[Federal Register Volume 64, Number 11 (Tuesday, January 19, 1999)]
[Rules and Regulations]
[Pages 2853-2855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1032]


    [Repeat as necessary]

[[Page 2854]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F-0421]


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 di-tert-butyl-m-
cresyl phosphonite condensation product with biphenyl for use as an 
antioxidant and/or stabilizer for olefin polymers intended for use in 
contact with food. This action responds to a petition filed by 
Yoshitomi Fine Chemicals, Ltd.

DATES:  The regulation is effective January 19, 1999. Submit written 
objections and requests for a hearing by February 18, 1999.

 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:  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 October 17, 1997 (62 FR 54117), FDA announced that a food 
additive petition (FAP 7B4557) had been filed by Yoshitomi Fine 
Chemicals, Ltd., 6-9 Hiranomachi 2-chome, Chuo-ku, Osaka 541, Japan. 
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 di-tert-butylcresyl 
phosphonite condensation product with biphenyl, produced by the 
condensation of 2,4-di-tert-butylcresol with the Friedel-Crafts 
addition product of phosphorus trichloride and biphenyl, for use as an 
antioxidant and/or stabilizer for olefin polymers intended for use in 
contact with food.
    The agency notes that the petitioner later requested that the term 
meta (m) be placed between butyl and cresyl in the name of the subject 
additive and between butyl and cresol in the name of one of the 
starting materials in order to provide more accurate and descriptive 
names. FDA agrees that this nomenclature provides a more accurate 
description of the additive and its starting materials. Therefore, FDA 
uses this nomenclature in the final rule.
     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 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 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.
    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.
    Any person who will be adversely affected by this regulation may at 
any time on or before February 18, 1999, 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 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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  *                    *                    *                    *
                   *                    *                    *
Di-tert-butyl-m-cresyl phosphonite   For use only:
 condensation product with biphenyl  1. At levels not to exceed 0.1
 (CAS Reg. No. 178358-58-2)           percent by weight of olefin
 produced by the condensation of      polymers complying with Sec.
 2,4-di-tert-butyl-m-cresol with      177.1520(c) of this chapter, items
 the Friedel-Crafts addition          1.1, 2.1, 2.2, 3.1(a), 3.1(b),
 product (phosphorus trichloride      3.2(a), or 3.2(b).
 and biphenyl) so that the food
 additive has a minimum phosphorus
 content of 5.0 percent.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: January 6, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-1032 Filed 1-15-99; 8:45 am]
BILLING CODE 4160-01-F