Kerry Scott Lane, MD - Comment

See attached file(s)Specifically, I believe regulation of Mycotoxins in general, and Aflatoxin in particular, will provide substantial public health benefits. Aflatoxin is a fungal toxin produced by Aspergillus and Penicillium fungi, and is a complex aromatic hetero-cycle, decomposing at 561F. Aflatoxin has been shown to survive in Environmental tobacco smoke. Aspergillus is found worldwide as a storage fungus and production is favored by heat and humidity. Aflatoxin has been regulated by the FDA on all agricultural commodities such as milk, corn, grains and peanuts since 1966, but surprisingly, not on tobacco. There is irrefutable evidence for contamination of tobacco by aflatoxin which is beyond the scope of my comments today. The documents proving this can be found by viewing my submitted comments. Hundreds of internal documents discovered in tobacco litigation along with others give us insight into the work done in this area from the 1960s through today. More recently p53tumor suppressor gene research is evidence of aflatoxin contamination of tobacco. P53 is the “Guardian of the Genome” which instructs genetically damaged cells to repair or die. P53 is the most common mutation in all cancers and most laboratory cancer experiments use aflatoxin to mutate p53 as a positive control. The World Health Organization-IARC database analysis shows substantial mutations in human cancers consistent with an aflatoxin etiology. Most cancers show p53 mutations, especially Lung, Breast, and others. These may be due to Aflatoxin-chemically a benzopyran- or to combustion of Aflatoxin- leading to Benzpyrene. Significantly, Aflatoxin is 200 times more carcinogenic than Benzpyrene, also a recognized tobacco carcinogen. Acting alone, aflatoxin, or fungal toxigenic spores which are semi-fire resistant, may produce toxins in vivo, acting as infectious cancer foci. Focal Aspergillus spores producing AFB would mutate p53 while Gliotoxin produced