[Federal Register Volume 59, Number 10 (Friday, January 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-897]


[[Page Unknown]]

[Federal Register: January 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 92F-0056]

 

Indirect Food Additives: Paper and Paperboard Components

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 expand the safe use of aromatic petroleum 
hydrocarbon resin hydrogenated, as a component of wax polymer blend 
coatings for paper and paperboard in contact with fatty foods. This 
action responds to a food additive petition filed by Arakawa Chemical 
Industries, Ltd.

DATES: Effective on January 14, 1994; written objections and requests 
for a hearing by February 14, 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: Andrew J. Zajac, 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 March 17, 1992 (57 FR 9260), FDA announced that a food 
additive petition (FAP 2B4315) had been filed by Arakawa Chemical 
Industries, Ltd., c/o 1001 G St. NW., suite 500 West, Washington, DC 
20001. The petition proposed that Sec. 176.170 Components of paper and 
paperboard in contact with aqueous and fatty foods (21 CFR 176.170) be 
amended to provide for the safe use of hydrogenated aromatic petroleum 
hydrocarbon resin in coatings on paper and paperboard in contact with 
fatty foods.
    FDA has evaluated data in the petition and other relevant material 
and concludes that the proposed expanded use of the additive is safe. 
The agency further concludes that Sec. 176.170 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 February 14, 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 176

    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 176 is amended as follows:

PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

    1. The authority citation for 21 CFR part 176 continues to read as 
follows:

    Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
    2. Section 176.170 is amended in the table in paragraph (a)(5) by 
revising the entry for ``Aromatic petroleum hydrocarbon resin, 
hydrogenated (CAS Reg. No. 88526-47-0)'' to read as follows:


Sec. 176.170  Components of paper and paperboard in contact with 
aqueous and fatty foods.

* * * * *
    (a) * * *
    (5) * * *

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         List of Substances                       Limitations           
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                                  *****                                 
Aromatic petroleum hydrocarbon        For use only as modifiers in wax  
 resin, hydrogenated (CAS Reg. No.     polymer blend coatings for paper 
 88526-47-0), produced by the          and paperboard at a level not to 
 catalytic polymerization of           exceed 50 weight-percent of the  
 aromatic substituted olefins from     coating solids under conditions  
 low boiling distillates of cracked    of use E, F, and G identified in 
 petroleum stocks with a boiling       Table 2 of paragraph (c) of this 
 point no greater than 220  deg.C      section.                         
 (428  deg.F), and the subsequent                                       
 catalytic reduction of the                                             
 resulting aromatic petroleum                                           
 hydrocarbon resin. The resin meets                                     
 the following specifications:                                          
 softening point 85  deg.C (185                                         
 deg.F) minimum, as determined by                                       
 ASTM Method E 28-67 (Reapproved                                        
 1982), ``Standard Test Method for                                      
 Softening Point by Ring-and-Ball                                       
 Apparatus,'' and aniline point 70                                      
 deg.C (158  deg.F) minimum, as                                         
 determined by ASTM Method D 611-82,                                    
 ``Standard Test Methods for Aniline                                    
 Point and Mixed Aniline Point of                                       
 Petroleum Products and Hydrocarbon                                     
 Solvents,'' which are incorporated                                     
 by reference in accordance with 5                                      
 U.S.C. 552(a) and 1 CFR part 51.                                       
 Copies may be obtained from the                                        
 American Society for Testing and                                       
 Materials, 1916 Race St.,                                              
 Philadelphia, PA 19103, or may be                                      
 examined at the Office of the                                          
 Federal Register, 800 North Capitol                                    
 Street, NW., suite 700, Washington,                                    
 DC.                                                                    
                                  *****                                 
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    Dated: January 4, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-897 Filed 1-13-94; 8:45 am]
BILLING CODE 4160-01-F