[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Rules and Regulations]
[Pages 14175-14176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05440]


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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.

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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: http://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 http://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 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: Isabel W. Pocurull, Center for 
Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6853, 
[email protected].

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 http://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