[Federal Register Volume 65, Number 245 (Wednesday, December 20, 2000)]
[Rules and Regulations]
[Pages 79718-79719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32376]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 95F-0305]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Polydextrose
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 polydextrose as a
bulking agent, texturizer, or both in fruit and water ices. This action
is in response to a petition filed by Pfizer, Inc.
DATES: This rule is effective December 20, 2000. Submit written
objections and requests for a hearing by January 19, 2001.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Rosalie M. Angeles, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3107.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notice published in the Federal Register of September 20, 1995
(60 FR 48716), FDA announced that a food additive petition (FAP 5A4478)
had been filed by Pfizer, Inc., 235 East 42d St., New York, NY 10017-
5755. Pfizer, Inc., subsequently announced the sale of the Pfizer Food
Science Group and the transfer of the petition to Cultor Food Science,
Inc., 430 Saw Mill River Rd., Ardsley, NY 10502. Recently, the
petitioner announced a name change from Cultor Food Science, Inc., to
Danisco Cultor America, Inc. (Danisco), to reflect the acquisition of
the company by Danisco. The petition proposed to amend the food
additive regulations in Sec. 172.841 Polydextrose (21 CFR 172.841) to
provide for the safe use of polydextrose as a bulking agent,
texturizer, or both in fruit and water ices. Polydextrose is intended
to replace all, or in part, fully-caloric ingredients to produce
reduced- or lower-calorie and/or reduced- or lower-sugar fruit and
water ices. The intent of this petitioned use is to enable
manufacturers to formulate all types of frozen desserts, whether or not
they contain dairy ingredients.
The proposed use level of polydextrose in fruit and water ices is 5
to 15 percent with the weighted mean use level estimated to be 10
percent. The petitioner claims that this use level makes possible the
formulation of lower-calorie fruit and water ices that compare
favorably with prototypes that contain no polydextrose. The petitioner
claims that the 15 percent use level is technologically self-limiting
because of less than optimum mouthfeel, increased iciness, unfavorable
taste and reduced acceptability at higher levels. The petitioner
submitted data from sensory studies to substantiate this claim.
II. Conclusions
FDA estimated that the mean chronic consumption of polydextrose
from the proposed use in fruit and water ices is 0.1 gram per person
per day (g/p/d). The agency considers this consumption insignificant
compared to the estimated cumulative intake of polydextrose of 18 g/p/d
from all currently regulated uses of the additive. Therefore, FDA
concludes that there will be a negligible increase in dietary exposure
to polydextrose from the issuance of this amendment to the regulation
(Ref. 1).
FDA has evaluated data in the petition and other relevant material
in its files. Based on this information, the agency concludes that: (1)
The proposed food additive use is safe, (2) the additive will achieve
its intended technical effect, and therefore, (3) the regulation in
Sec. 172.841 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.
An inadvertent error was made in the Federal Register of October
30, 2000 (65 FR 64604 at 64605) when ``dressings for salads'' was
inadvertently combined with ``confections and frostings'' in
Sec. 172.841(c)(3). This document corrects that error in Sec. 172.841
by designating ``dressings for salads'' as paragraph (c)(4) and
redesignating paragraphs (c)(4) through (c)(11) as paragraphs (c)(5)
through (c)(12).
III. Environmental Impact
In the notice of filing, FDA gave interested parties an opportunity
to submit comments on the petitioner's environmental assessment. The
agency received no comments in response to that notice.
The agency has carefully considered the potential environmental
effects of this action. 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 an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
V. Objections
Any person who will be adversely affected by this regulation may at
any time file with the Dockets Management Branch (address above)
written objections by January 19, 2001. 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 are be
submitted and are to be identified with the docket number found in
[[Page 79719]]
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.
VI. References
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from Z. Olempska-Beer, Division of Product
Manufacture and Use, FDA, to R. Angeles, Division of Product Policy,
FDA, November 21, 1995.
List of Subjects in 21 CFR Part 172
Food additives, Reporting and recordkeeping requirements.
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 172 is amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
2. Section 172.841 is amended by revising paragraph (c) to read as
follows:
Sec. 172.841 Polydextrose.
* * * * *
(c) Polydextrose is used in accordance with current good
manufacturing practices as a bulking agent, formulation aid, humectant,
and texturizer in the following foods when standards of identity
established under section 401 of the act do not preclude such use:
(1) Baked goods and baking mixes (restricted to fruit, custard, and
pudding-filled pies, cakes, cookies, and similar baked products);
(2) Chewing gum;
(3) Confections and frostings;
(4) Dressings for salads;
(5) Film coatings on single and multiple vitamin and mineral
supplement tablets;
(6) Frozen dairy desserts and mixes;
(7) Fruit and water ices;
(8) Fruit spreads;
(9) Gelatins, puddings and fillings;
(10) Hard and soft candy;
(11) Peanut spread;
(12) Sweet sauces, toppings, and syrups;
(13) Tablespreads.
* * * * *
Dated: December 12, 2000.
Janice F. Oliver,
Deputy Director, Center for Food Safety and Nutrition.
[FR Doc. 00-32376 Filed 12-19-00; 8:45 am]
BILLING CODE 4160-01-F