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 Internal Revenue Service (IRS) announced on March 16, 2023, that it received a petition requesting that cellulose acetate (degree of substitution (DS) = 1.5-2.0) be added to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. 88 Fed. Reg. 16307. The petitioner is Celanese Ltd., an exporter of cellulose acetate (DS = 1.5-2.0). According to the notice, cellulose acetate (DS = 1.5-2.0) “is made from cellulose (wood pulp) and methane. The production process is a reaction of cellulose (from wood pulp) with acetic anhydride, normally using a solvent such as acetic acid and a strong acid such as sulfuric acid as a catalyst.” The petition covers cellulose acetate (DS = 1.5-2.0), “commonly referred to as cellulose diacetate. Cellulose acetate in this range generally has similar properties. The petition uses the lowest end of the range cellulose acetate DS = 1.5 to demonstrate that >20% of the substance is made from taxable chemicals, and the midpoint cellulose acetate DS = 1.75 to calculate the tax rate for the entire range.” Comments and requests for a public hearing are due May 15, 2023. More information on the Superfund excise tax on chemicals is available in our July 13, 2022, memorandum, “Superfund Tax on Chemicals: What You Need to Know to Comply,” and our May 19, 2022, memorandum, “Reinstated Superfund Excise Tax Imposed on Certain Chemical Substances.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The Senate Committee on Environment and Public Works will hold a hearing on March 22, 2023, on the proposed fiscal year (FY) 2024 budget for the U.S. Environmental Protection Agency (EPA). The only listed witness is EPA Administrator Michael Regan. As reported in our March 14, 2023, blog item, the budget requests over $12 billion in discretionary budget authority for EPA, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:

• Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement the Toxic Substances Control Act (TSCA). Under TSCA, EPA has a responsibility to ensure the safety of chemicals in or entering commerce. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] to ensure pesticides pose no unreasonable risks to human health and the environment.”
   
• Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.

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By Lynn L. Bergeson and Carla N. Hutton
 
The National Science and Technology Council announced on March 14, 2023, that the White House Office of Science and Technology Policy (OSTP) released a state of science report on per- and polyfluoroalkyl substances (PFAS). The report was prepared by the interagency PFAS Strategy Team created by OSTP at the direction of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021. It provides an analysis of the state of the science of PFAS and information that will be used to direct the development of a federal strategic plan. The report focuses on the current science of PFAS as a chemical class, identifies scientific consensus, and portrays uncertainties in the scientific information where consensus is still sought. The report identifies four key strategic areas that, when addressed, will generate actionable information to address PFAS:

• Removal, destruction, or degradation of PFAS: This section details technologies used for removal, safe destruction, and degradation of PFAS in various environmental media (e.g., air, water), including benefits and limitations of existing technologies;
   
• Safer and environmentally friendlier alternatives: This section highlights ongoing activities around the development of safer and more environmentally friendly alternatives that are functionally similar to those made with PFAS. Specific challenges highlighted include firefighting foams, industrial uses, food packaging and contact materials, pesticides, textiles, recreation products, cosmetics and personal care products, pharmaceuticals, and medical devices. An important consideration to advancing this area of research and development is identifying critical uses of PFAS;
   
• Sources and pathways of exposure: PFAS sources, releases, fate and transport considerations, and potential pathways of exposure, such as exposure media and routes, are detailed. Mitigation efforts and health-protective measures cannot be implemented without the ability to detect PFAS at levels of concern. Addressing the challenge of developing additional analytical methods with higher sensitivity to detect both single PFAS and mixtures of PFAS is a critical opportunity to accelerate advancement across all other areas; and
   
• Toxicity: PFAS toxicity information is informed by laboratory animal data, ecological data, human health data, and predictive modeling information. To leverage fully the understanding of PFAS toxicity, a weight-of-evidence approach that takes into account the different evidence streams is needed. Because of the large number of PFAS currently identified in commerce, one goal of future research is to determine whether all PFAS, or specific groups, might pose a similar hazard to human and ecological receptors. The report notes that such PFAS groupings may provide a means by which agencies might regulate PFAS for the protection of humans and ecological receptors.

The report identifies data gaps within each strategic area to provide a roadmap for research and development (R&D) activities that, when addressed, will generate actionable information to guide federal agencies and PFAS collaborators and partners. Over the next year, the PFAS Strategy Team will operationalize a strategic plan and implementation framework that organizes and coordinates activities in these strategic areas by harnessing existing research and accelerating transformative advancements. The report states that information generated will inform PFAS advisories, disposal approaches, and development of PFAS alternatives, and fuel other innovative public health actions.

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 By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of $16 million for two new grant opportunities to support states and Tribes in providing technical assistance to businesses seeking to develop and adopt pollution prevention (P2) practices that advance environmental justice in underserved communities. The Request for Applications for P2 investments include the Pollution Prevention Grant: Environmental Justice Through Safer and More Sustainable Products. The goal of this grant is to address environmental justice by providing P2 technical assistance to businesses (e.g., information, training, expert advice) to improve human health and the environment in disadvantaged communities by increasing the supply, demand, and use of safer and more sustainable products, such as those that are certified by EPA’s Safer Choice Program, or those that conform to EPA’s Recommendations for Specifications, Standards and Ecolabels for Federal Purchasing (EPA Recommendations).
 
To allow a greater number of disadvantaged communities to benefit from the results and lessons learned from projects funded by these grants, EPA states that it is requiring recipients to develop P2 case studies on approaches to make safer and sustainable products more available in disadvantaged communities where the approaches are new, not widely known or adopted, or where the recipient believes detailed information on the project could support more widespread project replication. Recipients must develop at least one case study during the grant period. According to EPA, it will use these case studies to build and share a body of knowledge about P2 approaches to make safer and sustainable products more available in disadvantaged communities that could be implemented by other enterprises.
 
Eligible entities include the 50 states, the District of Columbia, the U.S. Virgin Islands, the Commonwealth of Puerto Rico, any territory or possession of the United States, any agency or instrumentality of a state or Tribe, including colleges and universities, and federally recognized Tribes and intertribal consortia. EPA “strongly” encourages applicants to develop partnerships where they can strengthen their ability to provide P2 technical assistance to businesses in disadvantaged communities.
 
EPA will hold informational webinars on March 21, March 23, March 28, and March 30, 2023. Although EPA’s press release states that applications for the grant are due June 6, 2023, the information on grants.gov states that the closing date for applications is June 20, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 9, 2023, President Biden released his fiscal year (FY) 2024 budget. According to the U.S. Environmental Protection Agency’s (EPA) March 9, 2023, press release, the budget requests over $12 billion in discretionary budget authority for EPA in FY 2024, a $1.9 billion or 19 percent increase from the FY 2023 enacted level. Highlights of the FY 2024 budget include:

• Ensuring Safety of Chemicals for People and the Environment: The budget provides an investment of $130 million, $49 million more than the 2023 enacted level, to build core capacity to implement the Toxic Substances Control Act (TSCA). Under TSCA, EPA has a responsibility to ensure the safety of chemicals in or entering commerce. According to EPA, in FY 2024, it “will focus on evaluating, assessing, and managing risks from exposure to new and existing industrial chemicals to advance human health protection in our communities.” EPA states that “[a]nother priority is to implement [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)] to ensure pesticides pose no unreasonable risks to human health and the environment.”
   
• Tackling Per- and Polyfluoroalkyl Substances (PFAS) Pollution: The budget provides approximately $170 million to combat PFAS pollution. This request allows EPA to continue working toward commitments made under EPA’s 2021 PFAS Strategic Roadmap, including: increasing its knowledge of PFAS impacts on human health and ecological effects; restricting use to prevent PFAS from entering the air, land, and water; and remediating PFAS that have been released into the environment.

EPA states that it will release the full Congressional Justification and Budget in Brief materials “soon.”

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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) Office of Inspector General (OIG) announced on March 7, 2023, that EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 perfluorobutane sulfonic acid (PFBS) toxicity assessment. OIG conducted its evaluation to determine whether EPA followed applicable policies and procedures to develop and publish the PFBS toxicity assessment. OIG notes that two weeks after publication, EPA removed the toxicity assessment from its website, citing political interference and Scientific Integrity Policy violations. EPA republished the toxicity assessment in April 2021.
 
According to OIG, EPA did not follow the typical intra-agency review and clearance process during the development and publication of the January 2021 toxicity assessment. OIG states that during final clearance, “a political appointee directed that a last-minute review be conducted of the uncertainty factors used to calculate toxicity values, resulting in a scientific disagreement that caused delay, confusion, and significant changes to the near-final, peer-reviewed work product.” The changes included replacing single toxicity values with “unprecedented toxicity ranges.” Users of the toxicity assessment, including regulated entities cleaning up PFBS contamination, “could have selected a less stringent value within this range, which may have been less costly but also less protective of human health.” While EPA staff expressed scientific integrity concerns about the last-minute review and risks to public health, EPA lacked policies and procedures to address these concerns. According to OIG, without updates to policies and procedures, EPA cannot fulfill its commitment to scientific integrity and information quality.
 
OIG made five recommendations:

• Three to the Assistant Administrator for Research and Development to reduce procedural confusion and strengthen existing policies, procedures, and guidance by clarifying if and when comments expressing scientific disagreement can be expressed; making clear if and when toxicity ranges are acceptable; and using OIG as a resource for high-profile scientific integrity concerns that relate to political interference or that assert risk to human health or the environment;
• One to the Assistant Administrator for Mission Support to update policies and procedures on environmental information quality to require additional quality assurance reviews for EPA products; and
• One to the Deputy Administrator to strengthen EPA’s culture of scientific integrity, transparency, and accountability of political leadership actions when changes occur as a result of policy decisions.

OIG notes that “EPA disagreed with all five recommendations, which remain unresolved.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On March 8, 2023, the U.S. Environmental Protection Agency opened a 30-day comment period on nominations for candidates to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). According to EPA, there are currently 17 SACC members, with eight membership terms that will soon expire. Biographies for all candidates under consideration are available online. In addition, biographies for current SACC members are available on the SACC website. Comments on the nominations are due April 7, 2023. EPA states that it will use comments received to assist it in selecting new members of the SACC by June 2023.
 
SACC serves as a scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). SACC provides independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.

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