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EPA should ‘reconsider’ strategy for chemical risk evaluations: National Academies

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Washington — The systematic review process used by the Environmental Protection Agency to complete chemical risk evaluations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act contains multiple shortcomings, and the agency should “reconsider its overall strategy” for such assessments, concludes a recently published report from the National Academies of Sciences, Engineering and Medicine.

While examining the approach of the EPA Office of Pollution Prevention and Toxics, a National Academies committee found that the review process was not “comprehensive, workable, objective and transparent.”

Although acknowledging the agency “faced substantial challenges in integrating review methods on the schedule required by the Lautenberg Act” – which amended the Toxic Substances Control Act – National Academies offered multiple recommendations to EPA. They include:

  • OPPT staff should engage in ongoing cross-sector efforts to develop and validate new tools and approaches for exposure, environmental health and other areas where systematic review is applied. TSCA evaluation approaches would benefit from the substantial external expertise available, as well as acceptance from outside stakeholders as the approaches are developed.
  • The decision to develop a wholly original approach to hazard assessment, rather than starting with other extant protocols as a foundation, is one source of the process’s problems. OPPT should consider incorporating components of methodologies from the National Institute of Environmental Health Sciences Office of Health Assessment and Translation and EPA’s Integrated Risk Information System and Navigation Guide.
  • Documentation of the process is incomplete and hard to follow. OPPT should assemble a handbook for TSCA review and evidence integration methodology to detail steps in the process.
  • The terms “weight of evidence” and “systematic review” are used interchangeably. The report urges OPPT to use standard descriptors for the strength of evidence instead.

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.

The agency found that the substance, primarily used as a colorant in consumer products such as paints, coatings, plastics and rubber products, presents an “unreasonable risk” to workers under certain conditions. The path to that determination, however, illustrates various concerns outlined in the National Academies report, as the final risk evaluation 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,” prompting EPA to issue a revision.

As required under TSCA, the release of a final risk evaluation compels EPA to address risks of each chemical substance 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.


Responding to the report in a recent press release, EPA said it “will refine its approach to selecting and reviewing the scientific studies that are used to inform” chemical risk evaluations, performing a review in accordance with Executive Orders and directives from the Biden Administration “to ensure that all agency actions meet statutory obligations, be guided by the best available science, ensure the integrity of federal decision-making, and protect human health and the environment.”

In the coming months, the agency says it expects to publish and solicit public comment on revised TSCA systematic review protocol that incorporates many of the recommendations from the National Academies report.

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