iThe U.S. Environmental Protection Agency (EPA) released a final rule on April 23, 2024, that amends the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). According to the final rule, published in the Federal Register on May 3, 2024, EPA reconsidered the procedural framework rule for conducting such risk evaluations and is revising certain aspects of that framework to align better with the statutory text and applicable court decisions, to reflect its experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of future scientific advances in the risk evaluation process without the need to amend further the Agency’s procedural rule. 89 Fed. Reg. 37028. The final rule will take effect July 2, 2024.
General Provisions
EPA is amending the general provisions at 40 C.F.R. Section 702.31 as proposed. The procedures will apply to all risk evaluations initiated 30 days after the date of the final rule or later. For manufacturer-requested risk evaluations (MRRE) in process as of the date of the final rule, EPA expects to apply the proposed changes to those risk evaluations “only to the extent practicable, taking into consideration the statutory requirements and deadlines.”
EPA states that the final rule includes the minor clarification with respect to the applicability of the rule to risk evaluations on categories of chemical substances in 40 C.F.R. Section 702.31(d). EPA notes that the rule does not prescribe how or whether it will identify categories appropriate for prioritization and risk evaluation. The criteria for establishing categories are specified in TSCA Section 26(c). According to the final rule, if EPA does categorize chemicals as a category, it will provide, on a case-by-case basis, the justification for inclusion of the chemicals in a category.
Technical Corrections and Reorganization
The proposed rule reflects a number of minor updates and corrections and general organizational restructuring. EPA states that it aimed to improve the readability of certain provisions, and, ultimately, enhance the public’s ability to understand how EPA will undertake TSCA risk evaluations. EPA reorganized the sequence and structure of regulatory provisions to establish sections that distinguish between the components of the risk evaluation, the analytic considerations to be applied in the risk evaluation, and the associated procedural timeframes and actions. EPA carried these changes through into the final rule.
Definitions
The final rule makes minor updates to definitions for “pathways,” “routes,” “aggregate exposure,” and “sentinel exposure.” The final rule also maintains the definitions for “act,” “conditions of use” (COU), “reasonably available information,” “uncertainty,” or “variability” — “all unchanged from the 2017 final rule.” EPA proposed to eliminate the codified definitions for “best available science” and “weight of scientific evidence.” According to the final rule, EPA “can say with confidence that the Agency is fully committed to meeting the requirements in the law, and to being transparent in each risk evaluation with respect to how scientific information, technical procedures, measures, methods, protocols, methodologies, or models are being employed in a manner consistent with the best available science and how decisions are based on the weight of the scientific evidence, as required by 15 U.S.C. 2625(h) and (i).” As such, the final rule removes these definitions from the codified regulatory text.
EPA also proposed changes to the definition of “potentially exposed or susceptible subpopulation” (PESS), which currently includes “infants, children, pregnant women, workers or the elderly.” Namely, EPA states, it proposed to add the phrase “overburdened communities” to the list of other examples of PESS that EPA might identify like “infants, children, pregnant women, workers, or the elderly.” After considering the comments, EPA determined to amend the PESS definition as proposed.
Scope of TSCA Risk Evaluations
Inclusion of All COUs
EPA states that it proposed a number of changes to the regulatory text to make clear that the scope of TSCA risk evaluations will not exclude any COUs. EPA states that it has some discretion; “the identification of a chemical’s conditions of use falls squarely within EPA’s purview and will necessarily involve the Agency applying both fact and professional judgment, particularly with respect to identifying whether a circumstance is reasonably foreseen.” EPA notes that it “also has discretion in tailoring its level of analysis with respect to individual conditions of use within the scope of the risk evaluation and may choose to, for example, take a more qualitative approach to conditions of use that it determines are negligible contributors to exposures and risks based on the reasonable available information.” According to the final rule, EPA does not view the statute as providing authority to exclude categorically known COUs or exposures from the scope of the risk evaluation entirely, however.
Determination of COUs
EPA distinguishes between its lack of discretion to exclude COUs as described in the previous section and its ability to exercise judgment in making its determination as to whether a particular circumstance is intended, known, or reasonably foreseen, and therefore falls within the definition of COU for a particular chemical. EPA states that for each risk evaluation, and consistent with the phrase “as determined by the Administrator” in the statutory definition of COUs, “EPA must analyze the reasonably available information and apply the facts, Agency expertise and professional judgment to determine that chemical’s conditions of use.” According to EPA, the determination of whether a particular circumstance is reasonably foreseen — and therefore an exposure that must be considered within the scope of the risk evaluation — “is necessarily going to require a fact-specific, chemical-by-chemical analysis.” EPA notes that ultimately, its determination on the chemical’s COUs and the rationale to support those conclusions will be subject to public review and comment as part of each risk evaluation.
Inclusion of All Exposure Pathways
EPA states that it concludes that the best interpretation of TSCA is that the law does not authorize the exclusion of relevant exposure pathways from consideration in a risk evaluation. EPA notes that certain risk evaluations published during the prior Administration were challenged, including on the grounds that EPA’s prior approach of excluding exposure pathways was inconsistent with TSCA requirements. According to EPA, the approach adopted in the final rule “may conserve judicial, EPA, and other federal government resources by avoiding or reducing the need for such litigation. In addition, EPA has discretion to carry out TSCA risk evaluations in a fit-for-purpose manner, tailoring the depth or extent of analysis commensurate with the nature and significance of the decision, and expects to employ these approaches to enable completion of risk evaluations within the statutory deadlines.”
Comprehensive but Fit-for-Purpose
As noted in the proposed rule, EPA “does not believe risk evaluations under TSCA should be so complex or procedurally cumbersome that they cannot reliably be completed within the timeframes required by the statute.” EPA states that at the same time, it cannot produce partial or incomplete TSCA risk evaluations or pursue risk evaluations in a manner that is otherwise incompatible with the statutory framework. EPA “appreciates the suggestion” that it develop guidance for how it might apply fit-for-purpose approaches in different circumstances. According to the final rule, EPA believes that fit-for-purpose approaches in risk evaluations are an essential part of implementing the TSCA program and sustaining it over the long-term.
Additional Efficiencies
EPA states that it will continue to abide by the statutory requirement to publish the final scope within the first six months after initiation of a risk evaluation. EPA has already been maintaining the practice of publishing a preliminary list of COUs during the Proposed Designation step of the prioritization process, as some commenters suggest. EPA sees additional value in publishing more robust preliminary information on the COUs, hazards, exposures, and PESS that it expects to consider, and any early indications as to how it may apply fit-for-purpose approaches, however. EPA notes that public comments received on this information can inform the final priority designation and, if the chemical is then designated as a high-priority substance, the scope of the risk evaluation.
Risk Determinations
Single Determination on the “Chemical Substance”
EPA states that it agrees that TSCA requires consideration of the chemical’s COUs and that the potentially different exposure scenarios presented by different COUs should be reflected in the risk evaluation’s exposure assessment. According to EPA, “the plain language of the law requires EPA to determine whether the chemical substance, rather than individual conditions of use, presents an unreasonable risk,” however. EPA notes that in addition to aligning its process with the statutory text and structure, this approach ensures that it is best positioned to incorporate reasonably available information, make determinations consistent with the best available science and based on the weight of scientific evidence, including, where appropriate, risk determinations that consider aggregate exposure resulting from multiple COUs. The final rule will amend the regulatory text to ensure risk evaluations will always culminate in a single risk determination on the “chemical substance,” including the language in 40 C.F.R. Sections 702.37(a)(5) and 702.39(f)(1).
Risk Communication Related to Single Risk Determination
EPA states that it appreciates the concerns regarding clear risk communication as part of each risk determination but disagrees with the suggestion that the single risk determination approach will lead to a finding of unreasonable risk in every instance. EPA “is strengthening its commitment” in the final rule to identify which COUs are significant contributors to the unreasonable risk by changing the text to indicate a more affirmative “will identify” from the proposed “intends to” and by moving the regulatory text directly into the section on the “Unreasonable Risk Determination” at 40 C.F.R. Section 702.39(f). According to EPA, “[w]hile not necessarily a perfect indicator of how EPA will ultimately regulate to address unreasonable risk, this communication should give industry stakeholders significant insight and more certainty.” EPA notes that in addition to providing a rationale and explanation in the risk determination itself, it is further committed to communicating clearly on its analysis of particular uses in other venues, “and will refrain from making unqualified statements about the risk associated with the chemical substance that could generate the type of confusion commenters are concerned about.”
