What is Scott Pruitt’s “secret science?:” an in depth analysis of the EPA proposed rule “Strengthening Transparency in Regulatory Science”

In April 2018, the EPA proposed a rule titled, “Strengthening Transparency in Regulatory Science.” The goal of this rule is to make data for “pivotal regulatory science” available to the public for “independent validation.” Supporters of the rule cite that billions of dollars that will be saved upon removing unnecessary regulations. Opponents are worried that since public health studies don’t publish the identity of their study subjects, the EPA will no longer use public health studies to craft their industry regulations.

Ironically, the transparency rule is filled with misdirection and oblique language. Instead of directly stating the purpose of the rule, the document begins with praise for the EPA basing regulatory decisions on the “best science available,” the benefits of data sharing in general, and then transitions into the reproducibility crisis in science. To the casual reader, the case seems like an attempt to generally improve the science that goes into policymaking. Who can argue with using the best science available?

Upon close inspection, clues are revealed for the actual purpose of the proposed rule. The main targets for this transparency rule are “dose response data and models,” which are specifically related to the quantitative relationship between the amount of “pollutant, contaminant, or substance” and the undesirable health or environmental impact. Conveniently, the proposed rule does not apply to models designed to “predict costs, benefits, market impacts and/or environmental effects of specific regulatory interventions on complex economic or environmental systems.” Furthermore, the market impact quote was buried in the “request for comments” section of the rule. I can only imagine concerned EPA scientists attempting to alert the public to this distinction while also following the orders of their agency. Together, these clues indicate that the purpose is not to use the best science available, but to cherry-pick or even suppress studies that are directly related to human health.

In summary, the transparency rule:

  • Markets itself as a way for the EPA to be better informed about scientific studies.
  • Indicates that the only science the rule is targeting is the toxic concentrations of pollutants.
  • Would potentially save billions of dollars in regulatory compliance for industries, by ignoring the public health studies that set the standards.
  • Since their data contains confidential patient information that scientists have historically refused to give up.  

Another disconcerting note is that the language used to describe the transparency problem is much stronger than the language used to describe risk mitigation for patient confidentiality. Strong active verbs describe the apparent crisis in public health data presentation, but language describing risk mitigation of obvious confidentiality concerns is noncommittal. The “EPA should (not will) collaborate with other federal agencies to identify strategies to protect confidential…information.” The strategies “may also include: requiring applications for access; establishing physical controls on data storage; online training for researchers; nondisclosure agreements.” Well, which ones are best? There has been a lot of thought into how to get this rule passed, but not much thought put into how to protect the identities and futures of the human beings on which these sensitive public health publications are based.

Not the first battle between “secret science” and public health: the Six Cities study and the origin of  legislating “secret science”

The 1993 Six Cities study from the Harvard T.H. Chan School of Public Health, on which the Clean Air Act amendments were partially based, found fine particulate matter was a huge risk factor for premature death. The Clean Air Act was expensive and complicated for industry to comply with and they responded with protests demanding, “Harvard, release the data!” Industries, such as manufacturing, power, steel, and auto waged an expensive war on public opinion (very reminiscent of the tobacco industry’s plight), attempting to discredit the EPA and the science by suggesting the authors were hiding secret data. The war was successful in that it prompted congress and some governors to also demand the release of the data. The war failed because the scientists held their ground. The data was collected on the grounds of confidentiality. Not only would releasing the data break that bond, but it would discourage people from participating in sensitive studies in the future. In addition, the scientists were worried that the released data could be manipulated by “biased groups” to attack and undermine the results of the study.

The scientists of the Six Cities study had a right to be concerned. Two decades after publication, Congressman Lamar Smith, subpoenaed the EPA for the long-contested data and accused the agency of using “secret science” to enact regulations. When the EPA Administrator Gina McCarthy stalled on the release citing much of the data was “held solely by the outside research institutions,” Rep. Smith responded “I will not hesitate to pursue all other means available to compel production of the relevant data.” Those “other means” meant constant hearings, press releases, and legislation such as the EPA Science Advisory Board Reform Act of 2013, Secret Science Reform Act of 2014, Secret Science Reform Act of 2015 (specifically demanding EPA transparency) and the HONEST Act of 2017.

When Gina McCarthy was replaced with Scott Pruitt, Lamar Smith set up up a meeting with the new EPA administrator in early January 2018. Emails were exchanged in February between the offices of Pruitt and Rep. Smith describing a “pitch that EPA internally implement the HONEST Act” by preventing regulation unless “scientific data is publically available for review.” A few short months later, Strengthening Transparency in Regulatory Science was born.

So, finally, I can answer, “what is Scott Pruitt’s secret science?” The answer is: it’s not Pruitt’s secret science at all. It’s Lamar Smith’s secret science based on a decades-old fight between industry and public health patient confidentiality. But what is Lamar Smith’s motive? Confidentiality is one of three main pillars of ethical research along with informed consent and external review by the Institutional Review Board. And the reason Lamar Smith, Scott Pruitt, and industry lobbyists want to erode this pillar of ethical research is for “independent validation” of the data. However, the Six Cities data was handed over to a third-party, the Health Effects Institute (HEI), for reanalysis. It took three years, but HEI finally concluded in 2001 that the original results were verified. Furthermore, the air pollution results from Six Cities, have been independently and globally validated by other research institutions since the contested publication. Since Lamar Smith is still actively campaigning against “secret science” despite this data validation, it suggests “independent validation” is not his actual goal.

What is the goal? By following the history of this issue we can hypothesize that his goal is to undermine scientific institutions for personal gain. Now, this is not a Republican problem. President Richard Nixon, a Republican, founded the EPA. However, we cannot ignore the multifaceted attack on institutions that uphold truth, such as the free press, law enforcement (FBI) and science. By confusing the purpose of these institutions, politicians can create whatever reality they see fit. Whatever reality that is convenient for their political aspirations and financially benefits their donors.

Thankfully, this is still a democracy. When we pay attention to the rules and legislation our electorate are proposing, we can keep an eye out for potential corruption and make our opinions known. The commenting period for strengthening “transparency” in regulatory science has been extended until August 17th. Please let Scott Pruitt know that he can’t fool us. We know this rule will not strengthen transparency in science, and it will allow the EPA to ignore the public health studies, the result of which, will directly harm the American people.