[Federal Register Volume 60, Number 183 (Thursday, September 21, 1995)]
[Proposed Rules]
[Pages 48939-48940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 184
[Docket No. 95N-0189]
Maltodextrin; Food Chemicals Codex Specifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to adopt
the Food Chemicals Codex specifications for maltodextrin derived from
corn starch. The agency is proposing to amend its regulations by
removing the requirement that maltodextrin be of a purity suitable for
its intended use and by adding a requirement that the substance comply
with the Food Chemicals Codex, 3d ed., 3d supp. (1992) specifications
for maltodextrin. Elsewhere in this issue of the Federal Register, the
agency is also publishing a final rule adopting the same specifications
for maltodextrin derived from potato starch.
DATES: Written comments by November 20, 1995.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Andrew D. Laumbach, Center for Food
Safety and Applied Nutrition (HFS-217), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3071.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 15, 1983
(48 FR 51911), FDA published a final rule that affirmed the use in food
of maltodextrin derived from corn starch as generally recognized as
safe (GRAS) in Sec. 184.1444 (21 CFR 184.1444). No food-grade
specifications were available for maltodextrin at that time. Therefore,
the regulation required that the maltodextrin be of a purity suitable
for its intended use. The agency stated, however, that it was working
with the Committee on Food Chemicals Codex of the National Academy of
Sciences to develop food-grade specifications for maltodextrin, and
that it would incorporate the specifications into the maltodextrin
regulation upon completion.
In 1992, the Food Chemicals Codex Committee published its third
supplement to the third edition of the Food Chemicals Codex. The
supplement contains food-grade specifications for maltodextrin that is
derived from any edible starch. FDA has reviewed these specifications
and tentatively concludes that they are acceptable for maltodextrin
derived from corn starch. Therefore, the agency is proposing in
Sec. 184.1444 to adopt these specifications for maltodextrin derived
from corn starch. Elsewhere in this issue of the Federal Register, the
agency is also publishing a final rule adopting the same specifications
for maltodextrin derived from potato starch.
The agency has determined under 21 CFR 25.24(a)(9) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
FDA has examined the economic implications of removing the current
requirement that maltodextrin be of a purity suitable for its intended
use and of adding a requirement that the additive meet the Food
Chemicals Codex specifications for maltodextrin, as required by
Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-
354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The agency
believes that this proposed rule is consistent with the regulatory
philosophy and principles identified in the Executive Order. In
addition, the proposed rule is not a significant regulatory action as
defined by the Executive Order and so is not subject to review under
the Executive Order.
The Regulatory Flexibility Act requires agencies to minimize the
impact of their regulation on small entities. Because the proposed rule
requires no change in the current industry practice concerning the
manufacture and use of this ingredient, the agency certifies that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
Interested persons may, on or before November 20,1995, submit to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 184
Food ingredients, Incorporation by reference.
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, it is proposed that 21 CFR part 184 be amended as follows:
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
1. The authority citation for 21 CFR part 184 continues to read as
follows:
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
2. Section 184.1444 is amended by revising paragraph (b) to read as
follows:
184.14444 Maltodextrin.
(a) * * *
(b) Maltodextrin derived from potato starch or corn starch meets
the specifications of the Food Chemicals Codex, 3d ed., 3d supp.
(1992), p. 125, which are 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 Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC 20408, or at the
Division of Petition Control (HFS-217), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204.
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[[Page 48940]]
Dated: September 6, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-23241 Filed 9-20-95; 8:45 am]
BILLING CODE 4160-01-F
