[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Rules and Regulations]
[Pages 29135-29136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 96F-0489]


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 5,7-bis(1,1-
dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-
xylene, as an antioxidant and/or stabilizer for olefin polymers 
intended for use in contact with food. This action responds to a 
petition filed by Ciba Specialty Chemicals Corp.

DATES: The regulation is effective May 28, 1998. Submit written 
objections and request for a hearing by June 29, 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: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3086.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 2, 1997 (62 FR 100), FDA announced that a food 
additive petition (FAP 7B4529) had been filed by Ciba Specialty 
Chemicals Corp., 540 White Plains Rd., Tarrytown, NY 10591-9005. The 
petition proposed to amend the food additive regulations in 
Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR 
178.2010) to provide for the safe use of 5,7-bis(1,1-dimethylethyl-3-
hydroxy-2(3H)-benzofuranone, reaction products with o-xylene as an 
antioxidant and/or stabilizer for olefin polymers intended for use in 
contact with food.
    FDA has evaluated data in the petition and other relevant material. 
Based on this information, the agency concludes that: (1) The proposed 
use of the additive is safe, (2) the food additive will achieve its 
intended technical effect, and therefore, (3) the regulations in 
Sec. 178.2010 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 June 29, 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 178

    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 178 is amended as follows:

PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

    1. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348, 379e.

    2. Section 178.2010 is amended in the table in paragraph (b) by 
alphabetically adding an entry to read as follows:


Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

[[Page 29136]]



                                                                        
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               Substances                          Limitations          
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  *                    *                    *                    *      
                   *                    *                    *          
5,7-bis(1,1-dimethylethyl)-3-hydroxy-    For use only:                  
 2(3H)-benzofuranone, reaction products  1. At levels not to exceed 0.1 
 with o-xylene (CAS Reg. No. 181314-48-   percent by weight of olefin   
 7).                                      polymers complying with Sec.  
                                          177.1520(c) of this chapter.  
                                          The finished polymers may only
                                          be used in contact with food  
                                          of the types identified in    
                                          Sec.  176.170(c) of this      
                                          chapter, Table 1, under       
                                          Categories I, II, IV-B, VI-A, 
                                          VI-B, VII-B, and VIII, and    
                                          under conditions of use B     
                                          through H described in Table 2
                                          of Sec.  176.170(c) of this   
                                          chapter.                      
                                         2. At levels not to exceed 0.02
                                          percent by weight of propylene
                                          polymers and copolymers       
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          items 1.1, 1.2, 3.1a, 3.2a,   
                                          3.2b, 3.4, or 3.5, and        
                                          ethylene polymers and         
                                          copolymers complying with Sec.
                                           177.1520(c) of this chapter, 
                                          items 2.1, 2.2, 2.3, 3.1a,    
                                          3.1b, 3.2a, or 3.6 (where the 
                                          density of each of these      
                                          polymers is at least 0.94 gram
                                          per cubic centimeter), or 5.  
                                          The finished polymers may only
                                          be used in contact with food  
                                          of the types identified in    
                                          Sec.  176.170(c) of this      
                                          chapter, Table 1, under       
                                          Categories III, IV-A, V, VI-C,
                                          VII-A, and IX, and under      
                                          conditions of use B through H 
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter;   
                                          provided that the finished    
                                          food-contact articles have a  
                                          volume of at least 18.9 liters
                                          (5 gallons).                  
                                         3. At levels not to exceed 0.02
                                          percent by weight of ethylene 
                                          polymers and copolymers       
                                          complying with Sec.           
                                          177.1520(c) of this chapter,  
                                          items 2.1, 2.2, 2.3, 3.1a,    
                                          3.1b, 3.2a, 3.4, 3.5, or 3.6  
                                          (where the density of each of 
                                          these polymers is less than   
                                          0.94 gram per cubic           
                                          centimeter). The finished     
                                          polymers may only be used in  
                                          contact with food of the types
                                          identified in Sec.  176.170(c)
                                          of this chapter, Table 1,     
                                          under Categories III, IV-A, V,
                                          VI-C, VII-A, and IX, and under
                                          conditions of use B through H 
                                          described in Table 2 of Sec.  
                                          176.170(c) of this chapter;   
                                          provided that the average     
                                          thickness of such polymers in 
                                          the form in which they contact
                                          food shall not exceed 50      
                                          micrometers (0.002 inch).     
  *                    *                    *                    *      
                   *                    *                    *          
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    Dated: May 11, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-14104 Filed 5-27-98; 8:45 am]
BILLING CODE 4160-01-F