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

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 proposed action to a particular entity, consult the technical information contact listed under FOR FURTHER INFORMATION CONTACT .

B. What is the Agency's authority for this proposed action?

The statutory authority for this proposed action is TSCA section 6(b)(4)(B), which requires EPA to establish, by rule, a process to conduct risk evaluations that meet applicable

statutory requirements (15 U.S.C. 2605(b)(4)(B)). As detailed in Units II.A and II.B of this preamble, EPA originally promulgated the procedural framework rule for risk evaluations under TSCA section 6(b)(4)(B) in 2017 and subsequently revised the procedural framework rule in 2024. Unless provided otherwise by law, agencies may reconsider, revise, or rescind prior rules by acknowledging the change, offering a reasonable basis for the change, and taking any significant reliance interests into account. See FDA v. Wages & White Lion Invs., L.L.C., 145 S. Ct. 898, 917 (2025); FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009); Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42 (1983)

sk evaluations on existing chemical substances under TSCA section 6(b) (15 U.S.C. 2605(b)). These proposed amendments are specifically targeted towards changes made in the 2024 final rule that may not be consistent with the best reading of TSCA and that may impede the timely completion of risk evaluations and unnecessarily impair the effective and efficient protection of health and the environment. Provisions being reconsidered include whether TSCA necessitates a single risk determination for each chemical substance evaluated versus a risk determination for each condition of use of the given chemical substance, outlined in Unit III.B; whether EPA must evaluate all conditions of use and all exposure routes and pathways in a risk evaluation, outlined in Unit III.A.3; whether and how the use of personal protective equipment and engineering and administrative controls in an occupational work environment should be considered, outlined in Unit III.C.1; certain regulatory definitions and whether regulatory definitions should be broader than the statutory definitions, outlined in Unit III.D.2; and what process EPA should follow when reconsidering aspects of a risk evaluation, outlined in Unit III.E. EPA is also proposing certain amendments to the process and requirements that manufacturers (including importers) would be required to follow when they request an Agency-conducted TSCA risk evaluation on a particular chemical substance, outlined in Unit III.F

tions, outlined in Unit III.D.2; and what process EPA should follow when reconsidering aspects of a risk evaluation, outlined in Unit III.E. EPA is also proposing certain amendments to the process and requirements that manufacturers (including importers) would be required to follow when they request an Agency-conducted TSCA risk evaluation on a particular chemical substance, outlined in Unit III.F.

Specifically, EPA is proposing to amend the regulations at: 40 CFR 702.31 so that the changes to the procedures as part of this rulemaking would be applied to all risk evaluations initiated on or after the date of the final rule and would be applied to risk evaluations that are in process as of the date of the final rule, but not yet finalized, to the extent practicable; 40 CFR 702.33 to revise or add definitions to ensure transparency and accountability in conducting risk evaluations; 40 CFR 702.37 and 40 CFR 702.39 to remove provisions in the 2024 final rule that require EPA to consider every condition of use and every exposure route and pathway based on reasonably available information without exception when conducting a risk evaluation under TSCA section 6(b); 40 CFR 702.39, to return to the risk determination approach in the 2017 final rule, which required EPA to make a determination of unreasonable risk for each condition of use instead of a single risk determination on the chemical substance as a whole, and to further clarify how EPA will take occupational exposure controls into account when conducting risk evaluations and making risk determinations; 40 CFR 702.43 to revise procedures established in the 2024 final rule for whether and how EPA would endeavor to revise or supplement final scope documents and draft or final risk evaluations; and 40 CFR 702.45 to generally scale back the information collection obligations that the 2024 final rule imposed on requesting manufacturers, and to clarify that manufacturers that withdraw a request before it is granted do not incur fees

res established in the 2024 final rule for whether and how EPA would endeavor to revise or supplement final scope documents and draft or final risk evaluations; and 40 CFR 702.45 to generally scale back the information collection obligations that the 2024 final rule imposed on requesting manufacturers, and to clarify that manufacturers that withdraw a request before it is granted do not incur fees.

There are certain aspects of the current risk evaluation procedural regulations that EPA is not proposing to change, including the general revised organization of the regulations as amended in the 2024 final rule. EPA is not proposing to make edits to the definitions found in 40 CFR 702.33, some of which were changed in the 2024 final rule, except for those specifically called out in this proposal ( e.g., overburdened communities). Further, EPA is not proposing to make changes to the general requirements (40 CFR 702.37) and components of risk evaluations (40 CFR 702.39), some of which were amended in the 2024 rule, except where changes are outlined in this proposal ( e.g., deletion of 40 CFR 702.39(8) and (9)).

For risk evaluations initiated prior the effective date of the final rule, but not yet finalized, EPA will seek to apply the requirements to the extent practicable. These requirements shall not apply retroactively to risk evaluations already finalized.

EPA is requesting public comment on all aspects of this proposal.

D. Why is the Agency proposing this action?

As further explained in Units I, II, and III of this preamble, EPA has reviewed the May 3, 2024, final rule entitled Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (89 FR 37028, May 3, 2024) (FRL-8529-02-OCSPP) (Ref. 1) (hereinafter “2024 final rule”), which amended the July 20, 2017, final rule entitled Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726, July 20, 2017) (FRL-9964-38) (Ref

EPA has estimated the potential burden and costs associated with the proposed requirements for submitting such a request. These estimates of burden and costs are available in the docket (Ref. 5), discussed in Unit VI of this preamble, and briefly summarized here.

The total estimated annual burden is 166 hours and $91,831 (per year), which is based on an estimated per request burden of 166 hours.

EPA's evaluation of the potential costs associated with this action is discussed in Unit VI.C of this preamble. Because this proposed action focuses on the activities that a manufacturer must perform in voluntarily requesting a risk evaluation, the estimated incremental costs to the public are expected to be negligible. However, there are Paperwork Reduction Act (PRA) related burden and costs if industry chooses to submit a manufacturer requested risk evaluation to the Agency. This rulemaking is expected to reduce the regulatory burden associated with these submissions resulting in an estimated PRA activity cost savings of $23,880 per year (assuming one submission per year) as compared to the 2024 final rule.

EPA specifically requests comment on the burden estimate and assumptions associated with the calculation associated with the burden ( e.g., number of requests EPA expects). More generally, EPA requests comment on whether and how the proposed rule would reduce burdens, and welcomes detailed information, examples, and data addressing the impacts of the rule.

F. What should I consider as I prepare my comments for EPA?

EPA is requesting public comment on all aspects of this proposal. Throughout this proposed rule, the Agency is soliciting feedback from the public on specific issues. See Unit IV for a summary of those specific requests for comment.

1. Submitting CBI

Do not submit CBI to EPA through https://www.regulations.gov or email

f the rule.

F. What should I consider as I prepare my comments for EPA?

EPA is requesting public comment on all aspects of this proposal. Throughout this proposed rule, the Agency is soliciting feedback from the public on specific issues. See Unit IV for a summary of those specific requests for comment.

1. Submitting CBI

Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that you claim to be 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 https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

TSCA section 6(b)(4)(B) requires EPA to establish, by rule, a process to conduct risk evaluations that meet applicable statutory requirements (15 U.S.C. 2605(b)(4)(B)). EPA originally promulgated the procedural framework rule for risk evaluations under TSCA section 6(b)(4)(B) in 2017 and subsequently revised the procedural framework rule in 2024. This Unit summarizes the background for this proposed rule, including the 2017 final rule, judicial review of the 2017 final rule, the 2024 final rule, and EPA's review of the 2024 final rule in consideration of the Administration's priorities and recent judicial decisions on statutory interpretation, including the Supreme Court's decision in Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024).

A. The 2017 Final Rule

As amended by the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182, 130 Stat

inal rule, and EPA's review of the 2024 final rule in consideration of the Administration's priorities and recent judicial decisions on statutory interpretation, including the Supreme Court's decision in Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024).

A. The 2017 Final Rule

As amended by the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182, 130 Stat. 448) (Lautenberg Act), TSCA section 6(b)(4)(B) requires EPA to establish, by rule, a process to conduct risk evaluations in accordance with statutory requirements (15 U.S.C. 2605(b)(4)(B)). Specifically, Congress directed EPA to use this process to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use” (15 U.S.C. 2605(b)(4)(A)). TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements applicable to this process, including provisions that direct which chemical substances must undergo risk evaluation, the development of criteria for manufacturer-requested risk evaluations, the minimum components of an Agency risk evaluation, and the timelines for public comment and completion of the risk evaluation (15 U.S.C. 2605(b)(4)(A) through (H)). The statute also requires EPA to consider reasonably available information and operate in a manner that is consistent with the best available science and make decisions based on the weight of the scientific evidence (15 U.S.C. 2625(h), (i), (k)).

Accordingly, on July 20, 2017, EPA promulgated a final rule that established the process for conducting risk evaluations under TSCA section 6(b)

(H)). The statute also requires EPA to consider reasonably available information and operate in a manner that is consistent with the best available science and make decisions based on the weight of the scientific evidence (15 U.S.C. 2625(h), (i), (k)).

Accordingly, on July 20, 2017, EPA promulgated a final rule that established the process for conducting risk evaluations under TSCA section 6(b). The 2017 final rule identified the components of the risk evaluation process applicable to a chemical substance or category of chemical substances including: scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. For the unreasonable risk determination, the 2017 final rule at 40 CFR 702.47 stated that “EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of uses [sic] within the scope of the risk evaluation.” This process was intended to be used for the initial ten chemicals identified for evaluation, for chemical substances designated as high-priority substances during the prioritization process under TSCA section 6(b)(1), and for those chemical substances for which EPA has initiated a risk evaluation in response to a manufacturer request.

While the regulatory text of the 2017 final rule did not directly address the risk evaluation scope decisions that EPA might make, EPA explained in the preamble that it interpreted the requirements of TSCA section 6 to apply to conditions of use for which manufacturing, processing, or distribution in commerce is intended, known to be occurring, or reasonably foreseen to occur, rather than to legacy uses, which EPA used as a term for continuing, in-situ uses of chemicals for which manufacturing, processing, or distribution in commerce had ceased ( e.g., certain phased-out flame retardants present in textiles or furniture that continue to be used, asbestos-containing pipe wrap, etc.), associated disposal (disposal of legacy uses), or legacy disposal

risk evaluations in the manner [those litigants] fear[ed].” Safer Chems., 943 F.3d at 413. (Ref. 6). With regard to petitioners' claim that EPA intended to exclude conditions of use out of the scope of the risk evaluations, the court held that claim not ripe and did “not interpret the language in the [2017 final rule] to say anything about exclusion of conditions of use.” Id. at 420 (Ref. 6).

C. The 2024 Revisions to the 2017 Final Rule

After a change in Administration, President Biden issued Executive Order 13990 on January 20, 2021 (86 FR 7037, January 25, 2021) (Ref. 8) which instructed agencies to review and consider revising regulations finalized by the prior Administration according to a new set of environmental policies. In response to the Executive Order, EPA announced certain policy changes for TSCA risk evaluations on June 30, 2021, including expanded consideration of exposure pathways, constraints on EPA's assumptions regarding personal protective equipment (“PPE”) use, and making risk determinations on the “whole chemical,” rather than on individual conditions of use (Ref. 9).

In consideration of Executive Order 13990, EPA issued a Notice of Proposed Rulemaking on October 30, 2023 ( Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA), 88 FR 74292, October 30, 2023 (FRL-8529-01-02-OCSPP)) (hereinafter “2023 proposed rule”) (Ref. 10), that included the policy changes identified in 2021, the changes EPA determined necessary to make the rule consistent with the Ninth Circuit's decision in Safer Chemicals, and a number of other proposed revisions

Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA), 88 FR 74292, October 30, 2023 (FRL-8529-01-02-OCSPP)) (hereinafter “2023 proposed rule”) (Ref. 10), that included the policy changes identified in 2021, the changes EPA determined necessary to make the rule consistent with the Ninth Circuit's decision in Safer Chemicals, and a number of other proposed revisions. During a 45-day public comment period, public commenters raised a multitude of issues, including but not limited to concerns about the proposed expanded consideration of exposure pathways, proposed constraints on EPA's assumptions regarding personal protective equipment (“PPE”) use, and EPA's proposal to make risk determinations on the “whole chemical,” rather than on individual conditions of use as detailed in EPA's Response to Comment Document on the 2023 proposed rule (Ref. 11). EPA issued the 2024 final rule on May 3, 2024 (89 FR 37028) (FRL-8529-02-OCSPP) (Ref. 1). Provisions of the 2024 final rule being reconsidered in this proposed action are described in this Unit and in Unit III.

The 2024 final rule codifies provisions requiring EPA to consider all exposure pathways, including those covered by other statutes such as the Clean Air Act and the Clean Water Act, and to include all reasonably known conditions of use within the scope of the risk evaluation, based on an interpretation of TSCA section 6(b)(4) that limits EPA's discretion on scoping of risk evaluations. Likewise, the 2024 final rule interprets TSCA section 6(b)(4)(A) to require that EPA make a single determination of unreasonable risk for the entire chemical substance rather than a risk determination for each individual condition of use assessed

ns of use and collecting hazard and exposure information for the requested chemical substances. Under the 2024 final rule, manufacturers requesting risk evaluations bear the burden of providing EPA with all of the information necessary to conduct the risk evaluation. The revisions require manufacturers to gather and provide all such information that is known to, or reasonably ascertainable by them. The 2024 final rule explains that manufacturers must exercise due diligence in collecting this information, which includes a thorough search of publicly available information, an inquiry throughout the manufacturer's entire organization, and inquiries to upstream suppliers, downstream users, and employees and other agents of the manufacturer. The 2024 final rule, at 40 CFR 702.45(a)(4), generally holds manufacturer-requested risk evaluations to the same information standards as EPA-initiated risk evaluations, which would preclude limited risk evaluations on a subset of the conditions of use of interest to the requesting manufacturers.

Other revisions related to the 2021 policy changes included the addition of the phrase “overburdened communities” to the definition of the term “potentially exposed or susceptible populations”; the definition in the 2017 final rule had simply repeated the definition in the statute. In addition, the preamble to the 2024 final rule discussed EPA's intention to adhere to the Ninth Circuit's decision in Safer Chemicals, 943 F.3d 397 (Ref. 6), and to

include legacy uses and associated disposals in a “part 2” risk evaluation for asbestos, as well as in future risk evaluations.

Provisions of the 2024 final rule not directly related to the 2021 policy change announcement included language on the process EPA will follow to revise risk evaluation scope documents and other risk evaluation documents

ound in the preamble to the 2024 final rule.

Petitions for review of the 2024 final rule were filed by industry stakeholders, a union, and environmental advocacy organizations. See United Steel, et al. v. EPA, No. 24-1151 (D.C. Cir.). The litigation was consolidated in the U.S. Court of Appeals for the D.C. Circuit Court and is currently in abeyance while EPA reconsiders the 2024 final rule.

D. Review of the 2024 Final Rule

Following another change in Administration, President Trump revoked E.O. 13990 on January 20, 2025 (90 FR 8353) (Ref. 12) and issued Executive Order 14219 on February 19, 2025, which directs agency heads to review all regulations under their jurisdiction for consistency with law and Administration policy and identify inconsistent regulations for recission or modification (90 FR 10583) (Ref. 3). Among the categories of regulations to be identified are those that are based on anything other than the best reading of the underlying statutory authority; those that significantly and unjustifiably impede technological innovation, infrastructure development, disaster response, inflation reduction, research and development, economic development, energy production, land use, and foreign policy objectives; and those that impose undue burdens on small business and impede private enterprise and entrepreneurship.

On March 10, 2025, Administrator Zeldin identified the 2024 final rule as one such regulation under review and announced that EPA would be conducting a rulemaking to review multiple aspects of the 2024 final rule for consistency with law and Administration policy (Ref. 13)

icient and would further delay progress in the overall undertaking.

Completing these comprehensive risk evaluations within the timeframes set forth by Congress, only 3 to 3.5 years, represents a significant ongoing challenge for EPA. EPA believes that risk evaluations under TSCA cannot be so complex or procedurally cumbersome that they cannot reliably be completed within the statutory timeframes. At the same time, EPA also believes it should not routinely produce partial or incomplete TSCA risk evaluations. In order for TSCA implementation efforts to be sustainable while also meeting the statutory timeframes for completing evaluations, EPA believes risk evaluations must be fit-for-purpose such that the Agency meets both the substantive statutory and regulatory requirements for conducting risk evaluations, while completing those evaluations within the statutory deadlines. Further, the statute provides EPA with discretion as to the “hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider” in a risk evaluation under TSCA (15 U.S.C. 2065(b)(4)(D)) as well as on the level of evaluation expected for each aspect of the risk evaluation.

EPA believes that risk evaluation scoping decisions are highly fact-specific and are made on a case-by-case basis. EPA intends to generally explain its scoping decisions in the draft scope document or the draft risk evaluation, as appropriate. EPA intends to continue to release draft scope documents and draft risk evaluations for public comment, to provide multiple opportunities for stakeholders to review scoping decisions. In addition, TSCA section 19 provides for judicial review of such decisions, which must be based on substantial evidence in the rulemaking record taken as a whole (15 U.S.C. 2618).

2. Conditions of Use

EPA proposes that there are two different types of discretion involved in considering the scope of a risk evaluation with regard to conditions of use

or stakeholders to review scoping decisions. In addition, TSCA section 19 provides for judicial review of such decisions, which must be based on substantial evidence in the rulemaking record taken as a whole (15 U.S.C. 2618).

2. Conditions of Use

EPA proposes that there are two different types of discretion involved in considering the scope of a risk evaluation with regard to conditions of use. First, early in the TSCA section 6(b) process, EPA must determine what the conditions of use are for a candidate chemical substance. That is, “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of” (15 U.S.C. 2602(4)). The decision as to whether a circumstance is “intended, known, or reasonably foreseen” to occur necessarily involves the exercise of discretion, particularly as to whether an intention to take an action exists, or whether an occurrence is reasonably foreseeable. Second, once a particular circumstance is determined to be a condition of use, EPA has discretion to exclude it from the scope of the risk evaluation under TSCA section 6(b)(4)(D) (15 U.S.C. 2605(b)(4)(D)). The question whether the Agency has discretion under TSCA to exclude that condition of use from the scope of a risk evaluation has been the source of much discussion publicly, particularly during the development of the 2017 and 2024 final rules. While EPA agrees with the goal of the TSCA amendments to establish a systematic approach to reviewing and addressing potential risks posed by chemicals already in commerce, it also believes that eliminating the Administrator's discretion to determine which conditions of use are included in the risk evaluation is neither mandated by the statute nor workable, given the magnitude of the task.

In the 2017 final rule EPA expressed that it had discretionary scoping authority (82 FR 33726, July 20, 2017) (Ref. 2 at p. 33729)

oduct example above, while still maintaining EPA's ability to ensure an appropriately scoped risk evaluation.

In the preamble to the 2023 proposed rule, EPA also discussed the Ninth Circuit's Safer Chemicals decision on legacy use, associated disposal, and legacy disposal (88 FR 74292, October 30, 2023) (FRL-8529-01-OCSPP) (quoting Safer Chems., 943 F.3d at 425 through 426) (Ref. 10 at p. 74298). As the Agency explained at the time, the 2017 final rule identified legacy disposal as falling outside the statutory definition of “conditions of use” because EPA interpreted the definition as focusing on circumstances that are prospective or on-going, rather than reaching back to evaluate risks associated with “legacy disposal” ( i.e., disposal that has already occurred). The Ninth Circuit agreed that “legacy disposal” falls outside the statutory definition of conditions of use, reasoning that a substance that has already been disposed of will not ordinarily be intended, known, or reasonably foreseen to be used again ( Safer Chems., 943 F.3d at 425 through 427) (Ref. 6). However, the court additionally held that EPA could not categorically exclude legacy uses and associated disposals from the definition of “conditions of use” because they represent future use and disposals that do clearly fall within the statutory definition of condition of use ( id. at 424 through 425) (Ref. 6). The court reasoned that to the extent that these are prospective use and disposal of a chemical substance that are intended, known, or reasonably foreseen, they “unambiguously fall within TSCA's definition of `condition of use,'” regardless of whether there is ongoing upstream manufacture, processing, or distribution in commerce ( id. at 424 through 425). According to the 2017 final rule, a legacy use is the continued use of a product, such as in-place asbestos insulation, after manufacturing has ceased, and an associated disposal is the disposal of a legacy use product (82 FR 33726, July 20, 2017) (Ref. 2 at p. 33729)

,'” regardless of whether there is ongoing upstream manufacture, processing, or distribution in commerce ( id. at 424 through 425). According to the 2017 final rule, a legacy use is the continued use of a product, such as in-place asbestos insulation, after manufacturing has ceased, and an associated disposal is the disposal of a legacy use product (82 FR 33726, July 20, 2017) (Ref. 2 at p. 33729).

As explained in the preamble to the 2024 final rule, EPA has committed to complying with the Safer Chemicals decision and continues to exclude legacy disposals, but not legacy uses or associated disposals, from the statutory definition of “conditions of use.” (89 FR 37028, May 3, 2024) (Ref. 1 at 37032). EPA includes this information as background and does not propose to revisit or revise its position on the matter.

EPA is proposing to delete the phrase “EPA will not exclude conditions of use from the scope of the risk evaluation”

from 40 CFR 702.37(a)(4) and combine, “a fit-for-purpose approach may result in varying types and levels of analysis and supporting information for certain conditions of use, consistent with paragraph (b) of this section. The extent to which EPA will refine its evaluations for one or more condition of use in any risk evaluation will vary as necessary to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment,” with 40 CFR 702.37(a)(3). The revised subparagraph (a)(3) would read as follows:

EPA will ensure that all supporting analyses and components of the risk evaluation are suitable for their intended purpose, and tailored to the problems and decision at hand, in order to inform the development of technically sound determinations as to whether each condition of use presents an unreasonable risk of injury to health or the environment, based on the weight of the scientific evidence

EPA will ensure that all supporting analyses and components of the risk evaluation are suitable for their intended purpose, and tailored to the problems and decision at hand, in order to inform the development of technically sound determinations as to whether each condition of use presents an unreasonable risk of injury to health or the environment, based on the weight of the scientific evidence. A fit-for-purpose approach may result in varying types and levels of analysis and supporting information for certain conditions of use, consistent with paragraph (b) of this section. The extent to which EPA will refine its evaluations for one or more conditions of use in any risk evaluation will vary as necessary to determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under that condition of use.

As discussed in this Unit, EPA agrees that the amended TSCA requires the Agency to conduct comprehensive risk evaluations, not multiple risk evaluations for the same chemical, a handful of conditions of use at a time. However, without the ability to decide where unintentional byproduct manufacture will be evaluated, for example, or whether an activity need not be assessed because it is unlikely to result in exposures to a chemical substance, EPA will be unable to focus its risk evaluations on the conditions of use that have the greatest potential for risk and thereby effectively evaluate and manage risks while also meeting the statutory deadlines. EPA requests comment on all aspects of its proposed amendments to 40 CFR 702.37(a)(3) and (4), including whether the revisions are sufficiently clear as to EPA's intent regarding appropriately scoped, fit-for-purpose risk evaluations under TSCA section 6(b). Based on additional information submitted to EPA, the Agency also considered alternative provisions regarding the scope of TSCA risk evaluations that the Agency is not proposing to include in this action but is instead requesting comment on

uding whether the revisions are sufficiently clear as to EPA's intent regarding appropriately scoped, fit-for-purpose risk evaluations under TSCA section 6(b). Based on additional information submitted to EPA, the Agency also considered alternative provisions regarding the scope of TSCA risk evaluations that the Agency is not proposing to include in this action but is instead requesting comment on. Specifically, EPA requests comment on whether a definition of “reasonably foreseen” would enhance the transparency and predictability of EPA's decisions on the circumstances of manufacture, processing, distribution in commerce, use, or disposal that constitute conditions of use. EPA would likely draw a definition from the considerations outlined by EPA's new chemicals program under section 5 of TSCA (Ref. 18, at footnote 1). EPA also requests comment on whether this rule should provide more specific considerations that EPA will use in determining which conditions of use are within the scope of the risk evaluation. Such considerations could include whether there is a reasonable potential for exposure to humans or the environment as a result of the condition of use, the extent to which the potential risks posed by a chemical impurity can be addressed in a risk evaluation for the separate chemical substance that bears the impurity, and the extent to which risk reduction opportunities are available for the condition of use. EPA requests comment on whether one of these considerations should be whether the substance is present at a de minimis level under the condition of use, and, if so, whether EPA should promulgate a definition of de minimis, recognizing that the toxicity of chemical substances vary. Finally, EPA is also interested in comments on how to address conditions of use that are identified after the conclusion of a risk evaluation on a chemical substance

nsiderations should be whether the substance is present at a de minimis level under the condition of use, and, if so, whether EPA should promulgate a definition of de minimis, recognizing that the toxicity of chemical substances vary. Finally, EPA is also interested in comments on how to address conditions of use that are identified after the conclusion of a risk evaluation on a chemical substance. As previously stated, EPA does not believe stakeholders have reliance interests pertaining to the process for future, yet-to-be-completed risk evaluations that will be carried out in accordance with this proposed rule, but seeks comments on any reliance interests commenters believe they have.

3. Inclusion of All Exposure Pathways

In carrying out the first ten risk evaluations under TSCA, EPA appropriately scoped those evaluations by excluding analysis of certain exposures to the general population from releases to air, water, and land. The approach, which was not contemplated in the 2017 rule but was first articulated in “Problem Formulation” documents published in 2018 (after the Final Scope documents) for each of the first ten chemicals undergoing risk evaluation, premised on an argument that those pathways were already adequately assessed and managed—or could be adequately assessed and managed—under other EPA statutes and regulatory programs (Ref. 19 and 20). EPA further stated at that time that its intention was to use Agency resources efficiently under the TSCA program, avoid duplicating efforts taken pursuant to other Agency programs, maximize scientific and analytical efforts, and meet TSCA's statutory deadlines for completing risk evaluations

ould be adequately assessed and managed—under other EPA statutes and regulatory programs (Ref. 19 and 20). EPA further stated at that time that its intention was to use Agency resources efficiently under the TSCA program, avoid duplicating efforts taken pursuant to other Agency programs, maximize scientific and analytical efforts, and meet TSCA's statutory deadlines for completing risk evaluations. In the final risk evaluations for the first ten chemicals, EPA excluded exposure pathways that could be covered by regulatory programs under the Clean Air Act (CAA), Clean Water Act (CWA), Safe Drinking Water Act (SDWA), Resource Conservation and Recovery Act (RCRA), and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) ( e.g., drinking water pathways covered under the SDWA due to the existence of National Primary Drinking Water Regulations (NPDWRs) with chemical-specific, enforceable Maximum Contaminant Levels (MCL), or the inclusion of the chemical as an unregulated chemical on the Candidate Contaminant List (CCL)). EPA further asserted that this approach was supported by several TSCA authorities, including TSCA section 6(b)(4)(D), which in part directs the Agency to identify, in the scope document, the exposures that the Administrator “expects to consider” in the applicable risk evaluation, and TSCA section 9(b)(1), which allows the Administrator to use other EPA administered statutes to address risks to health or the environment, if the Administrator determines that these risks “could be eliminated or reduced to a sufficient extent” by actions taken under other EPA administered statutes (Ref. 15).

This approach was criticized by EPA's Science Advisory Committee on Chemicals (SACC) and several public commenters in comments on individual risk evaluation documents (Refs. 22, 23, and 24)

procedural framework rule, EPA indicated that if accidents, spills, leaks, or extreme weather-related events result in regular and predictable changes in exposures associated with a given condition of use of a chemical substance, such exposures would be known or reasonably foreseen and would be considered within the scope of the risk evaluation (88 FR 74292, October 30, 2023) (Ref. 10 at p. 74298). In the 2024 final rule, EPA added that it would consider whether exposures from accidents, spills, leaks, and weather-related events “would be regular or predictable, versus those that are unsubstantiated, speculative or otherwise not likely to occur” (89 FR 37028, May 3, 2024) (Ref. 1 at p. 37033). Regardless, whether exposures associated with such events might be reasonably foreseeable, EPA has determined that, in the absence of reasonably available information that shows that they are regular and predictable, it would be too difficult to assess and accurately characterize the risks associated with these events. Additionally, in May 2025 EPA denied a citizen's petition submitted under section 21 of TSCA for a section 6 rulemaking proceeding primarily because it was premised on the potential for accidental and catastrophic releases of a chemical which did not result in regular and predictable exposures. See Hydrogen Fluoride; TSCA Section 21 Petition for Rulemaking Under TSCA Section 6; Reasons for Agency Response; Denial of Requested Rulemaking (90 FR 20575, May 15, 2025).

In the 2024 final rule, EPA added a provision at 40 CFR 702.39(d)(9) that requires the Agency to “assess all exposure routes and pathways relevant to the chemical substance under the conditions of use, including those that are regulated under other federal statutes.” The rationale for this addition was that TSCA sections 6(b)(4)(D) and 9(b)(1) do not specifically authorize EPA to exclude exposure routes or pathways in the risk evaluation

tion 9(b) as amended in 2016 ( see H. Rep. No. 114-176 at p. 28 (stating that the 2016 TSCA amendments “reinforce TSCA's original purpose of filling gaps in Federal law,” and citing new language in section 9(b)(2) intended “to focus the Administrator's exercise of discretion regarding which statute to apply and to encourage decisions that avoid confusion, complication, and duplication”)) (Ref. 26). So, for example, if EPA began a TSCA risk evaluation on a chemical substance that is also regulated as a Hazardous Air Pollutant under CAA section 112(42 U.S.C. 7412), 40 CFR 702.39(d)(9) currently would require another robust assessment of the potential risks to the general population through ambient air exposures.

EPA proposes that such duplication is not what Congress intended in amending TSCA in 2016. Under this proposed rule, when an exposure pathway of a chemical substance is not already evaluated and managed by another EPA program, EPA may assess the particular exposure pathway under TSCA. If EPA finds unreasonable risk, then it intends to, pursuant to TSCA section 9(b), coordinate risk management under the other EPA-administered statute when EPA determines that such risk can be eliminated or reduced to a sufficient extent by another EPA-administered statute, unless EPA determines it is in the public interest to take action under TSCA. Likewise, when a condition of use of a chemical substance is not evaluated, managed, or both, by another Federal Agency, EPA intends to evaluate the condition of use and determine whether it presents unreasonable risk. If EPA makes an unreasonable risk finding, it will, in its discretion, follow the procedures of TSCA section 9(a) to coordinate risk management.

EPA requests comments on all aspects of its proposed changes to 40 CFR 702.37(a) and 702.39(d) that relate to the conditions of use and the exposure routes and pathways assessed in TSCA section 6(b) risk evaluations

hether it presents unreasonable risk. If EPA makes an unreasonable risk finding, it will, in its discretion, follow the procedures of TSCA section 9(a) to coordinate risk management.

EPA requests comments on all aspects of its proposed changes to 40 CFR 702.37(a) and 702.39(d) that relate to the conditions of use and the exposure routes and pathways assessed in TSCA section 6(b) risk evaluations. EPA also requests comment on whether this rule should provide more specificity on EPA's coordination activities under TSCA section 9, such as a requirement to document consultations with other Federal agencies on draft scope documents and draft risk evaluations. EPA requests comment on how EPA should consider, for TSCA section 6(b) risk evaluation purposes, existing federal statutes and regulations and risk assessments performed by other governmental entities. EPA requests comment on whether the Agency should include regulatory text, such as text that specifies that EPA has discretion to exclude conditions of use as well as exposure pathways and routes. Further, EPA requests comment on specific instances where EPA should exercise its authority to exclude conditions of use and exposure pathways and routes. EPA also requests comment on whether to add regulatory text that states that EPA can coordinate actions with other federal laws administered by EPA to ensure that chemical risks “could be eliminated or reduced to a sufficient extent” by other EPA actions, pursuant to TSCA section 9(b). Finally, EPA welcomes suggested regulatory text that could be considered. EPA is not currently aware of any significant reliance interests in the 2024 amendments regarding these proposed changes, given the 2024 amendments are fairly recent and apply almost exclusively to internal Agency process.

B. Risk Determinations

The 2024 final rule included a number of revisions to regulatory provisions on unreasonable risk determinations that EPA is now proposing to modify

evaluation, either in a single decision document or in multiple decision documents.” EPA is also proposing to revise 40 CFR 702.39(f)(3), which would be superfluous, given that a risk determination would be made for each condition of use. The rationale for these proposed changes is discussed in this Unit. Proposed revisions to subparagraph (f)(2) are discussed in Unit III.C.1 of this preamble.

1. Background

In each risk evaluation under TSCA section 6(b), EPA must determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, under the conditions of use. In making a risk determination, EPA must evaluate relevant risk-related factors, including, but not limited to: the severity of the hazard ( e.g., the nature of the hazard and irreversibility of the hazard); exposure-related considerations ( e.g., duration, intensity, and frequency of exposure); the population exposed (including any potentially exposed or susceptible subpopulations (PESS)); and the confidence in the information used to inform the hazard and exposure values. This includes an evaluation of the strengths, limitations, and uncertainties associated with the information used to inform the risk estimate and the risk characterization. Descriptions of risk estimates that are based on highly refined hazard and exposure information would be considered differently than risk estimates based on compounding conservative assumptions on both hazard and exposure. The process of determining unreasonable risk is made on a case-by-case basis, given the inherently unique nature of risk evaluations, and benchmarks are not treated as bright lines.

In proposing the 2017 rule (82 FR 7562, January 19, 2017) (Ref

d and exposure information would be considered differently than risk estimates based on compounding conservative assumptions on both hazard and exposure. The process of determining unreasonable risk is made on a case-by-case basis, given the inherently unique nature of risk evaluations, and benchmarks are not treated as bright lines.

In proposing the 2017 rule (82 FR 7562, January 19, 2017) (Ref. 27), EPA included a regulatory provision on unreasonable risk determinations that largely mirrored the language of TSCA section 6(b)(4)(A) and clarified that the phrase “under the conditions of use” meant the conditions of use identified in the final scope document published for the chemical substance. EPA also included an exception in the 2017 final rule that would allow EPA to make an “early determination” for any specific condition of use that the Agency had sufficient information to find that it presents an unreasonable risk. Where such an early determination was made, the Agency could initiate risk management under TSCA section 6(a) for that specific condition of use immediately without waiting for the completion of the risk evaluation for all covered conditions of use of the chemical substance, which often takes multiple years (Ref. 27 at pp. 7568 and 7578).

EPA received comments on the 2017 proposed rule asserting that such early determinations of unreasonable risk for particular conditions of use was unfair and represented an inherent bias “toward Risk Evaluation outcomes that require regulatory actions” (Ref. 28). These commenters encouraged the Agency to extend this concept of early risk determinations to conditions of use found not to present an unreasonable risk (Ref. 29 at p. 47). Other commenters discouraged the Agency from allowing early determinations for conditions of use that do not present unreasonable risk. According to these commenters, a determination that a condition of use does not present unreasonable risk cannot be made until the risks of all conditions of use have been evaluated

to conditions of use found not to present an unreasonable risk (Ref. 29 at p. 47). Other commenters discouraged the Agency from allowing early determinations for conditions of use that do not present unreasonable risk. According to these commenters, a determination that a condition of use does not present unreasonable risk cannot be made until the risks of all conditions of use have been evaluated. One commenter argued that, while it is possible to conclude that a chemical substance presents an unreasonable risk based on the evaluation of a subset of uses before all of the conditions of use are evaluated, the reverse is not true. The same commenter also expressed concern over the potential for an early determination that a particular condition of use does not present unreasonable risk foreclosing the possibility of an aggregate exposure analysis across all of the conditions of use (Ref. 29 at p. 47).

After considering these comments, EPA finalized language in the 2017 final rule at 40 CFR 702.47 providing that the Agency would determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of use within the scope of the risk evaluation, either in a single decision document or in multiple decision documents (82 FR 33726) (Ref. 2). In the preamble to the 2017 final rule, EPA explained that the Agency would make individual risk determinations for each condition of use identified as within the scope of the risk evaluation (82 FR 33726) (Ref. 2 at p. 33744). EPA further explained in its Response to Public Comments that the sooner the Agency can determine whether a particular condition of use of a chemical substance does or does not present an unreasonable risk, the better (Ref. 29 at p. 47)

gency would make individual risk determinations for each condition of use identified as within the scope of the risk evaluation (82 FR 33726) (Ref. 2 at p. 33744). EPA further explained in its Response to Public Comments that the sooner the Agency can determine whether a particular condition of use of a chemical substance does or does not present an unreasonable risk, the better (Ref. 29 at p. 47). With respect to comments about aggregate exposures, EPA explained that the Agency is likely to take a variety of approaches depending on the chemical substance at issue, including only making an early determination in cases where EPA has decided not to do an aggregate exposure assessment, or for those conditions of use where an aggregate exposure assessment may not be appropriate (Ref. 29 at pp. 47 through 48).

Certain petitioners challenged the 2017 final rule's condition-of-use-specific approach to risk determinations in the Safer Chemicals litigation before the Ninth Circuit. 943 F.3d at 412. (Ref. 6). Among other things, petitioners argued that issuing early determinations that certain conditions of use present no unreasonable risk to health or the environment would lead EPA to underestimate risk where exposure results from multiple activities involving a chemical substance, such as when the same individuals are exposed through multiple conditions of use ( e.g., in the workplace and in the home). According to petitioners, such exposures may present unreasonable risk only when combined. Consistent with EPA's explanation in the Response to Public Comments document, the Agency responded that the 2017 final rule allowed EPA to issue early determinations when appropriate and that EPA would consider possible aggregate exposures in exercising such discretion, when appropriate

ne 2021 announcement that it would make a single risk determination on a chemical when it was “clear that majority of conditions of use warrant one determination,” the preamble to the 2023 proposed rule went a step further, stating that EPA now believed that the plain reading of the statute mandates a single determination for the chemical substance in every instance (88 FR 74292, October 30, 2023). The preamble also asserted that this approach was consistent with Congressional intent and would enable the Agency's risk determinations to better reflect the potential for combined exposures across multiple conditions of use. In support of this position, EPA noted that TSCA section 6(b)(4)(A) specifies that, in a risk evaluation, the Agency must determine whether “a chemical substance” presents an unreasonable risk of injury to health or the environment “under the conditions of use” (15 U.S.C. 2605(b)(4)(A)). EPA interpreted this language at the time as requiring an evaluation on the chemical substance—not each of its conditions of use—and for the evaluation to be based collectively on all of the chemical substance's “conditions of use.” EPA cited other provisions of TSCA section 6 to support its new reading of the statute, including TSCA section 6(a), which requires EPA to apply risk-

management requirements “to the extent necessary so that the chemical substance or mixture no longer presents such risk” (15 U.S.C. 2605(a)) and which the Agency read as suggesting that the chemical substance presents the unreasonable risk, not specific conditions of use

ations that EPA issued for most of the first ten priority chemicals. The Agency noted that some commenters thought that a singular risk determination could create confusion as to whether all conditions of use or only certain conditions of use of a chemical substance pose unreasonable risk, but asserted that the potential confusion would be a communications issue that EPA would strive to improve on. The Agency also noted that other commenters expressed concern that EPA would use a single risk determination for the chemical substance to regulate in an overly broad manner, but asserted nevertheless that its statutory authority to regulate chemicals under TSCA section 6(a) is available only “to the extent necessary so that the chemical substance or mixture no longer presents [unreasonable] risk” (15 U.S.C. 2605(a)).

During the comment period on the 2023 proposal, some commenters supported the single risk determination approach and others opposed for similar reasons as those asserted in comments on the revised risk determinations. Industry commenters generally disagreed with EPA's reading of the statute on this point. One commenter (Ref. 33) observed that Congress found in TSCA section 2(a)(2) that “among the many chemical substances and mixtures which are constantly being developed and produced, there are some whose manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment” (15 U.S.C. 2601(a)(2)). According to the commenter, this language reflects a congressional recognition that particular applications of chemical substances have the potential to pose unreasonable risk, not the chemical substances themselves. Another commenter (Ref

facture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment” (15 U.S.C. 2601(a)(2)). According to the commenter, this language reflects a congressional recognition that particular applications of chemical substances have the potential to pose unreasonable risk, not the chemical substances themselves. Another commenter (Ref. 34) contended that the phrasing in TSCA section 6(a), along with the fact that the tools provided therein for managing unreasonable risks include both broader tools (“prohibiting or otherwise restricting the manufacturing, processing, or distribution in commerce of such substance or mixture”) and narrower ones (“prohibiting or otherwise restricting the manufacture, processing, or distribution in commerce of such substance or mixture for . . . a particular use”), means that Congress envisioned use-by-use determinations.

Industry commenters also contended that the legislative history of the 2016 TSCA amendments did not support the single risk determination approach as EPA claimed in the 2023 proposal. They cited floor statements, including by Senator Inhofe, one of the legislation's key sponsors, that “there could be circumstances where EPA determines that a chemical does not present an unreasonable risk in certain uses, but does in others” and that “[p]reemption for no significant risk determinations would apply as these determinations are made on a use-by-use basis” (Ref. 14 at p. S3521). They also cited statements by Senator Vitter, another key sponsor, stating that “[t]o be clear, every condition of use identified by the Administrator in the scope of the risk evaluation must, and will be either found to present or not present an unreasonable risk” (Ref. 14 at p. S3520).

In the 2024 Response to Comments, EPA disagreed with the industry commenters on the proper interpretation of both the language of TSCA and the legislative history of the 2016 amendments (Ref. 11)

be clear, every condition of use identified by the Administrator in the scope of the risk evaluation must, and will be either found to present or not present an unreasonable risk” (Ref. 14 at p. S3520).

In the 2024 Response to Comments, EPA disagreed with the industry commenters on the proper interpretation of both the language of TSCA and the legislative history of the 2016 amendments (Ref. 11). Instead, the Agency finalized the language that currently appears at 40 CFR 702.39(f)(1), which requires EPA to issue a single risk determination for the chemical substance for each risk evaluation.

2. Risk Determinations by Condition of Use

Upon further review of the 2024 final rule, EPA believes that TSCA section 6 is best read as requiring that risk determinations be made for each condition of use evaluated in the risk evaluation. There is ample support for this position in the language of TSCA section 6(b)(4)(A), which provides that EPA “shall conduct risk evaluations . . . to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation . . . under the conditions of use.” EPA proposes that by specifying “risk evaluations” in the plural and “a chemical substance” in the singular, Congress intended to authorize the Agency to perform more than one risk evaluation, and therefore at least more than one risk determination, for the same chemical. For example, EPA could re-prioritize a chemical substance for which it already conducted a risk evaluation on, resulting in a second risk evaluation of the chemical substance. This clear authority to make multiple risk determinations is incongruent with the single risk determination approach required by the 2024 final rule

therefore at least more than one risk determination, for the same chemical. For example, EPA could re-prioritize a chemical substance for which it already conducted a risk evaluation on, resulting in a second risk evaluation of the chemical substance. This clear authority to make multiple risk determinations is incongruent with the single risk determination approach required by the 2024 final rule.

EPA further proposes that the condition-of-use by condition-of-use approach to risk determinations is the only way to give independent meaning to the phrase “under the conditions of use,” which Congress added to TSCA section 6(b) and throughout the statute in the 2016 amendments. If Congress intended to require a single risk determination for a chemical substance, there would have been no need to add the phrase at the conclusion of this provision. EPA believes this reading is also supported by TSCA section 3(4), which defines the phrase “conditions of use” as “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of” (15 U.S.C. 2602(4)). Congress used “circumstances” in the plural and included a variety of contexts that are necessarily different from one another and involve different exposures, different potentially exposed populations, and ultimately different risks.

Further, EPA proposes that the language in TSCA section 6(a) supports this reading. TSCA Section 6(a) states that “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an

unreasonable risk of injury to health or the environment, the Administrator shall by rule . .

6(a) supports this reading. TSCA Section 6(a) states that “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an

unreasonable risk of injury to health or the environment, the Administrator shall by rule . . . apply one or more of the following requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk” (15 U.S.C. 2605(b)(4)(A)). The Agency believes that this language contemplates that risk determinations will be made for each condition of use. As pointed out by several commenters on the 2023 proposal and original first ten chemical risk evaluations, it is difficult to ensure that EPA has addressed unreasonable risk in accordance with TSCA section 6(a) without first having determined whether each of the conditions of use, or any combination of particular conditions of use, presents or present an unreasonable risk to health or the environment (Ref. 11).

More generally, making a risk determination for each condition of use provides greater clarity and transparency for the regulated community and the general public. The greater clarity afforded to the regulated community by this approach fulfills the congressional policy enshrined in TSCA itself by ensuring that EPA exercises its authority to regulate unreasonable risk “in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation” (15 U.S.C. 2601(b)(3))

parency for the regulated community and the general public. The greater clarity afforded to the regulated community by this approach fulfills the congressional policy enshrined in TSCA itself by ensuring that EPA exercises its authority to regulate unreasonable risk “in such a manner as to not impede unduly or create unnecessary economic barriers to technological innovation” (15 U.S.C. 2601(b)(3)). Indeed, Senate Report 114-67 states that the 2016 legislation was “intended to enhance confidence in the federal chemical regulatory system, provide EPA the authority necessary for efficient and effective regulation of chemical risks, and foster safety and innovation in commercial chemistry.” The Senate Report goes on to explain that the legislation is “designed to ensure that the competitive advantage of the U.S. chemical industry is not eroded by regulatory mandates and that industry is subject to a more consistent set of regulations that equally protect citizens across the nation” (Ref. 35 at p. 2).

In contrast, the single risk determination approach of the 2024 final rule does not appear to align with the stated goals of the 2016 TSCA amendments. As several industry commenters on the 2023 proposal observed, the single risk determination approach is likely to result in increased confusion on the part of the regulated community, workers, consumers, and the general public (Refs. 36 and 37). EPA reiterated in the 2024 final rule that where “one or more conditions of use for the chemical present an unreasonable risk, the chemical substance itself necessarily presents an unreasonable risk” (89 FR 37028) (Ref. 1 at p. 37035). In this way, however, the single risk determination required under the 2024 final rule is uninformative for consumers wondering whether their use of a chemical substance is safe, for workers wondering whether the exposure controls associated with their occupational exposure are sufficient to protect them (Ref

ontribute to the unreasonable risk and/or are targeted for risk management. (89 FR 37028) (Ref. 1 at p. 37036). EPA now proposes that this reading of the phrase “included in any final action” was unnatural but necessary because when making a single risk determination on the chemical substance, no TSCA section 6(i) order would be issued for COUs that were not regulated in the TSCA section 6(a) rule. In contrast, under the condition-of-use by condition-of-use approach, a TSCA section 6(a) rule and/or a TSCA section 6(i) order would be issued, so that every COU within the scope of the risk evaluation is addressed in, that is, `included in,” one of those final agency actions and not just the risk evaluation. Although the scope of permanent preemption is the same under either approach, the condition-of-use by condition-of-use approach achieves that same scope with a more natural reading of the language “included in any final action” in TSCA section 18(c). Thus, EPA proposes that the condition-of-use by condition-of-use approach results in a more harmonious interpretation of the statute.

The preemption provisions added in the 2016 TSCA amendments are important to the regulated community. As explained in Senate Report 114-67, stakeholders were concerned that TSCA had not “fostered a robust Federal chemical regulatory system,” which resulted in increased State actions on chemicals (Ref. 35 at p. 6). In the view of these stakeholders, “a proliferation of different State requirements will create confusion for the general public, and significantly increase the cost and burden of regulatory compliance for chemical manufacturers, importers and users while failing to apply any protections to more than a relatively small number of citizens” (Ref. 35 at p. 6). A commenter on the 2023 proposal stated that “[a] key motivation for TSCA reform was to create one federal standard for chemical regulation rather than a patchwork of state/local laws” (Ref. 34 at p. 8)

ost and burden of regulatory compliance for chemical manufacturers, importers and users while failing to apply any protections to more than a relatively small number of citizens” (Ref. 35 at p. 6). A commenter on the 2023 proposal stated that “[a] key motivation for TSCA reform was to create one federal standard for chemical regulation rather than a patchwork of state/local laws” (Ref. 34 at p. 8). In a floor statement, Senator Inhofe expressed the view that “the preemption section of this bill was the most contentious issue” during the negotiations on the compromise bill that became the Lautenberg Chemical Safety for the 21st Century Act and was “the most important linchpin in the final deal” (Ref. 14 at p. S3521). Given the importance of the preemption provisions and the more natural and clearer interpretation of TSCA section 18(c) that results from the condition-of-use by condition-of-use risk determination approach, EPA now believes that it is the best interpretation of TSCA section 6(b)(4)(A).

For all of these reasons, EPA is proposing to return to making a risk determination for each of the conditions of use covered by the scope of a TSCA section 6(b) risk evaluation. Accordingly, EPA proposes to revise 40 CFR 702.39(f)(1) to read as follows: “As part of the risk evaluation, EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use by making separate risk determinations for each condition of use within the scope of the risk evaluation, either in a single decision document or in multiple decision documents.” EPA also proposes to revise 40 CFR 702.39(f)(3) because it would be superfluous, given that a risk determination would be made for each condition of use. EPA would replace the existing text in 40 CFR 702.39(f)(3) with the risk-related factors described in following paragraph

bpopulations), the severity of hazard (the nature of the hazard, the irreversibility of hazard), and uncertainties (89 FR 37028) (Ref. 1); (82 FR 33726) (Ref. 2). To provide more clarity and transparency surrounding what EPA considers in determining whether unreasonable risk is presented, EPA is proposing to codify the risk-related factors EPA considers in making an unreasonable risk determination. Specifically, EPA is proposing to replace the existing text in 40 CFR 702.39(f)(3) to require that EPA consider

risk-related factors in determining whether unreasonable risk is presented, including but not limited to: the severity of the hazard ( e.g., the nature of the hazard and irreversibility of the hazard); exposure-related considerations ( e.g., duration, intensity, and frequency of exposure); the population exposed (including any potentially exposed or susceptible subpopulations (PESS)); and the confidence in the information used to inform the hazard and exposure values, including an evaluation of the strengths, limitations, and uncertainties associated with the information used to inform the risk estimate and the risk characterization. These risk-related factors are components of the risk evaluation, as outlined in 40 CFR 702.39 (c), (d), and (e) with respect to the hazard assessment, exposure assessment, and risk characterization, respectively.

EPA requests comment on this change to the regulatory requirements for risk determinations discussed in this Unit as well as the changes regarding occupational exposure assumptions discussed in Unit III.C.1. In addition, EPA requests comments more generally on TSCA section 6(b)(4)(A) risk determinations, including whether there should be more specific requirements for how EPA is to make and document its risk determinations or whether EPA's proposal to specifically describe the factors EPA considers when making risk determinations adds sufficient clarity

.134. In support of this assumption, EPA relied on public comments indicating that employers, particularly in the industrial setting, implement engineering and administrative controls and provide PPE to their employees, and follow established worker protection standards ( e.g., OSHA regulatory requirements, recommendations from the American Conference of Governmental Industrial Hygienists (ACGIH)). Parties in litigation as well as public commenters on several TSCA risk evaluations argued that making risk determinations based on assumptions of PPE conflates the risk evaluation and risk management phases ( e.g., Ref. 41). In June 2021, the Agency announced it would be revisiting the risk determinations that were based on these assumptions and noted its plans to consider information on use of PPE and other ways industry protects its workers during the risk management process (Ref. 9).

The 2024 final rule added a requirement at 40 CFR 702.39(f)(2) for EPA to consider “known and reasonably foreseen circumstances where subpopulations of workers are exposed due to the absence or ineffective use of personal protective equipment.” This regulatory provision further prohibits EPA from considering “exposure reduction based on assumed use of personal protective equipment as part of the risk determination.” As explained in the 2024 final rule, EPA believed that the assumed use of PPE in a risk determination could lead to an underestimation of the risk to workers for several reasons, including that not all workers are covered by OSHA standards, their employers may be out of compliance with OSHA standards, the PPE is not sufficient to address the risk from the chemical, or the PPE does not fit or function properly (89 FR 37028) (Ref. 1 at p. 37037). EPA also noted that many of OSHA's chemical-specific permissible exposure limits have not been updated in recent years

llows the Agency to conduct risk evaluations on categories of chemicals. EPA is not currently proposing to amend this definition but requests comment on the utility and clarity of the current definition.

EPA is, however, proposing to delete the language from the 2024 final rule that requires the Agency, for all risk evaluations that do not include an aggregate exposure assessment, to explain why. There are a variety of reasons why EPA would not be able to perform an aggregate exposure assessment, or why an aggregate exposure assessment would not be appropriate for one or more conditions of use. For example, while the 2024 Supplement to the Risk Evaluation for 1,4-Dioxane evaluated combined exposure and risk from multiple sources of 1,4-dioxane in surface water and combined exposure and risk across multiple facilities in proximity releasing to air, EPA did not quantitatively aggregate exposures across exposure routes and pathways due to uncertainties around the additivity of effects (Ref. 16 at sec. 1.3.1.3.3.).

The proposed removal of the language that requires EPA to explain the basis for not performing an aggregate exposure assessment, which is in addition to the statutory directive to explain the basis for performing an aggregate exposure assessment, is not meant to suggest that EPA rejects the notion of performing aggregate exposure assessments where appropriate and supported by the best available science. Rather, the burden of explaining the absence of an aggregate risk evaluation is significant and cumulative with the challenging undertaking already required to complete a risk evaluation and is not mandated by the statute. EPA is proposing to return to the language in the 2017 final rule, which tracks the statute. Accordingly, EPA proposes to delete 40 CFR 702.39(d)(8) and revise paragraph (d)(7) to include aggregate exposures.

3

cussed its experiences with the peer reviews conducted for the risk evaluations for the first ten TSCA risk evaluations and explained that, in the future, rather than peer reviewing an entire risk evaluation, in adhering to applicable peer review guidance, it may be appropriate for EPA to conduct peer review on only portions or sections that constitute unreviewed influential information (88 FR 74292, October 30, 2023) (Ref. 10 at p 74307). EPA also explained that it expects that a TSCA risk evaluation may use peer reviewed products ( e.g., risk assessments, hazard assessments, models), or portions thereof, conducted by another EPA office or other authoritative body ( e.g., state, national, or international programs) that adhered to the best available science and weight of scientific evidence standards. To clarify, EPA proposed revisions to 40 CFR 702.41 that would incorporate EPA's expectation that peer review activities could be conducted on risk evaluations “or portions thereof.”

As stated in the 2024 final rule, EPA received many comments on these proposed changes, most of which did not support the new approach to peer review. Commenters thought that the removal of the references to specific guidance documents could potentially result in a lack of clarity as to which policies, procedures, guidance documents, and methods were applicable (Ref. 37). Commenters also thought that the addition of the phrase “or portions thereof” and the framing of “EPA expects” would give EPA too much flexibility, resulting in limited, less transparent peer reviews, or potentially none at all. In response to these comments, the 2024 final rule removed the reference to specific guidance documents as proposed, and included the “EPA expects” framing, but did not add the phrase “or portions thereof” (89 FR 37028) (Ref. 1 at 37041 through 37042)

e information or of the procedures, measures, methods, protocols, methodologies or models. Id. Section 26(i) states “the Administrator shall make decisions under sections 4, 5, and 6 based on the weight of scientific evidence.” 15 U.S.C. 2625(i). TSCA does not define either “best available science” or “weight of scientific evidence” and there is no requirement in the statute to define them by rule.

During the development of the 2017 proposed rule, EPA received input from stakeholders about the codification of definitions for these terms (Refs. 2 and 29). Some noted that it is imperative that the Agency have specific criteria which would allow for consistency and transparency for how EPA will implement science. Others contended that since interested persons may submit risk assessments to the Agency for consideration (under TSCA section 26(l)(5)), it is necessary for the Agency to provide a standard and expectation. 15 U.S.C. 2625(l)(5). Many noted that there are a number of ways the Agency could and has defined these terms across other statutory obligations and suggested this could be both a reason to codify TSCA-specific definitions, or to not codify them to avoid future limitations in implementation approaches. Others thought that codification of specific process definitions would limit the Agency's ability to adapt to the changing science of risk evaluation, as well as the science that informs risk evaluation.

The 2017 proposed rule did not include definitions for either of these terms (82 FR 7562) (Ref. 27 at p. 7572), citing the need to remain flexible to changing science and approaches.

Ultimately, EPA chose to codify definitions for both of these terms in the final rule, explaining that this would instill confidence, increase transparency, predictability, and provide the public with assurance that EPA will adhere to the requirements of the statute (Ref. 29 at p. 11). The definition of “best available science” incorporated much of the direction from TSCA section 26(h)

oaches.

Ultimately, EPA chose to codify definitions for both of these terms in the final rule, explaining that this would instill confidence, increase transparency, predictability, and provide the public with assurance that EPA will adhere to the requirements of the statute (Ref. 29 at p. 11). The definition of “best available science” incorporated much of the direction from TSCA section 26(h). In the response to comments document, EPA further explained that the definitions that EPA had chosen to codify, particularly for best available science and weight of scientific evidence were not overly prescriptive, but instead captured universal principles, which EPA did not think would restrict flexibility or scientific advancement.

In the 2024 final rule EPA removed the definitions of best available science and weight of the scientific evidence, explaining that they were unnecessary and could act to limit the Agency's flexibility and, therefore, its ability to meeting the science standards of TSCA section 26. EPA discussed in detail the existing requirements for using the best available science in TSCA section 6(b) risk evaluations, including TSCA itself, as well as other guidance documents such as OMB's Information Quality Guidelines (Ref. 44). Similarly, EPA described four guidance documents that it would look to in implementing the TSCA section 26(i) directive to make decisions based on the weight of the scientific evidence (89 FR 37028) (Ref. 1 at 37044). EPA further explained that the 2017 final rule's definition of weight of the scientific evidence appeared to conflate two ideas, weight of the scientific evidence and systematic review

milarly, EPA described four guidance documents that it would look to in implementing the TSCA section 26(i) directive to make decisions based on the weight of the scientific evidence (89 FR 37028) (Ref. 1 at 37044). EPA further explained that the 2017 final rule's definition of weight of the scientific evidence appeared to conflate two ideas, weight of the scientific evidence and systematic review. In the 2024 final rule EPA also described the expected application of systematic review methods for identifying and assessing reasonably available information to uphold TSCA's scientific standards for “best available science” and “weight of scientific evidence,” including that the Agency may consider existing assessments conducted by EPA or other federal, state, or international authoritative bodies, determine whether these existing assessments or reviews represent the best available science as required under TSCA, and use portions of them to directly inform a risk evaluation. More information on the rationale for removing these definitions and not promulgating alternatives, or a definition of systematic review, can be found in the 2024 final rule ( Id. at 37042 through 37045).

EPA is not proposing to restore the 2017 final rule definition for best available science because much of the 2017 definition is incorporated into 40 CFR 702.37(a). However, to enhance transparency in its approach to risk evaluations, EPA is proposing to incorporate the definition of “weight of scientific evidence” from section 2(e) of Executive Order 14303 (Ref. 4). EPA believes that this definition appropriately captures the intention behind TSCA sections 6(b)(4)(F)(v) and 26(i). The proposed definition is “an approach to scientific evaluation in which each piece of relevant information is considered based on its quality and relevance, and then transparently integrated with other relevant information to inform the scientific evaluation prior to making a judgment about the scientific evaluation

the consideration of strengths, limitations, and uncertainties associated with integrating lines of relevant information, is appropriately captured. Additionally, the Agency seeks comment on whether the 2017 definition for “best available science” should be restored, whether other definitions for these terms should be considered, and whether EPA should promulgate a definition of systematic review. EPA is also requesting comment on how the Agency can apply systematic review methods for TSCA risk evaluations that leverage consideration of systematic review approaches and risk assessments from other EPA offices and authoritative bodies. More generally, EPA requests comment on how to ensure transparency and accountability in conducting risk evaluations, including making risk determinations.

3. Occupational Exposure Value

The 2024 final rule preamble contained a discussion of how Existing Chemical Exposure Limits (ECELs) were calculated for the first ten priority chemicals, and how some ECELs were issued at a different time than the risk evaluation on which they were based (89 FR 37028) (Ref. 1 at 37040). EPA also explained that these early ECELs were risk-based occupational exposure values, and did not take non-risk factors into account. Using the same terminology, EPA incorporated these ECELs into the subsequent TSCA section 6(a) risk management rules ( e.g., Ref. 46). However, EPA soon realized that using the same term, ECEL, for both a risk-based occupational exposure value and an enforceable regulatory exposure limit applied in a risk management rule, where costs and other non-risk factors may be considered, was confusing. As a result, EPA stopped referring to the risk-based occupational exposure value as an ECEL.

In the 2023 proposed rule EPA requested comment on how the Agency could improve the transparency of risk-based occupational exposure values derived from the risk evaluation process (88 FR 74292, October 30, 2023) (Ref. 10)

ion process for that chemical substance, except where EPA has determined it to be in the interest of protecting human health or the environment to do so . . . .” Should EPA determine to revise or supplement a final risk evaluation, 40 CFR 702.43(g)(4) requires EPA to follow the procedures set forth in the section, including publication of draft and final risk evaluations and public comment periods.

One rationale given for the new procedures and criteria is to provide greater certainty and transparency for stakeholders. However, as explained in the 2023 proposal, given the tens of thousands of existing chemical substances in commerce and EPA's responsibility to assess and manage risks from those chemicals through a statutory deadline-driven pipeline of prioritization, risk evaluation and risk management activities, the new procedures and criteria for revising final risk evaluations are intended to ensure that the Agency continues to make forward progress on existing chemicals as Congress intended, and does not drain already limited resources and divert attention from other chemicals actively in the prioritization, risk evaluation or risk management phases by continuously revisiting final risk evaluations (88 FR 74292, October 30, 2023) (Ref. 10 at p. 74311). In the 2023 proposal, EPA further explained that re-prioritizing a chemical substance will provide the public with ample notice and opportunity to engage, provide anticipatable milestones and process, and better position the Agency to maintain a manageable workload (88 FR 74292, October 30, 2023) (Ref. 10 at p. 74312). Nevertheless, EPA recognized in the 2023 proposal that there may be instances where revisions to a final risk evaluation outside of re-prioritization of a chemical are in the interest of protecting human health and the environment

aluation and solicitation of public comment in accordance with §§ 702.43(c) and (d), and peer review, as appropriate, in accordance with § 702.41.” EPA requests comment on this change, and also on whether there are circumstances that would allow for the correction of a scientific error or to make other revisions without reopening the risk evaluation or going back to the draft risk evaluation stage. EPA requests comment on whether there should be criteria for when a final risk evaluation should be revised, including circumstances where EPA becomes aware of information that was developed after the risk evaluation was finalized, as well as comment on circumstances that would not warrant reopening the risk evaluation or going back to the draft risk evaluation stage.

EPA requests comment on two alternatives to the above approach. First, the Agency could remove all regulatory text related to revising or supplementing existing risk evaluations and not replace the current language with an analogous provision. Under this approach, EPA's procedural framework rule would arguably satisfy the statutory requirement to “establish, by rule, a process to conduct risk evaluations” (15 U.S.C. 2605(b)(4)(C)) by setting out the process for a risk evaluation while remaining silent on whether and how to revise or supplement an evaluation. That would leave the Agency's assertion of authority to revise and supplement an evaluation to particular cases. While this approach would increase flexibility, EPA acknowledges that the absence of such language could undermine interests in certainty and predictability.

Second, the Agency could retain the current regulatory language added in the

2024 final rule, except for the provision allowing EPA to supplement or revise on an ad hoc basis in the interest of public health or the environment

ar cases. While this approach would increase flexibility, EPA acknowledges that the absence of such language could undermine interests in certainty and predictability.

Second, the Agency could retain the current regulatory language added in the

2024 final rule, except for the provision allowing EPA to supplement or revise on an ad hoc basis in the interest of public health or the environment. This approach would address the Agency's concerns with the one-sided nature of the current regulatory allowance for supplementation and revision while retaining the position that EPA generally will not revise or supplement a risk evaluation without re-prioritizing the chemical substance for a new risk evaluation. While this approach would increase certainty and predictability, and helps to ensure that the Agency proceeds to evaluate listed chemicals promptly rather than revisiting already evaluated chemicals, EPA acknowledges such a requirement would make it more difficult to update evaluations and determinations for evaluated chemicals and conditions of use and reduce the Agency's flexibility. EPA seeks comment on both alternative approaches and any other approaches that commenters believe the Agency should take to revisions and supplements in any final rule.

F. Requirements for Manufacturer-Requested Risk Evaluations

The 2024 final rule incorporated a number of changes to the provisions for manufacturer-requested risk evaluations (MRREs). TSCA section 6(b)(4)(C)(ii) allows a manufacturer or group of manufacturers to request that the Agency conduct a risk evaluation of a chemical substance (or category of substances) that they manufacture. TSCA section 6(b)(4)(C)(ii) directs EPA to establish the “form . . . manner and . . . criteria” for such requests by rule, which the Agency finalized in 2017.

Many of the changes in the 2024 final rule were understandable process changes based on EPA's experience in handling such requests and on implementing TSCA section 6(b) in general

ubstance (or category of substances) that they manufacture. TSCA section 6(b)(4)(C)(ii) directs EPA to establish the “form . . . manner and . . . criteria” for such requests by rule, which the Agency finalized in 2017.

Many of the changes in the 2024 final rule were understandable process changes based on EPA's experience in handling such requests and on implementing TSCA section 6(b) in general. However, the 2024 final rule includes new requirements for requesting manufacturers, including requirements to provide all information “known to or reasonably ascertainable by” the requesting manufacturer regarding a chemical substance's conditions of use, hazards, and exposures. 40 CFR 702.43(a)(8) defines the phrase “known to or reasonably ascertainable by” as including all information in the requesting manufacturer's possession or control, as well as information obtained through a thorough search of publicly available information, a reasonable inquiry within the requester's entire organization, and a reasonable inquiry outside of the requester's organization, including suppliers and downstream users. Further, 40 CFR 702.43(e)(7) provides that, should EPA determine that additional information is needed to carry out the risk evaluation, the requester will provide the requested information, withdraw the risk evaluation request, or request that EPA use its authorities under TSCA sections 4, 8, or 11 to obtain the information because the information is not reasonably ascertainable to the requester.

As explained in the 2024 final rule, the process established for MRREs in 2017 was challenging for EPA in a number of ways. The 2017 final rule allowed requests to contain information relevant only to conditions of use of the chemical of interest to the requesting manufacturer and also gave EPA a relatively short period of time in which to grant or deny the request. Once EPA granted the request, the statutory three-year clock for completing the risk evaluation began

in 2017 was challenging for EPA in a number of ways. The 2017 final rule allowed requests to contain information relevant only to conditions of use of the chemical of interest to the requesting manufacturer and also gave EPA a relatively short period of time in which to grant or deny the request. Once EPA granted the request, the statutory three-year clock for completing the risk evaluation began. EPA further explained that the process effectively left the Agency with the heavy burden of identifying the remaining conditions of use, reviewing information that came in with the request, obtaining and reviewing additional available literature, and determining any missing information or data needs—all within a matter of months. The 2024 final rule asserted that, in addition to needing more information in incoming requests, and additional time to properly review them and determine any additional information needs prior to initiating the evaluation, EPA also needed some flexibility in the process to pursue data collection or development during the risk evaluation. In support, EPA pointed to the process and timeframes that precede EPA-initiated risk evaluations in prioritization, which provides a significant amount of time to review and analyze available information, identify data gaps and needs, and pursue various data gathering strategies, all before initiating the risk evaluation and the associated deadlines.

While these challenges are evident with the MRREs that EPA has received, the 2024 final rule's solution requires manufacturers to take on the obligation to identify all of the conditions of use for the chemical substance and to supply all of the information that would be needed for EPA to perform the risk evaluation, including information for conditions of use that they, their suppliers, and their customers were not engaged in

by the requesting manufacturer that supports the identification of the requested

circumstances, and a rationale for why the requested circumstances constitute conditions of use under 702.33.”

EPA is similarly proposing to revise 40 CFR 702.45(e) to limit manufacturer information obligations to information about the identified conditions of use, and to clarify the decisions EPA will make regarding request completeness and the result of the request. In general, EPA will grant requests that are complete and that provide sufficient information to permit EPA to complete a risk evaluation on the identified conditions of use. To the extent that EPA lacks other information needed to perform a comprehensive risk evaluation on the chemical substance, such as information about other conditions of use, revised paragraph (e)(7) would require EPA to develop a strategy to obtain the information and would permit EPA to delay initiation of the risk evaluation on the chemical substance for up to one year in order to obtain the information using available TSCA authorities.

Finally, EPA is revising paragraphs (g) and (k) to clarify that manufacturer requests that are withdrawn before the request is granted do not incur fees. EPA requests comment on all aspects of the changes being proposed to the requirements for manufacturer-requested risk evaluations.

G. Severability

EPA intends that the provisions of this proposed rulemaking would, if finalized, be severable from one another. In the event that any individual provision or part of this rulemaking is invalidated, EPA intends that this would not render the entire rulemaking invalid, and that any individual provisions that are finalized would continue to be followed.

IV. Requests for Comment

EPA requests comment on all aspects of the proposal. Additionally, within this proposal, the Agency is soliciting feedback from the public on specific issues throughout this proposed rule

s rulemaking is invalidated, EPA intends that this would not render the entire rulemaking invalid, and that any individual provisions that are finalized would continue to be followed.

IV. Requests for Comment

EPA requests comment on all aspects of the proposal. Additionally, within this proposal, the Agency is soliciting feedback from the public on specific issues throughout this proposed rule. For ease of review, this unit summarizes those specific requests for comment, with numbering provided to help simplify referencing.

1. In Unit I.C., EPA requests comment on how the requirements of this rule, when finalized, would apply to risk evaluations initiated prior the effective date of the final rule, and whether these requirements shall not apply retroactively to risk evaluations already finalized.

2. In Unit I.E, EPA requests specific comment on the burden estimate and assumptions associated with the calculation associated with the burden ( e.g., number of manufacturer requests for risk evaluations that EPA expects). More generally, EPA requests comment on whether and how the proposed rule would reduce burdens, and welcomes detailed information, examples, and data addressing the impacts of the rule.

3. In Unit III.A.2, EPA requests comment on the proposed amendments to 40 CFR 702.37(a)(3) and (4), including whether the revisions are sufficiently clear as to EPA's intent regarding appropriately scoped, fit-for-purpose risk evaluations under TSCA section 6(b). EPA is also interested in comments on how to address conditions of use that are identified after the conclusion of a risk evaluation on a chemical substance.

4. In Unit III.A.3, EPA requests comment on whether the Agency should include regulatory text that specifies that EPA has discretion to exclude conditions of use as well as exposure pathways and routes. Further, EPA requests comment on specific instances where EPA should exercise its authority to exclude conditions of use and exposure pathways and routes

risk evaluation on a chemical substance.

4. In Unit III.A.3, EPA requests comment on whether the Agency should include regulatory text that specifies that EPA has discretion to exclude conditions of use as well as exposure pathways and routes. Further, EPA requests comment on specific instances where EPA should exercise its authority to exclude conditions of use and exposure pathways and routes. EPA also requests comment on whether to add regulatory text that states that EPA can coordinate actions with other federal laws administered by EPA to ensure that chemical risks “could be eliminated or reduced to a sufficient extent” by other EPA actions, pursuant to TSCA section 9(b). Finally, EPA welcomes suggested regulatory text that could be considered.

5. In Unit III.B.2, EPA requests comment on the change to the regulatory requirements for risk determinations discussed in Unit III.B.2., as well as the changes regarding occupational exposure assumptions discussed in Unit III.C.1. In addition, EPA requests comments more generally on TSCA section 6(b)(4)(A) risk determinations, including whether there should be more specific requirements for how EPA is to make and document its risk determinations.

6. In Unit III.C, EPA requests comment on all aspects of the proposed regulatory modifications and clarifications to provisions from the 2024 final rule related to risk evaluation.

7. In Unit III.C.2 EPA requests comment on the clarity and utility of the current definition of “aggregate exposure.”

8. In Unit III.C.3, EPA requests comment on the extent to which the regulatory definition of PESS and other terms should depart from the definitions provided by TSCA.

9. In Unit III.D.1, EPA requests comment on whether the 2017 language describing peer review provisions should be restored, or whether other amendments to peer review should be considered. More generally, EPA requests comment on how to ensure transparency and accountability in the peer review of risk evaluations.

10

ments for Ten Chemical Substances under the Toxic Substances Control Act. https://www.regulations.gov/docket/EPA-HQ-OPPT-2016-0723-0089 25. U.S. EPA. Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0. EPA/744/D/22/001. Washington, DC. 2022. https://www.epa.gov/system/files/documents/2022-01/draft-fenceline-report_sacc.pdf 26. U.S. House Report on the TSCA Modernization Act of 2015, H.R.2576, H.Rept. 114-176. June 23, 2015. https://www.congress.gov/congressional-report/114th-congress/house-report/176/1 27. U.S. EPA. Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act; Proposed Rule. Federal Register (82 FR 7562, January 19, 2017) (FRL-9957-75). https://www.govinfo.gov/content/pkg/FR-2017-01-19/pdf/2017-01224.pdf 28. American Cleaning Institute. Public Comment. Comments on Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act; Proposed Rule. Docket EPA-HQ-OPPT-2016-0654-0073. March 2017. https://www.regulations.gov/comment/HQ-OPPT-2016-0654-0073 29. U.S. EPA. Response to Public Comments on the Proposed Rule on Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act. July 2017. Docket EPA-HQ-OPPT-2016-0654-0109. https://www.regulations.gov/document/EPA-HQ-OPPT-2016-0654-0109 30. Brief of Respondents U.S. EPA et al., Safer Chemicals, Healthy Families, et al. v. U.S. EPA, et al., No. 17-72260 (9th Cir. August 8, 2018). 31. U.S. EPA. Risk Evaluation for Perchloroethylene (Ethene, 1,1,2,2-Tetrachloro-) CASRN: 127-18-4. EPA-740-R1-8011. Office of Chemical Safety and Pollution Prevention. December 2020. https://www.epa.gov/sites/default/files/2020-12/documents/_risk_evaluation_perchloroethylene_pce_casrn_127-18-4_0.pdf 32. U.S. EPA. Risk Evaluation for Trichloroethylene. CASRN: 79-01-6. EPA-740-R1-8008. Office of Chemical Safety and Pollution Prevention. November 2020

Ethene, 1,1,2,2-Tetrachloro-) CASRN: 127-18-4. EPA-740-R1-8011. Office of Chemical Safety and Pollution Prevention. December 2020. https://www.epa.gov/sites/default/files/2020-12/documents/_risk_evaluation_perchloroethylene_pce_casrn_127-18-4_0.pdf 32. U.S. EPA. Risk Evaluation for Trichloroethylene. CASRN: 79-01-6. EPA-740-R1-8008. Office of Chemical Safety and Pollution Prevention. November 2020. https://www.epa.gov//default/files/2020-11/documents/1._risk_evaluation_for_trichloroethyene_tce_casrn_79-01-6.pdf 33. Center for Environmental Accountability. Public Comment. Comments on Procedure for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA) Proposed Rule. Docket EPA-HQ-OPPT-2023-0496-0251. December 2023. https://www.regulations.gov//HQ-OPPT-2023-0496-0251 34. Silicones Environmental, Health and Safety Center (SEHSC). Public Comment Re: Comments on Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA). Docket EPA-HQ-OPPT-2023-0496-

0246. December 2023. https://www.regulations.gov//EPA-HQ-OPPT-2023-0496-0246 35. U.S. Senate Report on the Frank R. Lautenberg Chemical Safety for the 21st Century Act, S.697, S.Rept. 114-67. June 18, 2015. https://www.congress.gov/congressional-report/114th-congress/senate-report/67/1 36. Household & Commercial Products Association (HCPA). Public Comment Re: Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA). Docket EPA-HQ-OPPT-2023-0496-0239. December 2023. https://www.regulations.gov//EPA-HQ-OPPT-2023-0496-0239 37. American Chemistry Council (ACC). Public Comment Re: Proposed rule, Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA). Docket EPA-HQ-OPPT-2023-0496-0249. December 2023. https://www.regulations.gov/comment/EPA-HQ-OPPT-2023-0496-0249 38. U.S. EPA. Risk Evaluation for Diisononyl Phthalate (DINP). CASRNs 28553-12-0 and 68515-48-0. EPA-740-R-25-001. January 2025

review_handbook_4th_edition.pdf 43. OMB. Final Information Quality Bulletin for Peer Review; Final Bulletin. Federal Register (70 FR 2664, January 14, 2005). https://www.govinfo.gov/content/pkg/FR-2005-01-14/pdf/05-769.pdf 44. OMB. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies; Republication; Final Guidelines. Federal Register (67 FR 8452, February 22, 2002). https://www.govinfo.gov/content/pkg/FR-2002-02-22/pdf/R2-59.pdf 45. OMB. Memorandum M-19-15, Memorandum for the Heads of Executive Departments and Agencies: Improving Implementation of the Information Quality Act. April 24, 2019. https://www.whitehouse.gov/wp-content/uploads/2019/04/M-19-15.pdf 46. U.S. EPA. Methylene Chloride; Regulation Under the Toxic Substances Control Act (TSCA); Final Rule. Federal Register (89 FR 39254, May 8, 2024) (FRL-8155-01-OCSPP). https://www.govinfo.gov/content/pkg/FR-2024-05-08/pdf/2024-09606.pdf 47. U.S. EPA. Draft Risk Evaluation for Tris(2-chloroethyl) Phosphate (TCEP). EPA-740-D-23-002. Office of Chemical Safety and Pollution Prevention. Washington, DC. December 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2023-0265-0030 48. U.S. EPA. Existing Chemical Exposure Limit (ECEL) for Occupational Use of 1,4-Dioxane. Docket EPA-HQ-OPPT-2022-0905-0039. August 8, 2023. https://www.regulations.gov/document/EPA-HQ-OPPT-2022-0905-0039 49. U.S. EPA. Draft Risk Evaluation for 1,4-Dioxane. EPA-740-R1-8007. Office of Chemical Safety and Pollution Prevention. Washington, DC June 2019. https://www.regulations.gov//EPA-HQ-OPPT-2019-0238-0011 50. U.S. EPA. Information Collection Request (ICR) for the Final Rule: Procedures for Chemical Risk Evaluation Under TSCA (RIN 2070-AL27). EPA ICR No. 2781.02 and OMB Control No. 2070-0231. June 24, 2024. VI. Statutory and Executive Order Reviews

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

A

11 50. U.S. EPA. Information Collection Request (ICR) for the Final Rule: Procedures for Chemical Risk Evaluation Under TSCA (RIN 2070-AL27). EPA ICR No. 2781.02 and OMB Control No. 2070-0231. June 24, 2024. VI. Statutory and Executive Order Reviews

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

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

This action is a significant regulatory action that was submitted to OMB for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 11, 2011). Any changes made in response to Executive Order 12866 review have been documented in the docket. EPA prepared an analysis of the potential costs and burdens associated with this action. This analysis can be found in Unit VI.C.

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

This action is expected to be an Executive Order 14192 deregulatory action. Details on the estimated direct cost savings of this proposed rule can be found in Unit I.E and in the Information Collection Request (ICR) document entitled “Procedures for Requesting a Chemical Risk Evaluation under TSCA (Proposed Rule)” (Ref. 5). Additionally, although EPA's determinations as to whether a chemical presents unreasonable risk under its conditions of use are necessarily made without consideration of cost or other non-risk factors through the course of a TSCA risk evaluation, by proposing to amend the procedural rule to reassert EPA's discretion ( e.g., to determine the scope of the risk evaluation and to make a risk determination for each condition of use of a chemical substance instead for the chemical substance as a whole), the Agency anticipates that it could also be responsive to public comments that have suggested that unreasonable risk determinations formulated under the 2024 final rule would necessarily result in regulatory actions tha

., to determine the scope of the risk evaluation and to make a risk determination for each condition of use of a chemical substance instead for the chemical substance as a whole), the Agency anticipates that it could also be responsive to public comments that have suggested that unreasonable risk determinations formulated under the 2024 final rule would necessarily result in regulatory actions that would be overbroad and overly burdensome compared to potential actions in response to unreasonable risk determinations that are tailored to individual conditions of use.

C. Paperwork Reduction Act (PRA)

The information collection activities in this proposed rule have been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. EPA has prepared a new rule-related Information Collection Request (ICR) document entitled “Procedures for Requesting a Chemical Risk Evaluation under TSCA (Proposed Rule)” and is identified by EPA ICR No. 2781.03, to replace an existing approved ICR. You can find a copy of the new ICR document (Ref. 5) in the docket for this rule, and it is briefly summarized here.

The information activities related to the current requirements for manufacturer-requested risk evaluations are already approved by OMB in an ICR entitled, “Procedures for Requesting a Chemical Risk Evaluation under TSCA” (EPA ICR No. 2781.02 and OMB Control No. 2070-0231) (Ref. 50). The proposed rule replacement ICR addresses the information collection requirements contained in the current regulations as well as in the amendments identified in this proposed rule. As addressed in the currently approved ICR and pursuant 40 CFR 702, subpart B, the information collection activities are those carried out by a chemical manufacturer in requesting a specific chemical risk evaluation under TSCA be conducted by EPA. EPA established the process for conducting risk evaluations under TSCA

by OMB under OMB Control No. 2070-0231 is 166 hours. The total estimated annual respondent burden being proposed in the replacement ICR is 166 hours, a net decrease of 0 hours. Certain information included with a manufacturer-requested risk evaluation may be claimed as TSCA CBI in accordance with TSCA section 14 (15 U.S.C. 2613), and any such claims must be substantiated in accordance with the Act.

Respondents/affected entities: Persons that manufacture chemical substances and request a chemical be considered for risk evaluation by EPA. Such persons may voluntarily request a risk evaluation but would be required to comply with the requirements for such a request. See Unit I.A.

Respondent's obligation to respond: Voluntary (15 U.S.C. 2605(b)(4)).

Estimated number of respondents: 1 (per year).

Frequency of response: On occasion.

Total estimated burden: 166 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $91,831 (per year), includes $0 annualized capital or operation and maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this rule. EPA will respond to any ICR-related comments in the final rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at https://www.reginfo.gov/public/do/PRAMain. Find this particular ICR by selecting “Currently under Review—Open for Public Comments” or by using the search function. OMB must receive comments no later than October 23, 2025.

D

espond to any ICR-related comments in the final rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at https://www.reginfo.gov/public/do/PRAMain. Find this particular ICR by selecting “Currently under Review—Open for Public Comments” or by using the search function. OMB must receive comments no later than October 23, 2025.

D. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, EPA concludes that the impact of concern for this action is any significant adverse economic impact on small entities and that the Agency is certifying that this action will not have a significant economic impact on a substantial number of small entities because the action can relieve regulatory burden on the small entities subject to the rule and the number of small entities likely to be affected may be approximately 1 or less a year as estimated in Unit VI.C of this preamble. As described in Units I.E and VI.B, this proposal would reduce the amount of information a manufacturer would have to provide with a voluntary request for a risk evaluation. Details of this analysis are presented in the rule-related ICR (Ref. 5). We have therefore concluded that this action can relieve regulatory burden for all directly regulated small entities.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments. The costs involved in this action are imposed only on the private sector entities (manufacturers) that may voluntarily elect to submit a request for a risk evaluation as they would be required to comply with the proposed requirements for such requests

, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments. The costs involved in this action are imposed only on the private sector entities (manufacturers) that may voluntarily elect to submit a request for a risk evaluation as they would be required to comply with the proposed requirements for such requests. Such costs are estimated not to exceed $183 million in 2023$ ($100 million in 1995$ adjusted for inflation using the GDP implicit price deflator) or more in any one year.

F. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999) because 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.

G. 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) because it will not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Thus, Executive Order 13175 does not apply to this action.

H. 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 regulatory actions considered significant under section 3(f)(1) of Executive Order 12866 and that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of Executive Order 13045

ntific evaluation prior to making a judgment about the scientific evaluation. Quality and relevance determinations, at a minimum, should include consideration of study design, fitness for purpose, replicability, peer review, and transparency and reliability of data.

4. Amend § 702.37 by revising and republishing paragraphs (a)(3) and (4) to read as follows:

§ 702.37 Evaluation requirements.

(a) Considerations.

(3) EPA will ensure that all supporting analyses and components of the risk evaluation are suitable for their intended purpose, and tailored to the problems and decision at hand, in order to inform the development of technically sound determinations as to whether the chemical substance presents an unreasonable risk of injury to health or the environment under each of the conditions of use, based on the weight of the scientific evidence. A fit-for-purpose approach may result in varying types and levels of analysis and supporting information for certain conditions of use, consistent with paragraph (b) of this section. The extent to which EPA will refine its evaluations for one or more conditions of use in any risk evaluation will vary as necessary to determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under that condition of use.

(4) EPA will evaluate chemical substances that are metals or metal compounds in accordance with 15 U.S.C. 2605(b)(2)(E).

5. Amend § 702.39 by removing paragraphs (d)(8) and (9), and revising paragraphs (d)(7) and (f) to read as follows:

§ 702.39 Components of risk evaluation.

(d) Exposure assessment.

(7) EPA will describe whether aggregate or sentinel exposures under the conditions of use were considered and the basis for their consideration.

metal compounds in accordance with 15 U.S.C. 2605(b)(2)(E).

5. Amend § 702.39 by removing paragraphs (d)(8) and (9), and revising paragraphs (d)(7) and (f) to read as follows:

§ 702.39 Components of risk evaluation.

(d) Exposure assessment.

(7) EPA will describe whether aggregate or sentinel exposures under the conditions of use were considered and the basis for their consideration.

(f) Risk determination.

(1) As part of the risk evaluation, EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use by making separate risk determinations for each condition of use within the scope of the risk evaluation, either in a single decision document or in multiple decision documents.

(2) In determining whether unreasonable risk is presented, EPA's consideration of occupational exposure scenarios will take into account reasonably available information on the implementation and use of occupational exposure control measures such as engineering and administrative controls and personal protective equipment.

(3) In determining whether unreasonable risk is presented, EPA will consider the following risk-related factors included in the risk evaluation, as outlined in 40 CFR 702.39 (c), (d), and (e), and any other risk-related factors that are relevant:

(i) The severity of the hazard ( e.g., the nature of the hazard and irreversibility of the hazard);

(ii) Exposure-related considerations ( e.g., duration, intensity, and frequency of exposure);

(iii) The population exposed (including any potentially exposed or susceptible subpopulations (PESS)); and

l initiate action as required pursuant to 15 U.S.C. 2065(a).

(f) Final determination of no unreasonable risk. A determination by EPA pursuant to § 702.39(f) that a condition of use of a chemical substance does not present an unreasonable risk of injury to health or the environment will be issued by order and considered to be a final Agency action, effective on the date of issuance of the order.

(g) Substantive revisions to scope documents and risk evaluations. The circumstances under which EPA will undertake substantive revisions to scope and risk evaluation documents are as follows:

(1) Draft documents.

To the extent there are changes to a draft scope or draft risk evaluation, EPA will describe such changes in the final document.

(2) Final scope.

To the extent there are changes to the scope of the risk evaluation after publication of the final scope document, EPA will describe such changes in the draft risk evaluation, or, where appropriate and prior to the issuance of a draft risk evaluation, may make relevant information publicly available in the docket and publish a notice of availability of that information in the Federal Register .

(3) Final risk evaluations.

Where EPA supplements or revises, in whole or in part, a final risk evaluation, EPA will follow the procedures in this section including publication of a new draft and final risk evaluation and solicitation of public comment in accordance with §§ 702.43(c) and (d), and peer review, as appropriate, in accordance with § 702.41.

7. Amend § 702.45 by revising and republishing to read as follows:

§ 702.45 Submission of manufacturer requests for risk evaluations. (a) General provisions.

(1) One or more manufacturers of a chemical substance may request that EPA conduct a risk evaluation on a chemical substance.

(2) Such requests must comply with all the requirements, procedures, and criteria in this section.

the identification of the requested circumstances, and a rationale for why the requested circumstances constitute conditions of use under 702.33.

(5) All information known to or reasonably ascertainable by the requesting manufacturer on the health and environmental hazard(s) of the chemical substance, human and environmental exposure(s), and exposed population(s), including but not limited to:

(i) The chemical substance's exposure potential, including occupational, general population and consumer exposures, and facility release information;

(ii) The chemical substance's hazard potential, including all potential environmental and human health hazards;

(iii) The chemical substance's physical and chemical properties;

(iv) The chemical substance's fate and transport properties including persistence and bioaccumulation;

(v) Industrial and commercial locations where the chemical is used or stored;

(vi) Whether there is any storage of the chemical substance near significant sources of drinking water, including the storage facility location and the nearby drinking water source(s);

(vii) Consumer products containing the chemical;

(viii) The chemical substance's production volume or significant changes in production volume; and

(ix) Any other information relevant to the hazards, exposures and/or risks of the chemical substance.

(6) Where information described in paragraph (c)(4) or (5) of this section is unavailable, an explanation as to why, and the rationale for why, in the requester's view, the provided information is nonetheless sufficient to allow EPA to complete a risk evaluation on the conditions of use identified by the manufacturer.

(7) Copies of all information referenced in paragraph (c)(5) of this section, or citations if the information is readily available from public sources.

ates have the potential to have a significant impact on interstate commerce or health or the environment, and that as a consequence the request is entitled to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii).

(d) Confidential business information.

Persons submitting a request under this subpart are subject to EPA confidentiality regulations at 40 CFR part 2, subpart B, and 40 CFR part 703.

(e) EPA process for reviewing requests.

(1) Public notification of receipt of request.

Within 15 days of receipt of a manufacturer-requested risk evaluation, EPA will notify the public that such request has been received.

(2) Initial review for completeness.

EPA will determine whether the request appears to meet the requirements specified in this section ( i.e., complete), or whether the request appears to not have met the requirements specified in this section ( i.e., incomplete). EPA will notify the requesting manufacturer of the outcome of this initial review. For requests initially determined to be incomplete, EPA will cease review, pending actions taken by the requesting manufacturer pursuant to paragraph (f) of this section. For requests initially determined to be complete, EPA will proceed to the public notice and comment process described in paragraph (e)(3) of this section.

(3) Public notice and comment.

No later than 90 days after initially determining a request to be complete pursuant to paragraph (e)(2) of this section, EPA will submit for publication the receipt of the request in the Federal Register, open a docket for that request and provide no less than a 60-day public comment period. The docket will contain the CBI sanitized copies of the request and all supporting information

, as determined by the Administrator, that will be included in this risk evaluation.

(6) Publication of draft conditions of use and request for information.

EPA will publish a notice in the Federal Register that identifies draft conditions of use, requests relevant information from the public, and provides no less than a 60-day public comment period.

(7) Identification of information needs.

(i) Within 90 days following the close of the public comment period in paragraph (e)(6), EPA will determine whether further information is needed to carry out the risk evaluation and notify the requesting manufacturer of its determination. If EPA determines at this time that no further information is necessary, EPA will initiate the risk evaluation, pursuant to paragraph (e)(8) of this section.

(ii) Where additional information needs are identified, EPA will notify the requesting manufacturer and develop a strategy for obtaining the information using available TSCA authorities.

(iii) EPA may delay initiating the risk evaluation for up to 1 year if necessary to obtain information needed to complete the risk evaluation for the chemical substance.

(8) Initiation of the risk evaluation.

Within 90 days of the end of the comment period provided in paragraph (e)(6) of this section, unless EPA determined that that additional information would be needed to complete the risk evaluation pursuant to paragraph (e)(7) of this section, then within 1 year of that determination, EPA will initiate the requested risk evaluation and follow all requirements in this subpart, including but not limited to §§ 702.37 through 702.43 and §§ 702.47 through 702.49 of this subpart, and notify the requesting manufacturer and the public.

micals and requests for non-TSCA Work Plan chemicals, EPA will give preference to requests for risk evaluations on chemical substances:

(i) First, for which EPA determines that restrictions imposed by one or more States have the potential to have a significant impact on interstate commerce, health or the environment; and then

(ii) Second, based on the order in which the requests are received.

(j) Fees.

Manufacturers must pay fees to support risk evaluations as specified under 15 U.S.C. 2605(b)(4)(E)(ii), and in accordance with 15 U.S.C. 2625(b) and 40 CFR 700.45. In the event that a request for a risk evaluation is withdrawn by the requesting manufacturer after EPA has granted the request, but before EPA has initiated the risk evaluation, the total fee amount due will be either, in accordance with 40 CFR 700.45(c)(2)(x) or (xi) (as adjusted by 40 CFR 700.45(d) when applicable), 50% or 100% of the actual costs expended in carrying out the risk evaluation as of the date of receipt of the withdrawal notice. The payment amount will be determined by EPA, and invoice or refund issued to the requesting manufacturer as appropriate.

[FR Doc. 2025-18431 Filed 9-22-25; 8:45 am] BILLING CODE 6560-50-P