[Federal Register Volume 62, Number 150 (Tuesday, August 5, 1997)]
[Rules and Regulations]
[Pages 42050-42051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20498]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 89F-0176]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

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 disodium 4-isodecyl 
sulfosuccinate as an emulsifier in the production of food-contact 
polymers. This action responds to a petition filed by American Cyanamid 
Co.

DATES: The regulation is effective August 5, 1997; written objections 
and request for a hearing by September 4, 1997.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Richard H. White, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3094.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 13, 1989 (54 FR 25174), FDA announced that a food 
additive petition (FAP 9B4122) had been filed by American Cyanamid Co., 
One Cyanamid Plaza, Wayne, NJ 07470 (currently Cytec Industries Inc., 
c/o Keller and Heckman, 1001 G St. NW., Washington, DC 20001). The 
petition proposed to amend the food additive regulations in 
Sec. 175.105 Adhesives (21 CFR 175.105) and Sec. 178.3400 Emulsifiers 
and/or surface active agents (21 CFR 178.3400) to provide for the safe 
use of disodium 4-isodecyl sulfosuccinate as a component of adhesives 
and as an emulsifier in the production of food-contact polymers. The 
petitioner later requested that the agency proceed with a decision 
regarding the regulation of the additive for use only as a component of 
adhesives in food-contact materials. The agency published a final rule 
in the Federal Register of April 20, 1993 (58 FR 21257) amending 
Sec. 175.105 to provide for the use of disodium 4-isodecyl 
sulfosuccinate as a component of adhesives. In that final rule, the 
agency stated that its decision regarding the petitioned use of the 
additive as an emulsifier in the production of food-contact polymers 
would be addressed in a future Federal Register document. The agency is 
addressing that decision in this final rule.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that the proposed use 
of the subject additive as an emulsifier in the production of food-
contact polymeric coatings is safe, that the additive will have the 
intended technical effect, and that therefore, Sec. 178.3400 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.
    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 September 4, 1997, 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

[[Page 42051]]

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 178

    Food additives, Food packaging.
    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 178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    1. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    2. Section 178.3400 is amended in the table in paragraph (c) by 
alphabetically adding a new entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:

Sec. 178.3400  Emulsifiers and/or surface active agents.

* * * * *
    (c) *  *  *

                                                                        
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            List of substances                       Limitations        
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
Disodium 4-isodecyl sulfosuccinate (CAS     For use only as an          
 Reg. No. 37294-49-8).                       emulsifier at levels not to
                                             exceed 5 percent by weight 
                                             of polymers intended for   
                                             use in coatings.           
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

* * * * *

    Dated: July 23, 1997.
 Janice F. Oliver,
 Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-20498 Filed 8-4-97; 8:45 am]
BILLING CODE 4160-01-F