[Federal Register Volume 62, Number 124 (Friday, June 27, 1997)]
[Rules and Regulations]
[Pages 34629-34631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0062]


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 expanded safe use of 
triisopropanolamine as a component of phosphorous acid, cyclic 
butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester, a stabilizer 
for olefin polymers intended for use in contact with food. This action 
is in response to a petition filed by General Electric Co.

DATES: Effective June 27, 1997; written objections and requests for a 
hearing by July 28, 1997.

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: 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 February 28, 1997 (62 FR 9197), FDA announced that a food 
additive petition (FAP 7B4535) had been filed by General Electric Co., 
One Lexan Lane, Mt. Vernon, IN 47620-9364. 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 
expanded safe use of triisopropanolamine as a component of phosphorous 
acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-butylphenyl ester, 
a stabilizer for olefin polymers intended for use in contact with food.
    FDA has evaluated data in the petition and other relevant material. 
The agency concludes that: (1) The proposed use of the additive is 
safe, (2) the additive will achieve its intended technical effect, and 
(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

[[Page 34630]]

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 July 28, 1997, 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: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

    2. Section 178.2010 is amended in the table in paragraph (b) by 
revising the entry for ``Phosphorous acid, cyclic butylethyl 
propanediol, 2,4,6-tri-tert-butylphenyl ester'' under the headings 
``Substances'' and ``Limitations'' to read as follows:

Sec. 178.2010  Antioxidants and/or stabilizers for polymers.

* * * * *
    (b) * * *

                                                                                                                
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                       Substances                                              Limitations                      
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
Phosphorous acid, cyclic butylethyl propanediol, 2,4,6-  For use only:                                          
 tri-tert-butylphenyl ester (CAS Reg. No. 161717-32-4),  1. At levels not to exceed 0.2 percent by weight of    
 which may contain not more than 1 percent by weight of   olefin polymers complying with Sec.  177.1520(c) of   
 triisopropanolamine (CAS Reg. No. 122-20-3).             this chapter, items 1.1, 1.2, or 1.3, and items 2.1,  
                                                          2.2, or 2.3 (where the density of these polymers is   
                                                          not less than 0.94 gram per cubic centimeter), and    
                                                          items 3.1 or 3.2, provided that the finished polymer  
                                                          contacts foods of types I, II, and VI-B as described  
                                                          in Table 1 of Sec.  176.170(c) of this chapter only   
                                                          under conditions of use B, C, D, E, F, G, and H as    
                                                          described in Table 2 of Sec.  176.170(c) of this      
                                                          chapter.                                              
                                                         2. At levels not to exceed 0.1 percent by weight of    
                                                          olefin polymers complying with Sec.  177.1520(c) of   
                                                          this chapter, items 1.1, 1.2, or 1.3, that contact    
                                                          food of types III, IV, V, VI-A, VI-C, VII, VIII, and  
                                                          IX as described in Table 1 of Sec.  176.170(c) of this
                                                          chapter, only under conditions of use C, D, E, F, and 
                                                          G as described in Table 2 of Sec.  176.170(c) of this 
                                                          chapter.                                              
                                                         3. At levels not to exceed 0.1 percent by weight of    
                                                          olefin copolymers complying with Sec.  177.1520(c) of 
                                                          this chapter, items 3.1 or 3.2, having a density less 
                                                          than 0.94 grams per cubic centimeter, in contact with 
                                                          food only of types III, IV, V, VI-A, VI-C, VII, VIII, 
                                                          and IX and under conditions of use C, D, E, F, and G  
                                                          as described in Tables 1 and 2 of Sec.  176.170(c) of 
                                                          this chapter; provided that the food-contact surface  
                                                          does not exceed 0.003 inch (0.076 mm) in thickness.   
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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[[Page 34631]]

    Dated: June 16, 1997.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 97-16795 Filed 6-26-97; 8:45 am]
BILLING CODE 4160-01-F