[Federal Register Volume 63, Number 208 (Wednesday, October 28, 1998)]
[Rules and Regulations]
[Pages 57596-57597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28780]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 97F-0388]


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 permit aqueous transition metal catalytic 
hydrogenation in the production of polydextrose and to adopt the 
specifications for polydextrose of the Food Chemicals Codex, 4th ed., 
1996. This action is in response to a petition filed by Cultor Food 
Science, Inc.

DATES: This regulation is effective October 28, 1998; written 
objections and requests for a hearing by November 27, 1998. The 
Director of the Office of the Federal Register approves the 
incorporation by reference in accordance with 5 U.S.C 552(a) and 1 CFR 
part 51 of certain publications in Sec. 172.841(b) (21 CFR 172.841(b), 
October 28, 1998.

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: In a notice published in the Federal 
Register of September 25, 1997 (62 FR 50387), FDA announced that a food 
additive petition (FAP 7A4556) had been filed by Cultor Food Science, 
Inc., 205 East 42d St., New York, NY 10017, proposing that Sec. 172.841 
Polydextrose (21 CFR 172.841) be amended to permit aqueous transition 
metal catalytic hydrogenation in the production of polydextrose and to 
adopt the specifications for polydextrose of the Food Chemicals Codex, 
4th ed., 1996, pp. 297-300.
    The proposed optional transition metal catalytic hydrogenation step 
in the production of polydextrose yields a partially reduced form of 
polydextrose in which the glucose moiety of glucose-terminated 
polydextrose polymers and the residual glucose monomers are converted 
to sorbitol moieties. The petitioner submitted data demonstrating that 
this partially reduced form of polydextrose is functionally equivalent 
to the currently regulated polydextrose and that no new chemical 
species are formed as a result of the proposed hydrogenation step. 
These data also show that the components of polydextrose produced by 
the proposed hydrogenation step are the same as the compounds of the 
currently regulated polydextrose and that only the relative amounts of 
sorbitol-terminated polydextrose and of free sorbitol are changed. The 
proposed adoption of the specifications for polydextrose in the Food 
Chemicals Codex, 4th ed., will allow the partially reduced form of 
polydextrose, with increased residual free sorbitol, to meet the 
specifications for polydextrose.
    No new uses and no changes in current use levels of polydextrose 
are proposed in the petition. Polydextrose produced by the proposed 
hydrogenation step is expected to be used as a replacement for the 
currently regulated polydextrose. Therefore, FDA concludes that there 
will be no increase in dietary exposure to polydextrose from the 
promulgation of this amendment to the regulation (Ref. 1).
     Based on its evaluation of the data in the petition and other 
relevant material in its files, FDA concludes that the reduced form of 
polydextrose produced by the proposed optional hydrogenation step is 
safe, that it will achieve its intended technical effect, and that 
therefore, the regulations 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 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.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
any time on or before November 27, 1998, 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.

Reference

    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 dated September 27, 1997, from M. DiNovi, Division 
of Product Manufacture and Use, FDA, to R. M. Angeles, Division of 
Product Policy, FDA.

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements, 
Incorporation by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 57597]]

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 paragraphs (a)(2) and (b) 
to read as follows:

Sec. 172.841  Polydextrose.

* * * * *
    (a) * * *
    (2) Polydextrose may be partially neutralized with potassium 
hydroxide, or partially reduced by transition metal catalytic 
hydrogenation in aqueous solution.
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 4th ed. (1996), pp. 297-300, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
200 C St. SW., rm. 3321, Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
* * * * *

    Dated: October 18, 1998.
 L. Robert Lake,
 Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-28780 Filed 10-27-98; 8:45 am]
BILLING CODE 4160-01-F