Pruitt’s Open Data Plan Could Limit Usable Research, Critics Say

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By Jennifer Lu and Sylvia Carignan

EPA head Scott Pruitt’s plan to ban the agency from using private or confidential data in making policy decisions would eliminate most of the scientific literature the agency reviews, scientists told Bloomberg Environment.

Pruitt told the Daily Caller March 19 about his intentions for allowing only “open data” in drafting regulations and said the Environmental Protection Agency could only consider studies that make their data available for public scrutiny. Further, EPA-funded studies would have to make all of their data public.

Researchers are concerned that the policy could have far-reaching effects for how the agency regulates drinking water, air quality, and chemicals including pesticides and herbicides. Supporters of the idea, however, say the public has a right to view the information used to craft rules that affect them.

The EPA estimated in 2017 that a similar requirement for open data would limit usable studies by 95 percent.

“That will essentially lead to excluding massive bodies of evidence,” Jonathan Samet, a former chair of the EPA’s Clean Air Scientific Advisory Committee, told Bloomberg Environment.

Pruitt’s policy is similar to language in a 2017 bill (H.R.1430) introduced by Rep. Lamar Smith (R-Texas) barring the EPA from basing certain actions on anything but studies that are publicly available and substantially reproducible.

The actions include risk, exposure, or hazard assessments, air quality science documents, standards, chemical limits, waste regulations, cost-benefit reviews, and guidance.

Right to See Data

Smith believes the public has a right to see data that EPA uses to justify its regulations, Thea McDonald, a spokesperson for the House Science, Space, and Technology Committee, told Bloomberg Environment in an emailed statement March 26. Smith is the committee’s chairman.

“The public, including scientists, should have the opportunity to evaluate the agency’s data and independently determine whether the data supports the EPA’s conclusions,” Smith said in the statement.

It’s unclear how much of Smith’s bill will be part of Pruitt’s policy. The EPA didn’t respond to Bloomberg Environment’s emailed requests for comment.

The EPA told the Congressional Budget Office in 2017 that the provisions in Smith’s bill would “strongly discourage” industry and academic researchers from working with the agency, because the EPA couldn’t guarantee to protect intellectual property, trade secrets like chemical formulas, or personally identifiable information in health studies.

“It’s all part of the removal of science and scientists from the decision-making process,” Samet said. “We’re moving away from evidence-based regulations, which is what EPA does, which is what EPA should do, which is what EPA was set up to do.”

Confidential Information

There’s an ongoing debate in the research world about the merits of confidentiality versus the need for reproducible results, Tony Cox, a member of the EPA’s Science Advisory Board and chairman of the Clean Air Scientific Advisory Committee.

Pruitt’s plans align with scientific journals’ increasing desire to promote transparency with data and to make more models and analyses readily available, Cox told Bloomberg Environment in an email.

Transparency “is an important part of the process of creating sound and trustworthy science,” he said.

The EPA’s Office of Pesticides Programs recently relaunched an attempt to obtain data on a Columbia University public health study on the effects of the insecticide chlorpyrifos on children exposed in utero. The EPA, under the Obama administration, justified banning the chemical in part on the study, which linked levels of the pesticide in umbilical cord blood with neurodevelopmental delays in childhood.

Chlorpyrifos manufacturer Dow AgroSciences criticized the Columbia study on grounds that the EPA didn’t have access to the raw data.

Institutional Review Boards

The ability to reproduce a study’s results is important, but the relevant methods and techniques are what need to be shared, not patient personal data, or trade secrets and intellectual property, Gretchen Goldman, research director at the Union of Concerned Scientists’ Center for Science and Democracy, told Bloomberg Environment.

Research institutions, such as universities and military facilities, have institutional review boards, which protect sensitive information by requiring researchers to sign ethics agreements before reviewing data.

The boards review researchers’ intent to view or use sensitive data, and ensure researchers have gone through training about the appropriate uses of human studies data and how to secure it.

Boards also want to ensure ethical guidelines are followed in how test animals or people are exposed to harms and that personally identifying information will not be released, Goldman said.

Foundational Fine Particulates

Rallying cries against “secret science” can be traced back two decades to when fine particulate matter was included in the list of EPA-regulated air pollutants in 1997, Samet said.

Fine particulate matter—microscopic particles 2.5 microns in diameter or smaller—is emitted by a range of sources, including motor vehicles, power plants, and factories.

The agency had based its particulate-matter standards on two landmark studies, the Harvard Six Cities study and the American Cancer Society study.

Both contained “pivotal evidence” showing that people living in cities with higher levels of air pollution were at higher risk of dying, said Samet, the dean of the Colorado School of Public Health.

“At the time, there was a lot of discussion generated by industry stakeholders where if this data was so important, the data should be public,” Samet said.

Peer Review

Those who decry “secret science” don’t understand or don’t acknowledge that the two studies were peer-reviewed and the raw data was reanalyzed by an independent research group, C. Arden Pope III, a co-author on the Harvard Six Cities study, told Bloomberg Environment.

That independent research group, the Health Effects Institute, gets funding from government agencies, including the EPA, and the automotive industry.

Health Effects Institute researchers found similar relationships between living in more polluted areas and a higher risk of death, Daniel Greenbaum, president of HEI, told Bloomberg Environment.

Findings from the two original studies became the bedrock for how the agency justifies its air regulations, from the Clean Power Plan to rules reducing mercury and toxic air emissions from power plants.

If you look at the cost-benefit analyses the EPA has done, most of them point to fine particulate matter exposure as the single largest contributor to the number of avoidable deaths, Greenbaum said. “And that is primarily calculated using the American Cancer Society and the Harvard Six Cities results.”

“For those that don’t want to reduce their pollution, one of the strategies they use is to criticize the science itself,” Pope said. “I think that’s pretty obvious to anyone that watches what’s going on.”

Greenbaum also warned that limiting what kind of science can be used to set regulations would “cut both ways.”

While particulate-matter studies point toward lowering the threshold to protect public health, studies on nitrogen dioxide—emitted by cars and factories, eventually forming ozone—suggest no additional health benefits at lower nitrogen dioxide standards, Greenbaum said.

If Smith’s bill had been passed, the “Honest Act would say those studies aren’t available,” and regulated industries wouldn’t receive relief, Greenbaum said.

—With assistance from Tiffany Stecker.

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