[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