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EPA's Toxic Substance Evaluation to Get Review

Tuesday, December 17, 2019

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The Environmental Protection Agency recently announced that it has contracted the National Academies of Science to conduct a peer review of the “Application of Systematic Review in Toxic Substance Control Act Risk Evaluations.”

The announcement comes about a week after the agency held a public meeting on the implementation of its TSCA New Chemicals program.

“This review will help provide EPA with important feedback on the agency’s approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act risk evaluations,” the agency said in an emailed press release.

“Integrating systematic review principles into the TSCA risk evaluation process is critical to developing transparent, reproducible and scientifically credible risk evaluations.”

© iStock / Skyhobo

The Environmental Protection Agency recently announced that it has contracted the National Academies of Science to conduct a peer review of the “Application of Systematic Review in Toxic Substance Control Act Risk Evaluations.”

The NAS has been performing independent reviews of government bodies for more than 150 years, according to the organization, dating back to an 1863 Congressional charter signed by former President Lincoln that authorized “this non-governmental institution to honor top scientists with membership and to serve the nation whenever called upon.”

“Like no other organization, the Academies can enlist the nation's foremost scientists, engineers, health professionals and other experts to address the scientific and technical aspects of society's most pressing problems. Each year, more than 6,000 of these experts are selected to serve on hundreds of study committees that are convened to answer specific sets of questions. All serve without pay.”

The EPA will be providing the NAS with the TSCA evaluations document, published in June 2018, as well as all publicly available information—including public comments—to inform the review, which is slated to include a public meeting and a final report by June 2020.

TSCA Background

In 2016, the TSCA got its first upgrade in 40 years as part of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which now requires the EPA to test all of the chemicals that had gotten through the previously weak TSCA (about 85,000 untested chemicals) with a target of about 2,000 a year.

Chemicals are sorted into “high” and “low” priority categories. No further action is taken with chemicals considered to be “low priority,” but “high priority” chemicals then move on to a risk evaluation.

The risk evaluation first looks at all possible uses of a chemical (everything from how it’s manufactured to how it’s used and how it’s disposed of). Then, it will look at how many possible ways it can come into contact with people and the impact it will have. After its possible exposure is totaled, the EPA will then look at the impact it will have on society’s most vulnerable—such as children—industry workers or the environment. This step has to be concluded within three years. If the EPA thinks it needs more time for analysis, it can extend the process one additional year.

After the evaluation is complete, the EPA decides whether or not to regulate the chemical. If the chemical is deemed unsafe, the EPA then has two years to specify restrictions. This timeframe can also extend an additional year.

In December 2016, the EPA designated the first 10 substances up for evaluation, which included substances such as Methylene Chloride, N-Methylpyrolidone and Pigment Violet 29.

In March of this year, the EPA issued a final rule to prohibit the manufacture and importing, processing and distribution of methylene chloride in all paint removers for consumer use. And, in June, the EPA held a meeting to discuss Pigment Violet 29 to get the independent review of the science underlying the PV29 risk assessment, including the hazard assessment, assessment of dose-response, exposure assessment and risk characterization.

In August, the EPA designated 20 substances as “low priority” and 20 substances as “high priority.”

Again, for the chemicals with a final designation of “low priority,” a risk evaluation is not warranted.

For the high-priority chemicals, though, the agency asked stakeholders and the public to submit comments. That deadline was in late November, and the EPA is expected to make final designations for these substances this month, which would start the three-year risk evaluation process.


Tagged categories: EPA; EPA; Government; Health & Safety; Health and safety; Laws and litigation; NA; North America; Regulations; Safety

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