[Federal Register Volume 59, Number 46 (Wednesday, March 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5320]


[[Page Unknown]]

[Federal Register: March 9, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177

[Docket No. 88F-0199]

 

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-octene 
copolymers, ethylene-octene-hexene copolymers, ethylene-octene-butene 
copolymers, ethylene-octene-propylene copolymers, and ethylene-octene-
4-methylpentene-1 copolymers, which contain not less than 80 weight 
percent of polymer units derived from ethylene, as articles or 
components of articles for use in contact with food. This action is in 
response to a petition filed by the Dow Chemical Co.

DATES: Effective March 9, 1994; written objections and requests for a 
hearing by April 8, 1994.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

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, 202-254-9500.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of June 24, 1988 (53 FR 23798), FDA announced that a food 
additive petition (FAP 8B4091) had been filed by the Dow Chemical Co., 
1803 Bldg., Door 7, Midland, MI 48674, proposing 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-octene copolymers, 
ethylene-octene-hexene copolymers, ethylene-octene-butene copolymers, 
ethylene-octene-propylene copolymers, and ethylene-octene-4-
methylpentene-1 copolymers, which contain not less than 75 weight 
percent of polymer units derived from ethylene, as articles or 
components of articles for use in contact with food.
    The notice stated that the copolymers, which are the subject of 
this action, would contain not less than 75 weight percent of polymer 
units derived from ethylene. Upon review of the data presented in the 
petition and subsequent amendments, FDA determines that the subject 
copolymers should contain not less than 80 weight percent of polymer 
units derived from ethylene. The attached order reflects this change.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that the proposed use of the additives 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 April 8, 1994, 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)(e), and in the table in paragraph (c) by redesignating 
item``3.1'' in the first column as item ``3.1a'' and revising it, and 
by adding a new item ``3.1b'' to read as follows:


Sec. 177.1520  Olefin polymers.

* * * * *
    (a) * * *
    (3) * * *
    (i) * * *
    (e) Olefin basic copolymers manufactured by the catalytic 
polymerization of ethylene and octene-1, or ethylene, octene-1, and 
either hexene-1, butene-1, propylene, or 4-methylpentene-1 shall 
contain not less than 80 weight percent of polymer units derived from 
ethylene.
* * * * *
    (c) * * *




----------------------------------------------------------------------------------------------------------------
                                                                      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    
----------------------------------------------------------------------------------------------------------------
                                                     *******                                                    
3.1a Olefin            0.85-1.00............  .....................  5.5 pct at 50 deg. C.  30 pct at 25 deg. C 
 copolymers 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)(e) of this                                                                                           
 section and listed                                                                                             
 in item 3.1b of this                                                                                           
 table.                                                                                                         
3.1b Olefin            0.9-1.00.............  .....................  Do...................  Do.                 
 copolymers described                                                                                           
 in paragraph                                                                                                   
 (a)(3)(i)(e) of this                                                                                           
 section for use in                                                                                             
 contact with food                                                                                              
 only under                                                                                                     
 conditions of use D,                                                                                           
 E, F, G, and H                                                                                                 
 described in Sec.                                                                                              
 176.170(c) of this                                                                                             
 chapter, Table 2.                                                                                              
                                                     *******                                                    
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: February 28, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-5320 Filed 3-8-94; 8:45 am]
BILLING CODE 4160-01-F