Aren't animal studies (
http://en.wikipedia.org/wiki/Animal_testing ) supposed to precede human trials?
Much of that SCIENCE was circumvented in the development of GMOs by the creation and application of the concept of 'substantial equivalence'
(
http://en.wikipedia.org/wiki/Substantial_equivalence ) by presidential signing statement.
Not scientific, not acceptable.
http://www.nytimes.com/2001/01/25/business/25FOOD.html?pagewanted=allJanuary 25, 2001
Biotechnology Food: From the Lab to a Debacle
By KURT EICHENWALD, GINA KOLATA and MELODY PETERSENThe following article was reported by Kurt Eichenwald, Gina Kolata and Melody Petersen and was written by Mr. Eichenwald. In late 1986, four executives of the Monsanto Company, the leader in agricultural biotechnology, paid a visit to Vice President George Bush at the White House to make an unusual pitch. Although the Reagan administration had been championing deregulation across multiple industries, Monsanto had a different idea: the company wanted its new technology, genetically modified food, to be governed by rules issued in Washington — and wanted the White House to champion the idea. "There were no products at the time," Leonard Guarraia, a former Monsanto executive who attended the Bush meeting, recalled in a recent interview. "But we bugged him for regulation. We told him that we have to be regulated."
Government guidelines, the executives reasoned, would reassure a public that was growing skittish about the safety of this radical new science. Without such controls, they feared, consumers might become so wary they could doom the multibillion-dollar gamble that the industry was taking in its efforts to redesign plants using genes from other organisms — including other species. In the weeks and months that followed, the White House complied, working behind the scenes to help Monsanto — long a political power with deep connections in Washington — get the regulations that it wanted. It was an outcome that would be repeated, again and again, through three administrations. What Monsanto wished for from Washington, Monsanto — and, by extension, the biotechnology industry — got. If the company's strategy demanded regulations, rules favored by the industry were adopted. And when the company abruptly decided that it needed to throw off the regulations and speed its foods to market, the White House quickly ushered through an unusually generous policy of self-policing. Even longtime Washington hands said that the control this nascent industry exerted over its own regulatory destiny — through the Environmental Protection Agency, the Agriculture Department and ultimately the Food and Drug Administration — was astonishing.
<...> More at link.
http://www.seedsofdeception.com/utility/showArticle/?objectID=1479...FDA microbiologist Louis Pribyl wrote about the policy, “What has happened to the scientific elements of this document? Without a sound scientific base to rest on, this becomes a broad, general, ‘What do I have to do to avoid trouble’-type document. . . . It will look like and probably be just a political document. . . . It reads very pro-industry, especially in the area of unintended effects.”<8>
The FDA scientists’ concerns were not only ignored, their very existence was denied. Consider the private memo summarizing opinions at the FDA, which stated, “The processes of genetic engineering and traditional breeding are different and according to the technical experts in the agency, they lead to different risks.”<9> Contrast that with the official policy statement: “The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way.”<10>
On the basis of this manufactured and false notion of no meaningful differences, the FDA does not require GM food safety testing.
To further justify their lack of oversight, they claimed that GM crops were “substantially equivalent” to their natural counterparts. But this concept does not hold up to scrutiny.
The Royal Society of Canada described substantial equivalence as “scientifically unjustifiable and inconsistent with precautionary regulation of the technology.” In sharp contrast to the FDA’s position, the Royal Society of Canada said that “the default prediction” for GM crops would include “a range of collateral changes in expression of other genes, changes in the pattern of proteins produced and/or changes in metabolic activities.”<11>
Footnotes:
11] “Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada; An Expert Panel Report on the Future of Food Biotechnology prepared by The Royal Society of Canada at the request of Health Canada Canadian Food Inspection Agency and Environment Canada” The Royal Society of Canada, January 2001.
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