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Toxic L-tryptophan: Shedding Light on a Mysterious Epidemic
by William E. Crist
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Discrepancy over Genetically Engineered Cultures
FDA officials say that Showa Denko never gave the agency sample cultures of the genetically engineered bacteria.1, 2
Don Morgan, an attorney representing Showa Denko (SDK) in the US litigations, commented:
“It was only after the plant inspection [in May 1990] that FDA requested samples of the bacilli. Presumably that is why FDA did not receive samples during the inspection.”3
“SDK offered to supply cultures of the bacteria to FDA but was reluctant to put live bacteria into the mail. Bacteria naturally mutate, and if fermentation is not done correctly, the bacteria die and can release chemicals not found in SDK’s product (None of the bacteria are found in the [end] product). SDK invited FDA to send someone to Japan to receive the bacteria and learn how to care for them and run jar fermentations correctly. FDA never followed up on this offer, or expressed any criticism of SDK’s reluctance to send live bacteria by mail.”4
“FDA did not so much decline to receive sample bacteria as not following up on SDK’s offer to make the samples available in a safe and responsible, informed way. FDA had asked for samples, (but) SDK said it would provide them but not by mail, and FDA did not take advantage of SDK’s offer. Why, we do not know.” 4
Next: 'Table Genetic Modifications of the different strains of Bacillus amyloliquefaciens used [by Showa Denko] to manufacture L-tryptophan,” TIBTECH, Sept. 1994 (Vol. 12), p. 348>>
For more on this subject, see also:
References
1. James Maryanski, biotech coordinator, FDA, phone interview, July 5, 1996.
2. Sam Page, Chief, Natural Products, Center for Food Safely and Applied Nutrition, FDA, Congressional Hearing, Subcommittee, July 18, 1991.
3-4. Don Morgan, attorney, Cleary, Gottlieb, Hamilton & Steen, email correspondence, April 19 and March 5, 2001 respectively.
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© Copyright 2005 William E. Crist. All Rights Reserved
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