By Lesley Witter, NFDA Senior Vice President, Advocacy

NFDA has been a vocal advocate for funeral service and embalming during the multi-year U.S. Environmental Protection Agency (EPA) assessment of the human health and environmental risks of formaldehyde under the Toxic Substances Control Act (TSCA). TSCA is a law passed by Congress that requires EPA to conduct a risk evaluation to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors. If the EPA finds that a particular use of a chemical presents an unreasonable risk to health or the environment, the EPA must consider whether to require management controls to minimize harm.

The use of formaldehyde during embalming was exempted from the draft TSCA risk assessment recently published by the EPA. Read NFDA’s assessment of the draft risk assessment here. The use of formaldehyde in embalming meets the definition of “pesticide” under FIFRA (7 U.S.C. § 136(u)) and is therefore excluded from the TSCA section 3(2) definition of “chemical substance” when manufactured, processed, or distributed in commerce for these uses. 
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is the Federal statute that governs the registration, distribution, sale, and use of pesticides in the United States. 

Additionally, in the new EPA Draft Risk Assessment for Use of Formaldehyde as a Pesticide under FIFRA released on April 19, embalming has also been excluded from the FIFRA risk assessment. FIFRA 40 CRF section § 152.25 (1)embalming fluids as used as preservatives for biological specimens have been determined to be of a character not requiring regulation under FIFRA and are therefore exempt from all provisions of FIFRA when used in the manner specified.

However, the EPA preliminarily finds that formaldehyde presents an unreasonable risk of injury to human health. These risks result from specific activities using, and products containing, formaldehyde and, therefore, may not apply to everyone, everywhere.

NFDA remains committed to strongly advocating for the interests of funeral service as the review of formaldehyde continues. The EPA’s determination that formaldehyde constitutes an “unreasonable risk” may trigger regulations under various laws overseen by EPA and other agencies. 

Excluding embalming from both TSCA and FIRFA does not provide any protection for the upstream and intermediate uses of formaldehyde (e.g., the manufacturing of embalming chemicals, transportation of embalming chemicals, etc.), which may be subject to bans or unachievable standards, with a corresponding negative impact on cost or availability of formaldehyde-based products. 

In essence, if the exposure limit is set so low that chemical manufacturers can’t make the product in the U.S., and it becomes expensive and burdensome to transport or resell the chemical, funeral service and embalmers may not have access to formaldehyde – at least from U.S. sources. This could raise the cost of formaldehyde so high that it becomes cost prohibitive for use in funeral service. 

Additionally, other bodies, including other parts of EPA and OSHA or state agencies, may use the EPA determinations and accompanying unachievable draft workplace levels (as low as 11 parts per billion) as the basis for regulatory or enforcement actions. 

Recently, the U.S. EPA finalized a rule that changes its process for conducting risk evaluations on chemicals under TSCA. When the EPA announced many of the changes included in the final rule in 2021, NFDA provided comment and feedback to the EPA. The EPA then proposed a revised procedural framework rule in October 2023 and, after carefully considering public comment on the proposed rule, released the final rule. 

The procedures outlined in the rule apply to all risk evaluations initiated 30 days after the date of publication of the final rule or later. For risk evaluations that are currently in process, EPA expects to apply the new procedures to those risk evaluations to the extent practicable, taking into consideration the statutory requirements and deadlines.

These changes to EPA’s processes are designed to advance the goals of this important chemical safety law, ensure that TSCA risk evaluations comprehensively account for the risks associated with a chemical, and provide a solid foundation for protecting public health, including workers and communities, from toxic chemicals. 

Learn more about the TSCA risk evaluation process.

EPA’s final rule includes revisions made to respond to the court’s ruling, as well as several changes to improve EPA’s process for TSCA risk evaluations, including:

• Consideration of real-world exposure scenarios such as multiple exposure pathways (e.g., in air and water) to the same chemical, and combined risks from multiple chemicals when EPA has the scientific information to do so, which may be particularly important for communities who face greater exposures or susceptibilities to chemicals than the rest of the general population. 
• A requirement that risk evaluations are comprehensive in scope and do not exclude conditions of use or exposure pathways.
• Clarifications to ensure EPA appropriately considers risks to all workers in its risk evaluations.
• Consideration of chemical uses that may be required for national security or critical infrastructure by other Federal agencies.
• Assurance the agency will continue to use the best available science to conduct risk evaluations, that decisions are based on the weight of the scientific evidence and that risk evaluations will be peer reviewed in accordance with both federal and EPA guidance.
• Discussion of chemical-specific fit-for-purpose approaches that allow for varying types and levels of analysis so that risk evaluations focus less rigorously on the conditions of use that are expected to pose low potential risk and can reliably be completed within the timeframes required by the statute.
• A clear requirement for risk evaluations to culminate in a single risk determination on the chemical substance, rather than on individual chemical conditions of use in isolation, and improved communications regarding the uses that significantly contribute to the unreasonable risk.
• New procedures and criteria for whether and how EPA will revise scope and risk evaluation documents, to improve transparency.
• Adjustments to the process for submission and review of manufacturer requests for risk evaluations of chemicals to better align with the process and timeline associated with EPA-initiated risk evaluations, while also ensuring that the agency can use the authorities provided under the law for gathering any needed additional information on such chemicals.
• A requirement that risk evaluations must explicitly consider overburdened communities when identifying potentially exposed and susceptible populations as relevant to the risk evaluation.

Throughout the entire TSCA review of formaldehyde, NFDA has advocated for the EPA to use the best available science to make their risk determination. The highest quality data on exposure to formaldehyde involved exposures prior to the 1990s and did not reflect current practices due to improvement on formaldehyde handling practices; changes in technology, products, or practices related to embalming; and the reduction in number of embalmings over time. 

This is why the NFDA embarked on the first of its kind formaldehyde exposure study. NFDA Advocacy staff worked with a scientific consulting firm to do an exposure study on formaldehyde in embalming and submitted comments and the study results to the EPA. Additionally, NFDA’s study was accepted for publication in the July 2022 issue of the peer-reviewed Journal of Occupational of Environmental Hygiene. 

What Does this Mean for Funeral Service? 

Because the TSCA risk assessment of formaldehyde is already underway, the EPA will apply these new procedures to the extent practicable, taking into consideration the statutory requirements and deadlines.

NFDA does not expect the implementation of these new procedures to impact the EPA’s decision to exempt formaldehyde from the TSCA review. However, these procedures could impact other aspects of the review process, such as potential management controls imposed on the manufacturing or transportation of embalming fluid, which would, in turn, impact the use of formaldehyde during embalming. 

Overall, many of these changes are positive, such as requiring the EPA to give consideration to real-world exposure scenarios and use the best available science, such as the NFDA exposure study.

However, the new requirement for risk evaluations to culminate in a single risk determination on a chemical substance, rather than on individual chemical conditions of use, could be problematic. Your NFDA Advocacy staff will continue to be active with federal policy makers on this issue to in an effort to ensure there are no negative developments for funeral service.