[Federal Register Volume 65, Number 55 (Tuesday, March 21, 2000)]
[Rules and Regulations]
[Pages 15057-15058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6875]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 99F-0461]


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 polyphenylene 
sulfone resins as articles or components of articles intended for 
repeated use in contact with food. This action is in response to a 
petition filed by Ticona.

DATES: This rule is effective March 21, 2000; submit written objections 
and requests for a hearing by April 20, 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: 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 March 19, 1999 (64 FR 13586), FDA announced that a food 
additive petition (FAP 9B4644) had been filed by Ticona, c/o Keller and 
Heckman LLP, 1001 G St. NW., suite 500 West, Washington, DC 20001. The 
petition proposed to amend the food additive regulations in part 177 
Indirect Food Additives: Polymers (21 CFR part 177) to provide for the 
safe use of polyphenylene sulfone resins as articles or components of 
articles intended for repeated use in contact with food.
    FDA has evaluated the 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) that the regulations in 
part 177 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 9B4644 (64 FR 
13586, March 19, 1999). 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 April 20, 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

[[Page 15058]]

objection. Three copies of all documents are to be submitted and are to 
be identified with the docket number found in brackets in the heading 
of this document. Any objection 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 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 177.2500 is added to subpart C to read as follows:


Sec. 177.2500  Polyphenylene sulfone resins.

    The polyphenylene sulfone resins (CAS Reg. No. 31833-61-1) 
identified in paragraph (a) of this section may be safely used as 
articles or components of articles intended for repeated use in contact 
with food, subject to the provisions of this section.
    (a) Identity. For the purpose of this section, polyphenylene 
sulfone resins consist of basic resin produced by reacting 
polyphenylene sulfide with peracetic acid such that the finished resins 
meet the specifications set forth in paragraph (c) of this section. The 
polyphenylene sulfide used to manufacture polyphenylene sulfone is 
prepared by the reaction of sodium sulfide and p-dichlorobenzene, and 
has a minimum weight average molecular weight of 5,000 Daltons.
    (b) Optional adjuvant substances. The basic polyphenylene sulfone 
resins identified in paragraph (a) of this section may contain optional 
adjuvant substances required in the production of such basic resins. 
These optional adjuvant substances may include substances permitted for 
such use by regulations in parts 170 through 189 of this chapter, 
substances generally recognized as safe in food, or substances used in 
accordance with a prior sanction or approval.
    (c) Specifications. The glass transition temperature of the polymer 
is 3605  deg.C as determined by the use of differential 
scanning calorimetry.

    Dated: February 29, 2000.
L. Robert Lake,
Director, Office of Regulations Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 00-6875 Filed 3-20-00; 8:45 am]
BILLING CODE 4160-01-F