The Food and Drug Administration (FDA) has issued a final rule amending the food additive regulations at 21 CFR part 177 “to no longer provide for the use of polycarbonate (PC) resins,” including bisphenol A (BPA), in infant feeding bottles or spill-proof sippy cups. Effective July 17, 2012, the final rule apparently responds to a petition filed by the American Chemistry Council (ACC), which claimed that “that baby bottles and sippy cups manufactured from PC resins are no longer being introduced into the U.S. market and that manufacturers of baby bottles and sippy cups have abandoned the use of PC resins in making these products.” After reviewing the submitted data and seven public comments addressing the petition, FDA concluded that the use of PC resins in these products has been “completely and permanently abandoned,” and agreed to amend the regulations accordingly. The agency has requested objections to the final rule or requests for a public hearing by August 16, 2012.

In a related development, FDA has also announced a new petition filed by U.S. Representative Edward Markey (D-Mass.) proposing “that the food additive regulations be amended to no longer provide for the use of [BPA]-based epoxy resins as coatings in packaging for infant formula because these uses have been abandoned.” Markey’s petition reportedly contains “public information and information collected from a survey of U.S. registered manufacturers of infant formula to support [the claim] that all U.S. infant formula manufacturers have abandoned the use of BPA-based epoxy resins as coatings in all food contact packaging for infants.” To verify these claims, FDA has requested comments by September 17, 2012, that address, among other things, (i) “whether these uses of BPA-based epoxy resins have been completely abandoned, such as information on whether infant formula packaging containing BPA-based epoxy resins as coatings is currently being introduced or delivered for introduction into the U.S. market,” and (ii) “whether the uses that are the subject of the petition… have been adequately defined.”

“With the FDA moving forward with my petition, and coupled with the
American Chemistry Council petition to end the use of BPA in baby bottles and sippy cups, industry practice can follow consumer demand, and we
will be able to end the use of BPA in infant formula forever,” said Markey in
a July 17, 2012, press release. “There are viable alternatives for BPA in food
packaging, and I urge companies to stop poisoning our food supply with this
dangerous chemical. FDA now must complete and make public their long
overdue assessment of BPA’s health impacts and make clear its next steps for
ensuring our entire food supply is free from this damaging chemical.”

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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