[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Rules and Regulations]
[Pages 29133-29135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 173
[Docket No. 97F-0283]
Secondary Direct Food Additives Permitted in Food for Human
Consumption; Monester of alpha-Hydro-omega-Hydroxy-Poly(Oxyethylene)
Poly(Oxypropylene) Poly(Oxyethylene) (15 Mole Minimum) Blocked
Copolymer
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 safe use of monoester of alpha-hydro-omega-
hydroxy-poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole
minimum) blocked copolymer derived from low erucic acid rapeseed oil as
a component of defoaming agents used in the washing of sugar beets for
processing into sugar. This action responds to a petition filed by Akzo
Nobel Chemical, Inc.
DATES: The regulation is effective May 28, 1998; written objections and
requests for a hearing by June 29, 1998.
[[Page 29134]]
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Vivian M. Gilliam, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3167.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 11, 1997 (62 FR 37266), FDA announced that a food
additive petition (FAP 6A4494) had been filed by Akzo Nobel Chemical,
Inc., 5 Livingstone Ave., Dobbs Ferry, NY 10522-3407. The petition
proposed to amend the food additive regulations in Sec. 173.340
Defoaming agents (21 CFR 173.340) to provide for the safe use of
monoester of -hydro--hydroxy-poly(oxyethylene)
poly(oxypropylene) poly(oxyethylene)(15 mole minimum) blocked copolymer
derived from low erucic acid rapeseed (LEAR) oil as a component of
defoaming agents used in the washing of sugar beets for processing into
sugar. (Although the additive was named in the filing notice using the
Greek symbols for alpha and omega, the agency has chosen to spell out
the words in the listing of the additive to facilitate electronic
searches.)
FDA has evaluated data in the petition and other relevant
material. Based on this information the agency concludes that the
proposed use of monoester of alpha-hydro-omega-hydroxy-
poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole
minimum) blocked copolymer is safe, that the additive will achieve its
intended technical effect, and therefore, that the regulations 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 Sec. 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
6A4494 (62 FR 37266). 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 a environmental assessment, may be seen in the Dockets Management
Branch (address above) between 9 a.m. and 4 p.m., Monday through
Friday. No comments were received during the 30-day comment period
specified in the filing notice for comments on the environmental
assessment submitted with the petition.
Any person who will be adversely affected by this regulation may
at any time on or before June 29, 1998 , 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.
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
List of Subjects in 21 CFR Part 173
Food additives.
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: 21 U.S.C. 321, 342, 348.
2. Section 173.340 is amended by revising paragraph (a)(4) and in
the table in paragraph (a)(4) by revising the first heading and by
alphabetically adding the entry for ``monoester of alpha-hydro-omega-
hydroxy-poly(oxyethylene) poly(oxypropylene) poly(oxyethylene) (15 mole
minimum) blocked copolymer derived from low erucic acid rapeseed oil''
under the newly revised heading ``Substances'' to read as follows:
Sec. 173.340 Defoaming agents.
* * * * *
(a) * * *
(4) The substances listed in this paragraph (a) (4), provided they
are components of defoaming agents limited to use in processing beet
sugar only, and subject to the limitations imposed:
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Substances Limitations
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* * * * * *
*
Monoester of alpha-hydro-omega-hydroxy-
poly(oxyethylene) poly(oxypropylene) poly(oxyethylene)
(15 mole minimum) blocked copolymer derived from low
erucic acid rapeseed oil.
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[[Page 29135]]
* * * * *
Dated: May 19, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 98-14105 Filed 5-27-98; 8:45 am]
BILLING CODE 4160-01-F
