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14608 Federal Register / Vol 14608 Federal Register / Vol. 63, No. 58 / Thursday, March 26, 1998 / Rules and Regulations Street, Kansas City, Missouri 64106; DEPARTMENT OF TRANSPORTATION DEPARTMENT OF HEALTH AND telephone: (816) 426±3408. HUMAN SERVICES Federal Aviation Administration SUPPLEMENTARY INFORMATION: On Food and Drug Administration January 20, 1998, the FAA published in 14 CFR Part 71 Federal Register a direct final rule; 21 CFR Part 184 request for comments which modified [Airspace Docket No. 97±ACE±20] the Class E airspace at Columbus [Docket No. 91G±0451] Municipal Airport, NE (FR Doc. 98± Amendment to Class E Airspace; Direct Food Substances Affirmed as 1230, 63 FR 2887, Airspace Docket No. Marshall Army Airfield, Fort Riley, KS Generally Recognized as Safe; 97±ACE±32). The effective date of the Maltodextrin Derived From Rice Starch document is amended to coincide with AGENCY: Federal Aviation the chart change date. After careful Administration, DOT. AGENCY: Food and Drug Administration, review of all available information HHS. ACTION: Direct final rule; confirmation of related to the subject presented above, ACTION: Final rule. effective date. the FAA has determined that air safety and the public interest require adoption SUMMARY: The Food and Drug SUMMARY: This notice confirms the of the rule. The FAA has determined Administration (FDA) is amending its effective date of a direct final rule which that these corrections will not change regulations to affirm that maltodextrin revises Class E airspace at Marshall the meaning of the action nor add any derived from rice starch is generally Army Airfield, Fort Riley, KS. additional burden on the public beyond recognized as safe (GRAS). This action is in response to a petition filed by that already published. This action DATES: The direct final rule published at Zumbro, Inc. amends and confirms the effective date 63 FR 2885 is effective on 0901 UTS, of the direct final rule. April 23, 1998. DATES: Effective March 26, 1998. The Director of the Office of the Federal The FAA uses the direct final FOR FURTHER INFORMATION CONTACT: Register approves the incorporation by rulemaking procedure for a non- Kathy Randolph, Air Traffic Division, reference in accordance with 5 U.S.C. controversial rule where the FAA Airspace Branch, ACE±520C, Federal 552(a) and 1 CFR part 51, of a certain believes that there will be no adverse Aviation Administration, 601 East 12th publication at 21 CFR 184.1444, public comment. This direct final rule Street, Kansas City, Missouri 64106; effective March 26, 1998. advised the public that no adverse telephone: (816) 426±3408. FOR FURTHER INFORMATION CONTACT: comments were anticipated, and that Andrew D. Laumbach, Center for Food unless a written adverse comment, or a SUPPLEMENTARY INFORMATION: The FAA Safety and Applied Nutrition (HFS± written notice of intent to submit such published this direct final rule with a 215), Food and Drug Administration, an adverse comment, were received request for comments in the Federal 200 C St. SW., Washington, DC 20204, within the comment period, the Register on January 20, 1998 (63 FR 202±418±3071. regulation would become effective on 2885). The FAA uses the direct final SUPPLEMENTARY INFORMATION: April 23, 1998, the effective date as rulemaking procedure for a non- I. Background herein amended. No adverse comments controversial rule where the FAA were received, and thus this notice believes that there will be no adverse In accordance with the procedures confirms that this direct final rule will public comment. This direct final rule described in § 170.35 (21 CFR 170.35), become effective on that date. advised the public that no adverse Zumbro, Inc., Rt. 1, Box 3, Hayfield, MN comments were anticipated, and that 55940, submitted a petition (GRASP Correction unless a written adverse comment, or a 2G0380) proposing that maltodextrin derived from rice starch be affirmed as In rule FR Doc. 98±1230 published in written notice of intent to submit such an adverse comment, were received GRAS for use as a direct food the Federal Register on January 20, ingredient. 1998, 63 FR 2887, make the following within the comment period, the regulation would become effective on FDA published a notice of filing of correction to the Columbus Municipal this petition in the Federal Register of Airport, NE, Class E airspace April 23, 1998. No adverse comments were received, and thus this notice April 23, 1992 (57 FR 14839), and gave designation incorporated by reference in interested parties an opportunity to 14 CFR 71.1: confirms that this direct final rule will become effective on that date. submit comments to the Dockets § 71.1 [Corrected] Management Branch (HFA±305), Food Issued in Kansas City, MO on February 23, and Drug Administration, 12420 On page 2887 in the second column, 1998. Parklawn Dr., rm. 1±23, Rockville, MD after DATES, correct ``April 20, 1998,'' to Christopher R. Blum, 20857. FDA received no comments in read, ``April 23, 1998.'' Acting Manager, Air Traffic Division Central response to that notice. Issued in Kansas City, MO, on February 26, Region. II. Standards for GRAS Affirmation 1998. [FR Doc. 98±7904 Filed 3±25±98; 8:45 am] Under § 170.30 (21 CFR 170.30), BILLING CODE 4910±13±M Bryan H. Burleson, general recognition of safety may be Acting Manager, Air Traffic Division, Central based only on the views of experts Region. qualified by scientific training and [FR Doc. 98±7906 Filed 3±25±98; 8:45 am] experience to evaluate the safety of food BILLING CODE 4910±13±M substances. The basis of such views may be either: (1) Scientific procedures, or (2) in the case of a substance used in food prior to January 1, 1958, through Federal Register / Vol. 63, No. 58 / Thursday, March 26, 1998 / Rules and Regulations 14609 experience based on common use in polymers of amylose and amylopectin hydrolysis, from simple glucose food (§ 170.30(a)). General recognition polysaccharides (Refs. 1 and 3). The molecules to more complex starch of safety based upon scientific relative proportions of amylose and hydrolysates, such as dextrins and procedures requires the same quantity amylopectin are characteristic of the maltodextrins, are essentially equivalent and quality of scientific evidence as is plant species from which the starch is in terms of chemical, physical, and required to obtain approval of a food derived (Refs. 3 and 4). organoleptic properties. additive, and ordinarily is to be based Because food starches derived from B. Corroborative Evidence of Chemical upon published studies, which may be different plant sources are equivalent in Equivalency corroborated by unpublished studies all material respects (Ref. 1), FDA's food and other data and information (21 CFR additive regulation for modified food The petitioner has submitted data to 170.30(b)). General recognition of safety starch (21 CFR 172.892) does not specify demonstrate the equivalency of through experience based on common that any particular source of food starch maltodextrin derived from rice starch use of a substance in food prior to be used to manufacture the additive. In with maltodextrin derived from tapioca January 1, 1958, may be determined the Federal Register of April 1, 1985 (50 and potato starches, based upon without the quantity or quality of FR 12821) (Ref. 5), FDA published a chemical properties such as dextrose scientific procedures required for proposal to affirm that rice starch (as equivalents (D.E.) and commercial uses approval of a food additive, and well as several other starches) is GRAS (Refs. 11 and 12). Additionally, the ordinarily is to be based upon generally for use in food. FDA has not issued a petitioner provided carbohyrate profiles available data and information final rule in that rulemaking. In for corn maltodextrin and rice concerning the pre-1958 history of use addition, the Committee on Food maltodextrin that demonstrate that the of the substance in food (§ 170.30(c)(1)). Chemicals Codex of the National range of carbohydrate composition in Academy of Sciences has published a maltodextrins derived from corn starch III. Safety Evaluation monograph on maltodextrin stating that is virtually identical to that for FDA has evaluated the petition it may be obtained from any edible maltodextrins derived from rice starch submitted by Zumbro, Inc., (GRASP starch (Ref. 6). Like FDA's food additive (Ref. 13). Moreover, based upon 2G0380) on the basis of scientific regulation for modified food starch, the information submitted by the petitioner procedures to determine whether the monograph does not require that the and on information available in the use of maltodextrin derived from rice starch be derived from any particular current scientific literature, FDA starch is GRAS. In addition to plant source. concludes (Ref. 10) that rice starch may evaluating the data in the petition, FDA Producing maltodextrin by the be considered chemically equivalent to also has considered published articles degradation of starch requires the corn starch in regard to the content of in scientific journals along with other formation of intermediate breakdown the basic chemical components of starch available information in its review. The products called dextrins, which result (i.e., amylose and amylopectin) (Refs. 1, agency concludes, based upon scientific from the partial hydrolysis of starch 2, 3, 4, 7, 14, and 15). procedures, that the information with mineral acids or amylase (Refs. 2 presented in the petition, and other and 7). Further hydrolysis of the starch C. Proposed Use in Food published and unpublished dextrins yields maltodextrins. Information supplied by the petitioner information, support a determination Dextrins are affirmed as GRAS under indicates that maltodextrin derived from that the use of maltodextrin derived 21 CFR 184.1277 and can be prepared rice starch will be used as a replacement from rice starch is GRAS. by partially hydrolyzing the starch in for maltodextrin derived from corn Data in the petition, along with other corn, potato, arrowroot, wheat, rice, or starch or potato starch in the same information in the agency's files, other starch sources.
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