On March 18, the Environmental Protection Agency (EPA) published Strengthening Transparency in Regulatory Science Supplemental Notice of Proposed Rulemaking (the Supplement). This Supplement alters the scope  of the original “Strengthening Transparency in Science” rule (the Original Rule) proposed by the EPA in 2018. The Agency initially opened the floor for public response to the Supplement for the legal minimum of 30 days after publishing, but extended the deadline to 60 days after receiving criticism about the narrow response window, given the COVID-19 pandemic. PRIM&R joined a number of organizations and members of the public in submitting comments critical of the Supplement. Read our full comments here.

As we explained regarding the Original Rule on Ampersand back in 2018:

“…the proposed rule is ‘designed to increase transparency in the preparation, identification, and use of science in policymaking.’ On its face, this sounds good. Many of us support the idea of increased transparency in science—and, in particular, data sharing—as a means to shoring up accountability for the use of public funds and resources, promoting reproducibility, augmenting the impact of resources spent on science and research, and enhancing public trust in and support for science as an endeavor that helps to improve human lives. Indeed, many of these concepts are specifically cited in the proposed rule notice.

However, many in the scientific community are expressing deep concern that this proposed rule is actually a way for EPA to limit the types of science it can and will use in regulatory decision-making, to the detriment of environmental policy and the public’s health.”

[We delved deeper into the history of this rule in the April issue of the PRIM&R Member Newsletter. Become a member to learn more about the politics and policy behind the EPA’s efforts.]

At the heart of the Original Rule was the definition of transparency, which the EPA has chosen to define as studies whose underlying data is fully public. As we said in our previous blog post, it is a fallacy to “[equate] support of transparency, reproducibility, and open science with the view that scientific data that are not publicly available are therefore unreliable and useless.”

The Supplement has two primary aims. First, instead of disqualifying the use of all studies using non-fully-public data, it will deprioritize that science. Though this is theoretically a more flexible criterion for choosing which science to use, it does not prevent the Agency from, in practice, fully eliminating the use of those studies, which have been essential in the creation of vital public health policies.

Second, the Supplement would expand the scope of the rule by having it apply to not only the science used to create regulations (as the Original Rule stipulated), but to “all influential science” that may impact regulations or even private sector decisions. In order to comply with basic privacy protections, the Original Rule suggested that science whose data wasn’t already fully public could have its sensitive information redacted. At best, this process would be immensely burdensome for researchers to apply to data, especially retroactively to already-completed studies. At worst, redaction sufficient to comply with the EPA’s mandates may render some public health science completely unusable. Expanding the amount of research that these mandates apply to, as the Supplement does, exacerbates our original concerns significantly.

Further still, mandating that scientific data be public leaves potential human subjects of research with an uncomfortable choice: take part in studies that may compromise their privacy and confidentiality, or lose the opportunity to participate in science for the betterment of human health altogether. Undermining potential subjects’ confidence that their information will be protected skews the already unfavorable relationship between risk and benefit of participation in research. This will likely reduce the population of people willing to participate in research, which will severely hamper the conduct of science.

The proposed Supplement subverts the aims of scientific transparency in a manner that potentially harms public health, increases time and resource burdens on scientists, and threatens to reduce the ability of researchers to recruit study subjects. PRIM&R joins stakeholders in urging the EPA to reconsider the rule, so that vital, potentially life-saving research may continue.

Read PRIM&R’s full comments to the EPA here.