More than a year after EPA leaders ignited a firestorm with a plan for limiting the agency’s use of scientific research, they still have no clear answers on how fundamental aspects of the proposed regime would work, according to an update recently provided to an independent advisory panel.
The proposed rule, titled "Strengthening Transparency in Regulatory Science," would bar the agency from tapping scientific studies in crafting major new regulations unless the underlying research data "are publicly available in a manner sufficient for independent validation," according to the text.
But agency staffers are still working on a precise definition of "validation," they wrote last month in response to questions from Science Advisory Board members who are reviewing the proposal. Also up in the air is the scope of the term "data," how the agency will handle data sets created long ago, and the criteria for allowing the EPA administrator to grant exemptions to the rule’s requirements, the unsigned responses indicated.
Frustration about the lack of information repeatedly surfaced during a board conference call yesterday.
"We don’t really have any detail to react to, and so it’s a real mystery as to what we might be agreeing to or not agreeing to," said Janice Chambers, a science professor at Mississippi State University.
The call’s ostensible purpose was to address EPA’s request for a "consultation" on a thorny issue surrounding the draft rule: What mechanisms are available for safeguarding trade secrets and the personally identifiable information of study subjects while still meeting the proposal’s disclosure requirements?
Following the lead of agencies like the National Institutes of Health, EPA is considering a "tiered" approach for access to personally identifiable information. The more sensitive the data, the tighter the access, meaning such information would be off-limits to the general public, Maria Doa, an EPA senior science adviser, told board members.
"You would restrict it to those who would be qualified," Doa said. EPA is working with the Centers for Disease Control and Prevention on a pilot study on handling data sets in a "restricted use environment"; the agency has also paid for an outside evaluation of what’s needed to "optimize" public access to research data while protecting personal information.
Some SAB members voiced qualified approval for the tiered approach.
"Yes, it will work," said Richard Williams, a consultant and retired government economist, noting that the IRS has found ways to cloak taxpayer data for research purposes. "It’s just a question of how do you do it."
But Steven Hamburg, chief scientist for the Environmental Defense Fund, asked why EPA had not done an advance analysis on the proposed rule’s implications, given that other federal agencies are already addressing such issues.
"That analysis was not part of the rulemaking," Doa said. When Hamburg asked why it wasn’t, she replied that the proposal’s developers thought the regulatory text would clearly indicate "what is in and what is out."
"That’s the extent I can talk to that," Doa said.
Then-EPA Administrator Scott Pruitt unveiled the draft rule in April 2018, saying more openness would bolster confidence in the agency’s regulatory decisionmaking. The agency hopes to issue the final version by December.
The proposal, however, is based on legislation unsuccessfully pushed by congressional Republicans. Detractors say its true purpose is to exclude research that might help justify the need for stricter regulations.
The 45-member SAB is charged with providing outside expertise to EPA on a range of scientific and technical issues. Current agency Administrator Andrew Wheeler had sought the consultation on the handling of trade secrets and personally identifiable information in April. On its own initiative, the board is also pursuing a broader review of the entire proposal, although that assessment is now likely to take longer than expected (E&E News PM, Aug. 22).
The proposal has faced an onslaught of criticism from scientific, public health and environmental groups. During the portion of yesterday’s three-hour call set aside for public feedback, the panel heard repeated calls to push back.
"Your answer to EPA should be that it is impossible to be certain that privacy protections would not be violated, so approving this approach would eliminate the use of the best research to support EPA regulation," said Roy Gamse, who served in top posts at the agency from 1977 to 1981. "It should be rejected."
Under SAB procedures, a consultation skirts the need for the board to come to a consensus on addressing the issues raised by Wheeler. Instead, members will provide individual responses that will be pulled together into a report. Board Chairman Michael Honeycutt, a senior official with the Texas Commission on Environmental Quality, set a Sept. 13 deadline for members to submit their comments to the SAB Staff Office.