The world according to Monsanto : pollution, corruption, and

scientists suppressed 157court in the spring of 2006. “We won’t give up,” Mendelson told me, “especiallybecause quite obviously the mechanism for voluntary consultation theFDA had set up wasn’t working.”He showed me a study by Dr. Douglas Gurian-Sherman, a former FDA scientistwho had worked on assessing transgenic plants before joining the Centerfor Science in the Public Interest. 17 He had gotten access to fourteen“voluntary consultation” files submitted to the FDA by biotechnology companiesbetween 1994 and 2001 (out of a total of fifty-three), five of whichconcerned Monsanto. He found that in six cases, the FDA had asked the producerto provide more data so the agency could completely assess the safetyof the products. “In three [50 percent] of those cases FDA’s requests wereeither ignored by the developer or the developer affirmatively declined toprovide the requested information.” Two of these three cases concernedMonsanto’s transgenic corn, notably MON 810, to which I will return. Monsantohad never provided the further information the FDA had requested tobe able to determine whether GM corn was in fact substantially equivalentto its conventional counterpart. The agency could do nothing, because, as Dr.Gurian-Sherman noted, the policy document—unlike an actual regulation—gave it “no authority to require the developers to submit the desired additionaldata unless it decided to evaluate the crop as a food additive.”This was a decision the FDA made only once, on the Flavr Savr tomato atCalgene’s request. A declassified document shows that that decision had littleeffect and that, despite the results of toxicological tests, the agency approvedthe product. On June 16, 1993, Dr. Fred Hines sent a memorandumto Linda Kahl concerning the three toxicological tests conducted on rats fedwith transgenic tomatoes for twenty-eight days. “In the second study, grosslesions were described in the stomachs of four out of twenty female rats fedone of the two lines of transgenic tomato. . . . The Sponsor’s ...report concludedthat ...these lesions were incidental in nature. . . . The criteria forqualifying a lesion as incidental were not provided in the sponsor’s report.” 18But one year later, the FDA gave its approval to the tomato with the longshelf life.Dr. Gurian-Sherman also examined the data summaries companies providedto the FDA for their “voluntary consultation” and found that in threecases out of fourteen, they contained “obvious errors” that had not been detectedby agency scientists during their review. This point is very important,