Formaldehyde fallout: Why the EPA's risk evaluation has industry on edge
With formaldehyde—a critical component in various industries—undergoing a dual review by the EPA, the final evaluations are set to be released by late 2024.
In March 2024, the EPA unveiled its Draft Risk Evaluation for Formaldehyde, which prompted over 200 public comments. Many critics, including the ACC, argue that the proposed toxicity values are rooted in flawed data, potentially leading to harsh restrictions that could affect the availability of essential products.
Sahar Osman-Sypher, senior director of the ACC's chemical products and technology division, emphasized that decades of peer-reviewed studies support a safe exposure level to formaldehyde, higher than typical concentrations found in homes and sufficient to protect worker health.
She noted that global regulatory bodies have used these findings to establish risk-based exposure levels. "After years of study, the weight of scientific evidence shows formaldehyde does not cause leukemia and that safe thresholds for exposure are well-established."
In April 2024, the EPA also released draft human health and ecological risk assessments under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which faced similar backlash. The ACC highlighted that the nearly 50 comments received on the Draft FIFRA Risk Assessment echoed concerns from the TSCA evaluation.
The EPA’s Scientific Advisory Committee on Chemicals (SACC) discussed these issues during a May 2024 virtual meeting. Peer reviewers flagged significant flaws, particularly in the reliance on the Draft IRIS Assessment, and called for greater alignment with TSCA’s scientific standards, noted the ACC.
Formaldehyde has been banned as a feed additive in the EU since February 2018. The product was denied authorization in the EU, mainly based on concerns regarding the health of workers handling the substance, leading to its complete removal from the market as a hygiene condition enhancer.
A critical tool for the ag and feed sector
Leah Wilkinson, vice president of public policy and education at the American Feed Industry Association (AFIA), voiced concerns over the potential impact on the US feed sector. She pointed out formaldehyde's long-standing role in controlling food safety pathogens and its emerging use in combating the African swine fever (ASF) virus. "The US animal food industry has safely used formaldehyde for over 40 years," Wilkinson said, stressing the need to maintain access to this critical tool.
Osman-Sypher warned that unreasonable standards or bans not based on sound science could destabilize the US agriculture and food system. "Without the risk mitigation tools formaldehyde provides, American farmers could face over $50bn in economic losses, and consumers might encounter food shortages, higher grocery prices, and less safe products."
She also raised concerns about the EPA's IRIS program, criticizing its scientific assessments as substandard and lacking Congressional authorization. "The IRIS program’s methodological shortcomings and disregard for the best available science make it unsuitable for regulatory decision-making, potentially leading to flawed regulations and unjustified public alarm," she told us.
Unintended consequences
Other stakeholders, including federal agencies, state and tribal organizations, and elected officials, have echoed these concerns:
The National Association of State Departments of Agriculture called the EPA’s reliance on the draft IRIS assessment a "fatal flaw" that violates statutory science requirements.
The California Department of Food and Agriculture (CDFA) warned of unintended consequences for aquaculture and animal feed producers, urging the EPA to consult the best available science.
The Northwest Indian Fisheries Commission stressed the importance of considering the TSCA process's impact on treaty fisheries and endangered species.
The Association of Fish and Wildlife Agencies highlighted the potential harm to threatened and endangered species recovery programs, cautioning against reliance on the IRIS assessment.
The US Department of Homeland Security (DHS) supported the continued use of formaldehyde for decontamination at the Plum Island Animal Disease Center, a key defense against transboundary animal diseases.
The US Department of Agriculture (USDA) underscored formaldehyde's importance to animal health and food safety.
A bipartisan group of Members of Congress also expressed concern that the EPA’s reliance on the IRIS assessment could disrupt critical supply chains across multiple industries. State Attorneys General, led by Iowa’s Brenna Bird, warned that the EPA’s actions could effectively ban formaldehyde, jeopardizing the food supply, and threatening the entire agricultural industry.
Interagency review
Osman-Sypher is urging the EPA to undergo a comprehensive interagency review for any draft or final risk evaluation for formaldehyde, overseen by the White House Office of Management and Budget (OMB), with input from relevant agencies like the USDA and FDA.
She also called for a robust, independent peer review process that includes perspectives from agriculture and aquaculture stakeholders. "Draft or final regulations must be fully reviewed by EPA’s Agricultural Science Committee of the Science Advisory Board (SAB) to ensure scientific quality, transparency, and consistency with real-world exposure scenarios."
From disinfectant to disease control
According to the ACC, formaldehyde plays a critical role across various sectors in the US including in the meat, poultry, crop protection, and aquaculture sectors. It serves as:
- A feed additive to control pathogens: “Formaldehyde is used in feed mills under strict safety standards to manage pathogens like Salmonella and E. coli."
- A disinfectant in poultry production: “It effectively safeguards bird health and food safety by preventing viruses and bacteria such as Salmonella, E. coli, and staph.”
- A protector for hatching eggs: “During incubation, formaldehyde helps shield eggs from bacteria that can negatively impact chick quality and farmer profits.”
- An agricultural enhancer: “It is essential in granular and slow-release fertilizers, herbicides, pesticides, and nitrification inhibitors, leading to increased crop yields and optimized agricultural production worldwide.”
- A protector of salmon and steelhead populations: “Formaldehyde is crucial for disease and parasite control in US hatcheries and fisheries.”
- A disease controller in aquaculture: “It helps fish hatcheries manage fungi and treat deadly bacterial infections, benefiting species like salmon, catfish, rainbow trout, tilapia, and several endangered or threatened fish species.”
