U.S. EPA's long-awaited study of formaldehyde's toxicity got panned today by a National Academy of Sciences' panel that sharply disagreed with the agency's conclusions and declared the effort in need of "substantial revision."
The panel convened by the academy's National Research Council is likely to further delay EPA efforts to finalize a 12-year-old effort to assess risks posed by formaldehyde, a widely used residential construction material.
NAS said EPA's draft assessment, which was issued last June and concludes that the chemical is a human carcinogen (E&ENews PM, June 2), fails to support its conclusion that formaldehyde causes respiratory cancers, leukemia and several other health problems, including asthma.
The panel also said EPA "overstated" its conclusion that formaldehyde damages the nervous system and questioned the agency's linking formaldehyde to reproductive effects such as infertility in women.
And in its most critical passages, NAS also takes EPA to task for its methodology.
"Overall, the committee found that EPA's draft assessment was not prepared in a logically consistent fashion, lacks clear links to an underlying conceptual framework and does not sufficiently document methods and criteria used to identify evidence for selecting and evaluating studies," NAS said.
NAS added that EPA's chemical assessments have consistently displayed these problems in recent years.
In its response, EPA said the NAS review demonstrates the agency is engaged in "a strong scientific process."
"EPA conducts peer review to assure only the highest quality science is used as the basis of our actions," the agency said in a statement. "We will carefully and expeditiously review the report and examine how best to respond to its recommendations."
Sen. David Vitter (R-La.) called for the NAS review in 2009, eventually putting a hold on confirming EPA nominees until the academy agreed to the study (E&E Daily, Sept. 23, 2009).
Vitter said the NAS report vindicated his actions, which many in the environmental community viewed as a dilatory tactic on behalf of a billion dollar industry.
"I'm extremely glad I fought so hard for this review," Vitter said in a statement. "It confirms what I feared -- serious shortcomings and bias at the EPA. Louisiana citizens should be able to count on EPA conclusions and advice. This study shows that we can't."
Panel does back some EPA conclusions
The NAS report, however, does not bear all bad news for the EPA assessment.
The review panel found that the agency sufficiently supported its conclusions that formaldehyde can irritate eyes, noses and throats and cause respiratory lesions. It also backed EPA's conclusion that formaldehyde exposure causes cancer in the nose and upper throat.
Environmental groups applauded that conclusion.
"The report confirmed EPA's determination that formaldehyde is known to cause cancer in humans," said Jennifer Sass, a senior scientist at the Natural Resources Defense Council. "Let's not lose sight of what is important. This chemical has been known for years to cause cancer. And, it contaminates the air in our homes and workplaces, leaching from plywood and particle board furniture and other household products."
Formaldehyde has become a hot-button issue for EPA since the chemical was detected in Federal Emergency Management Agency trailers sent to the Gulf Coast following Hurricane Katrina (Greenwire, Oct. 1, 2010).
EPA's long, slow assessment has frustrated many environmentalists who saw the lagging effort hurting Gulf Coast residents.
Becky Gillette, the formaldehyde campaign director at the Sierra Club, said industry has wielded its considerable influence to stall EPA's assessment process.
"The strategy of 'we need more study' has been successful for decades in making big profits for companies that produce and use formaldehyde," Gillette said. "The problem is those profits have come at the expense of human lives. ... I hope that EPA will not let this delaying tactic keep it from doing its job."
Chemical watchdogs point out that EPA currently lags behind other health organizations in how it characterizes formaldehyde. The International Agency for Research on Cancer (IARC) said formaldehyde is a known carcinogen in 2006. The Department of Health and Human Services has also reached a similar conclusion.
In May of 2009, the National Cancer Institute released study results linking formaldehyde exposure to leukemia. IARC and the U.S. National Toxicology Program released similar findings later that year.
Until the ongoing EPA Integrated Risk Information System (IRIS) assessment is finalized, EPA will continue to list formaldehyde as a "probable" carcinogen and will not be able to set more stringent standards on the chemical.
Industry groups said the NAS findings demonstrate that most exposures to formaldehyde are not harmful.
"The levels of formaldehyde at which most people are exposed are not high enough to cause adverse health effects, according to the large body of research available," said the American Chemistry Council's Ann Mason. "We call on EPA to adopt the NAS findings when revising the IRIS risk assessment for formaldehyde."