FDA Denies Citizen Petition Seeking Ban Of Bisphenol A; Safety Review Continues

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FDA Review of Bisphenol A  

Key Development: Bisphenol A may continue to be used as a component of food packaging, FDA said March 30 as it denied a citizen's petition to ban the chemical in food-contact materials.

What's Next: FDA said it will complete an updated review of bisphenol A's safety this year.

By Pat Rizzuto  

The Food and Drug Administration denied on March 30 a citizens' petition asking the agency to ban bisphenol A from food-contact materials.

The decision means companies may continue to use the chemical for food packaging, FDA said in a letter denying the Natural Resources Defense Council's 2008 petition (36 CRR 362, 3/26/12).

According to the agency, NRDC's petition failed to provide sufficient evidence that bisphenol A harms human health to persuade it to launch a rulemaking to ban the chemical. Bisphenol A, or BPA, is used to make polycarbonate plastic beverage bottles and food packaging as well as epoxy resins used to coat metal food cans and jar tops.

The studies NRDC presented to support its call for a ban had a number of limitations, including too few animals in the studies, inconsistent results, and laboratory animals being injected with BPA rather than ingesting it through their diets, FDA said.

In a statement, FDA spokesman Douglas Karas said: “I cannot stress enough that this is not a final safety determination on BPA. This is a decision on the NRDC petition. The FDA denied the NRDC petition because it did not have the scientific data needed for the FDA to change current regulations, which allow the use of BPA in food packaging.”

“FDA has been studying and continues to study the effects of BPA and will make any necessary changes to BPA's status based on the science. FDA is working toward completion of another updated safety review on BPA this year to include all relevant studies and publications,” FDA said.

FDA Lowers Exposure Estimates.

The agency said information it has received since the filing of NRDC's petition in 2008 continue to support the use of bisphenol A.

For example, data show that infants' exposure to bisphenol A is 84 percent to 92 percent lower than previously estimated, FDA said.

Initially, FDA had estimated adults were exposed to 0.185 micrograms BPA per kilogram bodyweight per day (µ/kg-bw/day) while it estimated infants were exposed to 2.42 µ/kg-bw/day.

New data indicate that infants are exposed to 0.2-0.4 µ/kg-bw/day, while children and adults consume 0.1-0.2 µ/kg-bw/day, the agency said.

In addition, the concentration of BPA in food that pregnant rodents ate that could be passed on to their unborn pups was so low it could not be measured, FDA said.

“Researchers fed pregnant rodents 100 to 1,000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus eight hours after the mother's exposure,” the agency said.

NRDC Says 'FDA Made the Wrong Call.'

NRDC issued a statement criticizing the agency's decision.

Sarah Janssen, senior scientist in NRDC's public health program, said: “We believe FDA made the wrong call. The agency has failed to protect our health and safety--in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies, and young children. … This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals.”

The North American Metal Packaging Alliance Inc. praised the FDA decision as a “welcome development, demonstrating the seriousness of the agency's commitment to doing its job of protecting public health.”

“Instead of bowing to pressure from activist groups, the agency is relying on science to set public health policy. FDA's decision to pursue an updated risk assessment is especially important given that preliminary results from ongoing government funded research support the safety of BPA in food contact uses,” said John Rost, the alliance's chairman.

In another statement, the American Chemistry Council said: “FDA's decision today, which has taken into consideration the best available science, again confirms that BPA is safe for use in food-contact materials, as it has been approved and used safely for four decades.”

By Pat Rizzuto  

The FDA letter denying NRDC's petition is available at http://op.bna.com/env.nsf/r?Open=smiy-8svr53.


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