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Diverse Group of Stakeholders, Experts, and Peer Reviewers Identify Major Issues with EPA’s Draft Formaldehyde Risk Evaluation Under TSCA

EPA Building from Below

From May 20-23, 2024, the Environmental Protection Agency (EPA) held a four-day, virtual public meeting of its Science Advisory Committee on Chemicals (SACC) as part of a review of its draft risk evaluation of formaldehyde under the Toxic Substances Control Act (TSCA), which had been released on March 15. You can view the recordings of the May 20-23 meetings here. Nearly 40 public commenters from a variety of different sectors and backgrounds presented oral comments during the first two days, highlighting the legal, scientific, and economic issues with EPA’s draft risk evaluation. The American Chemistry Council submitted written comments on this draft risk assessment on March 8, May 3, and May 14.

EPA also held a “preparatory” virtual meeting with the peer reviewers on May 7 (you can view that meeting here), and peer reviewers raised a number of critical questions regarding the scope of the review and EPA’s “charge” questions.

More than 20 public speakers (including individuals 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 during the preparatory SACC meeting. None of the speakers supported EPA’s draft risk evaluation 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, draft occupational exposure value, and approach for “unreasonable risk” determinations, and the need to integrate TSCA scientific standards around “best available science” and the “weight of scientific evidence.” Several peer reviewers called on EPA to address these issues after the call.

Rushed Review

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

Widespread Criticisms – More than 200 Public Comments Submitted to EPA

In addition to ACC, numerous elected officials, trade associations, companies, and scientific experts have also submitted comments on the TSCA risk evaluation echoing these concerns and highlighting additional ones. Formaldehyde remains a critical building block for essential applications including agriculture, food safety, medical devices, semiconductors, automobiles/electric vehicles, and affordable housing. Formaldehyde technologies have broad roles 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 comments from key stakeholders.

Elected Officials and State or Tribal Organizations

Building on numerous Congressional letters to EPA raising concerns with EPA’s formaldehyde activities under TSCA and the Integrated Risk Information System (IRIS) since 2021, a bipartisan group of Members of Congress from North Carolina, Oregon, Georgia, Ohio, Wisconsin, Iowa, Minnesota, and Virginia, led by Reps. Don Davis (D-NC) and Lori Chavez-DeRemer (R-OR), commented that EPA’s risk evaluation could disrupt supply chains for the automotive, aerospace, building and construction, agriculture, defense, health care, and semiconductors industries. They also called on EPA to extend the comment period, “revise its workplace limits for formaldehyde to bring them in line with accepted standards in other jurisdictions” and “undertake a comprehensive interagency review process.” 20 State Attorneys General, led by Brenna Bird of Iowa, argued that EPA’s action could “in effect, ban formaldehyde and place billions of dollars of livestock at risk of disease, jeopardize the food supply, and threaten the entire agricultural industry.” These officials urged “EPA to look at the best available science, reconsider its draft evaluation, and maintain the current regulatory levels.”

Other state commenters included the National Association of State Departments of Agriculture (“EPA’s reliance on the draft IRIS assessment is a fatal flaw and violates statutory requirements for best available science”), the California Department of Food and Agriculture (“Notwithstanding EPA’s exclusion of the aquaculture from the TSCA risk evaluation, CDFA AUS respectfully urges the EPA to proceed cautiously and in consultation with the best available science. The formaldehyde risk analysis findings may result in unintended consequences that inadvertently, negatively affect aquaculture and animal feed producers’ legitimate access to formaldehyde for FDA-approved uses…. aquaculture producers may face prohibitive costs and undue delays or barriers in accessing this critical therapeutic, which could ultimately increase the need to use antibiotics and threaten food security for our great state and nation”), and current and former state legislators from Arizona, North Carolina, Georgia, Nevada, and Montana. In addition, 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 [Endangered Species Act]-listed stocks, and the ecological balance of our marine and freshwater ecosystems.”

Trade Associations & Agricultural Groups

In addition to ACC’s Formaldehyde Panel, a large number of trade associations, professional societies, and agricultural organizations raised fundamental issues with EPA’s draft risk evaluation of formaldehyde. For example, the American Veterinary Medical Association highlighted concerns “about how the availability, affordability, or both of products…could be impacted directly, indirectly, or both by EPA’s preliminary findings of unreasonable risk for some conditions of use…. 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 “The EPA’s risk evaluation overestimates the risk to workers by not considering the highly developed safety procedures, protocols and PPE used throughout industry—incorrectly inferring that neither manufacturers’ safety commitments nor OSHA standards are enforced.” Joint comments from the American Home Furnishings Alliance, International Wood Products Association, and National Retail Federation cautioned: “Before EPA considers actions that could disrupt businesses and jobs across the United States and have wide ranging implications beyond its regulations, EPA must consider the best information and science available.”

Additional comments were filed by: 

Affected Companies

A wide variety of companies in the chemical, wood products, agriculture, and garden products sectors also weighed in with EPA, raising significant scientific and legal issues with the draft TSCA risk evaluation of formaldehyde. 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.; The Scotts Company LLC; and The Westervelt Company.

Scientific Experts, Former EPA Officials, and Authors of Key Studies

A number of scientific experts also provided detailed comments and critiques to EPA on the draft risk evaluation. Dr. Dr. Harvey Checkoway, Professor, University of California, San Diego School of Public Health and Member of National Academies 2011 Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde stated: “Based on my review of the draft EPA report, I do not find that its conclusions are grounded in the best available science and also fails to fully incorporate key recommendations from previous peer reviews.”

An expert panel review of EPA’s draft risk evaluation by SciPinion “identified some important areas where EPA should change their approach to be consistent with best available science.” Other expert commenters included: ALL4 LLC; Dr. Jimmy Avery, Thad Cochran National Warmwater Aquaculture Center, Mississippi State University; Dr. Andy Maier and Heather Lynch, Integral (see review of outdoor occupational exposure scenario); Dr. Chad Thompson, ToxStrategies; Dr. Christoph van Thriel, Leibniz Research Centre; Dr. Dennis Paustenbach, Paustenbach & Associates; Drs. Elaine Freeman & Pam Dopart & Renee Kalmes, Exponent (see review of occupational and consumer exposures for wood products and review of occupational assessment); Dr. Harvey Clewell, Ramboll; Dr. James Sherman, Consultant; Dr. Joel Cohen, Gradient; Linda D. Dell, Ramboll; Dr. Lyle Burgoon, Raptor Pharm & Toxicology; Melissa Vincent, ToxStrategies; Dr. Pamela Dalton, Monell Chemical Senses Center; Drs. 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 Drs. Tony Cox and Kenneth Mundt, Consultants Mundt.

Non-Profit Organizations and Community and Union Leaders

Several public interest and non-profit organizations also provided substantive comments to the Agency. For example, the Center for Environmental Accountability detailed how EPA’s draft is “plagued by fatal scientific and procedural deficiencies that cannot be corrected during the risk management phase.” EPA’s docket also includes key comments from mayors, state or city councilmembers or commissioners, farmers, union leaders, healthcare workers, and small business owners.

 

 

American Chemistry Council

The American Chemistry Council’s mission is to advocate for the people, policy, and products of chemistry that make the United States the global leader in innovation and manufacturing. To achieve this, we: Champion science-based policy solutions across all levels of government; Drive continuous performance improvement to protect employees and communities through Responsible Care®; Foster the development of sustainability practices throughout ACC member companies; and Communicate authentically with communities about challenges and solutions for a safer, healthier and more sustainable way of life. Our vision is a world made better by chemistry, where people live happier, healthier, and more prosperous lives, safely and sustainably—for generations to come.

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