[Federal Register Volume 65, Number 199 (Friday, October 13, 2000)]
[Rules and Regulations]
[Pages 60858-60859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 99F-3087]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Sodium Stearoyl Lactylate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of sodium stearoyl 
lactylate as an emulsifier, stabilizer, and texturizer in cream liqueur 
drinks. This action is in response to a petition filed by the American 
Ingredients Co.

DATES: This rule is effective October 13, 2000. Submit written 
objections and requests for a hearing by November 13, 2000.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary E. LaVecchia, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW.,Washington, DC 20204, 202-418-3047.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register on September, 13, 
1999 (64 FR 49495), FDA announced that a food additive petition (FAP 
9A4684) had

[[Page 60859]]

been filed by the American Ingredients Co., 3947 Broadway, Kansas City, 
MO 64111. The petition proposed to amend the food additive regulations 
in Sec. 172.846 Sodium stearoyl lactylate (21 CFR 172.846) to provide 
for the safe use of sodium stearoyl lactylate as an emulsifier, 
stabilizer, and texturizer in cream liqueur drinks.

II. Conclusions

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of sodium stearoyl lactylate is safe, that the additive 
will achieve its intended technical effect, and, therefore, that the 
regulation in Sec. 172.846 should be amended as set forth below.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(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 Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.

III. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 9A4684. No new 
information or comments have been received that would affect the 
agency's previous determination that there is no significant impact on 
the human environment and that an environmental impact statement is not 
required.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. Objections

    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by November 13, 2000. 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 are to be 
submitted and are to 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 172

    Food additives, Reporting and recordkeeping requirements.


    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 Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.


    2. Section 172.846 is amended by adding paragraph (c)(9) to read as 
follows:


Sec. 172.846  Sodium stearoyl lactylate

* * * * *
    (c) * * *
    (9) As an emulsifier, stabilizer, or texturizer in cream liqueur 
drinks, at a level not to exceed 0.5 percent by weight of the finished 
product.

    Dated: October 2, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-26251 Filed 10-12-00; 8:45 am]
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