The US Environmental Protection Agency (EPA) proposed a rule on 24 April that would prevent it from basing regulatory decisions on studies whose full underlying data is not publicly available.
EPA administrator Scott Pruitt says that the controversial proposal is intended to promote transparency and to ensure that the research the agency relies upon can be reproduced by others. But researchers and science advocates maintain that the rule is little more than a ruse intended to limit the EPA’s access to scientific studies and ultimately, to prevent new health and environmental regulations from going into effect.
For instance, epidemiologists often agree not to release study participants’ addresses or other private, identifying information in order to gain access to their medical data. But the EPA’s proposed plan is a Trojan horse, says Dan Costa, former head of the agency’s air, climate and energy research programme, who retired in January. “If you can eliminate everything that is key to the analysis, then you can’t do the analysis.”
The proposal must undergo a 30-day public comment period once it’s published online, among other things, before it is finalized. But it aligns with legislation that Republicans in the House of Representatives have attempted to pass for years. And this isn’t the first time that Pruitt has followed their playbook. In October, he announced that the EPA would bar researchers with current agency grants from serving on its science advisory panels — a move proposed by House Republicans earlier that year in a bill that stalled before reaching the Senate.
Nearly 1,000 scientists signed a 23 April letter urging Pruitt to abandon the proposed rule change. They argue that it could fundamentally alter how the EPA does business, including how the agency uses public-health research.
Researchers often release limited data sets that contain information about exposure levels and health outcomes when they publish in peer-reviewed journals. But scientists say that the EPA’s proposed rule could set a higher standard and require the release of raw data if the agency used the research in regulatory decisions.
“Epidemiology by its nature involves protecting the identity of the people who are participating in these studies,” says Joel Kaufman, an epidemiologist at the University of Washington in Seattle. He adds that Pruitt and others who have pushed for the rule are not interested in open science, but in blocking the use of valid research in regulatory decisions. It’s a way of undoing public-health regulations, Kaufman says.
The debate over the use of data in the agency’s regulatory decisions dates back to the mid-1990s, when researchers at Harvard University in Cambridge, Massachusetts, and the American Cancer Society in Atlanta, Georgia, first documented the link between long-term exposure to air pollution and mortality due to cardiopulmonary disease1,2. Industry raised questions about the research when the EPA cited it in support of new air pollution standards in 1997. In response, both research teams opened up their data for an independent review by the Health Effects Institute (HEI), a non-profit research group jointly funded by the EPA and industry.
The HEI review confirmed the study’s findings, and the controversy died down until House Republicans revived the issue several years ago, says Arden Pope, an epidemiologist at Brigham Young University in Provo, Utah, who was a co-author on the Harvard study and a lead author on the American Cancer Society study. “You sort of chuckle when you hear them talk about ‘secret science’, because you are publishing in the best journals in the world.”
Costa says the proposed rule reads like it was written by and for industry. “This is like the tobacco story all over again,” he says. “They are trying to pull the carpet out from under scientists.”