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Fiberglass industry lost national toxicology program report battle in 1994, but still wages war in political trenches
By Robert Horowitz
In June, 1994, Secretary of Health and Human Services Donna Shalala signed the Seventh Annual Report on Carcinogens, listing glass fibers of respirable size as a substance "reasonably anticipated to cause cancer in humans."
This was a rare and bitter defeat for the fiberglass industry, which waged a loud, expensive campaign to derail the Report. Industry delayed the Report's release for three years, despite the fact fiberglass clearly met the listing criteria, and despite two unanimous votes by the National Toxicology Program (NTP) Executive Committee in favor of the listing.
The battle did not end with Shalala's signature, however. Fiberglass joined with other big industries-also unhappy with the NTP-to change the rules of the game. In this endeavor they have been wildly successful. Activists, who do not have the campaign money and relentless lobbying resources to successfully compete in Washington, won a battle but may yet lose the war.
Industry's power to suppress the report-and then to belittle the prestigious NTP once the report was released-was painfully evident the Washington Post and the Wall Street Journal. Mainstream media paid scant attention to the implications of the carcinogencity of a product in an estimated 90 percent of American homes, prefering to regurgitate calmly conniving quotes from smarmy industry mouthpeices. Fiberglass was perfectly ok to use, they said, the government listing was an arcane scientific argument with no practical consequences. Backpedaling government officials, under threat from a contemptuous Congress, meekly went along with the charade.
The annual report on carcinogens is now the Biannual Report. The criteria for listing a substance in the BRC has been modified, an outside "peer" review committee-containing members from industry-has been added to the listing process, and a process for taking items off the carcinogen list has been formalized. Already, the makers of saccharine have petitioned to have the cancer label removed from their product. Other industries are lining up.
Industry had been pining for some time to have the NTP consider research other than laboratory studies on rodents. Since the first Annual Report on Carcinogens was published in 1981, risk analysis and the study of mechanisms-the actions of substances on living cells-have gained in stature among the ruling elite. The new NTP guidelines allow such work to be used when formulating a listing decision.
According to a HHS press release dated Sept. 26, 1996, the criteria have been revised to say, "Conclusions regarding carcinogenicity in human or experimental animals are based on scientific judgment with consideration given to all relevant information. Relevant information includes, but is not limited to, dose response, route of exposure, chemical structure, metabolism, pharmacokinetics, sensitive sub-populations, genetic effects or other data relating to mechanism of action, or factors tht may be unique to a given substance. For example, there may be substances for which there is evidence of carcinogenicity in laboratory animals, but there are compelling data indicating that the agent acts through mechanisms which do not operate in humans and would, therefore, not reasonably be anticipated to cause cancer in humans."
"The state of the art is progessed to the point now, we do know some of the mechanisms by which tumors are produced, and we can use that data," according to C.W. "Bill" Jameson, Chairman of the NTP Executive Commitee.
The new peer review commitee, formally known as the Board of Scientific Counselors BRC Subcomittee, will be the third forum for materials under consideration for listing or de-listing, after the NTP working group and a sub-group of the Executive Committee. Its recommendations, like those of the first two committees, go directly to the NTP Director Dr. Ken Olden.
"Each committee is independent and each committeee makes an independent recommendation to the director," said Jameson. "But is it also sequential, so the second committee has the benefit of knowing what the first committee's discussion and recommendation was, and the third committee has the benefit of knowing what the second committee's review and discussion was... but they don't always necesarily agree."
Of the BRC Subcommittee's 11 current members, two represent big industry; one from Procter & Gamble and the other from the Chemical Industry Institute of Toxicology. There is one member from big labor (UAW), one from the International Agency for Research on Cancer, and two from the U.S. Government. The remainder are from private hospitals and cancer institutes with unknown affiliations.
The new procedures for de-listing a substance from the BRC are much the same as the procedures for listing, said Jameson, only in reverse. This method was always available, he added; the criteria was just not formalized and published.
The most likely outcome of the cumulative changes is more efforts to de-list, Jameson concedes.
"It's hard to predict," he noted. "But, we will probably see more materials formally petitioned for de-listing, because we have a formal process. Since we also have revised criteria, we will receive petitions to reconsider compounds for de-listing."
