[Federal Register Volume 62, Number 45 (Friday, March 7, 1997)]
[Rules and Regulations]
[Pages 10452-10453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5558]



[[Page 10452]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 96F-0242]


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 additional safe use of 
perfluoroalkyl substituted phosphate ester acids, ammonium salts formed 
by the reaction of 2,2-bis[(,-perfluoroC4-
20alkylthio)methyl]-1,3-propanediol, polyphosphoric acid and ammonium 
hydroxide, as an oil and water repellant for paper and paperboard 
intended for use in contact with food. This action is in response to a 
petition filed by Ciba-Geigy Corp.

DATES: Effective March 7, 1997; written objections and requests for a 
hearing by April 7, 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 July 18, 1996 (61 FR 37483), FDA announced that a food 
additive petition (FAP 6B4513) had been filed by Ciba-Geigy Corp., P.O. 
Box 18300, Greensboro, NC 27419-8300. 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 additional safe use of perfluoroalkyl substituted 
phosphate ester acids, ammonium salts formed by the reaction of 2,2-
bis[(,-perfluoroC4-20alkylthio)methyl]-1,3-
propanediol, polyphosphoric acid and ammonium hydroxide, as an oil and 
water repellant for paper and paperboard intended for use in contact 
with food.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additive in paper and 
paperboard products in contact with non-alcoholic foods under condition 
of use C through G as described in Table 2 of Sec. 176.170(c) is safe, 
that the additive will have the intended technical effect, and, 
therefore, that Sec. 176.170 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 environmental 
assessment submitted with the petition.
    Any person who will be adversely affected by this regulation may at 
any time on or before April 7, 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 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, 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 
revising the entry for ``Perfluoroalkyl substituted phosphate ester 
acids, ammonium salts formed by the reaction of 2,2-
bis[(,-perfluoroC4-20alkylthio)methyl]-1,3-
propanediol, polyphosphoric acid and ammonium hydroxide'' under the 
heading ``Limitations'' to read as follows:

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

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

[[Page 10453]]



                                                                        
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         List of Substances                      Limitations            
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  *                    *                    *                    *      
                   *                    *                    *          
Perfluoroalkyl substituted           For use only as an oil and water   
 phosphate ester acids, ammonium      repellant at a level not to exceed
 salts formed by the reaction of      0.44 percent perfluoroalkyl       
 2,2-bis[(,-       actives by weight of the finished 
 perfluoroC4-20alkylthio)methyl]-     paper and paperboard in contact   
 1,3-propanediol, polyphosphoric      with non-alcoholic foods under    
 acid and ammonium hydroxide.         condition of use H as described in
                                      Table 2 of paragraph (c) of this  
                                      section; and in contact with food 
                                      of types III, IV-A, V, VII-A, and 
                                      IX described in Table 1 of        
                                      paragraph (c) of this section     
                                      under conditions of use C through 
                                      G as described in Table 2 of      
                                      paragraph (c) of this section.    
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: February 7, 1997.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 97-5558 Filed 3-6-97; 8:45 am]
BILLING CODE 4160-01-F