[Federal Register Volume 59, Number 41 (Wednesday, March 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4661]


[[Page Unknown]]

[Federal Register: March 2, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 177

 [Docket No. 92F-0100]

 

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 the polymeric 
reaction product of 1,3,5-benzenetricarbonyl trichloride with 
piperazine and 1,2-diaminoethane as a food-contact layer of reverse 
osmosis membranes. This action responds to a petition filed by PCI 
Membrane Systems, Ltd.

 DATES: Effective March 2, 1994; written objections and requests for a 
hearing by April 1, 1994.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Julius Smith, Center for Food Safety 
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-254-9500.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of March 23, 1992 (57 FR 10028), FDA announced that a food 
additive petition (FAP 9B4157) had been filed by PCI Membrane Systems, 
Ltd., Laverstoke Mill, Whitechurch, Hampshire RG28 7NR, England. The 
petition proposed that the food additive regulations be amended to 
provide for the safe use of the reaction product of 1,3,5-
benzenetricarbonyl trichloride with piperazine and 1,2-diaminoethane as 
a food-contact layer of reverse osmosis membranes.
     FDA has evaluated the data in the petition and other relevant 
material and concludes that the proposed use for the polymeric reaction 
product of 1,3,5-benzenetricarbonyl trichloride with piperazine and 
1,2-diaminoethane as the food-contact layer of reverse osmosis 
membranes is safe. Based on this information, the agency has also 
concluded that the additive will have the intended technical effect and 
therefore, Sec. 177.2550 (21 CFR 177.2550) 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 21 CFR 
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 April 1, 1994, 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: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

     2. Section 177.2550 is amended by adding new paragraph (a)(5) and 
by revising paragraph (d)(1) to read as follows:


Sec. 177.2550   Reverse osmosis membranes.

 * * * * *
     (a) *   *  *
     (5) A polyamide reaction product of 1,3,5-benzenetricarbonyl 
trichloride polymer (CAS Reg. No. 4422-95-1) with piperazine (CAS Reg. 
No. 110-85-0) and 1,2-diaminoethane (CAS Reg. No. 107-15-3). The 
membrane is the food-contact layer and may be applied as a film on a 
suitable support. Its maximum weight is 15 milligrams per square 
decimeter (1 milligram per square inch).
* * * * *
     (d) Conditions of use--(1) Reverse osmosis membranes described in 
paragraphs (a)(1), (a)(2), (a)(3), and (a)(5) of this section may be 
used in contact with all types of liquid food at temperatures up to 80 
deg.C (176  deg.F).
 * * * * *

    Dated: February 16, 1994.
Janice F. Oliver,
Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-4661 Filed 3-1-94; 8:45 am]
BILLING CODE 4160-01-F