• In the Name of Transparency: EPA’s Proposed Rule to Limit Scientific Studies Raises Concern
  • May 16, 2018
  • On April 24, 2018, U.S. Environmental Protection Agency Administrator Scott Pruitt proposed a rule to impose limitations on what scientific studies may be used by the agency to promulgate regulations. Mr. Pruitt seeks to exclude from the agency’s consideration any scientific studies that contain confidential data on the grounds that the agency ought to be transparent about the information it relies upon in crafting regulations. The proposed rule has garnered support from certain scientific organizations, like the American Chemistry Council, but other scientific and public health groups have criticized the move as one that will hinder the EPA from relying on the best available scientific evidence.

    According to the Environmental Defense Fund, a similar rule was proposed by bill in 2015, and at that time, the Congressional Budget Office found that such a rule would effectively reduce by half the number of studies the agency relies upon. The reduction would be created by conflict with other privacy laws and agreements on personal and proprietary information as well as costs of compliance.

    In order to justify its policies and regulations, the EPA typically relies on scientific findings of adverse effects on human health or the environment. For example, in 1993, a significant study by Harvard University found that fine particulate air matter was linked to premature deaths. The findings in Harvard’s study were made possible in part by the fact that its scientists had collected personal data from people that they promised to keep confidential. Relying on this study, the EPA promulgated several regulations regarding particulate air matter to guard against premature deaths. Critics of Mr. Pruitt’s proposed rule claim that if it is promulgated, researchers will find it difficult to recruit study participants, even if they pledge to redact private information. Furthermore, reliance on existing studies that contain confidential information will be hindered.

    While the proposed rule will allow third parties to test and replicate the findings of existing studies, the Union of Concerned Scientists does not believe that many studies can be replicated: “Many public health studies cannot be replicated, as doing so would require intentionally and unethically exposing people and the environment to harmful contaminants or recreating one-time events.” In addition, former EPA Administrator Gina McCarthy stated that, “The best studies follow individuals over time, so that you can control all the factors except for the ones you’re measuring, but it means following people’s personal history, their medical history. And nobody would want somebody to expose all of their private information.”

    According to the Environmental Protection Network, an organization comprised of former EPA employees, many of the older EPA studies relied on data that the agency has either not maintained or that has been stored in outdated formats. There is currently no estimate for how much it would cost the EPA to obtain these studies, redact confidential information, and then disseminate the studies. However, in response to a similar bill that had been proposed in 2015, as mentioned above, the Congressional Budget Office had projected that initial compliance would be approximately $250 million, and provided a wide range of $1 million to $100 million to comply annually thereafter.

    The proposed rule also faces legal challenges. In 2002, the U.S. Court of Appeals for the District of Columbia responded to a request by industry petitioners to require EPA to publicize data underlying its studies by stating the EPA was not legally required to do so: “More generally, we agree with EPA that requiring agencies to obtain and publicize the data underlying all studies on which they rely ‘would be impractical and unnecessary.’”

    However, unlike in 2002, the EPA now itself seeks to require that it publicize the studies on which it relies. Courts typically grant broad deference to agency rule makings, so it is possible that this rule will pass judicial review.

    The EPA is accepting comments on the proposed rule until May 30, 2018. We’ll continue to monitor and report on developments.