Steven M. Druker, J.D., attorney and the Executive Director at Alliance for Bio-Integrity has made insightful points at their site

  • U.S. Law Requires That GE Foods Be Proven Safe
  • US Approval of GE Foods Is Contrary to Law and Occurs Through Government Deception
  • The Bush Administration’s Assault on the EU Moratorium is Based on Major Misrepresentations
  • US Law Mandates Rigorous Application of the Precautionary Principle

U.S. food safety law has mandated the precautionary approach since 1958. In that year, Congress passed the Food Additive Amendment to the Food, Drug and Cosmetic Act, requiring that new additives to food be demonstrated safe through standard scientific testing before they are marketed. (21 U.S.C. Sec. 321).

An official Senate report described the intent of this amendment as follows: “While Congress did not want to unnecessarily stifle technological advances, it nevertheless intended that additives created through new technologies be proven safe before they go to market. S. Rep. 2422, 1958 U.S.C.C.A.N. 5301-2.  This clearly shows that the precautionary principle is the cornerstone of food safety law in the United States.

However, although the Bush Administration is legally required to uphold the precautionary principle at home and honor it abroad, it is doing neither.

Instead, it claims that the principle is an illegitimate restraint on business and trade, and that the United States is free to disregard it and to resist its application by the EU. As reported in the New York Times, “The Bush administration believes the precautionary principle is an unjustified constraint on business and does not even recognize the existence of the doctrine.”

If the U.S. government was following the law, not only would it respect the EU’s precautionary policy on Genetically Engineered (GE) foods, it would have prevented these foods from coming to market in America until they had been proven safe.

By allowing GE foods to be marketed without proof of safety, the U.S. Food and Drug Administration (FDA) is violating its own laws; and it attempts to justify this violation by fallacious arguments.

While FDA administrators acknowledge that pieces of foreign DNA spliced into an edible plant (and all substances produced by them) are in principle food additives, they claim these genes and gene-products are exempt from the testing ordinarily required for additives because they are “generally recognized as safe” (GRAS).

This claim is patently false.

The law specifies that in order to be classified GRAS, foods containing new additives must meet two requirements; and GE foods do not fulfill either of them.

First, as both the FDA’s regulations 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, any significant disagreement prevents a determination that consensus exists.

The requisite consensus for GE foods has never existed, and the FDA is well aware of it because the predominant consensus among its own experts was that these foods entail unique risks and cannot be presumed safe. The FDA’s scientists repeatedly warned their superiors that genetic engineering can disrupt the organism in unpredictable ways and cause the production of unintended harmful substances that are difficult to detect. For instance, an FDA toxicologist cautioned that GE plants could contain unexpected toxins that might “…be uniquely different chemicals that are usually expressed in unrelated plants.”

The pervasiveness of concern within the FDA’s scientific staff is attested by the official responsible for summarizing the expert input, who reported: “The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks.”

Because of the potential for unexpected harmful effects, the FDA experts stated that every GE food should undergo rigorous testing to screen for them.

Further, FDA’s Biotechnology Coordinator is aware and has admitted there is also not a consensus regarding safety among experts outside the FDA.

On October 23, 1991, he wrote a letter to a Canadian health official commenting on a document that discussed GE foods. He stated: “As I know you are aware, there are a number of specific issues addressed in the document for which a scientific consensus does not exist currently, especially the need for specific toxicology tests.”

Today, experts are even more divided about the safety of GE foods than in 1991.

For instance, hundreds have signed an open letter calling for a moratorium, and a 2001 report of the expert panel of the Royal Society of Canada states that (a) it is “scientifically unjustifiable” to presume that GE foods are safe and (b) the “default presumption” for every GE food should be that the genetic alteration has induced unintended and potentially hazardous side effects.

But even in the case of unanimity, U.S. law additionally prescribes that consensus cannot rest on hypotheses but must be based on scientific evidence that clearly establishes safety.

Both the FDA’s regulations and the federal courts have consistently held that such evidence should include studies published in the peer-reviewed scientific literature. (21 CFR Sec. 170.3(h)). Moreover, FDA regulations emphasize that the tests supporting a general recognition of safety “…require the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive.” (21 CFR Sec. 170.30(b)) This means, in the FDA’s words, that the tests must demonstrate “a reasonable certainty … that the substance is not harmful under its intended conditions of use.” (21 CFR Sec. 170.3(i)). Therefore, even if expert consensus about the safety of GE foods actually existed, the law requires that their safety still must be established through standard scientific tests.

Again, the FDA’s own files reveal this requirement has not been met. One of the agency’s scientists noted “the paucity of data” about GE foods (FDA Administrative Record at 18695), and another wrote a memo to the Biotechnology Coordinator saying: ” . . . (A)re we asking the scientific experts to generate the basis for this policy statement in the absence of any data?”

Further, because the FDA does not require tests of GE foods and performs no substantial scientific reviews, it still has no evidence demonstrating that any are safe.

As the agency has itself acknowledged: “FDA has not found it necessary to conduct comprehensive scientific reviews of foods derived from bioengineered plants … consistent with its 1992 policy.” (Reported in The Lancet, Vol. 353, No. 9167, May 29, 1999)

Moreover, eminent experts have made formal declarations that no GE food has been proven safe according to the legal standard. (e.g. Lacey Declaration )

The FDA Is Breaking the Law and Misrepresenting the Facts.

Jail

However, as the FDA administrators themselves admit, they have been operating since 1987 under an ongoing White House directive “to foster” the biotech industry. And in their desire to do so, they claimed there is an overwhelming consensus among experts that GE foods are as safe as others, even though they knew that their own experts regarded them as uniquely hazardous and that no such consensus exists in the scientific community.

Further, although US law requires that every GE food be demonstrated safe prior to marketing, and although the FDA experts called for extensive safety testing as a matter of scientific as well as legal necessity, the FDA administrators allowed GE foods to be marketed without requiring any safety testing at all. And to deepen the deception, besides disregarding their experts’ warnings, they covered them up and then denied they had received any such input by claiming: “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….” (Federal Register vol. 57, No. 104 at 22991.)

The sole purported legal basis for the marketing of GE foods in the U.S. is the blatantly false claim that they are recognized as safe by an overwhelming consensus of scientific experts.

The U.S. government requires no testing of GE foods and has no reliable evidence they are safe; it has disregarded and misrepresented the warnings of its own scientists; its own law mandates the precautionary principle, yet it attacks that principle as a grievous violation of international law; and the sole purported legal basis for its approval of GE foods is the fraudulent claim they are generally recognized as safe.

In light of the above facts, the U.S. challenge to the EU’s policy on GE foods is quite vulnerable, especially because it appears that any member of the WTO is empowered by WTO rules to adopt the standard dictated by U.S. law; and the U.S. could not justifiably object to it. (Agreement on Sanitary and Phytosanitary Measures, Art. 5 paragraph 7).

In May 1998 the Alliance for Bio-Integrity led a group of public interest organizations, life scientists, and religious leaders in filing a lawsuit against the U.S. Food and Drug Administration (FDA) to gain mandatory safety testing and labeling of Genetically Engineered foods. During the discovery process, the agency was required to provide plaintiffs copies of over 44,000 pages of internal records. In doing so, this has revealed the unsoundness of the FDA’s policy on Genetically Engineered Foods.

Photocopies of the 24 documents are available for viewing and printing on BioIntegrity‘s website.

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FDA IS BREAKING THE LAW AND MISREPRESENTING FACTS

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