The Trump EPA appears to be doubling down on its proposal to limit scientific research used in rulemakings — a plan that could have far-reaching implications for agency regulations.
Simply put, the plan would require that EPA use only publicly available data when crafting regulations. Critics are blasting the effort to limit use of science in a wide range of EPA regulations affecting the environment and public health.
Yesterday the latest iteration of the rule, "Strengthening Transparency in Regulatory Science," began circulating in Washington, D.C. The New York Times first reported the leak. The proposal is intended to clarify the controversial plan first issued by former EPA Administrator Scott Pruitt in April 2018, according to the document shared by the Times and other news outlets, including E&E News.
This morning, EPA pushed back on the news reports, saying the leaked document was merely a draft — not the actual text submitted to the White House Office of Management and Budget, which reviews rules before they are released.
EPA declined to go on the record, but a spokesperson issued a statement saying the agency on Friday sent OMB a draft supplemental Federal Register notice to "clarify, modify and supplement certain provisions included in the 2018 proposed Strengthening Transparency in Regulatory Science rule." Around noon today, EPA issued a lengthy press release challenging multiple parts of the Times story, including the notion that the proposal was susceptible to political meddling or would affect existing regulations.
The statement said EPA would issue a final rule in 2020 after taking into account comments received on both the initial proposal and the recent supplemental notice, as well as those submitted to the Science Advisory Board.
EPA Administrator Andrew Wheeler has said the measure would help instill public trust in EPA decisions.
"I fundamentally believe that the more information we provide to the public, the better our regulations will be and the more they will trust our decisions," Wheeler told the House Science, Space and Technology Committee in September.
Tomorrow the committee will hold a hearing on the proposed rule. House Democrats and science advocates are expected to forcefully attack it (E&E Daily, Nov. 12).
The draft proposal's plan to bar agency officials from tapping scientific studies in crafting major new regulations unless the underlying research data "are publicly available in a manner sufficient for independent validation" is not a new idea.
Congressional Republicans — especially former House Science, Space and Technology Chairman Lamar Smith (R-Texas) — have for years alleged that the federal government depends on "secret science" in the rulemaking process. Science advocacy groups have protested.
The April 2018 draft, rushed through a review by the White House Office of Information and Regulatory Affairs in a matter of days, was riddled with gaps to be filled in later. (When asked, Chase Jennings, OMB press secretary, today called the 2018 review "thorough and expeditious.")
As late as this past July, for example, EPA officials were still trying to hammer out a precise definition of "validation," according to written answers provided to an agency advisory panel (Greenwire, Aug. 28).
Under the supplemental proposal, EPA would also replace the legal underpinning for its authority to impose the new requirements.
The original draft had listed the Clean Air Act and other environmental laws. Now, as "sole authority for taking this action," the supplemental proposal cites an obscure federal law giving the heads of executive branch agencies the latitude to set regulations for their respective departments, including those covering the use and preservation of records.
"This section does not authorize withholding information from the public or limiting the availability of records to the public," the provision says.
But an avalanche of science advocates have sought to debunk the idea on multiple fronts.
"This is not a scientific debate," said Michael Halpern, deputy director of the Center for Science and Democracy. "This is a political debate about whether EPA is going to be able to consider the best possible evidence. Let's see if the politics wins out here."
Critics, like Halpern, have stressed that the idea originated from the tobacco industry in the 1990s and is intended to prevent EPA from issuing regulations that industry finds cumbersome. Specifically, the Trump rule is seen as a way to weaken regulations for air pollution.
"The idea is that if we require EPA to make public the underlying data for these studies to be used, it would be a huge procedural hurdle to set more protective health standards," said Genna Reed of the Union of Concerned Scientists.
UCS obtained emails through the Freedom of Information Act showing staff at OIRA and EPA were corresponding just days before Pruitt held a ceremony to unveil the rule — further evidence, they charged, that the process was rushed and driven by politics (E&E News PM, April 24, 2018).
Clint Woods, then EPA's deputy assistant administrator, wrote on April 20, 2018, to EPA press staff, "Happy to work on some talking points for a release to accompany Tuesday's announcement."
Reaction and ramifications
Environmentalists have responded to the leaked draft with outrage.
"Only the anti-science zealots running the Trump EPA would dramatically limit use of human health studies when assessing toxins that harm human health," said Nathan Donley, a senior scientist at the Center for Biological Diversity.
James Goodwin of the Center for Progressive Reform said the plan "might be the single-most dangerous and outrageous action the Trump EPA has perpetrated." Similarly, Amit Narang of Public Citizen said the proposal would "force EPA to ignore bedrock science, not improve it."
But Susan Dudley, director of the George Washington University Regulatory Studies Center, downplayed the gravity of the proposal.
"No one is immune to the temptation to spin science to advance their policy goal," she wrote via email this morning. "Greater transparency could encourage more openness and constructive discussion about science and policy."
While the effort is aimed at curbing regulations of air pollution, it could undermine rules on lead and other contaminants in drinking water, said Ronnie Levin, a former EPA staffer who manages the water and health program at Harvard University's T.H. Chan School of Public Health.
"I am so angry, I am beyond having clever things to say," she said.
Much of the research on lead's health effects, for example, involved studying children with extremely high levels of lead in their blood, and validating those with new studies would be unethical because it would require exposing kids to higher doses of the toxin than they currently encounter.
"This is aimed at air pollution, but it applies to everything," Levin said. "Anything that isn't a rat study is out the door."
Some foes of Pruitt's original plan have presumed he was targeting ambient air quality standards for fine particulate matter, technically known as PM2.5 because individual particles are no wider than 2.5 microns in diameter.
Creation of the original standards was prompted in part by the famed "Six Cities" study published by Harvard University researchers in 1993. In a blog post late yesterday, Steve Milloy, who dismisses findings that PM2.5 represents a public health threat, cited reporting by the Times that the supplemental proposal would apply retroactively and that EPA had rejected an option that would allow continued use of the Six Cities study. If true, Milloy wrote, the study is "history and won't be used by EPA again. Fantastic!"
In today's statement, however, EPA said both the original draft and the supplemental proposal "will not apply to any regulations already in place" and would allow research like the Six Studies study to be taken into account in the future.
EPA is in the midst of a legally required review of the current PM2.5 limits. George Allen, a former member of the agency's Clean Air Scientific Advisory Committee, said in an interview this morning that the Six Cities study has been supplanted by more recent Harvard research examining PM2.5's health effects on tens of millions of Medicare recipients.
The underlying data is not private, Allen said, and the research could be replicated, although few organizations have the resources and expertise to do so.
This "puts EPA in a bind," Allen said. "I don't know if they've figured that out."
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