[Federal Register Volume 60, Number 126 (Friday, June 30, 1995)]
[Rules and Regulations]
[Pages 34134-34135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16092]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 91F-0339]


Indirect Food Additives: Paper and Paperboard Components

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 2-bromo-2-nitro-
1,3-propanediol as an antimicrobial/preservative in fillers, pigment 
slurries, starch sizing solutions, and latex coatings used in the 
manufacture of paper and paperboard articles intended to contact food. 
This action responds to a food additive petition filed by Betz 
Laboratories, Inc.

DATES: Effective June 30, 1995; written objections and requests for a 
hearing by August 29, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
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 September 19, 1991 (56 FR 47478), FDA announced that a food 
additive petition (FAP 1B4279) had been filed by Betz Laboratories, 
Inc., 4636 Somerton Rd., Trevose, PA 19053. The petition proposed to 
amend the food additive regulations in Sec. 176.170 Components of paper 
and paperboard in contact with aqueous and fatty foods (21 CFR 176.170) 
to provide for the safe use of 2-bromo-2-nitro-1,3-propanediol as an 
antimicrobial/preservative in fillers, binders, pigment slurries, 
sizings, and coatings used in the manufacture of paper and paperboard 
articles intended for food-contact use. The petitioner later limited 
and clarified the requested use of the additive to provide for its safe 
use as an antimicrobial/preservative in fillers, pigment slurries, 
starch sizing solutions, and latex coatings used as components of paper 
and paperboard in contact with aqueous and fatty foods.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the additive is safe and effective for the 
proposed use and that 21 CFR 176.170 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 July 31, 1995, 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 

[[Page 34135]]
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 176

    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 176 is amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

    1. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
     2. Section 176.170 is amended in the table in paragraph (a)(5) by 
alphabetically adding a new entry under the headings ``List of 
Substances'' and ``Limitations'' to read as follows:


Sec. 176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

* * * * *
    (a) *  *  *
    (5) *  *  *

                                                                        
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         List of Substances                      Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
2-Bromo-2-nitro-1,3-propanediol      For use only as an antimicrobial/  
 (CAS Reg. No. 52-51-7).              preservative in fillers, pigment  
                                      slurries, starch sizing solutions,
                                      and latex coatings at levels not  
                                      to exceed 0.01 percent by weight  
                                      of those components.              
  *                    *                    *                    *      
                   *                    *                    *          
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* * * * *

    Dated: June 21, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-16092 Filed 6-29-95; 8:45 am]
BILLING CODE 4160-01-F