A Plan Made to Shield Big Tobacco From Facts Is Now E.P.A. Policy


WASHINGTON — Nearly a quarter century ago, a team of tobacco industry consultants outlined a plan to create “explicit procedural hurdles” for the Environmental Protection Agency to clear before it could use science to address the health impacts of smoking.

President Trump’s E.P.A. embedded parts of that strategy into federal environmental policy on Monday when it completed a new regulation that favors certain kinds of scientific research over others in the drafting of public health rules.

A copy of the final measure, known as the Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information Rule, says that “pivotal” scientific studies that make public their underlying data and models must be given more weight than studies that keep such data confidential. The agency concluded that the E.P.A. or anyone else should be able to independently validate research that impacts regulations.

Andrew Wheeler, the administrator of the E.P.A., is expected to formally announce the rule on Tuesday during an online forum with the Competitive Enterprise Institute, a free-market think tank that opposes most environmental regulation.

The new rule, public health experts and medical organizations said, essentially blocks the use of population studies in which subjects offer medical histories, lifestyle information and other personal data only on the condition of privacy. Such studies have served as the scientific underpinnings of some of the most important clean air and water regulations of the past half century.

Critics say the agency’s leaders disregarded the E.P.A.’s scientific review system to create an additional layer of scrutiny designed to impede or block access to the best available science, weakening the government’s ability to create new protections against pollution, pesticides, and possibly even the coronavirus.

“Right now we’re in the grips of a serious public health crisis due to a deadly respiratory virus, and there’s evidence showing that air pollution exposure increases the risk of worse outcomes,” said Dr. Mary Rice, a pulmonary and critical care physician who is chairwoman of the environmental health policy committee at the American Thoracic Society.

“We would want E.P.A. going forward to make decisions about air quality using all available evidence, not just putting arbitrary limits on what it will consider,” she said.

A spokesman for President-elect Joseph R. Biden declined last week to comment on the expected rule, but activists said they expected him to quickly work to suspend and then repeal it.

Until then, it is unclear just how much the new rule will bind the hands of Mr. Biden’s intended E.P.A. administrator, Michael S. Regan. The measure includes a provision that allows the administrator to exempt studies, on a case-by-case basis, from the rule. The final measure acknowledges that there could be some cases in which complying with the rule could be “impracticable,” like in the use of older studies in which data is not easily available.

The rule going into effect also only sets public-data requirements for “dose-response” studies — that is, studies that measure how much an increase of exposure to a chemical or pollutant increases the risk of harm to human health. Previous versions of the regulation applied to a wider array of studies.

At the same time, the final rule now demands the E.P.A. apply the new standards not just to rules but “influential scientific information” — a standard that could even influence what the agency puts on its website.

Had the transparency rule been in effect already, several people said, the E.P.A. could not have made the case to regulate mercury releases from power plants because it could not have shown that the heavy metal impairs brain development. Nor could the agency have successfully linked cloudy drinking water to higher rates of gastrointestinal illnesses, and then imposed more rigorous clean water standards.

Already, the Trump administration has used the policy to reject an agency finding that chlorpyrifos, a pesticide, causes serious health problems.

Trump administration officials have not offered examples of policies that they say were wrongly enacted based on studies that did not make underlying data available. But academic and industry opponents of regulation have argued the change will make the E.P.A. more rigorous in its decision-making.

“The concern is, going forward, the E.P.A. could not consider some of the most compelling evidence on how air pollution affects the risks of adverse outcomes with the infection,” she said.

Another point of contention is whether the new rule would be retroactive to public health regulations already in place. The E.P.A. says the regulation only deals with future rules. Public health experts, however, warned that studies that have been used for decades to show, for example, that lead in paint dust is tied to behavioral disorders in children might be inadmissible when existing regulations come up for renewal.

Most significantly, they warned, a groundbreaking 1993 Harvard University project that definitively linked polluted air to premature deaths, currently the foundation of the nation’s air-quality laws, could become inadmissible as the agency considers whether to strengthen protections. In that study, scientists signed confidentiality agreements to track the private medical and occupational histories of more than 22,000 people in six cities. Its findings have long been attacked by the fossil fuel industry and some Republican lawmakers.



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