[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Rules and Regulations]
[Pages 7106-7107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2789]



Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2009-F-0525]

Food Additives Permitted in Feed and Drinking Water of Animals; 
Formic 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 formic acid 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 February 9, 2011. Submit either 
electronic or written objections and requests for a hearing by March 
11, 2011. 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-2009-F-0525, 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 No. FDA-2009-F-0525 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, e-mail: 
[email protected].


I. Background

    In a notice published in the Federal Register of December 7, 2009 
(74 FR 64091), FDA announced that a food additive petition (animal use) 
(FAP 2262) had been filed by Kemira Oyj, Porkkalantatu 3, P.O. Box 330, 
001000 Helsinki, Finland. The petition proposed to amend the food 
additive regulations to provide for the safe use of formic acid as an 
acidifying agent at levels not to exceed 1.2 percent 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 
formic 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 (see DATES). 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. 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.

    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:


1. The authority citation for 21 CFR part 573 continues to read as 

    Authority:  21 U.S.C. 321, 342, 348.

2. Revise Sec.  573.480 to read as follows:

Sec.  573.480  Formic acid.

    The food additive, formic acid, may be safely used in accordance 
with the following conditions:
    (a) The additive is used as a preservative in hay crop silage in an 
amount not to exceed 2.25 percent of

[[Page 7107]]

the silage on a dry weight basis or 0.45 percent when direct cut, as 
    (1) The top foot of silage stored should not contain formic acid 
    (2) Silage should not be fed to livestock within 4 weeks of 
    (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.
    (1) The additive consists of not less than 85 percent formic acid 
(CAS 64-18-6).
    (2) The additive meets the following specifications:
    (i) Free methyl alcohol not to exceed 1,000 parts per million 
    (ii) Methyl formate not to exceed 1,000 ppm; and
    (iii) Moisture not to exceed 15 percent.
    (3) To assure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug and Cosmetic Act, the 
label and labeling shall contain:
    (i) The name of the additive.
    (ii) Adequate directions for use including a statement that formic 
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 formic acid.
    (4) 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)(3) of this section, the label and labeling shall contain:
    (i) Appropriate warnings and safety precautions concerning formic 
acid (85 percent formic acid).
    (ii) Statements identifying formic acid (85 percent formic acid) as 
a corrosive and possible severe irritant.
    (iii) Information about emergency aid in case of accidental 
    (A) 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.
    (B) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Material Safety Data Sheet 

    Dated: February 3, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-2789 Filed 2-8-11; 8:45 am]