Procedures for Submission of Rules Under the Horseracing Integrity and Safety Act

Published date05 October 2021
Citation86 FR 54819
Record Number2021-21306
SectionRules and Regulations
CourtFederal Trade Commission
Federal Register, Volume 86 Issue 190 (Tuesday, October 5, 2021)
[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
                [Rules and Regulations]
                [Pages 54819-54826]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-21306]
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                FEDERAL TRADE COMMISSION
                16 CFR Part 1
                Procedures for Submission of Rules Under the Horseracing
                Integrity and Safety Act
                AGENCY: Federal Trade Commission.
                ACTION: Final rule.
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                SUMMARY: The Federal Trade Commission (``FTC'' or ``Commission'') is
                issuing rules pursuant to the Horseracing Integrity and Safety Act
                (``Act'') to provide procedures for the Horseracing Integrity and
                Safety Authority (``Authority'') to submit its proposed rules and
                proposed rule modifications to the Commission for review.
                DATES: These rule revisions are effective on October 5, 2021.
                FOR FURTHER INFORMATION CONTACT: Austin King (202-326-3166), Associate
                General Counsel for Rulemaking, Office of the General Counsel, Federal
                Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
                SUPPLEMENTARY INFORMATION: The Horseracing Integrity & Safety Act,\1\
                enacted on December 27, 2020, directs the Federal Trade Commission to
                oversee the activities of a private, self-regulatory organization
                called the Horseracing Integrity and Safety Authority.
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                 \1\ 15 U.S.C. 3051 through 3060.
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                 Section 4(a) of the Act, 15 U.S.C. 3053(a), requires the Authority
                to submit to the Commission, in accordance with such rules as the
                Commission may prescribe under Section 553 of Title 5, United States
                Code, any proposed rule, or proposed modification to a rule, of the
                Authority relating to: (1) The bylaws of the Authority; (2) a list of
                permitted and prohibited medications, substances, and methods,
                including allowable limits of permitted medications, substances, and
                methods; (3) laboratory standards for accreditation and protocols; (4)
                standards for racing surface quality maintenance; (5) racetrack safety
                standards and protocols; (6) a program for injury and fatality data
                analysis; (7) a program of research and education on safety,
                performance, and anti-doping and medication control; (8) a description
                of safety, performance, and anti-doping and medication control rule
                violations applicable to covered horses and covered persons; (9) a
                schedule of civil sanctions for violations; (10) a process or
                procedures for disciplinary hearings; and (11) a formula or methodology
                for determining the assessments described in 15 U.S.C. 3052(f).
                 Accordingly, the Commission is adding a new subpart S to part 1 of
                its Rules of Practice, to provide procedures for the Authority to file
                its proposed rules and proposed modifications to existing rules with
                the Commission for review.
                I. Section 1.140--Definitions
                 Section 1.140 defines relevant terms used in the proposed
                regulations. Each definition is based on a corresponding definition
                contained in Section 2 of the Act, 15 U.S.C. 3051, except as otherwise
                noted below.
                 The definition of ``HISA Guidance'' derives from Section 5(g)(1) of
                the Act, 15 U.S.C. 3054(g)(1), which states the Authority may issue
                guidance that ``sets forth an interpretation of an existing rule,
                standard, or procedure of the Authority'' or a ``policy or practice
                with respect to the administration or enforcement of such an existing
                rule, standard, or procedure'' and ``relates solely to the
                administration of the Authority; or any other matter, as specified by
                the Commission, by rule, consistent with the public interest and the
                purposes of this subsection [15 U.S.C. 3054(g)(1)].'' The Commission is
                adopting this definition and adding that HISA Guidance does not have
                the force of law, to distinguish HISA Guidance from a proposed
                modification to a rule.
                 The Act does not contain definitions for ``proposed rule'' or
                ``proposed modification.'' However, because these terms are used
                frequently throughout the regulations, the Commission is defining them
                for clarity. ``Proposed rule'' is defined as any rule proposed by the
                Authority pursuant to the Act. ``Proposed rule modification'' or
                ``modification'' is defined as any proposed modification to a rule,
                proposed rule change, or any interpretation or statement of policy or
                practice relating to an existing rule of the Authority that is not HISA
                Guidance and would have the force of law if
                [[Page 54820]]
                approved as a final rule. A proposed modification is distinguished from
                HISA Guidance in that a modification would have the force of law if
                approved and must therefore be approved by the Commission pursuant to
                Section 4(b)(2) of the Act, 15 U.S.C. 3053(b)(2). HISA Guidance need
                not be approved by the Commission but takes effect upon submission to
                the Commission pursuant to Section 5(g)(3) of the Act, 15 U.S.C.
                3054(g)(3).
                II. Section 1.141--Required Submissions
                 The Act requires the Authority to submit proposed rules or proposed
                rule modifications on certain subjects to the Commission for approval.
                These subjects are set forth in Section 4(a) of the Act, 15 U.S.C.
                3053(a), which states the Authority must submit to the Commission, in
                accordance with such rules as the Commission may prescribe under
                Section 553 of Title 5, any proposed rule, or proposed modification to
                a rule, of the Authority relating to: (1) The bylaws of the Authority;
                (2) a list of permitted and prohibited medications, substances, and
                methods, including allowable limits of permitted medications,
                substances, and methods; (3) laboratory standards for accreditation and
                protocols; (4) standards for racing surface quality maintenance; (5)
                racetrack safety standards and protocols; (6) a program for injury and
                fatality data analysis; (7) a program of research and education on
                safety, performance, and anti-doping and medication control; (8) a
                description of safety, performance, and anti-doping and medication
                control rule violations applicable to covered horses and covered
                persons; (9) a schedule of civil sanctions for violations; (10) a
                process or procedures for disciplinary hearings; and (11) a formula or
                methodology for determining assessments described in 15 U.S.C. 3052(f).
                The Commission is adopting this language in its regulations.
                 The Commission is also adding a provision that the Authority must
                submit ``any other proposed rule or modification the Act requires the
                Authority to submit to the Commission for approval.'' For instance, the
                Act requires the Authority to submit rules regarding modifications to
                baseline anti-doping standards (15 U.S.C. 3055(g)(3)(b)) and
                modifications to racetrack safety rules (15 U.S.C. 3056(c)(2)(B)(ii)).
                Section 5(c)(2) of the Act, 15 U.S.C. 3054(c)(2), requires the
                Authority to submit to the Commission for approval any rules and
                procedures under Section 5(c)(1)(A) of the Act, 15 U.S.C.
                3054(c)(1)(A), authorizing access to offices, racetrack facilities,
                other places of business, books, records, and personal property of
                covered persons used in the care, treatment, training, and racing of
                covered horses; authorizing the issuance and enforcement of subpoenas
                and subpoenas duces tecum; and authorizing other investigatory powers
                of the nature and scope exercised by State racing commissions before
                the program effective date. Such proposed rules and modifications must
                also be submitted to the Commission for approval.
                III. Section 1.142--Submission of Proposed Rule or Modification
                 The Act requires the Commission to evaluate the Authority's
                proposed rules and modifications to determine whether they are
                consistent with the Act and the applicable rules approved by the
                Commission. See 15 U.S.C. 3053(c)(2). To avoid delays in the rule
                review process, the Commission is requiring the Authority to submit the
                information necessary for it to evaluate the proposed rule or
                modification promptly and efficiently. Section 1.142 is designed to
                elicit the information the Commission needs to determine whether the
                proposed rule or modification is consistent with the Act and the rules
                and regulations issued thereunder.
                A. Contents of Submission
                 For a submission to qualify as a proposed rule or proposed
                modification to a rule under Section 4(a) of the Act, 15 U.S.C.
                3053(a), the Authority must submit a complete draft of the Federal
                Register document for its proposed or modified rule, which includes the
                text of the rule and a statement of the purpose of, and statutory basis
                for, the proposed rule or modification. The Commission's intention is
                to require the Authority to provide an explanation of its rules that
                will allow both the Commission and the public to understand the nature
                and purpose of its proposed rules or modifications--the reasons for
                adopting the proposed rule or modification; any problems the proposed
                rule or modification is intended to address and how the proposed rule
                or modification will resolve those problems; and how the proposed rule
                or modification will affect covered persons, covered horses, and
                covered horseraces.
                 The Commission is also requiring the Authority to explain the
                statutory basis for its proposed rules or modifications. To evaluate a
                proposed rule or modification, the Commission must be able to
                understand why the Authority believes its proposed rule or modification
                is consistent with the Act and the applicable rules approved by the
                Commission. Evaluation of a proposed rule or modification will also be
                aided by the Authority's description of any reasonable alternatives it
                considered and the reasons it selected the proposed rule or
                modification over the alternatives.
                 The Act does not give the Authority broad discretion in developing
                rules. It sets forth guardrails, in the form of baseline standards for
                anti-doping and medication control (15 U.S.C. 3055(g)(2)(A)), racetrack
                safety standards which the Authority must consider (15 U.S.C.
                3056(a)(2)), guidelines for determining funding and calculating costs
                (15 U.S.C. 3052(f)(1)(C)(ii)), a specific formula for the assessment
                and collection of fees (15 U.S.C. 3052(f)(3)(C)), who must register
                with the Authority and the conditions of registration (15 U.S.C.
                3054(d)), guidelines for establishing rule violations (15 U.S.C.
                3057(a)(2)), requisite elements of the Authority's results management
                and disciplinary program (15 U.S.C. 3057(c)(2)), guidelines for
                establishing civil sanctions (15 U.S.C. 3057(d)(2)), and more.
                Accordingly, the Authority must explain why its proposed rule or
                modification is consistent with any standards in the Act and the rules
                approved by the Commission. Because the requisite considerations for
                anti-doping and racetrack safety are the most prescriptive, this
                section specifically addresses those standards and factors. The less
                prescriptive standards and factors must also be addressed, and the
                Commission provides for this in a less prescriptive rule, as discussed
                below.
                1. Anti-Doping and Medication Control Program Considerations
                 When proposing a rule or modification to the horseracing anti-
                doping and medication control program, the Authority must explain how
                it considered the factors in Section 6 of the Act, 15 U.S.C. 3055,
                including the unique characteristics of a breed of horse made subject
                to the Act by election of a State racing commission or breed governing
                organization for such horse pursuant to Section 5(l) of the Act, 15
                U.S.C. 3054(l), as required by Section 6(a)(2) of the Act, 15 U.S.C.
                3055(a)(2). The Authority must explain how it considered the factors in
                Section 6(b) of the Act, 15 U.S.C. 3055(b), namely that: (1) Covered
                horses should compete only when they are free from the influence of
                medications, other foreign substances, and methods that affect their
                performance; (2) covered horses that are injured or unsound should not
                train or participate in covered races, and the use
                [[Page 54821]]
                of medications, other foreign substances, and treatment methods that
                mask or deaden pain in order to allow injured or unsound horses to
                train or race should be prohibited; (3) rules, standards, procedures,
                and protocols regulating medication and treatment methods for covered
                horses and covered races should be uniform and uniformly administered
                nationally; (4) to the extent consistent with chapter 57A of title 15,
                consideration should be given to international anti-doping and
                medication control standards of the International Federation of
                Horseracing Authorities and the Principles of Veterinary Medical Ethics
                of the American Veterinary Medical Association; (5) the administration
                of medications and treatment methods to covered horses should be based
                on an examination and diagnosis that identifies an issue requiring
                treatment for which the medication or method represents an appropriate
                component of treatment; (6) the amount of therapeutic medication a
                covered horse receives should be the minimum necessary to address the
                diagnosed health concerns identified during the examination and
                diagnostic process; and (7) the welfare of covered horses, the
                integrity of the sport, and the confidence of the betting public
                require full disclosure to regulatory authorities regarding the
                administration of medications and treatments to covered horses.
                 In addition, Section 6(g)(2)(A) of the Act, 15 U.S.C.
                3055(g)(2)(A), provides that certain baseline anti-doping and
                medication control rules must constitute the initial rules of the
                horseracing anti-doping and medication control program and, except as
                exempted pursuant to Section 6(e) and (f) of the Act, 15 U.S.C. 3055(e)
                and (f), remain in effect at all times after the program effective
                date. Such baseline anti-doping and medication control rules include:
                (1) The lists of permitted and prohibited substances (including drugs,
                medications, and naturally occurring substances and synthetically
                occurring substances) in effect for the International Federation of
                Horseracing Authorities, including the International Federation of
                Horseracing Authorities International Screening Limits for urine, dated
                May 2019, and the International Federation of Horseracing Authorities
                International Screening Limits for plasma, dated May 2019; (2) the
                World Anti-Doping Agency International Standard for Laboratories
                (version 10.0), dated November 12, 2019; (3) the Association of Racing
                Commissioners International out-of-competition testing standards, Model
                Rules of Racing (version 9.2); and (4) the Association of Racing
                Commissioners International penalty and multiple medication violation
                rules, Model Rules of Racing (version 6.2). In the case of a conflict
                among the rules, Section 6(g)(2)(B) of the Act, 15 U.S.C.
                3055(g)(2)(B), provides that the most stringent rule shall apply.
                Accordingly, the Commission is requiring the Authority to state whether
                a proposed rule adopts the baseline standards identified in Section
                6(g)(2)(A) of the Act, 15 U.S.C. 3055(g)(2)(A). If there is a conflict
                in any baseline standards identified in Section 6(g)(2)(A) of the Act,
                15 U.S.C. 3055(g)(2)(A), the Authority must identify the conflict and
                state whether the standard it adopted is the most stringent standard.
                Under Section 6(g)(3)(C) of the Act, 15 U.S.C. 3055(g)(3)(C), ``[t]he
                Authority shall not approve any proposed modification that renders an
                anti-doping and medication control rule less stringent than the
                baseline anti-doping and medication control rules . . . without the
                approval of the anti-doping and medication control enforcement
                agency.'' Thus, for a proposed rule modification, the Authority must
                explain whether the modification renders an anti-doping and medication
                control rule less stringent than the baseline anti-doping and
                medication control rules described in Section 6(g)(2)(A) of the Act, 15
                U.S.C. 3055(g)(2)(A), and state whether the anti-doping and medication
                control enforcement agency has approved of the change.
                2. Racetrack Safety Program Considerations
                 Section 7 of the Act, 15 U.S.C. 3056, requires the Authority to
                consider certain factors when developing the racetrack safety program.
                Accordingly, when proposing a rule or modification to any rule
                regarding its racetrack safety program, the Authority must explain how
                the proposed rule or modification meets the requirements in Section
                7(b) of the Act, 15 U.S.C. 3056(b), which provides that the horseracing
                safety program must include the following: (1) A set of training and
                racing safety standards and protocols taking into account regional
                differences and the character of differing racing facilities; (2) a
                uniform set of training and racing safety standards and protocols
                consistent with the humane treatment of covered horses, which may
                include lists of permitted and prohibited practices or methods (such as
                crop use); (3) a racing surface quality maintenance system that takes
                into account regional differences and the character of differing racing
                facilities (which may include requirements for track surface design and
                consistency and established standard operating procedures related to
                track surface, monitoring, and maintenance, such as standardized
                seasonal assessment, daily tracking, and measurement); (4) a uniform
                set of track safety standards and protocols, that may include rules
                governing oversight and movement of covered horses and human and equine
                injury reporting and prevention; (5) programs for injury and fatality
                data analysis, that may include pre- and post-training and race
                inspections, use of a veterinarian's list, and concussion protocols;
                (6) the undertaking of investigations at racetrack and non-racetrack
                facilities related to safety violations; (7) procedures for
                investigating, charging, and adjudicating violations and for the
                enforcement of civil sanctions for violations; (8) a schedule of civil
                sanctions for violations; (9) disciplinary hearings, which may include
                binding arbitration, civil sanctions, and research; (10) management of
                violation results; (11) programs relating to safety and performance
                research and education; and (12) an evaluation and accreditation
                program that ensures racetracks in the United States meet the standards
                described in the elements of the Horseracing Safety Program.
                 The Authority must also consider the safety standards in Section
                7(a)(2) of the Act, 15 U.S.C. 3056(a)(2), which provide that in the
                development of the horseracing safety program for covered horses,
                covered persons, and covered horseraces, the Authority and the
                Commission must take into consideration existing safety standards,
                including the National Thoroughbred Racing Association Safety and
                Integrity Alliance Code of Standards, the International Federation of
                Horseracing Authority's International Agreement on Breeding, Racing,
                and Wagering, and the British Horseracing Authority's Equine Health and
                Welfare program. The Commission is therefore requiring the Authority to
                explain how it considered and whether it adopted any of the standards
                in Section 7(a)(2) of the Act,15 U.S.C. 3056(a)(2). If any horseracing
                safety standards in Section 7(a)(2) of the Act, 15 U.S.C. 3056(a)(2),
                were considered but not adopted or were modified, the Authority must
                explain why it decided not to adopt or why it decided to modify such
                standard.
                3. Other Considerations
                 The Commission is incorporating the specific anti-doping and
                racetrack safety standards into this section because they are the most
                prescriptive and extensive, but this should not be read as an
                [[Page 54822]]
                invitation to dispense with the less-prescriptive guardrails set forth
                in the Act. To the extent the Act requires the Authority to consider
                any factors or standards not specifically referenced in this section,
                the Authority must explain whether and how it considered those factors
                when proposing a rule or modification. For instance, when proposing a
                civil sanctions rule or modification pursuant to Section 8(d)(1) of the
                Act, 15 U.S.C. 3057(d)(1), the Authority must explain how the rule or
                modification meets the requirements of Section 8(d)(2) of the Act, 15
                U.S.C. 3057(d)(2).
                B. Supporting Documentation
                 The Commission is requiring the Authority to submit any pertinent
                factual information it relied on in developing its proposed rule or
                modification. More specifically, the Authority's submission to the
                Commission must include a copy of existing standards used as a
                reference for the development of a proposed rule or modification and
                any scientific data, studies, or analysis underlying the development of
                the proposed rule or modification. The Commission anticipates
                receiving, for instance, a copy of the lists of permitted and
                prohibited substances in effect for the International Federation of
                Horseracing Authorities, including the International Federation of
                Horseracing Authorities International Screening Limits for urine, dated
                May 2019, and any other rules and standards referenced in Section
                6(g)(2)(A) of the Act, 15 U.S.C. 3055(g)(2)(A) when the Authority's
                baseline rules for anti-doping are submitted. For organizational
                purposes, supporting documentation must be attached as exhibits, and
                each exhibit must clearly identify the proposed rule or modification it
                supports.
                C. Redline Document for Proposed Rule Modification
                 To enable the Commission to quickly and easily identify the
                substance of a proposed rule modification, the Commission is requiring
                the Authority to provide a redline document of the existing rule,
                marked with the proposed changes.
                D. Timing of Submission
                 Section 4(c)(1) of the Act, 15 U.S.C. 3053(c)(1) provides for a 60-
                day timeframe between the Commission's publication of the Authority's
                proposed rule or modification in the Federal Register for public
                comment and the date the Commission must approve or disapprove the
                Authority's proposed rule or modification. To ensure it has sufficient
                time for review, the Commission is requiring the Authority to provide
                the information it needs to evaluate the Authority's proposed rule or
                modification at least 90 days in advance of the date the Authority
                proposes having its proposed rule or modification published in the
                Federal Register for public comment. This will give the Commission
                additional time to evaluate the Authority's proposed rule or
                modification. It should be noted this 90-day timeframe serves as a
                minimum, not a maximum, timeframe. The Secretary may shorten the
                timeframe if the Authority demonstrates that a shorter timeframe is
                necessary to meet statutory deadlines.
                E. Conclusory Statements and Failure To Provide Requisite Analysis
                 The Authority must provide an adequate basis for the Commission's
                review of its rules. The Commission seeks to understand the Authority's
                analysis of the information it relied on to determine whether a
                proposed rule or modification was warranted and if so, what provisions
                the rule should contain. To this end, the information required under
                this section must be sufficiently detailed and contain sufficient
                analysis to support a Commission finding that a proposed rule or
                modification satisfies the statutory requirements. A mere assertion or
                conclusory statement that a proposed rule or modification is consistent
                with the requirements of the Act, for instance, is insufficient. If the
                Authority fails to describe and justify the proposed rule or
                modification in the manner described in this section, or fails to
                submit the information required by this section, the Commission may not
                have sufficient information to make an affirmative finding that the
                proposed rule or modification is consistent with the Act and the
                applicable rules approved by the Commission.
                F. Public Comments
                 Section 4(d)(2) of the Act, 15 U.S.C. 3053(d)(2), provides the
                ``Commission shall publish in the Federal Register any [ ] proposed
                rule, standard, or procedure and provide an opportunity for public
                comment.'' However, the Act gives the Commission only a total of 60
                days after publication to approve or disapprove a proposed rule or
                modification once it has been published in the Federal Register. Given
                that the Commission and the Authority will need time to review
                comments, the Act functionally provides for a much more limited comment
                period of approximately 30 days or less. To ensure the public has an
                adequate opportunity to review and understand the Authority's rules,
                ask questions, and provide comments, the Commission is encouraging the
                Authority to make its proposed rules publicly available and solicit
                public comments in advance of providing any submissions to the
                Commission. To avoid delays in Commission approval of its rules, the
                Authority should not wait until its proposed rule is published in the
                Federal Register to solicit its own public comments.
                 In a March 21, 2021 letter \2\ to the Acting Chairwoman, Rebecca
                Kelly Slaughter, the Act's sponsors stated ``[t]he relationship between
                the [Commission] and the Authority is closely modeled on the enduring
                and effective relationship between the Securities and Exchange
                Commission (SEC) and Financial Industry Regulatory Authority (FINRA), a
                private self-regulatory organization.'' As part of its own rulemaking
                process, the FINRA Board of Governors may authorize the publication of
                its own Regulatory Notice soliciting comments on a rule proposal prior
                to its submission to the SEC.\3\ If FINRA decides to issue a Regulatory
                Notice soliciting public comment on a proposal, the comment period
                typically is open for one to two months.\4\ All comments become part of
                FINRA's ``official record'' of the rule proposal, and since December 1,
                2003, FINRA has posted all comment letters on its website.\5\ Depending
                on the comments received in response to the Regulatory Notice and any
                changes made to the proposal, FINRA staff will either return to the
                FINRA Board with a revised proposal or will file the rule proposal with
                the SEC for notice and comment.\6\ Soliciting comments, as FINRA does,
                in advance of submitting any proposed rules or modifications to the
                Commission would benefit both the Authority, the regulated community,
                and the Commission. It would provide transparency and enable the
                Authority to resolve any issues with its rules prior to their
                submission to the Commission.
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                 \2\ See Letter from Senator Mitch McConnell to Acting Chairwoman
                Rebecca Kelly Slaughter (Mar. 23, 2021) (on file with the Federal
                Trade Commission).
                 \3\ See FINRA Rulemaking process, https://www.finra.org/rules-guidance/rulemaking-process (last visited July 9, 2021).
                 \4\ Id.
                 \5\ Id.
                 \6\ Id.
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                 If public comments are solicited, the Commission is requiring the
                Authority to attach, as an exhibit to its submission under Sec. 1.142,
                a copy of the comments. The Commission encourages the Authority to make
                such comments publicly available on its own website. In
                [[Page 54823]]
                addition, the Authority's draft Federal Register document must include
                a summary of the substance of all comments received and the Authority's
                written response to all significant issues raised in such comments.
                This advance resolution of comments will greatly facilitate the process
                of review of any proposed rules or modifications the Authority submits
                to the Commission.
                IV. Section 1.143--Submissions to the Secretary
                 This section provides guidance for the Authority when submitting
                documents to the Secretary of the Commission.
                 All rule submissions made pursuant to Sec. 1.142 and 15 U.S.C.
                3053(a), rate increases which must be reported to the Commission under
                15 U.S.C. 3052(f)(1)(C)(iv), or HISA Guidance which must be submitted
                to the Commission under 15 U.S.C. 3054(g)(2), must be emailed to the
                Secretary of the Commission at [email protected]. The subject
                line of the email must state: ``HISA Rule Submission,'' ``HISA Rate
                Increase Submission,'' or ``HISA Guidance Submission'' as applicable.
                This will enable the Secretary to easily identify submissions from the
                Authority and route them to the appropriate office.
                 To facilitate Commission review, documents must be organized and
                sent in a format that will facilitate the submission of documents to
                the Office of the Federal Register. Except for supporting documentation
                submitted pursuant to Sec. 1.142(b) (existing standards used as a
                reference for the development of the proposed rule or modification, and
                scientific data, studies, or analysis underlying the development of the
                proposed rule or modification) and copies of public comments submitted
                pursuant to Sec. 1.142(f), all documents submitted to the Secretary
                must be in a word processing format. This will enable the Commission to
                more easily make modifications to Federal Register documents, provide
                feedback on rule text, and draft orders. For organizational purposes,
                the Commission is requiring submissions with more than one attachment
                to contain a table of contents in the body of the email with a brief
                description of each item. The Authority must also provide the contact
                information for a person on the staff of the Authority responsible for
                responding to questions from the Commission. To facilitate submissions
                to the Office of the Federal Register, the Commission is requiring that
                the Authority's draft Federal Register documents follow the relevant
                format and editorial requirements for regulatory documents in the
                Office of Federal Register's Document Drafting Handbook, 1 CFR parts
                18, 21, and 22. Specifically, draft Federal Register documents must
                contain proper preamble captions and content; state the purpose of, and
                basis for, the proposed rule or modification; set forth regulatory
                text, headings, and authority citations; use correct numbering,
                structure, and amendatory language; and conform to style and formatting
                established by the Office of the Federal Register and Government
                Publishing Office (see, specifically, section 2.17 (proposed rules) of
                the Office of the Federal Register's Document Drafting Handbook).
                 If a document filed with the Secretary contains confidential
                information, the Secretary must be so informed, and a request for
                confidential treatment must be submitted in accordance with 16 CFR 4.9.
                Filings submitted electronically on or before 5:30 p.m. Eastern Time,
                on a business day, will be deemed filed on that business day, and all
                filings submitted after 5:30 p.m. Eastern Time, will be deemed filed on
                the next business day. This section also provides the Secretary of the
                Commission may reject a document for filing that fails to comply with
                the Commission's rules for filing in this section or Sec. 1.142.
                Finally, if the conditions in this section and Sec. 1.142 have been
                satisfied, the Commission will publish the proposed rules or
                modifications in the Federal Register for public comment.
                V. Section 1.144--Approval or Disapproval of Proposed Rules or
                Modifications
                 Section 4(c)(1) of the Act, 15 U.S.C. 3053(c)(1) provides, ``Not
                later than 60 days after the date on which a proposed rule or
                modification is published in the Federal Register, the Commission shall
                approve or disapprove the proposed rule or modification.'' In addition,
                Section 4(c)(2) of the Act, 15 U.S.C. 3053(c)(2), provides ``[t]he
                Commission shall approve a proposed rule or modification if the
                Commission finds that the proposed rule or modification is consistent
                with [ ] this chapter; and [ ] applicable rules approved by the
                Commission.'' Accordingly, Sec. 1.144 provides the Commission will
                approve or disapprove a proposed rule or modification by issuing an
                order within 60 days of the date the proposed rule or modification was
                published in the Federal Register for public comment. The Commission
                will approve a proposed rule or modification if it finds such proposed
                rule or modification is consistent with the Act and the applicable
                rules approved by the Commission. Further, a proposed rule or
                modification will not take effect unless it has been approved by the
                Commission.
                 Because these rule revisions relate solely to agency procedure and
                practice, publication for notice and comment is not required under the
                Administrative Procedure Act. 5 U.S.C. 553(b).\7\
                ---------------------------------------------------------------------------
                 \7\ For this reason, the requirements of the Regulatory
                Flexibility Act are also inapplicable. 5 U.S.C. 601(2), 604(a).
                Likewise, the amendments do not modify any FTC collections of
                information within the meaning of the Paperwork Reduction Act. 44
                U.S.C. 3501 et seq.
                ---------------------------------------------------------------------------
                List of Subjects in 16 CFR Part 1
                 Administrative practice and procedure.
                 For the reasons set forth in the preamble, the Federal Trade
                Commission amends title 16, chapter I, subchapter A of the Code of
                Federal Regulations as follows:
                PART 1--GENERAL PROCEDURES
                0
                1. The authority citation for part 1 continues to read as follows:
                 Authority: 15 U.S.C. 46; 15 U.S.C. 57a; 5 U.S.C. 552; 5 U.S.C.
                601 note.
                0
                2. Add subpart S to read as follows:
                Subpart S--Procedures for Submissions Under the Horseracing
                Integrity and Safety Act
                Sec.
                1.140 Definitions.
                1.141 Required submissions.
                1.142 Submission of proposed rule or modification.
                1.143 Submissions to the Secretary.
                1.144 Approval or disapproval of proposed rules and proposed rule
                modifications.
                 Authority: 15 U.S.C. 3053.
                Sec. 1.140 Definitions.
                 When used in relation to the Horseracing Integrity and Safety Act,
                15 U.S.C. 3051 through 3060, and this subpart--
                 Act means the Horseracing Integrity and Safety Act, 15 U.S.C. 3051
                through 3060.
                 Breeder means a person who is in the business of breeding covered
                horses.
                 Commission means the Federal Trade Commission.
                 Covered horse means any Thoroughbred horse, or any other horse made
                subject to the Act by election of the applicable State racing
                commission or the breed governing organization for such horse under 15
                U.S.C. 3054(l), during the period--
                 (1) Beginning on the date of the horse's first timed and reported
                workout at a racetrack that participates in covered horseraces or at a
                training facility; and
                [[Page 54824]]
                 (2) Ending on the date on which the Authority receives written
                notice that the horse has been retired.
                 Covered horserace means any horserace involving covered horses that
                has a substantial relation to interstate commerce, including any
                Thoroughbred horserace that is the subject of interstate off-track or
                advance deposit wagers.
                 Covered persons means all trainers, owners, breeders, jockeys,
                racetracks, veterinarians, persons (legal and natural) licensed by a
                State racing commission and the agents, assigns, and employees of such
                persons and other horse support personnel who are engaged in the care,
                training, or racing of covered horses.
                 HISA Guidance means Horseracing Integrity and Safety Authority
                (Authority) guidance issued under 15 U.S.C. 3054(g)(1), which does not
                have the force of law.
                 Horseracing anti-doping and medication control program means the
                anti-doping and medication program established under 15 U.S.C. 3055(a).
                 Horseracing Integrity and Safety Authority or Authority means the
                private, independent, self-regulatory, nonprofit corporation recognized
                for purposes of developing and implementing a horseracing anti-doping
                and medication control program and a racetrack safety program for
                covered horses, covered persons, and covered horseraces.
                 Interstate off-track wager has the meaning given such term in
                Section 3 of the Interstate Horseracing Act of 1978, 15 U.S.C. 3002.
                 Jockey means a rider or driver of a covered horse in covered
                horseraces.
                 Owner means a person who holds an ownership interest in one or more
                covered horses.
                 Proposed rule means any rule proposed by the Authority pursuant to
                the Act.
                 Proposed rule modification or modification means:
                 (1) Any proposed modification to a rule or proposed rule change; or
                 (2) Any interpretation or statement of policy or practice relating
                to an existing rule of the Authority that is not HISA Guidance and
                would have the force of law if approved as a final rule.
                 Racetrack means an organization licensed by a State racing
                commission to conduct covered horseraces.
                 Racetrack safety program means the program established under 15
                U.S.C. 3056(a).
                 State racing commission means an entity designated by State law or
                regulation that has jurisdiction over the conduct of horseracing within
                the applicable State.
                 Trainer means an individual engaged in the training of covered
                horses.
                 Training facility means a location that is not a racetrack licensed
                by a State racing commission that operates primarily to house covered
                horses and conduct official timed workouts.
                 Veterinarian means a licensed veterinarian who provides veterinary
                services to covered horses.
                 Workout means a timed running of a horse over a predetermined
                distance not associated with a race or its first qualifying race, if
                such race is made subject to the Act by election under 15 U.S.C.
                3054(l) of the horse's breed governing organization or the applicable
                State racing commission.
                Sec. 1.141 Required submissions.
                 The Authority must submit to the Commission any proposed rule, or
                proposed rule modification, of the Authority relating to--
                 (a) The bylaws of the Authority;
                 (b) A list of permitted and prohibited medications, substances, and
                methods, including allowable limits of permitted medications,
                substances, and methods;
                 (c) Laboratory standards for accreditation and protocols;
                 (d) Standards for racing surface quality maintenance;
                 (e) Racetrack safety standards and protocols;
                 (f) A program for injury and fatality data analysis;
                 (g) A program of research and education on safety, performance, and
                anti-doping and medication control;
                 (h) A description of safety, performance, and anti-doping and
                medication control rule violations applicable to covered horses and
                covered persons;
                 (i) A schedule of civil sanctions for violations;
                 (j) A process or procedures for disciplinary hearings;
                 (k) A formula or methodology for determining assessments described
                in 15 U.S.C. 3052(f); and
                 (l) Any other proposed rule or modification the Act requires the
                Authority to submit to the Commission for approval.
                Sec. 1.142 Submission of proposed rule or modification.
                 (a) Contents of submission. In order for a submission to qualify as
                a proposed rule or proposed rule modification under 15 U.S.C. 3053(a),
                the Authority must submit to the Commission a complete draft of the
                Federal Register document for the proposed rule or proposed rule
                modification, which includes the text of the rule and a statement of
                the purpose of, and statutory basis for, the proposed rule or
                modification (``statement of basis and purpose''). The statement of
                basis and purpose must contain:
                 (1) The reasons for adopting the proposed rule or modification.
                 (2) Any problems the proposed rule or modification is intended to
                address and how the proposed rule or modification will resolve those
                problems.
                 (3) A description of any reasonable alternatives to the proposed
                rule or modification that may accomplish the stated objective and an
                explanation of the reasons the Authority chose the proposed rule or
                modification over its alternatives.
                 (4) How the proposed rule or modification will affect covered
                persons, covered horses, and covered horseraces.
                 (5) Why the proposed rule or modification is consistent with the
                requirements of the Act and any rules and regulations applicable to the
                Authority, including the following:
                 (i) Anti-doping and medication control program. When proposing a
                rule or modification to the horseracing anti-doping and medication
                control program, the Authority must explain how it considered the
                factors in 15 U.S.C. 3055, including:
                 (A) Under 15 U.S.C. 3055(a)(2), the unique characteristics of a
                breed of horse made subject to the Act by election of a State racing
                commission or breed governing organization for such horse pursuant to
                15 U.S.C. 3054(l);
                 (B) The factors listed in 15 U.S.C. 3055(b); and
                 (C) The baseline anti-doping and medication control rules
                identified in 15 U.S.C. 3055(g)(2)(A). For a proposed rule, the
                Authority must state whether its proposed rule adopts the baseline
                standards identified in 15 U.S.C. 3055(g)(2)(A). If there is a conflict
                in any baseline standards identified in 15 U.S.C. 3055(g)(2)(A), the
                Authority must identify the conflict and state whether the standard it
                adopted is the most stringent standard. For a proposed rule
                modification, the Authority must explain whether the modification
                renders an anti-doping and medication control rule less stringent than
                the baseline anti-doping and medication control rules described in 15
                U.S.C. 3055(g)(2)(A), and state whether the anti-doping and medication
                control enforcement agency has approved of the change.
                 (ii) Racetrack safety program. When proposing a rule or
                modification to any rule regarding the racetrack safety program
                required under 15 U.S.C. 3056(a)(1), the Authority must explain how the
                proposed rule or modification
                [[Page 54825]]
                meets the requirements in 15 U.S.C. 3056(b). The Authority must explain
                how it considered and whether it adopted the safety standards in 15
                U.S.C. 3056(a)(2). If any horseracing safety standards in 15 U.S.C.
                3056(a)(2) were considered but not adopted or were modified, the
                Authority must explain why it decided not to adopt or why it decided to
                modify such standard.
                 (iii) Other rules. To the extent the Act requires the Authority to
                consider any factors or standards not specifically referenced in this
                section, the Authority must explain whether and how it considered those
                factors when proposing a rule or modification. For instance, when
                proposing a civil sanctions rule or modification pursuant to 15 U.S.C.
                3057(d)(1), the Authority must explain how the rule or modification
                meets the requirements of 15 U.S.C. 3057(d)(2).
                 (6) If written comments were solicited, the Authority's draft
                Federal Register document must include a summary of the substance of
                all comments received and the Authority's written response to all
                significant issues raised in such comments.
                 (7) The date that the Authority proposes for the Federal Register
                to publish its proposed rule or modification.
                 (b) Supporting documentation. The Authority's submission to the
                Commission required under paragraph (a) of this section must also
                include copies of the pertinent factual information underlying the
                Authority's development of the proposed rule or modification, including
                a copy of existing standards used as a reference for the development of
                the proposed rule or modification and scientific data, studies, or
                analysis underlying the development of the proposed rule or
                modification. Supporting documentation must be attached as exhibits,
                and each exhibit must clearly identify the proposed rule or
                modification it supports.
                 (c) Redline document for proposed rule modification. For proposed
                rule modifications, the Authority must also provide, in a document
                separate from the Federal Register document, a redline version of the
                existing rule that will enable the Commission to immediately identify
                any proposed changes.
                 (d) Timing of submission. To qualify as a proposed rule or proposed
                modification under 15 U.S.C. 3053(a), the Authority's submission must
                provide the information in paragraphs (a), (b), and (c) of this section
                at least 90 days in advance of the proposed date for the Federal
                Register to publish a proposed rule or modification for public comment
                pursuant to 15 U.S.C. 3053(b)(1). The Secretary may waive the 90-day
                requirement in this section if the Authority demonstrates such waiver
                is necessary to meet statutory deadlines.
                 (e) Conclusory statements and failure to provide requisite
                analysis. Information required to be submitted under this section must
                be sufficiently detailed and contain sufficient analysis to support a
                Commission finding that a proposed rule or modification satisfies the
                statutory requirements. For instance, a mere assertion or conclusory
                statement that a proposed rule or modification is consistent with the
                requirements of the Act is insufficient. Failure to describe and
                justify the proposed rule or modification in the manner described in
                this section or failure to submit the information required by this
                section may result in the Commission's having insufficient information
                to make an affirmative finding that the proposed rule or modification
                is consistent with the Act and the applicable rules approved by the
                Commission.
                 (f) Public comments. The Authority is encouraged to solicit public
                comments on its proposed rule or modification in advance of making a
                submission to the Commission pursuant to this section. If the Authority
                solicits public comments, it must attach a copy of the comments as an
                exhibit to its submission. By soliciting public comments and addressing
                significant issues raised therein, the Authority facilitates the
                Commission's review and approval of the Authority's proposed rule or
                modification.
                Sec. 1.143 Submissions to the Secretary.
                 (a) Electronic submission. All rule submissions under Sec. 1.142
                and 15 U.S.C. 3053(a), rate increases that must be reported to the
                Commission under 15 U.S.C. 3052(f)(1)(C)(iv), or HISA Guidance that
                must be submitted to the Commission under 15 U.S.C. 3054(g)(2) must be
                emailed to the Secretary of the Commission at
                [email protected]. The subject line of the email must state:
                ``HISA Rule Submission,'' ``HISA Rate Increase Submission,'' or ``HISA
                Guidance Submission,'' as applicable.
                 (b) Format for submission of proposed rules or modifications--(1)
                Electronic format. Except for supporting documentation submitted
                pursuant to Sec. 1.142(b) and copies of comments submitted pursuant to
                Sec. 1.142(f), all documents submitted to the Secretary must be in a
                word processing format.
                 (2) Table of contents. Submissions with more than one attachment
                must contain a table of contents in the body of the email with a brief
                description of each item.
                 (3) Contact information. The Authority must provide the name,
                telephone number, and email address of a person on the staff of the
                Authority responsible for responding to questions and comments on the
                submission in the body of the email.
                 (4) Draft Federal Register documents. Draft Federal Register
                documents must follow the relevant format and editorial requirements
                for regulatory documents under 1 CFR parts 18, 21, and 22 (see Office
                of Federal Register's Document Drafting Handbook). The Document
                Drafting Handbook specifies that draft Federal Register documents (see
                1 CFR 15.10) must:
                 (i) Contain proper preamble captions and content;
                 (ii) State the purpose of, and basis for, the proposed rule or
                modification;
                 (iii) Set forth regulatory text, headings, and authority citations;
                 (iv) Use correct numbering, structure, and amendatory language; and
                 (v) Conform to the style and formatting established by the Office
                of the Federal Register and Government Publishing Office. (See,
                specifically, section 2.17 (proposed rules) of the Office of the
                Federal Register's Document Drafting Handbook.)
                 (c) Confidential information. If a document filed with the
                Secretary contains confidential information, the Secretary must be so
                informed, and a request for confidential treatment must be submitted in
                accordance with 16 CFR 4.9.
                 (d) Date of filing. If the conditions of this section are otherwise
                satisfied, all filings submitted electronically on or before 5:30 p.m.
                Eastern Time, on a business day, will be deemed filed on that business
                day, and all filings submitted after 5:30 p.m. Eastern Time, will be
                deemed filed on the next business day.
                 (e) Authority to reject documents for filing. The Secretary of the
                Commission may reject a document for filing that fails to comply with
                the Commission's rules for filing in this section or Sec. 1.142.
                 (f) Federal Register publication. If the conditions in this section
                and Sec. 1.142 have been satisfied, the Commission will publish the
                proposed rules or modifications in the Federal Register and request
                public comment on those proposed rules or modifications.
                Sec. 1.144 Approval or disapproval of proposed rules and proposed
                rule modifications.
                 (a) Commission decision. The Commission will approve or disapprove
                [[Page 54826]]
                a proposed rule or modification by issuing an order within 60 days of
                the date the proposed rule or modification was published in the Federal
                Register for public comment.
                 (b) Standard of review. The Commission will approve a proposed rule
                or modification if the Commission finds that the proposed rule or
                modification is consistent with the Act and the applicable rules
                approved by the Commission. If the Commission disapproves a rule or
                modification, it will make recommendations to the Authority to modify
                the proposed rule or modification within 30 days of such disapproval.
                 (c) Effect. A proposed rule or modification will not take effect
                unless it has been approved by the Commission.
                 By direction of the Commission.
                April J. Tabor,
                Secretary.
                [FR Doc. 2021-21306 Filed 10-4-21; 8:45 am]
                BILLING CODE 6750-01-P
                

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