[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17923]
[[Page Unknown]]
[Federal Register: July 22, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 172
[Docket Nos. 87F-0389, 88F-0151, and 89F-0042]
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 in
peanut spread, fruit spreads, sweet sauces, toppings, and syrups. This
action is in response to three petitions filed by Pfizer Central
Research, Pfizer, Inc. (Pfizer).
DATES: Effective July 22, 1994; written objections and requests for a
hearing by August 22, 1994. 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 a certain publication in 21 CFR
172.841(b), effective July 22, 1994.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Rosalie M. Angeles, Center for Food
Safety and Applied Nutrition (HFS-207), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-254-9528.
SUPPLEMENTARY INFORMATION:
I. Background and Estimates of Consumption
In a notice published in the Federal Register of January 26, 1988
(53 FR 2093), which was amended in the Federal Register of June 9, 1988
(53 FR 21729), FDA announced that a food additive petition (FAP 7A3998)
had been filed by Pfizer, 235 East 42d St., New York, NY 10017,
proposing that Sec. 172.841 Polydextrose (21 CFR 172.841) be amended to
provide for the safe use of polydextrose in peanut spread. In a notice
published in the Federal Register of May 26, 1988 (53 FR 19046), FDA
announced that another food additive petition (FAP 8A4068) had been
filed by Pfizer, proposing to amend the same regulation for the safe
use of polydextrose in fruit spreads. Then, in a notice published in
the Federal Register of March 15, 1989 (54 FR 10727), the agency
announced that Pfizer had filed a third food additive petition (FAP
9A4126), proposing to amend the same regulation for the safe use of
polydextrose in sweet sauces, toppings, and syrups. In a notice
published in the Federal Register of November 18, 1992 (57 FR 54406),
FDA announced that the agency was amending the filing notices for three
food additive petitions (FAP's 7A3998, 8A4068, and 9A4126) filed by
Pfizer, dated January 26 and May 26, 1988, and March 15, 1989,
respectively, to state that the petitioner had requested that
Sec. 172.841 be amended to include, through incorporation by reference,
specifications of the ``Food Chemicals Codex,'' 3d ed. (1981), 2d supp.
(1986), pp. 57 through 59, and 3d supp. (1992), p. 136.
The agency has estimated that the proposed uses of polydextrose in
peanut spread, fruit spreads, sweet sauces, toppings, and syrups would
add no more than 4.2 grams per person per day (g/p/d) to the mean and
4.6 g/p/d to the 90th percentile estimated daily intake (EDI) for the
2- to 5-year age group and 3.2 g/p/d to the mean and 4.1 g/p/d to the
90th percentile EDI for the 2+ years age group (all ages). Upon
regulation, the cumulative EDI will be no greater than 16 g/p/d for
mean consumption and 26 g/p/d for consumption at the 90th percentile
for the 2- to 5-year-old-age group and 18 g/p/d (mean) and 29 g/p/d
(90th percentile) for the ``all ages'' age group (Ref. 1).
II. Lead Specification for Polydextrose
The agency has been attempting to reduce consumer exposure to lead
in foods by revising or setting new lead specifications for food
additives. (See 59 FR 5363, February 4, 1994). During the Food
Chemicals Codex (FCC) Committee workshop on May 2, 1991, the agency
presented its concerns regarding lead levels in food additives. The FCC
Committee of the National Academy of Science/Institute of Medicine
thereafter revised its policy for establishing lead specifications for
food additives to require that lead specifications should be set at the
lowest levels practicable on the basis of: (1) Current good
manufacturing practice; (2) potential hazard; (3) the availability of
analytical methodology for the determination of low lead levels in food
matrices; and (4) estimates of food intake. Revised and new lead
specifications have recently been published for a number of food
ingredients in the ``Food Chemicals Codex,'' 3d ed., 3d supp. (1992).
In amending the current regulation for polydextrose (21 CFR 172.841),
the agency is incorporating by reference the specifications for
polydextrose set out in the ``Food Chemicals Codex ,'' 3d ed., 2d supp.
(1986), as amended by the 3d supp. (1992), including the new lowered
specifications for lead (0.5 parts per million (ppm)) as well as that
for heavy metals (as lead) (5 ppm).
III. Conclusion
The agency concludes that the available data provide reasonable
certainty of no harm from the proposed food additive uses. In reaching
this conclusion, the agency has considered the potential for excessive
consumption of polydextrose to cause laxation effects in sensitive
individuals. 21 CFR 172.841(d) currently requires that consumers be
informed of this potential through special labeling of products
containing more than 15 g of polydextrose per serving. The agency has
considered the cumulative effect of the additional petitioned uses and
has concluded that the current labeling requirement is adequate to
protect the public. Accordingly, the agency is amending Sec. 172.841 of
the food additive regulations to provide for the safe use of
polydextrose in peanut spread, fruit spreads, sweet sauces, toppings,
and syrups.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petitions
and the documents that FDA considered and relied upon in reaching its
decision to approve the petitions 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 21 CFR
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.
IV. Environmental Impact
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 for each of the three
petitions, may be seen in the Dockets Management Branch (address above)
between 9 a.m. and 4 p.m., Monday through Friday.
V. Objections
Any person who will be adversely affected by this regulation may at
any time on or before August 22, 1994, 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.
VI. 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. FDA, Memoranda of September 30, 1992, and September 7, 1993,
by M. J. DiNovi, Division of Product Manufacture and Use.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by reference, 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: Secs. 201, 401, 402, 409, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371,
379e).
2. Section 172.841 is amended by redesignating paragraphs (b), (c),
and (d) as paragraphs (c), (d), and (e), respectively, by adding new
paragraph (b), and by revising newly redesignated paragraph (c) to read
as follows:
Sec. 172.841 Polydextrose.
* * * * *
(b) The additive meets the specifications of the ``Food Chemicals
Codex,'' 3d ed. (1981), 2d supp. (1986), pp. 57-59, as amended by the
3d supp. (1992), p. 136, 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 Division of Product
Policy (HFS-205), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 200 C St. SW., Washington DC, or at the Office
of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC.
(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:
Baked goods and baking mixes (restricted to fruit, custard, and
pudding-filled pies; cakes; cookies; and similar baked products);
chewing gum; confections and frostings; dressings for salads; frozen
dairy desserts and mixes; fruit spreads; gelatins, puddings and
fillings; hard and soft candy; peanut spread; sweet sauces, toppings,
and syrups.
* * * * *
Dated: June 6, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-17923 Filed 7-21-94; 8:45 am]
BILLING CODE 4160-01-F