[Federal Register Volume 63, Number 34 (Friday, February 20, 1998)]
[Rules and Regulations]
[Pages 8571-8572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 177

[Docket No. 96F-0477]


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 polyamide/polyether 
block copolymers prepared by reacting a copolymer of omega-laurolactam 
and adipic acid with poly(tetramethylene ether glycol) for use in the 
manufacture of rubber articles intended for repeated use in contact 
with food. This action responds to a petition filed by Elf Atochem 
North America, Inc.

DATES: The regulation is effective February 20, 1998. Submit written 
objections and request for a hearing by March 23, 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: Hortense S. Macon, Center for Food 
Safety and Applied Nutrition (HFS-

[[Page 8572]]

 216), 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 December 12, 1996 (61 FR 65405), FDA announced that a food 
additive petition (FAP 7B4528) had been filed by Elf Atochem North 
America, Inc., 2000 Market St., Philadelphia, PA 19103-3222 . The 
petition proposed to amend the food additive regulations in 
Sec. 177.2600 Rubber articles intended for repeated use (21 CFR 
177.2600) to provide for the safe use of polyamide/polyether block 
copolymers prepared by reacting a copolymer of omega-laurolactam and 
adipic acid with poly(tetramethylene ether glycol) for use in the 
manufacture of rubber articles intended for repeated use in contact 
with food.
    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 that therefore, (3) the regulations in 
Sec. 177.2600 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 action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    Any person who will be adversely affected by this regulation may at 
any time on or before March 23, 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 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 177.2600 is amended in paragraph (c)(4)(i) by 
alphabetically adding a new entry to read as follows:

Sec. 177.2600  Rubber articles intended for repeated use.

* * * * *
    (c) * * *
    (4) * * *
    (i) * * *
    Polyamide/polyether block copolymers (CAS Reg. No. 77402-38-1 
prepared by reacting a copolymer of omega-laurolactam and adipic 
acid with poly(tetramethylene ether glycol). The polyamide and 
polyether components are reacted in ratios such that the polyamide 
component constitutes a minimum of 30 weight-percent of total 
polymer units. The copolymers may be used in contact with foods of 
Types I, II, III, IV, V, VI, VII, VIII, and IX identified in Table 1 
of Sec. 176.170(c) of this chapter at temperatures not to exceed 150 
 deg.F except that those copolymers prepared with less than 50 
weight-percent of polyamide are limited to use in contact with such 
foods at temperatures not to exceed 100  deg.F.
* * * * *

    Dated: February 6, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-4310 Filed 2-19-98; 8:45 am]
BILLING CODE 4160-01-F