WASHINGTON – Nearly a quarter of a century ago, a team of tobacco industry consultants outlined a plan to create “explicit procedural hurdles” for the Environmental Protection Agency before it could use science to address the health effects of smoking.
President Trump’s EPA embed parts of that strategy into federal environmental policy on Monday when it passed a new ordinance favoring certain types of scientific research over others when formulating public health regulations.
A copy of the final action known as “Strengthening Transparency in Core Science Underlying Essential Regulatory Measures and Influential Scientific Information Rules” states that more weight will be given to “core” scientific studies that publish their underlying data and models As studies that contain such data, data must be confidential. The Agency concluded that the EPA or anyone else should be able to independently validate research that has an impact on regulation.
Andrew Wheeler, the EPA’s administrator, is expected to officially announce the rule on Tuesday during an online forum with the Competitive Enterprise Institute, a free market think tank that defies most environmental regulations.
The new regulation, according to public health experts and medical organizations, essentially blocks the use of population studies, in which subjects only offer medical histories, lifestyle information and other personal data on the condition of privacy. Such studies have served as the scientific basis for some of the most important clean air and water regulations of the past half century.
Critics say agency officials disregarded the EPA’s scientific scrutiny system to create an extra layer of control designed to hinder or block access to the best scientific evidence available, thereby weakening the government’s ability to provide new protection against pollution, pesticides and possibly even create the coronavirus.
“Right now we are in a major public health crisis due to a deadly respiratory virus, and there is evidence that exposure to air pollution increases the risk of poorer outcomes,” said Dr. Mary Rice, a pulmonologist and critical care doctor.She chairs the American Thoracic Society’s Environmental Health Policy Committee.
“We want the EPA to make future air quality decisions using whatever evidence is available, rather than just setting arbitrary limits on consideration,” she said.
A spokesman for President-elect Joseph R. Biden declined to comment on the expected rule last week, but activists said they expected him to work quickly to suspend and then lift it.
Until then, it is unclear to what extent the new rule will tie the hands of Mr. Biden’s intended EPO administrator Michael S. Regan. The measure contains a provision that allows the administrator to exempt studies from the rule on a case-by-case basis. The final measure recognizes that there may be some instances where compliance with the rule may be “impractical”, such as in older studies where data are not readily available.
The new rule also only specifies requirements for public data for “dose-response” studies, ie studies that measure the extent to which increased exposure to a chemical or pollutant increases the risk of harm to human health. Earlier versions of the regulation covered a wider range of studies.
At the same time, the final rule now requires the EPA to apply the new standards not only to rules but also to “influential scientific information” – a standard that could even affect what the agency publishes on its website.
If the transparency rule had already been in place, several people would not have been able to justify regulating the release of mercury from power plants because they would not have been able to prove that the heavy metal impaired brain development. Nor could the agency have successfully linked cloudy drinking water to a higher rate of gastrointestinal disease and then imposed stricter standards on clean water.
The Trump administration has already used the directive to reject an agency finding that chlorpyrifos, a pesticide, is causing serious health problems.
Trump administration officials have not offered examples of guidelines that they say have been mishandled due to studies that did not make the underlying data available. However, academic and industrial opponents of the regulation have argued that the change will make EPA stricter in their decisions.
Environmental groups attacked the rule as the culmination of a decade-long strategy to undermine science that began in the Tobacco Wars of the 1990s and continued to cast doubt on compliance with pollution regulations.
“We will endanger the health of many people and maybe even lead to their death,” said Delaware Senator Tom Carper, the senior Democrat on the Senate’s Committee on Environment and Public Works, of the rule last year. and added, “We’re better than that.”
Mr. Carper’s staff have pointed out a handful of specific studies whose importance could be downgraded or made ineligible for examination. One was a survey in March 2020 that described how various coronaviruses react with chemical agents on surfaces. The EPA is responsible for recommending disinfectants for use against SARS-CoV-2, the novel coronavirus that causes Covid-19. This survey does not contain raw data from the various studies.
Another paper from 2003 found a statistical correlation between SARS deaths in China and higher air pollution. Mr. Carper’s staff said information might be relevant to regulators considering new pollution standards but could be excluded from testing without the original Chinese health data.
The best-known study linking long-term exposure to air pollution to higher coronavirus death rates is preliminary and relies on extensive information at the county level. It already meets the criteria for public data under the new rule.
However, to really understand whether differences in pollution explain a higher susceptibility to Covid-19, more detailed studies would be needed to take into account the exact location, poverty, smoking habits and other granular and private data of individual subjects. Dr. Said Rice.
“The concern is that going forward, the EPA may fail to consider some of the most compelling evidence of how air pollution affects the risks of adverse consequences from infection,” she said.
Another point of contention is whether the new regulation will have retroactive effect on existing public health regulations. The EPA says the regulation only covers future rules. However, public health experts warned that studies that have been used for decades to show, for example, that lead in paint dust is linked to behavioral disorders in children, may be inadmissible if existing regulations are pending renewal.
Most importantly, they warned, a groundbreaking 1993 Harvard University project to definitively link polluted air to premature death, which is currently the basis of national air quality laws, could become illegal as the agency considers whether protection should be strengthened. In this study, scientists signed confidentiality agreements to track the personal medical and professional histories of more than 22,000 people in six cities. Its findings have long been challenged by the fossil fuel industry and some Republican lawmakers.
Some of the first attempts to limit the types of studies used in regulations emerged in 1996 when Chris Horner, a noted climate denier who was an attorney for Bracewell & Patterson at the time, suggested in a memo to RJ Reynolds Tobacco to secondhand smoking regulations could be beaten back by undermining science.
One “mechanism to oversee EPA and other regulators” has been to insist on full transparency of scientific studies and to ensure that they can be reproduced.
In 1998, the Powell Tate lobbying firm developed a PR strategy for the tobacco industry based on this tactic, the Secret Science Action Plan.
“Focus public attention on the importance of disclosure of tax-funded analytical data on which federal and state rules and regulations are based,” suggested another memo, “and the analytical data underlying government-funded health and safety studies lie.” ”
The documents were collected by the University of California at San Francisco as part of their tobacco dispute archives.
Former Representative Lamar Smith, a Republican from Texas, took up the transparency plan and campaigned for what is variously referred to as the Secret Science Reform Act and the Honest and Open New EPA Science Treatment Act. It happened to Republican Houses twice just to die in the Senate.
When President Trump took office, his first EPA administrator, Scott Pruitt, worked closely with Mr. Smith’s office to embed the failed legislation into regulation. Mr Smith, now a lobbyist with Akin Gump law firm, has since refused to comment on the regulation.
In an email, Mr Horner denied the formulation of this strategy, saying it was based on principles that have long been enshrined in federal proceedings.
In response to a questioning by Senator Sheldon Whitehouse, Democrat of Rhode Island, Mr. Wheeler said at a hearing in May, “I was unaware of the relationship with the tobacco lobby in the 1990s.”
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