EPA Issues Draft Risk Evaluation for Formaldehyde
NAA Editor Note (4/19/2024):
NAA Editor Note: Today’s EPA announcement describes the second of two EPA formaldehyde risk assessments now available for public comment. The first announcement was released March 15th under the authority granted by the Toxic Substances Control Act. Scroll down to the bottom for links.
The NAA recommends members share this information and comment to the regulations.gov links provided to describe the importance of formaldehyde-based products (therapeutants or tissue fixatives) to your farms and laboratories.
NAA Comments:
FDA labeled formaldehyde derived aquatic animal therapeutants are critical to treating fish for external parasites and eggs to prevent fungus. There is no effective alternative. The National Aquaculture Association, Aquatic Animal Drug Coalition, American Chemistry Council, American Veterinary Medicine Association have been and are commenting to EPA; however, the agency is focused on human exposure. There appears to be no consideration of benefit versus risk. If formalin-based therapeutants are important to the care and health of your fish, we strongly encourage you to submit comments to the agency.
In addition, the NAA and AVMA have strongly supported Dr. Anita Kelly, Extension Professor, School of Fisheries, Aquaculture and Aquatic Sciences, Auburn University, to serve on the EPA’s Formaldehyde Science Advisory Committee on Chemicals. This will be no small task and for her dedication to this effort, we cannot express our appreciation strongly enough.
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Today, the U.S. Environmental Protection Agency (EPA) released its draft risk evaluation for formaldehyde under the Toxic Substances Control Act (TSCA) for public comment and peer review. In the draft risk evaluation, EPA preliminarily finds that formaldehyde poses unreasonable risk to human health. The risk evaluation notes that these risks may not apply to everyone, everywhere and describes some of the sources of uncertainties in EPA’s findings.
Formaldehyde is found nearly everywhere. People and animals produce and release formaldehyde. Formaldehyde is produced when organic material including leaves, plants, and woodchips decay. Formaldehyde is also produced and released into the air when things burn, such as when cars emit exhaust, when furnaces and stoves operate, and through forest fires, burning candles, and smoking. Finally, formaldehyde is used to make many products including composite wood products and other building materials, plastics, pesticides, paints, adhesives, and sealants. Over time, formaldehyde may be released from these products and people may inhale it.
Due to its varied sources, people are routinely exposed to formaldehyde in indoor and outdoor environments, often from more than one source at a time. High levels of exposures to formaldehyde can cause health problems when inhaled and if it is absorbed into the skin. Inhaling high levels of formaldehyde for a short period of time can cause sensory irritation such as eye irritation. Inhaling formaldehyde for longer periods of time can damage the lungs and increase asthma and allergy-related conditions, sensory irritation, reproductive toxicity, and cancer. Skin contact with products containing formaldehyde can also cause allergic reactions.
In the draft risk evaluation, EPA evaluated the risks that arise from ways in which people may be exposed to formaldehyde from the production and use of products that are subject to TSCA - as opposed to exposures from those products that are excluded from TSCA (such as pesticides and exposures from sources of formaldehyde that are biogenic such as breathing and the decomposition of leaves) and exposures from other sources of formaldehyde.
This draft risk evaluation attempts to understand whether the risks from those uses contribute to the unreasonable risk presented by formaldehyde. EPA assessed exposure for 62 TSCA conditions of use of formaldehyde, using many scenarios, considering multiple human life stages (e.g., childhood, adulthood) and how people might be exposed outdoors in the open air, in their homes or other buildings, at workplaces that use formaldehyde, and in communities located close to industrial sources of formaldehyde.
In evaluating these exposures, EPA faces a unique challenge: the formaldehyde released from commercial activities and products is mixed in with the naturally formed formaldehyde. It is often difficult to estimate how much of the formaldehyde a person is exposed to comes from a given source at any given time. Similarly, EPA’s finding of unreasonable risk does not mean that a single exposure to formaldehyde will result in adverse health effects.
EPA found that workers who are in workplaces where formaldehyde is used are at the most risk from formaldehyde exposure. Workers may be exposed to formaldehyde by inhaling it after it is released into the air or by making skin contact with formaldehyde-containing materials. EPA made these conclusions without assuming that worker protections, such as wearing protective equipment, were in place, although EPA is aware that many employers do take measures to protect the safety of their workers.
EPA also found that people who frequently use certain consumer products that contain formaldehyde are at risk. These products included car waxes, some crafting supplies, and fabrics or leather goods treated with formaldehyde. However, a person’s risk from these products depends on how long and how frequently the products are used, and in many cases, exposures from these products are at the same or lower levels than exposures from other sources of formaldehyde in the home such as candles or cooking. People may also be exposed to more formaldehyde in their homes if the homes are newer or contain newer furniture because building products and furniture can release formaldehyde at higher levels when newly formulated. Lastly, people living near facilities releasing formaldehyde may have higher exposures than those located further away.
EPA also evaluated formaldehyde’s impact on the environment and found that formaldehyde is not expected to last long in water, sediment, or soil based on its physical and chemical properties. EPA did not identify risk of injury to the environment that would contribute to the unreasonable risk determination for formaldehyde.
Next Steps
EPA is accepting public comments on the draft risk evaluation for 60 days via docket EPA-HQ-OPPT-2023-0613 at www.regulations.gov. The draft risk evaluation will also be reviewed by the Agency’s Science Advisory Committee on Chemicals (SACC). Following a call for nominations in December 2023, the biographical sketches of the candidates under consideration as prospective peer reviewers were posted for public comment in February 2024.
EPA will hold a virtual public meeting for the SACC to discuss the draft risk evaluation from May 20-23, 2024. Registration instructions for the meeting will be announced on the SACC website in April 2024, including information about how to register to present oral comments during the meeting. For additional information, please see the Federal Register notice or contact the Designated Federal Official, Tamue Gibson at gibson.tamue@epa.gov.
EPA will hold a virtual preparatory public meeting on May 7, 2024, for the SACC and the public to consider and ask questions regarding the scope and clarity of the draft charge questions. Register for the meeting here.
EPA will use feedback received from public comments and the SACC to inform the final risk evaluation. To read or download, the draft risk evaluation, click here.
American Chemistry Council (ACC) Value Chain Webinar on EPA’s Draft TSCA Risk Evaluation for Formaldehyde
Date: Wednesday, April 3, 2024
Time: 3:00 – 4:00 pm US Eastern Time
Cost: Complimentary
Registration: Webinar Registration - Zoom
On March 15, 2024, EPA released the draft risk evaluation under the Toxic Substances Control Act (TSCA) for formaldehyde for public comment and peer review. Formaldehyde is a critical building block for essential applications including agriculture, food safety, medical devices, semiconductors, automobiles/electric vehicles, and affordable housing. Please join us for a complimentary webinar for the formaldehyde value chain that will provide an overview of EPA’s proposal, potential impacts to your industry, and opportunities to engage in the process.
Learn more: TSCA Risk Evaluation - American Chemistry Council
This webinar is intended for industry trade associations and their members only. No media or press may participate.