Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants; Extension of Submission Deadline, 54386-54390 [2021-21164]

Download as PDF 54386 Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations that it receives from the final recovery or disposal facility within one year of shipment delivery to the final recovery or disposal facility that performed one of recovery operations R1 through R11, or RC1, or one of disposal operations D1 through D12, or DC1 to DC2, to the competent authority of the country of export that controls the shipment as an export of hazardous waste, and on or after the electronic import-export reporting compliance date, to EPA electronically using EPA’s Waste Import Export Tracking System (WIETS), or its successor system. The recovery and disposal operations in this paragraph are defined in 40 CFR 262.81. * * * * * ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 716 [EPA–HQ–OPPT–2020–0474; FRL–8204–02– OCSPP] RIN 2070–AB11 Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants; Extension of Submission Deadline Environmental Protection Agency (EPA). ACTION: Final rule; extension of submission deadline. AGENCY: EPA is amending the deadline for reporting pursuant to the Toxic Substances Control Act (TSCA) Health and Safety Data Reporting rule, which requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. Specifically, EPA will be amending the deadline from September 27, 2021 to December 1, 2021 for 20 of the 50 chemical substances and to January 25, 2022 for 30 of the 50 chemical substances. The Health and Safety Data Reporting Rule, promulgated pursuant to TSCA section 8(d), requires manufacturers (including importers) of certain chemical substances to submit lists and copies of certain unpublished health and safety studies to EPA. DATES: This final rule is effective October 1, 2021. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPPT–2020–0474, is available at https://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. Please note that due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on the EPA/DC and docket access, visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Virginia Lee, Data Collections Branch, Data Gathering and Analysis Division (7410M), Office of Pollution Prevention and Toxics, Environmental Protection SUMMARY: PART 265—INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES 7. The authority citation for part 265 continues to read as follows: ■ Authority: 42 U.S.C. 6905, 6906, 6912, 6922, 6923, 6924, 6925, 6935, 6936, and 6937. 8. Revise § 265.12(a)(4)(ii) to read as follows: ■ § 265.12 Required notices. (a) * * * (4) * * * (ii) If the facility performed any of recovery operations R12, R13, or RC3, or disposal operations D13 through D15, promptly send copies of the confirmation of recovery or disposal that it receives from the final recovery or disposal facility within one year of shipment delivery to the final recovery or disposal facility that performed one of recovery operations R1 through R11, or RC1, or one of disposal operations D1 through D12, or DC1 to DC2, to the competent authority of the country of export that controls the shipment as an export of hazardous waste, and on or after the electronic import-export reporting compliance date, to EPA electronically using EPA’s Waste Import Export Tracking System (WIETS), or its successor system. The recovery and disposal operations in this paragraph are defined in 40 CFR 262.81. [FR Doc. 2021–21417 Filed 9–30–21; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 16:40 Sep 30, 2021 Jkt 256001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 564–4142; email address: lee.virginia@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in 40 CFR 716.120(d) of the regulatory text of this document. 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: Chemical manufacturers (including importers), (NAICS codes 325 and 324110), e.g., persons who manufacture (defined by statute to include import) one or more of the subject chemical substances. B. What action is the Agency taking? EPA promulgated a final rule in the Federal Register of June 29, 2021 (86 FR 34147) (FRL–10020–38) to require manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. The chemical substances subject to this rule are listed in this document and consist of the 20 designated by EPA as high-priority substances and the 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA), The Agency.is extending the submission deadline established in that final rule from September 27, 2021 to December 1, 2021 for the following chemicals: • Ethylene Dibromide • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8hexamethylcyclopenta [g]-2benzopyran (HHCB) • Tris(2-chloroethyl) phosphate (TCEP) • Phthalic Anhydride • p- Dichlorobenzene • o-Dichlorobenzene • Phosphoric acid, triphenyl ester (TPP) • Di-ethylhexyl phthalate (DEHP) • 1,2-Dichloroethane • trans-1,2-Dichloroethylene • 1,1,2-Trichloroethane • 1,2-Dichloropropane E:\FR\FM\01OCR1.SGM 01OCR1 Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations • • • • • • • • 1,1-Dichloroethane 1,3-Butadiene Formaldehyde Dibutyl phthalate (DBP) Butyl benzyl phthalate (BBP) Di-isobutyl phthalate Dicyclohexyl phthalate 4,4′-(1-Methylethylidene)bis[2, 6dibromophenol] (TBBPA) EPA is also extending the deadline established in the June 29, 2021 final rule from September 27, 2021 to January 25, 2022 for the following chemicals: • Bis(2-ethylhexyl) tetrabromophthalate • Bis(hexachlorocyclopentadieno) cyclooctane • 1,2-Bis(2,4,6-tribromophenoxy)ethane • 1,1′-Ethane-1,2diylbis(pentabromobenzene) • 2-Ethylhexyl-2,3,4,5tetrabromobenzoate • 2-(2-Hydroxyethoxy)ethyl 2hydroxypropyl 3,4,5,6tetrabromophthalate • 2,2′-[(1-Methylethylidene)bis[(2,6dibromo-4,1-phenylene) oxymethylene]]bis[oxirane] • Mixture of chlorinated linear alkanes C14–17 with 45–52% chlorine • N,N-Ethylenebis(tetrabromophthalimide) • Pentabromochlorocyclohexane • (Pentabromophenyl)methyl acrylate • Pentabromotoluene • Perbromo-1,4-diphenoxybenzene • Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester • Phosphoric acid, 2,2bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) ester • Propanoic acid, 2-bromo-, methyl ester • Tetrabromobisphenol A-bis(2,3dibromopropyl ether) • Tetrabromobisphenol A-bis(2hydroxyethyl) ether • Tetrabromobisphenol A diallyl ether • Tetrabromobisphenol A dimethyl ether • 2,4,6-Tribromoaniline • 1,3,5-Tribromo-2-(prop-2-en-1yloxy)benzene • Tris(2-chloroethyl)phosphite • Tris(1-chloro-2-propyl)phosphate • Tris(2-chloro-1-propyl)phosphate • Tris(2,3-dibromopropyl)phosphate • 1,3,5-Tris(2,3-dibromopropyl)-1,3,5triazine-2,4,6(1H,3H,5H)-trione • Tris(1,3-dichloro-2-propyl)phosphate • Tris(tribromoneopentyl)phosphate • 2,4,6-Tris-(2,4,6-tribromophenoxy)1,3,5-triazine C. Why is the Agency taking this action? The Agency is taking this action to provide additional time for the regulated community to familiarize themselves with new TSCA Health and VerDate Sep<11>2014 16:40 Sep 30, 2021 Jkt 256001 Safety Data Reporting requirements. EPA has not added chemicals to the TSCA section 8(d) rule in a manner that would affect a large group of stakeholders since 2006, for the orphan High Production Volume chemicals. With respect to the timing of this action, the need for the Agency to extend the deadline arose, in part, as a result of receiving a sizable number of requests to extend the reporting deadline. Additionally, the Agency recognizes that complications exist for certain entities subject to this rule resulting from the COVID–19 pandemic, which can present challenges to accessing records that may only be available in hard copy formats (e.g., microfiche). EPA therefore believes it is appropriate to extend the reporting period to allow the regulated community additional time for data reporting. EPA is making available a historic question and answer document about reporting under TSCA 8(d) and additional content on its web page for the rulemaking (available at https:// www.epa.gov/chemicals-under-tsca/ health-and-safety-data-reportingaddition-20-high-priority-substancesand-30), providing reporting entities additional time to review these materials and prepare any necessary submissions to improve reporting quality for this rule. EPA’s timeline for risk evaluations under TSCA section 6 necessitates that data received via the TSCA section 8(d) action be received in time for use in risk evaluations for chemical substances that have been designated as high-priority substances. Thus, EPA is limiting the deadline extension to December 1, 2021 for these chemical substances. Receiving TSCA section 8(d) submissions on these high-priority substances by December 1, 2021 will ensure that such information will be received in time for use in risk evaluations on these chemical substances. For the remaining organohalogen flame retardants subject to the rule, EPA is extending the deadline to January 25, 2022. D. What is the Agency’s authority for taking this action? EPA promulgated the Health and Safety Data Reporting rule under TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 CFR part 716. EPA is using this TSCA section 8(d) rule in accordance with 40 CFR 716.105 to gather information on chemical substances. Under section 553(b)(B) of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), an agency may issue a final rule without providing notice and an opportunity for public comment if it for good cause finds that PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 54387 notice and public procedures are impracticable, unnecessary, or contrary to the public interest. In this instance, the Agency finds that notice and public comment procedures are unnecessary because this is merely an extension of the reporting period that does not alter the substantive TSCA section 8(d) reporting requirements in any way and are impracticable because there is insufficient time for notice and comment on an extension to the deadline prior to the reporting deadline, and EPA only became aware of the need for the extension upon receiving numerous requests recently. The Agency believes the extension will not result in a significant delay in the processing and availability of information to EPA for TSCA section 6 risk evaluations or to Consumer Product Safety Commission’s (CPSC) evaluation for risks under the Federal Hazardous Substances Act (FHSA). Receiving TSCA section 8(d) submissions pursuant to these deadlines (i.e., December 1, 2021 for the high-priority substances and January 25, 2022 for the Organohalogen Flame Retardants) will ensure that such information will be received in time for use in these respective activities (i.e., evaluations pursuant to TSCA and FHSA). Further, any impact on the regulated community is expected to be beneficial to the public interest given that the extension provides additional time to submit complete and accurate unpublished health and safety studies to EPA. This final rule is effective immediately upon publication. Section 553(d)(1) of the Administrative Procedure Act, 5 U.S.C. 553(d)(1), provides that final rules shall not become effective until 30 days after publication in the Federal Register ‘‘except . . . a substantive rule which grants or recognizes an exemption or relieves a restriction.’’ The purpose of this provision is to ‘‘give affected parties a reasonable time to adjust their behavior before the final rule takes effect.’’ Omnipoint Corp. v. Fed. Commc’n Comm’n, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However, when the agency grants or recognizes an exemption or relieves a restriction, affected parties do not need a reasonable time to adjust because the effect is not adverse. EPA has determined that this rule relieves a restriction because it provides manufacturers (including importers) additional time to comply with the Health and Safety Data Reporting rule. E:\FR\FM\01OCR1.SGM 01OCR1 54388 Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations II. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review The Office of Management and Budget (OMB) has exempted actions under TSCA section 8(d) related to the Health and Safety Data Reporting rule from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993). As such, this final rule was not reviewed by OMB under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). B. Paperwork Reduction Act (PRA) This action does not contain any new or revised information collections subject to OMB approval under the PRA, 44 U.S.C. 3501 et seq. Information collection activities contained in the TSCA 8(d) rule are already approved by the Office of Management and Budget (OMB) under OMB Control No. 2070– 0004. C. Regulatory Flexibility Act (RFA) This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA applies only to rules subject to notice and comment rulemaking requirements under the APA, 5 U.S.C. 553, or any other statute. This rule is not subject to notice and comment requirements under the APA because the Agency has invoked the APA ‘‘good cause’’ exemption. D. Unfunded Mandates Reform Act (UMRA) This action will not impose any enforceable duty or contain any unfunded mandate as described under Title II of UMRA, 2 U.S.C. 1531–1538 et seq. E. Executive Order 13132: Federalism This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the 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. VerDate Sep<11>2014 16:40 Sep 30, 2021 Jkt 256001 F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, E.O. 13175 does not apply to this action. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the Agency has reason to believe may disproportionately affect children, per the definition of ‘‘covered regulatory action’’ in section 2–202 of the Executive Order. This action is not a covered regulatory action because it is not ‘‘economically significant’’ under Executive Order 12866 and it does not concern an environmental health risk or safety risk. Although this action would not establish an environmental standard intended to mitigate health or safety risks, the information that would be submitted to EPA in accordance with this rule would be used to inform the Agency’s decision-making process regarding chemical substances to which children may be disproportionately exposed. This information may also assist the Agency and others in determining whether the chemical substances covered in this proposed rule present potential risks, which would allow the Agency and others to take appropriate action to investigate and mitigate those risks. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not a ‘‘significant energy action’’ as defined in Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy and has not otherwise been designated by the Administrator of OMB’s Office of Information and Regulatory Affairs as a ‘‘significant energy action.’’ PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 I. National Technology Transfer and Advancement Act (NTTAA) Because 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). However, the Agency believes that the information collected through this rule will inform the TSCA risk evaluations that are planned for these chemicals and will thereby enable the Agency to better protect human health and the environment, including in low-income and minority communities. K. Congressional Review Act (CRA) This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 716 Environmental protection, Chemicals, Hazardous substances, Health and safety, Reporting and recordkeeping requirements. Dated: September 23, 2021. Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 716—HEALTH AND SAFETY DATA REPORTING 1. The authority citation for part 716 continues to read as follows: ■ Authority: 15 U.S.C. 2607(d). 2. In § 716.120(d), amend the table by revising all the entries under the headings ‘‘High-Priority Substances’’ and ‘‘Organohalogen flame retardants’’ to read as follows: ■ § 716.120 Substances and listed mixtures to which this subpart applies. * * * (d) * * * E:\FR\FM\01OCR1.SGM 01OCR1 * * 54389 Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations Category CASRN * * * * High-Priority Substances: 1,3-Butadiene ........................................................................................................ Butyl benzyl phthalate (BBP)—1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester ........................................................................................ Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester) ......... o-Dichlorobenzene ................................................................................................ p-Dichlorobenzene ................................................................................................ 1,1-Dichloroethane ................................................................................................ 1,2-Dichloroethane ................................................................................................ Trans-1,2-Dichloroethylene ................................................................................... 1,2-Dichloropropane .............................................................................................. Dicyclohexyl phthalate .......................................................................................... Di-ethylhexyl phthalate (DEHP)—(1,2-Benzene-dicarboxylic acid, 1,2-bis(2ethylhexyl) ester) ............................................................................................... Di-isobutyl phthalate (DIBP)—(1,2-Benzene-dicarboxylic acid, 1,2-bis(2methylpropyl) ester) ........................................................................................ Ethylene dibromide ............................................................................................... Formaldehyde ....................................................................................................... 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) .............................................................................................................. 4,4′-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) ................................... Phosphoric acid, triphenyl ester (TPP) ................................................................. Phthalic anhydride ................................................................................................. 1,1,2-Trichloroethane ............................................................................................ Tris(2-chloroethyl) phosphate (TCEP) .................................................................. * * * * * Organohalogen flame retardants: Bis(2-ethylhexyl) tetrabromophthalate .................................................................. Bis(hexachlorocyclopentadieno) cyclooctane ....................................................... 1,2-Bis(2,4,6-tribromophenoxy)ethane .................................................................. 1,1′-Ethane-1,2-diylbis(pentabromobenzene) ....................................................... 2-Ethylhexyl-2,3,4,5-tetrabromobenzoate ............................................................. 2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate .............. 2,2′-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bis[oxirane] ...................................................................... Mixture of chlorinated linear alkanes C14–17 with 45–52% chlorine .................. N,N-Ethylene-bis(tetrabromophthalimide) ............................................................. Pentabromochlorocyclohexane ............................................................................. (Pentabromophenyl)methyl acrylate ..................................................................... Pentabromotoluene ............................................................................................... Perbromo-1,4-diphenoxybenzene ......................................................................... Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester .................................. Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) ester ................................................................................................................... Propanoic acid, 2-bromo-, methyl ester ................................................................ Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) .......................................... Tetrabromobisphenol A bis(2-hydroxyethyl) ether ................................................ Tetrabromobisphenol A diallyl ether ..................................................................... Tetrabromobisphenol A dimethyl ether ................................................................. 2,4,6-Tribromoaniline ............................................................................................ 1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene ...................................................... Tris(2-chloroethyl)phosphite .................................................................................. Tris(1-chloro-2-propyl)phosphate .......................................................................... Tris(2-chloro-1-propyl)phosphate .......................................................................... Tris(2,3-dibromopropyl)phosphate ........................................................................ 1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione .................... Tris(1,3-dichloro-2-propyl)phosphate .................................................................... Tris(tribromoneopentyl)phosphate ........................................................................ 2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine .................................................. * VerDate Sep<11>2014 * 16:40 Sep 30, 2021 * Jkt 256001 PO 00000 * Frm 00051 Fmt 4700 Special exemptions * Sunset date * 106–99–0 § 716.21(a)(9) 7/29/21 12/01/21 85–68–7 84–74–2 95–50–1 106–46–7 75–34–3 107–06–2 156–60–5 78–87–5 84–61–7 § § § § § § § § § 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 12/01/21 12/01/21 12/01/21 12/01/21 12/01/21 12/01/21 12/01/21 12/01/21 12/01/21 117–81–7 § 716.21(a)(9) 7/29/21 12/01/21 84–69–5 106–93–4 50–00–0 § 716.21(a)(9) § 716.21(a)(9) § 716.21(a)(9) 7/29/21 7/29/21 7/29/21 12/01/21 12/01/21 12/01/21 § § § § § § 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 12/01/21 12/01/21 12/01/21 12/01/21 12/01/21 12/01/21 1222–05–5 79–94–7 115–86–6 85–44–9 79–00–5 115–96–8 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) 716.21(a)(9) * * * 26040–51–7 13560–89–9 37853–59–1 84852–53–9 183658–27–7 20566–35–2 § § § § § § 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 3072–84–2 85535–85–9 32588–76–4 87–84–3 59447–55–1 87–83–2 58965–66–5 6294–34–4 § § § § § § § § 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 38051–10–4 5445–17–0 21850–44–2 4162–45–2 25327–89–3 37853–61–5 147–82–0 3278–89–5 140–08–9 13674–84–5 6145–73–9 126–72–7 52434–90–9 13674–87–8 19186–97–1 25713–60–4 § § § § § § § § § § § § § § § § 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 716.21(a)(10) 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 7/29/21 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 1/25/22 * Sfmt 4700 Effective date E:\FR\FM\01OCR1.SGM * 01OCR1 * 54390 Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Rules and Regulations Affordable Life-Saving Medications’’ rule. The 2021 NPRM provided for a 30day comment period, and HHS received 332 comments. HHS carefully considered all comments in developing this rule, as outlined in Section VI below, and presents a summary of all significant comments and HHS responses. [FR Doc. 2021–21164 Filed 9–30–21; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 51c RIN 0906–AB30 Implementation of Executive Order on Access to Affordable Life-Saving Medications; Rescission of Regulation Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Final rule; rescission of regulations. AGENCY: HHS is rescinding the final rule entitled ‘‘Implementation of Executive Order on Access to Affordable Life-Saving Medications,’’ published in the December 23, 2020, Federal Register (2020 Rule). HHS is rescinding the 2020 Rule due to the excessive administrative costs and burdens that implementation would have imposed on health centers. In particular, the 2020 Rule required health centers to create and maintain new practices necessary to determine patients’ eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees plus a minimal administration fee. HHS finds the 2020 Rule’s implementation would have resulted in reduced resources available to support critical services to health center patients— including those who use insulin and injectable epinephrine. HHS’s consideration of the 2020 Rule’s impact was informed, in part, by the demands on health centers resulting from the COVID–19 pandemic. As Executive Order 13937 remains in effect, HHS is exploring non-regulatory options to implement the Executive Order. DATES: This rule is effective November 1, 2021. FOR FURTHER INFORMATION CONTACT: Jennifer Joseph, Director, Office of Policy and Program Development, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857; email: jjoseph@hrsa.gov; telephone: 301–594–4300; fax: 301– 594–4997. SUPPLEMENTARY INFORMATION: SUMMARY: I. Public Participation On June 16, 2021, HHS published a Notice of Proposed Rulemaking (2021 NPRM) in the Federal Register (86 FR 32008) to rescind the ‘‘Implementation of Executive Order on Access to VerDate Sep<11>2014 16:40 Sep 30, 2021 Jkt 256001 II. Background HHS published the subject NPRM in the Federal Register on September 28, 2020 (85 FR 60748), and the 2020 Rule on December 23, 2020 (85 FR 83822). The 2020 Rule established a new requirement directing all health centers receiving grants under section 330(e) of the Public Health Service Act (42 U.S.C. 254b(e)) that participate in the 340B Program (42 U.S.C. 256b), to the extent that they plan to make insulin and/or injectable epinephrine available to their patients, to provide assurances that they have established practices to provide these drugs at or below the discounted price paid by the health center or subgrantees under the 340B Program (plus a minimal administration fee) to health center patients with low incomes, as determined by the Secretary, who have a high cost sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or who have no health insurance. On June 16, 2021, after a careful reassessment of the comments submitted in response to the proposed rule published at 85 FR 60748 (September 28, 2020) and consideration of the comments received on the proposed rule to delay the effective date published at 86 FR 13872 (March 11, 2021), HHS published the 2021 NPRM to rescind the 2020 Rule. The 2021 NPRM cited significant concerns regarding health centers needing to divert vital resources to implement the 2020 Rule. The 2021 NPRM requested comment on the administrative burden and costs to comply with the 2020 Rule and thus maintain eligibility for future Health Center Program grants. The 2021 NPRM also requested comment on whether a rescission would assist health centers in continuing to provide primary care services to medically underserved and vulnerable populations. HHS noted the administrative burdens associated with the 2020 Rule, particularly in light of health centers’ continuing role in ensuring equitable access to COVID–19 vaccination and maintaining the capacity to provide primary and preventive care that addresses the ongoing and evolving needs of hard-toreach and disproportionately affected PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 populations. HHS also noted that the 2020 Rule would carry increased administrative costs and administrative burden and would result in reduced resources being available to support services to health center patients. In addition, most comments submitted previously noted that, in many cases, health centers already voluntarily provided medications at reduced prices to their patients. The 2021 NPRM comment period ended on July 16, 2021. After review and consideration of all submitted comments, HHS has concluded that the 2020 Rule created excessive administrative burden for health centers, which in turn would have resulted in reduced resources for health center patient services. HHS has determined that the overall impacts of the administrative burden outweigh benefits to patients from the reduction in prices of insulin and injectable epinephrine. Therefore, HHS is issuing this final rule rescinding the 2020 Rule, which was published at 85 FR 83822. The 2020 Rule became effective on July 20, 2021, prior to publication of this rescission. Due to the timing of Health Center Program funding, grants awarded in Fiscal Year 2022 would be the first opportunity for HRSA to impose the requirements of the ‘‘Implementation of Executive Order on Access to Affordable Life-Saving Medications’’ rule, and so the requirements have not yet been implemented. III. Statutory Authority The statement of authority for 42 CFR part 51c cites to sections 330 (42 U.S.C. 254b) and 215 of the Public Health Service Act, (42 U.S.C. 216), respectively. IV. Overview of This Rule HHS is rescinding the 2020 Rule and therefore deleting the associated revision to the regulations codified at 42 CFR 51c.303(w). 42 CFR 51c.303(w) stated: ‘‘To the extent that an applicant for funding under Section 330(e) of the Public Health Service Act (42 U.S.C. 254b(e)) has indicated that it plans to distribute, either directly, or through a written agreement, drugs purchased through the 340B Drug Pricing Program (42 U.S.C. 256b), and to the extent that such applicant plans to make insulin and/or injectable epinephrine available to its patients, the applicant shall provide an assurance that it has established practices to provide insulin and injectable epinephrine at or below the discounted price paid by the health center grantee or subgrantee under the 340B Drug Pricing Program (plus a E:\FR\FM\01OCR1.SGM 01OCR1

Agencies

[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Rules and Regulations]
[Pages 54386-54390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21164]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 716

[EPA-HQ-OPPT-2020-0474; FRL-8204-02-OCSPP]
RIN 2070-AB11


Health and Safety Data Reporting; Addition of 20 High-Priority 
Substances and 30 Organohalogen Flame Retardants; Extension of 
Submission Deadline

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; extension of submission deadline.

-----------------------------------------------------------------------

SUMMARY: EPA is amending the deadline for reporting pursuant to the 
Toxic Substances Control Act (TSCA) Health and Safety Data Reporting 
rule, which requires manufacturers (including importers) of 50 
specified chemical substances to report certain lists and copies of 
unpublished health and safety studies to EPA. Specifically, EPA will be 
amending the deadline from September 27, 2021 to December 1, 2021 for 
20 of the 50 chemical substances and to January 25, 2022 for 30 of the 
50 chemical substances. The Health and Safety Data Reporting Rule, 
promulgated pursuant to TSCA section 8(d), requires manufacturers 
(including importers) of certain chemical substances to submit lists 
and copies of certain unpublished health and safety studies to EPA.

DATES: This final rule is effective October 1, 2021.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2020-0474, is available at 
https://www.regulations.gov or at the Office of Pollution Prevention 
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC.
    Please note that due to the public health concerns related to 
COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to 
visitors with limited exceptions. The staff continues to provide remote 
customer service via email, phone, and webform. For the latest status 
information on the EPA/DC and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Virginia Lee, Data Collections 
Branch, Data Gathering and Analysis Division (7410M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-4142; 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 
(defined by statute to include import) any of the chemical substances 
that are listed in 40 CFR 716.120(d) of the regulatory text of this 
document. 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: 
Chemical manufacturers (including importers), (NAICS codes 325 and 
324110), e.g., persons who manufacture (defined by statute to include 
import) one or more of the subject chemical substances.

B. What action is the Agency taking?

    EPA promulgated a final rule in the Federal Register of June 29, 
2021 (86 FR 34147) (FRL-10020-38) to require manufacturers (including 
importers) of 50 specified chemical substances to report certain lists 
and copies of unpublished health and safety studies to EPA. The 
chemical substances subject to this rule are listed in this document 
and consist of the 20 designated by EPA as high-priority substances and 
the 30 organohalogen flame retardants being evaluated for risks by the 
Consumer Product Safety Commission (CPSC) under the Federal Hazardous 
Substances Act (FHSA), The Agency.is extending the submission deadline 
established in that final rule from September 27, 2021 to December 1, 
2021 for the following chemicals:

 Ethylene Dibromide
 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-
benzopyran (HHCB)
 Tris(2-chloroethyl) phosphate (TCEP)
 Phthalic Anhydride
 p- Dichlorobenzene
 o-Dichlorobenzene
 Phosphoric acid, triphenyl ester (TPP)
 Di-ethylhexyl phthalate (DEHP)
 1,2-Dichloroethane
 trans-1,2-Dichloroethylene
 1,1,2-Trichloroethane
 1,2-Dichloropropane

[[Page 54387]]

 1,1-Dichloroethane
 1,3-Butadiene
 Formaldehyde
 Dibutyl phthalate (DBP)
 Butyl benzyl phthalate (BBP)
 Di-isobutyl phthalate
 Dicyclohexyl phthalate
 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)

    EPA is also extending the deadline established in the June 29, 2021 
final rule from September 27, 2021 to January 25, 2022 for the 
following chemicals:

 Bis(2-ethylhexyl) tetrabromophthalate
 Bis(hexachlorocyclopentadieno) cyclooctane
 1,2-Bis(2,4,6-tribromophenoxy)ethane
 1,1'-Ethane-1,2-diylbis(pentabromobenzene)
 2-Ethylhexyl-2,3,4,5-tetrabromobenzoate
 2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-
tetrabromophthalate
 2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-
phenylene)oxymethylene]]bis[oxirane]
 Mixture of chlorinated linear alkanes C14-17 with 45-52% 
chlorine
 N,N-Ethylene-bis(tetrabromophthalimide)
 Pentabromochlorocyclohexane
 (Pentabromophenyl)methyl acrylate
 Pentabromotoluene
 Perbromo-1,4-diphenoxybenzene
 Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester
 Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl 
tetrakis(2-chloroethyl) ester
 Propanoic acid, 2-bromo-, methyl ester
 Tetrabromobisphenol A-bis(2,3-dibromopropyl ether)
 Tetrabromobisphenol A-bis(2-hydroxyethyl) ether
 Tetrabromobisphenol A diallyl ether
 Tetrabromobisphenol A dimethyl ether
 2,4,6-Tribromoaniline
 1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene
 Tris(2-chloroethyl)phosphite
 Tris(1-chloro-2-propyl)phosphate
 Tris(2-chloro-1-propyl)phosphate
 Tris(2,3-dibromopropyl)phosphate
 1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-
trione
 Tris(1,3-dichloro-2-propyl)phosphate
 Tris(tribromoneopentyl)phosphate
 2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine

C. Why is the Agency taking this action?

    The Agency is taking this action to provide additional time for the 
regulated community to familiarize themselves with new TSCA Health and 
Safety Data Reporting requirements. EPA has not added chemicals to the 
TSCA section 8(d) rule in a manner that would affect a large group of 
stakeholders since 2006, for the orphan High Production Volume 
chemicals. With respect to the timing of this action, the need for the 
Agency to extend the deadline arose, in part, as a result of receiving 
a sizable number of requests to extend the reporting deadline. 
Additionally, the Agency recognizes that complications exist for 
certain entities subject to this rule resulting from the COVID-19 
pandemic, which can present challenges to accessing records that may 
only be available in hard copy formats (e.g., microfiche).
    EPA therefore believes it is appropriate to extend the reporting 
period to allow the regulated community additional time for data 
reporting. EPA is making available a historic question and answer 
document about reporting under TSCA 8(d) and additional content on its 
web page for the rulemaking (available at https://www.epa.gov/chemicals-under-tsca/health-and-safety-data-reporting-addition-20-high-priority-substances-and-30), providing reporting entities additional 
time to review these materials and prepare any necessary submissions to 
improve reporting quality for this rule.
    EPA's timeline for risk evaluations under TSCA section 6 
necessitates that data received via the TSCA section 8(d) action be 
received in time for use in risk evaluations for chemical substances 
that have been designated as high-priority substances. Thus, EPA is 
limiting the deadline extension to December 1, 2021 for these chemical 
substances. Receiving TSCA section 8(d) submissions on these high-
priority substances by December 1, 2021 will ensure that such 
information will be received in time for use in risk evaluations on 
these chemical substances. For the remaining organohalogen flame 
retardants subject to the rule, EPA is extending the deadline to 
January 25, 2022.

D. What is the Agency's authority for taking this action?

    EPA promulgated the Health and Safety Data Reporting rule under 
TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 CFR 
part 716. EPA is using this TSCA section 8(d) rule in accordance with 
40 CFR 716.105 to gather information on chemical substances. Under 
section 553(b)(B) of the Administrative Procedure Act (APA), 5 U.S.C. 
553(b)(B), an agency may issue a final rule without providing notice 
and an opportunity for public comment if it for good cause finds that 
notice and public procedures are impracticable, unnecessary, or 
contrary to the public interest. In this instance, the Agency finds 
that notice and public comment procedures are unnecessary because this 
is merely an extension of the reporting period that does not alter the 
substantive TSCA section 8(d) reporting requirements in any way and are 
impracticable because there is insufficient time for notice and comment 
on an extension to the deadline prior to the reporting deadline, and 
EPA only became aware of the need for the extension upon receiving 
numerous requests recently. The Agency believes the extension will not 
result in a significant delay in the processing and availability of 
information to EPA for TSCA section 6 risk evaluations or to Consumer 
Product Safety Commission's (CPSC) evaluation for risks under the 
Federal Hazardous Substances Act (FHSA). Receiving TSCA section 8(d) 
submissions pursuant to these deadlines (i.e., December 1, 2021 for the 
high-priority substances and January 25, 2022 for the Organohalogen 
Flame Retardants) will ensure that such information will be received in 
time for use in these respective activities (i.e., evaluations pursuant 
to TSCA and FHSA). Further, any impact on the regulated community is 
expected to be beneficial to the public interest given that the 
extension provides additional time to submit complete and accurate 
unpublished health and safety studies to EPA.
    This final rule is effective immediately upon publication. Section 
553(d)(1) of the Administrative Procedure Act, 5 U.S.C. 553(d)(1), 
provides that final rules shall not become effective until 30 days 
after publication in the Federal Register ``except . . . a substantive 
rule which grants or recognizes an exemption or relieves a 
restriction.'' The purpose of this provision is to ``give affected 
parties a reasonable time to adjust their behavior before the final 
rule takes effect.'' Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d 
620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551 
F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However, 
when the agency grants or recognizes an exemption or relieves a 
restriction, affected parties do not need a reasonable time to adjust 
because the effect is not adverse. EPA has determined that this rule 
relieves a restriction because it provides manufacturers (including 
importers) additional time to comply with the Health and Safety Data 
Reporting rule.

[[Page 54388]]

II. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) has exempted actions 
under TSCA section 8(d) related to the Health and Safety Data Reporting 
rule from the requirements of Executive Order 12866 (58 FR 51735, 
October 4, 1993). As such, this final rule was not reviewed by OMB 
under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not contain any new or revised information 
collections subject to OMB approval under the PRA, 44 U.S.C. 3501 et 
seq. Information collection activities contained in the TSCA 8(d) rule 
are already approved by the Office of Management and Budget (OMB) under 
OMB Control No. 2070-0004.

C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA 
applies only to rules subject to notice and comment rulemaking 
requirements under the APA, 5 U.S.C. 553, or any other statute. This 
rule is not subject to notice and comment requirements under the APA 
because the Agency has invoked the APA ``good cause'' exemption.

D. Unfunded Mandates Reform Act (UMRA)

    This action will not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of UMRA, 2 U.S.C. 1531-
1538 et seq.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have 
substantial direct effects on the 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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes. Thus, E.O. 13175 does not apply to this 
action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that the Agency has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order. This 
action is not a covered regulatory action because it is not 
``economically significant'' under Executive Order 12866 and it does 
not concern an environmental health risk or safety risk. Although this 
action would not establish an environmental standard intended to 
mitigate health or safety risks, the information that would be 
submitted to EPA in accordance with this rule would be used to inform 
the Agency's decision-making process regarding chemical substances to 
which children may be disproportionately exposed. This information may 
also assist the Agency and others in determining whether the chemical 
substances covered in this proposed rule present potential risks, which 
would allow the Agency and others to take appropriate action to 
investigate and mitigate those risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy and has not otherwise been designated by 
the Administrator of OMB's Office of Information and Regulatory Affairs 
as a ``significant energy action.''

I. National Technology Transfer and Advancement Act (NTTAA)

    Because 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). However, the Agency believes that the 
information collected through this rule will inform the TSCA risk 
evaluations that are planned for these chemicals and will thereby 
enable the Agency to better protect human health and the environment, 
including in low-income and minority communities.

K. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 716

    Environmental protection, Chemicals, Hazardous substances, Health 
and safety, Reporting and recordkeeping requirements.

    Dated: September 23, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 716--HEALTH AND SAFETY DATA REPORTING

0
1. The authority citation for part 716 continues to read as follows:

    Authority: 15 U.S.C. 2607(d).


0
2. In Sec.  716.120(d), amend the table by revising all the entries 
under the headings ``High-Priority Substances'' and ``Organohalogen 
flame retardants'' to read as follows:


Sec.  716.120  Substances and listed mixtures to which this subpart 
applies.

* * * * *
    (d) * * *

[[Page 54389]]



----------------------------------------------------------------------------------------------------------------
                                                                              Special       Effective    Sunset
                        Category                              CASRN          exemptions        date       date
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
High-Priority Substances:
    1,3-Butadiene......................................        106-99-0              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    Butyl benzyl phthalate (BBP)--1,2-Benzene-                  85-68-7              Sec.     7/29/21   12/01/21
     dicarboxylic acid, 1-butyl 2(phenylmethyl) ester..                      716.21(a)(9)
    Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic           84-74-2              Sec.     7/29/21   12/01/21
     acid, 1,2-dibutyl ester)..........................                      716.21(a)(9)
    o-Dichlorobenzene..................................         95-50-1              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    p-Dichlorobenzene..................................        106-46-7              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    1,1-Dichloroethane.................................         75-34-3              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    1,2-Dichloroethane.................................        107-06-2              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    Trans-1,2-Dichloroethylene.........................        156-60-5              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    1,2-Dichloropropane................................         78-87-5              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    Dicyclohexyl phthalate.............................         84-61-7              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-              117-81-7              Sec.     7/29/21   12/01/21
     dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester)...                      716.21(a)(9)
    Di-isobutyl phthalate (DIBP)--(1,2-Benzene-                 84-69-5              Sec.     7/29/21   12/01/21
     dicarboxylic acid, 1,2-bis-(2methylpropyl) ester).                      716.21(a)(9)
    Ethylene dibromide.................................        106-93-4              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    Formaldehyde.......................................         50-00-0              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-                        1222-05-5              Sec.     7/29/21   12/01/21
     hexamethylcyclopenta [g]-2-benzopyran (HHCB)......                      716.21(a)(9)
    4,4'-(1-Methylethylidene)bis[2,6-dibromophenol]             79-94-7              Sec.     7/29/21   12/01/21
     (TBBPA)...........................................                      716.21(a)(9)
    Phosphoric acid, triphenyl ester (TPP).............        115-86-6              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    Phthalic anhydride.................................         85-44-9              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    1,1,2-Trichloroethane..............................         79-00-5              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
    Tris(2-chloroethyl) phosphate (TCEP)...............        115-96-8              Sec.     7/29/21   12/01/21
                                                                             716.21(a)(9)
 
                                                  * * * * * * *
Organohalogen flame retardants:
    Bis(2-ethylhexyl) tetrabromophthalate..............      26040-51-7              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Bis(hexachlorocyclopentadieno) cyclooctane.........      13560-89-9              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    1,2-Bis(2,4,6-tribromophenoxy)ethane...............      37853-59-1              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    1,1'-Ethane-1,2-diylbis(pentabromobenzene).........      84852-53-9              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    2-Ethylhexyl-2,3,4,5-tetrabromobenzoate............     183658-27-7              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-        20566-35-2              Sec.     7/29/21    1/25/22
     tetrabromophthalate...............................                     716.21(a)(10)
    2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-           3072-84-2              Sec.     7/29/21    1/25/22
     phenylene)oxymethylene]]bis[oxirane]..............                     716.21(a)(10)
    Mixture of chlorinated linear alkanes C14-17 with        85535-85-9              Sec.     7/29/21    1/25/22
     45-52% chlorine...................................                     716.21(a)(10)
    N,N-Ethylene-bis(tetrabromophthalimide)............      32588-76-4              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Pentabromochlorocyclohexane........................         87-84-3              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    (Pentabromophenyl)methyl acrylate..................      59447-55-1              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Pentabromotoluene..................................         87-83-2              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Perbromo-1,4-diphenoxybenzene......................      58965-66-5              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Phosphonic acid, (2-chloroethyl)-, bis(2-                 6294-34-4              Sec.     7/29/21    1/25/22
     chloroethyl) ester................................                     716.21(a)(10)
    Phosphoric acid, 2,2-bis(chloromethyl)-1,3-              38051-10-4              Sec.     7/29/21    1/25/22
     propanediyl tetrakis(2-chloroethyl) ester.........                     716.21(a)(10)
    Propanoic acid, 2-bromo-, methyl ester.............       5445-17-0              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tetrabromobisphenol A-bis(2,3-dibromopropyl ether).      21850-44-2              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tetrabromobisphenol A bis(2-hydroxyethyl) ether....       4162-45-2              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tetrabromobisphenol A diallyl ether................      25327-89-3              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tetrabromobisphenol A dimethyl ether...............      37853-61-5              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    2,4,6-Tribromoaniline..............................        147-82-0              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene........       3278-89-5              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tris(2-chloroethyl)phosphite.......................        140-08-9              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tris(1-chloro-2-propyl)phosphate...................      13674-84-5              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tris(2-chloro-1-propyl)phosphate...................       6145-73-9              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tris(2,3-dibromopropyl)phosphate...................        126-72-7              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-            52434-90-9              Sec.     7/29/21    1/25/22
     2,4,6(1H,3H,5H)-trione............................                     716.21(a)(10)
    Tris(1,3-dichloro-2-propyl)phosphate...............      13674-87-8              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    Tris(tribromoneopentyl)phosphate...................      19186-97-1              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
    2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine..      25713-60-4              Sec.     7/29/21    1/25/22
                                                                            716.21(a)(10)
 
                                                  * * * * * * *
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[[Page 54390]]

[FR Doc. 2021-21164 Filed 9-30-21; 8:45 am]
BILLING CODE 6560-50-P


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