[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 <greek-a>-hydro-<greek-oh>-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]]

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    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