US Environmental Agency Will Limit Use of Science in Public Health Rules

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The Donald Trump administration is preparing to significantly limit the government's use of scientific and medical research for public health regulations, ignoring protests from scientists and doctors who say the new rule would undermine the scientific basis of government decision-making.

A new draft Environmental Protection Agency (EPA) proposal entitled “Enhancing Transparency in Regulatory Science” would require scientists to disclose all their raw data, including confidential medical records, before the agency considers the findings of an academic study.

EPA officials defined the plan as a step towards transparency and said that the disclosure of raw data allows the findings to be independently verified.

“We have a commitment to the highest quality science,” he said. Andrew Wheeler, the EPA administrator, to a congressional committee in September. “Good science is science that can be independently reproduced and validated, science that can be scrutinized. That's why we are going ahead to make sure the science behind the agency's decisions is transparent and available to the public and all stakeholders. ”

The measure would make it harder to enforce new rules on air and water pollution, because many of the studies detailing the links between pollution and disease depend on personal health information gathered under confidentiality agreements. And unlike a version of the proposal that emerged in early 2018, the new text would apply retroactively to existing public health regulations.

“This means that the EPA may justify repealing rules or not updating rules based on the best available information on protecting public health and the environment, which means more air pollution and more premature deaths”Said Paul Billings, senior vice president of campaigns for the American Pulmonary Association.

Public health experts warn that studies that have been used for decades — to demonstrate, for example, that mercury from power plants impairs brain development, or that lead in paint dust is linked to behavioral disorders in children – could be inadmissible when it comes time to renew existing regulations.

For example, a landmark Harvard University study in 1993 directly linked polluted air to premature deaths, and serves as the foundation for US air quality control laws today, but could become inadmissible.

In gathering data for their research, called the “Six Cities Project,” scientists signed confidentiality agreements to track the private medical and occupational histories of more than 22,000 people in the six cities involved. They combined this personal data with air quality data to study the link between chronic exposure to air pollution and mortality.

But the fossil fuel industry and some Republican lawmakers have long criticized the analysis and a similar study conducted by the American Cancer Society, saying that the data sets underlying both studies have never been made public, which precludes independent analysis of the findings. .

The change is part of the government's broader efforts to weaken the scientific basis of political decisions. Leading Trump officials tried to soften the testimony of government scientists, publicly criticized scientists who disagreed with President Trump's positions and prevented government researchers from traveling to conferences to present their work.

In this case, the government is targeting public health studies conducted outside the government that could justify tightening regulations on air pollution, the presence of mercury in water, lead in paints, and other potential threats to human health.

Former EPA administrator Scott Pruitt has made the publication of scientific data on which research is a top priority, and has tried to approve a proposal on an urgent basis in 2018.

Pruitt resigned in July last year, and Wheeler, his successor, postponed the adoption of the transparency rule and hinted that the EPA needed time to address vigorous opposition from environmental and public health organizations.

But a draft of the revised regulation, which would be submitted for review by the White House and was obtained by The New York Times, shows that the government intends to broaden the scope of the proposal, not restrict it.

The earlier version of the regulation would have applied only to a certain type of research, “dose response” studies, in which toxicity levels are studied in animals and humans. The new proposal would require access to raw data from virtually all studies that the EPA will consider.

"The EPA is proposing broader application," the text says, making it clear that open data should not be limited to certain types of studies.

Most significantly, the new proposal would apply retroactively. An internal EPA memo to which The New York Times had access shows that the agency considered, but eventually rejected, an option that could have allowed essential studies such as Harvard's "Six Cities Project" to continue to be used.

An EPA spokeswoman said via email that "the agency does not discuss drafts, deliberative documents or actions prior to the internal and interagency review process."

On Wednesday, the Science Committee. Space and Technology of the US House of Representatives will hold a hearing on EPA efforts. A leading pulmonary expert and a representative of the largest nonprofit organization involved in funding Parkinson's disease research, the Michael J. Fox Foundation, must testify that the rule proposed by the EPA would eliminate the use of valuable research demonstrating the benefits of the disease. dangers of pollution to human health.

Pruitt's original proposal drew about 600,000 comments, the vast majority of which were negative. These included opinions from leading public health organizations and some of the leading scientific organizations in the United States, such as the American Association for the Progress of Science.

The National Association of Pediatric Nurses said it was "strongly concerned" that the rule would result in exclusion from studies, "ultimately resulting in weaker environmental and health protections and greater risks to children's health."

The National Center for Science Education said that discarding studies that do not use open data "would send a profoundly misleading message and ignore the thoughtful processes that scientists employ to ensure that all relevant evidence is considered."

The Association of Medical Libraries and the Association of Academic Health Libraries said the proposal "contradicts our core values."

Business groups say the rule would ensure a deeper public understanding of the science behind taxpayer regulations that cost money.

"Transparency, reproducibility and application of current scientific knowledge are essential to provide the foundation required for sound regulation," wrote the American Chemical Council in support of the EPA plan.

The new version does not seem to have taken any of the critics' objections into account. At an EPA science advisory board meeting a few weeks ago, Wheeler said he was "a little shocked" by the intensity of opposition to the proposal, but was determined to finalize it.

In addition to retroactivity, the most recent version stipulates that all data and models used in studies under consideration by the EPA would have to be made available to the agency to review the research. The agency administrator, a political appointee, would have broad power to accept and reject studies.

"It was hard to imagine that they could make the proposal even worse, but they succeeded," said Michael Halpern, assistant director of the Center for Science and Democracy at Union of Concerned Scientists, an activist organization. He added that "the process is being completely politicized."

Academics typically do not need to submit private data when they submit studies for review by other specialists in their field, or for publication in academic journals, the traditional forms of scientific evaluation. If academics were to submit the raw data for public review, the EPA would need to spend hundreds of millions of dollars censoring private information, according to a federal estimate.

The "Six City Project" and a 1995 study by the American Cancer Society involving 1.2 million people, which confirmed the findings of the Harvard team, appear to have inspired regulation.

The proposal gives 30 days for public comment on the EPA plan. Agency officials said they expect to complete the process by 2020.

"The original goal was to prevent the EPA from relying on these two studies unless their data is made public," said Steven Milloy, who was part of Trump's transition team at EPA and runs, which questions the science on climate change and claims that climate …

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