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1995S-0316
RPT 276
Volume 213

Cover Page, Letter from CFSAN to Japan Applied Microbiology Research Institute, LTD

Cover Letter to CFSAN

Table of Contents

75- Day Notification for New Dietary Ingredient (ABPC)

Appendices

Tab 1 - Chang, Hui-Ling, et al., "Non-volatile Taste Components of Agaricus blazei, Antrodia camphorate and Cordyceps militaris mycelia" Food Chemistry 74: 203-207 (2001) Published Material

Tab 2 - Dikeman, Cheryl, et al., "Effects of Stage of Maturity and Cooking on the Chemical Composition of Selected Mushroom Varieties," J. Agric. Food Chem., 53: 1130-1138 (2005) Published Material

Tab 3 - Iwade, I., ed., "Kinokorunio Baiyouhou" (The mushrooms and cultivation method) revised fifth edition, Tikyusya, Japan, pp. 342-347 (1985) in Japanese with English translation Published Material

Tab 4 - Koike, Tsuneo, "Single Dose Oral Toxicity Test of ABPC in Rats," Nihon Bioresearch Inc. Hashima Laboratory, Study Number 402323, July 28, 2004, in Japanese with an English translation of the final report and an English Summary

Tab 5 - Manzi, Pamela and Pizzoferrato, Laura, "Beta-glucans in edible mushrooms," Food Chernistty 68: 315-318 (2000) Published Material

Tab 6 - Mattila, Pirjjo, et al., "Contents of Vitamins, Mineral Elements, and Some Phenolic Compounds in Cultivated Mushrooms," J. Agric Food Chem 49: 2343-2348 (2001) Published Material

Tab 7 - Miwa, Koshihisa, "Reverse Mutation Test of ABPC on Bacteria (Ames Test)," Nihon Elioresearch Inc. Hashima Laboratory Study Number 900823, June 10, 2004a, in Japanese with English translation of final report and an English Summary

Tab 8 - Miwa, Koshihisa, "In Vitro Chromosomal Aberration Test of ABPC on Cultured Chinese Hamster Ovary Cells," Nihon Bioresearch Inc. Hashima Laboratory Study Number 970224, August 5, 2004b in Japanese with English translation of final report and an English Summary

Tab 9 - Murrill, William A., "New Florida Fungi," Quart. Jour. Fla., Acad. Sci., 8: 175, 193 (1945). Published Material

Tab 10 - Stamets, Paul, ed., Growing Gourmet and Medicinal Mushrooms, third edition, Ten Speed Press, Berkeley Toronto, Chapter 21, “Growth Parameters for Gourmet and Medicinal Mushroom Species, ” pp. 201, 208 - 216, (2000). Published Material

Tab 11 - Wako Pure Chemical Industries, Ltd., Wako Autokit Glucose Enzymatic Method (Mutarotase-GOD), undated (best copy available).

Tab 12 - Koike, Tsuneo, "The Repetitive Medication Toxicity Examinqtion by the Oral Medication During 91 Days Using the Rat of ABPC," Nihon Bioresearch Inc. Hashima Laboratory Study Number 500324, Final Report through Tables with an English translation of Final Report and an English Summary [Vol. 2 of 3].

Tab 13 - Continued: Appendices of Koike, Tsuneo, "The Repetitive Medication Toxicity Examination by the Oral Medication During 91 Days Using the Rat of ABPC," Nihon Bioresearch Inc. Hashima Laboratory Study Number 500324, and Protocol and Amendments to Protocol, January 25, 2005 in’Japanese with art English translation of Protocol [vol. 3 of 3].

Cover Letter

Table of Contents

Tab 1 - March 18, 2005 letter and fax cover from Clyde A. Takeguchi, Ph.D., Phoenix Regulatory Associates, Ltd. to Linda Pellicore, Ph.D., Center for Food Safety and Applied Nutrition, Food and.Drug Administration, regarding Clarification Amendment for new Dietary Ingredient Notification for enzyme-treated Agaricus blazei Murill mycelia (ABPC)

Tab 2 - March 18, 2005 statement from Takeru Suyama, Japan Applied Microbiology Research Institute Ltd. to Clyde A. Takeguchi, Ph.D., Phoenix Regulatory Associates, Ltd., regarding ABPC production, raw material and final product

Tab 3 - March 15, 2005 letter from Stephanie Benefield stating that she translated the protocol document and the final report both entitled, "A 91 Day Repeated Dose Oral Toxicity Study with ABPC in Rats," word-for-word

Tab 4 - March 18, 2005 letter from Takeru Suyama, Japan Applied Microbiology Research Institute Ltd. stating that he translated the single dose oral toxicity test in rats, Ames reverse mutation test, In Vitro Chromosomal Aberration test, word-for-word

Tab 5 - March 18, 2005 letter from Kenji Yoshida, Japan Applied Microbiology Research Institute Ltd. stating that he translated the Iwade articie, word-for-word

Tab 6 - Material Safety Data Sheet, Asahi Food & Healthcare, Ltd., Ingredient name: Dried brewery yeast Y3 (November 19, 2004)

Tab 7 - Material Safety Data Sheet, Asahi Food & Healthcare, Ltd., Ingredient name: Meast powder K (November 18, 2004)

Tab 8 - Material Safety Data Sheet, Asahi Food & Healthcare, Ltd., Ingredient name: Malt extract powder I-1451 (November 18, 2004)

Tab 9 - Enzyme Material Safety Data.Sheet, Amano Enzyme Inc., Commercial product name: Hemicellulase "Amano" 90 (January 3, 2003)

Tab 10 - Safety Data Sheet for Chemical Products, New Energy and Industrial Technology Development Organization, Chemical name: Ethanol (April 1, 2004)

Tab 11 - Specification sheet, Dai-Nippon Meiji Sugar Co., Ltd., Product name: White soft sugar ST (March 18, 2005)

Tab 12 - Material Safety Data Sheet, Leprino Foods Company, Product: Lactose (May 8, 2003)

Tab 13 - Material Safety Data Sheet, Dai-Ichi Kogyo Seiyaku Co., Ltd., Identification of the Substance: DK Ester F-20W (Creation date: September 4, 2002; Revision, date: August 3, 2005)


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