Bloomberg Law
Jan. 5, 2021, 2:11 PMUpdated: Jan. 5, 2021, 6:53 PM

EPA Restricts How Science Can Be Used to Shape Regulations (2)

Stephen Lee
Stephen Lee

Narrowing the science underpinning EPA regulations should make the agency’s rules more defensible, removing judges from disputes about the validity of research, the agency’s chief said.

The Environmental Protection Agency rule, released Tuesday (RIN:2080-AA14), would restrict the agency’s ability to use scientific studies that include patients’ private medical data when issuing regulations. It’s a sharp break from its decades-old approach to new rules, which relied on those kinds of studies to issue some of its most expansive regulations, including air quality standards for fine particle pollution.

EPA Administrator Andrew Wheeler defended the new rule, called the Strengthening Transparency in Regulatory Science, as a win for “sunshine” in regulations.

The rule would get judges “out of the habit of making scientific determinations for the agency,” and cut back on litigation, Wheeler said at a web briefing hosted by the Competitive Enterprise Institute, a libertarian nonprofit.

But the rule, which takes effect immediately upon publication in the Federal Register on Wednesday, is expected to lead to immediate legal challenges. President-elect Joe Biden also is expected to seek to reverse the measure, but writing a new regulation would take years.

“This rule would bar regulators from considering bedrock scientific evidence about the dangers of pollution,” Richard Revesz, director of the Institute for Policy Integrity at the New York University School of Law, said in a statement.

Limited Exemptions

Wheeler said the rule wouldn’t categorically rule out any scientific studies; any future administrator could still use pivotal studies if the underlying information isn’t publicly available, as long as an explanation is provided.

He said he imagines the exemption will be used “sparingly.” Under the rule, the EPA must give greater consideration to studies whose underlying dose-response data is publicly available for independent validation.

But to critics, the new approach makes it harder for future administrations to issue new standards by severely narrowing the kinds of data the agency can draw upon.

In May, dozens of science groups, representing most of the American scientific consensus, told Wheeler that the rule would diminish the agency’s ability to regulate contaminants in water, air, and land.

‘Smoke-Filled’ Room

Betsy Southerland, former director of EPA’s Office of Water who left the agency in 2017, said in a statement that the EPA is now “the only agency in the federal government unable to base rules and guidance on public health studies unless participants’ private information is made publicly available.”

But Wheeler shot back at critics, saying that “I believe a number of the critics are very cynically trying to kill this effort because they prefer the agency to make decisions in a proverbial smoke-filled back room, where they don’t have to explain how the agency reached a particular decision on a pesticide or chemical.”

Wheeler sought to cement the rule on the books, stating on Tuesday that it isn’t subject to being overturned by Congress through the Congressional Review Act—which gives lawmakers 60 days after a rule takes effect to vote to strike it down.

That’s because it’s “an internal housekeeping regulation that does not affect external people to the agency,” and because it isn’t economically significant, meaning it isn’t expected to have an annual effect on the economy of at least $100 million, he said.

(Revises with additional comments from Wheeler.)

To contact the reporter on this story: Stephen Lee in Washington at

To contact the editor responsible for this story: Anna Yukhananov at