[Federal Register Volume 63, Number 35 (Monday, February 23, 1998)]
[Rules and Regulations]
[Pages 8852-8853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0375]


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 
phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-tert-
butylphenyl ester, which may contain up to 1 percent by weight of 
triisopropanolamine, as an antioxidant and/or stabilizer for olefin 
copolymers intended for use in contact with food. This action is in 
response to a petition filed by General Electric Co.

DATES: The regulation is effective February 23, 1998; written 
objections and requests for a hearing by March 25, 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: 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 16, 1997 (62 FR 48665), FDA announced that a food 
additive petition (FAP 7B4553) 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 phosphorous acid, cyclic butylethyl propanediol, 
2,4,6-tri-tert-butylphenyl ester, which may contain up to 1 percent by 
weight of triisopropanolamine, as an antioxidant and/or stabilizer for 
olefin copolymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2, 
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 and the additive will achieve its intended 
technical effect. Therefore, the regulations in Sec. 178.2010

[[Page 8853]]

should be amended as set forth below. In amending the regulation in 
Sec. 178.2010, the agency updated the reference to items 3.1 and 3.2 
found in Sec. 177.1520(c) to include the current subparts listed for 
these items, i.e., 3.1a, 3.1b, 3.2a, and 3.2b.
    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 rule as announced in the notice of filing for the 
petition. No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.
    Any person who will be adversely affected by this regulation may at 
any time on or before March 25, 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 
revising the entry for ``Phosphorous acid, cyclic butylethyl 
propanediol, 2,4,6-tri-tert-butylphenyl ester'' in item ``3.'' under 
the heading ``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),   * * *                                                 
 which may contain not more than 1 percent by weight of  3. At levels not to exceed 0.1 percent by weight of    
 triisopropanolamine (CAS Reg. No. 122-20-3).             olefin copolymers complying with Sec.  177.1520(c) of 
                                                          this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b, 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 B,
                                                          C, D, E, F, G, and H 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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    Dated: February 2, 1998.
L. Robert Lake,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 98-4530 Filed 2-20-98; 8:45 am]
BILLING CODE 4160-01-F