health standards which,
                among other things, must be at least as effective in providing safe and
                healthful employment and places of employment as Federal standards. 29
                U.S.C. 667.
                ---------------------------------------------------------------------------
                 \80\ The Court held that the dual impact licensing statutes were
                preempted; however, no rationale commanded a majority. A four-
                justice plurality found that supplementary State regulation is
                impliedly preempted. Id. at 98-99. Justice Kennedy's concurrence
                would have found express preemption rather than implied preemption,
                Id. at 110-111, but otherwise agreed that ``in the OSH statute
                Congress intended to pre-empt supplementary state regulation.'' Id.
                at 113.
                ---------------------------------------------------------------------------
                 Second, State and local laws that do not constitute occupational
                safety or health laws because they are ``laws of general
                applicability'' that regulate workers and nonworkers alike are
                preempted only if they conflict with the federal standard. Laws of
                general applicability that are consistent with the federal standard are
                not preempted. Gade, 505 U.S. at 107.
                 While section 18 applies to every occupational safety and health
                standard that OSHA promulgates, this ETS raises particular concerns
                because of the current landscape of existing State and local
                requirements that may overlap with, or directly conflict with, the
                requirements of this ETS. As discussed in Need for the ETS (Section
                III.B. of this preamble), OSHA is adopting this ETS in response to an
                unprecedented health crisis that has resulted in a global pandemic
                severely impacting the health and wellbeing of people in the United
                States, and globally. This ETS is issued based on OSHA's determination
                that employees in the United States face a grave danger from workplace
                exposures to SARS-CoV-2, that the ETS is necessary to protect those
                workers, and that the measures for vaccination, vaccine verification,
                face coverings, and testing that this ETS requires will help ensure
                that workers covered by the ETS are protected from severe illness and
                death resulting from contracting COVID-19 in the workplace.
                 As explained in Need for the ETS (Section III.B. of this preamble),
                the lack of a national standard on this hazard has led to disparate
                State and local requirements, and this underscores the need for OSHA's
                ETS to provide clear and consistent protection to employees across the
                country. Over the past months, an increasing number of States have
                passed laws or enacted other requirements banning workplace vaccination
                policies that would mandate vaccination or require proof of vaccination
                status, thus prohibiting employers operating in those jurisdictions
                from implementing this proven method of protecting workers from the
                hazard of COVID-19 that is at the core of this ETS (see, e.g., Texas
                Executive Order GA-40, October 11, 2021; Montana H.B. 702, July 1,
                2021; Arkansas S.B. 739, October 4, 2021 and Arkansas H.B. 1977,
                October 1, 2021; AZ Executive Order 2021-18, Aug. 16, 2021). While some
                States' bans have focused on preventing local governments from
                requiring their public employees to be vaccinated or show proof of
                vaccination, the Texas, Montana, and Arkansas requirements apply to
                private employers as well. Likewise, some States and localities
                [[Page 61508]]
                have enacted requirements that prohibit businesses, government offices,
                schools or other public spaces from requiring that face coverings be
                worn (see, e.g., Florida Executive Order 21-102, May 3, 2021; Texas
                Executive Order GA-34, March 2, 2021; Texas Executive Order GA-36, May
                18, 2021). State and local requirements that prohibit employers from
                implementing employee vaccination mandates, or from requiring face
                coverings in workplaces, serve as a barrier to OSHA's implementation of
                this ETS, and to the protection of America's workforce from this deadly
                virus.
                 As discussed below, state restrictions of this kind are clearly
                preempted whether they take the form of direct workplace regulation or
                are part of a law of general applicability because they relate to the
                issues addressed by this standard and conflict with it. Gade, 505 U.S.
                at 99, 107. As is also discussed below, this is true even for State or
                local requirements that may not prevent employers from compliance with
                the ETS, but that prescribe or limit the employer's ability to mandate
                vaccination for its workforce as the employer's chosen means of
                compliance. See Gade, 505 at 107; see also Geier v. American Honda, 529
                U.S. 861, 869, 875-886 (2000) (finding Department of Transportation
                (DOT) regulations preempted a State tort action where the state action
                ``upset the careful regulatory scheme established by federal law'' and
                placing weight on DOT's interpretation that such tort suit would be
                ``an obstacle to the accomplishment and execution'' of Agency
                objectives). An employer's choice to mandate vaccination is a critical
                aspect of this ETS, and state laws that remove that choice conflict
                with it.
                 Thus, to ensure that the ETS supplants the existing State and local
                vaccination bans and other requirements that could undercut its
                effectiveness, and to foreclose the possibility of future bans, OSHA
                has clearly defined the issues addressed by this section to encompass
                vaccination, face covering, and testing needed to protect against
                transmission of COVID-19 to employees in the workplace. To avoid
                ambiguity, OSHA has stated expressly that it intends this ETS to
                preempt all State and local workplace requirements that ``relate'' to
                these issues, except pursuant to a State Plan. 29 U.S.C. 667(b).
                 The ``unavoidable implication'' of section 18 is that because OSHA
                has adopted this ETS, States may no longer regulate these issues except
                with OSHA's approval and the authority of a Federally-approved State
                Plan. Gade, 505 U.S. at 99. As the Court explained, section 18 preempts
                States without approved plans from adopting or enforcing any laws that
                constitute, ``in a direct, clear and substantial way regulation of
                worker health and safety'' relating to an issue addressed by an OSHA
                standard. Id. at 107.
                 State and local requirements that ban or otherwise limit workplace
                vaccination, face covering, or testing clearly ``relate'' to the
                occupational safety and health ``issues'' that OSHA is regulating in
                this ETS. 29 U.S.C. 667(b). Such bans regulate key workplace COVID-19
                protections that are encompassed by this ETS ``in a direct, clear and
                substantial way.'' Gade, 505 U.S. at 107. The direct effect of such
                bans is to prohibit employers from requiring employees to implement
                measures, such as vaccination requirements, face coverings, or testing.
                These workplace protective measures are covered by, and, in many
                circumstances required by, this ETS. For example, vaccination mandate
                bans directed at employers specifically bar them from requiring
                employee vaccination requirements for the purposes of protecting their
                workforce. Prohibitions on face covering mandates likewise directly
                prohibit individuals in positions of authority, including employers,
                from requiring face covering use.
                 Although the expressly stated purposes for State and local
                requirements banning or limiting employers from requiring vaccinations,
                face coverings, or testing may not be occupational safety and
                health,\81\ this does not control their preemption under section 18 of
                the OSH Act. In assessing State and local requirements' impact on a
                federal statutory scheme, courts ``have refused to rely solely on the
                legislature's professed purpose and have looked as well to the effects
                of the law.'' Gade, 505 U.S. at 105; see also, e.g., Perez v. Campbell,
                402 U. S. 637, 651-652 (1971) (``[A]ny state legislation which
                frustrates the full effectiveness of federal law is rendered invalid by
                the Supremacy Clause''); Napier v. Atlantic Coast Line R. Co., 272 U.S.
                605, 612 (1926) (pre-emption analysis does not depend on whether
                federal and State laws ``are aimed at distinct and different evils''
                but whether they ``operate upon the same object'').
                ---------------------------------------------------------------------------
                 \81\ The express purposes of such requirements banning or
                limiting employers from requiring vaccination, face coverings, or
                testing may often not relate to occupational safety and health. For
                example, Governor Greg Abbott's Texas face covering mandate ban in
                Executive Order GA-16, is based on alleged decreasing COVID-19 rates
                and the need to alleviate ``confusion,'' (Texas Executive Order GA-
                36, May 18, 2021); the stated purpose of Montana's vaccination
                mandate ban is to address health care privacy interests (Montana
                H.B. 702, July 1, 2021).
                ---------------------------------------------------------------------------
                 That a State has articulated a purpose other than, or in addition
                to, workplace health and safety would not divest the OSH Act of its
                preemptive force, because preemption law looks to the effects as well
                as the purpose of a State law, and thus a dual-impact State law cannot
                avoid OSH Act preemption simply because the regulation serves several
                objectives. Gade, 505 U.S. at 107 (holding ``a law directed at
                workplace safety is not saved from pre-emption simply because the State
                can demonstrate some additional effect outside of the workplace'' and
                ``[t]hat such law may also have a nonoccupational impact does not
                render it any less of an occupational standard for purposes of pre-
                emption analysis''). Thus, to the extent that the stated purpose of a
                requirement that bans or limits employers from requiring vaccinations,
                face coverings, or testing is something other than, or in addition to,
                occupational health, such laws, which have a specific and direct impact
                on worker health, are nevertheless preempted.
                 Further, section 18 preempts even ``nonconflicting'' State and
                local occupational safety and health requirements relating to the
                issues addressed by this standard. Gade, 505 U.S. at 98-99, 103; see
                id. at 100 (``state laws regulating the same issue as federal laws are
                not saved, even if they merely supplement the federal standard''). This
                is because OSHA ``'pre-empts the field' for any nonapproved State law
                regulating the same safety and health issue.'' See Gade, 505 U.S. at
                104, n. 2, citing English v. General Electric. Co., 496 U.S. 72, 79-80,
                n.5 (``[F]ield preemption may be understood as a species of conflict
                pre-emption: A State law that falls within a pre-empted field conflicts
                with Congress' intent (either express or plainly implied) to exclude
                state regulation''); see also id. at 105 (discussing effect of field
                preemption). See generally Geier, 529 U.S. at 869, 875-886 (finding
                State law preemption where it ``upset the careful regulatory scheme
                established by federal law''); Williamson v. Mazda Motor of Am., Inc.,
                562 U.S. 323, 330-36 (2011) (affirming the conflict pre-emption
                principle that ``a state law that stands as an obstacle to the
                accomplishment and execution of the full purposes and objectives of a
                federal law is pre-empted'' and finding preemption where State law
                interfered with ``significant objective'' of the federal regulation).
                 For example, the ETS would preempt State or local governments from
                [[Page 61509]]
                dictating that employers adopt a scheme of testing and face coverings
                that complies with 1910.501(g) and (i) of the ETS, but that bars
                employers from electing the preferred vaccine mandate alternative in
                paragraph (d), because this interferes with OSHA's significant
                regulatory objectives and its preemption of the field.\82\ (See Need
                for the ETS (Section III.B. of this preamble) discussing that
                vaccination is the preferred compliance option under this rule because
                it is the most effective method of protecting workers from COVID-19).
                Likewise, the ETS would preempt such State or local occupational
                requirements, even to the extent that they may regulate employers with
                fewer than 100 employees, notwithstanding that the requirements in this
                ETS only apply to employers with more than 100 employees.
                ---------------------------------------------------------------------------
                 \82\ OSHA is aware that some States have adopted or are
                considering adopting such requirements, which this ETS would preempt
                (see, e.g., Arkansas S.B. 739, October 4, 2021 and Arkansas H.B.
                1977, October 1, 2021, which Arkansas Governor Asa Hutchinson
                allowed to became law without his signature, and which require
                employers in Arkansas to allow employees to opt out of vaccination
                for purposes of complying with federal vaccination requirements; see
                also Governor Hutchinson, October 13, 2021; Marr, October 7, 2021
                (describing the Arkansas legislation and noting that other states
                may contemplate similar legislation)).
                ---------------------------------------------------------------------------
                 Case law is instructive on this point. In Gade, the Supreme Court
                found regulations implementing a State statute that required training
                for workers handling hazardous waste that went beyond, but did not
                conflict with, OSHA's hazardous waste training requirements to be
                preempted by the OSHA requirements. Id. Likewise, in Industrial Truck
                Association Incorporated v. Henry, the Ninth Circuit found that OSHA's
                hazard communication standard preempted California's Hazard
                Communication regulations that were not submitted to OSHA for approval
                through its State Plan, even to the extent that California's Hazard
                Communication rule regulated manufacturers and distributers who were
                excluded from coverage under federal OSHA's rule. Indust. Truck Ass'n
                v. Henry, 125 F.3d 1305, 1311-14 (9th Cir. 1997). In the same way, the
                ETS preempts all State and local requirements that bar or limit the
                ability of an employer to require workplace vaccination, testing, and
                face coverings to protected employees against COVID-19 in any respect,
                since OSHA has occupied the entire field of regulation on these issues.
                 OSHA's definition of the ``issue'' in this rule should be afforded
                weight, since the OSH Act vests OSHA with standard-setting
                responsibility and, therefore, the authority to determine which
                ``issues'' to address with occupational safety and health standards.
                See Indust. Truck, 125 F.3d at 1311 (relying on OSHA's regulation and
                statements in the preamble to identify the relevant ``issue'' for
                preemption purposes in OSHA's Hazard Communication standard).
                 Importantly, although OSHA's stated intention is to preempt
                conflicting State and local requirements relating to the issues
                addressed by this standard, OSHA recognizes that the OSH Act does not
                allow, and OSHA does not intend, for the ETS to preempt non-conflicting
                State or local requirements of general applicability. In Gade, the
                Supreme Court qualified its ruling by saving from preemption non-
                conflicting State and local ``laws of general applicability (such as
                laws regarding traffic safety or fire safety) that do not conflict with
                OSHA standards and that regulate the conduct of workers and nonworkers
                alike.'' Gade, 505 U.S. at 107. The Majority reasoned that,
                ``[a]lthough some laws of general applicability may have a `direct and
                substantial' effect on worker safety, they cannot fairly be
                characterized as `occupational' standards, because they regulate
                workers simply as members of the general public.'' Id.
                 During the pandemic, many States and municipal governments have
                adopted requirements intended to protect public health by helping to
                prevent the spread of COVID-19 in public spaces. These have included
                requirements mandating face coverings in indoor public spaces,
                including businesses, government buildings, and schools (see, e.g.,
                Baltimore City Health Department, August 10, 2021; Illinois Executive
                Order 2021-20, August 26, 2021; Hawai'i Emergency Proclamation, October
                1, 2021). In addition, in recent months, some States and municipal
                governments have adopted requirements mandating that members of the
                public provide proof of vaccination or recent COVID-19 testing in order
                to enter restaurants, bars, or other businesses or public spaces (see,
                e.g., NYC Emergency Executive Order 225, August 16, 2021 (mandating
                COVID-19 vaccination for most individuals for indoor entertainment,
                recreation, dining and fitness settings)). Requirements such as these
                apply to ``workers and nonworkers alike'' and ``regulate workers simply
                as member of the general public'' and are accordingly not preempted.
                Gade, 505 U.S.at 107.
                 Based on OSHA's observations and experience during the past year
                and a half that the pandemic has been ongoing, OSHA is confident that
                protective State and local regulations of general applicability that
                mandate face coverings or vaccination will complement, rather than
                interfere with OSHA's enforcement of the ETS, and also does not intend
                to preempt such requirements. Indeed, OSHA believes that such measures
                have significantly reduced the harmful effects of the pandemic and
                total fatalities. See Steel Institute of NY v. The City of NY, 716 F.3d
                31, 38 (affording some weight to OSHA's view that municipal regulations
                governing construction cranes did not interfere with OSHA's regulatory
                scheme in its crane standards and ultimately adopted OSHA's view in
                finding these municipal regulations were not preempted by OSHA crane
                standards).\83\
                ---------------------------------------------------------------------------
                 \83\ OSHA's Cranes and Derricks in Construction rule directly
                discussed its expectations and intent regarding the preemptive
                effect of the rule, including that it was not intended to preempt
                generally applicable municipal regulations, such as building codes,
                which serve public safety purposes. Cranes and Derricks in
                Construction, 75 FR 47,906, 48,128 (August 9, 2010). This rule also
                includes a provision that requires employers to comply with State
                crane operator licensing requirements that meet the federal floor
                for crane operator certification in the rule. 29 CFR
                1926.1427(c)(1). OSHA has also indicated that its rule would not
                preempt State or local requirements in other rulemakings. See e.g.,
                72 FR 7136, 7188 (Feb. 14, 2007) (Preamble to OSHA's most recent
                electrical safety standard) (``State and local fire and building
                codes, which are designed to protect a larger group of persons than
                employees,'' are not preempted); 29 CFR 1910.134(e) (requiring
                compliance with State and local laws by requiring ``a licensed
                health care professional'' to perform a medical evaluation of an
                employee's ability to use a respirator).
                ---------------------------------------------------------------------------
                 In Steel Institute, the Second Circuit held that OSHA's crane
                regulations did not preempt New York City municipal regulations
                governing construction cranes, finding that such regulations were
                requirements of general applicability, notwithstanding their direct
                bearing on worker safety, because their primary purpose and effect was
                to preserve the safety of the general public, and they regulated
                workers and nonworkers alike. Id. The Steel Institute court noted the
                ``strong presumption against preemption when states and localities
                ``exercise[ ] their police powers to protect the health and safety of
                their citizens.'' Id. at 36, citing Medtronic, Inc. v. Lohr, 518 U.S.
                470, 475 (1996). The Second Circuit was also influenced by the clear
                danger presented to the public by unsafe crane operation. This is
                analogous to the situation here, because exposure to COVID-19 is a
                hazard that directly impacts everyone. Thus, generally applicable State
                and local mandates requiring face coverings or vaccination should not
                be preempted and should
                [[Page 61510]]
                remain in effect, notwithstanding this ETS.\84\
                ---------------------------------------------------------------------------
                 \84\ In addition, some State and local governments have adopted
                vaccination mandates directed at State and/or local government
                employees. The OSH Act and OSHA's standards would not preempt such
                requirements since State or local government employers and employees
                are exempt from OSHA coverage under the OSH Act. 29 U.S.C. 652 (5)
                (defining employer to exclude ``any State or political subdivision
                of a State''). However, many State and local government employers in
                States with OSHA-approved State Plans will be covered by State
                occupational safety and health requirements, and State Plans must
                adopt requirements for State and local government employers, as well
                as covered private sector employers, that are at least as effective
                as federal OSHA's requirements; State Plans may also choose to adopt
                more protective occupational safety and health requirements. 29
                U.S.C. 667(c).
                ---------------------------------------------------------------------------
                 On the other hand, as noted above, this standard will preempt
                requirements that conflict with it, regardless of whether the
                requirements are part of a law of general applicability.\85\
                ---------------------------------------------------------------------------
                 \85\ As previously discussed, bans on mandating vaccinations or
                face coverings have not typically been generally applicable, but
                even the least workplace-specific, most generally applied bans will
                not survive preemption because they directly interfere with the
                ETS's regulatory scheme.
                ---------------------------------------------------------------------------
                 The effect of the ETS on State law requirements in State Plan
                States works somewhat differently. As previously noted, under section
                18 of the OSH Act States that wish to assume responsibility for the
                development and enforcement of ``occupational safety and health
                standards relating to any occupational safety or health issue with
                respect to which a Federal standard has been promulgated'' may submit a
                State Plan to OSHA for approval. Id. section 667(b); see also id.
                section 667(c) (describing requirements for OSHA approval of State
                Plans on issues for which OSHA has adopted standards). There are 22
                States and territories that have OSHA-approved State Plans for private
                employers, and 6 additional States and territories that have OSHA-
                approved State Plans for public employers only.
                 Under section 18(c)(2) of the OSH Act, State Plans are required to
                adopt and enforce occupational safety and health standards that are at
                least as effective as federal OSHA's requirements. Id. section
                667(c)(2). In addition, the OSH Act requires that State Plans must
                cover State and local government employees (including, e.g., State and
                local school systems within the scope of this rule), even though
                federal OSHA does not have coverage over such employees in States
                without OSHA-approved State Plans.
                 Once OSHA promulgates an ETS, OSHA's regulations provide that those
                States have ``30 days after the date of promulgation of the Federal
                standard to adopt a State emergency temporary standard,'' or to
                demonstrate ``that promulgation of an emergency temporary standard is
                not necessary because the State standard is already the same or at
                least as effective as the Federal standard change.'' 29 CFR
                1953.5(b)(1). The new ETS becomes part of the OSHA-approved State Plan
                through the State Plan's submission to OSHA documentation showing it
                adopted an identical ETS or a ``Plan Change Supplement'' showing that
                it has adopted requirements that are ``at least as effective'' as
                federal OSHA's ETS. 29 CFR 1953.5(b)(3); 1953.4.
                 Even in States with OSHA-approved State Plans, any State law
                relating to an occupational safety and health issue that OSHA regulates
                is preempted unless it is submitted for OSHA's approval as a supplement
                to the State Plan. Indust. Truck Ass'n, 125 F.3d at 1311 (``If a State
                wishes to regulate an issue of worker safety for which a federal
                standard is in effect, its only option is to obtain the prior approval
                of the Secretary of Labor . . . [and] [i]t would make the state plan
                approval requirement superfluous if a state could pick and choose which
                occupational health and safety regulations to submit to OSHA''). Thus,
                a State or local requirement banning or limiting employer vaccine
                mandates would similarly be preempted because it has not been approved
                by federal OSHA as part of the State Plan. And, indeed, it could not be
                approved by federal OSHA, because such bans or limitations undercut the
                ETS's requirements and are clearly not as effective as the federal ETS.
                See 29 U.S.C. 667(c)(2).\86\
                ---------------------------------------------------------------------------
                 \86\ For example, Arizona has an OSHA-approved State Plan, but
                its vaccination ban, which is not part of its State Plan, is
                preempted by this ETS (see AZ Executive Order 2021-18, Aug. 16,
                2021).
                ---------------------------------------------------------------------------
                 Finally, this provision includes a note that this section
                establishes minimum requirements for employers, that nothing in this
                section prevents employers from agreeing with their employees to
                implement additional measures, and that this section does not supplant
                collective bargaining agreements or other collectively negotiated
                agreements in effect that may have negotiated terms that exceed the
                requirements herein. It also references the National Labor Relations
                Act of 1935, which protects most private-sector employees' right to
                take collective action. The purpose of this note is to remind employers
                and employees that OSHA's ETS establishes a floor for protections, and
                that it does not preclude bargaining for additional protective
                measures. For example, employers might agree to cover the costs of face
                coverings or medical removal, or to a requirement that all employees,
                regardless of vaccination status, wear face coverings while working
                indoors.
                References
                An Act Prohibiting Discrimination Based on a Person's Vaccination
                Status or Possession of an Immunity Passport; Montana H.B. 702.
                (2021, July 1). https://leg.mt.gov/bills/2021/billpdf/HB0702.pdf.
                (Montana H.B. 702, July 1, 2021)
                Arizona Executive Order 2021-18. (2021, August 16). https://azgovernor.gov/sites/default/files/eo_2021-18.pdf. (AZ Executive
                Order 2021-18, August 16, 2021)
                Arkansas H.B. 1977. (2021, October 1). To Provide Employee
                Exemptions From Federal Mandates and Employer Mandates Related to
                Coronavirus 2019 (COVID-19); and to Declare an Emergency. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FAMEND%2F2021R%2FPublic%2FHB1977-H1.pdf.
                (Arkansas H.B. 1977, October 1, 2021)
                Arkansas S.B. 739. (2021, October 4). An Act Concerning Employment
                Issues Related to Coronavirus 2019 (COVID-19); To Provide Employee
                Exemptions From Federal Mandates and Employer Mandates Related to
                Coronavirus 2019 (COVID-19); To Declare and Emergency; and For Other
                Purposes. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FBills%2F2021R%2FPublic%2FSB739.pdf. (Arkansas
                S.B. 739, October 4, 2021)
                Arkansas Governor Asa Hutchinson. (2021, October 13). Press Release:
                Governor Hutchinson Allows Vaccine Mandate, Redistricting Bills to
                Become Law Without His Signature. https://governor.arkansas.gov/news-media/press-releases/governor-hutchinson-allows-vaccine-mandate-redistricting-bills-to-become-la. (Governor Hutchinson,
                October 13, 2021)
                Baltimore City Health Department. (2021, August 10). Health
                Commissioner Updated Directive and Order for Face Coverings. https://www.baltimorecity.gov/sites/default/files/HEALTH%20COMMISSIONER%20AUGUST%2010,%202021%20DIRECTIVE%20AND%20ORDER%20FOR%20FACE%20COVERINGS_FINAL.pdf. (Baltimore City Health
                Department, August 10, 2021)
                Emergency Executive Order 225. (2021, August 16). Key to NYC:
                Requiring COVID-19 Vaccination for Indoor Entertainment, Recreation,
                Dining and Fitness Settings. https://www1.nyc.gov/office-of-the-mayor/news/225-001/emergency-executive-order-225. (NYC Emergency
                Executive Order 225, August 16, 2021)
                Florida Executive Order 21-102. (2021, May 3). https://
                www.flgov.com/wp-content/
                [[Page 61511]]
                uploads/orders/2021/EO_21-102.pdf. (Florida Executive Order 21-102,
                May 3, 2021)
                Hawai'i Emergency Proclamation Related to the State's COVID-19 Delta
                Response. (2021, October 1). https://governor.hawaii.gov/wp-content/uploads/2021/10/2109152-ATG_Emergency-Proclamation-Related-to-the-States-COVID-19-Delta-Response-distribution-signed.pdf. (Hawai'i
                Emergency Proclamation, October 1, 2021)
                Illinois Executive Order 2021-20. (2021, August 26). https://www.illinois.gov/government/executive-orders/executive-order.executive-order-number-20.2021.html. (Illinois Executive Order
                2021-20, August 26, 2021)
                Marr C. (2021, October 7). Workplace Vaccine Exemption Bills Sent to
                Arkansas Governor. Bloomberg Law. https://news.bloomberglaw.com/daily-labor-report/workplace-vaccine-exemption-bills-sent-to-arkansas-governor. (Marr, October 7, 2021)
                Texas Executive Order GA-34. (2021, March 2). Executive Order No.
                GA-34 relating to the opening of Texas in response to the COVID-19
                disaster. https://open.texas.gov/uploads/files/organization/opentexas/E.O.-GA-34-opening-Texas-response-to-COVID-disaster-IMAGE-03-02-2021.pdf. (Texas Executive Order GA-34, March 2, 2021)
                Texas Executive Order GA-36. (2021, May 18). Executive Order No. GA-
                36 relating to the prohibition of governmental entities and
                officials from mandating face coverings or restricting activities in
                response to the COVID-19 disaster. https://gov.texas.gov/uploads/files/press/E.O.-GA-36_prohibition_on_mandating_face_coverings_response_to_COVID-19_disaster_IMAGE_05-18-2021.pdf. (Texas Executive Order GA-36, May
                18, 2021)
                Texas Executive Order GA-40. (2021, October 11). Executive Order No.
                GA-40 relating to prohibiting vaccine mandates, subject to
                legislative action. https://gov.texas.gov/uploads/files/press/E.O.-GA-40_prohibiting_vaccine_mandates_legislative_action_IMAGE_10-11-2021.pdf. (Texas Executive Order GA-40, October 11, 2021)
                B. Scope and Application
                 Paragraph (b)(1) of this ETS provides that the ETS applies to all
                employers that have a total of at least 100 employees at any time the
                ETS is in effect. OSHA has determined that the unvaccinated employees
                of these employers face a grave danger of exposure to SARS-CoV-2,
                including the Delta variant, while they are at work (see Grave Danger,
                Section III.A. of this preamble). Because this grave danger finding
                applies to all unvaccinated employees who come into contact with other
                people in indoor work settings as part of their employment, this ETS is
                not limited by industrial sector or NAICS code. Therefore, this
                standard generally covers employers in all workplaces that are under
                OSHA's authority and jurisdiction, including industries as diverse as
                manufacturing, retail, delivery services, warehouses, meatpacking,
                agriculture, construction, logging, maritime, and healthcare.
                I. Decision To Limit Coverage of This ETS to Employers With 100 or More
                Employees
                 This ETS applies to employers with a total of 100 or more employees
                at any time the standard is in effect. In light of the unique
                occupational safety and health dangers presented by COVID-19, and
                against the backdrop of the uncertain economic environment of a
                pandemic, OSHA established this coverage threshold for four reasons.
                First, OSHA is confident that employers with 100 or more employees will
                be able to meet the standard's requirements promptly, as the emergency
                addressed by the standard necessitates. OSHA is less confident that
                smaller employers can do so without undue disruption. Second, this
                coverage threshold will enable the standard to reach two-thirds of all
                private-sector workers in the nation, providing them with prompt
                protection. Third, the standard will reach the largest facilities,
                where the most deadly outbreaks of COVID-19 can occur. Fourth, the 100-
                employee threshold in this standard is comparable with the size
                thresholds established by congressional and agency decisions in
                analogous contexts.
                a. Challenges to Feasibility Analysis for Small Businesses
                 An OSHA standard, including an ETS, must be both economically and
                technologically feasible. A standard is economically feasible under the
                OSH Act if it neither threatens ``massive dislocation to'' nor upsets
                the ``competitive stability of'' the regulated industries. United
                Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1265 (D.C.
                Cir. 1980). Technological feasibility has been interpreted broadly to
                mean ``capable of being done'' Am. Textile Mfrs. Inst. v. Donovan, 452
                U.S. 490, 509-510 (1981).
                 As shown in Economic Analysis, Section IV.B. of this preamble, OSHA
                is confident that this standard is feasible for employers with 100 or
                more employees. OSHA is not at this time making any determination about
                whether it would be appropriate to extend the ETS to cover smaller
                employers. Put simply, the agency is requiring that employers it is
                confident can implement the provisions of the standard without delay do
                so. At the same time, the agency is soliciting public comment and
                seeking additional information to assess the ability of smaller
                employers to do so in the rulemaking commenced by this ETS. OSHA will
                determine the issue on the basis of the record, after receiving public
                comment.\87\ The SARS-CoV-2 virus continues to spread rapidly, and each
                day that passes, tens of thousands more people are infected. The
                employees of larger firms should not have to wait for the protections
                of this standard while OSHA takes the additional time necessary to
                assess the feasibility of the standard for smaller employers.
                ---------------------------------------------------------------------------
                 \87\ If OSHA receives information suggesting that a broader
                scope would be appropriate, the agency could expand the scope of the
                ETS quickly through a supplemental action. Fla. Peach Growers Ass'n,
                Inc. v. U. S. Dep't of Labor, 489 F.2d 120, 127 (5th Cir. 1974)
                (``It is inconceivable that Congress, having granted the Secretary
                the authority to react quickly in fast-breaking emergency
                situations, intended to limit his ability to react to developments
                subsequent to his initial response.'')
                ---------------------------------------------------------------------------
                 The pandemic has presented special challenges for small businesses.
                According to a survey conducted during its early stages, 66% of
                businesses with fewer than 100 employees had suffered revenues losses
                exceeding 30%. (SHRM, May 6, 2020a). By contrast, only 27% of larger
                businesses with more than 100 employees had seen revenue drops of more
                than 30% (SHRM, May 6, 2020b). More recently, 61% of the members of the
                National Federation of Independent Businesses, mostly very small
                businesses, responded to a survey reported that they were experiencing
                staff shortages, with half of that group reporting a moderate to
                significant loss of sales because of unfilled positions (NFIB, July 12,
                2021).
                 The requirements of the ETS could have a differential impact on
                small businesses compared with larger firms. Many small businesses lack
                separate human resources departments and struggle to carry out HR
                functions. A study found that some 70% of small businesses (with 5 to
                49 employees) handle HR tasks in an ad hoc way. (ADP, December 2016).
                Only 23% of ad hoc managers believed they had the tools and resources
                necessary to perform HR tasks well, and only 19% were fully confident
                in their ability to handle HR tasks without making mistakes (ADP,
                December 2016). Another survey found that HR functions are
                proportionally far more expensive for smaller firms than for larger
                (small firms defined as up to 250 workers) (SHRM, 2015). The ETS
                requires employers to establish new systems to track vaccination status
                among workers, to keep related records, and for firms that allow the
                testing option, to keep records of each test.
                [[Page 61512]]
                These records must be treated as confidential medical records subject
                to detailed regulations, which is not something most smaller employers
                typically need to do or have existing systems in place to address. 29
                CFR 1910.1020. While OSHA has imposed similar requirements on smaller
                employers before, it has typically done so in highly regulated
                industries, such as healthcare, or in industries involving complicated
                industrial processes, which already require a certain degree of
                administrative capacity even when not responding to a grave danger,
                through a rulemaking process that provides additional time for notice
                and implementation, and when there is more time to assess the impact
                that the standard would have on small business. This emergency standard
                by contrast applies across the board to all industries, including less
                regulated retail and service sectors.
                 Moreover, OSHA estimates that some 5% of employees may have a
                medical contraindication or request an accommodation from the rule's
                requirements for disability or sincerely held religious belief reasons.
                (Please see Economic Analysis, Section IV.B. of this preamble).
                Assessing these requests may require more resources for smaller firms
                with less experience in this area, particularly if they lack HR staff.
                By the same token, a delay in applying the ETS to businesses with fewer
                than 100 employees would allow those businesses the benefit of learning
                from the models established by larger businesses with respect to
                accommodations. Similarly, implementing the ETS's testing provisions in
                a stepwise fashion will allow OSHA the time necessary to assess any
                impact the new requirements may have on the testing infrastructure and
                related supply chains before considering extending those requirements
                to additional employers.
                b. The ETS Provides Prompt Protection for Most of America's Workforce
                 The 100 employee threshold means the ETS will reach two-thirds of
                the nation's private sector workforce, providing protection to millions
                of workers while issues regarding smaller firms are reviewed. OSHA
                considered that a 100 employee threshold was superior to a 150 employee
                threshold in this respect, because it would protect more employees: 67%
                rather than 63%, which is a difference of 4.856 million workers. (U.S.
                Census Bureau, May 2021). And while a 50 employee threshold would have
                covered more employees (78%), it would have required additional
                feasibility analysis, while still leaving many employees outside the
                standard. (U.S. Census Bureau, May 2021).
                c. The ETS Will Help Prevent Large Outbreaks of COVID-19
                 The ETS's focus on employers with more than 100 employees will also
                help prevent large-scale outbreaks. As addressed in more detail in the
                discussion of Grave Danger (Section III.A. of this preamble), all
                unvaccinated employees who work in indoor settings face a grave danger
                from COVID-19, which is why the scope of the ETS is not limited to
                worksites of a specific size. The standard is based on employer size
                primarily because administrative capacity is more closely related to
                employer size. In addition, employer size provides a clear measure that
                is easy for employers (and OSHA) to track, as opposed to an alternative
                such as a workplace-based approach, which could fluctuate from day to
                day and mean more places and information for the employer to track. But
                OSHA also chose the 100 employee size threshold in recognition of the
                fact that larger employers are more likely to have many employees
                gathered in the same location. For employers with 100 or more
                employees, the median number of employees at any one location is
                approximately 50 (the average is also 50). (U.S. Census Bureau, May
                2021). For employers with fewer than 100 employees, the median number
                of any one location is approximately 2 (with an average number of 7)
                (U.S. Census Bureau, May 2021).
                 Employees at larger locations are statistically more likely to be
                exposed to someone with COVID-19 during the course of their shifts, and
                thus face a heightened risk of virus transmission. Studies indicate
                that introduction of infection and the risk of infection transmission
                is increased with the size of a gathering (Champredon et al., April,
                2021), and with larger populations (Shacham et al., July 5, 2021). See
                also (Contreras et al., July, 2021) (concluding that outbreaks were
                larger and lasted longer at facilities with more onsite staff). It is
                therefore not surprising that significant COVID-19 outbreaks have
                occurred at large facilities of employers with 100 or more employees
                \88\ (Oregon Health Authority, October 6, 2021; CDPHE, October 6,
                2021). A study of outbreaks in Los Angeles County found that the median
                number of employees in an establishment in which an outbreak occurred
                was 95, well above the 50 employee median for locations of employers
                covered by this rule, indicating that the rule will protect employees
                in the places where outbreaks are most likely to occur. (Contreras et
                al., July, 2021). And those outbreaks occurred even before the
                emergence of the SARS-CoV-2 Delta variant, which the CDC says ``causes
                more infections and spreads faster than early forms of SARS-CoV-2.''
                (CDC, August 26, 2021) In fact, the studies noted earlier in this
                paragraph were published just as the Delta variant was emerging,
                meaning that the risk of transmission cited in those studies has likely
                increased.
                ---------------------------------------------------------------------------
                 \88\ See, e.g., Oregon Health Authority, October 6, 2021,
                (publishing data on outbreaks in large workplaces including two
                Amazon facilities, several hospitals, and a Walmart distribution
                center); CDPHE, Oct. 6, 2021, (identifying an active Covid outbreak
                in Cargill's Fort Morgan, CO meat processing plant, which employs
                more than 2,000 workers). While some have speculated that clusters
                of infections among employees at the same facility might result
                initially from shared exposures outside of work, the original source
                of the infection would have little bearing on the statistical
                probability of exposure and transmission once the infected people
                are together in the workplace with unvaccinated co-workers. The most
                effective way to prevent further transmission is to protect the
                other workers through vaccination or, when that is not possible,
                identify and remove the infected workers from the workplace as
                quickly as possible.
                ---------------------------------------------------------------------------
                 While virus transmission is certainly not limited to large
                facilities, the potential scope of an outbreak is inherently more
                limited when fewer employees are present. In limiting the scope of the
                ETS to employers with 100 or more employees, OSHA is prioritizing
                coverage of those businesses in which the spread of the virus could
                potentially affect the largest number of employees and for which the
                agency is most confident that it is feasible to apply the standard.
                d. Analogous Regulatory Regimes Use Comparable Employee Size Thresholds
                 Congress and federal agencies have frequently recognized that an
                employee size threshold may be appropriate in different regulatory
                contexts. They have not settled on any one number as the most
                appropriate, presumably because that depends on balancing different
                considerations that are relevant to the particular context, as OSHA has
                done here. But several analogous regulatory regimes use employee size
                thresholds comparable to the one selected here, in light of similar
                concerns about administrative feasibility.
                 For example, the EEOC has issued regulations requiring employers
                with 100 or more employees to submit annual reports related to equal
                employment opportunity in their workforce, in recognition that larger
                employers are better equipped to absorb the types of administrative
                burdens
                [[Page 61513]]
                imposed by surveying, tracking and recordkeeping requirements. See 42
                U.S.C. 2000e-8(c), 29 CFR 1602.7-.14 and 41 CFR 60-1.7(a). In earlier
                measures adopted in response to the COVID-19 pandemic, Congress adopted
                special protections and exemptions based on employee counts. The
                Families First Coronavirus Response Act, Public Law 116-127 (2020),
                sections 7001 and 7003 provided tax credits to businesses with fewer
                than 500 employees to assist compliance with the Act's expansion of
                paid sick and family leave, in recognition of the challenges facing
                smaller employers. Congress again relied on the same 500 employee
                threshold when it later extended tax credits only to employers who
                granted employees paid time off to be vaccinated, implicitly
                acknowledging the financial obstacles that can exist for smaller
                employers for the same activity that this ETS promotes (and without the
                vaccine policy and verification requirement in this ETS). American
                Rescue Plan Act, Public Law 117-2, Sec. 9641 (2021).
                 In the Affordable Care Act, Congress set the maximum size of a
                ``small employer'' at 100 employees for purposes of allowing greater
                flexibility to these employers. 42 U.S.C.A. 18024(b)(3). Likewise,
                private employers with fewer than 50 employees are exempt from
                complying with the Family and Medical Leave Act, in recognition of
                smaller employers' decreased administrative capacity, as well as their
                inability to easily accommodate employee absences. 29 U.S.C.A.
                2611(2)(b)(2).
                e. The 100 Employee Coverage Provision Is a Reasonable Exercise of the
                Secretary's Authority
                 OSHA's choice of a 100 employee threshold is based on balancing the
                fundamentally incommensurable considerations described above. Under the
                statute OSHA ``shall'' issue an ETS when employees are exposed to grave
                danger, and is not to follow normal notice and comment procedures to
                build a record. 29 U.S.C. 655(e). But OSHA may not issue an ETS unless
                it shows that the rule is feasible for the employers covered, and it
                has not yet made a feasibility determination for smaller employers. In
                the circumstances of this case, OSHA considered that an ETS was
                urgently needed to protect employees, that a 100 employee threshold
                would protect the great majority of them and prevent the largest
                outbreaks, that it would avoid the delays that would be needed if the
                agency were required to gather information and analyze feasibility for
                smaller employers, and that a comparable size threshold has been found
                appropriate in similar contexts. Where employees are dying every day,
                it is not unreasonable for the agency to prioritize doing what it can
                to address the problem quickly, regardless of whether there are further
                actions it might be able to take later.
                 Doing so implements the statutory delegation of authority to the
                agency to establish priorities for issuing standards by giving ``due
                regard to the urgency of the need'' for standards for particular
                workplaces. 29 U.S.C. 655(g). The courts have recognized that this
                provision authorizes the Secretary to make reasonable decisions
                limiting the scope of a standard, particularly where as here the agency
                has said it will address the reserved issue in subsequent rulemaking.
                Forging Indus. Assoc. v. Donovan, 773 F.2d 1436, 1454 (4th Cir. 1985)
                (hearing conservation standard); United Steelworkers of Am. v.
                Marshall, 647 F.2d 1189, 1309-1310 (D.C. Cir. 1980) (lead standard).
                 Where competing considerations are in play and there is no clear
                perfect choice, OSHA has a degree of discretion to draw a reasonable
                line. Courts have consistently recognized that agencies have discretion
                to draw reasonable lines. As the D.C. Circuit has explained: An agency
                has ``wide discretion'' in making line-drawing decisions and ``[t]he
                relevant question is whether the agency's numbers are within a zone of
                reasonableness, not whether its numbers are precisely right.''
                WorldCom, Inc. v. FCC, 238 F.3d 449, 462 (D.C. Cir. 2001) (quotation
                marks omitted). An agency ``is not required to identify the optimal
                threshold with pinpoint precision. It is only required to identify the
                standard and explain its relationship to the underlying regulatory
                concerns.'' Id. at 461-62. Nat'l Shooting Sports Found. v. Jones, 716
                F.3d. 200, 214-215 (D.C. Cir 2013). See also Providence Yakima Med.
                Ctr. v. Sebelius, 611 F.3d 1181, 1190-1191 (9th Cir. 2010).
                 For the reasons discussed above, the balance the agency struck here
                falls well within this zone of reasonableness.
                II. Explanation of Who Is Included in the 100-Employee Threshold
                 The applicability of this ETS is based on the size of an employer,
                in terms of number of employees, rather than on the type or number of
                workplaces. In determining the number of employees, employers must
                include all employees across all of their U.S. locations, regardless of
                employees' vaccination status or where they perform their work. Part-
                time employees do count towards the company total, but independent
                contractors do not. As discussed above, OSHA has not found that the
                standard is feasible for firms with fewer than 100 employees, because
                it needs additional time to assess the impact of the standard on these
                employers, particularly as many smaller firms lack separate human
                resources departments and may face additional challenges when carrying
                out human resources functions. In contrast, OSHA has determined that
                the standard is feasible for firms with 100 or more employees,
                regardless of where those employees report to work. These firms
                generally have greater administrative capacities, and including all
                such employers in the scope of this ETS ensures that OSHA can cover
                two-thirds of all workers in the private sector as quickly as possible.
                 For a single corporate entity with multiple locations, all
                employees at all locations are counted for purposes of the 100-employee
                threshold for coverage under this ETS. In a traditional franchisor-
                franchisee relationship in which each franchise location is
                independently owned and operated, the franchisor and franchisees would
                be separate entities for coverage purposes, such that the franchisor
                would only count ``corporate'' employees, and each franchisee would
                only count employees of that individual franchise. In other situations,
                two or more related entities may be regarded as a single employer for
                OSH Act purposes if they handle safety matters as one company, in which
                case the employees of all entities making up the integrated single
                employer must be counted.
                 In scenarios in which employees of a staffing agency are placed at
                a host employer location, only the staffing agency would count these
                jointly employed workers for purposes of the 100-employee threshold for
                coverage under this ETS. Although the staffing agency and the host
                employer would normally share responsibility for these workers under
                the OSH Act, this ETS raises unique concerns in that OSHA has set the
                threshold for coverage based primarily on administrative capacity for
                purposes of protecting workers as quickly as possible, as discussed
                above, and the staffing agency would typically handle administrative
                matters for these workers. Thus, for purposes of the 100-employee
                threshold, only the staffing agency would count the jointly employed
                employees. The host employer, however, would still be covered by this
                ETS if it has 100 or more employees in addition to the employees of the
                staffing agency. For enforcement purposes, traditional joint employer
                principles would apply where both employers are covered by the ETS, as
                [[Page 61514]]
                illustrated further by the examples below. See also https://www.osha.gov/temporaryworkers/.
                 On a typical multi-employer worksite such as a construction site,
                each company represented--the host employer, the general contractor,
                and each subcontractor--would only need to count its own employees, and
                the host employer and general contractor would not need to count the
                total number of workers at each site. That said, each employer must
                count the total number of workers it employs regardless of where they
                report for work on a particular day. Thus, for example, if a general
                contractor has more than 100 employees spread out over multiple
                construction sites, that employer is covered under this ETS even if it
                does not have 100 or more employees present at any one worksite.
                Covering the employees of larger employers at multi-employer worksites
                would mitigate the spread of COVID-19 at the workplace even where not
                all employees are covered by this ETS because fully vaccinated
                employees (or unvaccinated employees wearing face coverings and
                submitting to weekly testing) would be less likely to spread the virus
                to unvaccinated workers at the site who are not covered by this ETS.
                 The determination as to whether a particular employer is covered by
                the standard should be made separately from whether individual
                employees are covered by the standard's requirements, as described by
                paragraph (b)(3) (e.g., some employers may be covered but have no
                duties with respect to some of their employees under this standard).
                Some additional examples include:
                 If an employer has 75 part-time employees and 25 full-time
                employees, the employer would be within the scope of this ETS because
                it has 100 employees.
                 If an employer has 150 employees, 100 of whom work from
                their homes full-time and 50 of whom work in the office at least part
                of the time, the employer would be within the scope of this ETS because
                it has more than 100 employees.
                 If an employer has 102 employees and only 3 ever report to
                an office location, that employer would be covered.
                 If an employer has 150 employees, and 100 of them perform
                maintenance work in customers' homes, primarily working from their
                company vehicles (i.e., mobile workplaces), and rarely or never report
                to the main office, that employer would also fall within the scope.
                 If an employer has 200 employees, all of whom are
                vaccinated, that employer would be covered.
                 If an employer has 125 employees, and 115 of them work
                exclusively outdoors, that employer would be covered.
                 If a single corporation has 50 small locations (e.g.,
                kiosks, concession stands) with at least 100 total employees in its
                combined locations, that employer would be covered even if some of the
                locations have no more than one or two employees assigned to work
                there.
                 If a host employer has 80 permanent employees and 30
                temporary employees supplied by a staffing agency, the host employer
                would not count the staffing agency employees for coverage purposes and
                therefore would not be covered. (So long as the staffing agency has at
                least 100 employees, however, the staffing agency would be responsible
                for ensuring compliance with the ETS for the jointly employed workers.)
                 If a host employer has 110 permanent employees and 10
                temporary employees from a small staffing agency (with fewer than 100
                employees of its own), the host employer is covered under this ETS and
                the staffing agency is not.
                 If a host employer has 110 permanent employees and 10
                employees from a large staffing agency (with more than 100 employees of
                its own), both the host employer and the staffing agency are covered
                under this standard, and traditional joint employer principles apply.
                 Generally, in a traditional franchisor-franchisee
                relationship, if the franchisor has more than 100 employees but each
                individual franchisee has fewer than 100 employees, the franchisor
                would be covered by this ETS but the individual franchises would not be
                covered.
                 As explained earlier, part of OSHA's rationale in adopting the 100-
                employee threshold is to focus the ETS on companies that OSHA is
                confident will have sufficient administrative systems in place to
                comply quickly with the ETS. Thus, the ETS applies to all employers who
                have the requisite number of employees at any time this ETS is in
                effect. Along with employers that always have more than 100 employees,
                OSHA intends to cover employers that fluctuate above and below the 100-
                employee threshold during the term of the ETS because those employers
                will typically have already developed systems and capabilities for
                compliance; a decrease in the number of employees is therefore unlikely
                to make them less capable of compliance.
                 The determination of whether an employer falls within the scope of
                this ETS based on number of employees should initially be made as of
                the effective date of the standard, as set out in paragraph (m)(1). If
                the employer has 100 or more employees on the effective date, this ETS
                applies for the duration of the standard. If the employer has fewer
                than 100 employees on the effective date of the standard, the standard
                would not apply to that employer as of the effective date. However, if
                that same employer subsequently hires more workers and hits the 100-
                employee threshold for coverage, the employer would then be expected to
                come into compliance with the standard's requirements. Once an employer
                has come within the scope of the ETS, the standard continues to apply
                for the remainder of the time the standard is in effect, regardless of
                fluctuations in the size of the employer's workforce. For example, an
                employer that has 103 employees on the effective date of the standard,
                but then loses four within the next month, would continue to be covered
                by the ETS. OSHA is confident that employers with 100 or more employees
                at any point while this ETS is in effect have the administrative
                capacity to comply with the ETS, even if the number of employees
                fluctuates somewhat above and below 100.
                 Paragraph (b)(2) of this ETS sets forth two exemptions to the
                standard.\89\ Under paragraph (b)(2)(i), this ETS does not apply to
                workplaces covered by the Safer Federal Workforce Task Force COVID-19
                Workplace Safety: Guidance for Federal Contractors and Subcontractors
                (see Safer Federal Workforce Task Force, September 24, 2021). With
                limited exceptions, such as where a medical contraindication,
                disability, or sincerely held religious belief would prevent an
                employee from complying with certain provisions, those guidelines
                require covered
                [[Page 61515]]
                contractors to ensure that all covered contractor employees (1) are
                fully vaccinated by December 8, 2021; (2) follow CDC guidelines for
                masks and physical distancing, including masking and distancing
                requirements based on the employee's vaccination status and the level
                of community transmission of COVID-19 where the workplace is located;
                and (3) designate a person to coordinate COVID-19 workplace safety
                efforts at covered workplaces. Because covered contractor employees are
                already covered by the protections in those guidelines, OSHA has
                determined that complying with this standard in addition to the federal
                contractor guidelines is not necessary to protect covered contractor
                employees from a grave danger posed by COVID-19. Although there may be
                some respects in which the OSHA standard is somewhat more protective,
                such as providing paid leave for vaccination, the federal contractor
                guidelines are somewhat more protective in other respects, such as
                requiring vaccination for everyone who does not have a right to an
                accommodation rather than allowing employees to submit to testing in
                lieu of vaccination. In essence, they are similar but slightly
                different schemes that provide roughly equivalent protection, and OSHA
                has determined that imposing a second set of similar protections on
                covered federal contractors by subjecting them to this ETS in addition
                to the federal contractor guidance is not necessary at this time to
                reduce a grave danger to covered contractor employees from COVID-19.
                ---------------------------------------------------------------------------
                 \89\ Note that, in addition to the scope exceptions contained in
                the ETS itself, which are discussed in this section, there may be
                situations where the ETS does not apply by operation of the OSH Act.
                For example, the OSH Act does not apply to working conditions of
                employees with respect to which other Federal agencies have
                exercised their statutory authority to prescribe or enforce
                standards or regulations affecting occupational safety or health
                (see 29 U.S.C. 653(b)(1)). Moreover, the ETS does not apply where
                states with OSHA-approved occupational safety and health programs
                (``State Plans'') have coverage (see 29 U.S.C. 667). State Plans
                must adopt and enforce COVID-19 requirements that are at least as
                effective as this ETS. Finally, the ETS does not apply to state and
                local government employers in states without State Plans (see 29
                U.S.C. 652(5)).
                ---------------------------------------------------------------------------
                 Under Executive Order 14043, every federal agency must implement a
                program requiring each of its federal employees to be vaccinated
                against COVID-19, except as required by law. 86 FR 50989. OSHA will
                regard a federal agency's compliance with this requirement, and the
                related Safer Federal Workforce Task Force guidance issued under
                section 4(e) of Executive Order 13991 and section 2 of Executive Order
                14043 (including guidance on employer support in the form of paid time
                for vaccination and paid leave for post-vaccination recovery), as
                sufficient to meet its obligation to comply with this ETS under Section
                19 of the OSH Act and Executive Order 12196. In essence, the federal
                government has chosen the mandatory vaccination option of this rule,
                and all federal employees are required to be fully vaccinated by the
                compliance date of this standard, except where entitled to a reasonable
                accommodation. The Safer Federal Workforce Task Force's guidelines for
                vaccination verification are consistent with the ETS's (see Safer
                Federal Workforce Task Force, October 11, 2021). Note, however, that
                under the OSH Act, the U.S. Postal Service is treated as a private
                employer, see 29 U.S.C. 652(5), and it is therefore required to comply
                with this ETS in the same manner as any other employer covered by the
                Act.
                 For similar reasons, paragraph (b)(2)(ii) provides that this ETS
                does not apply in settings where any employee provides healthcare
                services or healthcare support services while they are covered by the
                requirements of 29 CFR 1910.502. Section 1910.502 requires a multi-
                layered suite of protections for employees covered by its requirements,
                including patient screening and management, facemasks or respirators,
                other personal protective equipment (PPE), limiting exposure to
                aerosol-generating procedures, physical distancing, physical barriers,
                cleaning, disinfection, ventilation, health screening and medical
                management, access to vaccination, and medical removal protection.
                Section 1910.502 was carefully tailored to the healthcare workplaces it
                covers and, given the full suite of protections it requires, including
                (like this ETS) the provision of paid time for vaccination, OSHA has
                determined that it adequately protects the employees covered by its
                requirements from the grave danger posed by COVID-19. Therefore,
                complying with the additional requirements of this ETS is not necessary
                to protect those employees while they are covered by that standard's
                protections.
                 OSHA's intent was to leave no coverage gaps between section
                1910.502 and this ETS. In other words, the purpose of paragraph
                (b)(2)(ii) is to ensure that all workers in healthcare and healthcare
                support jobs who are at grave danger from exposure to SARS-CoV-2 are
                protected by either section 1910.502 or this ETS while performing their
                jobs. Therefore, it will be necessary for employers with employees
                covered by section 1910.502 to determine if they also have employees
                covered by this ETS. For example, a healthcare employer with more than
                100 employees that has non-hospital ambulatory care facilities that are
                exempt under section 1910.502(a)(2)(iii) (for non-hospital ambulatory
                care settings where all non-employees are screened prior to entry and
                those with suspected or confirmed COVID-19 are prohibited from entry)
                would be required to protect the employees in those ambulatory care
                facilities under this ETS. Similarly, a retail pharmacy chain that
                operates a series of ambulatory care clinics embedded in its stores,
                where those embedded clinics are the only areas in the store that are
                covered under 1910.502 (see section 1910.502(a)(3)(i)), would have to
                ensure that the remainder of its employees in other parts of its stores
                are protected under this ETS if the company has 100 or more employees
                company-wide, including those covered under 1910.502.
                 Paragraph (b)(3) provides that, even where the standard applies to
                a particular employer, its requirements do not apply to employees: (i)
                Who do not report to a workplace where other individuals such as
                coworkers or customers are present; (ii) while working from home; or
                (iii) who work exclusively outdoors. OSHA intends these provisions to
                exempt workplace settings where workers do not interact indoors with
                other individuals, and to exempt work performed in the employee's home
                regardless of whether other individuals may be present in the home.
                 OSHA has determined that the provisions of this ETS are not
                necessary to protect employees from COVID-19 when they are working
                alone, or when they are working from home (see Grave Danger, Section
                III.A. of this preamble). These two provisions may overlap in some
                cases, but also can apply to slightly different situations. Paragraph
                (b)(3)(i) would apply to work in a solitary location, such as a
                research station where only one person (the employee) is present at a
                time. In that situation, the employee is not exposed to any potentially
                infectious individuals at work. Paragraph (b)(3)(ii) would apply to
                employees working in their homes, regardless of whether other
                individuals who are not employees of the same employer are present. In
                a home telework environment, many factors--such as the presence of
                family members and other individuals unrelated to the employee's work,
                who may not be fully vaccinated or wearing face coverings--may be
                beyond the employer's control. Employees are typically in the best
                position to manage COVID-19 risks in their homes. Note that the
                exemption in paragraph (b)(3)(ii) only applies to employees while they
                are working from home. An employee who switches back and forth from
                teleworking to working in a setting where other people are present
                (e.g., an office) is covered by this ETS and must be vaccinated if
                required by the employer. If the employer does not require vaccination,
                the teleworking employee must either be vaccinated or complete testing
                and wear a face covering in accordance with their
                [[Page 61516]]
                employer's policy under paragraph (d). How often such an employee must
                be tested for COVID-19 and wear a face covering, however, depends on
                how often they report to the office (see, e.g., paragraph (g)(1)(ii)).
                 Paragraph (b)(3)(iii) provides that, even if a particular employer
                is covered by the standard, the requirements of the standard do not
                apply to employees who work exclusively outdoors. OSHA has determined
                that COVID-19 does not pose a grave danger to employees who work
                exclusively outdoors because of the significantly reduced likelihood of
                transmission in outdoor settings. As discussed in more detail in Grave
                Danger (Section III.A. of this preamble), the record contains very
                little evidence of COVID-19 transmission in outdoor settings. And, in
                studies where clusters were identified in worksites characterized as
                being outdoors, the study authors were not able to identify specific
                incidents that led to transmission. In addition, workplaces
                characterized as ``outdoors'' may in fact involve significant time
                spent indoors. For example, on a construction site, workers inside a
                partially complete structure are not truly outdoors, and some
                individuals on a construction site may spend significant amounts of
                time in a construction trailer where other individuals are present.
                Workers at outdoor locations may also routinely share work vehicles.
                These indoor exposures could account for COVID-19 clusters among
                employees at worksites otherwise characterized as being outdoors. And
                employees whose outdoor time is interrupted by the indoor periods will
                still be subject to the requirements in this ETS.
                 Studies of athletic teams further indicate that evidence of COVID-
                19 clusters among workers characterized as working outdoors could
                actually be caused by indoor exposures. Even where athletes were in
                very close contact during outdoor exposures on the playing field, the
                study authors could not identify a single case of COVID-19 transmission
                between teams that occurred outdoors (see Mack et al., January 29,
                2021; Egger et al., March 18, 2021; Jones et al., February 11, 2021).
                For all of these reasons, and as discussed more fully in Grave Danger
                (Section III.A. of this preamble), OSHA has determined that COVID-19
                does not pose a grave danger to employees who work exclusively
                outdoors.
                 As a practical matter, determining the applicability of paragraph
                (b)(3)(iii) depends on the working conditions of individual employees.
                For example, if a landscaping contractor has at least 100 employees and
                is not covered by the exemptions in paragraph (b)(2), the standard
                applies to that employer even if a majority of the company's employees
                work exclusively outdoors. The standard's protections would only apply
                to employees working in indoor settings around other individuals (other
                than telework in their own homes), not to those employees working
                exclusively outdoors. In some cases, it may be true that the standard
                applies to an employer but the employer would not have to implement its
                provisions at all because all of its employees fall within exemptions
                in paragraph (b)(3). Going back to the example of the large landscaping
                contractor, if all indoor workers either work from home or in locations
                where no other individuals are present, and all outdoors workers work
                exclusively outdoors and do not drive to worksites together in a
                company vehicle, the employer would be covered by the ETS but not
                required to comply with its provisions.
                 An employee will only be covered by the exemption in paragraph
                (b)(3)(iii) if the employee works exclusively outdoors. Thus, an
                employee who works indoors on some days and outdoors on other days
                would not be exempt from the requirements of this ETS. Likewise, if an
                employee works primarily outdoors but routinely occupies vehicles with
                other employees as part of work duties, that employee is not covered by
                the exemption in paragraph (b)(3)(iii). However, if an employee works
                outdoors for the duration of every workday except for de minimis use of
                indoor spaces where other individuals may be present--such as a multi-
                stall bathroom or an administrative office--that employee would be
                considered to work exclusively outdoors and covered by the exemption
                under paragraph (b)(3)(iii) as long as time spent indoors is brief, or
                occurs exclusively in the employee's home (e.g., a lunch break at
                home). Extremely brief periods of indoor work would not normally expose
                employees to a high risk of contracting COVID-19; however, OSHA will
                look at cumulative time spent indoors to determine whether that time is
                de minimis. Thus, if there are several brief periods in a day when an
                employee goes inside, OSHA will total those periods of time when
                determining whether the exception for exclusively outdoors work
                applies.
                 Finally, to qualify for this exception, the employee's work must
                truly occur ``outdoors,'' which would not include buildings under
                construction where substantial portions of the structure are in place,
                such as walls and ceiling elements that would impede the natural flow
                of fresh air at the worksite. Workplaces that are truly outdoors
                typically do not include any of the characteristics that normally
                enable transmission of SARS-CoV-2 to occur, such as poor ventilation,
                enclosed spaces, and crowding. As discussed in Bulfone et al. (November
                29, 2020), the lower risk of transmission in outdoor settings (i.e.,
                open air or structures with only one wall) is likely due to increased
                ventilation with fresh air and a greater ability to maintain physical
                distancing (see Grave Danger, Section III.A. of this preamble, for more
                information on risk of transmission outdoors).
                References
                Always Designing for People (ADP). (2016, December). Opportunity is
                calling. Answer it. Insights and solutions for moving beyond risky
                ad hoc HR management. (ADP, December 2016)
                Bulfone TC et al. (2020, November 29). Outdoor Transmission of SARS-
                CoV-2 and Other Respiratory Viruses: A Systematic Review. (2020).
                The Journal of Infectious Diseases 223: 550-561. https://doi.org/10.1093/infdis/jiaa742. (Bulfone et al., November 29, 2020)
                Centers for Disease Control and Prevention (CDC). (2021, August 26).
                Delta Variant: What We Know About the Science. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11512:cdc%20delta%20variant:sem.ga:p:RG:GM:gen:PTN:FY21. (CDC, August 26, 2021)
                Champredon D et al. (2021, May 12). Modelling approach to assessing
                risk of transmission of SARS-CoV-2 at gatherings. https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2021-47/issue-4-april-2021/assessing-risk-transmission-sars-cov-2-gatherings.html.
                (Champredon et al., May 12, 2021)
                Colorado Department of Public Health and Environment (CDPHE). (2021,
                October 6). CDPHE COVID-19 outbreak map updated October 6, 2021.
                https://cdphe.maps.arcgis.com/apps/webappviewer/index.html?id=dcc0b993632a4bc68dc7b9a1dd015cfe. (CDPHE, October 6,
                2021)
                Contreras Z et al. (2021, July). Industry Sectors Highly Affected by
                Worksite Outbreaks of Coronavirus Disease, Los Angeles County,
                California, USA, March 19-September 30, 2020. Emerg Infect Dis.
                2021; 27(7): 1769-1775. doi:10.3201/eid2707.210425. (Contreras et
                al., July, 2021)
                Egger F et al. (2021, March 18). Does playing football (soccer) lead
                to SARS-CoV-2 transmission?--a case study of 3 matches with 19
                infected football players. Science and Medicine in Football.
                doi:10.1080/24733938.2021.1895442. (Egger et al., March 18, 2021)
                Jones B et al. (2021, February 11). SARS-CoV-2 transmission during
                rugby league matches: do players become infected after participating
                with SARS-CoV-2
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                positive players? Br J Sports Med doi:10.1136/bjsports-2020-103714.
                (Jones et al., February 11, 2021)
                Mack CD et al. (2021, January 29). Implementation and evolution of
                mitigation measures, testing, and contact tracing in the national
                football league, August 9-November 21, 2020. MMWR 70: 130-135.
                doi:http://dx.doi.org/10.15585/mmwr.mm7004e2. (Mack et al., January
                29, 2021)
                National Federation of Independent Business (NFIB) Research Center.
                (2021, July 12). Covid-19 small business survey (18): federal small
                business programs, the vaccine, labor shortage, and supply chain
                disruptions. https://assets.nfib.com/nfibcom/Covid-19-18-Questionnaire.pdf. (NFIB, July 12, 2021)
                Oregon Health Authority. (2021, October 6). COVID-19 weekly outbreak
                report--October 6, 2021. https://www.oregon.gov/oha/covid19/Documents/DataReports/Weekly-Outbreak-COVID-19-Report.pdf. (Oregon
                Health Authority, October 6, 2021)
                Safer Federal Workforce Task Force. (2021, September 24). COVID-19
                Workplace Safety: Guidance for Federal Contractors and
                Subcontractors. https://www.saferfederal/workforce./gov/downloads/Draft%/20contractor%/20guidance%/20doc_20210922.pdf. (Safer Federal
                Workforce Task Force, September 24, 2021)
                Safer Federal Workforce Task Force. (2021, October 11).
                Vaccinations: Vaccination Documentation and Information. https://www.saferfederalworkforce.gov/faq/vaccinations/. (Safer Federal
                Workforce Task Force, October 11, 2021)
                Shacham E et al. (2021, July 5). Examining the relationship between
                COVID-19 vaccinations and reported incidence. doi:https://doi.org/10.1101/2021.06.30.21259794. (Shacham et al., July 5, 2021)
                Society for Human Resource Management (SHRM). (2015). How
                organizational staff size influences HR metrics. https://www.shrm.org/resourcesandtools/business-solutions/documents/organizational%20staff%20size.pdf. (SHRM, 2015)
                Society for Human Resource Management (SHRM). (2020a, May 6).
                Navigating COVID-19: impact of the pandemic on small businesses.
                https://shrm.org/hr-today/trends-and-forecasting/research-andsurveys/Documents/SHRM%20CV19%20SBO%20Research%20Presentation%20v1.1.pdf. (SHRM, May
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                Society for Human Resource Management (SHRM). (2020b, May 6).
                Survey: COVID-19 could shutter most small businesses. https://www.shrm.org/about-shrm/press-room/press-releases/pages/survey-covid-19-could-shutter-most-small-businesses.aspx. (SHRM, May 6,
                2020b)
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                C. Definitions
                 Paragraph (c) of the ETS provides definitions of terms used in the
                section.
                 ``Assistant Secretary'' means the Assistant Secretary of Labor for
                Occupational Safety and Health, U.S. Department of Labor, or designee.
                This definition provides clarification about who can request and
                receive records specified in paragraph (l)(3) of this section. A
                designee includes a representative conducting an inspection or an
                investigation.
                 ``COVID-19 (Coronavirus Disease 2019)'' means the disease caused by
                SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). SARS-CoV-
                2 is a highly transmissible virus that spreads primarily through the
                respiratory droplets that are produced when an infected person coughs,
                sneezes, sings, talks, or breathes. The nature of the disease, variants
                of SARS-CoV-2, disease transmission, and associated health effects are
                all described in great detail in Grave Danger (Section III.A. of this
                preamble). For clarity and ease of reference, the ETS also uses the
                term ``COVID-19'' when describing exposures or potential exposures to
                SARS-CoV-2. The requirements of the ETS are intended to address the
                grave danger of exposure to COVID-19 in the workplace.
                 A ``COVID-19 test'' means a test for SARS-CoV-2 that is: (1)
                Cleared, approved, or authorized, including in an Emergency Use
                Authorization (EUA), by the U.S. Food and Drug Administration (FDA) to
                detect current infection with the SARS-CoV-2 virus (e.g., a viral
                test); (2) administered in accordance with the authorized instructions;
                and (3) not both self-administered and self-read unless observed by the
                employer or an authorized telehealth proctor. Examples of tests that
                satisfy this requirement include tests with specimens that are
                processed by a laboratory (including home or on-site collected
                specimens which are processed either individually or as pooled
                specimens), proctored over-the-counter tests, point of care tests, and
                tests where specimen collection and processing is either done or
                observed by an employer.
                 Under paragraph (g), employees who are not fully vaccinated must be
                tested for COVID-19. When an employee must be tested, the test is
                considered acceptable only if the test and the administration of the
                test satisfy the definition of COVID-19 test in this standard.
                 COVID-19 tests can broadly be divided into two categories,
                diagnostic tests and antibody tests. Diagnostic tests detect parts of
                the SARS-CoV-2 virus and can be used to diagnose current infection. On
                the other hand, antibody tests look for antibodies in the immune system
                produced in response to SARS-CoV-2, and are not used to diagnose an
                active COVID-19 infection. Antibody tests do not meet the definition of
                COVID-19 test for the purposes of this ETS.
                 Diagnostic tests for current infection fall into two categories:
                Nucleic acid amplification tests (NAATs) and antigen tests. NAATs are a
                type of molecular test that detect genetic material (nucleic acids);
                NAATs for COVID-19 identify the ribonucleic acid (RNA) sequences that
                comprise the genetic material of the virus. NAATs can reliably detect
                small amounts of SARS-CoV-2 and are unlikely to return a false-negative
                result. NAATs use many different methods to detect the virus, including
                reverse transcription-polymerase chain reaction (RT-PCR), which is a
                high-sensitivity, high-specificity \90\ test for diagnosing SARS-CoV-2
                infection. Other types of NAATs that use isothermal amplification
                methods include nicking endonuclease amplification reaction (NEAR),
                transcription mediated amplification (TMA), loop-mediated isothermal
                amplification (LAMP), helicase-dependent amplification (HDA), clustered
                regularly interspaced short palindromic repeats (CRISPR), and strand
                displacement amplification (SDA) (CDC, June 14, 2021).
                ---------------------------------------------------------------------------
                 \90\ Test sensitivity indicates the ability of a test to
                correctly identify people who have a disease. Test specificity
                indicates the ability of a test to correctly identify people who do
                not have a disease. A test with high sensitivity and high
                specificity minimizes inaccurate results.
                ---------------------------------------------------------------------------
                 Most NAATs need to be processed in a laboratory with variable time
                to receive results (approximately 1-2 days), but some NAATs are point-
                of-care tests with results available in about 15-45 minutes. As of
                October 14, 2021, 264 molecular tests (NAATs) and collection devices
                have EUA from the FDA for COVID-19 (FDA, October 14, 2021b). These
                tests may be acceptable under the ETS.
                 Antigen tests may also meet the definition of COVID-19 test under
                this standard. Antigen tests indicate current infection by detecting
                the presence of a specific viral antigen. Most can be processed at the
                point of care with results available in about 1530 minutes. Antigen
                tests generally have similar specificity to, but are less sensitive
                than, NAATs (CDC, October 7, 2021). As of October 14, 2021, thirty-
                seven antigen
                [[Page 61518]]
                tests have EUA from the FDA for COVID-19 (FDA, October 14, 2021a).
                These tests may be acceptable under the ETS.
                 Most antigen tests and some NAATs are conducted at the point of
                care, which means the test processing and result reading is performed
                at or near the place where a specimen is collected so that results can
                be obtained within minutes rather than hours or days. Rapid point-of-
                care tests are administered in various settings operating under a
                Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate
                of waiver, such as physician offices, urgent care facilities,
                pharmacies, school health clinics, workplace health clinics, long-term
                care facilities and nursing homes, and at temporary locations, such as
                drive-through sites managed by local health organizations (FDA,
                November 16, 2020).
                 To be a valid COVID-19 test under this standard, a test may not be
                both self-administered and self-read unless observed by the employer or
                an authorized telehealth proctor. OSHA included the requirement for
                some type of independent confirmation of the test result in order to
                ensure the integrity of the result given the ``many social and
                financial pressures for test-takers to misrepresent their results''
                (Schulte et al., May 19, 2021). This independent confirmation can be
                accomplished in multiple ways, including through the involvement of a
                licensed healthcare provider or a point-of-care test provider. If an
                over-the-counter (OTC) test is being used, it must be used in
                accordance with the authorized instructions. The employer can validate
                the test through the use of a proctored test that is supervised by an
                authorized telehealth provider. Alternatively, the employer could
                proctor the OTC test itself.
                 Employers have the flexibility to select the testing scenario that
                is most appropriate for their workplace. Some employees and employers
                may rely on testing that is conducted by a healthcare provider (e.g.,
                doctor or nurse) who arranges for the specimen to be analyzed at a
                laboratory or at a point-of-care testing location (e.g., a pharmacy).
                The involvement of licensed or accredited healthcare providers allows
                employers to have a high degree of confidence in the suitability of the
                test and the test results. Some large employers who set up their own
                on-site testing program may partner with a healthcare organization
                (e.g., a local hospital or clinic) or rely on a licensed healthcare
                provider to help obtain a CLIA certificate of waiver. Other employers
                may simply require that employees perform and read their own OTC test
                while an authorized employee observes the administration and reading of
                the test to ensure that a new test kit was used and that the test was
                administered properly (e.g., nostrils were swabbed), and to witness the
                test result.
                 Due to the potential for employee misconduct (e.g., falsified
                results), tests that are both self-administered and self-read are not
                acceptable unless they are observed by the employer or an authorized
                telehealth proctor. Some COVID-19 tests are authorized by the FDA to be
                performed only with the supervision of a telehealth proctor, which is
                someone who is trained to observe sample collection and provide
                instructions and result interpretation assistance to individuals using
                the test. The term ``authorized telehealth proctor'' refers to proctors
                who follow the requirements for proctoring specified by the FDA
                authorization. For a more detailed discussion on COVID-19 testing
                requirements under this ETS, see the Summary and Explanation for
                paragraph (g) (Section VI.G. of this preamble).
                 A ``face covering'' means a covering that: (1) Completely covers
                the nose and mouth; (2) is made with two or more layers of a breathable
                fabric that is tightly woven (i.e., fabrics that do not let light pass
                through when held up to a light source); (3) is secured to the head
                with ties, ear loops, or elastic bands that go behind the head. If
                gaiters are worn, they should have two layers of fabric or be folded to
                make two layers; (4) fits snugly over the nose, mouth, and chin with no
                large gaps on the outside of the face; and (5) is a solid piece of
                material without slits, exhalation valves, visible holes, punctures, or
                other openings. This definition includes clear face coverings or cloth
                face coverings with a clear plastic panel that, despite the non-cloth
                material allowing light to pass through, otherwise meet this definition
                and which may be used to facilitate communication with people who are
                deaf or hard-of-hearing or others who need to see a speaker's mouth or
                facial expressions to understand speech or sign language respectively.
                Face coverings can be manufactured or homemade, and they can
                incorporate a variety of designs, structures, and materials. Face
                coverings provide variable levels of protection based on their design
                and construction.
                 As explained in paragraph (i), face covering use is required based
                on an employee's vaccination status. The criteria in the definition
                help to ensure that face coverings that are worn by workers who are not
                fully vaccinated will provide effective source control and some degree
                of personal protection. Source control means reducing the spread of
                large respiratory droplets to others by covering a person's mouth and
                nose. The personal protection afforded by face coverings, as well as
                the benefits and necessity, are described in the Summary and
                Explanation for paragraph (i) (Section VI.I. of this preamble).
                 Face coverings differ from facemasks and respirators, which are
                also defined in paragraph (c) of this section. Face coverings, unlike
                facemasks and respirators, are not considered to be personal protective
                equipment (PPE) under OSHA's general PPE standard (29 CFR 1910.132), as
                discussed in the Summary and Explanation for paragraph (i) (Section
                VI.I. of this preamble).
                 Lastly, face coverings as required by this standard do not have to
                meet a consensus standard, although face coverings that adhere to such
                consensus standards, with design and construction specifications, meet
                the definition and may offer both greater protection and the confidence
                that at least a minimum level of protection has been provided. The
                National Institute for Occupational Safety and Health (NIOSH)
                recommends that employers and workers who want a face covering that
                provides a known level of protection use face coverings that meet a new
                standard, called Workplace Performance and Workplace Performance Plus
                masks, for workplaces. As discussed in the Summary and Explanation for
                paragraph (i) (Section VI.I. of this preamble), the new NIOSH criteria
                and the ASTM Specification for Barrier Face Coverings, F3502-21 (ASTM
                Standard) provide a greater level of source control performance for
                workers when wearing the face covering according to manufacturer's
                instructions. The NIOSH criteria require that face coverings conform to
                the ASTM Standard and meet additional quantitative leakage criteria.
                Although not required by the standard, OSHA notes that face coverings
                that meet ASTM F3502-21 requirements and the new NIOSH criteria may
                offer a higher level of source control and wearer protection than those
                face coverings that do not meet a consensus standard.
                 A ``facemask'' means a surgical, medical procedure, dental, or
                isolation mask that is FDA-cleared, authorized by an FDA EUA, or
                offered or distributed as described in an FDA enforcement policy.
                Facemasks may also be referred to as ``medical procedure masks.'' This
                definition provides clarification about the exception to the face
                covering
                [[Page 61519]]
                requirement under paragraph (i)(1)(iii) that permits facemask use in
                lieu of face coverings. OSHA notes that facemasks are not respirators,
                which are also defined in this section.
                 Facemasks provide protection against exposure to splashes, sprays,
                and spatter of body fluids. Facemasks offer both source control, as
                defined in this section under face coverings, and protection for the
                wearer. OSHA has previously established that facemasks are essential
                PPE for employees in healthcare, under both the general PPE standard
                (29 CFR part 1910.132) and the Bloodborne Pathogens standard (29 CFR
                part 1910.1030). Although not required, the Summary and Explanation for
                paragraph (i) (Section VI.I. of this preamble) addresses their
                inclusion in this standard. Additional information on such facemasks
                can be found in relevant FDA guidance.
                 ``Fully vaccinated'' means (i) a person's status 2 weeks after
                completing primary vaccination with a COVID-19 vaccine with, if
                applicable, at least the minimum recommended interval between doses in
                accordance with the approval, authorization, or listing that is: (A)
                Approved or authorized for emergency use by the FDA; (B) listed for
                emergency use by the World Health Organization (WHO); or (C)
                administered as part of a clinical trial at U.S. site, if the recipient
                is documented to have of primary vaccination with the ``active'' (not
                placebo) COVID-19 vaccine candidate, for which vaccine efficacy has
                been independently confirmed (e.g., by a data and safety monitoring
                board) or if the clinical trial participant from the U.S. sites had
                received a COVID-19 vaccine that is neither approved nor authorized for
                use by the FDA but is listed for emergency use by the WHO. Currently-
                authorized FDA vaccines include Janssen (Johnson & Johnson), which is a
                single-dose primary vaccination, and Pfizer-BioNTech and Moderna, which
                have a two-dose primary vaccination series. This definition is
                consistent with the CDC definition of fully vaccinated (CDC, September
                16, 2021).
                 The definition of ``fully vaccinated'' also means a person's status
                2 weeks after receiving the second dose of any combination of two doses
                of a COVID-19 vaccine that is approved or authorized by the FDA, or
                listed as a two-dose series by the WHO (i.e., heterologous primary
                series of such vaccines, receiving doses of different COVID-19 vaccines
                as part of one primary series). The second dose of the series must not
                be received earlier than 17 days (21 days with a 4-day grace period)
                after the first dose (CDC, October 15, 2021). OSHA has included this
                because people who have received a heterologous primary vaccination
                series (including mixing of mRNA, adenoviral, and mRNA plus adenoviral
                products) are considered by the CDC to also meet this definition. OSHA
                considers a vaccination series that meets the definition in
                subparagraph (ii) to be a primary vaccination for purposes of the
                requirements to support vaccination in paragraph (f).
                 The employer obligations under the ETS differ based on whether each
                employee is fully vaccinated. This definition is relevant to the
                definition of mandatory vaccination policy, in this paragraph (c), as
                well as the provisions under paragraph (d) regarding written
                vaccination policy requirements and relevant procedures for workers who
                are fully vaccinated. Paragraph (e)(2) also addresses fully vaccinated
                employees, including the determination of vaccination status and
                acceptable forms of proof. Lastly, the definition provides clarity with
                regard to the requirements of paragraphs (g) and (i) respectively,
                which contain requirements for regular COVID-19 testing and face
                covering use among employees who are not fully vaccinated.
                 Paragraph (e) requires employers to determine each employee's
                vaccination status, including whether they are fully or partially
                vaccinated. By ``partially vaccinated,'' OSHA means someone who has
                started a primary vaccination series but not completed it (e.g., has
                received one dose of a two-dose series) or has completed their primary
                vaccination and two weeks have not elapsed since the last dose of the
                primary vaccination.
                 A ``mandatory vaccination policy'' is an employer policy requiring
                each employee to be fully vaccinated. To meet the definition of a
                mandatory vaccination policy, the policy must require: Vaccination of
                all employees, including vaccination of all new employees as soon as
                practicable, other than those employees (1) for whom a vaccine is
                medically contraindicated, (2) for whom medical necessity requires a
                delay in vaccination,\91\ or (3) who are legally entitled to a
                reasonable accommodation under federal civil rights laws because they
                have a disability or sincerely held religious beliefs, practices, or
                observances that conflict with the vaccination requirement. OSHA
                intends that ``employee,'' as used in this definition, includes only
                employees that are covered by this ETS and does not include employees
                who are excluded from coverage under paragraph (b)(3).
                ---------------------------------------------------------------------------
                 \91\ As defined by CDC's informational document, Summary
                Document for Interim Clinical Considerations for Use of COVID-19
                Vaccines Currently Authorized in the United States (CDC, September
                29, 2021).
                ---------------------------------------------------------------------------
                 Paragraph (d)(1) of the standard requires an employer to establish,
                implement, and enforce a written mandatory vaccination policy that
                meets this definition. The benefits of vaccination, including the
                effectiveness of vaccination mandates, are discussed in Grave Danger
                (Section III.A. of this preamble) and Need for the ETS (Section III.B.
                of this preamble).
                 OSHA recognizes that vaccination policies may vary, as indicated in
                paragraph (d)(2). Any policy that permits the employee to choose
                between vaccination and COVID-19 testing and face covering use would
                not be considered a mandatory vaccination policy under paragraph
                (d)(1), although such policy is permissible under paragraph (d)(2). In
                some cases, employers may implement vaccination policies that differ by
                location or type of business operation and thus the application of
                paragraph (d)(2) might vary across an employer's workforce. This is
                discussed in greater detail in the Summary and Explanation for
                paragraph (d) (Section VI.D. of this preamble).
                 A ``respirator'' is a type of PPE that is certified by NIOSH under
                42 CFR part 84 or is authorized under an EUA by the FDA. These
                specifications are intended to ensure some consistent level of testing,
                approval, and protection and to prevent the use of counterfeit
                respirators that will not offer adequate protection, which is important
                because respirators are intended to protect the wearer when directly
                exposed to hazards. Respirators protect against airborne hazards by
                removing specific air contaminants from the ambient (surrounding) air
                or by supplying breathable air from a safe source. Common types of
                respirators include filtering facepiece respirators (e.g., N95),
                elastomeric respirators, and powered air-purifying respirators (PAPRs).
                Face coverings, facemasks, and face shields are not respirators.
                 As stated above, there are various types of respirators that would
                fall within this definition. A filtering facepiece respirator (FFR) is
                a negative-pressure particulate respirator with a non-replaceable
                filter as an integral part of the facepiece or with the entire
                facepiece composed of the non-replaceable filtering medium. N95 FFRs
                are the most common type of FFR and are the type of respirator most
                often used to control exposures to infections transmitted via the
                airborne route. When properly worn, N95 FFRs filter at least 95% of
                airborne particles. An
                [[Page 61520]]
                elastomeric respirator is a tight-fitting respirator with a facepiece
                that is made of synthetic or rubber material that permits it to be
                disinfected, cleaned, and reused according to the manufacturer's
                instructions. Elastomeric respirators are equipped with replaceable
                cartridges, canisters, or filters. Lastly, a powered air-purifying
                respirator (PAPR) is an air-purifying respirator that uses a blower to
                force the ambient air through air-purifying elements to the inlet
                covering.
                 This standard does not require the use of respirators. This
                definition is included because it relates to paragraph (i)(1)(iii),
                which exempts employees from wearing face coverings when they are
                wearing respirators or facemasks. In addition, paragraph (i)(4)
                requires employers to permit employees to wear a respirator instead of
                a face covering and permits employers to provide respirators to their
                employees, instead of face coverings. When respirators are used
                pursuant to paragraph (i)(4), the employer must also comply with Sec.
                1910.504, the Mini Respiratory Protection Program.
                 NIOSH has developed a set of regulations in 42 CFR part 84 for
                testing and certifying non-powered, air-purifying, particulate-filter
                respirators. To help address concerns about availability during the
                COVID-19 pandemic, the FDA has issued EUAs for certain PPE products,
                including respiratory protective devices such as respirators. For the
                purposes of this standard, respirators certified by NIOSH, under 42 CFR
                part 84 or authorized under an EUA by the FDA meet the definition.
                Additional information on such respirators can be found in relevant FDA
                and NIOSH guidance.
                 A ``workplace'' is a physical location (e.g., fixed, mobile) where
                the employer's work or operations are performed. It does not include an
                employee's residence, even if the employee is teleworking from their
                residence. Examples of fixed locations include: Offices, retail
                establishments, co-working facilities, and factories or manufacturing
                facilities. A workplace includes the entire site (including outdoor and
                indoor areas, a structure or a group of structures) or an area within a
                site where work or any work-related activity occurs (e.g., taking
                breaks, going to the restroom, eating, entering or exiting work). The
                workplace includes the entirety of any space associated with the site
                (e.g., workstations, hallways, stairwells, breakrooms, bathrooms,
                elevators) and any other space that an employee might occupy in
                arriving, working, or leaving. Examples of employees who have mobile
                workplaces include maintenance and repair technicians who go to homes
                or businesses to provide repair services, or those who provide delivery
                services.
                References
                Centers for Disease Control and Prevention (CDC). (2021, June 14).
                Nucleic Acid Amplification Tests. https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html. (CDC, June 14, 2021).
                Centers for Disease Control and Prevention (CDC). (2021, September
                16). When You've Been Fully Vaccinated: How to Protect Yourself and
                Others. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. (CDC, September 16, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, September
                29). Summary Document for Interim Clinical Considerations for Use of
                COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf. (CDC, September 29, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, October 7).
                Interim Guidance for SARS-CoV-2 Testing in Non-Healthcare
                Workplaces. https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/testing-non-healthcare-workplaces.html. (CDC, October
                7, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, October
                15). Interim Public Health Recommendations for Fully Vaccinated
                People. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. (CDC, October 15, 2021)
                Equal Employment Opportunity Commission (EEOC). (2021, October 25).
                What You Should Know About COVID-19 and the ADA, the Rehabilitation
                Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
                (EEOC, October 25, 2021)
                Food and Drug Administration (FDA). (2020, November 16). COVID-19
                Test Settings: FAQs on Testing for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2. (FDA, November 16, 2020)
                Food and Drug Administration (FDA). (2021a, October 14). In Vitro
                Diagnostics EUAs--Antigen Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021a)
                Food and Drug Administration (FDA). (2021b, October 14)). In Vitro
                Diagnostics EUAs--Molecular Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021b)
                Schulte P et al. (2021, May 19). Proposed Framework for Considering
                SARS-CoV-2 Antigen Testing of Unexposed Asymptomatic Workers in
                Selected Workplaces. J Occup Environ Med. 2021 Aug; 63(8): 646-656.
                Published online 2021, May 19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8327768/. (Schulte et al., May 19, 2021)
                D. Employer Policy on Vaccination
                 Vaccination is a vital tool to reduce the presence and severity of
                COVID-19 cases in the workplace, in communities, and in the nation as a
                whole. Despite the robust protection against COVID-19 that vaccination
                affords, millions of eligible individuals have not yet been vaccinated.
                Current efforts to increase the proportion of the U.S. population that
                is fully vaccinated against COVID-19 are critical to ending the COVID-
                19 pandemic (CDC, September 15, 2021). As described more fully in Need
                for the ETS (Section III.B. of this preamble), mandatory vaccination
                policies work. Therefore, OSHA has determined that requiring or
                strongly encouraging vaccination--the most effective and efficient
                control for reducing COVID-19--is key to ensuring the protection of
                workers against the grave danger of exposure to SARS-CoV-2 in the
                workplace (see Grave Danger, Section III.A. of this preamble).
                Therefore, this ETS requires employers to adopt mandatory vaccination
                policies for their workplaces, with an exception for employers that
                instead adopt a policy allowing employees to elect to undergo regular
                COVID-19 testing and wear a face covering at work in lieu of
                vaccination. In Need for the ETS (Section III.B of this preamble), OSHA
                explains its rationale for providing the exception.
                 Paragraph (d) of this ETS is a critical element in ensuring
                employees' protection, as it requires covered employers to develop,
                implement, and enforce written policies on COVID-19 vaccination for
                their workforces. Paragraph (d)(1) requires the employer to establish,
                implement, and enforce a written mandatory vaccination policy. As
                defined in paragraph (c), a mandatory vaccination policy is an employer
                policy requiring each employee to be fully vaccinated. Such a policy
                must require vaccination of all employees, other than those employees
                who fall into one of three categories: (1) Those for whom a vaccine is
                medically contraindicated, (2) those for whom medical necessity
                requires a delay in
                [[Page 61521]]
                vaccination, or (3) those who are legally entitled to a reasonable
                accommodation under federal civil rights laws because they have a
                disability or sincerely held religious beliefs, practices, or
                observances that conflict with the vaccination requirement. The policy
                must also require all new employees to be vaccinated as soon as
                practicable.
                 Paragraph (d)(2) is a limited exemption from the mandatory
                vaccination policy requirement. As discussed in Need for the ETS
                (Section III.B. of this preamble), vaccination mandates are effective
                at increasing overall vaccination rates and protecting employees and,
                therefore, the agency encourages all employers to implement a mandatory
                vaccination policy. Under paragraph (d)(2), however, employers can
                avoid the mandate in paragraph (d)(1) if the employer establishes,
                implements, and enforces a written policy allowing any employee not
                subject to a mandatory vaccination policy to choose either to: (1) Be
                fully vaccinated against COVID-19 or (2) provide proof of regular
                testing for COVID-19 in accordance with paragraph (g) of this section
                and wear a face covering in accordance with paragraph (i). An employer
                who chooses to operate under paragraph (d)(2), however, must still
                offer the support for vaccination required under paragraph (f) and may
                not prevent employees from getting vaccinated. Adopting a policy under
                paragraph (d)(2) simply means that employees themselves may choose not
                to get vaccinated, in which case they must get tested and wear face
                coverings per the requirements of the standard.
                 OSHA recognizes there may be employers who develop and implement
                partial mandatory vaccination policies, i.e., that apply to only a
                portion of their workforce. An example might be a retail corporation
                employer who has a mixture of staff working at the corporate
                headquarters, performing intermittent telework from home, and working
                in stores serving customers. In this type of situation, the employer
                may choose to require vaccination of only some subset of its employees
                (e.g., those working in stores), and to treat vaccination as optional
                for others (e.g., those who work from headquarters or who perform
                intermittent telework). This approach would comply with the standard so
                long as the employer complies in full with paragraph (d)(1) and (d)(2)
                for the respective groups.
                 OSHA uses the terms establish, implement, and enforce in paragraph
                (d) to emphasize that it is necessary for an employer to first
                determine its policy and create a written record of that policy. After
                determining the policy, an employer must then ensure that it is
                following the policy, as laid out in its written plan. Finally,
                employers must ensure that they enforce the requirements of their
                policies with respect to their workforce, through training and the use
                of such mechanisms as work rules and the workplace disciplinary system,
                if necessary. These requirements apply to the written policy required
                under paragraph (d), whether employers choose to implement the
                mandatory vaccination policy under paragraph (d)(1) or utilize the
                exemption under paragraph (d)(2) for all or a portion of their
                workforce.
                 To ensure that employers' vaccination policies under paragraph (d)
                are comprehensive and effective, the policies should address all of the
                applicable requirements in paragraphs (e)-(j) of this standard,
                including: Requirements for COVID-19 vaccination; applicable exclusions
                from the written policy (e.g., medical contraindications, medical
                necessity requiring delay in vaccination, or reasonable accommodations
                for workers with disabilities or sincerely held religious beliefs);
                information on determining an employee's vaccination status and how
                this information will be collected (as described in paragraph (e));
                paid time and sick leave for vaccination purposes (as described in
                paragraph (f)); notification of positive COVID-19 tests and removal of
                COVID-19 positive employees from the workplace (as described in
                paragraph (h)); information to be provided to employees (pursuant to
                paragraph (j)--e.g., how the employer is making that information
                available to employees); and disciplinary action for employees who do
                not abide by the policy. In addition to addressing the requirements of
                paragraphs (e)-(j) of this standard, the employer should include all
                relevant information regarding the policy's effective date, who the
                policy applies to, deadlines (e.g., for submitting vaccination
                information, for getting vaccinated), and procedures for compliance and
                enforcement, all of which are necessary components of an effective
                plan. Having a comprehensive written policy will provide a solid
                foundation for an effective COVID-19 vaccination program, while making
                it easier for employers to inform employees about the program-related
                policies and procedures, as required under paragraph (j)(1).
                 If an employer utilizes the exemption under paragraph (d)(2), its
                workplace may contain employees who are vaccinated and unvaccinated.
                This might be the case even for employers who establish a mandatory
                vaccination policy under paragraph (d)(1); for example, an employer
                with a mandatory vaccination policy might have employees who cannot be
                vaccinated for medical reasons. Given the additional safety protocols
                under this standard for individuals who are not fully vaccinated (see
                paragraphs (g) and (i)), an employer who has both vaccinated and
                unvaccinated employees will have to develop and include the relevant
                procedures for two sets of employees in the written policy. The
                procedures for those who are fully vaccinated should contain all the
                information previously discussed relevant to establishing,
                implementing, and enforcing a comprehensive written policy. However,
                the procedures applicable to employees who are not fully vaccinated
                (i.e., those who decline vaccination, those who are unable to receive
                vaccination and are, absent undue hardship to their employers, entitled
                to reasonable accommodation) and those who are unable to provide proof
                of vaccination as required by paragraph (e) (who must be treated as not
                fully vaccinated), must include COVID-19 testing and face covering use
                as required by paragraphs (g) and (i), respectively, unless the
                reasonable accommodation from vaccination removes the employee from the
                scope of Sec. 1910.501 (e.g., full time telework consistent with one
                of the exceptions in Sec. 1910.501(b)(3)). OSHA intends that such an
                employer will develop one written plan that includes different policies
                and procedures for vaccinated and unvaccinated employees. The
                requirements of paragraphs (e), (f), (h), and (j) should be addressed
                in the policy regardless of the vaccination requirements adopted by the
                employer.
                 As with all elements of the written plan, an effective written plan
                will explain the testing requirements contained in paragraph (g) for
                unvaccinated employees, and how the employer will implement and enforce
                those policies. As described in paragraph (g)(1), the testing
                requirements differ for employees who report at least once every 7 days
                to a workplace compared to those who do not. Thus, the policy may
                describe different testing procedures for those different groups of
                employees, depending on how often they physically report to a workplace
                where other individuals are present. As described in paragraph (g)(3),
                the testing requirements are temporarily suspended for 90 days
                following a positive COVID-19 test or diagnosis. Thus, the employer's
                policy and procedures to implement this temporary suspension of
                [[Page 61522]]
                testing should be included in their written workplace policy. In
                addition to the testing requirements in paragraph (g), an effective
                policy must address mandatory face covering use as described in
                paragraph (i), including procedures for employee compliance. Employers
                can get more information on the requirements for paragraphs (e) through
                (j), and what they must do to comply with those provisions of the
                standard, in the relevant Summary and Explanation sections (see Section
                VI. of this preamble).
                 As an employer develops their written policy, they must address how
                the policy will apply to new employees. Although many new hires will be
                fully vaccinated, there should be procedures within the plan to collect
                information about the new employee's vaccination status, and determine
                when an unvaccinated new hire must be vaccinated and, for employers
                using a plan under paragraph (d)(2), when COVID-19 testing and face
                covering use will commence if an employee remains unvaccinated. All new
                hires should be treated similarly to any employee who has not entered
                the workplace in the last seven days and will need to be fully
                vaccinated or provide proof of a negative COVID-19 test within the last
                seven days prior to entering the workplace for the first time. It is
                not OSHA's intention to discourage employers from hiring new employees,
                but rather to ensure that new employees are as well-protected from
                COVID-19 hazards in the workplace as current employees and are less
                likely to spread the virus to other employees.
                 An employer may have already developed and implemented a written
                policy on vaccination, testing, and/or face covering use to protect
                employees from COVID-19. It is not OSHA's intent for employers to
                duplicate current effective policies covering the requirements of this
                ETS; however, each employer with a current policy must evaluate that
                policy to ensure it satisfies all of the requirements of this rule.
                Employers with existing policies must modify and/or update their
                current policies to incorporate any missing required elements, and must
                provide information on these new updates or modifications to all
                employees in accordance with paragraph (j)(1). Once the employer has
                developed its policy pursuant to paragraph (d), the policy must be
                reduced to writing in order to be compliant with paragraph (d).
                 The note to paragraph (d) was included in recognition that, under
                federal law, some employees may be entitled to a reasonable
                accommodation from their employer, absent undue hardship. If the worker
                requesting a reasonable accommodation cannot be vaccinated and/or wear
                a face covering because of a disability, as defined by the Americans
                with Disabilities Act (ADA), that worker may be entitled to a
                reasonable accommodation. In addition, if the vaccination, and/or
                testing for COVID-19, and/or wearing a face covering conflicts with a
                sincerely held religious belief, practice or observance, a worker may
                be entitled to a reasonable accommodation. Such accommodations exist
                independently of the Occupational Safety and Health Act and, therefore,
                OSHA does not administer or enforce these laws. Examples of relevant
                federal laws under which an accommodation can be requested include the
                Americans with Disabilities Act (ADA) and Title VII of the Civil Rights
                Act of 1964.
                 For more information, the note refers to a resource produced by the
                Equal Employment Opportunity Commission (EEOC), which is responsible
                for enforcing federal laws that prohibit employment-related
                discrimination based on a person's race, color, religion, sex
                (including pregnancy, gender identity, and sexual orientation),
                national origin, age (40 or older), disability, or genetic information.
                The EEOC resource listed in the note, What You Should Know About COVID-
                19 and the ADA, the Rehabilitation Act, and Other EEO Laws, available
                at https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws, should be helpful to
                employers in navigating employees' requests for accommodations,
                including the process for determining a reasonable accommodation and
                information on undue hardship (EEOC, October 25, 2021). An additional
                resource that might be helpful is the CDC's informational document,
                Summary Document for Interim Clinical Considerations for Use of COVID-
                19 Vaccines Currently Authorized in the United States (CDC, September
                29, 2021), which lists the recognized clinical contraindications to
                receiving a COVID-19 vaccine.
                References
                Centers for Disease Control and Prevention (CDC). (2021, September
                15). Science Brief: Background rationale and evidence for public
                health recommendations for fully vaccinated people. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. (CDC, September 15, 2021)
                Centers for Disease Control and Prevention (CDC). (2021, September
                29). Summary Document for Interim Clinical Considerations for Use of
                COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf. (CDC, September 29, 2021)
                Equal Employment Opportunity Commission (EEOC). (2021, October 25).
                What You Should Know About COVID-19 and the ADA, the Rehabilitation
                Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
                (EEOC, October 25, 2021)
                E. Determination of Employee Vaccination Status
                 To comply with the requirements of the standard, it is essential
                that employers are aware of each employee's vaccination status. As
                discussed in the Summary and Explanation for paragraph (d) (Section
                VI.D. of this preamble), effective implementation and enforcement of a
                written vaccination policy requires the employer to know the
                vaccination status of all employees. Furthermore, the employer must
                know each employee's vaccination status in order to ensure that the
                vaccination, testing, and face covering requirements of the standard
                are met. As such, paragraph (e) includes provisions for determining
                each employee's vaccination status. The standard requires employers to
                determine the vaccination status of each employee (paragraph (e)(1)),
                and also to maintain records of each employee's vaccination status,
                preserve acceptable proof of vaccination for each employee who is fully
                or partially vaccinated, and maintain a roster of each employee's
                vaccination status (paragraph (e)(4)). As discussed more fully below,
                maintenance of records in accordance with this paragraph is subject to
                applicable legal requirements for confidentiality of medical
                information. Additional provisions in paragraph (e) define acceptable
                proof of vaccination status for vaccinated employees (paragraph (e)(2))
                and provide that any employee who does not submit an acceptable form of
                proof of vaccination status must be treated as not fully vaccinated
                (paragraph (e)(3)).
                 Paragraph (e)(1) requires the employer to determine the vaccination
                status of each employee, including whether the employee is fully
                vaccinated. Under paragraph (e)(2), the employer must require each
                vaccinated employee to provide acceptable proof of vaccination status,
                including whether they are fully or partially vaccinated. This is an
                ongoing requirement for the employer (i.e., the employer needs to
                update this information as employees proceed through the vaccination
                process).
                 Paragraph (e)(2) defines what ``acceptable proof of vaccination
                status'' means for purposes of the ETS, and
                [[Page 61523]]
                employers must accept any of the proofs listed in accordance with the
                terms of the standard and as explained more fully below. Under
                paragraph (e)(2), the following are acceptable for proof of
                vaccination: (i) The record of immunization from a health care provider
                or pharmacy; (ii) a copy of the U.S. CDC COVID-19 Vaccination Record
                Card (CDC Form MLS-319813_r, published on September 3, 2020) (CDC,
                October 5, 2021); (iii) a copy of medical records documenting the
                vaccination; (iv) a copy of immunization records from a public health,
                state, or tribal immunization information system; or (v) a copy of any
                other official documentation that contains the type of vaccine
                administered, date(s) of administration, and the name of the health
                care professional(s) or clinic site(s) administering the vaccine(s).
                 To be acceptable as proof of vaccination, any documentation should
                generally include the employee's name, type of vaccine administered,
                date(s) of administration, and the name of the health care
                professional(s) or clinic site(s) administering the vaccine(s). In some
                cases, state immunization records may not include one or more of these
                data fields, such as clinic site; in those circumstances, an employer
                can still rely upon the State immunization record as acceptable proof
                of vaccination. OSHA notes that clinic sites can include temporary
                vaccination facilities used during large vaccine distribution
                campaigns, such as schools, churches, or sports stadiums. Copies,
                including digital copies, of the listed forms of proof are acceptable
                means of documentation so long as they clearly and legibly display the
                necessary information. Digital copies can include, for example, a
                digital photograph, scanned image, or PDF of an acceptable form of
                proof. Some state governments are utilizing digital COVID-19 vaccine
                records showing the same information as the U.S. CDC COVID-19
                Vaccination Record Card (CDC Form MLS-319813_r, published on September
                3, 2020) and providing quick response (QR) codes that when scanned will
                provide the same information (see, e.g., New York State Government,
                n.d., Retrieved October 4, 2021). In certain states, the QR code
                confirms the vaccine record as an official record of the state (see,
                e.g., State of California, n.d., Retrieved October 7, 2021) and
                therefore would provide acceptable proof of vaccination under the ETS
                (see paragraph (e)(2)(iv)). However, as discussed later, the employer
                must retain a copy of the vaccination information retrieved when the QR
                code is scanned, not just the QR code itself, to comply with paragraph
                (e)(4). In requesting proof of vaccination, the employer must take care
                to comply with any applicable Federal laws, including requirements
                under the Privacy Act, 5 U.S.C. 552a, and the Americans with
                Disabilities Act (ADA), 42 U.S.C. 12101 et seq.
                 Each employee who has been partially or fully vaccinated should be
                able to provide one of the forms of acceptable proof listed above
                (paragraphs (e)(2)(i)-(e)(2)(v)). An employee who does not possess
                their COVID-19 vaccination record (e.g., because it was lost or stolen)
                should contact their vaccination provider (e.g., local pharmacy,
                physician's office) to obtain a new copy or utilize their state health
                department's immunization information system. In instances where an
                employee is unable to produce acceptable proof of vaccination under
                paragraphs (e)(2)(i)-(e)(2)(v), paragraph (e)(2)(vi) provides that a
                signed and dated statement by the employee will be acceptable. The
                employee's statement must: (A) Attest to their vaccination status
                (fully vaccinated or partially vaccinated); (B) attest that they have
                lost or are otherwise unable to produce proof required by the standard;
                and (C) include the following language: ``I declare (or certify,
                verify, or state) that this statement about my vaccination status is
                true and accurate. I understand that knowingly providing false
                information regarding my vaccination status on this form may subject me
                to criminal penalties.'' The note to paragraph (e)(2)(vi) explains that
                an employee who attests to their vaccination status should, to the best
                of their recollection, include the following information in their
                attestation: The type of vaccine administered; date(s) of
                administration; and the name of the health care professional(s) or
                clinic site(s) administering the vaccine(s). For example, some of the
                information may be easier to recall, such as receiving a vaccine at a
                mass vaccination site or local pharmacy, while the dates of
                administration might only be remembered as falling within a particular
                month or months. OSHA understands that employees may not be able to
                recall certain information, such as the type of vaccine received.
                Employees providing attestations should include as much of this
                information as they can remember to the best of their ability.
                 Any statement provided under paragraph (e)(2)(vi) must include an
                attestation that the employee is unable to produce another type of
                proof of vaccination (paragraph (e)(2)(vi)(B)). Thus, before an
                employee statement will be acceptable for proof of vaccination under
                paragraph (e)(2)(vi), the employee must have attempted to secure
                alternate forms of documentation via other means (e.g., from the
                vaccine administrator or their state health department) and been
                unsuccessful in doing so. The agency recognizes that securing
                vaccination documentation may be challenging for some members of the
                workforce, such as migrant workers, employees who do not have access to
                a computer, or employees who may not recall who administered their
                vaccines (e.g., if the vaccination was provided at a temporary
                location, such as a church, or during a state or local mass vaccination
                campaign). Thus, for employees who have no other means of obtaining
                proof of vaccination, the standard permits employers to accept
                attestations meeting the requirements in paragraph (e)(2)(vi) as proof
                of vaccination. However, employers should explain to their employees
                that they need to produce vaccination proof through the other means
                listed in paragraph (e)(2), such as by contacting the vaccination
                administrator, if they are able to do so. Once the employee has
                provided a signed and dated attestation that meets the requirements of
                paragraph (e)(2)(vi), the employer no longer needs to seek out one of
                the other forms of vaccination proof for that employee and, depending
                on the content of the attestation, the employer may consider that
                employee either fully or partially vaccinated for purposes of the ETS.
                 Recently, there has been evidence of fraud associated with people
                attesting to their vaccination status (Bergal, September 16, 2021).
                While employers may not invite or facilitate fraud, the ETS does not
                require employers to monitor for or detect fraud. By defining what
                constitutes acceptable proof of vaccination under the ETS, OSHA is
                ensuring that employers can accept proof meeting the requirements of
                paragraph (e) for purposes of compliance with the standard. However,
                the standard's requirements for proof of vaccination are integral to
                ensuring that employees are protected appropriately, either through
                vaccination (the preferred and most effective workplace control in this
                ETS), or through regular testing and use of face coverings. Thus, it is
                paramount that employees provide truthful information regarding their
                vaccination status.
                 As discussed in more detail in the Summary and Explanation for
                paragraph (j) (Section VI.J. of this section), 18 U.S.C. 1001(a), which
                provides for fines or imprisonment of generally up to 5 years for any
                person who ``in any matter within the
                [[Page 61524]]
                jurisdiction'' of the executive branch U.S. Government ``knowingly and
                willfully'' engages in any of the following:
                 (1) Falsifies, conceals, or covers up by any trick, scheme, or
                device a material fact;
                 (2) makes any materially false, fictitious, or fraudulent statement
                or representation; or
                 (3) makes or uses any false writing or document knowing the same to
                contain any materially false, fictitious, or fraudulent statement or
                entry.
                 Similarly, the OSH Act recognizes that OSHA's ability to protect
                workers' safety and health hinges on truthful reporting. For that
                reason section 17(g) of the OSH Act subjects anyone who ``knowingly
                makes any false statement, representation, or certification in any
                application, record, report, plan, or other document filed or required
                to be maintained pursuant to this chapter'' to criminal penalties. 29
                U.S.C. 666(g). False statements made in any proof submitted under
                paragraph (e)(2) of the standard could fall under either or both of 18
                U.S.C. 1001 or section 17(g) of the OSH Act. And by requiring a
                specific declaration about the truth and accuracy of employee
                statements provided under paragraph (e)(2)(vi), employees who are
                unable to provide any means of proof other than their own attestation
                are being made aware that their words are being held to the same
                standard of truthfulness as any other record presented for proof of
                vaccination.
                 OSHA notes that these same prohibitions on false statements and
                documentation can apply to employers. If an employer knows that proof
                submitted by an employee is fraudulent, and even with this knowledge,
                accepts and maintains the fraudulent proof as a record of compliance
                with this ETS, it may be subject to the penalties in 18 U.S.C. 1001 and
                17(g) of the OSH Act.
                 Paragraph (e)(3) provides the mechanism for employers to determine
                vaccination status for employees who do not submit any of the
                acceptable forms of proof of vaccination status. Under paragraph
                (e)(3), any employee who does not provide their employer with one of
                the acceptable forms of proof of vaccination status in paragraph (e)(2)
                must be treated as not fully vaccinated for the purpose of the
                standard. An unvaccinated employee does not need to provide any
                documentation regarding vaccination status under this ETS; however,
                failing to provide acceptable proof of vaccination status will signal
                the employer to consider the employee as not fully vaccinated and to
                note that as their status in the roster. For employers that include
                COVID-19 testing in their written policies under paragraph (d),
                employees without acceptable proof of vaccination status must submit to
                weekly tests (as required by paragraph (g)) and wear a face covering
                (as required by paragraph (i)).
                 Paragraph (e)(4) requires the employer to maintain a record of each
                employee's vaccination status and preserve acceptable proof of
                vaccination for each employee who is fully or partially vaccinated. As
                discussed previously, the employer has various options for acquiring
                proof of vaccination from each employee. An employer may allow
                employees to provide a digital copy of acceptable records, including,
                for example, a digital photograph, scanned image, or PDF of such a
                record that clearly and legibly displays the necessary vaccination
                information. However, to be in compliance with paragraph (e)(4), the
                employer must ensure they are able to maintain a record of each
                employee's vaccination status. Therefore, obtaining an employee's
                vaccination information verbally would not comply with paragraph (e)(2)
                or satisfy the record maintenance requirements of the standard.
                Similarly, the record maintenance requirements of paragraph (e)(4)
                cannot be fulfilled by an employee merely showing the employer their
                vaccination status (e.g., by bringing the CDC COVID-19 vaccination card
                to the workplace and showing it to an employer representative or
                showing an employer representative a picture of the immunization
                records on a personal cellphone). To satisfy paragraph (e)(4), the
                employer must retain a copy of the documentation. As mentioned above,
                some states and local governments utilize QR codes to facilitate proof
                of vaccination. This can be an acceptable form of proof for compliance
                with the standard so long as the employer retains a copy of the
                information retrieved by scanning the QR code and maintains that
                record. Required records of vaccination status can be maintained
                physically or electronically, but the employer must ensure they have
                access to the records at all times.
                 In addition to obtaining and maintaining individual records of each
                employee's vaccination status and preserving acceptable proof of
                vaccination for each employee who is partially or fully vaccinated,
                under paragraph (e)(4) the employer must maintain a roster of each
                employee's vaccination status, subject to applicable confidentiality
                requirements. The roster must list all employees and clearly indicate
                for each one whether they are fully vaccinated, partially (not fully)
                vaccinated, not fully vaccinated because of a medical or religious
                accommodation (see Note to paragraph (d)), or not fully vaccinated
                because they have not provided acceptable proof of their vaccination
                status. As noted previously, any employee that has not provided
                acceptable proof of their vaccination status must be treated as not
                fully vaccinated. Although unvaccinated employees will not have proof
                of vaccination status, the standard requires the employer to include
                all employees, regardless of vaccination status, on the roster.
                 The roster allows the employer to easily access the vaccination
                status for any employee quickly and easily. This will be useful should
                the employer need to respond to a request from an employee or employee
                representative for the aggregate number of fully vaccinated employees
                at a workplace (along with the total number of employees at that
                workplace), as required under paragraph (l)(2). Additionally, the
                roster will help the employer implement the written policy developed in
                accordance with paragraph (d) and comply with other requirements of the
                ETS. And finally, the roster, which must be provided to OSHA on request
                (paragraph (l)(3)), will aid OSHA's ability to effectively and
                efficiently enforce this ETS.
                 The records and roster required by paragraph (e)(4) are considered
                to be employee medical records and must be maintained as such records
                in accordance with 29 CFR 1910.1020 and must not be disclosed except as
                required or authorized by this ETS or other federal law, including the
                Americans with Disabilities Act (ADA), 42 U.S.C. 12101 et seq. These
                records and roster are not subject to the retention requirements of 29
                CFR 1910.1020(d)(1)(i) but must be maintained and preserved while this
                ETS remains in effect. OSHA considers vaccination records required by
                paragraphs (e)(2) and (e)(4) of the ETS to be employee medical records
                concerning the health status of an employee and is requiring this
                personally identifiable medical information to be maintained in a
                confidential manner. OSHA notes that under paragraph (e)(4),
                vaccination records and rosters are employee medical records, and must
                be treated as employee medical records under 29 CFR 1910.1020, without
                regard to whether the records satisfy the definition of employee
                medical record at 29 CFR 1910.1020(c)(6)(i).
                 Paragraph (e) in 29 CFR 1910.1020 includes requirements for access
                to employee medical records by
                [[Page 61525]]
                employees, their designated representatives, and OSHA. However, as
                discussed in more detail below, paragraph (l) of the ETS includes
                specific timeframes within which employers must make vaccine records
                available to employees, OSHA, and other specified individuals.
                Accordingly, the timeframes for providing access to employee medical
                records in 29 CFR 1910.1020(e) do not apply, and employers must follow
                the specific timeframes set forth in paragraph (l) of the ETS for
                providing access to vaccination records.
                 Additionally, 29 CFR 1910.1020(d) addresses the preservation of
                employee exposure and medical records. Paragraph (d)(1)(i) in section
                1910.1020 generally provides that unless a specific occupational safety
                and health standard provides a different period of time, each employer
                must preserve and maintain employee medical records for at least the
                duration of employment plus thirty (30) years. Paragraph (e)(4) of the
                ETS specifically provides that the vaccination records required by the
                ETS are not subject to the retention requirements of 29 CFR
                1910.1020(d)(1)(i). Instead, paragraph (e)(4) states that vaccination
                records must be maintained and preserved only so long as the ETS
                remains in effect.
                 Finally, while the provisions on timeframes for access to records
                and the retention provisions of 29 CFR 1910.1020 do not apply to
                vaccine records required by the ETS, other provisions in that
                regulation can still apply. For example, 29 CFR 1910.1020(h) includes
                requirements for the transfer of employee medical records when an
                employer ceases to do business.
                 OSHA recognizes the possibility that an employer may have already
                collected information about the vaccination status of employees,
                including proof of vaccination, prior to the effective date of this
                ETS. Under paragraph (e)(5), when an employer has ascertained employee
                vaccination status prior to the effective date of the ETS through
                another form of attestation or proof, and retained records of that
                ascertainment, the employer is exempt from the requirements in
                paragraphs (e)(1)-(e)(3). The exemption applies only for each employee
                whose fully vaccinated status has been documented prior to the
                effective date of the standard. For example, an employer may have asked
                each employee to self-report their vaccination status without requiring
                the employee to provide any form of proof. If that self-reporting was
                through oral conversation only, and not documented in some way, the
                employer is not considered to have retained records of that
                ascertainment for the purposes of this ETS. However, if, for example,
                the employer had the employees provide their vaccine information on a
                dated form, or through individual emails retained by the employer, or
                on an employer portal specifically created for employees to provide
                documentation status, or the employer created and retained some other
                means of documentation, the employer is considered to have retained
                records of ascertainment for the purposes of this ETS. Even if the
                record does not have all of the elements of the acceptable forms of
                proof listed in paragraph (e)(2), so long as the employer has
                ascertained employee vaccination status prior to the effective date of
                the ETS through another form of attestation or proof, and retained
                records of that ascertainment, the employer does not need to re-
                determine vaccination status (paragraph (e)(1)) or obtain proof of
                vaccination status (paragraph (e)(2)) for fully vaccinated employees.
                For purposes of paragraph (e)(4), the employer's records of vaccination
                status for each employee whose fully vaccinated status was previously
                documented constitute acceptable proof of vaccination. However, the
                employer must still develop a roster of each employee's vaccination
                status and include on that roster the employees for whom it had
                previously determined and retained records of vaccination status. OSHA
                notes that if the employer has not ascertained employee vaccination
                status for employees prior to the effective date of the ETS, then all
                requirements of paragraph (e) would apply. And all requirements of
                paragraph (e) also apply with respect to employees for whom the
                employer ascertained only partial vaccination status prior to the
                effective date of the ETS.
                References
                Bergal J. (2021, September 16). Fake Vaccine Card Sales Have
                Skyrocketed Since Biden Mandate. https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2021/09/16/fake-vaccine-card-sales-have-skyrocketed-since-biden-mandate. (Bergal, September 16,
                2021).
                Centers for Disease Control and Prevention (CDC). (2021, October 5).
                Getting Your CDC COVID-19 Vaccination Record Card. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccination-card.html.
                (CDC, October 5, 2021).
                New York State Government. (n.d.) Excelsior Pass and Excelsior Pass
                Plus. Retrieved October 4, 2021 from https://covid19vaccine.health.ny.gov/excelsior-pass-and-excelsior-pass-plus.
                (New York State Government, n.d., Retrieved October 4, 2021).
                State of California. (n.d.) Frequently Asked Questions. Retrieved
                October 7, 2021 from https://myvaccinerecord.cdph.ca.gov/faq. (State
                of California, n.d., Retrieved October 7, 2021).
                F. Employer Support for Employee Vaccination
                 As discussed in the Summary and Explanation for paragraph (d)
                (Section VI.D. of this preamble), as well as in Grave Danger and Need
                for the ETS (Sections III.A. and III.B. of this preamble), vaccination
                is the single most efficient and effective method for protecting
                unvaccinated workers from the grave danger posed by COVID-19. This
                emergency temporary standard is therefore designed to strongly
                encourage vaccination. As discussed in detail below, paragraph (f)
                requires employers to support vaccination by providing employees
                reasonable time, including up to four hours of paid time, to receive
                each primary vaccination dose, and reasonable time and paid sick leave
                to recover from side effects experienced following each primary
                vaccination dose. For purposes of the requirements to support
                vaccination in paragraph (f), OSHA considers a vaccination series that
                meets the criteria in subparagraph (ii) of the definition of ``fully-
                vaccinated'' (i.e., a heterologous primary series of such vaccines,
                receiving doses of different COVID-19 vaccines as part of one primary
                series) to be a primary vaccination series, along with the primary
                vaccination described in subparagraph (i) of that definition (see the
                Summary and Explanation for paragraph (c), Section VI.C. of this
                preamble, for more information on the definition of fully vaccinated).
                 Removing logistical barriers to obtaining vaccination is essential
                to increasing workforce vaccination rates, and one such barrier for
                many employees is their lack of time off of work to receive the vaccine
                and recover from any potential side effects (SEIU Healthcare, February
                8, 2021). Employees' concerns about missing work to obtain and recover
                from a COVID-19 vaccination dose are well documented. In a McKinsey
                survey, 12% of respondents stated that the time spent away from work to
                get vaccinated or due to vaccine side effects was a barrier to
                vaccination (Azimi et al., April 9, 2021). In a survey conducted of
                unvaccinated adults in April 2021, a fifth of respondents said they
                were very or somewhat concerned that they may need to take time off to
                go and get the vaccine, and 48% of respondents said that they were very
                or somewhat concerned that they might miss work if
                [[Page 61526]]
                the vaccine side effects make them feel sick (KFF, May 6, 2021). Black
                and Hispanic adults were particularly worried about the potential time
                necessary to receive the vaccine and to recover from vaccine side
                effects; 64% of unvaccinated Hispanic adults and 55% of unvaccinated
                Black adults expressed concern that they might have to miss work due to
                the side effects of a COVID-19 vaccine, and 30% of Hispanic adults and
                23% of Black adults were concerned that they might need to take time
                off work to get a COVID-19 vaccine (KFF, May 6, 2021; KFF, May 17,
                2021). News and journal articles further evince this concern (Roy et
                al., December 29, 2020; Cleveland Documenters, 2021; Rosenberg and
                Stein, August 18, 2021).
                 This concern reflects the fact that many workers do not have access
                to paid time off to receive vaccination or to recover from side
                effects. A KFF survey found that only half of all workers reported that
                their employer provided them with paid time off either to get a COVID-
                19 vaccine or to recover from any side effects (KFF, June 30, 2021). A
                subsequent KFF survey found that only about one-third of workers were
                sure that their employer offered them paid time off to get a COVID-19
                vaccine and recover from side effects (KFF, September 28, 2021).
                Although employee access to paid sick leave is less of a concern for
                employers with 100 or more employees, approximately 12% of employees in
                these situations do not have paid sick leave (BLS, September 2021) and
                in some cases, employees may have already exhausted paid sick leave
                they have received and would need additional time from their employers
                to recover from vaccine side effects.
                 The scarcity of paid time off for vaccination and side effect
                recovery is particularly acute for certain demographic groups. The June
                2021 KFF survey found that only 38% of Black workers reported getting
                either paid time off to get a COVID-19 vaccine or to recover from side
                effects, and that only 41% of workers with household incomes less than
                $40,000 annually had access to such paid time off (KFF, June 30, 2021).
                Similarly, the September 2021 KFF survey found that lower-wage workers
                were particularly unlikely to report access to paid time off for
                vaccination or recovery, with only 23% of workers whose household
                incomes was less than $40,000 reporting that they could take paid time
                off to get vaccinated, and only 28% of that group reporting that they
                could take paid time off to recover from side effects (KFF, September
                28, 2021). Lower-wage workers' lack of access to paid time off for
                vaccination comports with a different report indicating that, before
                the pandemic, about 65% of the lowest-wage workers had no access to
                paid sick leave, meaning that any time off for vaccination or recovery
                would result in lost wages for those who can least afford those losses
                (BLS, September 2021). The need for paid time off to receive
                vaccination is also particularly important for workers with
                disabilities and workers in rural areas because travel to and from
                vaccination sites may take more time or be more logistically difficult
                for those populations (National Safety Council, 2021).
                 Paying workers for the time spent to receive vaccination and to
                recover from side effects has proven to be an effective method for
                increasing vaccination rates. In June 2021, KFF found that
                approximately 75% of employed adults surveyed who received paid time
                off to get the vaccine or to recover from side effects had received at
                least one dose of the vaccine compared to only 51% of those surveyed
                who did not receive paid time off from their employer (KFF, June 30,
                2021). KFF also found that employees who are provided paid time off and
                are encouraged by their employers to get vaccinated are more likely to
                get vaccinated, even after controlling for demographic characteristics
                that may impact vaccination uptake (KFF, June 30, 2021). Another KFF
                survey found that 28% of unvaccinated respondents who did not want to
                get the vaccine as soon as possible said that they would be more likely
                to obtain vaccination if their employer gave them paid time off to get
                vaccinated and recover from any side effects (KFF, May 6, 2021). KFF
                has also found that increasing access to paid leave for vaccination or
                recovery from side effects can also help further reduce disparities in
                vaccination by age and income (KFF, September 28, 2021).
                 In a different survey, paid time off for vaccination and the
                recovery period post-vaccination was the single most-influential action
                for encouraging employee vaccination, with 75% of respondents
                indicating that such paid time off would significantly or moderately
                increase the likelihood that they would get vaccinated (Azimi et al.,
                April 9, 2021). Another survey of nearly 9,000 service workers across
                large grocery, retail, food service, pharmacy, and delivery firms,
                found that vaccination rates were lower than other frontline workers
                who also regularly work in-person and indoors, and when employers
                supported and facilitated vaccination, such as through providing paid
                time off or paid sick leave for vaccination or for recovery from side
                effects, employee vaccination rates were higher than if no support was
                provided, and in May 2021, workers with paid sick leave were 15% more
                likely to have gotten the vaccine than workers without such leave
                (Bellew et al., June 2021).
                 To address this barrier to vaccination, paragraph (f) requires
                employers to support COVID-19 vaccination by providing each employee
                with reasonable time, including up to four hours of paid time, to
                receive each primary vaccination dose, and reasonable time and paid
                sick leave to recover from side effects experienced following any
                primary vaccination dose. Providing this time is essential for all
                unvaccinated employees who are covered by this rule to ensure that they
                can receive primary vaccination dose(s) and recover from side effects
                without sacrificing pay or their jobs. In workplaces where employers
                implement a mandatory vaccination policy in accordance with paragraph
                (d)(1) of this rule, the requirements of paragraph (f) ensure that
                employees are able to comply with the mandatory vaccination policy
                without concern about missing work to do so. In workplaces where the
                employer opts out of implementing a mandatory vaccination policy in
                accordance with paragraph (d)(2), the requirements of paragraph (f)
                encourage employees to choose vaccination, and ensure that employees
                who choose to obtain vaccination, rather than be regularly tested for
                COVID-19 and wear a face covering in most situations when they work
                near others, are not penalized for making that choice.
                 Paragraph (f)(1) requires employers to support COVID-19 vaccination
                for each employee by providing reasonable time to each employee during
                work hours for each of their primary vaccination dose(s), including up
                to four hours of paid time, at the employee's regular rate of pay, for
                the purposes of vaccination. Reasonable time may include, but is not
                limited to, time spent during work hours related to the vaccination
                appointment(s), such as registering, completing required paperwork, all
                time spent at the vaccination site (e.g., receiving the vaccination
                dose, post-vaccination monitoring by the vaccine provider), and time
                spent traveling to and from the location for vaccination (including
                travel to an off-site location (e.g., a pharmacy), or situations in
                which an employee working remotely (e.g., telework) or in an alternate
                location must travel to the workplace to receive the vaccine).
                 Employers are not, however, obligated by this ETS to reimburse
                employees for transportation costs (e.g., gas money,
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                train/bus fare, etc.) incurred to receive the vaccination. This could
                include the costs of travel to an off-site vaccination location (e.g.,
                a pharmacy) or travel from an alternate work location (e.g., telework)
                to the workplace to receive a vaccination dose.
                 Because employers are required to provide reasonable time for
                vaccination during work hours, if an employee chooses to receive a
                primary vaccination dose outside of work hours, employers are not
                required to grant paid time to the employee for the time spent
                receiving the vaccine during non-work hours. However, even if employees
                receive a primary vaccination dose outside of work hours, employers
                must still afford them reasonable time and paid sick leave to recover
                from side effects that they experience during scheduled work time in
                accordance with paragraph (f)(2).
                 An employer may make other efforts to facilitate vaccination of its
                employees by, for example, hosting a vaccine clinic at the workplace
                (e.g., mobile trailer) or partnering with another entity, such as a
                pharmacy or healthcare provider, so that employees can be vaccinated at
                the workplace or at an off-site location. If an employer chooses to
                make the vaccine available to its employees, it must support full
                vaccination (i.e., provide all doses in a primary vaccination, as
                applicable), and assure the availability of reasonable time and paid
                time to each employee to receive the full primary vaccination, and
                reasonable time and paid sick leave to recover from side effects that
                they may experience. Any additional costs incurred by the employer to
                bring vaccination on-site would be covered by the employer, though such
                an approach would likely reduce the amount of paid time needed for
                vaccine administration (but not side effects) because of reduced
                employee travel time.
                 Paragraph (f)(1) specifies that the amount of paid time that an
                employer is required to provide each employee to receive each primary
                vaccination dose is capped at four hours. OSHA has determined that four
                hours would provide reasonable time for most employees to get each
                vaccination dose. Vaccines are widely available to the public at
                clinics, pharmacies, and other locations across the country (see CDC,
                October 8, 2021). Providing four hours of paid time to receive each
                primary vaccination dose is consistent with OSHA's presumption of the
                amount of time needed to receive a vaccination dose in the June 2021
                Healthcare ETS (86 FR 32598), and with the U.S. Office of Personnel
                Management's guidance to federal government agencies on the use of the
                emergency paid leave created for federal employees in the American
                Rescue Plan Act of 2021 (Public Law 117-2), which encouraged agencies
                to offer up to four hours of administrative leave per dose to cover
                time spent getting a vaccine dose, plus additional time if reasonably
                necessary, instead of having employees use emergency paid leave (OPM,
                April 29, 2021). OSHA expects that most employees will need less than
                four hours to receive a vaccination dose.
                 The maximum of four hours of paid time that employers must provide
                under paragraph (f)(1)(ii) for the administration of each primary
                vaccination dose cannot be offset by any other leave that the employee
                has accrued, such as sick leave or vacation leave. OSHA is concerned
                that employees forced to use their sick leave or vacation leave for
                vaccination would have a disincentive to gaining the health protection
                of vaccination. Employers must pay employees for up to four hours of
                time at the employee's regular rate of pay. This may be achieved by
                paying for the time to be vaccinated as work hours for up to four
                hours. Requiring employers to pay for vaccine administration is
                consistent with OSHA's normal approach of requiring employers to bear
                the costs of compliance with safety and health standards.
                 OSHA understands that employees may need much less than four hours
                to receive a primary vaccination dose, for example, if vaccinations are
                offered on-site. However, OSHA also understands that, in some
                circumstances, an employee may need more than four hours to receive a
                primary vaccination dose, in which case the additional time, as long as
                it is reasonable, would be considered unpaid but protected leave. The
                employer cannot terminate the employee if they use a reasonable amount
                of time to receive their primary vaccination doses. The employee may
                use other leave time that they have available (e.g., sick leave or
                vacation time) to cover the additional time needed to receive a
                vaccination dose that would otherwise be unpaid.
                 Paragraph (f)(2) also requires employers to support COVID-19
                vaccination for each employee by providing reasonable time and paid
                sick leave to recover from side effects experienced following any
                primary vaccination dose to each employee for each dose. The paid sick
                leave can be in the form of an employee's accrued sick leave, if
                available. If the employee does not have available sick leave, leave
                must be provided for this purpose.
                 Although some individuals experience no side effects from COVID-19
                vaccination doses, the CDC has identified a range of side effects that
                other individuals may experience following a vaccination dose (CDC,
                April 2, 2021; CDC, September 30, 2021). Side effects may affect
                individuals' ability to engage in daily activities, are typically mild-
                to-moderate in severity, and usually go away in a few days. Common side
                effects include pain, redness, and swelling at the site of injection,
                and systemic side effects throughout the body, including tiredness,
                headache, muscle pain, chills, fever, and nausea. Side effects may be
                sufficiently severe to require the employee to take sick leave from
                work, but will rarely extend beyond a few days. One study found that
                ``unanticipated paid administrative leave was only required for 4.9%
                and 19.79% of individuals after the first and second doses of vaccine,
                respectively'' (Levi et al., September 25, 2021). Employees would not
                typically be expected to need leave solely to address redness or
                swelling at the site of injection, but it is not uncommon for vaccine
                recipients to require some recovery time for many of the other side
                effects. The CDC notes, however, that cough, shortness of breath, runny
                nose, sore throat, or loss of taste or smell are not consistent with
                post-vaccination symptoms and instead may be symptoms of COVID-19 or
                another infection (CDC, April 2, 2021).
                 If an employee already has accrued paid sick leave, an employer may
                require the employee to use that paid sick leave when recovering from
                side effects experienced following a primary vaccination dose.
                Additionally, if an employer does not specify between different types
                of leave (i.e., employees are granted only one type of leave), the
                employer may require employees to use that leave when recovering from
                vaccination side effects. If an employer provides employees with
                multiple types of leave, such as sick leave and vacation leave, the
                employer can only require employees to use the sick leave when
                recovering from vaccination side effects. Employers cannot require
                employees to use advanced sick leave to cover reasonable time needed to
                recover from vaccination side effects under paragraph (f)(2). An
                employer may not require an employee to accrue negative paid sick leave
                or borrow against future paid sick leave to recover from vaccination
                side effects. In other words, the employer cannot require an employee
                to go into the negative for paid sick leave if the employee does not
                have accrued paid
                [[Page 61528]]
                sick leave when they need to recover from side effects experienced
                following a primary vaccination dose. Neither the paid time required to
                receive any vaccine dose(s) nor the paid sick leave required to recover
                from side effects experienced following any vaccination dose are
                retroactive requirements for vaccine dose(s) received prior to the
                promulgation of this ETS.
                 Paragraph (f)(2) requires employers to provide reasonable time and
                paid sick leave to employees to recover from side effects experienced
                following a primary vaccination dose, but does not specify the amount
                of paid sick leave that the employer is required to provide for that
                purpose. Employers may set a cap on the amount of paid sick leave
                available to employees to recover from any side effects, but the cap
                must be reasonable. CDC notes that although some people have no side
                effects, side effects, if experienced, should go away in a few days
                (CDC, September 30, 2021). Another study found that the average
                unanticipated paid administrative leave required by individuals
                experiencing side effects was around two days (1.66 days for the first
                dose and 1.39 days for the second dose) (Levi et al., September 25,
                2021). Generally, OSHA presumes that, if an employer makes available up
                to two days of paid sick leave per primary vaccination dose for side
                effects, the employer would be in compliance with this requirement.
                When setting the cap, an employer would not be expected to account for
                the unlikely possibility of the vaccinat