[Federal Register Volume 61, Number 37 (Friday, February 23, 1996)]
[Rules and Regulations]
[Pages 6939-6940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4068]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 88F-0316]


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 3-iodo-2-propynyl-
N-butylcarbamate as an antifungal preservative in adhesives for food 
contact applications. This action responds to a petition filed by the 
Troy Chemical Corp.

DATES: Effective February 23, 1996; written objections and requests for 
a hearing by March 25, 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: Daniel N. Harrison, Center for Food 
Safety and Applied Nutrition (HFS-216) Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3080.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of October 25, 1988 (53 FR 43043), FDA announced that a food 
additive petition (FAP 8B4088) had been filed by the Troy Chemical 
Corp., 72 Eagle Rock Ave., P.O. Box 366, East Hanover, NJ, 07936-0366 
(formerly One Avenue L, Newark, NJ 07105-3895), proposing that the food 
additive regulations be amended to provide for the safe use of 3-iodo-
2-propynyl butyl carbamate as an antifungal preservative in adhesives 
for food contact applications.

    -FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the more accurate name for the 
additive is 3-iodo-2-propynyl-N-butylcarbamate (CAS Reg. No. 55406-53-
6), that the proposed food additive use is safe, that the additive will 
achieve its intended technical effect, and that Sec.  175.105 Adhesives 
(21 CFR 175.105) of the food additive regulations 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 March 25, 1996, file with the Dockets Management 
Branch 

[[Page 6940]]
(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 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 of the 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 paragraph (c)(5) by 
alphabetically adding the following new entry to the table to read as 
follows.


Sec.  175.105 Adhesives.

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

                                                                                                                                                        
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                                 Substances                                                                   Limitations                               
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          *                    *                    *                    *                    *                    *                    *     --        
3-Iodo-2-propynyl-N-butyl carbamate (CAS Reg. No. 55406-53-6)..............                For use only as an antifungal preservative- -------          
            *                    *                    *                    *                    *                    *                    *             
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    Dated: February 8, 1996.
 Fred R. Shank,
 Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-4068 Filed 2-22-96; 8:45 am]
BILLING CODE 4160-01-F