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On October 11, 2023, EPA released its final rule imposing detailed reporting requirements on entities that have manufactured or imported PFAS for commercial purposes. Notably, the reporting rule also applies to importers of articles containing PFAS, which could include many consumer, industrial, and commercial products, and requires reporting on PFAS as a component of a mixture. This rule is more expansive in scope than most rules under TSCA, and it will impact many companies that may be unfamiliar with TSCA. In this post, we provide responses to frequently asked questions about the new rule.
Continue Reading Frequently Asked Questions About EPA’s Expansive PFAS Reporting Rule under the Toxic Substances Control Act

EPA finalized a rule effective on August 7, 2023 concerning the treatment of confidential business information (CBI) claims made in Toxic Substances Control Act (TSCA) submissions. Companies who submit any information to EPA under TSCA and want their confidential information to be protected from public disclosure must comply with these new requirements for CBI claims. Failure to follow these procedural requirements can result in EPA’s denial of the confidentiality claims and the information being made public.Continue Reading EPA Waives Certain Requirements and Faces Litigation Over New TSCA Final Rule to Protect CBI Claims

In June 2023, federal agencies released their “Spring 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals which could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s regulatory team have provided analyses of these upcoming regulatory actions:

Continue Reading Recent Regulatory Agendas Show Robust Slate of Rulemakings Coming for TSCA and PFAS

On May 3, 2023, EPA released its proposed risk management rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to impose restrictions on the manufacture, import, processing, distribution, and use of methylene chloride, a widely-used solvent in a variety of consumer and commercial applications. This is the first risk management rule proposed by…

In late February 2023, EPA released for public comment its Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act (“Draft Principles”), which proposes a set of principles for evaluating cumulative risks for chemicals undergoing risk evaluation under the Toxic Substances Control Act (“TSCA”). In conjunction with the Draft Principles, EPA also released its “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substances Control Act,” (“Draft Proposed Phthalates Cumulative Risk Approach”), an approach for applying these Draft Principles to the evaluation of cumulative risks posed by certain phthalates undergoing TSCA risk evaluations. EPA referred to these documents as the “first steps” towards the Agency conducting cumulative risk assessments under TSCA.Continue Reading EPA Proposes A Cumulative Risk Approach for Chemical Risk Assessment under TSCA

In January 2023, federal agencies released their “Fall 2022” Regulatory Agendas that provide roadmaps for upcoming and long-term regulatory actions on chemicals that could have significant implications for the regulated community. These agendas make clear that the Biden Administration continues to prioritize regulatory actions to address per- and polyfluoroalkyl substances (PFAS) across multiple agencies. And the US Environmental Protection Agency (EPA) also continues to implement numerous regulatory initiatives to assess and mitigate chemical risks under the strengthened Toxic Substances Control Act (TSCA).

Hunton’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

Continue Reading Announcement: Recent Regulatory Agendas Show Numerous Delayed Awaited Agency Actions on PFAS and TSCA Chemicals

On December 22, 2022, EPA’s Integrated Risk Information System (IRIS) Program released its ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook). EPA began working on the approaches in the IRIS Handbook after a 2011 National Research Council report recommended several improvements to the overall IRIS assessment process. In 2020, EPA released a draft IRIS Handbook for public comment and commissioned a peer review by the National Research Council.

Established in 1985 to ensure Agency-wide consistent toxicity evaluations, IRIS assessments provide chemical toxicity values for noncancer and cancer human health effects resulting from chronic exposure to chemicals. These values are often utilized in EPA regulations under the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). While chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA) require more information and analysis than that provided by an IRIS assessment, IRIS assessments will likely continue to be used to inform TSCA risk evaluations. State agencies and international bodies also rely on IRIS assessments.Continue Reading EPA Finalizes its Long-Awaited IRIS Handbook Updating a Number of Key Elements

On December 29, the chemicals program at EPA closed out 2021 by proposing revisions to its risk determinations for the Cyclic Aliphatic Bromide Cluster (HBCD), a solvent used as a flame retardant and wetting agent which has not been manufactured in the United States in nearly five years. In doing so, the Biden EPA made good on its June 2021 promise to revisit risk determinations previously made during the Trump Administration in accordance with the Toxic Substances Control Act (TSCA). The draft “revisions” represent a significant shift from EPA’s prior approach to existing chemical risk evaluation and foreshadow increased regulatory and litigation risk for all companies—not just those whose operations may have historically involved HBCD.
Continue Reading Why EPA’s Announcement about a Chemical No Longer Manufactured is Big News for your Business

In a dramatic announcement last week, EPA suggested that if companies import, manufacture, or process a finished good for commercial sale, and that product is not a pesticide, not a firearm, not a tobacco product, and not a food, food additive, drug, cosmetic, or device, they will need to know all chemicals contained in those products. We explain more about this below.

EPA has traditionally declined to extend most of its chemical regulations to finished goods, which are known as “articles” under the Toxic Substances Control Act (TSCA), on the grounds it would be enormously difficult for importers of complex consumer products to determine the chemical identity of each chemical substance in these products. Industry stakeholders have generally supported this approach and have long taken the position that supply chains are too complex to expect finished product manufacturers to be aware of all chemicals in those products.Continue Reading EPA May Require Companies To Know All The Chemicals In Products They Make Or Sell

On January 26, 2021, a coalition of advocacy groups and prominent asbestos plaintiffs’ experts launched two challenges to “Part 1” of the asbestos risk evaluation recently released by the United States Environmental Protection Agency (EPA).  EPA concluded in Part 1 that 16 of the 32 “conditions of use” analyzed pose an “unreasonable risk” to human health, but advocacy groups have criticized EPA for only addressing risks associated with chrysotile asbestos and excluding review of other fiber types.  Now, those groups have teamed up on a pair of legal challenges that could force EPA to revisit its Part 1 asbestos risk evaluation, which could delay risk management regulations.
Continue Reading Advocacy Groups and Plaintiffs’ Experts Launch Two Challenges to EPA’s Asbestos Risk Evaluation – Are EPA Settlements Possible?