[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