[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