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FDA Publishes Final Rule on BPA Ban in Can Coatings for Infant Food Due to Abandonment

The Food and Drug Administration (FDA) has published a final rule amending 21 C.F.R 175.300 of the food additive regulations to prohibit the use of bisphenol A (BPA)-based epoxy resins as coatings in infant formula packaging. In announcing its plans to publish the final rule, the Agency stated that its "action is based solely on a determination of abandonment and is not related to the safety of BPA." That is, the Agency has determined that these types of epoxy based coatings are no longer used to package infant formula, and therefore, permitting their use in infant formula is unnecessary.

FDA promulgated the rule in response to a petition submitted by U.S. Representative (now Senator-elect) Edward J. Markey (D-Mass.). In his petition, Representative Markey asked FDA to ban the use of BPA-based coatings in canned infant formula, and baby and toddler food on the basis that such coatings are no longer being used to package such food products. FDA's rule grants the petition with respect to the former, but not the latter. FDA regulations, particularly 21 C.F.R. § 171.130, allow parties to petition the Agency to amend a food additive regulation if they can show that industry has abandoned an authorized use of an additive.

In response to the final rule, the American Chemistry Council stated in a news release that the final rule would help dispel consumer concerns that BPA is unsafe and that it is used in infant food products. In March, the FDA released updated information on the safety of BPA stating "that BPA is safe at the very low levels that occur in some foods."