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Daily News Blog

04
May

Mr. Pruitt’s Proposed “Science Transparency” Rule: Greenlighting Industry?

(Beyond Pesticides, May 4, 2018) Environmental Protection Agency (EPA) Administrator Scott Pruitt proposed a new rule, on April 24, that, if adopted, will restrict the use of certain kinds of science research in the agency’s writing of regulations. Titled “Strengthening Transparency in Regulatory Science,” the rule will permit EPA to consider only research studies for which the underlying data are publicly available when considering new “significant” regulations — typically, those estimated to impose costs of $100 million or more. Supporters of the rule say that EPA has, in crafting regulations in the past, relied on “secret science” — studies for which the underlying data cannot necessarily be accessed by members of the public.

At face value, this may sound reasonable. Administrator Pruitt and proponents call the proposed rule a plus for transparency that will boost public confidence in the science bases of EPA decision making. “Today is a red-letter day,” Mr. Pruitt told supporters at agency headquarters. “The science that we use is going to be transparent.” That so-called “transparency,” however, comes at a huge cost: the elimination of decades of scientific studies from consideration when EPA regulations are written.

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. 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.

If enacted, critics say, the rule will cause researchers great difficulty in recruiting subjects who, understandably, would not necessarily want their data shared publicly. In addition, it would have particular impact on longitudinal (long-term) studies. Former EPA Administrator Gina McCarthy commented, “The best studies follow individuals over time, so that you can control all the factors except for the ones you’re measuring. . . . But it means following people’s personal history, their medical history. And nobody would want somebody to expose all of their private information.” She notes that such a rule would have disqualified the federal government from using groundbreaking research, including, for instance, the studies that linked neurological damage to exposure to leaded gasoline, or the 1993 Harvard University “Six Cities” study that established the association between fine-particle air pollution and premature death.

Opponents of the rule say it would have enormous deleterious impacts on EPA’s ability to protect humans and the environment from pesticides and other toxic chemicals, air pollution, and other threats. Public health and environmental groups, and 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 because such research often involves proprietary information or confidential medical or personal histories.

For years, conservatives have worked to discredit independent research EPA has used to explain and justify its bases for regulation, such as banning some dangerous chemicals, or limiting air pollution from burning coal and other fossil fuels. Academic and public health research have been particular targets. A rule such as the one proposed by Administrator Pruitt has long been sought by industry and some conservative politicians, including Representative Lamar Smith of Texas. A FOIA (Freedom of Information Act) request by the Union of Concerned Scientists (UCS) yielded emails showing, among other facts, that Rep. Lamar met with Administrator Pruitt on January 9, 2018 — after he failed to get his 2017 “Honest and Open New EPA Science Treatment Act” passed in Congress — to pressure Mr. Pruitt to implement the “Honest” bill’s goals from inside the agency.

UCS spokesperson Yogin Kothari said the emails show that “the plan was crafted by political staff with little input from scientists. They also show that EPA’s political appointees are mostly concerned about industry, rather than environmental or health protections. . . . This idea to restrict the use of science at EPA was hatched solely and worked on almost exclusively by political appointees who are doing everything they can to ensure that independent science doesn’t get in the way of policy decisions at the agency. . . . It’s an effort to stack the deck in favor of industry that EPA is supposed to regulate.”

The day before the announcement of the rule, 985 scientists sent a letter, organized by UCS, to Administrator Pruitt urging him not to move ahead with the rule change. The letter said, “There are ways to improve transparency in the decision-making process, but restricting the use of science would improve neither transparency nor the quality of EPA decision making. If fully implemented, this proposal would greatly weaken EPA’s ability to comprehensively consider the scientific evidence across the full array of health effects studies. This would negatively impact EPA public protections.”

The proposed rule is subject to a 30-day comment period, and science groups are rallying to block its finalization. Legal experts say that, if implemented, it could trigger judicial challenges, noting that “in unanimous decisions in 2002 and 2010, the U.S. Court of Appeals for the District of Columbia Circuit said the EPA is not legally obligated to obtain and publicize the data underlying the research it considers in crafting regulations.” Richard J. Lazarus, a professor of environmental law at Harvard University, said Administrator Pruitt would be “walking into a judicial minefield” if he told EPA to stop considering certain studies in its rule-making. He indicated that would be an arbitrary and capricious decision under the Administrative Procedure Act, which governs agency rule-making, and would “subject any agency regulation issued based on such a defective record to ready judicial invalidation.”

There are any number of unknowns related to the fate of this proposed new rule, including its potential impacts on pesticide registration with EPA, as required under FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act). As if the registration process were not already labyrinthine — and for much of the public, inscrutable — enough, this rule’s potential influence is not yet clear. In applying only to “significant regulatory actions,” it appears that the rule specifically may not apply to individual adjudications or permit proceedings, and therefore, not to pesticide registrations or re-registrations. Under this interpretation, EPA’s “more transparent science” would seem potentially to hamstring science-based efforts to protect public health, but greenlight industry in registering potentially harmful pesticides. In this scenario, the pesticide industry will have been given a “pass” that could allow it to continue, more or less, with business as usual.

On the other hand, the rule might backfire on Administrator Pruitt’s and the Trump administration’s goal of making life easier for industry. As Lisa M. Campbell and James V. Aidala set out in the Pesticide Law and Policy Blog, “For pesticide registrants [aka pesticide manufacturers], the rule poses significant potential issues. For example, registrants [could end up] spending millions of dollars on studies necessary to register products that are proprietary and protected from release to those who might use them to register their own products without compensating the owners; issues with regard to EPA’s reliance under the proposed rule on these registrant generated and FIFRA required studies will need to be considered carefully. As another example, EPA’s review of epidemiology data underlying its conclusions regarding chlorpyrifos and other organophosphate pesticide requirements potentially may be subject to more stringent requirements than they previously were.”

Nancy Beck, deputy assistant administrator of EPA’s chemicals office, and formerly of the American Chemistry Council, has opined on what the rule might mean for pesticide registration, for chemical manufacturers, and for regulation of chemicals under the Toxic Substances Control Act (TSCA). “This directive needs to be revised. Without change it will jeopardize our entire pesticide registration/re-registration review process and likely all TSCA risk evaluations,” Dr. Beck wrote. She also notes that actually making underlying research data publicly available represents a massive undertaking. Dr. Beck said, “Making data available is very different than requiring a publication requirement. Such a requirement would be incredibly burdensome, not practical and you would need to create a whole new arm of the publishing industry to publish these types of studies that nobody is interested in. . . . [There is] no incentive for anyone, anywhere to publish them.”

Richard Denison, a senior scientist at the Environmental Defense Fund, notes that “what Nancy Beck is ironically pointing to is [that] the same set of issues would fall on the industry, because it is not only whether the information would be made public or not, it’s the cost and burden associated with doing so.” The rule may also have a potentially chilling effect on the kinds of data industry would be willing to submit to EPA in seeking registration of pesticides or other chemicals.

Making such data public would likely be very expensive. There is not yet an official estimate of the costs associated with EPA obtaining and disseminating the data underlying studies, but the Congressional Budget Office (CBO) has projected that Rep. Smith’s proposed bill, if enacted, would have cost the agency $250 million initially, and $1 million to $100 million annually. In 2015, the CBO estimated that the bill’s requirements about data would have reduced the number of studies EPA considered by half. Geophysicist Marcia McNutt, president of the National Academy of Sciences, has voiced her concern that the rule would prevent the EPA from being able to use the best available scientific evidence.

The Washington Post notes that this proposed rule “reflects a broader effort already underway to shift how the EPA conducts and uses science to guide its work.” Andrew Rosenberg, director of the Center for Science and Democracy at UCS, adds, “With false claims about transparency, the political appointees at the EPA are drastically restricting the ability of the agency to rely on science. They are ordering EPA employees to put on blinders and only see the science that they want them to see. They are sacrificing the health of Americans in favor of special interests, a disturbing pattern for this Administration. It’s no coincidence that the same people calling for this change have been funded by the petrochemical and tobacco industries for years. Pruitt has turned his back on the American people to stick his snout deep in the trough of corruption.”

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

Sources: https://www.washingtonpost.com/news/energy-environment/wp/2018/04/24/pruitt-to-unveil-controversial-transparency-rule-limiting-what-research-epa-can-use/?utm_term=.9b4dabe4f157 and http://www.sciencemag.org/news/2018/04/trump-s-epa-wants-stamp-out-secret-science-internal-emails-show-it-harder-expected

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