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[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11328-11330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4497]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. FDA-2010-F-0200]

Secondary Direct Food Additives Permitted in Food for Human 
Consumption

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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: 301-827-6870.
     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.

[[Page 11329]]

    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 (Sec.  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 Sec.  184.1366 requires either a 
food additive regulation or an amendment of Sec.  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 Sec.  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 Sec.  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 Sec.  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

[[Page 11330]]

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

0
1. The authority citation for 21 CFR part 173 continues to read as 
follows:

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

0
2. Section 173.356 is added to subpart D to read as follows:

Sec.  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.
[FR Doc. 2011-4497 Filed 3-1-11; 8:45 am]
BILLING CODE 4160-01-P
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