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. FD-302a (Rev. 10-6-95) 27 9A-WF-222936-USAMRITD Continuation of FD-302 of __Bruce E. Ivins ,On 09/08/2004 , Page _ 4 grew the 1994/1995 batches of spores. These batches were so good that this challenge protocol was formalized as SOP UIB-BI- 3. IVINS provided the interviewing agents with a copy of SOP UIB-BI-3, which is maintained in an FD-340, in the 1A section of the file. e After creating RMR 1030, IVINS[____——_—si(ealculated b6 the number of spores needed for upcoming vaccine study work and / determined that it would take approximately two years to grow enough spores for this work. As a result, IVINS contracted with Dugway to grow a large number of Ames spores (approximately 10° total spores). IVINS explained that the "Dugway spores" were made_in 1997, combined with spores made at USAMRIID by IVINS and given the name "RMR 1029". IVINS believes that the portion of RMR 1029 grown at USAMRIID was grown using SOP UIB- BI-3. IVINS was unsure of the seed stock for the RMR 1029 spores grown at USAMRIID, but believed that he would have used the same material as what was sent to Dugway. USAMRIID shipped spores to Dugway_in 1997 as seed stock for RMR 1029 spores. IVINS shi (that was He was unsure of the seed stock for this shipment, it may be in his notes. IVINS stated that for RMR 1029, he was more concerned with getting a large batch of spores than with ensuring uniformity in growth conditions. He was also not concerned with genetic variability in the Dugway batches that were prepared for RMR 1029. The entire RMR 1029 sample was considered one lot and IVINS was only concerned that the entire lot, once combined into RMR 1029, was consistent. The final RMR 1029 sample was 1000 mL at a concentration of approximately 3 x 107° cfu/mbL. IVINS noted that Dugway made 8 batches (IVINS later reviewed his notes and determined that only 7 batches were made by Dugway) and shipped them periodically during 1997. The eighth batch (later determined by IVINS to be the seventh) was dirty and could not be purified by density gradient. IVINS described this "dirty" sample as dark brown in color, clumpy, non-refractile with a lot of debris and vegetative matter. IVINS does not recall seeing a non-Ba contaminant and noted that the sample was just bad Ba. IVINS did not know why this shipment was bad and did not know why Dugway did not notice the quality of these spores prior to shipment. IVINS reviewed his notes and determined that this sample was autoclaved, although he does not recall if he was present when it was autoclaved.