US agency’s reassessment of silica exposure rules provokes
conflict-of-interest row with senators.
Senate accusations of prejudice have forced a US government
agency to defend its actions over a proposed tightening of regulations
concerning industrial workers’ exposure to deadly silica dust.
The row blew up late last year when the Occupational Safety
and Health Administration (OSHA) began a public consultation on setting new
limits for working with the dust, which is a major hazard for construction
workers, causing serious lung disease. The agency ruffled feathers in the
Senate when it asked that those submitting evidence should declare their
funding sources.
Last November, a group of 16 senators wrote an open letter
to OSHA criticizing the move for its implication that the agency might prejudge
submissions. The consultation period closed on 11 February, and OSHA is now
vigorously defending its request.
“What I’m doing here is essentially saying the information
that we will base our standard on has to be of the highest integrity, and we
have to do it in a transparent manner, and conflict-of interest disclosure is
an important component of both of those,” David Michaels, the head of OSHA,
told Nature. “It would be surprising right now if a scientific journal didn’t
ask for that information.”
Produced by tasks such as grinding concrete and
sandblasting, used in the construction and other industries, crystalline silica
dust can cause silicosis — an incurable disease involving inflammation of the
lungs — and lung cancer. The dust is thought to kill or disable thousands of
people in the United States every year, but guidelines on working with it have
not been updated for more than 40 years.
“Our current standard is antiquated,” says Michaels. “There
are literally millions of workers in the United States who are exposed to
dangerous levels of silica.”
The present rules generally advise limiting exposure to
roughly 100 micrograms of crystalline silica per cubic metre of air, averaged
over 8 hours. OSHA has proposed halving this limit. Workers would also have to
be better protected, for example by dust being ‘wetted down’ and with the use
of extraction fans. OSHA estimates that the new regulations will cost about
US$640 million a year, with employers picking up most of the tab, but the
agency believes that the rules will save up to 700 lives a year. US standards
are also influential in other countries, some note, potentially saving many
more workers’ lives.
The proposals were published in the Federal Register last
September, at the start of the consultation period. In a first for OSHA, those
wishing to submit scientific evidence as part of their comments were requested
— although not required — to provide information on the funding sources of the
research, as well as any funding received by the commenters that could
potentially be considered a conflict of interest.
The Associated General Contractors of America, an industry
group based in Arlington, Virginia, called the proposals “significantly flawed”
and “rife with errors and inaccurate data”. And shortly after they were
published, the group of senators, led by Lamar Alexander (Republican,
Tennessee), a senior member of the Senate Committee on Health, Education,
Labor, and Pensions, wrote to OSHA saying that they were “very concerned about
OSHA’s attempt to have commenters disclose their financial backers”. They added
that the request “raises questions” about whether OSHA would prejudge
submissions on the basis of who was sending them.
“The chilling effect the financial disclosure could have
seems counter to the idea of robust inclusion of a diverse set of ideas and
views to inform the rule-making,” Liz Wolgemuth, a spokeswoman for Alexander,
told Nature.
But pharmacologist Lisa Bero of the University of
California, San Francisco, says that her own research on similar rule-making
processes for tobacco control found that scientists opposing rules were often
funded by industry groups. She supports the new disclosure request. “The
regulatory agencies have to be in a position to critically appraise the studies
that come to them,” she says.
There is also support for the new silica standard. Tee
Guidotti, a physician in Washington DC and a member of the American Thoracic
Society’s Environmental Health Policy Committee, says that the scientific case
for the proposed limit is “close to being bulletproof”. He adds that, if it is
successful, it could provide a template for how OSHA deals with similar
hazards, such as dust and radon.
But Susan Dudley, director of George Washington University’s
Regulatory Studies Center in Washington DC, which conducts independent research
on regulatory proposals, argues that there has already been a drop in exposure
to silica dust and its health effects in recent years. She supports a lower
exposure limit, but believes evidence is weaker for some of the specific
requirements proposed to reach it, such as dust wetting.
The viewpoints contained in the 1,600 or so comments
received through the consultation will be discussed in public hearings starting
on 18 March. It will probably be several years before a final rule is enacted.
Source: Nature.com
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