By Lynn L. Bergeson and Carla N. Hutton
 
On March 28, 2023, the House Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing on the fiscal year (FY) 2024 budget request for the U.S. Environmental Protection Agency (EPA). As reported in our March 22, 2023, blog item, EPA has posted the justification for its 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.

Our March 24, 2023, blog item provides details on resources requested for the Safer Choice, Environmentally Preferable Purchasing (EPP), and Green Chemistry Programs. As reported in our March 23, 2023, memorandum, the Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on EPA’s FY 2024 budget request.

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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
 
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) 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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By Lynn L. Bergeson and Carla N. Hutton
 
In February 2023, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), published a summary of learnings and potential recommendations on broadening public engagement in the federal regulatory process. The learnings and recommendations were developed from written submissions and a public engagement session in November 2022 with hundreds of participants. OIRA invites feedback on the recommendations as it continues to consider them, with these questions as a starting point:

• Which of the recommendations would most effectively broaden public engagement in the federal regulatory process, especially from members of underserved communities and those who do not typically participate in the regulatory process? Are there recommendations that are not helpful?
   
• Are there obstacles or barriers to greater public participation, especially for underserved communities, that are not addressed by these recommendations? If so, are there other recommendations that we should consider?
   
• Are there existing materials, such as guides or tools, that would be especially effective in revising and potentially implementing these recommendations? What new tools or guidance are needed?
   
• How can intermediaries -- such as trade associations or coalitions -- be helpful in reaching individuals and small organizations or businesses, where have they been successful in doing so, and where might they be insufficient?

Interested members of the public can submit their feedback to .(JavaScript must be enabled to view this email address) as written feedback or recorded audio and video submissions. OIRA will be actively reviewing any submissions received through 5:00 p.m. (EST) March 10, 2023. OIRA states that it is also planning an additional virtual listening session during which members of the public can provide their views on these recommendations, to be held 3:00 p.m. - 4:30 p.m. (EST) on Tuesday, March 7, 2023.

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By L. Claire Hansen, Legal Intern
 
On January 27, 2023, plaintiffs in the Southern District of New York announced their displeasure with the inconvenient fact that Tom’s Wicked Fresh! mouthwash contains measurable concentrations of PFAS. They channeled their displeasure by bringing a class action suit against Colgate-Palmolive Company and Tom’s of Maine, Inc. for fraud and unjust enrichment based on several state consumer protection laws, the federal Magnuson-Moss Warranty Act, and common law tort. Plaintiffs assert that “natural” Tom’s Wicked Fresh! mouthwash is anything but natural, in that it contains per- and polyfluoroalkyl substances or “PFAS,” a category of synthetic chemicals are not natural.
 
Plaintiffs claim that Tom’s Wicked Fresh! mouthwash is a much-touted “natural” product and that its marketers have unjustly financially gained through deceptive and fraudulent marketing practices by leading consumers to believe that their product is natural when it actually contains hazardous substances. PFAS are not included in the product’s list of nine ingredients. That an amazing range of incidental contaminants (which PFAS could well be considered) end up in food and drug products that the U.S. Food and Drug Administration (FDA) expressly excludes from ingredient disclosure, including whole insects, rodent hairs, insect fragments, and rodent dung, is apparently beside the point because, presumably, it is natural. The Center for Disease Control and Prevention (CDC) states that PFAS is dangerous because these substances do not break down and linger stubbornly in the environment, they can travel through soil and groundwater, and they build up (bioaccumulate) in fish, wildlife, and humans.
 
Plaintiffs went looking for PFAS when they sent a mouthwash sample out for independent testing. Given their ubiquity, PFAS unsurprisingly were detected. Perfluorooctanoic acid (PFOA), a particularly potent variant and standard bearer of the PFAS class of toxic substances, was detected. The U.S. Environmental Protection Agency’s (EPA) recommended lifetime health advisory level for PFOA is 0.004 parts per trillion; the tested sample revealed that “the Product contains PFOA in amounts more than 100 times the EPA’s recommended levels [emphasis in original].”
 
To establish fraud, plaintiffs must prove defendants intentionally added PFAS to its product or that the defendants knew PFAS were in their product and failed to take corrective measures to remove it. There are at least two possible PFAS contamination sources. The first is if Tom’s used a fluorinated container to transfer the mouthwash before it was bottled. PFAS is known to migrate from fluorinated containers because of the fluorination process. The second possibility is through secondary contamination from plant process water used to make the mouthwash. Additional testing is needed to identify the source. Arguably, in either case, Tom’s did not engage in fraudulent business practices. It may well not have known PFAS contaminated its product because either migration pathway is speculative or completely unexpected. Given their ubiquity, every geographic area of the world and most things in it are contaminated with PFAS, including everyone reading this blog.
 
Why does this matter? One very real outcome of the case, win or lose, is the end of “natural” product claims. Can beef be “natural” if the cow that it came from is PFAS-contaminated? What about that fresh, “natural” spring water we all love -- does it contain PFAS? Probably, but does that make it not “natural”? We will leave for another blog whether a win for the plaintiffs punishes wrongly businesses that are victims of PFAS manufacturers and others whose PFAS products are now the source of seemingly endless contamination, litigation, and regulation.
 
Alternatively, if defendants reasonably believed, or should have known, that there were detectable PFAS in their supply chains and failed to act to remove them, then the claims may stick. Fluorinated containers are associated with PFAS contamination. If the defendants use such container technology, query whether they exercised due care in failing to use other technologies. If the contamination was from plant process water, they could and perhaps should have tested the intake water and filtered the PFAS out to ensure product purity.
 
A jury will decide. Even before it does, though, “natural” product claims may be a thing of the past. Businesses can be expected to be understandably nervous about passing the PFAS purity test.

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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our October 19, 2021, memorandum, the U.S. Environmental Protection Agency (EPA) published the PFAS Strategic Roadmap in October 2021, “laying out a whole-of-agency approach” to addressing per- and polyfluoroalkyl substances (PFAS). As part of the Roadmap, EPA committed to engage with communities in each EPA region to understand better their experiences and challenges in addressing PFAS contamination. To help inform EPA’s ongoing work under the Roadmap, EPA plans to facilitate a series of virtual community engagement sessions in 2023 for each of EPA’s ten regions. EPA states that it also plans to hold a session specifically designed to hear from its Tribal partners. The engagement sessions will provide opportunities for communities to share feedback directly with EPA regional and PFAS Council leaders to inform the implementation of the actions described in the Roadmap. Registration is now open for the following regional PFAS Community Engagement Sessions:

• February 28, 2023, at 6:00-8:00 p.m. (CST): Region 7 (Iowa, Kansas, Missouri, Nebraska, and nine Tribal Nations);
   
• March 2, 2023, at 6:00–8:00 p.m. (EST): Region 3 (Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia, and seven federally recognized Tribes); and
   
• March 8, 2023, at 6:00–8:00 p.m. (MST): Region 8 (Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming, and 28 Tribal Nations).

Registration for other regions will open soon. Stakeholders can sign up to be notified when registration for other regions is available. 

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By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2023, the U.S. Environmental Protection Agency (EPA) requested nominations for technical experts to serve as Special Government Employees (SGE) on a review panel under the authority of the Board of Scientific Counselors (BOSC), a federal advisory committee to the Office of Research and Development (ORD). 88 Fed. Reg. 9880. EPA states that selected experts will review ORD’s draft documents detailing scientific studies supporting the development of transcriptomic-based toxicity values and their implementation as a new EPA Transcriptomic Assessment Product (ETAP). According to EPA, the ETAP is a proposed ORD assessment product that uses a standardized short-term in vivo study design and data analysis procedures to develop transcriptomic-based toxicity values for data-poor chemicals. Draft documents will be provided in the BOSC docket prior to the meeting for an in-depth evaluation of:

• Literature review and scientific studies supporting the development of transcriptomic points of departure from short-term in vivo studies;
• Derivation of transcriptomic toxicity values for chronic toxicity;
• Incorporation of transcriptomic toxicity values into a new standardized assessment product that is intended for data-poor chemicals; and
• Example application of the ETAP to a data-poor per- and polyfluoroalkyl substance (PFAS).

According to EPA, the review of the draft documents detailing underlying scientific studies and implementation of ETAP by the BOSC is being performed in close coordination with a separate BOSC review of a value-of-information (VOI) analysis comparing the ETAP with traditional human health assessment practices. EPA states that the VOI analysis is intended to evaluate the public health and economic trade-offs associated with the timeliness, uncertainty, and costs of the different toxicity evaluation and assessment approaches.

The review will take place between April and July 2023. Nominations are due March 3, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023.
 
EPA states that the TSCA Inventory contains 86,685 chemicals, of which 42,170 are active in U.S. commerce. Other updates to the Inventory include new commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules and test orders). EPA notes that additionally, several hundred substances are now listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of EPA’s TSCA confidential business information (CBI) review efforts.
 
Lastly, EPA reminds TSCA submitters to check regularly for any correspondence relating to their submissions in EPA’s Central Data Exchange (CDX). EPA states that it sends “critical and time-sensitive information regarding confidentiality claims through CDX, and failing to open this correspondence can delay the Agency’s processing of those claims.”

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