[Federal Register Volume 60, Number 213 (Friday, November 3, 1995)]
[Rules and Regulations]
[Pages 55788-55789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27240]



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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 184

[Docket No. 83G-0277]


-Amylase Enzyme Preparation; Affirmation of GRAS Status 
as Direct Human Food Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is affirming that 
-amylase enzyme preparation derived from Bacillus 
stearothermophilus is generally recognized as safe (GRAS) for use in 
the processing of starch to make maltodextrins and nutritive 
carbohydrate sweeteners. This action is based on a petition requesting 
such affirmation.

DATES: Effective November 3, 1995. 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 part 184, effective November 3, 1995.

FOR FURTHER INFORMATION CONTACT: Vincent E. Zenger, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3105.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of September 21, 1983 (48 FR 43096), FDA 
announced that a petition (GRASP 3G0284) had been filed by CPC 
International, Inc., International Plaza, Englewood Cliffs, NJ 07632, 
requesting that -amylase enzyme from B. stearothermophilus 
used in the production of sweeteners from starch be affirmed as GRAS as 
a direct human food ingredient.
    In a tentative final rule published in the Federal Register of 
December 5, 1994 (59 FR 62366), FDA announced its tentative decision to 
affirm as GRAS the use of this enzyme preparation to produce 
maltodextrins, as well as nutritive carbohydrate sweeteners from 
starch. The agency published a tentative final rule before proceeding 
to final action because the end products of the -amylase 
hydrolysis of starch are maltodextrins, which are not sweet and are not 
used as sweeteners in food, as well as nutritive carbohydrate 
sweeteners. Maltodextrins may be used as a food ingredient or used as a 
raw material in the manufacture of nutritive carbohydrate sweeteners, 
for example, glucose syrups. Therefore, FDA found that the phrase 
``production of maltodextrins and nutritive carbohydrate sweeteners 
from starch'' was a more accurate description of the petitioned use of 
the -amylase enzyme preparation. FDA published the tentative 
final rule to afford interested persons the opportunity to comment on 
this change. FDA did not receive any comments in response to this 
tentative final rule. Therefore, the agency concludes that the 
tentative final rule should be issued as a final rule.

II. Environmental Impact

    The agency has determined under 21 CFR 25.24(b)(7) 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.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under 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 final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
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 analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because no current activity is prohibited by this 
final rule, the compliance cost to firms is zero. Because no increase 
in the health risks faced by consumers will result from this final 
rule, total costs are also zero. Potential benefits include the wider 
use of this enzyme because of reduced uncertainty concerning its GRAS 
status, and any resources saved by eliminating the need to prepare 
further petitions to affirm the GRAS status of this enzyme for this 
use. Thus the agency certifies that the final rule will not have a 
significant economic impact on a substantial number of small entities. 
Therefore, under the Regulatory 

[[Page 55789]]
Flexibility Act, no further analysis is required.

IV. Effective Date

    As this rule recognizes an exemption from the food additive 
definition in the Federal Food, Drug, and Cosmetic Act, and from the 
approval requirements applicable to food additives, no delay in 
effective date is required by the Administrative Procedure Act (5 
U.S.C. 553(d)). The rule will therefore be effective immediately (5 
U.S.C. 553(d)(1)).

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, 21 CFR part 184 is 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. New Sec. 184.1012 is added to subpart B to read as follows:


Sec. 184.1012  -Amylase enzyme preparation from Bacillus 
stearothermophilus.

    (a) -Amylase enzyme preparation is obtained from the 
culture filtrate that results from a pure culture fermentation of a 
nonpathogenic and nontoxicogenic strain of Bacillus stearothermophilus. 
Its characterizing enzyme activity is -amylase (1,4 -
D glucan glucanohydrolase (E.C. 3.2.1.1)).
    (b) The ingredient meets the general and additional requirements 
for enzyme preparations in the ``Food Chemicals Codex,'' 3d ed. (1981), 
pp. 107-110, 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 Office of Premarket Approval (HFS-200), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 1110 
Vermont Ave. NW., suite 1200, Washington, DC, or the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing 
practices. The affirmation of this ingredient as GRAS as a direct human 
food ingredient is based upon the following current good manufacturing 
practice conditions of use:
    (1) The ingredient is used as an enzyme, as defined in 
Sec. 170.3(o)(9) of this chapter, in the hydrolysis of edible starch to 
produce maltodextrins and nutritive carbohydrate sweeteners.
    (2) The ingredient is used at levels not to exceed current good 
manufacturing practices.

    Dated: October 19, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-27240 Filed 11-2-95; 8:45 am]
BILLING CODE 4160-01-F