“A proposed rule by the Environmental Protection Agency (EPA) that allegedly aims to strengthen transparency in regulatory science suggests that science is broken. It isn’t.
We know it works because we can see the life-saving transplant technologies, hurricane forecasts, new medications, pest-resistant crops, and countless other breakthroughs that exist because of science. This discipline isn’t perfect, but it is the best tool available to safeguard the planet and its people.
Last year, the EPA proposed a rule requiring that scientists disclose all raw data before any study conclusions would be considered. The rule, titled “Strengthening Transparency in Regulatory Science,” would apply retroactively to regulations already in place. It would make it harder to enact new regulations, because many studies from the past rely on personal medical information that was collected under confidentiality agreements and include consensus from reports that may not have shared all of the data according in ways compliant with the proposed rule….”
“Eighteen months after articulating our concerns (1) regarding the 2018 “Strengthening Transparency in Regulatory Science” rule proposed by the Environmental Protection Agency (EPA) (2), we have become more concerned in response to recent media coverage and a 13 November hearing on the role of science in decision-making at the EPA. These events suggest that the proposed rule is now moving toward implementation; whether it includes amendments sufficient to address the concerns raised by us and many others remains a question.
Our previous statement on the proposed rule, authored and published by the editors-in-chief of five major scientific journals in May 2018, reflected alarm that the proposal’s push for “transparency” would be used as a mechanism for suppressing the use of relevant scientific evidence in policy-making, including public health regulations. After the public comment period for the proposed rule closed, the EPA reported more than 590,000 comments from individuals and scientific, medical, and legal groups, many of which articulated similar concerns (3).
As leaders of peer-reviewed journals, we support open sharing of research data, but we also recognize the validity of scientific studies that, for confidentiality reasons, cannot indiscriminately share absolutely all data. Datasets featuring personal identifiers—including studies evaluating genomes of thousands of people to characterize medically relevant genetic variants—are but one example. Such data may be critical to developing new drugs or diagnostic tools but cannot be shared openly; even anonymized personal data can be subject to re-identification, and it has been a longstanding practice for agencies and journals to acknowledge the value of data privacy adjustments. The principles of careful data management, as they inform medicine, are just as applicable to data regarding environmental influences on public health. Discounting evidence from the decision-making process on the basis that some data are confidential runs counter to the EPA stated mission “to reduce environmental risks…based on the best available scientific information” (4)….
We urge the EPA to continue to adopt an approach that ensures the data used in decision-making are the best available, which will at times require consideration of peer-reviewed scientific data, not all of which may be open to all members of the public. The most relevant science, vetted through peer review, should inform public policy. Anything less will harm decision-making that claims to protect our health….”
“The Trump administration is preparing to significantly limit the scientific and medical research that the government can use to determine public health regulations, overriding protests from scientists and physicians who say the new rule would undermine the scientific underpinnings of government policymaking….”
“The most glaring disregard for science is at the Environmental Protection Agency. One blatant example has been an attempt to weaken the Mercury and Air Toxics Standards that were built on deep research into the health threats from mercury, arsenic, lead and other pollutants, which come in part from coal-burning power plants. We urge you to uphold those standards, and to fight the stream of reckless rollbacks by both the EPA and the Department of the Interior of measures that safeguard people and the environment. Clean water, clean air and clean land should not be sacrificed for commercial gain.
Another egregious step you should fight is the EPA’s proposed “Strengthening Transparency in Regulatory Science” rule. Despite the nice-sounding name, it would force EPA to use only studies that make all data publicly available—including sensitive, personal information about individuals who were involved in health studies. In effect, it would prevent EPA from using important research. A concise argument against the measure was published by the editors-in-chief of Nature, Science, PLOS, PNAS and other major journals….”
“The Environmental Protection Agency (EPA) plans to pursue next year a final version of its much-criticized rule that would restrict the scientific studies it can use to justify regulations.
In a Friday interview with The Hill, acting EPA chief Andrew Wheeler dismissed the idea that the science transparency regulation was on the “back burner” since the administration recently listed it as a “long-term” regulatory action.
“It is not a back-burner issue. I feel strongly about that,” Wheeler said. “And we will move forward to finalize that next year.” …
Wheeler rejected the main criticism from opponents of the rule, that it is meant to restrict the agency’s ability to regulate by putting out of reach large bodies of valuable science, such as many epidemiological studies that by their nature cannot be reproduced.
“I don’t think it’s designed to restrict what we use. It’s designed to get the information out to the public. The critics look at it as ‘oh, you’re trying to get rid of a lot of the studies, you’re trying to restrict what the agency can use.’ No,” he said. …
California Attorney General Xavier Becerra, who has sued the Trump administration’s EPA numerous times — frequently with success — said if the science rule moves forward, he’ll fight it….”