[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) * * *
[[Page 2855]]
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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
