[Federal Register Volume 60, Number 149 (Thursday, August 3, 1995)]
[Rules and Regulations]
[Pages 39647-39648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19092]



-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 177

[Docket No. 95F-0017]


Indirect Food Additives: Polymers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of diisopropyl 
xanthogen polysulfide as a component of rubber articles intended for 
repeated use in contact with food. This action is in response to a 
petition filed by Robinson Brothers Ltd.

DATES: Effective August 3, 1995; written objections and requests for a 
hearing by September 5, 1995.

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: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-216), 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 February 13, 1995 (60 FR 8243), FDA announced that a food 
additive petition (FAP 5B4437) had been filed by Robinson Brothers 
Ltd., Phoenix St., West Bromwich, West Midland, B70 OAH, England. 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 diisopropyl xanthogen 
polysulfide as a component of rubber articles intended for repeated use 
in contact with food.
     FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the proposed food additive use in 
repeated use food-contact articles is safe, and the regulation in 
Sec. 177.2600(c)(4)(ii) 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 September 5, 1995, 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).

 
[[Page 39648]]

     2. Section 177.2600 is amended in paragraphs (c)(4)(ii)(a) and 
(c)(4)(ii)(b) by alphabetically adding new entries for ``Diisopropyl 
xanthogen polysulfide'' to read as follows:


Sec. 177.2600  Rubber articles intended for repeated use.

 * * * * *
     (c) *   *   *
     (4) *   *  *
     (ii) *  *  *
     (a) *   *   *
 Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-
bis-thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate) 
for use as a cross linking agent in the vulcanization of natural 
rubber, styrene-butadiene copolymer, acrylonitrile-butadiene copolymer, 
and ethylene-propylene terpolymers identified under paragraph (c)(4)(i) 
of this section and limited to use at levels not to exceed 2.4 percent 
by weight of such copolymers.
 * * * * *
    (b) *  *   *
 Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-
bis-thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate).
 * * * * *

    Dated: July 22, 1995.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 95-19092 Filed 8-2-95; 8:45 am]
BILLING CODE 4160-01-F