2011-4497. Secondary Direct Food Additives Permitted in Food for Human Consumption

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the food additive regulations to permit the use of hydrogen peroxide as an antimicrobial agent in the manufacture of modified whey by ultrafiltration methods. This action is in response to a petition filed by Fonterra (USA), Inc.

DATES:

This rule is effective March 2, 2011. Submit either electronic or written objections and requests for a hearing by April 1, 2011. See section VI of this document for information on the filing of objections. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of March 2, 2011.

ADDRESSES:

You may submit either electronic or written objections and requests for a hearing, identified by Docket No. FDA-2010-F-0200, by any of the following methods:

Electronic Submissions

Submit electronic objections in the following way:

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

Written Submissions

Submit written objections in the following ways:

• FAX: [phone].
• Mail/Hand delivery/Courier (For paper, disk, 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-2010-F-0200 for this rulemaking. All objections received will be posted without change to http://www.regulations.gov,, including any personal information provided. For detailed instructions on submitting objections, see the “Objections” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or objections received, go to http://www.regulations.gov and insert the docket number, 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:

Celeste Johnston, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1282.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal Register of April 28, 2010 (75 FR 22411), FDA announced that Fonterra (USA), Inc., c/o Burdock Group, 801 N. Orange Ave., suite 710, Orlando, FL 32801 filed a food additive petition (FAP 0A4781). The petition proposed to amend the food additive regulations in part 173—Secondary Direct Food Additives Permitted in Food for Human Consumption (21 CFR part 173) to provide for the safe use of hydrogen peroxide as an antimicrobial agent in the manufacture of modified whey by ultrafiltration methods. In ultrafiltration, the whey stream is directed under pressure against membranes that permit undesirable substances to pass through the membranes while retaining the whey protein.

Hydrogen peroxide is currently affirmed as generally recognized as safe (GRAS) for use as an antimicrobial agent in the preparation of modified whey by electrodialysis methods at a maximum treatment level of 0.04 percent in the whey (§ 184.1366 (21 CFR 184.1366)). As a condition of use, the regulation requires that residual hydrogen peroxide be removed from the whey during processing by appropriate chemical and physical means.

Under 21 CFR 184.1(b)(2), a substance affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use. Therefore, any additional uses of hydrogen peroxide in processing food beyond those limitations set out in § 184.1366 requires either a food additive regulation or an amendment of § 184.1366. The current petition proposes to amend the food additive regulations to provide for the use of hydrogen peroxide in the preparation of modified whey by ultrafiltration methods, as an alternative to electrodialysis methods, at a maximum use level of 0.001 percent by weight of the whey, providing that residual hydrogen peroxide is removed from the whey during processing by appropriate chemical and physical means.

II. Conclusion

FDA reviewed data in the petition and other available relevant material to evaluate the safety of the use of hydrogen peroxide as an antimicrobial agent in the production of modified whey prepared by ultrafiltration methods. Based on this information, the Agency concludes that the proposed use of the additive will accomplish the intended technical effect, and that, since the proposed use of hydrogen peroxide in the preparation of modified whey by ultrafiltration would be substitutional for its already-regulated use in the preparation of modified whey by electrodialysis under § 184.1366, the exposure to hydrogen peroxide will not increase and may potentially decrease due to a lower maximum use level than what is currently permitted in the manufacture of modified whey by electrodialysis. Based on this information, FDA concludes that the proposed use of the additive is safe and the additive will achieve its intended technical effect as an antimicrobial agent under the proposed conditions of use. Therefore, the regulations in 21 CFR part 173 should be amended as set forth in this document.

III. Public Disclosure

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT). As provided in § 171.1(h), the Agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

IV. Environmental Impact

The Agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 0A4781 (75 FR 22411). No new information or comments have been received that would affect the Agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

V. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

VI. Objections

Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections by (see DATES). Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. It is only necessary to send one set of documents. It is no longer necessary to send three copies of all documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

VII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

FDA's review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exceptions in section 301(ll)(1) to (ll)(4) applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

List of Subjects in 21 CFR Part 173

• Food additives
• Incorporation by reference

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 173 is amended as follows:

PART 173—SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR part 173 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. Section 173.356 is added to subpart D to read as follows:

§ 173.356

Hydrogen peroxide.

Hydrogen peroxide (CAS Reg. No. 7722-84-1) may be safely used to treat food in accordance with the following conditions:

(a) The additive meets the specifications of the Food Chemicals Codex, 7th ed. (2010), pp. 496 and 497, which is incorporated by reference. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/​federal_​register/​code_​of_​federal regulations/ibr_locations.html.

(b) The additive is used as an antimicrobial agent in the production of modified whey (including, but not limited to, whey protein concentrates and whey protein isolates) by ultrafiltration methods, at a level not to exceed 0.001 percent by weight of the whey, providing that residual hydrogen peroxide is removed by appropriate chemical or physical means during the processing of the modified whey.

Dated: February 16, 2011.

Susan M. Bernard,

Acting Director, Office of Regulations, Policy and Social Services, Center for Food Safety and Applied Nutrition.