[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Rules and Regulations]
[Pages 54188-54190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25973]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 92F-0493]


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-maleic 
anhydride copolymers containing no more than 2 percent by weight of 
polymer units derived from maleic anhydride in contact with food at 
temperatures not to exceed 49  deg.C (120  deg.F). This action is in 
response to a petition filed by Showa Denko K. K.

DATES:  Effective October 20, 1995; written objections and requests for 
a hearing by November 20, 1995.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 

[[Page 54189]]
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Edward J. Machuga, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3085.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of February 12, 1993 (58 FR 8290), FDA announced that a food 
additive petition (FAP 3B4351) had been filed by Showa Denko K. K., 
Tokyo, Japan, c/o Center for Regulatory Services, 2347 Paddock Lane, 
Reston, VA 22091. The petition proposed to amend the food additive 
regulations in 21 CFR part 177 Indirect Food Additives: Polymers by 
adding a new section to provide for the safe use of ethylene-maleic 
anhydride copolymers containing no more than 2 percent by weight of 
polymer units derived from maleic anhydride in contact with food at 
temperatures not to exceed 49  deg.C (120  deg.F). However, subsequent 
to the publication of the filing notice, the agency decided, with 
concurrence of the petitioner, that the subject additive would be more 
appropriately regulated in Sec. 177.1520 Olefin polymers (21 CFR 
177.1520). Therefore, this final rule is amending Sec. 177.1520 to 
provide for the safe use of ethylene-maleic anhydride copolymers 
containing no more than 2 percent by weight of polymer units derived 
from maleic anhydride in contact with food at temperatures not to 
exceed 49  deg.C (120  deg.F).
     FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the proposed use of the food 
additive is safe and that the regulations in Sec. 177.1520 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 November 20, 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 177.1520 is amended by adding a new paragraph (a)(6) and 
in the table in paragraph (c) by adding a new item ``6'' to read as 
follows:


Sec.  177.1520  Olefin polymers.

* * * * *
    (a) * * *
    (6) Ethylene-maleic anhydride copolymers (CAS Reg. No. 9006-26-2) 
containing no more than 2 percent by weight of copolymer units derived 
from maleic anhydride.
* * * * *
    (c) * * *

                                                                                                                
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                                                                                Maximum                         
                                                                              extractable       Maximum soluble 
                                                                               fraction            fraction     
                                                      Melting point (MP)     (expressed as       (expressed as  
         Olefin polymers                Density       or softening point   percent by weight   percent by weight
                                                         (SP) (Degrees     of polymer) in N-    of polymer) in  
                                                          Centigrade)          hexane at           xylene at    
                                                                               specified           specified    
                                                                             temperatures        temperatures   
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
6. Ethylene-maleic anhydride      0.92-0.94           ..................  1.36 pct at 50      2.28 pct at 25    
 copolymers described in           ..........                              deg.C..             deg.C.           
 paragraph (a)(6) of this                                                                                       
 section for use as the adhesive                                                                                
 component in multilaminate                                                                                     
 structures, or as the sealant                                                                                  
 layer in flexible packaging, in                                                                                
 contact with food at                                                                                           
 temperatures not exceeding 49                                                                                  
 deg.C (120  deg.F).                                                                                            
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[[Page 54190]]


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    Dated: October 4, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-25973 Filed 10-19-95; 8:45 am]
BILLING CODE 4160-01-F