[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Rules and Regulations]
[Pages 6852-6854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 97F-0181]


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 change the melting point range for propylene 
homopolymers, intended for use in contact with food, from 160-180 
deg.C to 150-180  deg.C. This action is in response to a petition filed 
by Exxon Chemical Co.

DATES: The regulation is effective February 11, 1998; written 
objections and requests for a hearing by March 13, 1998.

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: Mark A. Hepp, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of May 16, 1997 (62 FR 27060), FDA announced that a food 
additive petition (FAP 7B4544) had been filed by Exxon Chemical Co., 
P.O. Box 3272, Houston, TX 77253-3272. The petition proposed to amend 
the food additive regulations in Sec. 177.1520 Olefin polymers (21 CFR 
177.1520), to change the melting point range for propylene polymers, 
intended for use in contact with food, from 160-180  deg.C to 150-180 
deg.C. However, the petitioner submitted data and information to 
support a proposed change in the melting point range from 160-180 
deg.C to 150-180  deg.C for propylene homopolymers prepared from 
metallocene catalysts. Therefore, FDA considered a change in the 
melting point only for propylene homopolymers prepared from metallocene 
catalysts.
    In the Federal Register of May 16, 1997 (62 FR 27060), the filing 
notice for the petition stated that the action resulting from the 
petition qualified for a categorical exclusion under previous 21 CFR 
25.24(9). This was a misprint and should have cited 21 CFR 25.24(a)(9). 
Upon further review, the agency determined that such a

[[Page 6853]]

categorical exclusion, which is based on a technical change in a 
regulation, is not appropriate for this action because the proposed 
amendment is not simply a technical change. Consequently, the agency 
considered the environmental effects of this action.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency determined that the petitioner 
has adequately demonstrated that propylene homopolymers manufactured by 
the catalytic polymerization of propylene with a metallocene catalyst, 
and with a melting point range between 150  deg.C and 180  deg.C, 
conform to the identity and specifications for polypropylene under 
Sec. 177.1520, in item 1.1(a) in the table in paragraph (c) (previously 
item 1.1), except for the melting point range specification. Thus, the 
agency concludes that: (1) The proposed use of the additive is safe, 
(2) the additive will achieve its intended technical effect, and (3) 
the regulations in Sec. 177.1520 should be amended as set forth in this 
document.
    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 previously. 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 March 13, 1998, 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: 21 U.S.C. 321, 342, 348, 379e.
    2. Section 177.1520 is amended by redesignating paragraph (a)(1) as 
paragraph (a)(1)(i), by adding paragraph (a)(1)(ii), and in the table 
in paragraph (c) by redesignating item 1.1 as item 1.1a, and by 
revising newly redesignated item 1.1a, and by adding item 1.1b to read 
as follows:

Sec. 177.1520   Olefin polymers.

* * * * *
    (a) * * *
    (1) * * *
    (ii) Propylene homopolymer consists of basic polymers manufactured 
by the catalytic polymerization of propylene with a metallocene 
catalyst.
 * * * * *
    (c) * * *

                                                                                                                
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                                                                                 Maximum                        
                                                                               extractable      Maximum soluble 
                                                                                fraction           fraction     
                                                        Melting Point (MP)    (expressed as      (expressed as  
                                                        or softening point     percent by      percent by weight
           Olefin polymers                 Density         (SP) (Degrees      weight of the     of polymer) in  
                                                            Centigrade)      polymer) in N-        xylene at    
                                                                                hexane at          specified    
                                                                                specified        temperatures   
                                                                              temperatures                      
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  1.1a Polypropylene described in     0.880-0.913       MP: 160-180 C.....  6.4 pct at        9.8 pct at 25 C   
   paragraph (a)(1)(i) of this                                               reflux                             
   section                                                                   temperature.                       
  1.1b Propylene homopolymer          0.880-0.913       MP: 150-180 C.....  6.4 pct at        9.8 pct at 25 C   
   described in paragraph (a)(1)(ii)                                         reflux                             
   of this section                                                           temperature.                       
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[[Page 6854]]

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    Dated: January 30, 1998.
 Janice F. Oliver,
 Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 98-3357 Filed 2-10-98; 8:45 am]
BILLING CODE 4160-01-F