[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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