JAPAN APPI IED MICROBIOLOGY RESEARCH IN TITUTE LTD RPT276

							                                JAPAN APPI+IED MICROBIOLOGY                                                          RESEARCH IN§TITUTE LTD.




                                                                                        Table of Contents




Cover Letter

Table of Contents


Appendices

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 enzymstreated A,g&cus
                                                                         .                                                                 .
blazei Murill mycelia (ABPC@)..,.........................................:. . . .. . .. . .. .. . .. .. . . .. . .. . . .. . . ... .. ... .~. .. .

March I8,2005 statement from Takeru Suyama,Japan Applied Microbiology
ResearchInstitute Ltd. to Clyde A. Takeguchi, Ph.D., Phoenix Regulatory
Associates, ILtd., regarding ABPC@production, raw material and finat product . .. . . ... . .. ... . .. ~

March IS,2005 letter from Stephanie Benefield stating that she translated the
protocol document and the final report both entitled, “A 9 1 Day RepeatedDose
Orai Toxicity Study with ABPC in Rats,” word-for-word ..,..f...............~..,................f.........

March 18,2005 letter from Takeru Suyama, JapanApplied Microb.ioJogy
ResearchInstitute 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 . .. . .. . . . .. ... . .. . .. . . .. . .. . .. . . .. . .. . .. . . .. . .. . . .. . . .. . . ... .. . . .. .. .. . .. . .. . . .. ... .. .. .. . . .. .. . . .,........,..............,..,..   4

March I8,2005 letter from Kenji Yoshida, Japan Applied Microbiology
ResearchInstitute Ltd. stating that he translated the Iwade articie, word-for-wor                                                                                                                           5

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

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

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

Enzyme Material Safety Data.Sheet,Amano Enzyme Inc., Commercialproduct
name: Hemicelhdase “Amano” 90 (January 3, 2003). . .. . .. . . .. . .. ... . .. . . .. ... .. . . . .. . .. .. ..I................                                                                          9




Phoenix Regulatory Associates, Ltd.m                                                                                                                                                               Page 1 of2
                          JAPAN APPLIED MICROBIOLOGY                                            RESEARCH INSTITUTE LTD.




Table of Cantentsfcontinuedj


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Safety Data Sheet for Chemical Products, New Energy and Industrial
Technology Development Organization, Chemical name: Ethanol
                                                                 ....I............*.........................*..................~...*...........~.*...
(April 1,2004) . . . .. .. . ... ... .. . . ... ... . .. . . ....‘                                                                                                            10

Specification sheet, Dai-Nippon Meiji Sugar Co., Ltd., Product name: White soft
sugar ST (h/larch 18,2005) . .. . .. .. .. ... . ....*~............................~.....~...~..........*..1..”...~..“..............L.11

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

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) ... .. . .. . . .. . .. . . . .. . ... . .. . . .. ....f.................................................‘                                               13




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