EPA’s Use of Scientific Studies Restricted
On March 19, 2018, Environmental Protection Agency (EPA) Administrator Scott Pruitt announced a new “science transparency policy” that restricts the scientific studies used in agency rulemakings. Under the policy, EPA will no longer use studies incorporating non-public scientific data in rulemakings, as has been its longstanding practice.
Administrator Pruitt has argued that the new policy is needed to prevent the use of so-called “secret science” that cannot be tested by third parties. In an interview published in The Daily Caller, Administrator Pruitt said:
“If we use a third party to engage in scientific review or inquiry, and that’s the basis of rulemaking, you and every American citizen across the country deserve to know what’s the data, what’s the methodology that was used to reach that conclusion that was the underpinning of what — rules that were adopted by this agency.”
According to Pruitt, if a study’s data and methodology are not published, “it’s not transparent. It’s not [able to be] objectively measured, and that’s important.” Others, however, point out that the studies undergo peer review. In an op-ed published in The New York Times, former top EPA officials Gina McCarthy and Janet McCabe wrote:
“Peer review ensures that the analytic methodologies underlying studies funded by the agency are sound . . .
[Administrator Pruitt] and some conservative members of Congress are setting up a nonexistent problem in order to prevent the E.P.A. from using the best available science. These studies adhere to all professional standards and meet every expectation of the scientific community in terms of peer review and scientific integrity.”
McCarthy and McCabe also emphasized that the new policy would restrict the studies able to be used in EPA rulemakings. They wrote:
“Some of [the] studies [at issue], particularly those that determine the effects of exposure to chemicals and pollution on health, rely on medical records that by law are confidential because of patient privacy policies. These studies summarize the analysis of raw data and draw conclusions based on that analysis. Other government agencies also use studies like these to develop policy and regulations, and to buttress and defend rules against legal challenges. They are, in fact, essential to making sound public policy . . .
For instance, foundational epidemiological research into the effects of air pollution on health by scientists at Harvard and the American Cancer Society established a clear connection between exposure to fine particles and increased mortality. This research led to further studies that supported the development of air quality standards and rules requiring industry to reduce pollution, improving health and reducing costs for millions of Americans.
Yet, because the personal health data associated with individuals participating in the studies were obtained with guarantees of confidentiality, Mr. Pruitt apparently would have argued for those studies to be tossed out had he been at the helm then.”
Update:
On April 24, 2018, Administrator Pruitt signed a proposed rule intended to implement the “science transparency policy.” The so-called Strengthening Transparency in Regulatory Science rule provides that, “when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.”
On May 17, 2018, E&E News reported that the proposed Strengthening Transparency in Regulatory Science rule “closely resemble[s]” proposals put forward by industry groups, including the National Association of Manufacturers and American Petroleum Institute.
On November 11, 2019 the New York Times reported that EPA was developing a new draft of its Strengthening Transparency in Regulatory Science proposal. The new draft reportedly contains provisions that would severely limit the scientific and medical research that can be used in agency rulemakings. As with the old draft, the new version of the rule would require that scientists disclose all of their raw data, including confidential medical records, before the agency could consider a study’s conclusions for regulatory purposes. Additionally, unlike the earlier version of the proposal, this new proposed rule could apply retroactively to public health regulations already in place. This would mean that studies that have been used for decades, such as those that show lead paint is linked to behavioral issues in children, might be inadmissible when these existing regulations come up for renewal.
On November 18, 2019, the Hill reported that EPA had repeatedly postponed a Science Advisory Board (SAB) meeting at which the proposed Strengthening Transparency in Regulatory Science rule was to be reviewed. The meeting was most recently scheduled for November 4 to 6, 2019, but was cancelled and not rescheduled. The Director of EPA's SAB staff office, Tom Brennan, indicated that the meeting would be delayed "until all new SAB members have been formally onboarded." However, critics allege that the delay is a "stall tactic," intended to prevent the SAB from reviewing the policy. Former SAB staff director, Chris Zarba, told reporters that "[t]here's always new people coming on board and there's always people leaving . . . [but that's] no reason not to go forward and no reason to hold up a review."
On March 3, 2020, Bloomberg Environment reported that EPA was looking at expanding its proposed Strengthening Transparency in Regulatory Science rule to apply to all "influential scientific information" even if that information is not used in regulatory processes.
On March 18, 2020, EPA published a Supplemental Notice of Proposed Rulemaking (SNPRM) in relation to its proposed Strengthening Transparency in Regulatory Science rule. The SNPRM proposes to, among other things, expand the scope of the rule to apply to all data and models underlying scientific studies that are relied on by EPA in promulgating significant regulatory actions and finalizing influential scientific information.
On April 28, 2020, EPA's SAB issued its final report on EPA's proposed Strengthening Transparency in Regulatory Science rule (as amended in the SNPRM). In the report, the SAB expressed broad support for increasing transparency in science, but raised several concerns about EPA's proposal. In particular, the SAB indicated that "key considerations that could inform the Proposed Rule are not present in the proposal or presented without analysis and explanation of scope. In addition, certain key terms and implementation issues have not been adequately defined or described. To provide clarity on the procedures for conducting the proposed efforts, the SAB strongly encourages the development of additional policy and/or guidance documents. In addition, the SAB has concerns about the scientific and technical challenges of implementing some requirements of the Proposed Rule." This language was omitted from an EPA press release discussing the report. The press release quoted only the two preceding sentences, in which the SAB expressed general support for transparency.
On January 5, 2021, EPA finalized the Strengthening Transparency in Regulatory Science rule. The final rule requires EPA, when using certain scientific studies, to "consider the availability" of the underlying data and "give greater consideration to studies where the underlying . . . data are available in a manner sufficient for independent validation." The rule has been widely criticized by scientists and others, who note that the rule will limit EPA's ability to rely on public health studies, where the underlying data contains study participants' confidential health or other information.