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t 54 t r FD-302a (Rev. 10-6-95) ®@ rd] 279A-WE-222936-PO0I Continuation of FD-302 of Bruce Ivins ; ,On 12/03 /2 004 =, Page 2 and the third challenge netted the same results. On one occasion, —_ IVINS consulted with] but could not recall the time ~ frame or the details of theX\conversation. IVINS thought that might have some insight regarding "hot" spores and the Situation they were faced with at Bioport. It was later determined that the guinea pigs were the cause of the failed challenges. TVINS could not recall the defect in the animals, but stated that Bioport bred their own guinea pigs. After determining that the guinea pigs were the problem, Bioport still encountered problems with their potency testing. Fifty percent (50%) of the Guinea pigs were dying upon being challenged. from Bioport formulated a greater response math formula utilizing four (4) different dilutions and looking for a mathematical response relating to survival. IVINS described that the doctors at Bioport felt that a fifty percent (50%) survival rate was acceptable. This caused a disagreement between IVINS and the doctors at Bioport. IVINS did not agree that a fifty percent (50%). survival rate was acceptable for human beings. IVINS further explained that [____] formulated a mathematical formula which consisted of "playing with the numbers" until the numbers reflected a survival rate acceptable to the FDA for approval of the’ vaccine. IVINS did not fight this issue any further because it was out of his control and area of responsibilities while assisting Bioport. IVINS' group worked_on this project until October 16, 2001 with no resolution. [___sikehanged the math, in which the potency of the vaccine reflected the acceptance for FDA approval. IVINS further added that he heard[ _] had been[L__ prior to working at Bioport. He did not hear any reasons for thisL_ Also involved in this project was from Bloport. [| still telephones IVINS and rom time to time with questions. IVINS could not recall the questions, they were laboratory related, however he does not pay much attention cof “IVINS described the doctors at Bioport as incompetent. He described the other individuals working at Bioport as "people with very poor laboratory practices". "Individuals with no science background, and essentially assembly line technicians hired to put © out a product". IVINS gave an example of poor quality control at Bioport which included an instance during an FDA inspection. A fan was found to have been replaced backwards after a routine preventive