Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 702</CFR> <DEPDOC>[EPA-HQ-OPPT-2023-0496; FRL-8529-02-OCSPP]</DEPDOC> <RIN>RIN 2070-AK90</RIN> <SUBJECT>Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or the Agency) is finalizing amendments to the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use. EPA reconsidered the procedural framework rule for conducting such risk evaluations and is revising certain aspects of that framework to better align with the statutory text and applicable court decisions, to reflect the Agency's experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of future scientific advances in the risk evaluation process without need to further amend the Agency's procedural rule. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective on July 2, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> EPA has established a docket for this action under Docket ID No. EPA-HQ-OPPT-2023-0496. All documents in the docket are listed on the <E T="03">https://www.regulations.gov</E> website. Although listed in the index, some information is not publicly available, <E T="03">e.g.,</E> CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through <E T="03">https://www.regulations.gov.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">For technical information contact:</E> Susanna Blair, Immediate Office, Office of Pollution Prevention and Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4371; email address: <E T="03">blair.susanna@epa.gov.</E> <E T="03">For general information contact:</E> The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: <E T="03">TSCA-Hotline@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> EPA is amending procedural requirements that apply to the Agency's activities in carrying out TSCA risk evaluations. EPA is also amending the process and requirements that manufacturers (including importers) are required to follow when they request an Agency-conducted TSCA risk evaluation on a particular chemical substance. You may be potentially affected by this action if you manufacture or import chemical substances regulated under TSCA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities and corresponding North American Industrial Classification System (NAICS) codes for entities that may be interested in or affected by this action. The following list of 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: • Petroleum Refineries (NAICS code 324110); • Chemical Manufacturing (NAICS code 325); • Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing (NAICS code 326113); • Unlaminated Plastics Profile Shape Manufacturing (NAICS code 326121); • Plastics Pipe and Pipe Fitting Manufacturing (NAICS code 326122); • Laminated Plastics Plate, Sheet (except Packaging), and Shape Manufacturing (NAICS code 326130); • Polystyrene Foam Product Manufacturing (NAICS code 326140); • Urethane and Other Foam Product (except Polystyrene) Manufacturing (NAICS code 326150); • Plastics Bottle Manufacturing (NAICS code 326160); • Plastics Plumbing Fixture Manufacturing (NAICS code 326191); • All Other Plastics Product Manufacturing (NAICS code 326199); • Tire Manufacturing (except Retreading) (NAICS code 326211); • Tire Retreading (NAICS code 326212); • Rubber and Plastics Hoses and Belting Manufacturing (NAICS code 326220); • Rubber Product Manufacturing for Mechanical Use (NAICS code 326291); • All Other Rubber Product Manufacturing (NAICS code 326299); • Pottery, Ceramics, and Plumbing Fixture Manufacturing (NAICS code 327110); • Clay Building Material and Refractories Manufacturing (NAICS code 327120); • Flat Glass Manufacturing (NAICS code 327211); • Other Pressed and Blown Glass and Glassware Manufacturing (NAICS code 327212); • Glass Container Manufacturing (NAICS code 327213); • Glass Product Manufacturing Made of Purchased Glass (NAICS code 327215); • Cement Manufacturing (NAICS code 327310); • Ready Mix Concrete Manufacturing (NAICS code 327320); • Concrete Block and Brick Manufacturing (NAICS code 327331); • Concrete Pipe Manufacturing (NAICS code 327332); and • Other Concrete Product Manufacturing (NAICS code 327390). If you have any questions regarding the applicability of this action to a particular entity, consult the technical information contact listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> EPA is promulgating this final rule pursuant to the authority in TSCA section 6(b)(4) (15 U.S.C. 2605(b)(4)). EPA has inherent authority to reconsider previous decisions and to revise, replace, or repeal a decision to the extent permitted by law and supported by reasoned explanation. <E T="03">See FCC</E> v. <E T="03">Fox Television Stations, Inc.,</E> 556 U.S. 502, 515 (2009); <E T="03">see also Motor Vehicle Mfrs. Ass'n</E> v. <E T="03">State Farm Mut. Auto. Ins. Co.,</E> 463 U.S. 29, 42 (1983). <HD SOURCE="HD2">C. What action is the Agency taking?</HD> EPA is amending regulations that address how the Agency conducts risk evaluations on chemical substances under TSCA. These changes include, but are not limited to, targeted changes to certain definitions, clarifications regarding the required scope of risk evaluations, considerations related to peer review and the Agency's implementation of the scientific standards, the approach for risk determinations on chemical substances and considerations related to unreasonable risk, and the process for revisiting a completed risk evaluation. EPA is also amending the process and requirements for manufacturers making a voluntary request for an Agency-conducted risk evaluation. <HD SOURCE="HD2">D. Why is the Agency taking this action?</HD> As further explained in Units I., II., III. and IV., EPA reexamined the July 20, 2017, final rule (Ref. 1) (hereinafter “2017 final rule”) that established procedures and requirements for chemical risk evaluation under TSCA, in consideration of: • The statutory text and structure and Congressional intent. • The November 14, 2019, opinion issued by U.S. Court of Appeals for the Ninth Circuit in response to petitions for judicial review, consolidated under <E T="03">Safer Chemicals, Healthy Families</E> v. <E T="03">USEPA</E> (Ref. 2), of the 2017 final rule and related court orders. • Executive Order 13990, <E T="03">Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis</E> (Ref. 3). • Lessons learned from the Agency's implementation of the risk evaluation program to date including feedback from the National Academies of Science Engineering and Medicine and scientific peer reviewers. The Agency is amending the 2017 final rule as a result of this reexamination for the reasons explained elsewhere through the preambles of the proposed and final rules and the response to comments. <HD SOURCE="HD2">E. What are the estimated incremental impacts of this action?</HD> The incremental impacts of this action are associated with procedural requirements, as described in Unit IV.J., which apply to manufacturers when manufacturers (including importers) elect to request that EPA perform a risk evaluation on a particular chemical substance. EPA estimated the potential burden and costs associated with the amended requirements for submitting a request for an Agency-conducted risk evaluation on a particular chemical substance. The estimates of burden and costs are available in the docket, and are discussed in Unit VII.B. and briefly summarized here (Ref. 4). The total estimated annual burden is 166 hours and $115,711 (per year), which is based on an estimated per request burden of 166 hours. In addition, EPA's evaluation of the potential costs associated with this action is discussed in Unit VII.B. Since the incremental impacts of this rule involve the activities that a manufacturer requesting a risk evaluation must perform, the estimated incremental costs to the public are expected to be negligible. <HD SOURCE="HD1">II. Background</HD> The background for this rulemaking, including the statutory requirements for risk evaluation, the judicial review of the 2017 final rule, EPA's review of the 2017 final rule, and lessons learned from the Agency's implementation of the risk evaluation program are discussed in the notice of proposed rulemaking (Ref. 5 at pp. 742 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 231k characters. 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