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August Updates from the PCRRTK Committee

Lynn L. Bergeson, Nancy Beck, Ryan Joseph Sylvester Carra, Sarah Kettenmann, Judah Prero, Javaneh Tarter, and David Weber


  • Features the article, “Chemical Restrictions and Worker Protections under TSCA”
  • Addresses EPA’s published supplemental proposed rule that would add the diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under EPCRA and PPA.
  • Discusses the Biden administration prioritization of addressing the environmental and health issues posed by the use of PFAS, including use by federal agencies and the military.
August Updates from the PCRRTK Committee
Sunyixun via Getty Images

August’s featured article: Chemical Restrictions and Worker Protections under TSCA

A recent U.S. Environmental Protection Agency (EPA) regulation and a proposed rule under the Toxic Substances Control Act (TSCA) have alarmed industry for overlapping with Occupational Safety and Health Administration (OSHA) standards for worker protection. TSCA sections 5 and 6 orders and rules aimed to protect potentially exposed or susceptible subpopulations from unreasonable risks from certain chemicals’ conditions of use have, or will have, requirements for personal protective equipment (PPE), permissible exposure limits (PELs), and hazard communication. These requirements build on and often go beyond OSHA standards. 

TSCA directs EPA to protect “potentially exposed or susceptible subpopulations,” including “workers.” TSCA § 3(12). EPA provisions protecting workers under TSCA from exposure to chemical hazards do not preempt OSHA requirements under the Occupational Safety and Health (OSH) Act section 4(b)(1). TSCA § 9(c). Thus, both OSHA and EPA have requirements that apply at the same time. The preamble to the section 6(a) proposed chrysotile asbestos rule suggests that EPA will conclude that OSHA cannot manage the risks of a chemical reviewed by EPA in a risk evaluation adequately, in part because OSHA standards must be economically and technologically feasible, while EPA risk determinations must be made “without regard to cost or other non-risk factors.” 87 Fed. Reg. 21706, 21711 (Apr. 12, 2022).

New Chemicals

In certain situations, EPA will require specific protections—including for workers—against exposures to new chemicals. EPA’s review of a premanufacture notice (PMN) for a new chemical entails determining whether the new chemical’s conditions of use “may present an unreasonable risk.” If EPA determines that the new chemical may present an unreasonable risk, it will issue a TSCA section 5(e) order imposing restrictions and possibly requirements for use of PPE and hazard communication. Despite evidence of actual PPE use by industry, EPA has suggested that because OSHA does not apply to all workers, and some noncompliance with OSHA is to be expected, EPA will impose its own PPE requirements.

Section 5(e) orders and significant new use rules (SNURs)—which apply section 5(e) restrictions to all manufacturers—may include these requirements. EPA revised its regulation on “protection in the workplace” to add language that would make it a significant new use to not implement a hierarchy of controls to protect workers. 40 C.F.R. § 721.63 (as amended July 5, 2022). It also updated its “hazard communication program” requirement to be consistent with OSHA requirements. 40 C.F.R. § 721.72 (as amended July 5, 2022). Unlike OSHA’s hazard communication standard, though, section 721.72 allows EPA to select specific kinds of hazards for specific chemicals. In addition, 98 SNURs include new chemical exposure limits (NCELs), which tend to be quite low.

Existing Chemicals

Since the 2016 amendments to TSCA, EPA has considered or is considering 38 chemicals on the TSCA Inventory. TSCA § 6(b)(4), (h). EPA is conducting or completing risk evaluations for many of these chemicals to determine whether they present an unreasonable risk under their conditions of use. Its determinations are to be made without consideration of costs or other non-risk factors. If EPA finds that a chemical would present an unreasonable risk under its conditions of use, it must issue restrictions under section 6(a) “to the extent necessary so that the chemical substance no longer presents an unreasonable risk.”

EPA seems to believe that risks need to be protected against more intensely than OSHA standards require, which must be economically and technologically feasible and leave PPE use and selection decisions to employers. EPA bases its restrictions on chemicals’ “conditions of use,” which are defined 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, or disposed of.” TSCA § 3(4). The Biden EPA is revising some Trump EPA risk determinations to remove an assumption that PPE is used. See, e.g., 87 Fed. Reg. 38747 (June 29, 2022); 87 Fed. Reg. 39085 (June 30, 2022). Under the Biden administration, EPA has emphasized that OSHA requirements do not apply to self-employed persons, or local or state government workers in states subject to OSHA’s jurisdiction, and that congressional appropriations generally limit OSHA enforcement against employers with 10 or fewer employees. EPA also expects some noncompliance with OSHA PPE requirements even where applicable. Accordingly, EPA expects that it is “reasonably foreseen” that some workers will not use OSHA-required PPE.

However, by regulating based on “reasonably foreseen,” EPA arguably is ignoring the “intended” and “known” information it must also consider. For example, where appropriate, employers covered by OSHA’s standards must provide, and ensure proper usage of, PPE to workers that face chemical exposure. 29 C.F.R. § 1910.132. EPA’s decision to not assume that PPE is being used arguably contradicts TSCA’s directive that it regulate based on “reasonably available” information and “the weight of the scientific evidence.” TSCA § 26(k), § 26(h).

Industrial employers may be in compliance with OSHA standards but not with TSCA PPE or hazard communication requirements. Employers should consider participating in TSCA risk evaluations to help influence risk determinations and risk management rulemaking.

Sarah A. Kettenmann is an associate at Beveridge & Diamond P.C.

August Updates

EPA Publishes 2021 TRI Preliminary Dataset and Plans to Remove De Minimis TRI Reporting Exemption for PFAS—published August 1, 2022, by Lydia González Gromatzky, Nancy B. Beck, PhD, DABT, Gregory R. Wall, Matthew Z. Leopold, and Javaneh S. Tarter

On July 28, 2022, the Environmental Protection Agency (EPA) published the 2021 Toxics Release Inventory (TRI) preliminary dataset that provides public access to data about chemical releases, waste management, and pollution prevention activities that took place in calendar year 2021 at more than 20,000 federal and industrial facilities across the country. The 2021 preliminary dataset, which for the second year includes reporting on per- and polyfluoroalkyl substances (PFAS) added to the TRI by the 2020 National Defense Authorization Act (NDAA), has not yet undergone the complete TRI data quality process. EPA plans to publish the quality-checked dataset in October 2022, at which time it will be the basis for the 2021 TRI National Analysis interpreting the information and examining trends that is expected to be published in early 2023. Companies should bear in mind that information collected under the TRI program can be used not only to inform regulatory action, but also as a basis for enforcement by EPA and citizen suits.

GAO Publishes Report on Technologies for PFAS Assessment, Detection, and Treatment—published August 3, 2022, by Lynn L. Bergeson and Carla N. Hutton

The U.S. Government Accountability Office (GAO) published a report on July 28, 2022, entitled Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment. GAO was asked to conduct a technology assessment on PFAS assessment, detection, and treatment. The report examines the technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and policy options that could help enhance benefits and mitigate challenges associated with these technologies. GAO assessed relevant technologies; surveyed PFAS subject matter experts; interviewed stakeholder groups, including government, nongovernmental organizations (NGO), industry, and academia; and reviewed key reports. 

NTP Publishes Revised Technical Reports on the Toxicity Studies of Perfluoroalkyl Sulfonates and Perfluoroalkyl Carboxylates—published August 4, 2022, by Lynn L. Bergeson and Carla N. Hutton

On July 28, 2022, the National Toxicology Program (NTP) announced that the following revised Technical Reports on the Toxicity Studies are available on the NTP website:

  • Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-96); and
  • Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-97).

EPA Amends SNUR Regulations to Protect Workers’ Health—published August 8, 2022, by Lynn L. Bergeson, Richard E. Engler, and Carla N. Hutton

On July 5, 2022, EPA issued a final rule amending the regulations governing significant new uses of chemical substances under TSCA to align with revisions that were made to the OSHA Hazard Communications Standard (HCS) and changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements for the respiratory protection of workers from exposure to chemicals. 87 Fed. Reg. 39756. In addition, EPA is amending the regulations governing SNURs to address issues that have been identified by EPA and raised by stakeholders through public comments. EPA is also making a minor change to reporting requirements for premanufacture notices and other TSCA notifications. EPA states that it “expects these changes to have minimal impact on the costs and burdens of compliance, while updating the significant new use reporting requirements to assist in addressing any potential risks to human health and the environment.”

White House OSTP Releases Plan to Advance Research on Emerging Contaminants in Drinking Water—published August 8, 2022, by Lynn L. Bergeson and Carla N. Hutton

The White House Office of Science and Technology Policy (OSTP) released on August 5, 2022, a new report on the National Emerging Contaminants Research Initiative (NECRI). The report outlines a federal strategy to address critical research gaps related to detecting and assessing emerging contaminants in drinking water, as well as identifying and mitigating the adverse health effects those contaminants cause. The report also outlines strategic steps needed to more effectively track, identify, and mitigate contaminants of emerging concern (CEC), which have been traditionally difficult to detect in drinking water.

Washington Advances the Western Front of Product Regulation—published August 8, 2022, by Ryan J. Carra, K. Russell LaMotte, David C. Weber, and Kirstin Gruver

The state of Washington has become a global player in product regulation. This month, the Department of Ecology issued a determination to restrict or require reporting on the use of five classes of chemicals in products. In some cases, the restrictions may be first-in-class—depending on how Ecology implements the determination—meaning that manufacturers may need to alter their product compositions to continue selling in Washington. Ecology must finalize the determination in a rulemaking by June 1, 2023.

On August 9, 2022, Ecology published a preliminary draft rule to implement the restrictions and reporting requirements Ecology identified in its final determination. Ecology has invited comments on a range of topics, including environmental justice, de minimis thresholds, and effective dates for material restrictions. Ecology was accepting comments on the draft rule until August 23, 2022, with another opportunity for comment after Ecology publishes the formal draft rule in December 2022.

EPA Issues Supplemental Proposed Rule to Add DINP Category to TRI List of Chemicals—published August 10, 2022, by Lynn L. Bergeson and Carla N. Hutton

EPA published a supplemental proposed rule that would add the diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 48128. EPA previously issued a proposed rule on September 5, 2000, in response to a petition filed under EPCRA, to add a DINP category to the list of toxic chemicals subject to the reporting requirements under EPCRA and the PPA.

EPA Updates Safer Chemical Ingredients List, Adding 22 Chemicals and Changing the Status of One Chemical—published August 11, 2022, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on August 11, 2022, that it updated the Safer Chemical Ingredients List (SCIL), “a living list of chemicals by functional-use class that EPA’s Safer Choice program has evaluated and determined meet the Safer Choice Standard.” EPA added 22 chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”

EPA Holds Kick-Off Meeting for TSCA New Chemical Engineering Outreach Initiative——published August 16, 2022, by Lynn L. Bergeson and Carla N. Hutton

EPA’s New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. In June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemicals submissions under TSCA and common issues that cause EPA to have to rework risk assessments for these submissions. EPA has posted the meeting slides online.

Federal Procurement and PFAS: The Push (and Push Back) for Policy Change—published August 17, 2022, by Judah Prero and Michael McGill

The Biden administration has prioritized addressing the environmental and health issues posed by the use of PFAS, including use by federal agencies and the military. EPA is already developing policy that applies to the procurement of products that contain PFAS. This is likely just the start of a broader effort to regulate PFAS in federal procurement. In an interesting twist, the administration is now opposing what it views as overly aggressive and thus unrealistic policies to combat PFAS. This remains a dynamic area and likely will remain so for the foreseeable future. In the meantime, it will be important for contractors to monitor the PFAS requirements and restrictions that currently apply to their contracts and track the policies developed that are likely to drive future changes to those requirements and restrictions.

EPA Holds Webinar on PFAS Strategic Roadmap: Research Tools and Resources—published August 19, 2022, by Lynn L. Bergeson and Carla N. Hutton

EPA held a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” The webinar provided a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key PFAS research needs for environmental decision-making. During the webinar, ORD scientists highlighted two recently released data sources: EPA’s Systematic Evidence Map (SEM) for PFAS, which summarizes available toxicity evidence for approximately 150 different PFAS, and EPA’s PFAS Thermal Treatment Database (PFASTT), which contains information on the treatability of PFAS via various thermal processes.

EPA Will Discontinue Use of Exposure Modeling Thresholds When Assessing Health and Environmental Risks of New Chemicals—published August 25 by Lynn L. Bergeson and Carla N. Hutton

EPA announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the TSCA New Chemicals Program to ensure they adhere to statutory requirements and the Biden administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA. According to EPA, due in part to the automation of modeling, it has become less burdensome to complete these calculations. Furthermore, according to EPA, removing the thresholds supports President Biden’s Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” which calls on federal agencies to advance equity, including by reviewing and revising as needed government policies and programs impacting underserved communities.

EPA Will Propose Revisions to RMP Rule to Enhance Chemical Safety—published August 26, 2022, by Lynn L. Bergeson, Richard E. Engler, and Carla N. Hutton

EPA announced on August 19, 2022, that it will propose revisions to the Risk Management Program (RMP) rule to protect further vulnerable communities from chemical accidents, especially those living near facilities with high accident rates. According to EPA, the “Safer Communities by Chemical Accident Prevention” (SCCAP) rule “would strengthen the existing program and includes new safeguards that have not been addressed in prior RMP rules, such as enhanced employee participation and transparency for communities on safety decisions.” On August 31, 2022, EPA issued the proposed rule in the Federal Register. 87 Fed. Reg. 53556. Comments must be received on or before October 31, 2022.