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By Stephen Lee
Oct. 15 --In a move widely believed to be a first, the Occupational Safety and Health Administration has asked parties who submit comments about the agency's pending silica rule to disclose their financial backers and potential conflicts of interest, teeing up another debate over the proper way to conduct rulemaking.
While good government advocates have hailed OSHA's move as an important step toward more transparency, industry representatives say they fear it will prejudice agencies' judgments against submissions merely on the basis of who submits them.
In its Sept. 12 Federal Register notice (78 Fed. Reg. 56,274), OSHA wrote that it is requesting, but not requiring, commenters to reveal their funding sources and sponsoring organizations, as well as any financial relationships they may have with organizations that have an interest in the rulemaking and the extent to which comments were reviewed by an interested party before they were submitted.
OSHA administrator David Michaels has a track record of calling for such reforms, publishing academic papers a decade ago recommending policy fixes to correct agency bias and suppression of private research.
According to OSHA, “Disclosure of such information is intended to promote transparency and scientific integrity of data and technical information submitted to the record.”
Agency officials weren't available to comment due to the government shutdown.
Celeste Monforton, an OSHA policy analyst from 1991 to 1995, told Bloomberg BNA Oct. 11 that the agency's request -- the first of its kind she had ever seen for any rulemaking -- will usher in more transparency, thus permitting the agency to better weigh submissions.
“Funders may not think the conclusions are strong enough, or are too strong, and if they have that kind of control over a study then it slips into this area where it's not really independent research anymore,” said Monforton, now a lecturer at George Washington University. “It's something that should be disclosed, so those of us who are relying on those studies can take that into consideration.”
To illustrate, Monforton sketched out a hypothetical scenario in which four studies show a link between silica exposure and lung cancer, each done by independent researchers with no financial interest in their conclusions, and a fifth study, submitted by organizations that have an economic interest in the outcome of the rulemaking, casts doubt on the silica-cancer link.
OSHA will look at the fifth study, but will weigh it in light of who was in charge and who paid for it, Monforton said. “It's an added piece of information in their weight of the evidence evaluation.”
Further, the disclosures, which OSHA said are consistent with President Barack Obama's Executive Order 13,563, will even the playing field by requiring sound science not only from agencies but also commenters, Monforton said.
David Sarvadi, an industry attorney with Keller & Heckman LLP, said Oct. 11 the disclosure request could lead to a form of ad hominem attack that challenges the commenter, not his or her comments.
The disclosures are also likely to color an agency's treatment of comments, Sarvadi said.
“When OSHA sees something that's been submitted by so and so that's been supported by such and such an organization, inevitably, in the back of their minds, a bias is going to be created against that information,” he said. “And their job is to evaluate it on its face -- its accuracy, logic, supporting information, whatever -- not on who the people are, or how they're paid.”
Moreover, the mere fact that a study was financed by an organization doesn't invalidate its findings, said Marc Freedman, executive director of labor law policy at the U.S. Chamber of Commerce.
“These types of studies cost money,” Freedman said Oct. 15. “Employers and the regulated community are forced to do their counter-studies and analyses of OSHA's studies, and that takes money. If you're going to make a credible argument for why OSHA's approach is not appropriate, then the only way that can happen is for some significant source of funding behind it.”
Sarvadi agreed, saying, “Look, everybody was paid by somebody else to do this stuff.”
Further, while transparency has value, it can also have a chilling effect on speech, Freedman said, observing that some companies may decide not to submit their comments for fear of negative publicity, thus hurting the robustness of the debate.
Richard Clapp, an epidemiology professor at the University of Massachusetts-Lowell, told Bloomberg BNA Oct. 12 that because OSHA is only requesting disclosure, not requiring it, the agency isn't raising any First Amendment issues.
“Requesting full disclosure means that, if someone doesn't do it, they run the risk of being found out later, and that would be pretty awkward,” Clapp said.
If too many commenters ignore the request, OSHA could later move to strengthen its language and propose sanctions against those who fail to comply, Clapp said.
Clapp further suggested that the disclosure request would be unlikely to have a significant effect on rulemaking, as OSHA officials are likely to continue to focus on the merits of all comments.
In criticizing OSHA's request, Sarvadi said a more appropriate point in the rulemaking process for transparency is the initial phase, in which the agency is gathering risk assessments and feasibility analyses and conducting peer reviews.
For the silica rule, the technical and economic feasibility analyses run thousands of pages, Sarvadi noted.
“We keep hearing about transparency, but all the important decisions, all of the important conversations, everything that has a significant impact on the proposal before it gets to the Federal Register, is done behind closed doors,” he said.
But Michael Halpern, program manager at the Union of Concerned Scientists' Center for Science and Democracy, told Bloomberg BNA Oct. 15 that exposing predecisional information to too much scrutiny could inhibit a frank and honest discussion.
“Certainly an appropriate level of transparency is important throughout the process, but that doesn't mean you turn over every single document, just as I don't expect industry is going to release every single e-mail that it sends to its lawyers or its scientists,” Halpern said. “It's important in science for there to be safe space to ask tough questions.”
The disclosure request is even more important because the Labor Department hasn't made adequate commitments to scientific integrity in the past, said Halpern.
In March, the Union for Concerned Scientists said there were “many flaws, weaknesses and gaps” in the Labor Department's scientific integrity policy.
Michaels himself weighed in on the topic before he was named agency administrator, co-writing an article in Science journal in 2003 that regulators “should not use conflict disclosures to exclude research,” but that federal agencies should “develop policies that strongly encourage clear disclosures that counteract the strong incentives for sponsors to influence research.”
Michaels was, at the time, a professor at George Washington University.
Similarly, in a 2004 paper that appeared in the American Journal of Law and Medicine, Michaels and co-author Wendy Wagner wrote that “public research is subject to increased scrutiny, while private research remains largely insulated from outside review and meaningful agency oversight.”
Michaels and Wagner offered a series of policy fixes, suggesting that the Environmental Protection Agency adopt mandatory conflict disclosures that would require researchers and scientists providing comments to sign a conflict form specifying the financial and sponsor influence on their work.
The two authors also recommended that the EPA and Congress implement tougher reporting requirements to close off the possibility of commenters relying on nondisclosure agreements as a means of hiding their funding sources.
“It's not a heavy lift,” Monforton said of OSHA's silica request. “It's not like if [a comment] is paid for by industry it's automatically bad, because sometimes you need that industry so you can get access to workers. But it puts it into context.”
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