Secondary Direct Food Additives Permitted in Food for Human Consumption, 11328-11330 [2011-4497]
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations
replaced with references to ‘‘Chapter X
of title 31.’’
II. Certain Findings
Under the Administrative Procedure
Act (‘‘APA’’), notice of proposed
rulemaking is not required when an
agency, for good cause, finds ‘‘that
notice and public procedure thereon are
impracticable, unnecessary, or contrary
to the public interest.’’ 6 The
Commission is making technical
amendments to Rule 17a–8 to update
the reference to the BSA implementing
regulations. The Commission finds that
because the amendment is technical in
nature and is being made solely to
reflect the changes in applicable
references to the BSA’s implementing
regulations, publishing the amendment
for comment is unnecessary.7
The APA also requires publication of
a rule at least 30 days before its effective
date unless the agency finds otherwise
for good cause.8 Due to the need to
coordinate the effectiveness of the
amendment to Rule 17a–8 with the
effective date of FinCEN’s rule
reorganization scheduled to take effect
on March 1, 2011, and for the same
reasons described above with respect to
notice and opportunity for comment,
the Commission finds that there is good
cause for these technical amendments to
take effect on March 1, 2011.
III. Consideration of Competitive Effects
of Amendment
Section 3(f) of the Exchange Act,9
provides that whenever the Commission
is engaged in rulemaking and is
required to consider or determine
whether an action is necessary or
appropriate in the public interest, the
Commission shall consider, in addition
to the protection of investors, whether
the action will promote efficiency,
competition, and capital formation.
Section 23(a)(2) of the Exchange Act
requires the Commission, in adopting
rules under the Exchange Act, to
consider the competitive effects of such
rules, if any, and to refrain from
adopting a rule that would impose a
burden on competition not necessary or
65
U.S.C. 553(b).
similar reasons, the amendments do not
require analysis under the Regulatory Flexibility
Act (‘‘RFA’’) or analysis of major rule status under
the Small Business Regulatory Enforcement
Fairness Act. See 5 U.S.C. 601(2) (for purposes of
RFA analysis, the term ‘‘rule’’ means any rule for
which the agency publishes a general notice of
proposed rulemaking); and 5 U.S.C. 804(3)(C) (for
purposes of Congressional review of agency
rulemaking, the term ‘‘rule’’ does not include any
rule of agency organization, procedure or practice
that does not substantially affect the rights or
obligations of non-agency parties).
8 See 5 U.S.C. 553(d)(3).
9 15 U.S.C. 78c(f).
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7 For
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appropriate in the furtherance of the
purposes of the Exchange Act.10
Because the amendments to Exchange
Act Rule 17a–8 are technical in nature,
and do not impose any additional
requirements beyond those already
required, we do not anticipate that the
amendments would have a significant
effect on efficiency, competition, or
capital formation, and we do not
anticipate that any competitive
advantages or disadvantages would be
created.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Statutory Authority
ACTION:
We are adopting this technical
amendment to Rule 17a–8 under the
authority set forth in the Exchange Act,
in particular, Sections 3, 10, 15, 17 and
23 thereof.11
SUMMARY:
List of Subjects in 17 CFR Part 240
Broker-dealers, Reporting and
recordkeeping requirements, Securities.
Text of Amendments
For the reasons set out in the
preamble, Title 17, Chapter II of the
Code of Federal Regulations is amended
as follows:
PART 240—GENERAL RULES AND
REGULATIONS, SECURITIES
EXCHANGE ACT OF 1934
1. The authority citation for Part 240
continues to read, in part, as follows:
■
Authority: 15 U.S.C. 77c, 77d, 77g, 77j,
77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn,
77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j,
78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78p,
78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a–
20, 80a–23, 80a–29, 80a–37, 80b–3, 80b–4,
80b–11, and 7201 et seq., and 18 U.S.C. 1350,
unless otherwise noted.
*
*
*
*
*
2. Amend § 240.17a–8 by removing
the phrase ‘‘part 103’’ in the two places
it appears and adding in its place
‘‘Chapter X.’’
■
Dated: February 23, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011–4694 Filed 3–1–11; 8:45 am]
BILLING CODE 8011–01–P
10 15
11 15
PO 00000
U.S.C. 78w(a)(2).
U.S.C. 78c, 78j, 78o, 78q, and 78w.
Frm 00010
Fmt 4700
Sfmt 4700
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.
Final rule.
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: https://
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 https://
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.
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations
Docket: For access to the docket to
read background documents or
objections received, go to https://
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:
WReier-Aviles on DSKGBLS3C1PROD with RULES
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
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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.
V. Paperwork Reduction Act of 1995
II. Conclusion
VI. Objections
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.
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.
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.
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
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.
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
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Rules and Regulations
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
https://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: https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 558
[Docket No. FDA–2011–N–0003]
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of a
New Animal Drug Applications;
Phenylbutazone; Pyrantel; Tylosin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of
eight new animal drug applications
(NADAs). In a notice published
elsewhere in this issue of the Federal
Register, FDA is withdrawing approval
of these NADAs.
SUMMARY:
DATES:
This rule is effective March 14,
2011.
John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079,
e-mail: john.bartkowiak@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
sponsors have requested that FDA
withdraw approval of the three NADAs
listed in table 1 of this document
because the products are no longer
manufactured or marketed:
SUPPLEMENTARY INFORMATION:
TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF THREE NADAS
Sponsor
NADA No. product
(established name of drug)
First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123
NADA
48–647;
Phenylbutazone
Boluses
(phenylbutazone).
NADA 96–161; Hy-Con TYLAN Premix (tylosin phosphate).
NADA 119–062; Cadco-BN-10 BANMINTH Premix
(pyrantel tartrate).
Yoder Feed, Division of Yoder, Inc., Kalona, IA 52247 ...
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Triple ‘‘F’’, Inc., 10104 Douglas Ave., Des Moines, IA
50322.
Truow Nutrition, Inc., 1590 Todd
Farm Dr., Elgin, IL 60123 (Truow) has
informed FDA that it is the owner of
five feed premix NADAs previously
owned by milling companies which it
has purchased. NADA 100–352 was
owned by NutriBasics Co., last doing
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15:24 Mar 01, 2011
Jkt 223001
business at P.O. Box 1014, Wilmar, MN
56201. NADA 107–002 and NADA 123–
000 were owned by Seeco, Inc., also last
doing business at P.O. Box 1014,
Wilmar, MN 56201. NADA 133–833 and
NADA 135–243 were owned by
Southern Micro-Blenders, Inc., last
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Frm 00012
Fmt 4700
Sfmt 4700
21 CFR section affected
(sponsor drug labeler code)
§ 520.1720a (058829).
§ 558.625 (035369).
§ 558.485 (011490).
doing business at 3801 N. Hawthorne
St., Chattanooga, TN 37406. Truow has
requested that FDA withdraw approval
of the five NADAs in table 2 of this
document because they are no longer
manufactured or marketed:
E:\FR\FM\02MRR1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11328-11330]
From the Federal Register Online via the Government Printing 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: https://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 https://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 https://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 https://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: https://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
