Food Additives Permitted in Feed and Drinking Water of Animals; Sodium Stearate

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.

-----------------------------------------------------------------------

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