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 April 6, 2023, President Biden issued Executive Order 14094, Modernizing Regulatory Review. This Executive Order (EO) makes several important changes to the Office of Management and Budget’s (OMB) regulatory review process for federal agency regulations. The EO significantly affects which regulations qualify for interagency review, modifies the OMB gatekeeping function by which meetings are granted on proposed rules, and requires the Office of Information and Regulatory Affairs’ (OIRA) to amend policies underlying how the federal government conducts cost-benefit analysis. In addition, OIRA has released a suite of new draft guidance documents that serve to implement the EO that, if finalized, will impact the review process for regulations. These guidance documents are open for comment as described below.
Continue Reading Biden Administration Changes White House Regulatory Review
President Biden issued his second veto late last week. The President’s second veto protects a U.S. EPA rule that went into effect on March 20, 2023. That rule redefines “waters of the United States” (WOTUS), and at a high conceptual level, returns the Agency’s interpretation of WOTUS to that of the Obama administration, an interpretation that was revoked and replaced by the Trump administration.
This matter has been hotly contested in the federal courts. Indeed, the U.S. Supreme Court is poised to issue a ruling within the next several weeks on Sackett v. EPA, a decision which could substantially revise and narrow the Agency’s definition of “waters of the United States.” The Court’s decision here could send the Biden administration’s revised definition of WOTUS back to EPA for changes needed in-line with the Court’s decision, if and when issued.
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
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
Yesterday, the US Environmental Protection Agency (EPA) and the US Army Corps of Engineers (Corps) (together, the Agencies) published a final rule revising the definition of “waters of the United States” (WOTUS) subject to federal regulation and permitting requirements under the Clean Water Act (CWA). This rule is the latest attempt by the Agencies to craft a durable rule defining WOTUS. The new rule, which largely mirrors the 2021 proposal, asserts a broader geographic scope of federal jurisdiction than the 2020 Navigable Waters Protection Rule (NWPR). In particular, the Agencies adopt the broadest possible interpretation of the Supreme Court’s decision in Rapanos (through incorporation of both the plurality’s “relatively permanent” test and Justice Kennedy’s “significant nexus” test). The final rule would, for the first time, codify aspects of the Agencies’ 2008 Rapanos Guidance and would rely on the significant nexus test’s case-by-case approach for evaluating jurisdiction for tributaries, wetlands, and other waters. The Agencies released the final rule while the Supreme Court considers the scope of CWA authority over a major category of WOTUS, “adjacent wetlands,” in Sackett v. EPA, and the Supreme Court could hand down a decision in the coming months that could require changes to the rule.