[Federal Register Volume 62, Number 121 (Tuesday, June 24, 1997)]
[Rules and Regulations]
[Pages 33995-33997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175 and 178

[Docket No. 96F-0292]


Indirect Food Additives: Adhesives and Components of Coatings; 
and 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 polyethyleneglycol 
alkyl(C10-C12) ether sulfosuccinate, disodium 
salt as a component of adhesives and as an emulsifier and/or surface-
active agent in the manufacture of articles or components of articles 
intended for use in contact with food. This action is in response to a 
petition filed by Cytec Industries, Inc.

DATES: Effective June 24, 1997; written objections and requests for a 
hearing by July 24, 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: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 26, 1996 (61 FR 43771), FDA

[[Page 33996]]

announced that a food additive petition (FAP 6B4518) had been filed by 
Cytec, Industries Inc., c/o Keller and Heckman, 1001 G St. NW., suite 
500 West, 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 polyethyleneglycol 
alkyl(C10-C12) ether sulfosuccinate, disodium 
salt as a component of adhesives and as an emulsifier and/or surface-
active agent in the manufacture of articles or components of articles 
intended for use in contact with food.
    Previously, the subject additive was listed in Secs. 175.105 (43 FR 
16311, April 18, 1978) and 178.3400 (58 FR 26684, May 5, 1993) with an 
alternative name (sulfosuccinic acid 4-ester with polyethylene glycol 
dodecyl ether, disodium salt with a corresponding CAS Reg. No. of 
39354-45-5). Subsequently, the petitioner found that the ethoxylated 
alcohol used to synthesize the polyethylene glycol dodecyl ether 
portion of the additive contained not a single C12 species, 
but was a mixture consisting predominantly of C10-
C12 alcohols. This final rule, in effect, lists the correct 
chemical description and the corresponding CAS Reg. No. of the 
additive.
    All of the chemistry and safety data presented in the earlier 
petitions (FAP's 8B3350 and 9B4120) resulting in the regulations cited 
above are incorporated in the present petition and remain unchanged. 
There are no compositional changes to the additive, its method of 
manufacture, use level, or technical effect. Further, there is no 
change in the safety evaluation. (For a full discussion of the safety 
evaluation, see 43 FR 16311 and 58 FR 26684.)
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive in adhesives 
and as an emulsifier and/or surface-active agent is safe, that the 
additive will have the intended technical effect, and, therefore, that 
Secs. 175.105 and 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. No comments were received during the 30-day comment 
period specified in the filing notice for comments on the environment 
assessment submitted with the petition.
    Any person who will be adversely affected by this regulation may at 
any time on or before July 24, 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 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

21 CFR Part 175

    Adhesives, Food additives, Food packaging.

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 parts 175 and 178 are amended to read as follows:

PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS

    1. The authority citation for 21 CFR part 175 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 175.105 is amended in the table in paragraph (c)(5) by 
alphabetically adding a new entry under the heading ``Substances'' to 
read as follows:

Sec. 175.105  Adhesives.

* * * * *
    (c) * * *
    (5) * * *

                                                                                                                
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                       Substances                                              Limitations                      
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate,                                                         
 disodium salt (CAS Reg. No. 68954-91-6).                                                                       
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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[[Page 33997]]

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AID, 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                      
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Polyethyleneglycol alkyl(C10-C12) ether sulfosuccinate,  For use only at levels not to exceed 5 percent by      
 disodium salt (CAS Reg. No. 68954-91-6).                 weight of total monomers used in the emulsion         
                                                          polymerization of polyvinyl acetate, acrylic, and     
                                                          vinyl/acrylic polymers intended for use as coatings   
                                                          for paper and paperboard.                             
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: June 5, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-16399 Filed 6-23-97; 8:45 am]
BILLING CODE 4160-01-F