[Federal Register Volume 60, Number 122 (Monday, June 26, 1995)]
[Rules and Regulations]
[Pages 32903-32904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15349]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 81F-0105]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Epoxidized Soybean Oil

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 epoxidized soybean 
oil as a halogen stabilizer in brominated soybean oil. This action is 
in response to a petition filed by Unitech Chemical, Inc.

DATES: Effective June 26, 1995; written objections and requests for a 
hearing by July 26, 1995. The Director of the Office of the Federal 
Register approves the incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51 of certain publications in new 
Sec. 172.723, effective June 26, 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: Martha D. Peiperl, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3077.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of April 28, 1981 (46 FR 23811), FDA announced that a food 
additive petition (FAP 7A3329) had been filed by Unitech Chemical, 
Inc., 115 West Jackson Blvd., Chicago, IL 60604. Subsequently, all 
rights to this petition were sold to American Chemical Service, Inc., 
P.O. Box 190, Griffith, IN 46319. The petition proposes that the food 
additive regulations be amended to provide for the safe use of 
epoxidized soybean oil as a halogen stabilizer at a level not to exceed 
1 percent in brominated soybean oil intended for use in foods for human 
consumption. Brominated soybean oil is permitted in food on an interim 
basis under 21 CFR 180.30 (brominated vegetable oil), for use only as a 
stabilizer for flavoring oils used in fruit-flavored beverages in an 
amount not to exceed 15 parts per million in the finished beverage.
     FDA has evaluated data in the petition and other relevant 
material. The agency concludes that the proposed use of the additive is 
safe, and that the food additive regulations should be amended by 
adding new Sec. 172.723 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 previously considered the environmental effects of 
this action as announced in the notice of filing for FAP 7A3329 (46 FR 
23811, April 28, 1981). 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. In addition, based on 
information in a letter from the petitioner dated February 15, 1990, 
FDA prepared a new finding of no significant impact. Both the letter of 
February 15, 1990, and the new finding of no significant impact 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 July 26, 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 172

    Food additives, Incorporation by reference, Reporting and 
recordkeeping requirements.
    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 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 172 continues to read as 
follows:

     Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).

    2. New Sec. 172.723 is added to subpart H to read as follows.


Sec. 172.723  Epoxidized soybean oil.

    Epoxidized soybean oil may be safely used in accordance with the 
following prescribed conditions: [[Page 32904]] 
    (a) The additive is prepared by reacting soybean oil in toluene 
with hydrogen peroxide and formic acid.

    (b) It meets the following specifications:

    (1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 
8.0 percent, as determined by the American Oil Chemists' Society 
(A.O.C.S.) method Cd 9-57, ``Oxirane Oxygen,'' reapproved 1989, which 
is incorporated by reference in accordance with 5 U.S.C 552(a) and 1 
CFR part 51. Copies are available from the American Oil Chemists' 
Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be examined 
at the Division of Petition Control (HFS-215), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. 
NW., suite 1200, Washington, DC, or at the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.

    (2) The maximum iodine value is 3.0, as determined by A.O.C.S. 
method Cd 1-25, ``Iodine Value of Fats and Oils Wijs Method,'' revised 
1993, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. The availability of this incorporation by 
reference is given in paragraph (b)(1) of this section.

    (3) The heavy metals (as Pb) content can not be more than 10 parts 
per million, as determined by the ``Heavy Metals Test,'' Food Chemicals 
Codex, 3d ed. (1981), p. 512, Method II (with a 2-gram sample and 20 
microgram of lead ion in the control), which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Box 285, Washington, DC 20055, or may be 
examined at the Division of Petition Control (HFS-215), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 1110 
Vermont Ave. NW., suite 1200, Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

    (c) The additive is used as a halogen stabilizer in brominated 
soybean oil at a level not to exceed 1 percent.

    Dated: June 14, 1995.

Fred R. Shank,

Director, Center for Food Safety and Applied Nutrition.

[FR Doc. 95-15349 Filed 6-23-95; 8:45 am]

BILLING CODE 4160-01-F