Critics of proposed data disclosure rule suggest it could undermine effective rulemaking.
The U.S. Environmental Protection Agency (EPA) is poised to self-impose stringent new limits on the use of science in its regulatory decisions.
The agency has proposed a new rule that would prohibit its rule-writers from relying on scientific studies for which the underlying data are not publicly available. The agency’s stated purpose for the rule—to enhance the “transparency and validity of the scientific information relied upon by EPA”—seems uncontroversial. But critics argue that the proposed rule could prevent the agency from relying on crucial science that might be unable to meet the rule’s stringent disclosure standards.
The proposed rule would require the disclosure of all data and models underlying “pivotal regulatory science,” defined as studies that are “critical to the calculation of a final regulatory standard or level or to the quantified costs, benefits, risks and other impacts on which a final regulation is based.” As originally proposed, the disclosure requirement was limited to so-called dose-response studies, which measure the effects of exposure to toxic chemicals on human subjects. A recently leaked document appears to suggest, however, that the agency intends to expand the rule’s scope to encompass all scientific studies.
The proposal was put forward initially as a major initiative of the agency’s embattled former administrator, Scott Pruitt, who resigned in July 2018 amid multiple corruption scandals. “The era of secret science at EPA is coming to an end,” Pruitt said in a statement accompanying the regulatory proposal, adding that “Americans deserve to assess the legitimacy of the science underpinning EPA decisions that may impact their lives.”
The proposed changes have prompted extensive backlash from prominent members of the scientific community. The editors of four leading scientific journals—Science, Nature, the Public Library of Science, and the National Academy of Science—issued a joint statement expressing concern that the proposed rule failed to account for cases where the underlying data cannot be shared, such as studies involving personal identifiers.
“Excluding relevant studies simply because they do not meet rigid transparency standards will adversely affect decision-making processes,” the journal editors wrote, noting that study validity can be assessed based on other factors such as “articulation and logic of the research design, the clarity of the description of the methods used for data collection and analysis, and appropriate citation of previous results.”
In its proposed rule, EPA argued that “concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the federal government.” It noted that federal agencies have developed various “tools and methods” to deal with the problem, including “simple data masking, coding, and de-identification techniques.”
Other critics have suggested that the proposed rule is unnecessary given EPA’s existing robust transparency laws. The critics have expressed concern about the scope of discretion granted under the proposal to the agency to determine which science could be used in rulemaking. “Science should inform decision-making, not be cherry-picked without sound reasoning for exclusion,” they have written.
EPA’s proposed rule echoes earlier proposals by Republican lawmakers to limit the use of so-called secret science in agency rulemaking, including a 2017 bill that would have imposed similar disclosure requirements. U.S. Senator Mike Rounds (R-S.D.), who co-sponsored that bill, praised the current EPA administration for wanting to ensure that “decisions are not made behind closed doors with information accessible only to those writing the regulations, but rather in the full view of those who will be affected.”
Democratic Senators, however, have suggested that the rule could run afoul of several federal laws, including the Toxic Substances Control Act and Safe Drinking Water Act, which stipulate that agencies must use the “best available science.” They also argued that the rule would violate the Administrative Procedures Act’s requirement that agencies consider and respond to all information submitted during rulemaking procedures.
After receiving nearly 600,000 public comments on its proposed rule, EPA moved the proposal to its long-term regulatory agenda in fall 2018. At that time, an agency spokesperson said the move was “not a delay” and indicated that the “agency is continuing its internal rulemaking development process for this action.”
That process appears to have borne fruit. In November, the New York Times published a leaked EPA draft supplemental proposal that suggests the agency is planning to expand the scope of the rule significantly. The leaked document also indicates, however, that the agency may be considering more flexible options.
The leaked draft would expand the proposed rule to include “all data and models, not only dose-response data and dose-response models.” But it also solicits input on two alternative approaches to data disclosure. The first would allow the agency to weigh the public disclosure of data as a factor in deciding whether to rely on a study. The second would still require disclosure of all data underlying pivotal regulatory science, but would provide for “tiered access” to data containing proprietary information or personal details that cannot be anonymized.
Responding to the leak, EPA confirmed that it had submitted a supplemental proposal to the U.S. Office of Management and Budget for its review, but the agency press office also stated that the leak involved “preliminary, draft documents that are not accurate and do not include the final text.” The agency also clarified that comments on the supplemental proposal would eventually be incorporated into any final rule.
Recent statements by EPA Administrator Andrew Wheeler indicate the supplemental proposal could be ready to release in early 2020. The agency has also moved the proposed rule off its “long term actions” list, suggesting that it plans to act soon.