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The American Society for Microbiology (ASM) is the largest single life science society in the world, representing over 42,000 scientists, some of whom work in the areas of mycotoxin detection, analysis and fungal genetics. The ASM supports the " Draft Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds." The Society concurs with the intended purpose of the draft guidance to ensure the control of fumonisins in human foods and animal feeds as a prudent public health measure.

Based on information to date, the ASM supports the FDA Guidance document and its contributing data, which show that the levels suggested on fumonisin are consistent with achieving optimal human and animal health. The ASM urges the FDA to consult with international bodies to assess their thinking on achievable mycotoxin levels. The ASM also applauds the FDA for recognizing that plants genetically engineered with genes from the microbe Bacillus thuringiensis are less susceptible to the mycotoxin producing fungi. The Society believes that with advances in biotechnology deterring infection with the fungi, altering the course of the infection or destroying toxin production in the plant may make it feasible to lower or even eliminate the tolerance levels for mycotoxin.

While fumonisin residues in meat, milk and eggs may not be a public health concern, there are segments of the population who consume organ meats, such as liver and brains that appear to either accumulate the toxin or are adversely affected. From the literature presented, it is not clear what could occur upon human ingestion of such products. Thus, at this time, the ASM would support a federal study into the toxicity of fumonisin in organ meats. The ASM supports the guidance levels in the interest of public health.

The ASM commends FDA for addressing fumonisin residue in the nation's food supply and developing this well conceived guidance.

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