2012-3744. American Chemistry Council; Filing of Food Additive Petition

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of petition.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that the American Chemistry Council (ACC) has filed a petition proposing that the food additive regulations be amended to no longer provide for the use of polycarbonate (PC) resins in infant feeding bottles and spill-proof cups designed to help train babies to drink from cups because these uses have been abandoned. PC resins are formed by the condensation of 4,4′-isopropylenediphenol (i.e., Bisphenol A (BPA)), and carbonyl chloride or diphenyl carbonate.

DATES:

Submit either electronic or written comments by April 17, 2012.

ADDRESSES:

You may submit comments, identified by Docket No. FDA-2012-F-0031 by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

• Fax: [phone].
• Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the Agency name and Docket No. FDA-2012-F-0031. All comments received may be posted without change to http://www.regulations.gov,, including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Vanee Komolprasert, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1217.

SUPPLEMENTARY INFORMATION:

I. Background

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 1B4783) has been filed by the American Chemistry Council (ACC), 700 Second St. NE., Washington, DC 20002. The petition proposes to amend the food additive regulations in 21 CFR 177.1580 to no longer permit the use of PC resins in infant feeding bottles (“baby bottles”) and spill-proof cups designed to help train babies to drink from cups (“sippy cups”) because these uses have been abandoned. Polycarbonate resins are formed by the condensation of 4,4′-isopropylenediphenol (i.e., BPA), and carbonyl chloride or diphenyl carbonate.

II. Abandonment

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.” (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 21 CFR 171.1 and 171.100 for submitting petitions.” (21 CFR 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 regulatory authorization is no longer necessary for the use of that food additive.

Abandonment may be based on the abandonment of certain authorized food additive uses for a substance (e.g., if a substance is no longer used in certain product categories), or on the abandonment of all authorized food additive uses of a substance (e.g., if a substance is no longer being manufactured). If a petition seeks an amendment to a food additive regulation based on the abandonment of certain uses of the food additive, such uses must be adequately defined so that both the scope of the abandonment and any amendment to the food additive regulation are clear.

The ACC petition contains public information and information collected from companies that produce PC resins to support the claim that baby bottles and sippy cups containing 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. The petition contains the results of an industry poll showing that the PC resin manufacturers, which represent over 97 percent of worldwide, global PC resin production capacity, are no longer, to their knowledge, selling PC resins to be used in the manufacture of baby bottles and sippy cups intended for import into the United States or sale in the U.S. market.

FDA expressly requests comments on ACC's proposal that FDA amend the food additive regulations to no longer permit the use of PC resins in baby bottles and sippy cups. For the purposes of this petition, FDA considers “sippy cups” to mean spill-resistant training cups, including their closures and lids, intended for use by babies or toddlers. As noted, the basis for the proposed amendment is that the use of PC resins in the manufacture of baby bottles and sippy cups has been abandoned. Accordingly, FDA requests comments that address whether these uses of PC resins have been abandoned, such as information on whether baby bottles or sippy cups containing PC resins are 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 ACC's petition (baby bottles and sippy cups) have been adequately defined. FDA is not currently aware of information that would suggest continued use of PC resins in the manufacture of baby bottles and sippy cups. FDA is providing the public 60 days to submit comments.

The Agency is not requesting comments on the safety of these uses of PC resins because, as discussed previously in this document, such information is not relevant to abandonment, which is the basis of the proposed action. Any comments addressing the safety of PC resins or containing safety information on these resins will not be considered in FDA's evaluation of this petition. Separate from FDA's consideration of this petition, FDA is actively assessing the safety of BPA (see 75 FR 17145, April 5, 2010). Interested persons with safety information that has not previously been submitted to FDA on the use of PC resins may provide that information to Docket No. FDA-2010-N-0100. Although this docket is no longer accepting electronic comments, written comments will be accepted by FDA's Division of Dockets Management (see ADDRESSES).

The Agency has determined under 21 CFR 25.32(m) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: February 13, 2012.

Dennis M. Keefe,

Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.