By Lynn L. Bergeson and Carla N. Hutton
 
On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
 
When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), EPA states that it is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. EPA notes that under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA proposes to amend the procedural regulations at 40 C.F.R. Parts 720, 721, and 725 to align with the requirements in TSCA Section 5, as amended by the Lautenberg Act, and to make additional updates. In particular, EPA proposes to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA proposes to clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN, or exemption notice for the notice to be considered complete. EPA also proposes amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period. Additionally, EPA is proposing to make several amendments to the regulations at 40 C.F.R. Section 723.50 for LVEs and LoREXs. According to EPA, these amendments would require EPA approval of an exemption notice before the submitter may commence manufacture, allow EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) and the chemical identity is confidential, make PFAS categorically ineligible for these exemptions, and codify EPA’s use of the 1999 PBT policy for these exemptions by making certain PBTs ineligible for these exemptions. Finally, EPA proposes to amend the regulations pertaining to suspensions for all TSCA Section 5 notices to allow submitters to request suspensions for up to 30 days via oral or e-mail request.

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Bergeson & Campbell, P.C.’s (B&C^®) May 17, 2023, webinar, “TOP TSCA TOPICS: PFAS, Cumulative Risk, NAMs, Risk Evaluations, CBI, and More,” is now available for on-demand viewing. During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing EPA decisions under TSCA Sections 5 and 6. Other consequential rulemakings involving per- and polyfluoroalkyl substances (PFAS) reporting and confidential business information (CBI) protections are equally significant, and all are likely to inspire significant disruption in the regulated community.
Watch the webinar now.

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By Lynn L. Bergeson and Carla N. Hutton
 
On April 20, 2023, the U.S. Government Accountability Office (GAO) issued its updated High Risk List, which highlights 37 areas across the federal government that are vulnerable to waste, fraud, abuse, and mismanagement, or that need broad reform. The High Risk List includes “Transforming EPA’s Process for Assessing and Controlling Toxic Chemicals.” GAO states that the U.S. Environmental Protection Agency’s (EPA) ability to implement its mission of protecting public health and the environment effectively depends on its assessing the risks posed by chemicals in commerce and those that have yet to enter commerce in a credible and timely manner. EPA supports the evaluation of such risks through its Integrated Risk Information System (IRIS) and by implementing the Toxic Substances Control Act (TSCA). According to GAO, because EPA had not developed sufficient chemical assessment and risk information under these programs to limit exposure to many chemicals that may pose substantial health risks, GAO added this issue to the High-Risk List in 2009. GAO reports that overall ratings for four criteria -- leadership commitment, capacity, action plan, and demonstrated progress -- remain unchanged since 2021. The overall rating for monitoring increased to partially met. For IRIS, leadership commitment, monitoring, and demonstrated progress increased to partially met. For TSCA, leadership commitment increased to met, and action plan and monitoring increased to partially met. GAO notes that as of February 2023, five recommendations related to the management of toxic chemicals remain open, such as:

• Periodically assessing the demand for chemical assessments and the resources needed to produce IRIS assessments; and
• Developing a process and timeline to ensure EPA’s workforce planning efforts fully align with relevant planning principles and incorporating the results, as appropriate, into EPA’s annual plan for chemical risk evaluations under TSCA. According to GAO, this will help ensure EPA can effectively implement its TSCA review responsibilities. In February 2023, GAO reported that strategic workforce planning is essential in helping agencies align their workforces with their current and emerging missions and that it also helps them develop long-term strategies for recruiting, developing, and retaining staff. More information on GAO’s February 2023 report is available in our February 24, 2023, memorandum.

GAO states that continued congressional oversight of EPA’s workforce planning efforts is needed to help ensure EPA identifies the resources it needs to assess and control toxic chemicals. According to GAO, this area has realized more than ten benefits since it was added to the High-Risk List in 2009, including:

• The IRIS Program increased its coordination with other EPA offices and external federal entities. This will help ensure the offices avoid duplicative work on chemical assessments, can assist each other with obtaining chemical data, and use many of the same chemical evaluation tools and techniques for greater consistency in final products; and
• The Office of Pollution Prevention and Toxics (OPPT) completed a skills gap assessment in March 2021 that included hiring targets and anticipated attrition counts for various years. This helped EPA better understand its future workforce needs for implementing TSCA and informed its budget request for fiscal year 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). As reported in our March 1, 2023, memorandum, earlier this year, EPA released for public comment and peer review a set of principles for evaluating cumulative risks under TSCA and an approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals undergoing TSCA Section 6 risk evaluation.

• Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act: The document discusses what cumulative risk assessment is and how it could be used in the scientific and regulatory context of TSCA. EPA notes that a cumulative risk assessment “will not always be the best approach, or possible to complete in the statutory timeframes provided for TSCA risk evaluations. But when chemicals are sufficiently similar toxicologically and are found to present co-exposures -- meaning people are . . .  exposed to multiple chemicals at the same time -- a cumulative risk assessment may be appropriate.”
   
• Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested Phthalate under the Toxic Substance Control Act: The document describes a proposed methodology for evaluating cumulative risk for the phthalate chemicals currently under review. EPA proposes in its approach submitted for public comment and peer review that di-ethylhexyl phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), di-isobutyl phthalate (DIBP), dicyclohexyl phthalate (DCHP), and di-isononyl phthalate (DINP) (but not di-isodecyl phthalate (DIDP)) are toxicologically similar (and pose an additive hazard) and that the U.S. population is co-exposed to these phthalates. Therefore, EPA proposes to group these phthalates for cumulative risk assessment under TSCA as described in the “Draft Proposed Approach” document. EPA notes that this proposed approach “is not itself a cumulative risk assessment nor does it make a finding of risk, but rather is a methodology that EPA proposes to use and seeks public input about and peer review on.”

Registration for the virtual preparatory meeting is open. To participate as a listen-only attendee, registration will be open up to the end of the meeting. Requests to make brief (up to five minutes) oral comments to the SACC during the preparatory meeting can be submitted when registering and will be accepted until April 21, 2023.
 
The two draft documents, draft charge questions, and other supporting materials are available online in docket EPA-HQ-OPPT-2022-0918. Written comments are due April 28, 2023, for distribution to SACC before the meeting.

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 23, 2023, that it is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the “2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.” 88 Fed. Reg. 17566. EPA states that it will release the draft supplement for public review and comment in June 2023. EPA also plans to submit the draft supplement to the SACC for peer review and is scheduling a four-day virtual public meeting for the SACC to consider and review the draft supplement in September 2023. Nominations are due April 24, 2023.
 
According to EPA, the focus of the four-day virtual public meeting is the SACC peer review of the methodologies that have not been previously peer reviewed and are used in the 2023 1,4-dioxane supplemental risk evaluation. EPA will consider feedback from this review in the development of the final supplement to the 1,4-dioxane risk evaluation. EPA notes that in addition, SACC reviewer feedback may help refine EPA’s methods for conducting release assessments and evaluating general population exposures in risk evaluations of other chemicals under the Toxic Substances Control Act (TSCA).
 
EPA intends to publish a separate document in the Federal Register to announce the availability of and solicit public comment on the draft supplement, at which time EPA will provide instructions for submitting written comments and registering to provide oral comments at the peer review meeting planned for September 2023. EPA also intends to provide a meeting agenda for each day of the meeting, and as needed, may provide updated times for each day in the meeting agenda that will be posted in the docket and on the SACC website.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). It provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, pollution prevention measures, and approaches for chemicals regulated under TSCA.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s FY 2024 budget includes $470.7 million and 1,677 full-time equivalents (FTE) for Objective 7.1, “Ensure Chemical and Pesticide Safety.” The CJ includes the following target dates for actions under the Toxic Substances Control Act (TSCA):

• By September 30, 2026, complete at least eight high-priority substance TSCA risk evaluations annually within statutory timelines compared to the FY 2020 baseline of one;
• By September 30, 2026, initiate all TSCA risk management actions within 45 days of the completion of a final existing chemical risk evaluation; and
• By September 30, 2026, review 90 percent of risk management actions for past TSCA new chemical substances reported to the 2020 Chemical Data Reporting Rule (CDR) compared to the FY 2021 baseline of none.

The CJ provides a summary of activities for the Chemical Risk Review and Reduction (CRRR) Program. According to the CJ, in FY 2024, EPA will emphasize the integrity of scientific products, adherence to statutory intent and requirements, and timelines applicable to pre-market review of new chemicals, chemical risk evaluation and management, data development and information collection, the review of confidential business information (CBI) claims, and other statutory requirements. The CJ states that the resources requested are essential for EPA to address its workload, including:

• Maintaining at least 20 EPA-initiated existing chemical risk evaluations in development at all times and completing EPA-initiated existing chemical risk evaluations within the statutory timeframe;
• Having up to five existing chemical risk evaluations requested by manufacturers in development;
• Issuing protective regulations in accordance with statutory timelines addressing all unreasonable risks identified in each risk evaluation;
• Establishing a pipeline of chemicals to be prioritized for future risk evaluation;
• Using test orders and a new strategy for tiered data collection, requiring development of data critical to existing chemical risk evaluation and risk management activities, and systematically collecting, reviewing, and synthesizing data for risk assessments in a transparent manner as mandated by the 2016 TSCA amendments;
• Conducting risk assessments for approximately 550 new chemical notices and exemption submissions and managing the identified risks associated with the chemicals;
• Continuing to implement a collaborative research program focused on developing new scientific approaches for performing risk assessments on new chemical substances;
• Reviewing and making determinations on CBI claims contained in TSCA submissions; making certain non-CBI available to stakeholders; and publishing identifiers for each chemical substance for which a confidentiality claim for specific chemical identity is approved; and
• Carrying out other required TSCA CRRR activities.

The Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on EPA’s proposed FY 2024 budget. A summary of the hearing will be available in our forthcoming memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has opened registration for the second of its two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). The webinar, which will be held March 30, 2023, will give an in-depth look into the standardized risk assessment approach and present various case scenarios and a decision tree for identifying potential hazards and risks. The kickoff webinar, held in November 2022, provided a broad overview of the approach and answered stakeholder questions. A summary of the first webinar is available in our November 23, 2022, memorandum.
 
Under the Toxic Substances Control Act (TSCA), EPA reviews all new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to human health or the environment. As reported in our October 11, 2022, memorandum, EPA announced an innovative effort to help make its review of new MMOs, including new and modified CAMs, more efficient. According to EPA, MMOs have many electrical applications in batteries and uses as catalysts, adsorbents, and in ceramics. Notably, MMOs, including CAMs, are a key component in lithium-ion batteries used in electric vehicles, making them a vital part of clean energy sectors.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 13, 2023, that it will accept public comments on candidates under consideration for selection as ad hoc reviewers to assist the Science Advisory Committee on Chemicals (SACC) with peer review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). Biographies of these candidates are available on regulations.gov. If selected, candidates will serve as peer reviewers for two documents, which will be reviewed by the SACC at a public virtual meeting May 8-11, 2023. Comments on the candidates are due February 25, 2023.
 
EPA states that it plans to release the following documents for public comment in late February 2023:

• Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act: According to EPA, this document will describe the fundamental principles of cumulative risk assessment of chemicals and how they may be applied within the regulatory requirements of TSCA to ensure TSCA risk evaluations are based on the best available science and are protective of human health; and
   
• Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate under the Toxic Substances Control Act: EPA states that this document will describe its proposed approach for evaluating a subset of high-priority and manufacturer-requested phthalates for cumulative risk to human health under TSCA based on the principles of cumulative risk assessment described in EPA’s draft principles document referenced above.

The SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). It provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, pollution prevention measures, and approaches for chemicals regulated under TSCA.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 21, 2022, that it seeks public nominations of scientific and technical experts whom EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of two draft documents entitled “Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act” and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer Requested Phthalate Under the Toxic Substance Control Act.” 87 Fed. Reg. 78103. EPA states that it will submit the two draft documents to SACC and release them for public review and comment in late February 2023. EPA will solicit comments from SACC on issues related to chemical grouping for purposes of cumulative risk assessment (CRA), health outcomes related to phthalate syndrome, and possible approaches to developing the cumulative hazard and exposure assessment for high-priority phthalates and a manufacturer-requested phthalate. EPA also announced the scheduling of a four-day virtual public meeting for SACC to consider and review the two draft documents. EPA provides the following chronological listing of the dates for the specific activities:

• January 20, 2023 -- Deadline for submitting all nominations to EPA;
   
• April 24, 2023 -- Deadline for submitting a request for special accommodations to allow EPA time to process the request before the meeting; and
   
• May 8 to 11, 2023, from 10:00 a.m. to approximately 5:30 p.m. (EDT) -- The public virtual meeting will be held via a webcast platform such as “Zoom.gov” and audio teleconference, and you must register to receive the links.

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