[Federal Register Volume 60, Number 149 (Thursday, August 3, 1995)]
[Rules and Regulations]
[Pages 39645-39647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19094]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 176

[Docket No. 92F-0504]


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 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 

[[Page 39646]]
paperboard intended for use in contact with food. This action is in 
response to a petition filed by Ciba-Geigy Corp.

DATES: Effective August 3, 1995 written objections and requests for a 
hearing by September 5, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, Parklawn Dr., 
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, 202-418-3080.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 12, 1993 (58 FR 8289), FDA announced that a food 
additive petition (FAP 3B4353) 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 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.
    During review of the petition, it was observed that the perfluoro 
reactant used in the synthesis of the additive was incorrectly 
described as 2,2-bis[(,-perfluoroC4-
20alkylthio)methyl]-1,3-propanediol. The petitioner was asked to 
confirm that the correct nomenclature should be 2,2-
bis[(,-perfluoroC4-20alkylthio)methyl]-1,3-
propanediol. In their submission of July 20, 1994, the petitioner 
provided their concurrence with the agency's finding. Therefore, this 
final rule uses the correct nomenclature.
    FDA has evaluated the 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 is 
safe. Based on this information, the agency has also concluded that the 
additive will have the intended technical effect. Therefore, 
Sec. 176.170 is 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 September 5, 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 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 
alphabetically adding a new entry under the heading ``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) * * *

                                                                        

[[Page 39647]]
                                                                        
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            List of Substances                      Limitations         
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  *                    *                    *                    *      
                   *                    *                    *          
Perfluoroalkyl substituted phosphate       For use only as an oil and   
 ester acids, ammonium salts formed by      water repellant at a level  
 the reaction of 2,2-bis[ (,-perfluoroC4-20alkylthio)     perfluoroalkyl actives by   
 methyl]-1,3-propanediol, polyphosphoric    weight of the finished paper
 acid and ammonium hydroxide.               and paperboard in contact   
                                            with non-alcoholic foods    
                                            under condition of use H as 
                                            described in Table 2 of     
                                            paragraph (c) of this       
                                            section                     
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: July 22, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 95-19094 Filed 8-2-95; 8:45 am]
BILLING CODE 4160-01-F