A diverse group of stakeholders, experts and reviewers identify major issues in EPA’s draft TSCA formaldehyde risk assessment

On May 20–23, 2024, the Environmental Protection Agency (EPA) hosted a four-day virtual public meeting of its Scientific Advisory Committee on Chemicals (SACC) as part of its Toxic Substances Control Act (TSCA) Formaldehyde Risk Assessment Draft Review ), which was published on March 15. Recordings of the meetings taking place on May 20–23 can be viewed here. Nearly 40 commentators from a variety of sectors and backgrounds provided oral comments during the first two days, highlighting legal, scientific, and economic issues related to EPA’s draft risk assessment. The American Chemistry Council provided written comments on this draft risk assessment on May 8, May 3, and May 14.

EPA also held a “preparatory” virtual meeting with reviewers on May 7 (you can watch that meeting here), and reviewers asked a number of critical questions about the scope of the review and questions about EPA’s “allegations.”

Over 20 speakers (including people from ACC, Composite Panel Association, American Wood Council, National Association of Landscape Professionals, The Fertilizer Institute, American Home Furnishings Alliance, International Wood Products Association and National Retail Federation, Squire Patton Boggs, Dr. Dennis Paustenbach , ToxStrategies, Raptor Pharm & Toxicology, Celanese, Bakelite and Methanol Institute) presented at the SACC preparatory meeting. None of the speakers supported EPA’s draft risk assessment or the limited scope and timing of the peer review. Key themes emphasized the exclusion of key issues from the peer review process, including the underlying IRIS assessment, the occupational exposure value design and the approach to determining “unreasonable risk”, as well as the need to integrate TSCA science standards around “best available science” and “weight scientific evidence.” Several reviewers urged EPA to address these issues after the solicitation.

Rushed review

During SACC meetings, reviewers made it clear that EPA had imposed a timeline on them that did not allow for adequate and independent peer review. In advance of the meetings, many organizations asked EPA to extend the public comment period or hold in-person public meetings, including the American Chemistry Council Formaldehyde Panel, the American Wood Council, the American Home Furnishings Alliance, the United States Small Business Administration, the Composite Panel Association, the Fertilizer Institute, Decorative Hardwood Association, International Wood Products Association, Methanol Institute and National Aquaculture Association. In April, the EPA rejected that request.

Widespread criticism – over 200 public comments were submitted to EPA

In addition to the ACC, numerous elected officials, industry associations, companies, and scientific experts also provided comments on TSCA’s risk assessment, echoing these concerns and highlighting additional ones. Formaldehyde remains a key building block in key applications including agriculture, food safety, medical devices, semiconductors, automobiles/electric vehicles and affordable housing. Formaldehyde technologies play a broad role in the economy, supporting 987,000 jobs and $552.7 billion in sales in 2022 in the United States.

Below are some illustrative examples of key stakeholder comments.

Elected officials and state or tribal organizations

Building on numerous letters from Congress to EPA expressing concerns about EPA’s formaldehyde activities under TSCA and the Integrated Risk Information System (IRIS) from 2021, a bipartisan group of members of Congress from North Carolina, Oregon, Georgia, Ohio , Wisconsin, Iowa, Minnesota, and Virginia, led by Representatives Don Davis (D-NC) and Lori Chavez-DeRemer (R-OR), commented that EPA’s risk assessment could disrupt supply chains for the automotive, aerospace, construction industries , agricultural, defense and healthcare and semiconductors. They also called on EPA to extend the comment period, “revise workplace formaldehyde limits to bring them in line with standards adopted in other jurisdictions,” and “conduct a comprehensive interagency review process.” 20 State attorneys general, led by Iowa’s Brenna Bird, argued that EPA action could “effectively ban the use of formaldehyde and put billions of dollars of farm animals at risk of disease, threaten the food supply and the entire agricultural industry.” These officials urged “EPA to look at the best available scientific evidence, reconsider the design of the assessment, and maintain current regulatory levels.”

Other state commenters included the National Association of State Departments of Agriculture (“EPA’s reliance on the draft IRIS assessment is fatally flawed and violates statutory requirements for best available science”), the California Department of Food and Agriculture (“Despite EPA’s exclusion of aquaculture under TSCA Risk Assessment, CDFA AUS respectfully urges EPA to proceed with caution and in consultation with the best available science. The results of the formaldehyde risk analysis may result in unintended consequences that unintentionally negatively impact feed and aquaculture producers’ legal access to formaldehyde. for FDA-approved uses… aquaculture producers may incur prohibitive costs and unnecessary delays or barriers in access to this critical therapeutic, which could ultimately increase the need for antibiotics and threaten the food security of our great state and nation”) and current and former state legislators from Arizona, North Carolina, Georgia, Nevada and Montana. Additionally, the Northwest Indian Fisheries Commission explained that “EPA must consider how the TSCA process will impact the use of this drug in programs that sustain treaty fisheries and support the recovery of listed stocks (Endangered Species Act). ) and the ecological balance of fish species. our marine and freshwater ecosystems.”

Industry associations and agricultural groups

In addition to the ACC Formaldehyde Panel, a large number of industry associations, professional associations, and agricultural organizations raised fundamental issues in EPA’s draft formaldehyde risk assessment. For example, the American Veterinary Medical Association has highlighted concerns “about how EPA’s preliminary findings of unreasonable risk for certain conditions of use may have a direct or indirect impact on the availability, affordability, or both…. Formaldehyde has many uses in veterinary medicine and animal husbandry, including as an ingredient in animal biologics, new animal drugs, feed additives, slide fixation in veterinary diagnostic laboratories, and as a fumigant. The National Association of Manufacturers noted that “EPA’s risk assessment overestimates the risk to workers without taking into account the highly developed safety procedures, protocols and PPE used throughout the industry, falsely concluding that neither manufacturers’ safety obligations nor OSHA standards are enforced.” Joint comments from the American Home Furnishings Alliance, the International Wood Products Association, and the National Retail Federation cautioned: “Before EPA considers actions that could disrupt businesses and jobs across the United States and have far-reaching consequences beyond its regulations, EPA must consider the best information and accessible learning.”

Additional comments were submitted by:

Affected companies

A wide range of companies in the chemical, timber, agricultural and horticultural sectors also weighed in on the EPA, raising significant scientific and legal issues in connection with the TSCA formaldehyde risk assessment project. They included: Anitox Corporation; BASF Corporation; Celanese Corporation; Covestro LLC; Dow Chemical; Georgia-Pacific Gypsum LLC; Hexion Inc.; Louisiana-Pacific Corporation (LP); PotlatchDeltic Corporation; Roseburg Forest Products Co.; Scotts Company LLC; and Westervelt Company.

Scientific experts, former EPA officials and authors of key studies

Many scientific experts also provided EPA with detailed comments and criticisms of the draft risk assessment. Dr. Harvey Checkoway, professor at the University of California, San Diego School of Public Health and member of the 2011 National Academies committee to review EPA’s draft IRIS formaldehyde assessment, stated: “Based on my review of the draft report, EPA does not conclude that the “The conclusions are based on the best available evidence and do not fully take into account key recommendations from previous scientific reviews.”

An expert panel review of the EPA’s risk assessment project by SciPinion “identified several important areas in which EPA should change its approach to be consistent with the best available science.” Other expert commentators include: ALL4 LLC; Dr. Jimmy Avery, Thad Cochran National Warmwater Aquaculture Center, Mississippi State University; Dr. Andy Maier and Heather Lynch, Integral (see outdoor occupational exposure scenario review); Dr. Chad Thompson, ToxStrategies; Dr. Christoph van Thriel, Leibniz Research Center; Dr. Dennis Paustenbach, Paustenbach & Associates; Dr. Elaine Freeman and Pam Dopart and Renee Kalmes, exponent (see Occupational and Consumer Exposure to Wood Products Review and Occupational Assessment Review); Dr Harvey Clewell, Ramboll; Dr. James Sherman, Consultant; Dr. Joel Cohen, Gradient; Linda D. Dell, Ramboll; Dr. Lyle Burgoon, Raptor Pharm and Toxicology; Melissa Vincent, ToxStrategies; Dr. Pamela Dalton, Monell Chemical Senses Center; Dr. Robinan Gentry, Ramboll and Chad Thompson, ToxStrategies; Dr. Rory Conolly, consultant and Michigan State University; Dr. Tunga Salthammer, Fraunhofer WKI; Dr. William Goodfellow, exponent; and William Thompson and Dr. Tony Cox and Kenneth Mundt, Mundt consultants.

Nonprofits and community and union leaders

Several public interest and nonprofit organizations also provided substantive comments to the Agency. For example, the Center for Environmental Responsibility detailed how the EPA project “is plagued by fatal scientific and procedural deficiencies that cannot be corrected through the risk management phase.” The EPA files also include key contributions from mayors, members of state or city councils or commissioners, farmers, labor leaders, health care workers and small business owners.