[Federal Register Volume 59, Number 164 (Thursday, August 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20984]


[[Page Unknown]]

[Federal Register: August 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 92F-0327]

 

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 an aromatic 
petroleum hydrocarbon resin, hydrogenated, as a component of 
polypropylene intended for food-contact use. This action is in response 
to a petition filed by Arakawa Chemical Industries, Ltd.

DATES: Effective August 25, 1994; written objections and requests for a 
hearing by September 26, 1994. The Director of the Office of the 
Federal Register approves the incorporations by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 
CFR 177.1520(b), effective August 25, 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.

FOR FURTHER INFORMATION CONTACT: Julius Smith, 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 September 22, 1992 (57 FR 43740), FDA announced that a food 
additive petition (FAP 2B4338) had been filed by Arakawa Chemical 
Industries, Ltd., c/o 1001 G St. NW., suite 500 West, Washington, DC 
20001. The petition proposed that the food additive regulations be 
amended to provide for the safe use of an aromatic petroleum 
hydrocarbon resin, hydrogenated, as a component of polypropylene 
intended for food-contact use.
    FDA has evaluated the data in the petition and other relevant 
material and concludes that the proposed use of the food additive in 
polypropylene articles in contact with food is safe. The agency has 
also concluded that the additive will have the intended technical 
effect, and that, therefore, 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 26, 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, Incorporation by reference.
    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 in the table in paragraph (b) by 
alphabetically adding a new entry under the headings ``Substance'' and 
``Limitations'' to read as follows:


Sec. 177.1520  Olefin polymers.

* * * * *
    (b) * * *

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              Substance                           Limitations           
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Aromatic petroleum hydrocarbon resin,  For use only as an adjuvant at   
 hydrogenated (CAS Reg. No. 88526-47-   levels not to exceed 25 percent 
 0), produced by the catalytic          by weight in blends with        
 polymerization of aromatic-            polypropylene complying with    
 substituted olefins from distillates   paragraph (c), item 1.1 of this 
 of cracked petroleum stocks with a     section. The finished polymer   
 boiling point no greater than 220      may be used in contact with food
 deg.C (428  deg.F), and the            Types I, II, IV-B, VI-A through 
 subsequent catalytic hydrogenation     VI-C, VII-B, and VIII identified
 of the resulting aromatic petroleum    in Table 1 of Sec. 176.170(c) of
 hydrocarbon resin, having a minimum    this chapter and under          
 softening point of 110  deg.C (230     conditions of use B through H   
 deg.F), as determined by ASTM Method   described in Table 2 of Sec.    
 E 28-67 (Reapproved 1982),             176.170(c) of this chapter; and 
 ``Standard Test Method for Softening   with food Types III, IV-A, V,   
 Point by Ring-and-Ball Apparatus,''    VII-A, and IX identified in     
 and a minimum aniline point of 107     Table 1 of Sec. 176.170(c) of   
 deg.C (225  deg.F), as determined by   this chapter and under          
 ASTM Method D 611-82, ``Standard       conditions of use D through G   
 Test Methods for Aniline Point and     described in Table 2 of Sec.    
 Mixed Aniline Point of Petroleum       176.170(c) of this chapter.     
 Products and Hydrocarbon Solvents,''                                   
 both of which are incorporated by                                      
 reference in accordance with 5                                         
 U.S.C. 552(a) and 1 CFR part 51.                                       
 Copies are available from the                                          
 American Society for Testing and                                       
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or from the                                    
 Division of Petition Control, Center                                   
 for Food Safety and Applied                                            
 Nutrition (HFS-216), Food and Drug                                     
 Administration, 200 C St. SW.,                                         
 Washington, DC 20204, or may be                                        
 examined at the Office of the                                          
 Federal Register, 800 North Capitol                                    
 St. NW., suite 700, Washington, DC.                                    
                                                                        
                              * * * * * * *                             
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* * * * *

    Dated: August 18, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-20984 Filed 8-24-94; 8:45 am]
BILLING CODE 4160-01-F