[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
