[Federal Register Volume 61, Number 227 (Friday, November 22, 1996)]
[Rules and Regulations]
[Pages 59330-59331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29874]



[[Page 59330]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 95F-0365]


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/pentene-1 
copolymers containing not less than 90 percent of polymer units derived 
from ethylene as components of articles intended for use in contact 
with food. This action is in response to a petition filed by Sasol 
Alpha Olefins.

DATES: Effective November 22, 1996; written objections and requests for 
a hearing by December 23, 1996.

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: Daniel N. Harrison, Center for Food 
Safety and Applied Nutrition (HFS-216), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3084.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of November 15, 1995 (60 FR 57434), FDA announced that a food 
additive petition (FAP 5B4482) had been filed by Sasol Alpha Olefins, 
P.O. Box 5486, Johannesburg 2000, Republic of South Africa. The 
petition proposed to amend the food additive regulations in 
Sec. 177.1520 Olefin polymers (21 CFR 177.1520) to provide for the safe 
use of ethylene/pentene-1 copolymers containing not less than 90 
percent of polymer units derived from ethylene as components of 
articles intended for use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that the proposed food 
additive use is safe, that it will achieve its intended technical 
effect, and therefore, 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 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.
    Any person who will be adversely affected by this regulation may at 
any time on or before December 23, 1996, 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)(3)(i)(a)(3), and in the table in paragraph (c) by revising item 
3.1a and by adding a new item 3.1c to read as follows:


Sec. 177.1520  Olefin polymers.

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

[[Page 59331]]



                                                                        
------------------------------------------------------------------------
                                            Maximum                     
                                          extractable    Maximum soluble
                                            fraction         fraction   
                        Melting point    (expressed as    (expressed as 
   Olefin                  (MP) or         percent by       percent by  
  polymers    Density  softening point     weight of        weight of   
                        (SP) (Degrees    polymer) in N-    polymer) in  
                         Centigrade)       hexane at        xylene at   
                                           specified        specified   
                                          temperatures     temperatures 
------------------------------------------------------------------------
  *                    *                    *                    *      
                   *                    *                    *          
3.1a Olefin  0.85-1.0      ...........  5.5 pct at 50 C  30 pct at 25 C 
 copolymers   0                                                         
 described                                                              
 in                                                                     
 paragraph                                                              
 (a)(3)(i)                                                              
 of this                                                                
 section                                                                
 for use in                                                             
 articles                                                               
 that                                                                   
 contact                                                                
 food                                                                   
 except for                                                             
 articles                                                               
 used for                                                               
 packing or                                                             
 holding                                                                
 food                                                                   
 during                                                                 
 cooking;                                                               
 except                                                                 
 olefin                                                                 
 copolymers                                                             
 described                                                              
 in                                                                     
 paragraph                                                              
 (a)(3)(i)(                                                             
 a)(3) of                                                               
 this                                                                   
 section                                                                
 and listed                                                             
 in item                                                                
 3.1c of                                                                
 this table                                                             
 and olefin                                                             
 copolymers                                                             
 described                                                              
 in                                                                     
 paragraph                                                              
 (a)(3)(i)(                                                             
 e) of this                                                             
 section                                                                
 and listed                                                             
 in item                                                                
 3.1b of                                                                
 this                                                                   
 table.                                                                 
  *                    *                    *                    *      
                   *                    *                    *          
3.1c Olefin  Not less      ...........      ...........                 
 copolymers   than                                                      
 described    0.92                                                      
 in                                                                     
 paragraph                                                              
 (a)(3)(i)(                                                             
 a)(3) of                                                               
 this                                                                   
 section                                                                
 for use in                                                             
 contact                                                                
 with food                                                              
 only under                                                             
 conditions                                                             
 of use B,                                                              
 C, D, E,                                                               
 F, G, and                                                              
 H                                                                      
 described                                                              
 in Sec.                                                                
 176.170(c)                                                             
 of this                                                                
 chapter,                                                               
 Table 2;                                                               
 except                                                                 
 that such                                                              
 copolymers                                                             
 when used                                                              
 in contact                                                             
 with food                                                              
 of the                                                                 
 types                                                                  
 identified                                                             
 in Sec.                                                                
 176.170(c)                                                             
 , Table 1,                                                             
 under                                                                  
 types III,                                                             
 IVA, V,                                                                
 VIIA, and                                                              
 IX, shall                                                              
 be used                                                                
 only under                                                             
 conditions                                                             
 of use D,                                                              
 E, F, and                                                              
 G                                                                      
 described                                                              
 in Sec.                                                                
 176.170(c)                                                             
 of this                                                                
 chapter,                                                               
 Table 2.                                                               
  *                    *                    *                    *      
                   *                    *                    *          
------------------------------------------------------------------------

* * * * *

    Dated: November 18, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-29874 Filed 11-21-96; 8:45 am]
BILLING CODE 4160-01-F