[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