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
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
Agency officials weren't available to comment due to the
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
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.
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.
disclosures are also likely to color an agency's treatment of comments, Sarvadi
“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
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
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
“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
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.
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
In March, the Union for Concerned Scientists said there were
“many flaws, weaknesses and gaps” in the Labor Department's scientific
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
Michaels was, at the time, a professor at George Washington
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.”
the reporter on this story: Stephen Lee in Washington at email@example.com
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