NCHR’s Comments on EPA’s Supplemental Notice of Proposed Rulemaking on Strengthening Transparency in Regulatory Science

May 18, 2020

National Center for Health Research’s Public Comments on  EPA’s Supplemental Notice of Proposed Rulemaking on Strengthening Transparency in Regulatory Science
[Docket Number EPA-HQ-OA-2018-0259]

We are writing to express our views on the Environmental Protection Agency’s (EPA) Supplemental of Proposed Rulemaking on Strengthening Transparency in Regulatory Science. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety.

The EPA has a responsibility to protect both the environment and public health using the best and most current available scientific evidence. However, this proposal, and the expansions outlined in the supplemental proposal, would undermine the availability of accurate scientific information. This would seriously limit EPA’s ability to fulfill its mission of protecting the environment and public health. We are strongly opposed to this proposed rule and the expansions of the supplemental proposal for the following reasons:

1.    The proposed rule requires that all data and information are accessible to the public. While public access is important, as written this would result in excluding many well-designed studies that contain private medical information that cannot ethically be made publicly available, because to do so would jeopardize the privacy of study participants’ medical data and possibly other information. Researchers should not be forced to choose whether to protect the privacy of participants’ data or to make their findings applicable to the EPA. Similarly, the data from some studies may not be fully accessible to the public because they contain confidential business information, intellectual property, or because the authors or data sources are no longer available for older studies. If EPA were to ignore findings from studies with private data, many high quality research findings could not be considered, which would weaken the basis of EPA decision-making. There is no scientific basis for discounting such findings, and valuable research would be suppressed, harming the public health.

2.    The proposed requirement for reanalysis has no exceptions for urgent public health situations. It would unduly delay the use of information from important, well-designed studies that could benefit public health. For example, if a community is at risk because of a pollutant, it would be dangerous and unethical to delay acting on the information that a study conducted in that community provides. Delaying action in order to reanalyze data would allow additional exposure to the pollutant, furthering a public health crisis there are possibly in other communities as well. The requirement for reanalysis would delay and hinder the dissemination of scientific information that could be used to protect public health. If reproduction was more broadly interpreted to include replication, it would create even further delays and would be potentially impossible when studies are based around an event, such as an industrial accident.

3.    The expansions named in the supplemental proposal would allow the rules regarding transparency to cover not only regulatory science, but also scientific information that is deemed influential and that informs agency regulations. This is troubling because it would further limit quality science from informing EPA’s policymaking. For any proposal with broad implications, there is a need to provide very explicit definitions for the proposed concepts such as “influential scientific information” and to define what are the constraints under which a study is deemed capable of being reproduced.

4.    It is deeply concerning that this proposed ruling is being considered for application to studies that have already been completed before the effective data of the ruling. To retroactively apply rules to data would mean the exclusion of studies that were unable to be designed with the new rules in mind, because the rules did not exist at the time of data collection. Excluding potentially valuable studies would hinder EPA’s ability to draw from scientific data, such as older studies, that are vital to making decisions.

5.    The EPA administrator should not be granted the authority to decide on a case-by-case basis whether or not studies should be included in EPA decision-making. To do so would grant the administrator the authority to effectively decide what should be considered the best available science relevant to decision-making. The decisions of what are and are not the best scientific data are decided through the scientific process and peer review, and a single person should not have the power to decide what scientific evidence is relevant to EPA.

The proposed rulemaking would greatly hinder the use of the best available scientific information that would serve the public. The result would provide industry with opportunities to question legitimate studies that indicate their products are causing harm to our nation’s citizens. Under the guise of transparency, the proposed rule and its expansions would prevent the EPA from using the best available science. There is no legitimate scientific basis for this proposal, which would disproportionately reduce the impact of key research findings that could save lives. It fails to improve transparency among the broader scientific community or between EPA and the public. We therefore strongly urge the rejection of this proposed rule and its expansions under the supplemental proposal.

The National Center for Health Research can be reached at or at (202) 223-4000.