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. It has been foods, at essentially the same levels, and demonstrate that rice starch is common industrial practice to use a for the same technical effects that chemically equivalent to corn starch or wide variety of starch sources in maltodextrin derived from corn starch potato starch. Additionally, the manufacturing commercial dextrin or potato starch is now used (Ref. 16). hydrolysis products made from these products (Refs. 2 and 7). During The petitioner indicates that starch sources, including maltodextrins, digestion, acid and enzymatic processes maltodextrins are currently used in a are essentially equivalent. Thus, in the stomach convert the starch wide range of processed and maltodextrin derived from rice starch is macromolecules to smaller molecules, convenience foods, principally as a equivalent in all material respects to such as maltodextrin, and eventually to filler or carrier for flavorings and maltodextrin derived from corn starch glucose. This digestion process is intensive sweeteners and as a sweetness or potato starch, both of which have similar to the commercial process used reducer or texture modifier. Because been affirmed as GRAS (§ 184.1444 (21 to produce glucose and fructose, which maltodextrin derived from rice starch CFR 184.1444)). are GRAS starch-based sweeteners will be used as a replacement for presently used in foods (Ref. 7). (See maltodextrin derived from corn starch A. Evidence of Chemical Equivalency of corn sugar, 21 CFR 184.1857; corn or potato starch, the exposure of Potato Starch and Corn Starch to Rice syrup, 21 CFR 184.1865; and high consumers to maltodextrin is not Starch fructose corn syrup, 21 CFR 184.1866). expected to increase. Starch is the reserve carbohydrate in Starch hydrolysates below 20 dextrose tubers such as potatoes, in grains such equivalents (D.E.) are classified as D. General Recognition of Safety as rice, corn, or barley, in seeds, and in maltodextrins (Refs. 8 and 9). The agency has determined, based on many fruits. As early as 1811, scientists Specifications for maltodextrins are published information, that the safety of had determined that food starches from listed in the Food Chemicals Codex, 4th maltodextrin derived from rice starch is various plant sources were essentially ed., (1996) (Ref. 6). Equivalent generally recognized by food safety equivalent (Ref. 1). All food starches, maltodextrin products result from experts. Foremost in the support of regardless of the plant source, are equivalent hydrolysis of edible starch safety is published information that composed of chemically equivalent sources (Ref. 10). Because corn starch, shows that corn starch, potato starch, polymeric forms of alpha-bond-linked potato starch, and rice starch are and rice starch are chemically glucose units (Ref. 2). Starch consists of essentially equivalent, the products of equivalent, and therefore, maltodextrin 14610 Federal Register / Vol. 63, No. 58 / Thursday, March 26, 1998 / Rules and Regulations derived from rice starch is equivalent to (2) Maltodextrin derived from rice current or future activity is prohibited the maltodextrin derived from corn starch is chemically equivalent to by this rule. starch or potato starch. Thus, maltodextrin derived from corn starch VII. Regulatory Flexibility Analysis maltodextrin derived from rice starch and potato starch, both of which are presents no more of a safety concern currently affirmed as GRAS for food use FDA has examined the impact of this than maltodextrin derived from corn without restriction under § 184.1444. final rule under the Regulatory starch or potato starch, both of which (3) When maltodextrin derived from Flexibility Act. The Regulatory have been affirmed as GRAS. rice starch is manufactured according to Flexibility Act (5 U.S.C. 601–612) Moreover, many countries, including the methods specified in § 184.1444, for requires Federal agencies to consider those represented by the European corn and potato starch, there is general alternatives that would minimize the Starch Association (Ref. 9), recognize recognition among qualified experts that economic impact of their regulations on ‘‘food starches,’’ including rice starch, the use of maltodextrin derived from small entities. FDA finds that this final as a suitable raw material for rice starch in food is safe. rule will not have a significant maltodextrin production. Furthermore, Based upon the evaluation of economic impact on a substantial published information, corroborated by the Food and Agriculture Organization/ number of small entities. World Health Organization and the Joint unpublished data and information, i.e., based upon scientific procedures No compliance costs are associated Expert Committee on Food Additives with this final rule because no new (JECFA) (Refs. 17 and 18) recognizes (§ 170.30(b)), the agency concludes that maltodextrin derived from rice starch is activity is required and no current or maltodextrin as an intermediate product future activity is prohibited. in the production of enzyme-treated GRAS for use as a replacement for maltodextrin derived from corn or Accordingly, under the Regulatory starches, a process that JECFA has stated Flexibility Act, 5 U.S.C. 605(b), the results in the production of normal potato starch. Therefore, the agency is affirming that maltodextrin derived agency certifies that this final rule will (meaning safe) food constituents. JECFA not have a significant economic impact does not restrict the sources of food from rice starch is GRAS when used in accordance with good manufacturing on a substantial number of small starches used in the production of entities. products such as maltodextrins. JECFA practice (21 CFR 184.1(b)(1)). also does not require toxicological V. Environmental Effects VIII. Effective Date testing of products such as The agency has determined under 21 As this rule recognizes an exemption maltodextrins that are produced from CFR 25.32(f) that this action is of a type from the food additive definition in the enzyme-treated starches. Finally, as that does not individually or Federal Food, Drug, and Cosmetic Act, noted in section III.A. of this document, cumulatively have a significant effect on and from the approval requirements the agency has proposed to find that rice the human environment. Therefore, applicable to food additives, no delay in starch is GRAS (Ref. 5). neither an environmental assessment effective date is required by the The agency concludes that nor an environmental impact statement Administrative Procedure Act (5 U.S.C. maltodextrin derived from rice starch is is required. 553(d)). The rule will therefore be chemically and functionally equivalent effective immediately (5 U.S.C. to maltodextrin derived from edible VI. Analysis for Executive Order 12866 553(d)(1)). starch from other sources (Ref. 10). No FDA has examined the impacts of this increase in exposure to maltodextrin final rule under Executive Order 12866. IX. References would be expected due to the Executive Order 12866 directs agencies The following references have been substitution of one source for the other. to assess the costs and benefits of placed on display at the Dockets Because rice starch is already a available regulatory alternatives and, Management Branch (address above) significant constituent of the typical diet when regulation is necessary, to select and may be seen between 9 a.m. and 4 (Ref. 5), the agency does not believe that the regulatory approaches that p.m., Monday through Friday. consumption of maltodextrin derived maximize net benefits (including from rice would cause a dietary concern 1. Wolfrom, M. L., and H. El Khadem, potential economic, environmental, ‘‘Chemical Evidence for the Structure of (Ref. 19). public health and safety effects; Starch,’’ Starch: Chemistry and Technology, E. Specifications distributive impacts; and equity). edited by R. L. Whistler, and E. F. Paschall, According to Executive Order 12866, a Academic Press, Inc., New York, pp. 251– The agency has reviewed the regulatory action is significant if it 278, 1965. specifications for maltodextrin meets any one of a number of specified 2. ‘‘Starch Hydrolysis Products: An published in the Food Chemicals Codex, conditions, including having an annual Introduction and History,’’ Starch Hydrolysis 4th ed. (1996), pp. 239 and 240, and it effect on the economy of $100 million, Products, Worldwide Technology, Production, and Applications, edited by F. finds that they are acceptable for adversely affecting in a material way a maltodextrin derived from edible W. Schenck and R. E. Hebeda, VCH sector of the economy, competition, or Publishers, Inc., New York, pp. 1–21, 1992. starches. Therefore, the agency is jobs, or if it raises novel legal or policy 3. ‘‘Evaluation of the Health Aspects of adopting the specifications for issues. FDA finds that this final rule is Starch and Modified Starches as Food maltodextrin derived from edible not a significant regulatory action as Ingredients,’’ Life Sciences Research Office, starches for maltodextrin derived from defined by Executive Order 12866. In Federation of American Societies for rice starch. addition, the agency has determined Experimental Biology, 1979. 4. Young, A. H., ‘‘Fractionation of Starch,’’ IV. Conclusions that this final rule is not a major rule for the purpose of congressional review. Starch, 2d ed., edited by R. L. Whistler, and The agency has evaluated the The primary benefit of this action is E. F. Paschall, Academic Press, Inc., New information in the petition, along with York, pp. 249–283, 1984. to remove uncertainty about the 5. ‘‘Unmodified Food Starches and Acid- other available data, and has reached regulatory status of the petitioned Modified Starches; Proposed Affirmation of the following conclusions: substance. No compliance costs are GRAS Status as Direct and Indirect Human (1) Rice starch is chemically associated with this final rule because Food Ingredients,’’ 50 FR 12821, April 1, equivalent to corn and potato starch. no new activity is required and no 1985. Federal Register / Vol. 63, No. 58 / Thursday, March 26, 1998 / Rules and Regulations 14611

6. Food Chemicals Codex, 4th ed., National Applied Nutrition, 21 CFR part 184 is 52237), to include some conforming Academy Press, Washington, DC, pp. 239 and amended as follows: amendments that were inadvertently 240, 1996. omitted. The final rule amended the 7. Evans, R. B., and O. B. Wurzburg, PART 184ÐDIRECT FOOD expedited safety reporting regulations ‘‘Production and Use of Starch Dextrins,’’ SUBSTANCES AFFIRMED AS for human drug and biological products. Starch: Chemistry and Technology, vol. 2, GENERALLY RECOGNIZED AS SAFE edited by R. L. Whistler, and E. F. Paschall, This action is being taken to ensure the Academic Press, Inc., New York, pp. 253– 1. The authority citation for 21 CFR accuracy and consistency of the 278, 1967. part 184 continues to read as follows: regulations. 8. ‘‘Food Additives and Contaminants EFFECTIVE DATE: April 6, 1998. Authority: 21 U.S.C. 321, 342, 348, 371. Committee Report on Modified Starches,’’ FOR FURTHER INFORMATION CONTACT: United Kingdom Ministry of Agriculture, 2. Section 184.1444 is amended by LaJuana D. Caldwell, Office of Policy Fisheries and Food, FAC/REP/31, Her revising the second sentence in (HF–27), Food and Drug Majesty’s Stationery Office, London, p. 5, paragraph (a) and by adding paragraph 1980. Administration, 5600 Fishers Lane, 9. ‘‘Definition of Maltodextrin,’’ European (b)(3) to read as follows: Rockville, MD 20857, 301–443–2994. Starch Associations, Circular Letter Stex 4/ SUPPLEMENTARY INFORMATION: In the 88, February 1988. § 184.1444 Maltodextrin. Federal Register of October 7, 1997 (62 10. Memorandum from the Chemistry (a) * * * It is prepared as a white FR 52237), FDA amended, among other Review Branch to the Direct Additives powder or concentrated solution by things, its regulations in § 314.80 Branch, ‘‘Maltodextrin from Rice,’’ dated partial hydrolysis of corn starch, potato Postmarketing reporting of adverse drug January 13, 1997. starch, or rice starch with safe and 11. ‘‘Paselli SA2,’’ Technical Bulletin, No. experiences (21 CFR 314.80) and suitable acids and enzymes. § 600.80 Postmarketing reporting of 5.12.33.188EU, AVEBE America, Inc., (b) * * * Princeton, NJ. adverse experiences (21 CFR 600.80). In 12. ‘‘INSTANT N–OIL II,’’ Techical Service (3) Maltodextrin derived from rice that document, the agency inadvertently Bulletin, No. 15889–238, National Starch and starch meets the specifications of the omitted conforming amendments to Chemical Corp., Bridgewater, NJ. Food Chemicals Codex, 4th ed. (1996), §§ 314.80(k) and 600.80(l) to correct the 13. Warthesen, J. J., ‘‘Analysis of pp. 239 and 240, which is incorporated current cross-references to Saccharides in Low-Dextrose Equivalent by reference in accordance with 5 U.S.C. §§ 314.80(c)(1)(ii) and 600.80(c)(1)(ii). Starch Hydrolysates Using High-Performance 552(a) and 1 CFR part 51. Copies are These paragraphs should reference Liquid Chromatography,’’ Cereal Chemistry. available from the National Academy vol. 61, No. 2, pp. 194 and 195, 1984. §§ 314.80(c)(1)(iii) and 600.80(c)(1)(iii), Press, 2101 Constitution Ave. NW., respectively. This correction does not, 14. Zuber, M. S., ‘‘Genic Control of Starch Washington, DC 20418, or may be Development’’ Starch: Chemistry and in any way, alter the scope or intent of Technology, edited by R. L. Whistler and E. examined at the Center for Food Safety the October 7, 1997, document. F. Paschall, Academic Press, Inc., New York, and Applied Nutrition’s Library, 200 C In final rule FR Doc. 97–26255, pp. 45, 61–63, 1965. St. SW., rm. 3321, Washington, DC, or published on October 7, 1997 (62 FR 15. Whistler, R. L., and J. R. Daniel, at the Office of the Federal Register, 800 52237), make the following corrections: ‘‘Starch,’’ Kirk-Othmer’s Encyclopedia of North Capitol St. NW., suite 700, Chemical Technology, 3d ed., vol. 21, edited Washington, DC. § 314.80 [Corrected] by J. Brown, C. I. Eastman, Galojuch, et al., * * * * * 1. On page 52251, in amendatory John Wiley & Sons, New York, pp. 492–507, instruction 8, in the second column, 1983. Dated: March 3, 1998. beginning in line 7, the phrase, ‘‘; and 16. ‘‘Maltodextrin; Proposed Affirmation of L. Robert Lake, by removing paragraph (j) and GRAS Status as Direct Human Food Director, Office of Policy, Planning and Ingredient,’’ 47 FR 36443, August 20, 1982. redesignating paragraphs (k) and (l) as Strategic Initiatives, Center for Food Safety paragraphs (j) and (k), respectively’’ is 17. ‘‘Specifications for the Identity and and Applied Nutrition. Purity of Food Additives and Their corrected to read, ‘‘; by removing Toxicological Evaluation,’’ FAO Nutrition [FR Doc. 98–7894 Filed 3–25–98; 8:45 am] paragraph (j), redesignating paragraphs Meetings Report Series, No. 46 and WHO BILLING CODE 4160±01±F (k) and (l) as paragraphs (j) and (k), Technical Report Series, No. 445, pp. 13 and respectively; and by revising the last 14, 1970. sentence in newly redesignated DEPARTMENT OF HEALTH AND 18. ‘‘Toxicological Evaluation of Some paragraph (k)’’. Food Colours, Emulsifiers, Stabilizers, Anti- HUMAN SERVICES 2. On page 52252, in the second Caking Agents, and Certain Other Substances,’’ FAO Nutrition Meetings Report Food and Drug Administration column, in § 314.80, the last sentence of Series, No. 46A, p. 62 and WHO/FOOD redesignated paragraph (k) is correctly ADD./70.36, 1970. 21 CFR Parts 314 and 600 revised to read as follows: 19. Memorandum from the Additives § 314.80 Postmarketing reporting of Evaluation Branch, to the Direct Additives [Docket No. 93N±0181] adverse drug experiences. Branch, ‘‘GRP 2G0380–GRAS Affirmation RIN 0910±AA97 Petition for Maltodextrin Derived from * * * * * Derived Rice: Division of Health Effects Expedited Safety Reporting (k) * * * For purposes of this Evaluation Review (DHEE; HFS–225),’’ dated Requirements for Human Drug and provision, the term ‘‘applicant’’ also August 3, 1993. Biological Products; Correction includes any person reporting under List of Subjects in 21 CFR Part 184 paragraph (c)(1)(iii) of this section. AGENCY: Food and Drug Administration, Food additives, Incorporation by HHS. § 600.80 [Corrected] reference. ACTION: Final rule; correction. 3. On the page 52252, in the second Therefore, under the Federal Food, column, in amendatory instruction 10, Drug, and Cosmetic Act and under SUMMARY: The Food and Drug beginning in line 5, the phrase, ‘‘; and authority delegated to the Commissioner Administration (FDA) is correcting a by removing paragraph (j) and of Food and Drugs and redelegated to document that appeared in the Federal redesignating paragraphs (k), (l), and (m) the Director, Center for Food Safety and Register of October 7, 1997 (62 FR as paragraphs (j), (k), and (l),