[Federal Register Volume 75, Number 137 (Monday, July 19, 2010)]
[Rules and Regulations]
[Pages 41725-41726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17565]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2008-F-0151] (formerly Docket No. 2007F-0478)


Food Additives Permitted in Feed and Drinking Water of Animals; 
Ammonium Formate

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 ammonium formate as an 
acidifying agent in swine feed. This action is in response to a food 
additive petition filed by Kemira Oyj of Finland.

DATES: This rule is effective July 19, 2010. Submit either electronic 
or written objections and requests for a hearing by August 18, 2010. 
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-2008-F-0151, by any 
of the following methods:
Electronic Submissions
    Submit electronic objections in the following ways:
     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 number for this rulemaking. All objections received will be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For detailed 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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of January 11, 2008 
(73 FR 2055), FDA announced that a food additive petition (animal use) 
(FAP 2258) had been filed by Kemira Oyj, Porkkalantatu 3, PO Box 330, 
001000 Helsinki, Finland. The petition proposed to amend the food 
additive regulations to provide for the safe use of partially 
ammoniated formic acid as an acidifying agent at levels not to exceed 
1.2 percent in swine feed. Subsequently, it was determined that the 
food additive is more accurately described as ammonium formate. The 
notice of filing provided for a 60-day comment period on the 
petitioner's environmental assessment. No comments have been received.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
ammonium formate 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 any 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

    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 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.

List of Subjects in 21 CFR Part 573

    Animal feeds, Food additives.

0
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

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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.  573.170 to read as follows:


Sec.  573.170  Ammonium formate.

    The food additive, partially ammonium formate, may be safely used 
in the manufacture of complete swine feeds in accordance with the 
following prescribed conditions:
    (a) The additive is manufactured by the reaction of 99.5 percent 
ammonia gas and 99 percent formic acid in a continuous loop reactor to 
produce a solution made up of 37 percent ammonium salt of formic acid 
and 62 percent formic acid.

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    (b) 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 
1.2 percent of the complete feed.
    (c) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act (the 
act), the label and labeling shall contain:
    (1) The name of the additive.
    (2) Adequate directions for use including a statement that ammonium 
formate must be uniformly applied and thoroughly mixed into complete 
swine feeds and that the complete swine feeds so treated shall be 
labeled as containing ammonium formate.
    (d) To assure safe use of the additive, in addition to the other 
information required by the act and paragraph (c) of this section, the 
label and labeling shall contain:
    (1) Appropriate warnings and safety precautions concerning ammonium 
formate (37 percent ammonium salt of formic acid and 62 percent formic 
acid).
    (2) Statements identifying ammonium formate in formic acid (37 
percent ammonium salt of formic acid and 62 percent formic acid) as a 
corrosive and possible severe irritant.
    (3) Information about emergency aid in case of accidental exposure 
as follows:
    (i) Statements reflecting requirements of applicable sections of 
the Superfund Amendments and Reauthorization Act (SARA), and the 
Occupational Safety and Health Administration's (OSHA) human safety 
guidance regulations.
    (ii) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Material Safety Data Sheet 
(MSDS).

    Dated: July 14, 2010.
Tracey H. Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2010-17565 Filed 7-16-10; 8:45 am]
BILLING CODE 4160-01-S