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, work in the Pollution Prevention (P2) Program supports Objective 7.2: Promote Pollution Prevention (P2) under Goal 7: Ensure Safety of Chemicals for People and the Environment. The FY 2024 budget includes $29 million and 69.2 full-time equivalents (FTE) to support the P2 Program in the Environmental Program and Management (EPM) appropriation, an increase of $16 million and 18 FTEs above the FY 2023 enacted budget. The CJ states that FY 2024 funding will continue to support the following P2 programs.
 
Safer Choice Program
 
The CJ states that Safer Choice is a voluntary program that certifies safer products so consumers, businesses, and purchasers can find products that work well and contain ingredients safer for human health and the environment. EPA certifies and allows use of the Safer Choice label on products containing ingredients that meet stringent health and environmental criteria. Under the same stringent criteria, EPA certifies disinfectant products registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) using the Design for the Environment logo. According to the CJ, the Safer Choice Program will expand into additional product categories and seek to increase consumer and commercial recognition of Safer Choice products. In FY 2024, EPA will continue its Partner of the Year Awards Program, recognizing organizations and companies for their leadership in formulating products made with safer ingredients and making them available to communities.
 
The CJ states that in FY 2024, Safer Choice will integrate and address environmental justice (EJ) concerns through outreach and partnership activities. Efforts to make Safer Choice-certified products more accessible to communities with EJ concerns will expand, with particular focus on low-income, Tribal, and indigenous populations and other vulnerable populations such as the elderly, children, and those with pre-existing medical conditions. According to the CJ, Safer Choice will work with retailers and product manufacturers to help them develop more products containing safer chemical ingredients that are easy to identify and purchase. Safer Choice will also work to empower custodial staff and house cleaning companies and enable facilities through education to gain access to Safer Choice-certified products to improve indoor air quality and reduce exposure-related asthma.
 
Environmentally Preferable Purchasing (EPP) Program
 
The EPP Program implements direction provided to EPA in several statutes and Executive Orders that mandate sustainable federal procurement, including through development and use of sustainability standards, specifications, and ecolabels. Beginning in FY 2023, the EPP Program is expanding the EPA Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing in new categories to support the Biden Administration’s environmental and human health goals and mandates, including net-zero emissions procurement, low embodied carbon construction materials, and products that do not contain per- and polyfluoroalkyl substances (PFAS). According to the CJ, the EPP Program has received applications for over 70 standards/ecolabels from 29 organizations to be considered for assessment and recommendation in federal purchasing. These cover the following high-impact federal procurement sectors: food and cafeteria services; uniforms/clothing; professional services; laboratories and healthcare; building/construction; infrastructure; and landscaping.
 
The CJ notes that EPA is characterizing PFAS provisions of existing private-sector sustainability standards, ecolabels, and certifications to identify products and purchase categories associated with key PFAS use and to prioritize PFAS conditions of use. In FY 2024, EPA will enhance public protection from potential effects of PFAS through recommendations of additional standards/ecolabels to help purchasers identify products that meet specific environmental performance criteria. EPA will conduct the following activities:

• Assess and recommend additional ecolabels and standards with criteria specifically supporting reduction or elimination of PFAS use in key product categories not yet covered by the EPA Recommendations for Standards, Specifications, and Ecolabels for Federal Purchasing.
• Build, implement, maintain, and update tools for integrating EPA recommendations into federal e-procurement systems, initiate identification and monitoring of relevant government contracts for sustainable purchasing requirements, and develop tools to ensure that PFAS data are captured for compliance in the Federal Procurement Data System (FPDS).
• Initiate and engage in private-sector standards development activities that address product categories known to contain PFAS.
• Work with the General Services Administration (GSA) and others to create a central product registry to identify products that meet EPA’s assessment of PFAS specifications.
• Collaborate with the Department of Defense (DOD) on performance-based, rather than material-based, specifications and standards for equipment (e.g., textiles, coatings, firefighting foam) for DOD and Department of Homeland Security (DHS) uses.
• Work with other federal agencies and the private sector to initiate a performance-based technology innovation challenge for a set of PFAS-free product categories for which use of non-PFAS options could be technically and economically feasible with respect to key federal purchasing categories.

According to the CJ, to support further EPA’s goals for equity and EJ, the EPP Program will begin to develop and implement training and outreach for disadvantaged communities, as well as state, Tribal, and local governments, to assist in facilitating product and service procurement choices that are environmentally sound and promote human and environmental health.
 
Green Chemistry Program
 
According to the CJ, the Green Chemistry Program fosters the sustainable design of chemical products and processes. It also analyzes green chemistry innovations and works with partners and external stakeholders to facilitate market adoption and penetration of new commercially successful chemistries and technologies. The CJ states that the program’s Green Chemistry Challenge Awards serve a critical role in raising the profile, importance, and credibility of innovative and market-ready green and sustainable chemistry technologies. In FY 2024, the Green Chemistry Program will begin to work with awardees and nominees to pursue the goal of market-oriented environmental and economic progress through increased adoption of these innovations. The CJ notes that EPA will support and lead portions of EPA’s responsibilities for implementation of the Sustainable Chemistry Research and Development Act of 2020. More information on the Sustainable Chemistry Research and Development Act of 2020 is available in our January 19, 2021, memorandum.

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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 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) announced on March 2, 2023, that the Office of Enforcement and Compliance Assurance (OECA) will hold two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). According to EPA, it will review and consider the input received in drafting a “CERCLA per- and polyfluoroalkyl substances (PFAS) enforcement discretion and settlement policy to the extent that PFAS cleanup enforcement efforts occur under CERCLA.” EPA states that there will be opportunities to provide verbal input during the public listening sessions and written input submissions in a separate form.
 
The listening sessions will focus on an enforcement policy related to responsible parties’ financial obligations under PFAS contamination response actions. EPA notes that the sessions “will not focus on the actions needed to address PFAS contamination or EPA’s progress in the Agency’s PFAS Strategic Roadmap commitments.”
 
The sessions will be held:

• Tuesday, March 14, 2023, from 1:00 p.m. to 3:00 p.m. (EDT); and
• Thursday, March 23, 2023, from 10:00 a.m. to noon (EDT).

EPA states that its CERCLA PFAS enforcement discretion and settlement policy “is aimed at addressing stakeholder concerns and reducing uncertainties by clarifying when EPA intends to use its CERCLA enforcement authorities or its CERCLA enforcement discretion.” To the extent that PFAS cleanup enforcement efforts occur under CERCLA, EPA will develop a CERCLA PFAS enforcement discretion and settlement policy. According to EPA, the policy will take into account various factors, such as EPA’s intention to focus enforcement efforts on PFAS manufacturers and other industries whose actions result in the release of significant amounts of PFAS into the environment, and EPA’s intention not to focus on pursuing entities where factors do not support taking an enforcement action.
 
Registration is required to attend a listening session. The registration form provides the option for participants to make live verbal remarks or to listen. Information on the opportunity to speak at the session is provided on the registration form. Written comments related to the listening sessions are due March 31, 2023.
 
EPA notes that these listening sessions are separate from its perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) hazardous substance designation rulemaking process. The input provided through the listening sessions is not part of the rulemaking comment docket. The hazardous substance designation rulemaking comment period has closed.

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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 January 12, 2023, that it is updating the Safer Chemical Ingredients List (SCIL), “a living list of chemicals organized by functional-use class that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.” EPA is adding nine chemicals to the SCIL. EPA states that to expand the number of chemicals and functional-use categories on the SCIL, it encourages manufacturers to submit their safer chemicals for review and listing on the SCIL. In support of the Biden Administration’s goals, the addition of chemicals to the SCIL “incentivizes further innovation in safer chemistry, which can promote environmental justice, bolster resilience to the impacts of climate change, and improve water quality.” According to EPA, chemicals on the SCIL “are among the safest for their functional use.”
 
EPA changed the status for one chemical (1-octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-) that has recently been identified on the SCIL as a per- or polyfluoroalkyl substance (PFAS). According to EPA, the chemical is not used in any Safer Choice-certified products. It was added to the SCIL in 2012 based on the data available and the state of EPA’s knowledge at the time. EPA has now updated the SCIL listing for this chemical to a grey square because of a growing understanding of the toxicological profiles for certain PFAS and incomplete information on the potential health and environmental effects of these substances. A grey square notation means that the chemical may not be allowed for use in products that are candidates for the Safer Choice label, and any current Safer Choice-certified products that contain this chemical must be reformulated unless relevant health and safety data are provided to justify continuing to list this chemical on the SCIL. EPA will determine the data required on a case-by-case basis. According to EPA, in general, data useful for making such a determination would provide evidence of low concern for human health and environmental impacts. Unless information provided to EPA adequately justifies continued listing, EPA will remove the chemical from the SCIL 12 months after the grey square designation.
 
EPA states that after this update, there are 1,064 chemicals listed on the SCIL. The SCIL is a resource that can help many different stakeholders:

• Product manufacturers use the SCIL to help make high-functioning products that contain safer ingredients;
• Chemical manufacturers use this list to promote the safer chemicals they manufacture;
• Retailers use the list to help shape their sustainability programs; and
• Environmental and health advocates use the list to support their work with industry to encourage the use of the safest possible chemistry.

EPA’s Safer Choice program certifies products containing ingredients that have met the program’s rigorous human health and environmental safety criteria. The Safer Choice program allows companies to use its label on products that meet the Safer Choice Standard. The EPA website contains a complete list of Safer Choice-certified products.

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