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Daily News Blog

08
Jan

Trump EPA Adopts Rule to Undermine Science in Decision-Making

(Beyond Pesticides, January 8, 2021) In an eleventh-hour move, the Trump administration’s Environmental Protection Agency (EPA) announced on January 5 the finalization of its controversial, so-called “transparency” rule. The agency claims that the rule— dubbed “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information”—which mandates that researchers provide to EPA access to their raw data, will improve the credibility of its regulations because the public would be able to validate research that influences EPA regulations. In fact, as researchers and advocates recognize, this rule will significantly restrict the scientific research EPA uses in developing regulations to protect human health. This rule will mitigate against use of the best and broadest knowledge base in developing protections for the American people. In its article on the EPA announcement, The Washington Post explains that the rule would “actually restrict the EPA from using some of the most consequential research on human subjects because it often includes confidential medical records and other proprietary data that cannot be released because of privacy concerns.”

Trevor Nace of Forbes magazine writes of the proposed rule: ‘It literally throws out fundamental and hallmark environmental studies the EPA paid scientists to conduct and [which it used to] build the foundation of many of our air and water quality guidelines.’ It should be noted that such studies have been rigorously peer reviewed, and vetted scientists can already obtain access to such anonymized data from the EPA, so the conservative claim that EPA has used ‘secret science’ is misleading.”

The rule will require access to the raw data underlying research being reviewed for agency rulemaking before the agency relies on any of its conclusions. It will, essentially, create “tiers” for the consideration of research studies, with those providing access to public data getting priority over those that do not. But the EPA-touted “transparency” comes at a huge cost: the elimination of the use of many, many studies from consideration in EPA’s development of protective regulations on all kinds of potentially harmful contaminants, including pesticides.

Public health advocates, environmental groups, and many scientists say that the rule would largely prevent the agency from using landmark, long-standing studies on the harmful effects of air pollution and pesticide exposure. Beyond Pesticides explained back in 2018, “In studies over the past few decades, researchers frequently collected data — often about personal, health, and medical status and practices — with subjects’ permission, and signed confidentiality agreements with those subjects, agreeing to keep the information private. Such data were anonymized and reported to the EPA with the requirement that subjects’ personal information not be made public.”

EPA will use this new rule in review of dose-response studies that assess the relationship between the magnitude of exposure to a substance or chemical and the risks of harm. The rule will apply not only to the research bases of “significant regulatory action,” says EPA, but also, to “influential scientific information” EPA might share, via its website, the Federal Register, or other means, with the public. EPA reassures that the rule would not be applied retroactively to research informing regulations already in place, but only to studies underlying future rules. However, as The New York Times reports, “Public health experts . . . 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.”

EPA Administrator Andrew Wheeler addressed such concerns by saying that important research studies, which have “influenced key federal pollution standards that have saved thousands of lives and been economically beneficial, might still be able to inform future policies if the next administrator determines it is justified and publishes the reasoning behind that decision.” The Washington Post notes that “The EPA administrator is allowed to waive the requirement on a case-by-case basis, but it is possible that outside groups could challenge those waivers in court.”

For years, conservative Republicans have lobbied for this restriction on useable research because it gives chemical industry and broader industrial interests far more latitude to challenge regulations. Some critics call the rule “litigation bait” that provides increased opportunity for industrial interests to do just that. According to The Washington Post, a couple of studies that resulted in tighter regulations, especially, got stuck in conservatives’ craws: “a 1993 Harvard University ‘Six Cities’ project that linked air pollution to premature deaths, and a Columbia University analysis of a widely used pesticide, chlorpyrifos, that suggested the chemical causes neurological damage in babies.”

In October 2020, Beyond Pesticides noted that: “E&E wrote in 2018 about the influence of the pesticide industry on the Trump EPA, noting that the agency’s rationale on the emerging new ‘secret science’ rule echoed closely the arguments that officials from CropLife America, an industry trade group, had been making in their multiple closed-door meetings with then-Administrator Pruitt and current Administrator Wheeler.” A former director of the EPA Science Advisory Board (who retired in 2018 after nearly four decades at the agency), Chris Zarba, called the rule “a bold attempt to get science out of the way so special interests can do what they want.”

This rule was pursued early on in the Trump administration by then–EPA Administrator Scott Pruitt. With several such conservatives installed in leadership at the current EPA, this restriction on useable research got significant traction. The New York Times writes that this move by EPA takes a page from the tobacco industry’s plan, 25 years ago, to create “explicit procedural hurdles” for EPA to navigate in order to address the health impacts of smoking. “President Trump’s EPA has now embedded parts of that strategy into federal environmental policy.”

The American Chemistry Council is pleased with this final rule; spokesperson Jon Corley issued a statement saying, “It will strengthen EPA’s regulatory process by helping ensure that it is relying on the best available science — science that is reliable and unbiased — and by making the underlying research and data publicly available in ways that protect personal privacy, confidential business information, proprietary interests and intellectual property rights.”

But Thomas Sinks, PhD, former leader of the EPA Office of the Science Advisor, and other scientists point to EPA’s existing and robust scientific integrity policy, as well as its long-standing peer-review process of any data on which the agency relies. He also notes that the impetus for this rule is “based on a conspiracy theory, which is that EPA practices secret science. But there’s no evidence EPA practices secret science. . . . I’m mostly concerned about the fact this rule and other actions like this rule are diminishing the efforts and the importance of science and scientists within the federal government. That is a dangerous precedent.”

The Union of Concerned Scientists Center for Science and Democracy Director Andrew Rosenberg, PhD, who commonly review scientific studies before they are published in academic journals, notes that EPA’s focus on access to raw data is misplaced. He counters EPA’s justification for the requirement: “As a well-experienced peer reviewer, I very rarely scrutinize raw data. Rather, I look at data collection and analysis methods, summary and other statistics and graphics[,] and results and conclusions to determine the validity of a study and the strength of its scientific evidence.”

Dr. Rosenberg’s critique continues: “Fundamentally what the tiering system does is substitute non-scientific criteria — availability of data — for weighing the study or deciding how important the study is. Whether the data is available or not has nothing to do with whether science is strong and whether it’s showing strong evidence of a health impact.” He added to this his doubt that members of the public will review millions of lines of raw data to evaluate EPA’s work.

Dr. Rosenberg adds that because researchers are reluctant to release individual medical records used in human studies, or are legally bound to keep such data private, this new rule “disproportionately affects ‘epidemiological studies, which is ironic in the midst of a pandemic. Because these data can’t be made public, EPA will ignore epidemiological evidence of population-level effects of contaminants, pollution and other environmental threats.’” According to The Hill, he also referenced the 2018 pushback on this rule from EPA’s independent Science Advisory Board in this comment: “Their own scientists said this is just a bad idea, and they said, ‘Well we’re doing it anyway.’ If it’s about better science, don’t you think the scientists might know something about that?”

The timing of such a rule is additionally disturbing. Dr. Mary Rice, a pulmonary and critical care physician who is chair of the environmental health policy committee at the American Thoracic Society, has commented: “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. We would want EPA going forward to make decisions about air quality using all available evidence, not just putting arbitrary limits on what it will consider.” She added, “The concern is . . . [that] EPA could not consider some of the most compelling evidence on how air pollution affects the risks of adverse outcomes with the infection.”

Senator Tom Carper of Delaware has “called the rule ‘one last gasp of science denial’ before the Biden administration is sworn in. ‘While I continue to be amazed by this administration’s penchant for science denial, I am confident that this irresponsible rollback — finalized in the last few days of the Trump administration — will not impede the incoming administration’s efforts to restore the use of science in rulemaking.’”

Finalizing the rule two weeks before the inauguration of a new President underscores the administration’s determination to carry out its agenda to the Nth degree and, some critics argue, to make undoing its damage as difficult as possible for the incoming Biden-Harris administration. The new administration’s EPA is likely to overturn the rule, but that process could take at least a few months, given the number of critical Trump policy and executive order “reversals” that the incoming administration is expected to undertake.

Source: https://www.washingtonpost.com/climate-environment/2021/01/04/epa-scientific-transparency/;

Final Rule – Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

 

 

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