[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Rules and Regulations]
[Pages 36175-36176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17543]



[[Page 36175]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 90F-0435]


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 isobutylene-butene 
copolymers as a plasticizer in polypropylene intended for use in 
contact with food. This action responds to a food additive petition 
filed by Amoco Chemical Co.

DATES: The regulation is effective July 2, 1998. Submit written 
objections and requests for a hearing by August 3, 1998.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Julius Smith, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-215), 
200 C St. SW., Washington, DC 20204,202-418-3091.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 11, 1991 (56 FR 1197), FDA announced that a 
petition (FAP 1B4238) had been filed by Amoco Chemical Co., Chicago, IL 
60601. The petition proposed to amend the food additive regulations in 
Sec. 177.1430 Isobutylene-butene copolymers (21 CFR 177.1430) to 
provide for the safe use of isobutylene-butene copolymers as components 
of food-contact articles and as plasticizers in polypropylene in 
contact with food complying with 21 CFR 177.1520. Upon further review 
of the petition, the agency has determined that the petitioner is 
proposing only the use of isobutylene-butene copolymers as a 
plasticizer in polypropylene.
    FDA has evaluated the data in the petition and other relevant 
material. The agency concludes that: (1) The proposed use of the 
additive in polypropylene articles is safe, (2) the additive will have 
the intended technical effect, and therefore, (3) the regulations in 
Sec. 177.1430 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 August 3, 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.
    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

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, 379(e).

    2. Section 177.1430 is amended in the table in paragraph (b) by 
revising item ``2.'' under the heading ``Isobutylene-butene 
copolymers'' to read as follows:


Sec. 177.1430  Isobutylene-butene copolymers.

* * * * *
    (b) * * *

                                                                                                                
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    Isobutylene-butene                                                                                          
        copolymers               Molecular weight (range)          Viscosity (range)      Maximum bromine value 
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
2. Used as plasticizers in                                                                                      
 polyethylene or                                                                                                
 polypropylene complying                                                                                        
 with Sec.  177.1520, and                                                                                       
 in polystyrene complying                                                                                       
 with Sec.  177.1640.                                                                                           
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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[[Page 36176]]

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    Dated: June 23, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-17543 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F