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ATTACHMENT I–FINAL RISK ASSESSMENT OFAspergillus oryzae(February 1997)I. INTRODUCTION
Aspergillus oryzae is an asexual, ascomycetous fungus usedfor hundreds of years in the production of soy sauce, miso andsake without recorded incidents. There are conflicting opinions
about whether A. oryzae can be isolated in nature. Although thedetails of the genetic relationship between A. oryzae and A.flavus remain unclear, the two species are so closely relatedthat all strains of A. oryzae are regarded by some as naturalvariants of A. flavus modified through years of selection forfermenting of foods. A. oryzae is regarded as not beingpathogenic for plants or animals, though there are a handful of
reports of isolation of A. oryzae from patients. There are alsoseveral reports of products of A. oryzae fermentations, e.g. a-amylase, that seem to be associated with allergic responses in
certain occupations with high exposure to those materials. A.oryzae can produce a variety of mycotoxins when fermentation isextended beyond the usual time needed for production of these
foods. While wild A. flavus isolates readily produce aflatoxinsand other mycotoxins, A. oryzae has not been shown to be capableof aflatoxin production. History of Commercial Use and Products Subject to TSCAJurisdictionAspergillus oryzae has apparently been an essential part oforiental food production for centuries and is now used in theproduction of many different oriental foods such as soy sauce,
sake and miso. Potential uses under TSCA include fermentations
of numerous enzymes, e.g., amylase, protease, B-galactosidase,
lipase, and cellulase, and organic compounds such as glutamic
acid. While these products have a variety of potential
commercial uses, some of them are mostly frequently used in food
processing. The experience of safe commercial use of A. oryzae isextraordinarily well established. As a “koji” mold it has been
used safely in the food industry for several hundred years. A.oryzae is also used to produce livestock probiotic feedsupplements. Even the commercialization of byproducts of the
fermentation was established nearly a century ago. The “koji”
mold enzymes were among the first to be isolated and
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