[Federal Register Volume 60, Number 202 (Thursday, October 19, 1995)]
[Rules and Regulations]
[Pages 54035-54036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25924]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 173

[Docket No. 94F-0415]


Secondary Direct Food Additives Permitted in Food for Human 
Consumption; Polypropylene Glycol

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 polypropylene 
glycol with a molecular weight range of 1,200-3,000 grams per mole (g/
mol) as a defoaming agent in processing beet sugar and yeast. This 
action is in response to a petition filed by Ashland Chemical Co.

DATES: Effective October 19, 1995; written objections and requests for 
a hearing by November 20, 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: Aydin Orstan, Center for Food Safety 
and Applied Nutrition (HFS-217), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3076.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 12, 1995 (60 FR 2975), FDA announced that a food 
additive petition (FAP 5A4436) had been filed by Ashland Chemical Co., 
One Drew Plaza, Boonton, NJ 07005, proposing that Sec. 173.340 
Defoaming agents (21 CFR 173.340) be amended to provide for the safe 
use of polypropylene glycol with a molecular weight range of 1,200-
3,000 g/mol as a defoaming agent in processing beet sugar and yeast.

    The additive polypropylene glycol with a molecular weight range of 
1,200-2,500 g/mol is currently listed in Sec. 173.340 for use as a 
defoaming agent in processing beet sugar and yeast. FDA has evaluated 
the data in the petition and other relevant material and concludes that 
the extension of the allowable molecular weight range for polypropylene 
glycol to a maximum of 3,000 from the current 2,500 g/mol would not 
result in a greater exposure to the additive or to residual oligomers 
and monomers. The longer polymer of propylene glycol is a more 
effective defoamer and can be used at lower levels than the currently 
regulated polymer. Therefore, FDA concludes that the proposed food 
additive use of polypropylene glycol with a molecular weight range of 
1,200-3,000 g/mol requested by the petitioner is safe and that 
Sec. 173.340 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 environmental effects of 
this rule and announced its conclusion in the notice of filing for FAP 
5A4436 (60 FR 2975, January 12, 1995). No new information or comments 
have been received that would affect the agency's conclusion that there 
is no significant impact on the human environment and that an 
environmental impact statement is not required.
    Any person who will be adversely affected by this regulation may at 
any time on or before November 20, 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.

[[Page 54036]]


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: Secs. 201, 402, 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 342, 348).

Sec. 173.340  [Amended]

    2. Section 173.340 Defoaming agents is amended in the table in 
paragraph (a)(3) in the entry for ``Polypropylene glycol'' under the 
heading ``Limitations'' by removing ``1,200-2,500'' and adding in its 
place ``1,200-3,000''.

    Dated: October 4, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-25924 Filed 10-18-95; 8:45 am]
BILLING CODE 4160-01-F