On May 3, 2024, the Environmental Protection Agency (EPA) published its Final Rule that amends the risk evaluation process for chemicals under the Toxic Substances Control Act (TSCA) and the steps chemical manufacturers and importers must follow when they request an EPA-conducted risk evaluation on a particular chemical substance. Effective July 2, 2024, the procedures adopted under the Final Rule will apply to all chemical risk evaluations initiated on or after August 1, 2024. Given the TSCA’s authority over all naturally occurring and synthetic chemicals that are not regulated under other federal laws concerning food, drugs, cosmetics, firearms, pesticides, or tobacco, the Final Rule will significantly impact the risk evaluation process for a wide range of chemicals going forward. Historically, the EPA has initiated the risk evaluation process for:

1. Solvents such as 1,4-dioxane, methylene chloride, 1-bromopropane;
2. Phthalates such as Di-ethylhexyl phthalate – (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester) and di-isononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl ester); and
3. Flame retardants such as cyclic aliphatic bromide cluster and phosphoric acid, triphenyl ester (TPP).

What is the Toxic Substances Control Act and the Risk Evaluation Process?

The TSCA authorizes the EPA to regulate reporting, recordkeeping, testing, and other requirements and restrictions relating to certain chemical substances and mixtures. (15 U.S.C. § 2601–2629)  Regulations adopted under the TSCA’s three-step risk evaluation process are enforceable against all facilities that use, store or manufacture affected chemicals.

The first step requires the EPA to conduct a screening process for designating chemicals as “High-Priority” for risk evaluation or “Low-Priority,” for which risk evaluation is not warranted at the time of the screening process. (15 U.S.C. § 2605 (b)(1)(B).)

During the second step, the EPA will create a risk evaluation scope to consider the chemical’s hazards, exposure pathways, and conditions of use. (15 U.S.C. § 2605 (b)(4)(D).) After soliciting public comment, the EPA will assess and determine if the chemical presents an unreasonable risk to health or the environment. (15 U.S.C. § 2605 (b)(4)(F).)

The third step requires the EPA to restrict chemicals that present an unreasonable risk to health or the environment within two years of the final risk evaluation. (15 U.S.C. §  2605(a), (c)–(d) [the two-year deadline is subject to a possible two-year extension and other limitations].) This regulation may include labeling, recordkeeping, and notice requirements, actions to reduce human exposure or environmental release, or a ban on the chemical or certain uses of the chemical.

What’s in the Final Rule?

The Final Rule supplements the TSCA Risk Evaluation Process by making several major changes to the program, such as:

• Requiring the EPA to consider “real-world exposure scenarios,” such as multiple exposure pathways (e.g., air and water) to the same chemical and combined risks from multiple chemicals when possible. (40 CFR 702.33 [defining aggregate exposure, pathways, routes, and sentinel exposure].)
• Mandating that risk evaluations must be comprehensive and not exclude conditions of use or exposure pathways. (40 CFR 702.49 (b)–(d).)
• Requiring the EPA to consider risks to all workers in its risk evaluations. (40 CFR 702.33 [defining potentially exposed or susceptible subpopulation].)
• Instructing the EPA to consider chemical uses necessary for national security or critical infrastructure by other Federal agencies. (40 CFR 702.39)
• Assuring that the EPA will use the best available science to conduct risk evaluations, base decisions on the weight of the scientific evidence, and peer-review risk evaluations according to federal and EPA guidance. (40 CFR § 702.43 (b)(4), 702.45).
• Requiring that the EPA consider chemical-specific fit-for-purpose approaches that allow for varying types and levels of analysis. (40 CFR 702.41 (a)(5).)
• Mandating that risk evaluations culminate in a single risk determination on the chemical substance rather than individual chemical conditions of use in isolation. (40 CFR 747)
• Adopting improved communication standards regarding a chemical’s uses that significantly contribute to the unreasonable risk. (40 CFR 702.41 (a)(6)–(7).)
• Adopting new procedures and criteria for whether and how the EPA will revise scope and risk evaluation documents to improve transparency. (40 CFR 702.43 (c)(4)–(5).)
• Adjusts the submission and review process for manufacturer-requested risk evaluations to better align with the process and timeline associated with EPA-initiated risk evaluations. (40 CFR 702.49)
• Requiring the EPA to explicitly consider overburdened communities in risk evaluations when identifying potentially exposed and susceptible populations. (40 CFR 702.33 [defining potentially exposed or susceptible subpopulation].)

What Steps Can My Affected Business or Industry Take to Ensure Compliance?

Facilities that manufacture, use, import, export, or otherwise handle chemicals subject to the TSCA should familiarize themselves with the Final Rule and existing High-Priority chemicals that have either undergone or are currently undergoing risk evaluations. The Final Rule will likely increase costs in chemical risk evaluations, another federal program that will weigh environmental justice factors in prioritizing environmental risks. Furthermore, the Final Rule could face legal challenges in the wake of the U.S. Supreme Court’s June 28^th decision in Loper Bright v. Raimondo and Relentless, Inc. v. Department of Commerce, which eliminated judicial deference to federal agency interpretations of statutes that do not explicitly authorize the federal agencies to take certain actions. Please contact us for more information about the Final Rule, the TSCA risk evaluation process, and EPA enforcement actions under the TSCA.

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