[Federal Register Volume 65, Number 210 (Monday, October 30, 2000)]
[Rules and Regulations]
[Pages 64604-64605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27734]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 92F-0305]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Polydextrose

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 tablespreads. This action is in 
response to a petition filed by Pfizer, Inc.

DATES: This rule is effective October 30, 2000. Submit written 
objections and requests for a hearing by November 29, 2000.

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 August 24, 1992 
(57 FR 38311), FDA announced that a food additive petition (FAP 2A4332) 
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 tablespreads.
    Polydextrose is intended to replace fully caloric ingredients and 
to produce reduced- or lower calorie and/or lower-fat tablespreads. The 
proposed use level of polydextrose in tablespreads is 5 to 12 percent 
with the weighted mean use level estimated to be 8.5 percent. The 
petitioner contends that this use level makes possible the formulation 
of lower-calorie tablespreads that compare favorably with prototypes 
that contain no polydextrose. The petitioner submitted data to 
substantiate this claim and to demonstrate that the use of polydextrose 
in tablespreads is technologically self-limiting (Ref. 1).

II. Conclusions

    FDA estimated that the mean consumption of polydextrose from the 
proposed use in tablespread is 0.7 gram per person per day (g/p/d). The 
agency considers this consumption insignificant compared to the 
estimated cumulative intake of polydextrose of 17.5 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. 2).
    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

[[Page 64605]]

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.
    On June 1, 1998, the President directed all Federal agencies to use 
``plain language'' in all new documents. In compliance with this 
directive, FDA has drafted its amendment to Sec. 172.841 using the 
principles of ``plain language'' set forth by the President. In 
amending the regulation, the agency is also making an editorial change 
by alphabetizing the list of regulated uses of polydextrose.

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 rule. 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 November 29, 2000. 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 to be 
submitted and are to 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.

VI. Reference

    The following references have 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 dated December 2, 1992, from the Division of 
Product Manufacture and Use to the Division of Petition Control, 
``FAP 2A4332: Pfizer, Inc., Polydextrose in Tablespreads, 
Technologically Self-limiting Level, Submission of 11-12-92.''
    2. Memorandum dated September 30, 1992, from the Division of 
Product Manufacture and Use to the Division of Petition Control, 
``FAP 2A4332 (MATS #658): Pfizer, Inc., Polydextrose as a Bulking 
Agent/Texturizer in Tablespreads, Submission of 6-22-92.''

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 practice 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; dressings for salads;
    (4) Film coatings on single and multiple vitamin and mineral 
supplement tablets;
    (5) Frozen dairy desserts and mixes;
    (6) Fruit spreads;
    (7) Gelatins, puddings and fillings;
    (8) Hard and soft candy;
    (9) Peanut spread;
    (10) Sweet sauces, toppings, and syrups; and
    (11) Tablespreads.
* * * * *

    Dated: October 20, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 00-27734 Filed 10-27-00; 8:45 am]
BILLING CODE 4160-01-F