[Federal Register Volume 60, Number 151 (Monday, August 7, 1995)]
[Rules and Regulations]
[Pages 40073-40075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19424]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 93F-0247]


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/hexene-1 
copolymers containing a maximum of 20 percent by weight of polymer 
units derived from hexene-1 as components of articles intended for use 
in contact with food. This action is in response to a petition filed by 
Exxon Chemical Co.
DATES: Effective August 7, 1995; written objections and requests for a 
hearing by September 6, 1995.

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

[[Page 40074]]
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St., SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 12, 1993 (58 FR 42976), FDA announced that a 
petition (FAP 3B4379) had been filed by Exxon Chemical Co., P.O. Box 
1607, Baton Rouge, LA 70821-1607. The petition proposed that the food 
additive regulations be amended in Sec.  177.1520 Olefin polymers (21 
CFR 177.1520) to provide for the safe use of ethylene/hexene-1 
copolymers containing a maximum of 20 percent by weight of polymer 
units derived from hexene-1 as components of articles 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 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 September 6, 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 redesignating paragraph 
(a)(3)(i)(a) as (a)(3)(i)(a)(1) and by adding a new paragraph 
(a)(3)(i)(a)(2), and in the table in paragraph (c) by revising item 
3.2a under the heading ``Olefin polymers'' to read as follows:


Sec.  177.1520 Olefin polymers.

 * * * * *
    (a) * * *
    (3) * * *
    (i) * * *
    (a)* * *
     (2) Olefin basic copolymers manufactured by the catalytic 
copolymerization of ethylene and hexene-1 shall contain not less than 
80 but not more than 90 weight percent of polymer units derived from 
ethylene.
* * * * *
    (c) Specifications:

                                                                                                                

[[Page 40075]]
                                                                                                                
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                                                                      Maximum extractable      Maximum soluble  
                                                                      fraction (expressed    fraction (expressed
                                              Melting point (MP) or   as percent by weight  as percent by weight
   Olefin polymers            Density          softening point (SP)    of polymer) in N-       of polymer) in   
                                               (Degrees Centigrade)   hexane at specified    xylene at specified
                                                                          temperatures          temperatures    
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
3.2a Olefin            0.85-1.00............  .....................  2.6 percent at 50      Do.                 
 copolymers described                                                 deg.C.                                    
 in paragraph                                                                                                   
 (a)(3)(i) of this                                                                                              
 section for use in                                                                                             
 articles used for                                                                                              
 packing or holding                                                                                             
 food during cooking;                                                                                           
 except olefin                                                                                                  
 copolymers described                                                                                           
 in paragraph                                                                                                   
 (a)(3)(i)(c)(2) of                                                                                             
 this section and                                                                                               
 listed in item 3.2b                                                                                            
 of this table;                                                                                                 
 except that olefin                                                                                             
 copolymers                                                                                                     
 containing 89 to 95                                                                                            
 percent ethylene                                                                                               
 with the remainder                                                                                             
 being 4-methyl-                                                                                                
 pentene-1 contacting                                                                                           
 food Types III, IVA,                                                                                           
 V, VIIA, and IX                                                                                                
 identified in Sec.                                                                                             
 176.170(c) of this                                                                                             
 chapter, Table 1,                                                                                              
 shall not exceed                                                                                               
 0.051 millimeter                                                                                               
 (mm) (0.002 inch                                                                                               
 (in)) in thickness                                                                                             
 when used under                                                                                                
 conditions of use A                                                                                            
 and shall not exceed                                                                                           
 0.102 mm (0.004 in)                                                                                            
 in thickness when                                                                                              
 used under                                                                                                     
 conditions of use B,                                                                                           
 C, D, E, and H                                                                                                 
 described in Sec.                                                                                              
 176.170(c) of this                                                                                             
 chapter, Table 2.                                                                                              
 Additionally, olefin                                                                                           
 copolymers described                                                                                           
 in (a)(3)(i)(a)(2)                                                                                             
 of this section may                                                                                            
 be used only under                                                                                             
 conditions of use B,                                                                                           
 C, D, E, F, G, and H                                                                                           
 described in Sec.                                                                                              
 176.170(c) of this                                                                                             
 chapter, Table 2, in                                                                                           
 contact with all                                                                                               
 food types                                                                                                     
 identified in Sec.                                                                                             
 176.170(c) of this                                                                                             
 chapter, Table 1.                                                                                              
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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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. 95-19424 Filed 8-4-95; 8:45 am]
BILLING CODE 4160-01-F