issued in the early 1960s by the Food and Drug Administration (FDA) designated some substances derived from microorganisms as generally recognized as safe (GRAS), including carbohydrase and protease enzymes from B. subtilis. The opinions were predicated on the use of nonpathogenic and nontoxicogenic strains of the respective organisms and on the use of current good manufacturing practices. The FDA stated that the enzymes derived from the B. subtilis strain were in common use in food prior to January 1, 1958, and that nontoxigenic and nonpathogenic strains of B. subtilis are widely available and have been safely used in a variety of food applications. This includes consumption of Japanese fermented soy bean, in the form of Natto, which is commonly consumed in Japan, and contains as many as 108 viable cells per gram. The fermented beans are recognized for their contribution to a healthy gut flora and vitamin K2 intake; during this long history of widespread use, natto has not been implicated in adverse events potentially attributable to the presence of B. subtilis. The natto product and the B. subtilis natto as its principal component are FOSHU (Foods for Specified Health Use) approved by the Japanese Ministry of Health, Labour, and Welfare as effective for preservation of health. Bacillus subtilis has been granted "Qualified Presumption of Safety" status by the European Food Safety Authority. See also Adenylosuccinate lyase deficiency Extremophile Guthrie test YlbH leader References External links SubtiWiki "up-to-date information for all genes of Bacillus subtilis" Bacillus subtilis Final Risk Assessment on EPA.gov. Archived from the original on 2015-09-09. Bacillus subtilis genome browser Type strain of Bacillus subtilis at BacDive - the Bacterial Diversity Metadatabase subtilis Bacteria described in 1872 Extremophiles