[Federal Register Volume 61, Number 6 (Tuesday, January 9, 1996)]
[Rules and Regulations]
[Pages 631-632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 95F-0244]
Secondary Direct Food Additives Permitted in Food for Human
Consumption
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 for n-butoxypoly(oxyethylene)poly(oxypropylene)
glycol intended for use in sugar beet processing to replace the
existing limitation on molecular weight with a limitation on viscosity.
This action responds to a petition filed by Union Carbide Corp.
DATES: Effective January 9, 1996; written objections and requests for a
hearing by FEbruary 8, 1996. 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 a certain publication in
Sec. 173.340 (21 CFR 173.340), effective January 9, 1996.
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: Mitchell A. Cheeseman, Center for Food
Safety and Applied Nutrition (HFS-217), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3083.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 8, 1995 (60 FR 40384), FDA announced that a food
additive petition (FAP 5A4473) had been filed by Union Carbide Corp.,
P.O. Box 670, Bound Brook, NJ 08805. The petition proposed to amend the
food additive regulations in Sec. 173.340 Defoaming agents (21 CFR
173.340) to redefine the limitations for n-
butoxypolyoxyethylenepolyoxypropyleneglycol intended for use as a
defoaming agent in sugar beet processing from molecular weight to
viscosity.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed technical amendment concerning
n-butoxypolyoxyethylenepolyoxypropyleneglycol raises no safety issue,
and that Sec. 173.340 should be amended as set forth below. FDA also
concludes that the appropriate syntax for the chemical name of the
additive is
n-butoxypoly(oxyethylene)poly(oxypropylene)glycol.
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
[[Page 632]]
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 potential environmental
effects of this action, as announced in the notice of filing for FAP
5A4473 (60 FR 40384). FDA has received no new information or comments
that would affect the agency's previous determination that this action
will not have a significant impact on the human environment and that
neither an environmental assessment nor an environmental impact
statement is required.
Any person who will be adversely affected by this regulation may at
any time on or before February 8, 1996, 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 173
Food additives, Incorporation by reference.
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 173 is amended as follows:
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
1.-The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348).
2. Section 173.340 is amended in the table in paragraph (a)(4) by
revising the entry for ``n-butoxypolyoxyethylenepolyoxypropylene
glycol'' under the headings `` Substance'' and ``Limitations'' to read
as follows:
Sec. 173.340 Defoaming agents.
* * * * *
(a) * * *
(4)- * * *
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Substance Limitations
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n-Butoxypoly(oxyethylene)- Viscosity range, 4,850-
poly(oxypropylene)glycol 5,350 Saybolt Universal
Seconds (SUS) at 37.8
deg.C (100 deg.F). The
viscosity range is
determined by the method
``Viscosity Determination
of n-
butoxypoly(oxyethylene)-
poly(oxypropylene)
glycol'' dated April 26,
1995, developed by Union
Carbide Corp., P.O. Box
670, Bound Brook, NJ
08805, which is
incorporated by reference
in accordance with 5
U.S.C. 552(a) and 1 CFR
part 51. Copies of the
material incorporated by
reference are available
from the Division of
Petition Control, Center
for Food Safety and
Applied Nutrition (HFS-
215), Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
and may be examined at the
Center for Food Safety and
Applied Nutrition's
Library, 200 C St. SW.,
rm. 3321, Washington, DC,
or at the Office of the
Federal Register, 800
North Capitol St. NW.,
suite 700, Washington, DC.
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* * * * * * *
Dated: December 21, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-228 Filed 1-8-96; 8:45 am]
BILLING CODE 4160-01-F
