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For Transparency’s Sake

House legislation would force EPA to ignore most scientific data that aren’t available to the public

by Cheryl Hogue
February 24, 2014 | A version of this story appeared in Volume 92, Issue 8

Credit: Shutterstock
Laptop computer with vault door over its screen.
Credit: Shutterstock

As part of an open democracy, U.S. regulatory agencies generally make public the scientific data and the analyses they use as the basis for their rules. The Environmental Protection Agency releases this sort of information as a matter of course. But there are exceptions.

EPA, for instance, cannot disclose raw data that are not in its possession, such as information developed by outside researchers and protected by patient privacy rules. And the agency doesn’t release proprietary computer models developed by the private sector that EPA uses as it analyzes potential regulations.

Republicans in the House of Representatives don’t like some of these exceptions—particularly when it comes to EPA air pollution regulations that affect the fossil-fuel industry. Now, GOP members of the House Science, Space & Technology Committee are pushing legislation that would, in most instances, bar the agency from using data it can’t provide to the public. Critics say the measure would seriously hamper EPA’s ability to regulate.

The bill, H.R. 4012, would prohibit EPA from proposing or finalizing regulations unless all scientific and technical information—including computer codes and models—that the agency relied on is available to the public. The same restriction would apply to data the agency uses in chemical risk assessments. The measure would also affect the scientific documents that EPA compiles about the public health harms from pollution as well as analyses the agency performs at the behest of Congress.

“Americans impacted by EPA regulations have a right to see the data and determine for themselves if the agency’s actions are based on sound science or a partisan agenda,” said Rep. Lamar S. Smith (R-Texas), who chairs the House Science, Space & Technology Committee. Smith, a cosponsor of H.R. 4012, spoke at a Feb. 11 hearing on the bill held by the panel’s Subcommittee on Environment.

The subcommittee’s top Democrat, Rep. Suzanne Bonamici of Oregon, said she supports improving transparency and access to data across the entire federal government, not just at EPA. But she is skeptical of H.R. 4012.

“The bill would prevent EPA from using the best available science to inform regulatory actions,” Bonamici said. If valuable technical data are not publicly available, EPA would have to proceed in its decisions as if that information did not exist, she said.

The introduction of H.R. 4012 on Feb. 6 follows a House Republican effort to obtain raw data about thousands of participants in two key studies that link particulate matter air pollution to health problems. EPA has repeatedly used the peer-reviewed studies, which date from the mid-1990s, as part of its justification for regulations that restrict emissions from power plants and industrial facilities. Harvard University conducted one of the studies, and the American Cancer Society did the other. The authors of the studies have thus far resisted congressional attempts to obtain the data, citing protection of participants’ privacy.

Smith has doggedly sought the data. Last summer, his committee took the unusual step of issuing a subpoena for EPA to turn over confidential data from the health studies (C&EN, Aug. 12, 2013, page 8). But, Smith said at the recent hearing, “much of the data either no longer exists or was never in the agency’s possession.”

In contrast, H.R. 4012 would force EPA to ensure that information it uses is publicly available in a manner that is sufficient for independent analysis and reproduction of research results, Smith said.

At the hearing, John D. Graham, dean of Indiana University’s School of Public & Environmental Affairs, pointed out that EPA had the two air pollution effects studies reanalyzed by an independent team of scientists. That reexamination found no major errors in the original conclusions, said Graham, who served as President George W. Bush’s White House regulatory overseer from 2001 to 2006.

But Graham criticized the control that Harvard University and the American Cancer Society wield over the data, which include patients’ clinical records.

“If the underlying data from the key health studies were made publicly available for all researchers to analyze—rather than just a select few—I think it is quite possible that many new insights would be gleaned and some of the conventional wisdoms we now accept as fact would be dislodged or refined,” he said.

Another witness at the hearing, Louis Anthony Cox Jr., stressed the importance of having underlying data available to a broad range of researchers. Cox is chief sciences officer at NextHealth Technologies, a Denver-based consulting firm.

“We are now living in an age of catastrophic failure in the reproducibility and trustworthiness of scientific results,” Cox said. “The best defense against unscrupulous use or motivated interpretations of data—whether from regulators or from industry or from anyone else—is to make it openly available.”

At the same time, Cox and another witness, Ellen K. Silbergeld, a professor at Johns Hopkins University’s Bloomberg School of Public Health, emphasized the need to safeguard study participants’ confidentiality if data are made public.

Protecting the privacy of individuals involved in environmental health studies, Cox said, can be addressed by technical solutions. For instance, the Census Bureau has developed methods to remove personally identifiable information while allowing access to data, he said. Graham added that the Institute of Medicine is grappling with how researchers can share environmental health information without breaching participants’ privacy. An IOM committee is holding a public workshop on this issue on March 19.

Silbergeld endorsed greater openness for all data that EPA uses in its decisions, not just health information. “We need more information disclosure by industry,” including data about the hazards of commercial chemicals, said Silbergeld, a toxicologist.

H.R. 4012, meanwhile, would put the chemical industry in the driver’s seat when EPA assesses the hazards of a substance, according to the Natural Resources Defense Council, an environmental group. In a Feb. 11 letter to the top Republicans and Democrats on the Science, Space & Technology Committee and its Environment Subcommittee, NRDC explained how this could happen if the bill became law. Chemical manufacturers could control which industry-supplied information EPA could use in a risk assessment simply by claiming that certain—but not all—data on a substance needs trade secret protection, NRDC asserted. EPA would then have to overlook the information claimed as confidential, which by law, the agency cannot release.

What’s more, the measure would put a serious crimp in EPA’s ability to control air pollution, NRDC said. EPA uses a proprietary computer model developed by consulting firm ICF International to estimate the impact that air regulations would have on the U.S. electric power sector. State governments, industry, and public interest groups also use this Integrated Planning Model. Under H.R. 4012, the agency could no longer rely on the model, NRDC said, because the bill would require the agency to make public any computer codes and models that it uses for policy analysis.

Overall, “this bill would make it incredibly difficult for EPA to do anything,” Yogin Kothari, legislative assistant at the Union of Concerned Scientists, told C&EN.

The Republican-controlled House could easily pass H.R. 4012, Kothari said. The Democrat-controlled Senate would be unlikely to take up the legislation if that happened. But House leaders could attach the wording of H.R. 4012 to a bill that Congress is under pressure to pass quickly, allowing the provisions to become law without Senate consideration, he added.  


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