Scientists decry proposed EPA rule to end “secret science”

Over the objections of nearly 1000 scientists and dozens of scientific, health, and academic organizations, embattled Environmental Protection Agency administrator Scott Pruitt signed a draft rulemaking on 24 April to require that only scientific studies backed by publicly disclosed data be used to develop environmental regulations.

“The era of secret science at EPA is coming to an end,” Pruitt said in a statement. “The ability to test, authenticate, and reproduce scientific findings is vital for the integrity of the rulemaking process. Americans deserve to assess the legitimacy of the science underpinning EPA decisions that may impact their lives.”

The proposed rule will become final following a 30-day public comment period, but legal challenges are likely. In a 2002 decision during the George W. Bush administration, the US Court of Appeals for the DC Circuit accepted the EPA’s argument that regulations should be based on the conclusions of scientific studies, not the raw data underlying them. The court said a data access requirement would be “impractical and unnecessary.”

Many third-party public health studies that have been used to support environmental regulations are based on confidential individual data, including the pivotal 1993 six-cities study that established a link between fine particulate emissions and premature deaths. The 985 scientists who signed a letter to Pruitt on 23 April said that withholding data is often necessary to protect privacy, intellectual property, and proprietary concerns. They noted that many studies can’t be replicated because they would require exposing people to the same contaminants that have been found to be harmful.

“If put into practice, EPA could prohibit, or make it incredibly costly, for the agency to use a wide swath of high-quality scientific research,” said Rush Holt, CEO of the American Association for the Advancement of Science, in a 20 April statement . The proposed rule “appears to be an attempt to remove valid and relevant scientific evidence from the rule-making process.”

Pruitt’s action is a vindication for House Science, Space, and Technology Committee chair Lamar Smith (R-TX), who has made two unsuccessful attempts since 2015 to legislate the public-data requirement. Smith met with Pruitt in January to urge the EPA chief to implement his legislation by agency action, according to emails obtained by the Union of Concerned Scientists. Smith and industry groups such as the American Chemistry Council have argued that supporting data should be readily accessible to allow others to replicate the studies. Previously, more than 50 scientific societies, health organizations, and academic institutions had signed letters opposing Smith’s 2017 legislation, known as the Honest and Open New EPA Science Treatment Act.

Defending the proposed rule before the House Energy and Commerce Committee on 26 April, Pruitt said that studies could redact both confidential business information and personal information and still serve the purpose of the proposed rule. “It’s common sense that as we do rule-making, we base our actions on the record of scientific conclusions . . . and we should be able to see the data and methodology” that lead to those conclusions, he said, adding that the requirement would apply equally to studies that are paid for by industry and those that are not.

Smith noted that some federal agencies already require redaction of personal information that could identify human subjects. For cases in which redaction would limit the quality of datasets, he said, those who review the data could be required to keep the information confidential.

Many scientists say it’s not that simple. Much of the data in public health studies are obtained under confidentiality agreements that are difficult or impossible to modify retroactively. “It does not strengthen policies based on scientific evidence to limit the scientific evidence that can inform them,” wrote five science journal editors in a 30 April editorial in Science. “Rather, it is paramount that the full suite of relevant science vetted through peer review, which includes ever more rigorous features, inform the landscape of decision making.”