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Aug2018

As I reported in an earlier post, on April 30, 2018, the Environmental Protection Agency (EPA) published in the Federal Register a proposed rule titled, Strengthening Transparency in Regulatory Science. The rule would prohibit the EPA from basing regulatory action on scientific studies for which the underlying raw data and models are not publicly available “in a manner sufficient for validation and analysis.” The due date for comments was originally May 30, but after an outcry from the scientific, conservation, and public health communities, the date was extended to August 16.

As a nonpartisan organization dedicated to advancing the highest ethical standards in the conduct of research that advances human health and well-being, PRIM&R decided it was important to comment on this proposed rule, detailing two main concerns. First, we believe that, far from enhancing transparency, the proposed rule arbitrarily restricts access to and use of rigorous, peer-reviewed science in environmental policymaking, to the detriment of the public’s health and trust in the regulatory process. Second, we argue that the proposed rule fails to respect the contributions of human research participants. We urge EPA to withdraw this misguided rule immediately.

With respect to the first concern, we point out the fallacy of equating support of transparency, reproducibility, and open science with the view that scientific data that are not publicly available are therefore unreliable and useless. There are legitimate scientific and ethical reasons why data underlying a study’s findings may not be publicly available, including reasons related to the technology available at the time of data collection, outdated formats in which data sets from older studies are stored, and promises made to protect the privacy of individual study participants. None of these are attempts to keep scientific data “secret,” as proponents of the proposed rule would have us believe. The proposed rule would disqualify high-quality, peer-reviewed studies from use in policymaking, preventing EPA from basing environmental policy on the best available scientific evidence. Furthermore, by promoting an opaque and arbitrary evidence base for policymaking, the proposed rule will erode public trust in the EPA and its regulatory processes.

With respect to the second concern, we point out that the proposed rule is retroactive and would thus prohibit the EPA from considering studies completed before the effective date of the rule for which the underlying data are not publicly available. This means rejecting the contributions of thousands of individuals who—for the benefit of future generations and to advance the public good—agreed to take part in research. Many important public health and environmental studies have taken place after one-time events and natural disasters, such as Hurricane Katrina or the Deepwater Horizon oil spill. Individuals who live through such events and agree to participate in research deserve to have their contributions recognized without compromising their privacy; the proposed rule ignores this obligation.

Furthermore, the proposed rule fails to acknowledge that large-scale public health and environmental studies of the sort that inform EPA policy typically collect sensitive health data and other information from individuals, sometimes over a long period of time, in an effort to determine the influence of environmental factors on health and well-being. People who agree to be in such studies are assured that their information will be kept confidential and their privacy protected. In proposing to redact private information, the proposed rule fails to acknowledge the enormously burdensome and costly complexities involved in redacting such information in a way that both protects individuals’ privacy and ensures that the data is still useful for future analysis. In our comments, we detail how these concerns are particularly relevant to the study of how exposure to pollutants affects vulnerable populations, including economically disadvantaged communities, the young, and the elderly.

Finally, we remind EPA that, though the scientific community is already using a range of mechanisms to meaningfully share study data and ensure participant privacy protections, these mechanisms are not appropriate for all types of research, and executing them can be resource-intensive. The proposed rule fails to recognize that the research needed to inform EPA’s decision-making is heterogeneous, and that for some types of research, making underlying data available is neither feasible nor ethical.

Let us know what you think of PRIM&R’s comments. And note that you still have time to submit comments on the proposed rule; if you are interested in doing so, please feel free to borrow from PRIM&R’s comments—we’ve made them available to members of our community. Comments can be submitted at https://www.regulations.gov, with reference to Docket ID No. EPA-HQ-OA-2018-0259.

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