• Genetically engineered (GE) plant materials may be finding their way into the human body. In the article, "Maternal and fetal exposure to pesticides associated to genetically modified [GM] foods in Eastern Townships of Quebec, Canada," (in press in Reproductive Toxicology), some 30 pregnant and 39 non-pregnant women in Quebec had blood tested for three pesticides associated with GE plants: glyphosate, glufosinate, and Cry1Ab toxin (from Bt corn). While very little of glyphosate and glufosinate were found, the surprising finding was that Cry1Ab was found in the blood of 69% of nonpregnant women, 90% of the pregnant women (average of 190 ppb) and, more amazingly, in 83% of the fetal cord blood (at 40 ppb). Such widespread exposure to Cry1Ab is very surprising particularly as it survived digestion. This is the first study of its kind and raises the question of what the health effects of such exposure could be.

• The Food and Drug Administration (FDA) does not require safety testing for genetically engineered (GE) plants. The FDA’s original policy on GE (or GM) plants was introduced at a press conference at an industry gathering on May 28, 1992 by then Vice-President Dan Quayle as a de-regulatory initiative. The policy was based on the notion “that the new techniques [e.g. genetic engineering] are extensions at the molecular level of traditional methods and will be used to achieve the same goals as pursued with traditional plant breeding” (57 FR 22991, May 29, 1992), and therefore should be regulated in the same way. In other words, no requirement for human safety testing. But there are “voluntary safety consultations.

• Other scientists have noted the lack of proper safety testing. For example, Dr. Belinda Martineau, the scientist who conducted the safety studies on the first GE plant, the Flavr Savr tomato (engineered for long shelf life) at Calgene, points out in her book First Fruit: the Creation of the Flavr Savr Tomato and the Birth of Biotech Foods: “Rather than personal opinion, the scientific community should give the public facts, hard facts; the results of studies that indicate these foods are safe to eat and that growing them on a large scale will not cause environmental damage. . . . . And simply proclaiming that ‘these foods are safe and there is no scientific evidence to the contrary’ is not the same as saying ‘extensive tests have been conducted and here are the results.’ In fact, without further elaboration, ‘no scientific evidence to the contrary’ could be construed as ‘no scientific evidence, period.’ ” italics added (Martineau, 2001: 2232-233).

• A major food safety concern for GE plants is allergenicity. In 2001, the report of a Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert Consultation on Allergenicity of Foods Derived from Biotechnology, held at WHO headquarters in Rome, laid out a detailed protocol (a decision tree) for evaluating the allergenicity of GM foods. None of the GE crops, including Bt corn, on the market in the U.S. have been assessed using such a protocol.

• Various types of scientific evidence suggest that GE corn may contain a transgenic allergen. One type of GE corn, Bt corn, contains genes coding for various modified endotoxins from the soil bacterium Bacillus thuringiensis (Bt). These -endotoxins are called Cry proteins, in particular Cry1Ab or Cry1Ac. A study of farmworkers who worked in onion fields where foliar Bt sprays were used found that 2 of them contained antibodies to the -endotoxins, Cry1Ab and/or Cry1Ac, consistent with an allergy (Bernstein et al., 1999).

• One of the endotoxins found in GE corn, Cry1Ac, has been found to have sequence similarity to a known human allergen. One of the first steps in assessing the allergic potential of a protein (most allergens are proteins) is to determine if it has similarity in amino acid sequence to a known allergen. A paper published in 1998 by the head of FDA’s own biotechnology studies branch, Dr. Steven Gendel, found significant amino acid sequence similarity between Cry1Ab and Cry1Ac (found in Bt corn and Bt cotton) and vitellogenin, the main precursor to egg yolk protein and a known allergen, as well as between Cry3A (Bt potatoes) and -lactoglobulin, a major milk allergen (Gendel, 1998a).

• Scientific studies also show Cry1Ac has a strong effect on the immune system as well as being a potent adjuvant. A series of five studies published in the last three years and carried out by a team of scientists from two Mexican universities and from Cuba have suggested that the Cry1Ac protein has immunogenic and allergenic properties. A mouse study demonstrated that the Cry1Ac was a potent systemic and mucosal adjuvant: “We conclude that Cry1Ac is a mucosal and systemic adjuvant as potent as CT [cholera toxin] which enhances mostly serum and intestinal IgG antibody responses” (Vazquez-Padron et al., 1999b: pg. 578). Another mouse study which further characterized the mucosal and systemic immune response induced in mice “confirm[ed] that the Cry1Ac protoxin is a potent immunogen able to induce a specific immune response in the mucosal tissue, which has not been observed in response to most other proteins” italics added (Vazquez-Padron et al., 2000a: 147). Another study concluded, “We think that previous to commercialization of food elaborated with self-insecticide transgenic plants it is necessary to perform toxocological tests to demonstrate the safety of Cry1A proteins for the mucosal tissue and for the immunological system of animals” (Vazquez-Padron et al., 2000b: 58). Such tests have never been carried out on GM Bt-corn.

• Global agreement has been reached on what constitutes proper safety assessment of foods derived from GE plants, yet such suggested studies have not been carried out on Bt corn (or any other GE crop approved in the US). Codex Alimentarius is the food safety standards organization of the United Nations and is jointly run by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex Alimentarius has developed a number of documents, including a Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants (CAC/GL 45, 2003) . The World Trade Organization (WTO) considers that the guidelines of Codex Alimentarius are deemed the global science-based standard for food safety and, thus, immune to trade challenges, i.e. they are not considered to be a “non-tariff trade barrier.” Since the US does not require safety assessments of GE plants, this means the US cannot meet the global standards for safety assessment of GE foods as outlined by the Codex Alimentarius. Consequently, countries that require food safety assessments for GE foods could block shipments of such GE foods from the US without fear of losing a WTO challenge.

• Seventeen state legislatures (IL,AK, CA, NC, IA, MD, NY, OR, RI, WV, VT, TN, HI, CT, MA, MO, NJ) have introduced bills to require mandatory labeling of GE foods.