Anti-GM protesters kept from tearing up wheat crop by police

[proverbialwisdom]

41. Fear, uncertainty, doubt? How about independent FDA scientists being overruled by bureaucrats?

Excerpts from the legal brief above, revisit the history of FDA approval.

http://www.purefood.org/gefood/fdasued.cfm

I. FDA's Claim That GE Foods Are Generally Recognized As Safe is False and Fraudulent

A. The Required Level of Consensus is Very High

As the FDA's regulations prescribe and the federal courts have decreed, general recognition of safety can only be imputed if there is an overwhelming consensus in the community of qualified experts. While unanimity is not required, a significant disagreement prevents a determination that consensus exists. (62 Fed. Reg. At 18939.) Further, it takes only a few experts to provide the requisite level of disagreement.

For instance, in United States v. Seven Cartons. Ferro-Lac, 293 F. Supp. 660, 664 (N.D. Il. 1968)* the court agreed with the FDA that there was not general recognition of safety, based solely on the affidavits of two scientists who said that they were not aware of any studies in the pharmacological-toxicological literature on the intended use of the substance.

*Modified on other grounds, 424 F.2d 136 (7th Cir. 1970)

B. There Was Sufficient Doubt About the Safety of GE Foods Within the FDA's Own Scientific Staff to Nullify GRAS Status

Prior to the FDA's issuance of its May 1992 policy statement presuming that GE foods are generally recognized as safe (GRAS), its own experts had expressed concerns about the unique potential health hazards of these new foods in numerous memos to agency decision-makers. The pervasiveness of the concerns within the scientific staff is attested by a memo from an FDA official stating:

"The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks." (FDA Administrative Record (hereinafter "A.R.&quot at 18,953.) Quotations from many of the FDA scientists are in the briefs we submitted to the court in the previously mentioned lawsuit.

The FDA has the original memos in its possession, and photocopies of over twenty key ones are on our website http://www.biointegrity.org/

Further, although the District Court upheld the FDA on narrow technical grounds in the lawsuit, it acknowledged that concerns had been raised by the FDA experts, and it did not state that the required level of disagreement was lacking. Rather, the court ruled that the upper level administrators had discretion to disregard their experts in making a GRAS determination.

Even if this ruling is correct (which is highly dubious), it is still the case that the overwhelming opinion of the FDA experts was that no GE food can be presumed safe unless it has been confirmed so through rigorous toxicological feeding studies.

C. The FDA Knows There Has Never Been Expert Consensus About the Safety of GE Foods

In 1992, when the FDA issued its formal presumption that GE foods are GRAS, it was well aware that not only were they not recognized as safe by its own experts but that there was in fact no consensus in the scientific community at large. This lack of consensus was
clearly acknowledged by Dr. James Maryanski, FDA's Biotechnology Coordinator, in a letter to a Canadian official on October 23, 1991. (A.R. at 22925)

Moreover, the FDA is also well aware that substantial disagreement in the scientific community about the safety of GE foods not only continues but is broadening and intensifying - and that it is more than enough to prevent these products from qualifying as GRAS. The mere fact that nine well-credentialed experts joined our lawsuit as plaintiffs and asserted they viewed GE foods as inherently more hazardous than their conventional counterparts was in itself sufficient evidence that the legally required level of consensus does not exist. The District Court clearly acknowledged the lack of consensus by stating: "Plaintiffs have produced several documents showing significant disagreements among scientific experts."

However, it said that because it was specifically reviewing FDA's policy decision of 1992, it was restricted to consider only the information the FDA had before it at that time. However, even if the court was correct in concluding that all evidence since May 1992 was irrelevant for purposes of that particular legal action (a conclusion that appears seriously flawed), it in no way told the FDA it had license to ignore such evidence in making its decisions after that date. But that is precisely what the FDA persists in doing. It systematically disregards the extensive evidence demonstrating the existence of significant expert disagreement about the safety of GE foods that has been presented to it by our lawsuit, at the series of public meetings it held in 1999, and through other formal channels; it pretends that this evidence is somehow nonexistent; and it gives the false impression in its public pronouncements that there is overwhelming consensus about safety.

More at link.

Tedious, nauseating and infuriating.