[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]



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

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.

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

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.
* * * * *


[[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