New EPA plans to limit “secret science” in policy making could unravel the agency’s decades-old approach to crafting environmental protections, both supporters and critics of the proposal said.

The Environmental Protection Agency April 24 proposed a rule barring secret science, or what Administrator Scott Pruitt described as scientific research including data that isn’t or can’t be made public. This includes epidemiological studies, which use private medical information that researchers are required to keep confidential.

The proposed rule focused on data used in “pivotal regulatory science,” which the EPA defines as studies that drive cost-benefit calculations and air quality standards. The rule would allow the administrator to exempt specific policy efforts from these restrictions.

“This could affect virtually every risk assessment or regulatory action based on science that EPA takes. The impact could be huge. I hope that it is huge,” Steven Milloy, founder of JunkScience.com, told Bloomberg Environment April 24.

“Air quality standards are going to be frozen,” Milloy, a conservative advocate who was on the Trump administration’s transition team, added.

Justifying Regulations

Secret science opponents have long attacked two studies known as the Harvard Six Cities study and the American Cancer Society study, both of which showed that long-term exposure to fine particulate matter—a widespread air pollutant emitted from fossil-fuel combustion—causes increased mortality and other negative health impacts.

The studies use individual medical data that can’t be made public, and that would be prohibited from agency use under the EPA’s new plans.

Excluding such studies paves the way for rolling back standards for fine particulate matter, as well as other air quality and climate regulations—especially ones that build on the public health dangers of breathing fine particle pollution.

“Particulate matter drives us to control other things,” John Bachmann, former EPA director for science policy in North Carolina, told Bloomberg Environment.

“EPA has been justifying the cost-benefit of a lot of their standards with studies like this that have been analyzed and replicated,” he said. “And the benefits are way bigger than the costs.”

EPA initiatives that consider the public health benefits of controlling fine particle pollution include the air toxics program, regulations on oil and gas operations, and carbon controls for existing power plants known as the Clean Power Plan.

“Every time the EPA does a significant air pollution rule, it has to do a cost-benefit analysis,” Janet McCabe, former acting EPA air office chief in the Obama administration, told Bloomberg Environment.

If these studies are off limits, she said, it could significantly alter the monetized benefit that EPA looks at in any air quality or climate proposal.

Studies’ Validity

Industry groups have long challenged the validity of the Harvard Six Cities and the American Cancer Society studies, even though an independent third-party study, conducted by the Health Effects Institute—which is co-funded by EPA and industry—successfully reproduced results from the two studies from scratch.

Other research groups also have confirmed those results. Most recently, a 2017 Harvard T.H. Chan School of Public Health study based on data from more than 60 million Medicare recipients showed that long-term particulate matter exposure, even at levels below current EPA standards, strongly increased the likelihood of premature mortality.

Even though Medicare data is confidential and protected, however, any reputable scientist in academia or industry can request that data from the government to conduct their own independent analyses, Bachmann said.

Potential Pushback

Outside groups and lawmakers are warning that the EPA’s proposal is based on shaky legal ground.

It could be difficult “to argue that it is not arbitrary and capricious to exclude studies which are informative and carried out under the standards of the scientific discipline from use in rulemaking,” Joseph Majkut, director of climate policy at the nonprofit Niskanen Center, told Bloomberg Environment April 24.

Senate Democrats also are questioning the legality of the EPA’s proposal.

“Such a policy would likely violate several laws that mandate the use of ‘best available science,’ including the Toxic Substances Control Act and Safe Drinking Water Act because it would require EPA to ignore some of the ‘best’ scientific studies,” seven Democratic senators, including environment committee ranking member Tom Carper (Del.) wrote in an April 24 letter to Pruitt.

Pruitt did not ask the agency’s Science Advisory Board for input on whether it’s appropriate to redact confidential patient information from epidemiological studies, much less for input about the proposed rule, Christopher Frey, SAB member and professor of environmental engineering at North Carolina State University, told Bloomberg Environment.

“This is exactly the kind of thing where, if you want to find out how science is done, you get input from the science advisers,” Frey said.