Food Additives Permitted in Feed and Drinking Water of Animals; Benzoic Acid, 14175-14176 [2014-05440]
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Federal Register / Vol. 79, No. 49 / Thursday, March 13, 2014 / Rules and Regulations
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Issued in Washington, DC, on March 7,
2014, by the Commission.
Christopher J. Kirkpatrick,
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[FR Doc. 2014–05465 Filed 3–12–14; 8:45 am]
BILLING CODE 6351–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA–2012–F–1100]
Food Additives Permitted in Feed and
Drinking Water of Animals; Benzoic
Acid
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Fmt 4700
The Food and Drug
Administration (FDA) is amending the
regulations for food additives permitted
in feed and drinking water of animals to
provide for the safe use of benzoic acid
as an acidifying agent in swine feed.
This action is in response to a food
additive petition filed by DSM
Nutritional Products.
DATES: This rule is effective March 13,
2014. Submit either written or
electronic objections and requests for a
hearing by April 14, 2014. See section
V of this document for information on
the filing of objections.
ADDRESSES: You may submit either
electronic or written objections and a
request for a hearing, identified by
Docket No. FDA–2012–F–1100, by any
of the following methods:
SUMMARY:
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:
• Mail/Hand delivery/Courier (for
paper 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 number for this rulemaking. All
objections received will be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information 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 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:
Isabel W. Pocurull, Center for Veterinary
Medicine (HFV–226), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6853,
isabel.pocurull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal
Register of December 4, 2012 (77 FR
Final rule.
Frm 00023
14175
Sfmt 4700
E:\FR\FM\13MRR1.SGM
13MRR1
14176
Federal Register / Vol. 79, No. 49 / Thursday, March 13, 2014 / Rules and Regulations
71750), FDA announced that a food
additive petition (animal use) (FAP
2273) had been filed by DSM
Nutritional Products, 45 Waterview
Blvd., Parsippany, NJ 07054. The
petition proposed to amend the food
additive regulations to provide for the
safe use of benzoic acid as a feed
acidifier in swine feed. The notice of
filing provided for a 30-day comment
period on the petitioner’s environmental
assessment. One comment was received
that was not substantive.
II. Conclusion
FDA concludes that the data establish
the safety and utility of benzoic acid for
use as proposed with modification and
that the food additive regulations
should be amended as set forth in this
document.
III. Public Disclosure
In accordance with § 571.1(h) (21 CFR
571.1(h)), the petition and the
documents that FDA considered and
relied upon in reaching its decision to
approve the petition are available for
inspection at the Center for Veterinary
Medicine by appointment with the
information contact person (see FOR
FURTHER INFORMATION CONTACT). As
provided in § 571.1(h), the Agency will
delete from the documents materials
that are not available for public
disclosure before making the documents
available for inspection.
ehiers on DSK2VPTVN1PROD with RULES
IV. Environmental Impact
The Agency has determined under 21
CFR 25.32(r) 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.
V. Objections and Hearing Requests
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. Each objection shall
be separately numbered, and each
numbered objection shall specify with
particularity the provision 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
VerDate Mar<15>2010
14:05 Mar 12, 2014
Jkt 232001
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. 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, and
will be posted to the docket at https://
www.regulations.gov.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 573 is amended as follows:
PART 573—FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
1. The authority citation for 21 CFR
part 573 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
■
2. Add § 573.210 to read as follows:
§ 573.210
Benzoic acid.
The food additive, benzoic acid, may
be safely used in the manufacture of
complete swine feeds in accordance
with the following prescribed
conditions:
(a) The additive is used or intended
for use as a feed acidifying agent, to
lower the pH, in complete swine feeds
at levels not to exceed 0.5 percent of the
complete feed.
(b) The additive consists of not less
than 99.5 percent benzoic acid (CAS 65–
85–0) by weight with the sum of 2methylbiphenyl, 3-methylbiphenyl, 4methylbiphenyl, benzyl benzoate, and
isomers of dimethylbiphenyl not to
exceed 0.01 percent by weight.
(c) To assure safe use of the additive,
in addition to the other information
required by the Federal Food, Drug, and
Cosmetic Act and paragraph (b) of this
section, the label and labeling shall
contain:
(1) The name of the additive.
(2) Adequate directions for use
including a statement that benzoic acid
must be uniformly applied and
thoroughly mixed into complete swine
feeds and that the complete swine feeds
so treated shall be labeled as containing
benzoic acid.
(3) Appropriate warnings and safety
precautions concerning benzoic acid.
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
(4) A warning statement identifying
benzoic acid as a possible irritant.
(5) Information about emergency aid
in case of accidental exposure.
(6) Contact address and telephone
number for reporting adverse reactions
or to request a copy of the Material
Safety Data Sheet (MSDS).
Dated: March 6, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–05440 Filed 3–12–14; 8:45 am]
BILLING CODE 4160–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2013–0683; FRL–9905–26–
Region 9]
Revisions to the California State
Implementation Plan; South Coast Air
Quality Management District and El
Dorado County Air Quality
Management District
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is finalizing approval of
revisions to the South Coast Air Quality
Management District and El Dorado
County Air Quality Management District
portions of the California State
Implementation Plan (SIP). The South
Coast action was proposed in the
Federal Register on September 13, 2013
and concerns carbon monoxide
emissions from cement kilns. The El
Dorado County action was proposed in
the Federal Register on October 25,
2013 and concerns the District’s
demonstration that its rules met
reasonably available control technology
(RACT) requirements under the 1997 8hour ozone National Ambient Air
Quality Standards (NAAQS). We are
approving these documents under the
Clean Air Act (CAA or the Act).
DATES: This rule will be effective on
April 14, 2014.
ADDRESSES: EPA has established docket
number EPA–R09–OAR–2013–0683 for
this action. Generally, documents in the
docket for this action are available
electronically at https://
www.regulations.gov or in hard copy at
EPA Region IX, 75 Hawthorne Street,
San Francisco, California 94105–3901.
While all documents in the docket are
listed at https://www.regulations.gov,
some information may be publicly
available only at the hard copy location
(e.g., copyrighted material, large maps,
SUMMARY:
E:\FR\FM\13MRR1.SGM
13MRR1
]]>Agencies
[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Rules and Regulations]
[Pages 14175-14176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05440]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2012-F-1100]
Food Additives Permitted in Feed and Drinking Water of Animals;
Benzoic Acid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for food additives permitted in feed and drinking water of
animals to provide for the safe use of benzoic acid as an acidifying
agent in swine feed. This action is in response to a food additive
petition filed by DSM Nutritional Products.
DATES: This rule is effective March 13, 2014. Submit either written or
electronic objections and requests for a hearing by April 14, 2014. See
section V of this document for information on the filing of objections.
ADDRESSES: You may submit either electronic or written objections and a
request for a hearing, identified by Docket No. FDA-2012-F-1100, 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:
Mail/Hand delivery/Courier (for paper 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 number for this rulemaking. All objections received will be
posted without change to https://www.regulations.gov, including any
personal information provided. For additional information 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 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: Isabel W. Pocurull, Center for
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-453-6853,
isabel.pocurull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of December 4, 2012
(77 FR
[[Page 14176]]
71750), FDA announced that a food additive petition (animal use) (FAP
2273) had been filed by DSM Nutritional Products, 45 Waterview Blvd.,
Parsippany, NJ 07054. The petition proposed to amend the food additive
regulations to provide for the safe use of benzoic acid as a feed
acidifier in swine feed. The notice of filing provided for a 30-day
comment period on the petitioner's environmental assessment. One
comment was received that was not substantive.
II. Conclusion
FDA concludes that the data establish the safety and utility of
benzoic acid for use as proposed with modification and that the food
additive regulations should be amended as set forth in this document.
III. Public Disclosure
In accordance with Sec. 571.1(h) (21 CFR 571.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Veterinary Medicine by appointment with the information
contact person (see FOR FURTHER INFORMATION CONTACT). As provided in
Sec. 571.1(h), the Agency will delete from the documents materials
that are not available for public disclosure before making the
documents available for inspection.
IV. Environmental Impact
The Agency has determined under 21 CFR 25.32(r) 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.
V. Objections and Hearing Requests
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. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision 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. 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, and will be posted to the docket at https://www.regulations.gov.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is
amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for 21 CFR part 573 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Add Sec. 573.210 to read as follows:
Sec. 573.210 Benzoic acid.
The food additive, benzoic acid, may be safely used in the
manufacture of complete swine feeds in accordance with the following
prescribed conditions:
(a) The additive is used or intended for use as a feed acidifying
agent, to lower the pH, in complete swine feeds at levels not to exceed
0.5 percent of the complete feed.
(b) The additive consists of not less than 99.5 percent benzoic
acid (CAS 65-85-0) by weight with the sum of 2-methylbiphenyl, 3-
methylbiphenyl, 4-methylbiphenyl, benzyl benzoate, and isomers of
dimethylbiphenyl not to exceed 0.01 percent by weight.
(c) To assure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act and
paragraph (b) of this section, the label and labeling shall contain:
(1) The name of the additive.
(2) Adequate directions for use including a statement that benzoic
acid must be uniformly applied and thoroughly mixed into complete swine
feeds and that the complete swine feeds so treated shall be labeled as
containing benzoic acid.
(3) Appropriate warnings and safety precautions concerning benzoic
acid.
(4) A warning statement identifying benzoic acid as a possible
irritant.
(5) Information about emergency aid in case of accidental exposure.
(6) Contact address and telephone number for reporting adverse
reactions or to request a copy of the Material Safety Data Sheet
(MSDS).
Dated: March 6, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-05440 Filed 3-12-14; 8:45 am]
BILLING CODE 4160-01-P
