[Federal Register Volume 63, Number 34 (Friday, February 20, 1998)]
[Rules and Regulations]
[Pages 8572-8573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4223]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. 96F-0410]
Food Additives Permitted in Feed and Drinking Water of Animals;
Sodium Stearate
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additives regulations to provide for the safe use of sodium stearate as
an anticaking agent in animal feeds. This action is in response to a
food additive petition (animal use) filed by Betty J. Pendleton,
Chesterfield, MO.
DATES: Effective February 20, 1998; written objections and requests for
a hearing by March 23, 1998.
ADDRESSES: Submit written objections and requests for a hearing to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John P. Honstead, Center for
Veterinary Medicine (HFV-222), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1728.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of December 6, 1996 (61 FR 64754), FDA announced that a food
additive petition (animal use) (FAP 2236) had been filed by Betty J.
Pendleton, 15505 Country Ridge Dr., Chesterfield, MO 63017. The
petition proposed that the regulations in Sec. 573.280 Feed-grade
calcium stearate (21 CFR 573.280) be amended to provide for the safe
use of sodium stearate as an anticaking agent in animal feeds. The
notice of filing provided for a 60-day comment period. No comments have
been received.
FDA has evaluated data in the petition and other relevant material.
FDA concludes that the proposed food additive use of sodium stearate as
an
[[Page 8573]]
anticaking agent for animal feeds is safe when used in accordance with
current good manufacturing practices.
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 listed above. As provided in 21 CFR 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.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before March 23, 1998, file with the Dockets Management
Branch (address above) written objections thereto. 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. Three copies of all documents shall be
submitted and shall be identified 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 Dockets Management Branch
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 Director, 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. Section 573.280 is revised to read as follows:
Sec. 573.280 Feed-grade calcium stearate and sodium stearate.
Feed-grade calcium stearate and sodium stearate may be safely used
in an animal feed in accordance with the following prescribed
conditions:
(a) Feed-grade calcium stearate and sodium stearate are the calcium
or sodium salts of a fatty acid mixture that is predominately stearic
acid. Associated fatty acids, including palmitic acid and minor amounts
of lauric, myristic, pentadecanoic, margaric, arachidic, and other
fatty acids may be contained in the mixture, but such associated fatty
acids in aggregate do not exceed 35 percent by weight of the mixture.
The fatty acids may be derived from feed-grade fats or oils.
(b) The additives meet the following specifications:
(1) Unsaponifiable matter does not exceed 2 percent.
(2) They are free of chick-edema factor.
(c) The additives are manufactured so that in aqueous solution they
are exposed for 1 hour or longer to temperature in excess of 180
deg.F.
(d) They are used as anticaking agents in animal feeds in
accordance with current good manufacturing practices.
Dated: January 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-4223 Filed 2-19-98; 8:45 am]
BILLING CODE 4160-01-F
