[Federal Register Volume 65, Number 170 (Thursday, August 31, 2000)]
[Rules and Regulations]
[Pages 52907-52908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 98F-0484]


Indirect Food Additives: Polymers

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-2-ethylhexyl 
terephthalate as a component of closures with sealing gaskets for food 
containers This action responds to a petition filed by Eastman Chemical 
Co.

DATES: This rule is effective August 31, 2000. Submit written 
objections and request for a hearing by October 2, 2000.

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 July 2, 1998 (63 FR 36246), FDA announced that a food 
additive petition (FAP 8B4593) had been filed by Eastman Chemical Co., 
P.O. Box 431, Kingsport, TN 37662. The petition proposed to amend the 
food additive regulations in Sec. 177.1210 Closures with sealing 
gaskets for food containers (21 CFR 177.1210) to provide for the safe 
use of di-2-ethylhexyl terephthalate as a component of closure-sealing 
gaskets for food containers.
    FDA has evaluated the 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. 177.1210 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 previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 8B4593. 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 collection 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 file with the Dockets Management Branch (address above) 
written objections by October 2, 2000. 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 are to be 
submitted and are to be identified with the docket number

[[Page 52908]]

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 177

    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 177 is amended as follows:

PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

    1. The authority citation for 21 CFR part 177 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 348, 379e.


    2. Section 177.1210 is amended in the table in paragraph (b)(5) by 
alphabetically adding an entry under the headings ``List of 
substances'' and ``Limitations'' to read as follows:


Sec. 177.1210  Closures with sealing gaskets for food containers.

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                                      Limitations (expressed as percent
         List of substances             by weight of  closure-sealing
                                             gasket composition)
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Di-2-ethylhexyl terephthalate (CAS   For use as a plasticizer at levels
 Reg. No. 006422-86-2).               not exceeding 75 parts per hundred
                                      by weight of permitted vinyl
                                      chloride homo- and/or copolymer
                                      resins used in contact with food
                                      of Types I, II, IV-B, VI-A, VI-B,
                                      VI-C (up to 15 percent alcohol by
                                      volume), VII-B, and VIII described
                                      in Sec.  176.170(c) of this
                                      chapter, table 1, and under
                                      conditions of use A through H
                                      described in Sec.  176. 170 (c) of
                                      this chapter, table 2.
 
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    Dated: August 21, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-22228 Filed 8-30-00; 8:45 am]
BILLING CODE 4160-01-F