[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Rules and Regulations]
[Pages 38747-38749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0405]


Indirect Food Additives: Adjuvants, Production Aids, and 
Sanitizers

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 aluminum borate as 
an antistatic agent and/or antifogging agent for olefin polymers 
intended for use as packaging materials in contact with food. This 
action is in response to a petition filed by Shikoku Chemical Corp.

DATES: The regulation is effective July 20, 1998; written objections 
and requests for a hearing by August 19, 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: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of September 25, 1997 (62 FR 50387), FDA announced that a food 
additive petition (FAP 7B4559) had been filed by Shikoku Chemical 
Corp., c/o SRS International Corp., suite 1000, 1625 K St. NW., 
Washington, DC 20006-1604. The petition proposed to amend the food 
additive regulations in Sec. 178.3130 Antistatic and/or antifogging 
agents in food-packaging materials (21 CFR 178.3130) to provide for the 
safe use of aluminum borate as an antistatic and/or antifogging agent 
for olefin polymers complying with 21 CFR 177.1520(c) as packaging 
materials 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 the proposed use 
of the additive is safe, that the additive will achieve its intended 
technical effect, and therefore, that the regulations in Sec. 178.3130 
should be amended as set forth below.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the

[[Page 38748]]

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 previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 7B4559 (62 FR 
50387, September 25, 1997). FDA has concluded that the action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment, and therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    Any person who will be adversely affected by this regulation may at 
any time on or before August 19, 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 collections 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 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 178.3130 is amended in the table in paragraph (b) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 178.3130  Antistatic and/or antifogging agents in food-packaging 
materials.

* * * * *
    (b) * * *

                                                                                                                
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                   List of substances                                          Limitations                      
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Aluminum Borate ((9Al2O3)2(B2O3), CAS Reg. No.   For use only:                                          
 11121-16-7) produced by reaction between aluminum         1. At levels not to exceed 1 percent by weight of    
 oxide and/or aluminum hydroxide with boric acid and/or   polypropylene films complying with Sec.  177.1520(c)  
 metaboric acid at temperatures in excess of 1000 C       of this chapter, item 1.1, of polyethylene films      
                                                          complying with Sec.  177.1520(c) of this chapter,     
                                                          items 2.1 and 2.2 and having a density greater than   
                                                          0.94 gram per cubic centimeter, and of polyolefin     
                                                          copolymer films complying with Sec.  177.1520(c) of   
                                                          this chapter, items 3.1(a), 3.1(b), 3.2(a), and       
                                                          3.2(b). The finished polymers may be used in contact  
                                                          with all food types identified in Table 1 of Sec.     
                                                          176.170(c) of this chapter, under conditions of use A 
                                                          through H as described in Table 2 of Sec.  176.170(c) 
                                                          of this chapter. The thickness of the films shall not 
                                                          exceed 0.005 inch.                                    
                                                           2. At levels not to exceed 2 percent by weight of    
                                                          polypropylene films complying with Sec.  177.1520(c)  
                                                          of this chapter, item 1.1, of polyethylene films      
                                                          complying with Sec.  177.1520(c) of this chapter,     
                                                          items 2.1 and 2.2 and having a density greater than   
                                                          0.94 gram per cubic centimeter, and of polyolefin     
                                                          copolymer films complying with Sec.  177.1520(c) of   
                                                          this chapter, items 3.1(a), 3.1(b), 3.2(a), and       
                                                          3.2(b). The finished polymers may be used in contact  
                                                          with all food types identified in Table 1 of Sec.     
                                                          176.170(c) of this chapter under conditions of use B  
                                                          through H as described in Table 2 of Sec.  176.170(c) 
                                                          of this chapter. The thickness of the films shall not 
                                                          exceed 0.005 inch.                                    
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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[[Page 38749]]

    Dated: June 24, 1998.
 L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-19174 Filed 7-17-98; 8:45 am]
BILLING CODE 4160-01-F