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
On March 29, 2023, the US Environmental Protection Agency (EPA) published in the Federal Register its long-awaited proposed rule to restrict certain per- and polyfluoroalkyl substances (PFAS) in drinking water under the Safe Drinking Water Act (SDWA). This action is part of EPA’s whole-of-agency approach in its PFAS Strategic Roadmap and is expected to directly affect 66,000 public water systems across the country. Comments on the proposal are due on May 30, 2023. EPA will also hold a public hearing on May 4, 2023 to receive stakeholder input on this important rulemaking.
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 February 2023, the US Environmental Protection Agency (EPA)’s Office of Enforcement and Compliance Assurance (OECA) quietly released a Compliance Advisory “What You Need to Know about Producing, Distributing, or Selling Pesticide Devices.” The advisory follows on the heels of similar advisories and provides information to the regulated community about requirements for pesticide devices under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in order to promote compliance. EPA issued this advisory in response to a “significant increase” in the number of pesticide devices being sold or distributed in the US in which EPA has found “substantial non-compliance” with FIFRA requirements. EPA has also experienced a high volume of inquiries from companies and other regulators seeking clarification about pesticide device requirements. The advisory suggests that EPA remains poised to continue taking enforcement actions against companies that import, distribute or sell pesticide devices that do not comply with FIFRA’s requirements.
The Maine Department of Environmental Protection (DEP) recently released a long anticipated proposed rule that would implement the procedures for Maine’s 2021 law[1] requiring manufacturers to submit notifications to DEP for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS) sold in the state. Stakeholders will have until May 19, 2023, to provide comments on the proposal.
While Maine’s notification requirements went into effect on January 1, 2023, the proposed rule provides critical details on the applicability and procedures for notifications. Many manufacturers who received extensions from the January 1, 2023 notification deadline will be interested in reviewing the details of this proposal. The proposed rule provides important clarifications about the notification requirements, including:
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:
Per- and polyfluoroalkyl substances (PFAS) have taken center stage. The Biden administration’s regulatory agenda plans numerous revisions to environmental regulations to address this broad class of pervasive substances. While the US Environmental Protection Agency grapples with implementing these initiatives, states are aggressively forging ahead with their own plans. Laws targeting PFAS in various products have taken effect and will continue to take effect in many states, representing a striking expansion from typical state regulations addressing environmental PFAS contamination from firefighting foam and other sources.
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 6 September, the US EPA released its proposed rule to add perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund.
If finalized, these hazardous substance designations could have a significant impact on many industries, from creating
On August 26, 2022, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated proposed rule adding perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). EPA asserts that this regulatory escalation of PFOA and PFOS will facilitate faster cleanup of contaminated sites and reduce exposures to these “forever chemicals.” If finalized, these hazardous substances designations will have significant and immediate impacts on many industries, from creating new reporting obligations to increased compliance, enforcement, and litigation risks related to site cleanup. EPA’s efforts involving PFOA and PFOS fall within the broader, whole-of-agency approach to addressing PFAS first announced in its PFAS Strategic Roadmap and represent its first ever exercise of its authority under CERCLA section 102(a) to designate a hazardous substance.