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Higher ed associations and scientific societies in recent weeks have joined a chorus of opposition to a proposed Environmental Protection Agency rule that would limit the use of science for crafting regulations where all underlying data aren’t publicly available.

The proposal fits into a decades-long debate over what data should be made public from research that informs government policy making. More recently, arguments for data transparency have been wielded by critics of environmental regulations, such as Representative Lamar Smith, the outgoing chair of the House science committee who has been a vocal opponent of new environmental regulations.

The agency says the proposal, which was announced in April, would ensure it pursues its public health mission in a manner the public can trust and understand. But university and medical groups that back scientific research say the rule would prevent EPA from using the best research available. The proposal could have huge implications for issuing regulations under environmental laws like the Clean Air Act.

“It codifies into regulation the ability to ignore important, credible and, in many cases, federally funded peer-reviewed studies because the data don't happen to be available,” said Heather Pierce, senior director for science policy and regulatory counsel at the Association of American Medical Colleges. “That can happen for many legitimate reasons.”

There’s good reason that data from many important studies cannot be made available to the public, Pierce and other critics say. Landmark studies linking air pollution to harmful health effects, for example, involved the study of large numbers of subjects promised anonymity as a condition of their participation. De-identifying those subjects would not be simple or inexpensive. And many individuals would not consent to being studied if their names and health histories later became public.

AAMC, along with the Association of American Universities, the Association of Public and Land-grant Universities, and the Council on Government Relations wrote to Acting EPA Administrator Andrew Wheeler this month urging that the proposed rule be dropped.

“The goals of open science are not advanced through this proposal, which does not provide incentives, funding, or infrastructure for increasing access to data, but simply allows the Agency to disregard important, ethical, well-designed and executed studies,” the groups wrote.

Rush Holt, president of the American Association for the Advancement of Science, and Drew Gilpin Faust, former Harvard University president, have also registered their opposition in separate letters to EPA.

Since the agency sought public comments on the proposal, more than 200,000 comments have poured in to the Federal Register.

Critics have noted the new EPA rule is backed by industry groups that have opposed regulatory activity. Conservative outfits like FreedomWorks and the Competitive Enterprise Institute have backed the proposal as well.

The National Association of Scholars, a conservative education advocacy group, said the proposed rule will address concerns about a reproducibility crisis in modern science.

“To a woeful extent, the scientific establishment in the United States has proved to be a poor guardian of the quality of scientific research, especially in situations where (A) a large amount of federal research funding is in play, (B) significant public policy decisions hang in the balance, and (C) fixed ideological goals have been set forth,” wrote Peter Wood, the group’s president, in a May letter to former EPA administrator Scott Pruitt.

The fight over transparency requirements for research used in EPA rule making goes back nearly two decades, to the inclusion of the Shelby Amendment in a 1999 omnibus appropriations bill. That language required that members of the public be allowed access through the Freedom of Information Act to data produced by federally sponsored research projects.

The issue became even more heated when Smith took over the gavel of the House Science Committee in 2013. In that position, the San Antonio Republican has issued subpoenaed EPA data used as the basis of air pollution regulations. And he has repeatedly introduced the Secret Science Reform Act, which would ban the agency from issuing regulations where underlying data are not completely transparent. The proposed EPA rule reflects many elements of the legislation.

Many researchers have for years pushed for more transparency from within the scientific community, arguing that research and data should be more accessible to the public and more reproducible.

Slate noted that the proposed EPA rule has put members of the open-science movement in an awkward spot. The EPA has said its proposal accounted for recommendations from groups advocating for open science. But researchers whose work was cited by the agency have pushed back against the proposal.

One researcher whose work was cited, John Ioannidis, responded that if the proposed rule is approved, “science will be practically eliminated from all decision-making processes. Regulation would then depend uniquely on opinion and whim.”

And while Brian Nosek, a co-founder of the Center for Open Science, has said policy makers should know how transparent data are, he warned that the proposal “converts transparency from a principle for improving science into a weapon that undermines it.”

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