[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