Source: https://www.federalregister.gov/documents/2012/07/17/2012-17367/representative-edward-j-markey-filing-of-food-additive-petition
Timestamp: 2017-05-30 09:36:37
Document Index: 270571421

Matched Legal Cases: ['§\u2009175', 'art 10', '§\u2009171', '§\u2009171', '§\u2009171', '§\u2009171', '§\u2009175', 'art 20']

:: Representative Edward J. Markey; Filing of Food Additive Petition
A Proposed Rule by the Food and Drug Administration on 07/17/2012
41953-41954
https://www.federalregister.gov/d/2012-17367
Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2B4791) has been filed by Representative Edward J. Markey, House of Representatives, 2108 Rayburn House Office Building, Washington, DC 20515-2107. The petition proposes to amend the food additive regulations in § 175.300 (21 CFR 175.300) to no longer provide for the use of BPA-based epoxy resins as coatings in packaging for infant formula because these uses have been intentionally and permanently abandoned. BPA-based epoxy resins are formed by the reaction of 4,4'-isopropylenediphenol (i.e., BPA), and epichlorohydrin.
Under section 409(i) of the FD&C Act, FDA “shall by regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations.” FDA's regulations specific to administrative actions for food additives provide as follows: “The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive.” (§ 171.130(a) (21 CFR 171.130(a))). These regulations further provide: “Any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or appeal. New data shall be furnished in the form specified in §§ 171.1 and 171.100 for submitting petitions.” (§ 171.130(b)). Under these regulations, a petitioner may propose that FDA amend a food additive regulation if the petitioner can demonstrate that there are “old uses abandoned” for the relevant food additive. Such abandonment must be complete for any intended uses in the U.S. market. While section 409 of the FD&C Act and § 171.130 also provide for amending or revoking a food additive regulation based on safety, an amendment or revocation based on abandonment is not based on safety, but is based on the fact that the regulatory authorization is no longer necessary because the use of the food additive has been abandoned.
FDA expressly requests comments on the petitioner's request that FDA amend the food additive regulations to no longer permit the use of BPA-based epoxy resins as coatings in packaging for infant formula. For the purposes of this petition, FDA considers the use of BPA-based epoxy resins as coatings (as described in § 175.300(a)) in packaging of infant formula to mean a metal substrate (single use) or any suitable substrate (repeated use) being coated with BPA-based epoxy resins as a continuous film or enamel, serving as a functional barrier between the infant formula (powder or liquid) and the substrate. As noted, the basis for the proposed amendment is that the use of BPA-based epoxy resins as coatings in packaging for infant formula has been permanently and completely abandoned. Accordingly, FDA requests comments that address 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. Further, FDA requests comments on whether the uses that are the subject of the petition (BPA-based epoxy resins as coatings in infant formula packaging) have been adequately defined. FDA is not aware of information that suggests continued use of BPA-based epoxy resins as coatings in packaging for powder or liquid infant formula. FDA is providing the public 60 days to submit comments. FDA anticipates that some interested persons may wish to provide FDA with certain information that they consider to be trade secret or confidential commercial information (CCI) that would be exempt under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552). Interested persons may claim information that is submitted to FDA as CCI or trade secret by clearly marking both the document and the specific information as “confidential.” Information so marked will not be disclosed except in accordance with the Freedom of Information Act (5 U.S.C. 552) and FDA's disclosure regulations (21 CFR part 20). For electronic submissions to http://www.regulations.gov, indicate in the “comments” box of the appropriate docket that your submission contains confidential information. Interested persons must also submit a copy of the comment that does not contain the information claimed as confidential for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice.