[Federal Register Volume 60, Number 226 (Friday, November 24, 1995)]
[Rules and Regulations]
[Pages 57926-57927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28545]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 92F-0086]


Indirect Food Additives: Polymers

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 ethylene-1,4-
cyclohexylene dimethylene terephthalate copolymer containing up to 5 
mole percent (7 weight percent) 1,4-cyclohexylene dimethylene 
terephthalate as a base sheet and base polymer for use in food-contact 
articles. This action is in response to a petition filed by Eastman 
Chemical Co.

DATES: Effective November 24, 1995; written objections and requests for 
a hearing by December 26, 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: Diane E. Robertson, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3089.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of April 13, 1992 (57 FR 12831), FDA announced that a food 
additive petition (FAP 2B4318) had been filed by Eastman Chemical Co., 
P.O. Box 511, Kingsport, TN 37662. The petition proposed to amend the 
food additive regulations to provide for the safe use of copolyesters 
containing up to 5 mole percent (7 weight percent) 1,4-cyclohexylene 
dimethylene terephthalate as the base sheet and base polymer for use in 
food-contact articles.
     FDA has evaluated the data and information in the petition and 
concludes that the proposed use of the additive as a base sheet and 
base polymer is safe. The agency also concludes that the additive is 
currently regulated under Sec. 177.1315 Ethylene-1,4-cyclohexylene 
dimethylene terephthalate copolymers (21 CFR 177.1315) and that this 
new use should be regulated under the same name. Further, the agency 
concludes that both Secs. 177.1315 and 177.1630 Polyethylene phthalate 
polymers (21 CFR 177.1630) 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 December 26, 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 177

     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 177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

     1. The authority citation for 21 CFR part 177 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 177.1315 is amended in the table in paragraph (b) by 
adding new entry ``3.'' to read as follows:


Sec. 177.1315  Ethylene-1,4-cyclohexylene dimethylene terephthalate 
copolymers.

-* * * * *
     (b) Specifications:

                                                                        

[[Page 57927]]
                                                                                                                
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                                                            Maximum                                             
                                                          extractable                                           
                                                       fractions of the                                         
                                                       copolymer in the                                         
                                                       finished form at                                         
   Ethylene 1,4-cyclohexylene                              specified                                            
    dimethylene terephthalate     Inherent viscosity   temperatures and        Test for        Conditions of use
           copolymers                                  times (expressed      orientability                      
                                                       in micrograms of                                         
                                                       the terephthaloyl                                        
                                                        moieties/square                                         
                                                      centimeter of food-                                       
                                                       contact surface)                                         
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
3. Ethylene-1,4-cyclohexylene     No test required..  For each            No test required..  For each          
 dimethylene terephthalate                             corresponding                           corresponding    
 copolymer is the reaction                             condition of use,                       specification,   
 product of dimethyl                                   must meet                               may be used as a 
 terephthalate or terephthalic                         specifications                          base sheet and   
 acid with a mixture containing                        described in Sec.                       base polymer in  
 99 to 95 mole percent of                               177.1630(f),                           accordance with  
 ethylene glycol and 1 to 5 mole                       (g), (h), or (j).                       conditions of use
 percent of 1,4-                                                                               described in Sec.
 cyclohexanedimethanol (70                                                                      177.1630(f),    
 percent trans isomer, 30                                                                      (g), (h), or (j).
 percent cis isomer).                                                                                           
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 * * * * *
     3. Section 177.1630 is amended by revising paragraphs (a), (b), 
and the introductory text of paragraph (j) and by amending paragraph 
(e)(4)(ii) by alphabetically adding a new substance to the ``List of 
Substances and Limitations'' to read as follows:


Sec. 177.1630  Polyethylene phthalate polymers.

 * * * * *-
     (a) Polyethylene phthalate films consist of a base sheet of 
ethylene terephthalate polymer, ethylene terephthalate-isophthalate 
copolymer, or ethylene-1,4-cyclohexylene dimethylene terephthalate 
copolyesters described in Sec. 177.1315(b)(3), to which have been added 
optional substances, either as constituents of the base sheet or as 
constituents of coatings applied to the base sheet.
    (b) Polyethylene phthalate articles consist of a base polymer of 
ethylene terephthalate polymer, or ethylene-1,4-cyclohexylene 
dimethylene terephthalate copolyesters described in 
Sec. 177.1315(b)(3), to which have been added optional substances, 
either as constituents of the base polymer or as constituents of 
coatings applied to the base polymer.
 * * * * * -----
    (e) * * *
    (4) * * *
    (ii) * * *
Ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters 
described in Sec. 177.1315(b)(3).
 * * * * *
     (j) Polyethylene phthalate plastics, composed of ethylene 
terephthalate-isophthalate containing a minimum of 98 weight percent of 
polymer units derived from ethylene terephthalate, or ethylene-1,4-
cyclohexylene dimethylene terephthalate copolyesters described in 
Sec. 177.1315(b)(3), conforming with the specifications prescribed in 
paragraph (j)(1) of this section, are used as provided in paragraph 
(j)(2) of this section.

    Dated: November 10, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-28545 Filed 11-22-95; 8:45 am]
BILLING CODE 4160-01-F