Senate Panel Advances Bill To Stop EPA From Using Clinical Data In Setting Regulations

Legislation that would undercut EPA’s ability to regulate pollution in air, water, and soil got approval from a Senate panel last week. The bill would force EPA to rely only on health research that is publicly available and reproducible.

The bill seemingly would impose uncontroversial data-sharing requirements on EPA. But the legislation would force the agency to ignore credible health data because of the need to protect patient confidentiality, critics charge. “It’s a catch-22 to say you may not release health data and therefore you may not regulate based on that information,” says Andrew Rosenberg at the Union of Concerned Scientists, an advocacy group.

The Senate Environment & Public Works Committee’s 11-9 party-line vote on S. 544, the so-called Secret Science Reform Act, echoes a companion bill, H.R. 1030, which the House of Representatives passed 241-175. The White House has threatened to veto the legislation.

Sen. John Barrasso (R-Wyo.), sponsor of S. 544, says the measure “will give Americans more confidence that EPA’s policies will deliver the environmental and public health benefits the agency has promised.”

Republicans are pushing the bill in large part because EPA failed to provide congressionally requested raw health data from studies the agency used to review the risks of particulate matter air pollution. The agency says information about individual participants remains under the control of the institutions that did the research.

“It would be good to see thoughtful legislation that advances data access while addressing the complexity and costs of doing so,” says Dan Greenbaum, president of the nonprofit Health Effects Institute, which is jointly funded by EPA and the automotive industry. The Congressional Budget Office says S. 544 would cost EPA $250 million a year to implement, but the bill only provides $1 million in funding, Democrats say.

Researchers are concerned that new mandates on EPA to release confidential health data would also constrain recruitment for clinical health studies. Institutional review boards that examine plans for studies involving human subjects “would take this very seriously and tell researchers, ‘You can’t guarantee subjects’ confidentiality if Congress wants to access your health information,’ ” Rosenberg says.