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EPA retools chemical risk evaluation process

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Washington — Responding to recent Executive Orders and directives from the Biden administration, the Environmental Protection Agency has announced changes to chemical risk evaluation policies under the Frank R. Lautenberg Chemical Safety for the 21st Century Act to “position EPA to move forward with actions to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law.”

According to a June 30 press release, actions will include:

  • Using a “whole substance” approach when determining unreasonable risk
  • Expanding consideration of exposure pathways
  • Establishing a “fenceline community exposure screening level” approach

The release notes that under the Trump administration, EPA “made separate unreasonable risk determinations for every condition of use of a chemical.” Now, under the Biden administration, EPA intends to continue to evaluate each condition of use before making a singular determination of unreasonable risk “for the whole chemical when it is clear the majority of the conditions of use warrant one determination.”

With respect to the first 10 chemicals under consideration for potential health and environmental risks under the Lautenberg Act, EPA intends to withdraw previous orders for conditions of use for which no unreasonable risk was found. The agency then will issue revised determinations of unreasonable risk for chemicals as a “whole substance” while requesting public comment on the approach.

EPA points out that the risk evaluations for the first 10 chemicals neglected to “assess air, water or disposal exposures to the general population” because they already were or could be regulated under existing statutes such as the Clean Air Act of 1963, Clean Water Act of 1972 or Safe Drinking Water Act of 1974. As a result, EPA says, the approach prompted “a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible populations” such as “fenceline communities,” or those adjacent to industrial facilities.

Consequently, EPA said it plans to reopen and update the risk evaluation for 1,4-dioxane, soliciting feedback before any potential changes are finalized. In the cases of methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, n-methylpyrrolidone and 1-bromopropane, the agency said it intends to “further examine whether the policy decision to exclude certain exposure pathways from the risk evaluations will lead to a failure to identify and protect fenceline communities.”

Existing risk evaluations for asbestos, cyclic aliphatic bromide cluster and Pigment Violet 29 “are likely sufficient to inform the risk management approaches being considered and these approaches will be protective,” the agency determined.

“EPA is committed to ensuring the safety of chemicals used in all communities, including those that have been historically underserved,” Michal Freedhoff, assistant administrator for the EPA Office of Chemical Safety and Pollution Prevention, said in the release. “The policy changes and path forward announced today will allow the agency to restore public trust, provide regulatory certainty and, most importantly, ensure that all populations that may be exposed to these chemicals are protected.”

As required under the Toxic Substances Control Act of 1976, which the Lautenberg Act amended, EPA must address risks by proposing within one year regulatory actions such as training, certification, restricted access and/or ban of commercial use, and then accept public comment on any proposals.

The National Academies of Sciences, Engineering and Medicine, in a February report, challenged the systematic review process used by EPA, suggesting the agency should “reconsider its overall strategy.”


In the Jan. 21 Federal Register, EPA published the final risk evaluation for Pigment Violet 29, marking the last of the first 10 chemicals that were evaluated for potential health and environmental risks under the Lautenberg Act. Although the agency found that the substance presents an “unreasonable risk” to workers under certain conditions, that conclusion represented a reversal of preliminary findings in the initial draft risk evaluation published in November 2018.

Requisite analysis from the Science Advisory Committee on Chemicals presented concerns over “large data gaps that preclude coming to confident conclusions regarding certain subpopulations,” triggering EPA’s ultimate revision.

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