Health professionals; scientists oppose “transparency” rule

The Senate Environment and Public Works committee held a hearing on EPA’s “Implementation of Sound and Transparent Science in Regulation.” EPA proposed a rule “Strengthening Transparency in Regulatory Science” on April 30, 2018.

In response, Dr. Tracey Woodruff, Professor and Director at the University of California, San Francisco Program on Reproductive Health and the Environment, gave this statement: “It is extremely concerning that the Senate hearing witnesses do not reflect the consensus in the scientific and medical community– which overwhelmingly recommended that EPA withdraw the rule because it will not improve the science used in decision-making, does not promote transparency, and in fact poses threats to public health.”


Background

EPA proposed the ‘science transparency’ rule shortly before the departure of former Administrator Scott Pruitt. A public meeting was held on July 17, 2018, with numerous scientists, doctors and their professional organizations commenting in opposition to the rule. The public comment period closed on August 16, 2018.


Selections from comments submitted to EPA

Over 100 scientists and clinicians, including almost a dozen deans of public health schools, commented to EPA “This rule will undoubtedly lead to EPA using inadequate science for making decisions, which in turn will lead to poor public health protections.”

Leading children’s health researchers worried about how the rule would ultimately affect our littlest and most vulnerable members of society—children–  and noted “To not use or consider studies that do not comply with the proposed rule is inconsistent with scientific principles and evidence-based policy, and would put the public at risk from toxic chemicals,” in their comments to EPA.

“The proposal would block the use of seminal health studies,” 65 medical and health associations including the American Lung Association, the American Academy of Pediatrics and the American Heart Association commented, noting that for data from human study participants, “The fact that this information must be kept confidential to protect patients does not make the data any less valid.”

The National Academies provides objective advice to the nation on matters involving science, engineering or medicine; their letter states they “have developed a long-standing body of work that demonstrates scientific literature can be evaluated in a transparent and objective manner without complete disclosure of the underlying data.” Further, their reports have recommended that EPA “consider all available science in the rule-making process” and that “systematic-review methods should be adopted to ensure objectivity, rigor, and transparency in performing literature-based reviews.”

Many of these comment letters also have concerns about how the proposal could generally exclude independent science, summed up in comments from The Endocrine Society: “…the focus on standardized test methods, consistent data evaluation procedures, and good laboratory practices (GLP), while appropriate for evaluating industry-funded studies in contract labs where the risk of conflicts of interest is high, may inappropriately marginalize academic studies…”

Associations representing hundreds of colleges and universities that perform federally-funded research echoed this, saying “…this proposed rule would effectively prevent the EPA from evaluating the best available evidence when developing regulations specifically aimed at protecting human health. While our Associations strongly support transparency, reproducibility, and open science…We are particularly concerned when such rationale becomes the justification for ignoring scientific evidence that can save lives.”

The University of California Office of the President and Vice Chancellors for Research concurred in separate letters, stating “There are many ways to increase transparency in regulatory decision-making, but limiting scientific research should not be one of them.”

Even the Department of Defense agreed: “…public access to information is very important, [but] we do not believe that failure of the Agency to obtain a publication’s underlying data from an author external to the Agency should negate its use.”


Overall, the comments to EPA from medical, health, science, research and policy experts could not be clearer: the transparency rule has no basis in sound science, and EPA should withdraw it.