By Katherine M. Rahill, Partner, Jenner & Block
On July 17, 2012, the U.S. Food and Drug Administration ("FDA") issued a final rule amending its food additive regulations to ban the use of polycarbonate resins in baby bottles and sippy cups. Bisphenol A ("BPA") is a key component of polycarbonate resins. The ban is in response to a petition by the American Chemistry Council seeking an amendment to food additive regulations to no longer allow for the use of BPA-based resins in these products. FDA's regulations allow for a petitioner to seek an amendment to the food additive rules based on a number of rationales including the development of new uses, the abandonment of old uses, or new information as to toxicity of a chemical.
Interestingly, the basis for the petition, and the FDA's final rule, is the abandonment of the use of BPA-based resins in these applications and not concerns about the safety of BPA-based resins in these products or food storage generally. The FDA's February 17, 2012 proposed rule (77 FR 9608) expressly stated that the FDA would not consider comments regarding the safety of BPA-based resins for food storage and that the FDA was reviewing the safety of BPA separate from the petition. According to the final rule, the petition cited a poll of BPA-based resin manufacturers in which the manufacturers stated that they were no longer selling these resins to manufacturers of baby bottles and sippy cups used in the United States as evidence of such abandonment.
In granting the petition and issuing the final rule, the FDA found that information provided in the petition and available from other sources demonstrated that the use of BPA-based resins in the manufacture of baby bottles and sippy cups has been "completely and permanently abandoned." 77 Fed. Reg. 41899, at 41901. According to a press release, FDA Acts on ACC Petition, Changes Rule Regulating BPA in Baby Bottles and Sippy Cups, issued by the American Chemistry Council, this amendment will clear up confusion and provide certainty to consumers that BPA is not contained in baby bottles and sippy cups.
The issuance of the final rule banning the use of BPA-based resins in baby bottles and sippy cups came on the same day the FDA announced the filing of a petition by Representative Edward Markey (D-Mass) seeking the banning of BPA-based epoxy resins in coatings used in packaging infant formula. Similarly, this petition is also based on abandonment. As a result, the FDA requested comment only on whether this use of BPA resins has been completely abandoned and whether the use has been adequately defined. The notice expressly states that any comments regarding the safety of BPA-based resins will not be considered.
A copy of the final rule can be found here. A copy of the notice of petition can be found here.
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