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3M and Scotchgard: 3M pushed for new uses up until phaseout

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All indications are that up until the phaseout announcement, 3M was aggressively lobbying for new uses for PFOS products despite the alarming studies that began surfacing in 1997. In January 1999, in the midst of the discovery of contaminated "clean" blood samples and the initial rat studies that EPA scientists found so disturbing, 3M continued petitioning the FDA to allow PFOS chemicals to be used on microwave popcorn bags. Amazingly, in this petition, 3M presented calculations showing how PFOS could be formed during metabolism of the proposed perfluoro food additive. (view entire document) Just four months later, 3M presented to EPA a study showing elevated PFOS levels in a group of children ages 6 to 12.

One particularly troublesome study for 3M is a 1983 two-year carcinogenicity study of PFOS compounds in rats. In the high-dose group of female rats, 8 of 50 animals developed non-cancerous liver tumors and 6 of 50 developed cancerous liver tumors, a notable increase compared to no tumors of any kind in the group of 50 control rats. Based on this result, the researchers concluded that the high-dose female rats possibly have a "tumor incidence outside historical control limits." (view entire document) Later amendments to the report would stress that this result lacked statistical significance. (view entire document)

This study is in fact extraordinarily significant because under the Delaney clause of the Food Drug and Cosmetics Act, chemicals that caused cancer in animals are not allowed to be used as food additives. 3M contracted for subsequent reviews of the study -- one of which, from 1998, was devastating: "Incidence values for liver proliferative lesions indicated that [the PFOS chemical] should be regarded as a liver carcinogen for Sprague Dawley rats under the conditions of this study." (view entire document) But not until the phaseout announcement of 2000 did 3M act to withdraw food additive uses of the chemical.

The final blow for PFOS came in April 2000 when 3M submitted to EPA a pivotal monkey study showing deaths of dosed animals at relatively low exposures. (view entire document) In the words of the 3M report: "monkeys exhibited low food consumption, excessive salivation, labored breathing, hypoactivity, ataxia, hepatic vacuolization and hepatocellular hypertrophy, significant reductions in serum cholesterol levels, and death." (view entire document)

The public record does not contain details about discussions or negotiations that might have occurred between 3M and EPA in the 70 days between 3M's "re-engineering" proposal and the public phaseout announcement. On May 18, two days after 3M's announcement, The New York Times reported that EPA officials had forced 3M's hand: "The E.P.A. account differs from that of 3M, which said on Monday that it had voluntarily decided to stop making the chemical. . . . [A] gency officials said that if 3M had not acted they would have taken steps to remove the product from the market."

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last updated: march.27.2009

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