[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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].
SUPPLEMENTARY INFORMATION:
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:
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. 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
follows:
(1) The top foot of silage stored should not contain formic acid
and
(2) Silage should not be fed to livestock within 4 weeks of
treatment.
(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
(ppm);
(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
exposure.
(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
(MSDS).
Dated: February 3, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-2789 Filed 2-8-11; 8:45 am]
BILLING CODE 4160-01-P