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EPA Criticized for How It Selects Data to Evaluate Chemical Risk

April 20, 2022, 10:00 AM

A strategy the EPA is using to decide what scientific data it will use to decide whether a chemical’s potential to harm people or the environment is so great it must be regulated could ignore potential harms, academic scientists and an environmental group said Tuesday.

Scientists and an attorney offered perspectives at an advisory committee meeting on a draft “systematic review” protocol. The Environmental Protection Agency revamped the protocol after dropping a previous method the National Academies of Sciences, Engineering, and Medicine criticized last year. The academies said EPA’s strategy wasn’t comprehensive, workable, objective, or transparent.

Systematic reviews determine what science is used, how it can be used, and what its strengths and limitations are. The EPA’s draft protocol also describes how the chemicals office will integrate vastly different types of toxicity, exposure, and physical-chemical information to reach a final conclusion about whether a chemical poses “unreasonable risk” of injury to people or the environment. If the potential for harm from the chemical is unreasonable, the 2016 Toxic Substances Control Act amendments require the EPA to regulate it.

The EPA’s Science Advisory Committee on Chemicals, or SACC, is reviewing the agency’s revised protocol, which is still in draft form, in a public meeting that continues through April 21.

If EPA’s method is too flawed, interested and affected parties may not accept its conclusions that determine whether regulations are warranted, Paul Whaley, a Lancaster University researcher focusing on the use of systematic methods to summarize environmental health information, told the committee.

Suzanne Hartigan, a senior director at the American Chemistry Council, which represents chemical manufacturers, told the panel EPA’s protocol needs further improvements, but is better than the 2018 strategy it replaced.

EPA Can’t ‘Pull Over’

Anthony Tweedale, a toxicology consultant working for nonprofit groups, said EPA’s method fails the first test of systematic review. Such analytic strategies are to be developed before being used, but the EPA is already using them to evaluate 25 chemicals.

The agency did that because the deadlines set by the 2016 TSCA amendments—which required the agency to start evaluating chemicals already being made and sold—mean “we’re not allowed to pull over and change the tire,” said Tala Henry, a deputy director in EPA’s Office of Pollution Prevention and Toxics.

The EPA’s revised draft protocol incorporates changes made to address criticisms from the National Academies, SACC, and the public, as well as lessons the agency learned as it used the 2018 strategy to evaluate 10 chemicals, she told the committee.

But Nicholas Chartres, who works on systematic review methods at the University of California, San Francisco, told the panel the draft doesn’t include a host of the academies’ recommendations.

SACC members said the agency’s revised strategy fails to incorporate changes both they and the National Academies made.

Ignoring ‘Sensitive Outcomes’

An important problem with EPA’s strategy is that it focuses on health problems, like cancer, where there’s clear, observable harm, but ignores other problems like a chemical’s ability to reduce thyroid hormones or weaken the immune system, which can lead to disease, said Tracey J. Woodruff, director of the University of California, San Francisco’s Program on Reproductive Health and the Environment.

EPA should include cellular changes and other sensitive outcomes as relevant, said Woodruff, a primary developer of the Navigation Guide, one of the first systematic review methods for environmental health.

Bob Sussman, an attorney who spoke on behalf of the non-profit Safer Chemicals Healthy Families organization, said problems such as those the University of California scientists identified mean the agency may be failing to meet TSCA’s requirement to use the best available science in its chemical risk evaluations.

He urged the agency to use the systematic review process developed by its research office that analyzes the health effects of chemicals, potency of carcinogens, and doses below which other types of disease would be unlikely.

But SACC members said that wouldn’t work, because the risk evaluations the chemicals office conducts use a much greater variety of data and examine a lot of issues the research office doesn’t.

The committee’s final, written suggestions to improve the draft are expected by July. A final protocol should be released in October, said Stan Barone, EPA’s senior science policy adviser for chemical safety.

To contact the reporter on this story: Pat Rizzuto in Washington at

To contact the editor responsible for this story: Renee Schoof at