[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15667]


[Federal Register: June 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 176

 [Docket No. 90F-0202]


 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 provide for the safe use of siloxanes 
(silicones), dimethyl, isopropyl methyl, methyl 1-methyl-C9-
49-alkyl, as a modifier for polyolefin resins to be used as 
coatings for paper and paperboard. This action responds to a food 
additive petition filed by Chugai Boyeki (America) Corp.

DATES: Effective June 28, 1994; written objections and requests for a 
hearing by July 28, 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 July 17, 1990 (55 FR 29105), FDA announced that a petition 
(FAP 9B4171) had been filed by Chugai Boyeki (America) Corp. 
(``Chugai'' was inadvertently misspelled in the filing notice as 
``Chaugai''), 500 Fifth Ave., suite 1730, New York, NY 10110. The 
petition proposed to amend the food additive regulations to provide for 
the safe use of the addition product of (C10-C50) alkene and 
propylene to polymethyl hydrogensiloxane for use as a modifier and as 
an antifoaming agent for polyolefin resin coatings for paper and 
paperboard.
     FDA has evaluated the data in the petition and other relevant 
material and concluded that the proposed use for the additive in paper 
and paperboard coatings is safe. However, based upon a complete review 
of the petition, the agency has determined that the appropriate 
technical effect of the additive is primarily as a polymer modifier, 
that effect is reflected in the listing regulation. The agency has 
further determined that the Chemical Abstracts Service nomenclature and 
registry number more accurately describe the additive than the 
description in the notice of filing, and therefore, the agency has used 
them in this rule. Under this nomenclature, the additive is denominated 
``Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1-methyl-
C9-49-alkyl.'' Accordingly, FDA concludes that the food 
additive regulations should be amended in Sec. 176.170 Components of 
paper and paperboard in contact with aqueous and fatty foods (21 CFR 
176.170) 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 July 28, 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 
alphabetically adding a new entry under the headings ``List of 
Substances'' and ``Limitations'' 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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                                 *******                                
 Siloxanes (silicones), dimethyl,     For use only as a component of    
 isopropyl methyl, methyl 1-methyl-   polyolefin coatings with Sec.     
 C9-49-alkyl (CAS Reg. No. 144635-    177.1520 of this chapter at a     
 08-5).                               level not to exceed 3 percent by  
                                      weight. The finished coating will 
                                      be used only for paper and        
                                      paperboard that contact food of   
                                      types VI-A and VI-B of Table 1 in 
                                      paragraph (c) of this section, and
                                      under conditions of use C, D, and 
                                      E, as described in Table 2 in     
                                      paragraph (c) of this section,    
                                      with a maximum hot fill           
                                      temperature of 200  deg.F (94     
                                      deg.C).                           
                                 *******                                
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    Dated: June 21, 1994.
 L. Robert Lake,
 Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-15667 Filed 6-27-94; 8:45 am]
BILLING CODE 4160-01-F