[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