Significant New Use Rules on Certain Chemical Substances (20-1.B)

Published date16 January 2020
Citation85 FR 2676
Record Number2019-26292
SectionProposed rules
CourtEnvironmental Protection Agency
Federal Register, Volume 85 Issue 11 (Thursday, January 16, 2020)
[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
                [Proposed Rules]
                [Pages 2676-2683]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-26292]
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                ENVIRONMENTAL PROTECTION AGENCY
                40 CFR Part 721
                [EPA-HQ-OPPT-2019-0595; FRL-10002-68]
                RIN 2070-AB27
                Significant New Use Rules on Certain Chemical Substances (20-1.B)
                AGENCY: Environmental Protection Agency (EPA).
                ACTION: Proposed rule.
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                SUMMARY: EPA is proposing significant new use rules (SNURs) under the
                Toxic Substances Control Act (TSCA) for chemical substances that are
                the subject of premanufacture notices (PMNs). This action would require
                persons to notify EPA at least 90 days before commencing manufacture
                (defined by statute to include import) or processing of any of these
                chemical substances for an activity that is designated as a significant
                new use by this proposed rule. This action would further require that
                persons not commence manufacture or processing for the significant new
                use until they have submitted a Significant New Use Notice, and EPA has
                conducted a review of the notice, made an appropriate determination on
                the notice under TSCA, and has taken any risk management actions as are
                required as a result of that determination.
                DATES: Comments must be received on or before February 18, 2020.
                ADDRESSES: Submit your comments, identified by docket identification
                (ID) number EPA-HQ-OPPT-2019-0595, by one of the following methods:
                 Federal eRulemaking Portal: http://www.regulations.gov.
                Follow the online instructions for submitting comments. Do not submit
                electronically any information you consider to be Confidential Business
                Information (CBI) or other information whose disclosure is restricted
                by statute.
                 Mail: Document Control Office (7407M), Office of Pollution
                Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
                Pennsylvania Ave. NW, Washington, DC 20460-0001.
                 Hand Delivery: To make special arrangements for hand
                delivery or delivery of boxed information, please follow the
                instructions at http://www.epa.gov/dockets/contacts.html.
                [[Page 2677]]
                 Additional instructions on commenting or visiting the docket, along
                with more information about dockets generally, is available at http://www.epa.gov/dockets.
                FOR FURTHER INFORMATION CONTACT: For technical information contact:
                Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
                Prevention and Toxics, Environmental Protection Agency, 1200
                Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
                (202) 564-9232; email address: [email protected].
                 For general information contact: The TSCA-Hotline, ABVI-Goodwill,
                422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
                554-1404; email address: [email protected].
                SUPPLEMENTARY INFORMATION:
                I. General Information
                A. Does this action apply to me?
                 You may be potentially affected by this action if you manufacture,
                process, or use the chemical substances contained in this proposed
                rule. The following list of North American Industrial Classification
                System (NAICS) codes is not intended to be exhaustive, but rather
                provides a guide to help readers determine whether this document
                applies to them. Potentially affected entities may include:
                 Manufacturers or processors of one or more subject
                chemical substances (NAICS codes 325 and 324110), e.g., chemical
                manufacturing and petroleum refineries.
                 This action may also affect certain entities through pre-existing
                import certification and export notification rules under TSCA. Chemical
                importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
                certification requirements promulgated at 19 CFR 12.118 through 12.127
                and 19 CFR 127.28. Chemical importers must certify that the shipment of
                the chemical substance complies with all applicable rules and orders
                under TSCA. Importers of chemicals subject to these proposed SNURs
                would need to certify their compliance with the SNUR requirements
                should these proposed rules be finalized. The EPA policy in support of
                import certification appears at 40 CFR part 707, subpart B. In
                addition, pursuant to 40 CFR 721.20, any persons who export or intend
                to export a chemical substance that is the subject of this proposed
                rule on or after February 18, 2020 are subject to the export
                notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and
                must comply with the export notification requirements in 40 CFR part
                707, subpart D.
                B. What should I consider as I prepare my comments for EPA?
                 1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
                or email. Clearly mark the part or all of the information that you
                claim to be CBI. For CBI information in a disk or CD-ROM that you mail
                to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
                electronically within the disk or CD-ROM the specific information that
                is claimed as CBI. In addition to one complete version of the comment
                that includes information claimed as CBI, a copy of the comment that
                does not contain the information claimed as CBI must be submitted for
                inclusion in the public docket. Information so marked will not be
                disclosed except in accordance with procedures set forth in 40 CFR part
                2.
                 2. Tips for preparing your comments. When preparing and submitting
                your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
                II. Background
                A. What action is the Agency taking?
                 EPA is proposing significant new use rules for six chemical
                substances that are the subjects of PMNs: P-16-291, P-16-486, P-17-184,
                P-18-232, P-18-236, and P-18-264. These proposed SNURs would require
                persons who intend to manufacture or process any of these chemical
                substances for an activity that is designated as a significant new use
                to notify EPA at least 90 days before commencing that activity.
                 The record for the proposed SNURs on these chemicals was
                established as docket EPA-HQ-OPPT-2019-0595. That record includes
                information considered by the Agency in developing these proposed
                SNURs.
                B. What is the Agency's authority for taking this action?
                 TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
                determine that a use of a chemical substance is a ``significant new
                use.'' EPA must make this determination by rule after considering all
                relevant factors, including the four TSCA section 5(a)(2) factors
                listed in Unit III. In the case of a determination other than not
                likely to present unreasonable risk, the applicable review period must
                also expire before manufacturing or processing for the new use may
                commence.
                C. Applicability of General Provisions
                 General provisions for SNURs appear in 40 CFR part 721, subpart A.
                These provisions describe persons subject to the rule, recordkeeping
                requirements, exemptions to reporting requirements, and applicability
                of the rule to uses occurring before the effective date of the rule.
                Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
                40 CFR 721.1(c), persons subject to these SNURs must comply with the
                same SNUN requirements and EPA regulatory procedures as submitters of
                PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
                include the information submission requirements of TSCA sections 5(b)
                and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1),
                5(h)(2), 5(h)(3) and 5(h)(5), and the regulations at 40 CFR part 720.
                Once EPA receives a SNUN, EPA must either determine that the use is not
                likely to present an unreasonable risk of injury under the conditions
                of use for the chemical substance or take such regulatory action as is
                associated with an alternative determination before the manufacture or
                processing for the significant new use can commence. If EPA determines
                that the use is not likely to present an unreasonable risk, EPA is
                required under TSCA section 5(g) to make public, and submit for
                publication in the Federal Register, a statement of EPA's findings.
                III. Significant New Use Determination
                 TSCA section 5(a)(2) states that EPA's determination that a use of
                a chemical substance is a significant new use must be made after
                consideration of all relevant factors, including:
                 The projected volume of manufacturing and processing of a
                chemical substance.
                 The extent to which a use changes the type or form of
                exposure of human beings or the environment to a chemical substance.
                 The extent to which a use increases the magnitude and
                duration of exposure of human beings or the environment to a chemical
                substance.
                 The reasonably anticipated manner and methods of
                manufacturing, processing, distribution in commerce, and disposal of a
                chemical substance.
                 In determining what would constitute a significant new use for the
                chemical substances that are the subject of these SNURs, EPA considered
                relevant information about the toxicity of the chemical substances, and
                potential human exposures and environmental releases that may be
                associated with the conditions of use of the substances, in
                [[Page 2678]]
                the context of the four bulleted TSCA section 5(a)(2) factors listed in
                this unit. During its review of these chemicals, EPA identified certain
                conditions of use that are not intended by the submitters, but
                reasonably foreseen to occur. EPA is proposing to designate those
                reasonably foreseen conditions of use as significant new uses.
                IV. Substances Subject to This Proposed Rule
                 EPA is proposing significant new use and recordkeeping requirements
                for six chemical substances in 40 CFR part 721, subpart E. In this
                unit, EPA provides the following information for each chemical
                substance:
                 PMN number.
                 Chemical name (generic name, if the specific name is
                claimed as CBI).
                 Chemical Abstracts Service (CAS) Registry number (if
                assigned for non-confidential chemical identities).
                 Basis for the SNUR.
                 Potentially Useful Information. This is information
                identified by EPA that would help characterize the potential health
                and/or environmental effects of the chemical substance in support of a
                request by the PMN submitter to modify the TSCA Order, or if a
                manufacturer or processor is considering submitting a SNUN for a
                significant new use designated by the SNUR.
                 CFR citation assigned in the regulatory text section of
                these proposed rules.
                 The regulatory text section of these proposed rules specifies the
                activities designated as significant new uses. Certain new uses,
                including production volume limits and other uses designated in the
                proposed rules, may be claimed as CBI.
                 The chemical substances that are the subject of these proposed
                SNURs are undergoing premanufacture review. In addition to those
                conditions of use intended by the submitter, EPA has identified certain
                other reasonably foreseen conditions of use. EPA has preliminarily
                determined that the chemicals under their intended conditions of use
                are not likely to present an unreasonable risk. However, EPA has not
                assessed risks associated with the reasonably foreseen conditions of
                use for these chemicals. EPA is proposing to designate these reasonably
                foreseen and other potential conditions of use as significant new uses.
                As a result, those conditions of use are no longer reasonably foreseen
                to occur without first going through a separate, subsequent EPA review
                and determination process associated with a SNUN.
                 The substances subject to these proposed rules are as follows:
                PMN Number: P-16-291.
                 Chemical name: 1,3-Cyclohexanedimethanamine adduct (generic).
                 CAS number: Not available.
                 Basis for action: The PMN states that the generic (non-
                confidential) use of the substance will be as a curing agent. Based on
                the physical/chemical properties of the PMN substance and Structure
                Activity Relationships (SAR) analysis of test data on analogous
                substances, EPA has identified concerns for irritation and corrosion to
                all tissues, skin sensitization, and aquatic toxicity if the chemical
                substance is used in ways other than as intended by the PMN submitter.
                Other conditions of use of the PMN substance that EPA intends to assess
                before they occur include the following:
                 1. Use in a consumer product; and
                 2. Release of a manufacturing, processing, or use stream associated
                with any use of the PMN substance into the waters of the United States
                exceeding a surface water concentration of 74 ppb.
                 The proposed SNUR would designate as a ``significant new use''
                these conditions of use.
                 Potentially useful information: EPA has determined that certain
                information may be potentially useful to characterize the health and
                environmental effects of the PMN substance if a manufacturer or
                processor is considering submitting a SNUN for a significant new use
                that would be designated by this proposed SNUR. EPA has determined that
                the results of skin and eye irritation, skin sensitization, and aquatic
                toxicity testing would help characterize the potential health and
                environmental effects of the PMN substance.
                 CFR citation: 40 CFR 721.11447.
                PMN Number: P-16-486.
                 Chemical name: Polychloropropane (generic).
                 CAS number: Not available.
                 Basis for action: The PMN states that the generic (non-
                confidential) use of the substance will be as a site-limited
                intermediate in the production of a refrigerant precursor. Based on the
                physical/chemical properties of the PMN substance, test data for the
                PMN substance, and SAR analysis of test data on analogous substances,
                EPA has identified concerns for reproductive effects and developmental
                toxicity, effects on the liver, kidney and nasal turbinates, and
                aquatic toxicity if the chemical substance is used in ways other than
                as intended by the PMN submitter. Other conditions of use of the PMN
                substance that EPA intends to assess before they occur include the
                following:
                 1. Use other than as a site-limited chemical intermediate;
                 2. Manufacture, processing, or use other than in an enclosed
                process;
                 3. Use of sampling methods other than the ``zero-contact'' methods
                described in the PMN; and
                 4. Disposal other than by incineration.
                 The proposed SNUR would designate as a ``significant new use''
                these conditions of use.
                 Potentially useful information: EPA has determined that certain
                information may be potentially useful to characterize the health and
                environmental effects of the PMN substance if a manufacturer or
                processor is considering submitting a SNUN for a significant new use
                that would be designated by this proposed SNUR. EPA has determined that
                the results of absorption, distribution, metabolism, and elimination
                (ADME), DNA binding, and chronic aquatic toxicity studies would help
                characterize the potential health and environmental effects of the PMN
                substance.
                 CFR citation: 40 CFR 721.11448.
                PMN Number: P-17-184.
                 Chemical name: 1-Propanaminium, 2-hydroxy-N, N-dimethyl-N-[3-[(1-
                oxooctyl)amino]propyl]-3-sulfo-, inner salt.
                 CAS number: 1612795-77-3.
                 Basis for action: The PMN states that the use of the substance will
                be in firefighting foams; industrial all-purpose cleaners;
                transportation washes; and personal care product uses not regulated
                under TSCA. Based on the physical/chemical properties of the PMN
                substance, test data for the PMN substance, and SAR analysis of test
                data on analogous substances, EPA has identified concerns for
                irritation to skin and mucous membranes; systemic effects;
                developmental effects; and lung effects if the chemical substance is
                used in ways other than as intended by the PMN submitter. Other
                conditions of use of the PMN substance that EPA intends to assess
                before they occur include the following:
                 1. Use other than in firefighting foams, industrial all-purpose
                cleaners, and transportation washes;
                 2. Processing to greater than 10% by weight in the final formulated
                products; and
                 3. Use without a NIOSH-certified respirator with an APF of at least
                1000, where there is a potential for inhalation exposures.
                [[Page 2679]]
                 The proposed SNUR would designate as a ``significant new use''
                these conditions of use.
                 Potentially useful information: EPA has determined that certain
                information may be potentially useful to characterize the health and
                environmental effects of the PMN substance if a manufacturer or
                processor is considering submitting a SNUN for a significant new use
                that would be designated by this proposed SNUR. EPA has determined that
                the results of specific target organ toxicity testing would help
                characterize the potential health and environmental effects of the PMN
                substance.
                 CFR citation: 40 CFR 721.11449.
                PMN Number: P-18-232.
                 Chemical name: Polyol, reaction products with formaldehyde and
                methanol (generic).
                 CAS number: Not available.
                 Basis for action: The PMN states that the use of the substance will
                be as hydrogen sulfide scavenger in oil and gas applications. Based on
                the physical/chemical properties of the PMN substance and SAR analysis
                of test data on the PMN substance and analogous substances, EPA has
                identified concerns for irritation, sensitization, mutagenicity,
                carcinogenicity, and aquatic toxicity if the chemical substance is used
                in ways other than as intended by the PMN submitter. Other conditions
                of use of the PMN substance that EPA intends to assess before they
                occur include the following:
                 1. Manufacture, processing, or use in a manner that results in
                inhalation exposure; and
                 2. Manufacture (including import) beyond the confidential annual
                production volume described in the PMN.
                 The proposed SNUR would designate as a ``significant new use''
                these conditions of use.
                 Potentially useful information: EPA has determined that certain
                information may be potentially useful to characterize the health and
                environmental effects of the PMN substance if a manufacturer or
                processor is considering submitting a SNUN for a significant new use
                that would be designated by this proposed SNUR. EPA has determined that
                the results of toxicokinetics, skin and eye irritation, skin
                sensitization, neurotoxicity, reproductive effects, developmental
                toxicity, specific target organ toxicity, cancer and aquatic toxicity
                testing would help characterize the potential health and environmental
                effects of the PMN substance.
                 CFR citation: 40 CFR 721.11450.
                PMN Number: P-18-236.
                 Chemical name: Metal, alkenoic acid-alkyl alkenoate-alkyl
                substituted alkenoate polymer carbopolycycle complexes (generic).
                 CAS number: Not available.
                 Basis for action: The PMN states that the generic (non-
                confidential) use of the substance will be as a paint additive. Based
                on the physical/chemical properties of the PMN substance and SAR
                analysis of test data on analogous substances, EPA has identified
                concerns for respiratory and skin sensitization, reproductive toxicity,
                specific target organ toxicity and aquatic toxicity if the chemical
                substance is used in ways other than as intended by the PMN submitter.
                Other conditions of use of the PMN substance that EPA intends to assess
                before they occur include the following:
                 1. Manufacture, processing, or use in a manner that results in
                inhalation exposure;
                 2. Use for other than the confidential use described in the PMN;
                and
                 3. Release of a manufacturing, processing, or use stream associated
                with any use of the PMN substance into the waters of the United States
                exceeding a surface water concentration of 50 ppb.
                 The proposed SNUR would designate as a ``significant new use''
                these conditions of use.
                 Potentially useful information: EPA has determined that certain
                information may be potentially useful to characterize the health and
                environmental effects of the PMN substance if a manufacturer or
                processor is considering submitting a SNUN for a significant new use
                that would be designated by this proposed SNUR. EPA has determined that
                the results of specific target organ toxicity and aquatic toxicity
                testing would help characterize the potential health and environmental
                effects of the PMN substance.
                 CFR citation: 40 CFR 721.11451.
                PMN Number: P-18-264.
                 Chemical name: Phosphonomethylated ether diamine (generic).
                 CAS number: Not available.
                 Basis for action: The PMN states that the generic (non-
                confidential) use of the substance will be as an intermediate. Based on
                the physical/chemical properties of the PMN substance and SAR analysis
                of test data on analogous substances, EPA has identified concerns for
                eye irritation, chelation effects, reproductive toxicity, and
                developmental toxicity, and aquatic toxicity if the chemical substance
                is used in ways other than as intended by the PMN submitter. Other
                conditions of use of the PMN substance that EPA intends to assess
                before they occur include the following:
                 Manufacture, processing, or use in a manner that results
                in inhalation exposure.
                 The proposed SNUR would designate as a ``significant new use'' this
                condition of use.
                 Potentially useful information: EPA has determined that certain
                information may be potentially useful to characterize the health and
                environmental effects of the PMN substance if a manufacturer or
                processor is considering submitting a SNUN for a significant new use
                that would be designated by this proposed SNUR. EPA has determined that
                the results of eye irritation, reproductive toxicity, specific target
                organ toxicity, and aquatic toxicity testing would help characterize
                the potential health and environmental effects of the PMN substance.
                 CFR citation: 40 CFR 721.11452.
                V. Rationale and Objectives of the Proposed Rule
                A. Rationale
                 During review of the PMNs submitted for the chemical substances
                that are the subject of these proposed SNURs and as further discussed
                in Unit IV, EPA identified certain other reasonably foreseen conditions
                of use, in addition to those conditions of use intended by the
                submitter. EPA has preliminarily determined that the chemical under the
                intended conditions of use is not likely to present an unreasonable
                risk. However, EPA has not assessed risks associated with the
                reasonably foreseen conditions of use. EPA is proposing to designate
                these conditions of use as significant new uses to ensure that they are
                no longer reasonably foreseen to occur without first going through a
                separate, subsequent EPA review and determination process associated
                with a SNUN.
                B. Objectives
                 EPA is proposing these SNURs because the Agency wants:
                 To have an opportunity to review and evaluate data
                submitted in a SNUN before the notice submitter begins manufacturing or
                processing a listed chemical substance for the described significant
                new use.
                 To be obligated to make a determination under TSCA section
                5(a)(3) regarding the use described in the SNUN, under the conditions
                of use. The Agency will either determine under section 5(a)(3)(C) that
                the significant
                [[Page 2680]]
                new use is not likely to present an unreasonable risk, including an
                unreasonable risk to a potentially exposed or susceptible subpopulation
                identified as relevant by the Administrator under the conditions of
                use, or make a determination under section 5(a)(3) (A) or (B) and take
                the required regulatory action associated with the determination,
                before manufacture or processing for the significant new use of the
                chemical substance can occur.
                 To be able to complete its review and determination on
                each of the PMN substances, while deferring analysis on the significant
                new uses proposed in these rules unless and until the Agency receives a
                SNUN.
                 Issuance of a proposed SNUR for a chemical substance does not
                signify that the chemical substance is listed on the TSCA Inventory.
                Guidance on how to determine if a chemical substance is on the TSCA
                Inventory is available on the internet at https://www.epa.gov/tsca-inventory.
                VI. Applicability of the Proposed Rules to Uses Occurring Before the
                Effective Date of the Final Rule
                 To establish a significant new use, EPA must determine that the use
                is not ongoing. The chemical substances subject to this proposed rule
                were undergoing premanufacture review at the time of signature of this
                proposed rule and were not on the TSCA Inventory. In cases where EPA
                has not received a notice of commencement (NOC) and the chemical
                substance has not been added to the TSCA Inventory, no person may
                commence such activities without first submitting a PMN. Therefore, for
                the chemical substances subject to these proposed SNURs, EPA concludes
                that the proposed significant new uses are not ongoing.
                 EPA designates December 2, 2019 (date of web posting) as the cutoff
                date for determining whether the new use is ongoing. The objective of
                EPA's approach is to ensure that a person cannot defeat a SNUR by
                initiating a significant new use before the effective date of the final
                rule.
                 Persons who begin commercial manufacture or processing of the
                chemical substances for a significant new use identified on or after
                that date would have to cease any such activity upon the effective date
                of the final rule. To resume their activities, these persons would have
                to first comply with all applicable SNUR notification requirements and
                EPA would have to take action under section 5 allowing manufacture or
                processing to proceed. In developing this proposed rule, EPA has
                recognized that, given EPA's general practice of posting proposed rules
                on its website a week or more in advance of Federal Register
                publication, this objective could be thwarted even before Federal
                Register publication of the proposed rule.
                VII. Development and Submission of Information
                 EPA recognizes that TSCA section 5 does not require development of
                any particular new information (e.g., generating test data) before
                submission of a SNUN. There is an exception: If a person is required to
                submit information for a chemical substance pursuant to a rule, Order
                or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
                section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
                to be submitted to EPA at the time of submission of the SNUN.
                 In the absence of a rule, Order or consent agreement under TSCA
                section 4 covering the chemical substance, persons are required only to
                submit information in their possession or control and to describe any
                other information known to or reasonably ascertainable by them (see 40
                CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the
                authority to require appropriate testing. Unit IV. lists potentially
                useful information for all SNURs listed here. Descriptions are provided
                for informational purposes. The potentially useful information
                identified in Unit IV. will be useful to EPA's evaluation in the event
                that someone submits a SNUN for the significant new use. Companies who
                are considering submitting a SNUN are encouraged, but not required, to
                develop the information on the substance, which may assist with EPA's
                analysis of the SNUN.
                 EPA strongly encourages persons, before performing any testing, to
                consult with the Agency pertaining to protocol selection. Furthermore,
                pursuant to TSCA section 4(h), which pertains to reduction of testing
                in vertebrate animals, EPA encourages consultation with the Agency on
                the use of alternative test methods and strategies (also called New
                Approach Methodologies, or NAMs), if available, to generate the
                recommended test data. EPA encourages dialog with Agency
                representatives to help determine how best the submitter can meet both
                the data needs and the objective of TSCA section 4(h).
                 The potentially useful information described in Unit IV. may not be
                the only means of providing information to evaluate the chemical
                substance associated with the significant new uses. However, submitting
                a SNUN without any test data may increase the likelihood that EPA will
                take action under TSCA sections 5(e) or 5(f). EPA recommends that
                potential SNUN submitters contact EPA early enough so that they will be
                able to conduct the appropriate tests.
                 SNUN submitters should be aware that EPA will be better able to
                evaluate SNUNs which provide detailed information on the following:
                 Human exposure and environmental release that may result
                from the significant new use of the chemical substances.
                VIII. SNUN Submissions
                 According to 40 CFR 721.1(c), persons submitting a SNUN must comply
                with the same notification requirements and EPA regulatory procedures
                as persons submitting a PMN, including submission of test data on
                health and environmental effects as described in 40 CFR 720.50. SNUNs
                must be submitted on EPA Form No. 7710-25, generated using e-PMN
                software, and submitted to the Agency in accordance with the procedures
                set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
                electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
                IX. Economic Analysis
                 EPA has evaluated the potential costs of establishing SNUN
                requirements for potential manufacturers and processors of the chemical
                substances subject to this proposed rule. EPA's complete economic
                analysis is available in the docket under docket ID number EPA-HQ-OPPT-
                2019-0595.
                X. Statutory and Executive Order Reviews
                 Additional information about these statutes and Executive Orders
                can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
                A. Executive Order 12866: Regulatory Planning and Review and Executive
                Order 13563: Improving Regulations and Regulatory Review
                 This proposed rule would establish SNURs for 8 new chemical
                substances that were the subject of PMNs. The Office of Management and
                Budget (OMB) has exempted these types of actions from review under
                Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
                3821, January 21, 2011).
                [[Page 2681]]
                B. Paperwork Reduction Act (PRA)
                 According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
                conduct or sponsor, and a person is not required to respond to a
                collection of information that requires OMB approval under PRA, unless
                it has been approved by OMB and displays a currently valid OMB control
                number. The OMB control numbers for EPA's regulations in title 40 of
                the CFR, after appearing in the Federal Register, are listed in 40 CFR
                part 9, and included on the related collection instrument or form, if
                applicable.
                 The information collection requirements related to this action have
                already been approved by OMB pursuant to PRA under OMB control number
                2070-0012 (EPA ICR No. 574). This action does not impose any burden
                requiring additional OMB approval. If an entity were to submit a SNUN
                to the Agency, the annual burden is estimated to average between 30 and
                170 hours per response. This burden estimate includes the time needed
                to review instructions, search existing data sources, gather and
                maintain the data needed, and complete, review, and submit the required
                SNUN.
                 Send any comments about the accuracy of the burden estimate, and
                any suggested methods for minimizing respondent burden, including
                through the use of automated collection techniques, to the Director,
                Regulatory Support Division, Office of Mission Support (2822T),
                Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
                DC 20460-0001. Please remember to include the OMB control number in any
                correspondence, but do not submit any completed forms to this address.
                C. Regulatory Flexibility Act (RFA)
                 Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
                Agency hereby certifies that promulgation of this proposed SNUR would
                not have a significant adverse economic impact on a substantial number
                of small entities. The requirement to submit a SNUN applies to any
                person (including small or large entities) who intends to engage in any
                activity described in the final rule as a ``significant new use.''
                Because these uses are ``new,'' based on all information currently
                available to EPA, it appears that no small or large entities presently
                engage in such activities. A SNUR requires that any person who intends
                to engage in such activity in the future must first notify EPA by
                submitting a SNUN. Although some small entities may decide to pursue a
                significant new use in the future, EPA cannot presently determine how
                many, if any, there may be. However, EPA's experience to date is that,
                in response to the promulgation of SNURs covering over 1,000 chemicals,
                the Agency receives only a small number of notices per year. For
                example, the number of SNUNs received was seven in Federal fiscal year
                (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and
                11 in FY2018, only a fraction of these were from small businesses. In
                addition, the Agency currently offers relief to qualifying small
                businesses by reducing the SNUN submission fee from $16,000 to $2,800.
                This lower fee reduces the total reporting and recordkeeping of cost of
                submitting a SNUN to about $10,116 for qualifying small firms.
                Therefore, the potential economic impacts of complying with this
                proposed SNUR are not expected to be significant or adversely impact a
                substantial number of small entities. In a SNUR that published in the
                Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
                presented its general determination that final SNURs are not expected
                to have a significant economic impact on a substantial number of small
                entities, which was provided to the Chief Counsel for Advocacy of the
                Small Business Administration.
                D. Unfunded Mandates Reform Act (UMRA)
                 Based on EPA's experience with proposing and finalizing SNURs,
                State, local, and Tribal governments have not been impacted by these
                rulemakings, and EPA does not have any reasons to believe that any
                State, local, or Tribal government will be impacted by this proposed
                rule. As such, EPA has determined that this proposed rule does not
                impose any enforceable duty, contain any unfunded mandate, or otherwise
                have any effect on small governments subject to the requirements of
                UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538 et seq.).
                E. Executive Order 13132: Federalism
                 This action would not have a substantial direct effect on States,
                on the relationship between the national government and the States, or
                on the distribution of power and responsibilities among the various
                levels of government, as specified in Executive Order 13132 (64 FR
                43255, August 10, 1999).
                F. Executive Order 13175: Consultation and Coordination With Indian
                Tribal Governments
                 This proposed rule would not have Tribal implications because it is
                not expected to have substantial direct effects on Indian Tribes. This
                proposed rule would not significantly nor uniquely affect the
                communities of Indian Tribal governments, nor does it involve or impose
                any requirements that affect Indian Tribes. Accordingly, the
                requirements of Executive Order 13175 (65 FR 67249, November 9, 2000),
                do not apply to this proposed rule.
                G. Executive Order 13045: Protection of Children From Environmental
                Health and Safety Risks
                 This action is not subject to Executive Order 13045 (62 FR 19885,
                April 23, 1997), because this is not an economically significant
                regulatory action as defined by Executive Order 12866, and this action
                does not address environmental health or safety risks
                disproportionately affecting children.
                H. Executive Order 13211: Actions Concerning Regulations That
                Significantly Affect Energy Supply, Distribution, or Use
                 This proposed rule is not subject to Executive Order 13211 (66 FR
                28355, May 22, 2001), because this action is not expected to affect
                energy supply, distribution, or use and because this action is not a
                significant regulatory action under Executive Order 12866.
                I. National Technology Transfer and Advancement Act (NTTAA)
                 In addition, since this action does not involve any technical
                standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to
                this action.
                J. Executive Order 12898: Federal Actions To Address Environmental
                Justice in Minority Populations and Low-Income Populations
                 This action does not entail special considerations of environmental
                justice related issues as delineated by Executive Order 12898 (59 FR
                7629, February 16, 1994).
                List of Subjects in 40 CFR Part 721
                 Environmental protection, Chemicals, Hazardous substances,
                Reporting and recordkeeping requirements.
                 Dated: November 26, 2019.
                Tala Henry,
                Deputy Director, Office of Pollution Prevention and Toxics.
                 Therefore, it is proposed that 40 CFR part 721 be amended as
                follows:
                PART 721--[AMENDED]
                0
                1. The authority citation for part 721 continues to read as follows:
                 Authority: 15 U.S.C. 2604, 2607, and 2625(c).
                [[Page 2682]]
                0
                2. Add Sec. Sec. 721.11447 through 721.11452 to subpart E to read as
                follows:
                Subpart E--Significant New Uses for Specific Chemical Substances
                Sec.
                * * * * *
                721.11447 1,3-Cyclohexanedimethanamine adduct (generic).
                721.11448 Polychloropropane (generic).
                721.11449 1-Propanaminium, 2-hydroxy-N, N-dimethyl-N-[3-[(1-
                oxooctyl)amino]propyl]-3-sulfo-, inner salt.
                721.11450 Polyol, reaction products with formaldehyde and methanol
                (generic).
                721.11451 Metal, alkenoic acid-alkyl alkenoate-alkyl substituted
                alkenoate polymer carbopolycycle complexes (generic).
                721.11452 Phosphonomethylated ether diamine (generic).
                * * * * *
                Sec. 721.11447 1,3-Cyclohexanedimethanamine adduct (generic).
                 (a) Chemical substance and significant new uses subject to
                reporting. (1) The chemical substance identified generically as 1,3-
                cyclohexanedimethanamine adduct (PMN P-16-291) is subject to reporting
                under this section for the significant new uses described in paragraph
                (a)(2) of this section.
                 (2) The significant new uses are:
                 (i) Industrial, commercial, and consumer activities. Requirements
                as specified in Sec. 721.80(o).
                 (ii) Release to water. Requirements as specified in Sec.
                721.90(a)(4), (b)(4), and (c)(4), where N=74.
                 (b) Specific requirements. The provisions of subpart A of this part
                apply to this section except as modified by this paragraph (b).
                 (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
                721.125(a) through (c), (i), and (k) are applicable to manufacturers,
                importers, and processors of this substance.
                 (2) Limitations or revocation of certain notification requirements.
                The provisions of Sec. 721.185 apply to this section.
                Sec. 721.11448 Polychloropropane (generic).
                 (a) Chemical substance and significant new uses subject to
                reporting. (1) The chemical substance identified generically as
                polychloropropane (PMN P-16-486) is subject to reporting under this
                section for the significant new uses described in paragraph (a)(2) of
                this section.
                 (2) The significant new uses are:
                 (i) Industrial, commercial, and consumer activities. Requirements
                as specified in Sec. 721.80(a), (b), (c), and (h). It is a significant
                new use to use sampling methods other than the ``zero-contact'' methods
                described in the PMN.
                 (ii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
                (b)(1), and (c)(1).
                 (b) Specific requirements. The provisions of subpart A of this part
                apply to this section except as modified by this paragraph (b).
                 (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
                721.125(a) through (c) (i), and (j) are applicable to manufacturers,
                importers, and processors of this substance.
                 (2) Limitations or revocation of certain notification requirements.
                The provisions of Sec. 721.185 apply to this section.
                Sec. 721.11449 1-Propanaminium, 2-hydroxy-N, N-dimethyl-N-[3-[(1-
                oxooctyl)amino]propyl]-3-sulfo-, inner salt.
                 (a) Chemical substance and significant new uses subject to
                reporting. (1) The chemical substance identified generically as 1-
                Propanaminium, 2-hydroxy-N, N-dimethyl-N-[3-[(1-oxooctyl-amino]propyl]-
                3-sulfo-, inner salt (PMN P-17-184; CASRN 1612795-77-3) is subject to
                reporting under this section for the significant new uses described in
                paragraph (a)(2) of this section.
                 (2) The significant new uses are:
                 (i) Protection in the workplace. Requirements as specified in Sec.
                721.63(a)(4) and (5), (b)(concentration set at 1.0%) and (c). When
                determining which persons are reasonable likely to be exposed as
                required for Sec. 721.63(a)(4), engineering control measures (e.g.,
                enclosure or confinement of the operation, general and local
                ventilation) or administrative control measures (e.g., workplace
                policies and procedures) shall be considered and implemented to prevent
                exposures, where feasible. For purposes of Sec. 721.63(a)(5),
                respirators must provide a National Institute for Occupational Safety
                and Health assigned protection factor of at least 1000.
                 (ii) Industrial, commercial, and consumer activities. It is a
                significant new use to manufacture, process or use the substance for
                use other than firefighting foams, industrial all-purpose cleaners, and
                transportation washes. It is a significant new use to process the
                substance to greater than 10% by weight in the final formulated
                products.
                 (b) Specific requirements. The provisions of subpart A of this part
                apply to this section except as modified by this paragraph (b).
                 (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
                721.125(a) through (c) and (i) are applicable to manufacturers,
                importers, and processors of this substance.
                 (2) Limitations or revocation of certain notification requirements.
                The provisions of Sec. 721.185 apply to this section.
                Sec. 721.11450 Polyol, reaction products with formaldehyde and
                methanol (generic).
                 (a) Chemical substance and significant new uses subject to
                reporting. (1) The chemical substance identified generically as polyol,
                reaction products with formaldehyde and methanol (PMN P-18-232) is
                subject to reporting under this section for the significant new uses
                described in paragraph (a)(2) of this section.
                 (2) The significant new uses are:
                 (i) Industrial, commercial, and consumer activities. It is a
                significant new use to manufacture, processing or use of the substance
                in a manner that results in inhalation exposure. It is a significant
                new use to manufacture the substance at greater than the confidential
                annual production volume described in the PMN.
                 (ii) [Reserved]
                 (b) Specific requirements. The provisions of subpart A of this part
                apply to this section except as modified by this paragraph (b).
                 (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
                721.125(a) through (c) and (i) are applicable to manufacturers,
                importers, and processors of this substance.
                 (2) Limitations or revocation of certain notification requirements.
                The provisions of Sec. 721.185 apply to this section.
                 (3) Determining whether a specific use is subject to this section.
                The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
                this section.
                Sec. 721.11451 Metal, alkenoic acid-alkyl alkenoate-alkyl substituted
                alkenoate polymer carbopolycycle complexes (generic).
                 (a) Chemical substance and significant new uses subject to
                reporting. (1) The chemical substance identified generically as metal,
                alkenoic acid-alkyl alkenoate-alkyl substituted alkenoate polymer
                carbopolycycle complexes (PMN P-18-236) is subject to reporting under
                this section for the significant new uses described in paragraph (a)(2)
                of this section.
                 (2) The significant new uses are:
                 (i) Industrial, commercial, and consumer activities. Requirements
                as specified in Sec. 721.80(j). It is a significant new use to
                manufacture, processing or
                [[Page 2683]]
                use of the PMN substance in a manner that results in inhalation
                exposure.
                 (ii) Release to water. Requirements as specified in Sec.
                721.90(a)(4), (b)(4), and (c)(4), where N=50.
                 (b) Specific requirements. The provisions of subpart A of this part
                apply to this section except as modified by this paragraph (b).
                 (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
                721.125(a) through (c), (i), and (k) are applicable to manufacturers,
                importers, and processors of this substance.
                 (2) Limitations or revocation of certain notification requirements.
                The provisions of Sec. 721.185 apply to this section.
                 (3) Determining whether a specific use is subject to this section.
                The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
                this section.
                Sec. 721.11452 Phosphonomethylated ether diamine (generic).
                 (a) Chemical substance and significant new uses subject to
                reporting. (1) The chemical substance identified generically as
                phosphonomethylated ether diamine (PMN P-18-264) is subject to
                reporting under this section for the significant new uses described in
                paragraph (a)(2) of this section.
                 (2) The significant new uses are:
                 (i) Industrial, commercial, and consumer activities. It is a
                significant new use to manufacture, processing or use of the PMN
                substance in a manner that results in inhalation exposure.
                 (ii) [Reserved]
                 (b) Specific requirements. The provisions of subpart A of this part
                apply to this section except as modified by this paragraph (b).
                 (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
                721.125(a) through (c) and (i) are applicable to manufacturers,
                importers, and processors of this substance.
                 (2) Limitations or revocation of certain notification requirements.
                The provisions of Sec. 721.185 apply to this section.
                [FR Doc. 2019-26292 Filed 1-15-20; 8:45 am]
                 BILLING CODE 6560-50-P
                

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