[Federal Register Volume 61, Number 49 (Tuesday, March 12, 1996)]
[Rules and Regulations]
[Pages 9903-9904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5812]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 93F-0358]


Indirect Food Additives: Adhesives and Components of Coatings

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 meta-
tetramethylxylene diisocyanate for reaction with one or more of the 
polyols and polyesters listed in the adhesive regulations and with 
dimethylolpropionic acid and trimethylamine, N-methyldiethanolamine, 2-
dimethylaminoethanol, 2-dimethylamino-2-methyl-1-propanol, and/or 2-
amino-2-methyl-1-propanol in the production of polyurethane resins 
intended for use as components of adhesive formulations used in food 
packaging applications. This action is in response to a petition filed 
by Cytec Industries.
DATES: Effective March 12, 1996; written objections and requests for a 
hearing by April 11, 1996.

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 October 26, 1993 (58 FR 57613), FDA announced that a food 
additive petition (FAP 3B4401) had been filed by Cytec Industries, c/o 
Keller and Heckman, 1001 G St. NW., suite 500 West, Washington, DC 
20001, proposing that Sec. 175.105 Adhesives (21 CFR 175.105) be 
amended to provide for the safe use of meta-tetramethylxylene 
diisocyanate for reaction with one or more of the polyols and 
polyesters listed in Sec. 175.105 and with dimethylolpropionic acid and 
trimethyamine, N-methyldiethanolamine, 2-dimethylaminoethanol, 2-
dimethylamino-2-methyl-1-propanol, and/or 2-amino-2-methyl-1-propanol 
in the production of polyurethane resins intended for use as components 
of adhesive formulations used in food packaging applications. This 
document is also amending Sec. 175.105(c)(5) to correct inconsistencies 
in the spelling of the Chemical Abstract Service Registry Numbers.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive is safe and 
that 21 CFR 175.105 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 21 CFR 
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 April 11, 1996, 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

[[Page 9904]]
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 175

    Adhesives, 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 175 is amended 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 
revising the entry for ``Polyurethane resins * * *'' under the heading 
``Substances'' to read as follows:


Sec. 175.105  Adhesives.

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

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                   Substances                           Limitations     
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*                  *                  *                  *              
                  *                  *                  *               
Polyurethane resins produced by: (1) reacting     ......................
 diisocyanates with one or more of the polyols                          
 or polyesters named in this paragraph, or (2)                          
 reacting the chloroformate derivatives of one                          
 or more of the polyols or polyesters named in                          
 this paragraph with one or more of the                                 
 polyamines named in this paragraph, or (3)                             
 reacting toluene diisocyanate or 4,4'-                                 
 methylenebis (cyclohexylisocyanate) (CAS Reg.                          
 No. 5124-30-1) with one or more of the polyols                         
 or polyesters named in this paragraph and with                         
 either N-methyldiethanolamine (CAS Reg. No. 105-                       
 59-9) and dimethyl sulfate (CAS Reg. No. 77-78-                        
 1) or dimethylolpropionic acid (CAS Reg. No.                           
 4767-03-7) and triethylamine (CAS Reg. No. 121-                        
 44-8), or (4) reacting meta-tetramethylxylene                          
 diisocyanate (CAS Reg. No. 2778-42-9) with one                         
 or more of the polyols and polyesters listed in                        
 this paragraph and with dimethylolpropionic                            
 acid (CAS Reg. No. 4767-03-7) and triethylamine                        
 (CAS Reg. No. 121-44-8), N-methyldiethanolamine                        
 (CAS Reg. No. 105-59-9), 2-dimethylaminoethanol                        
 (CAS Reg. No. 108-01-0), 2-dimethylamino-2-                            
 methyl-1-propanol (CAS Reg. No. 7005-47-2), and/                       
 or 2-amino-2-methyl-1-propanol (CAS Reg. No.                           
 124-68-5).                                                             
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
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    Dated: March 1, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-5812 Filed 3-11-96; 8:45 am]
BILLING CODE 4160-01-F