Brussels, February 10th January 2003

The information contained in this media briefing will be presented by Michael Hansen, Ph.D., representing Consumers International, at today's meeting in Brussels, hosted by the German Marshall Fund on GM crops and the implications for the import and production of these crops in the developing world.

MEDIA BRIEFING

The Food and Drug Administration (FDA) does not require safety testing for genetically engineered (GE) plants and has not formally approved any of the GE corn (maize) varieties being grown in the United States:

The FDA's original policy on GE/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 FDA will conduct "voluntary safety consultations" with companies.

The fact that FDA does not approve GE/GM crops can be seen in the letter FDA sends to the company after completion of a "safety consultation:"

For example, the letter sent to Monsanto on September 25, 1996 about its MON810 Bt maize states, "Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn grain and forage derived from the new variety are not materially different in composition, safety, or other relevant parameters from corn grain and forage currently on the market, and that they do not raise issues that would require premarket review or approval by FDA" bold added (www.cfsan.fda.gov/~acrobat2/bnfL034.pdf). Note that FDA does not state its own opinion about the safety of this crop; it only states what the company believes. The letters for all 52 "safety consultations" done since the Flavr Savr tomato contain basically the same language.

FDA has recently admitted that it should require mandatory notification of GE/GM food marketing, but has not issued such a regulation:

In 2001, the FDA made a proposal requiring companies to notify the government at least 120 days before commercializing a transgenic plant variety. As part of that proposed rule, the FDA asked for data on each separate transformation event: "[B]ecause some rDNA-induced unintended changes are specific to a transformational event (e.g. those resulting from insertional mutagenesis), FDA believes that it needs to be provided with information about foods from all separate transformational events, even when the agency has been provided with information about foods from rDNA-modified plants with the same intended trait and has had no questions about such foods. In contrast, the agency does not believe that it needs to receive information about foods from plants derived through narrow crosses [e.g. traditional breeding]" italics added (FR 66(12), pg. 4711). In other words, FDA finally admits that differences exist between GE and traditional breeding, that companies should inform and provide basic data before putting a GE/GM food on the market. Unfortunately, although the FDA received over 85,000 comments from the public overwhelmingly supporting mandatory notification, and although industry also supported it as well, the Bush Administration has not implemented this change and says it cannot predict when it will have time to consider it.

For GE/GM plants that produce a newly introduced pesticide, the Environmental Protection Agency (EPA) reviews and approves the safety of the pesticide, but not other plant characteristics. The safety of other changes in the food are not reviewed and approved, as they come under the jurisdiction of the FDA.

A major food safety concern for GE plants is allergenicity, which is not adequately addressed in the U.S:

Last year, the report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, held at FAO headquarters in Rome, laid out a detailed protocol (a decision tree) for evaluating the allergenicity of GM foods (FAO, 2001). None of the GE/GM crops, including GM maize, on the market in the U.S. have been assessed, either by the EPA or the FDA, using such a protocol.

Various types of scientific evidence suggest that Bt maize may contain a transgenic allergen:

Bt maize contains various modified endotoxins from the soil bacterium Bacillus thuringiensis (Bt). These d-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 d-endotoxins, Cry1Ab and/or Cry1Ac, consistent with an allergy (Bernstein et al., 1999). 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 maize and Bt cotton) and vitellogenin, the main precursor to egg yolk protein and a known allergen, as well as between Cry3A (Bt potatoes) and b-lactoglobulin, a major milk allergen (Gendel, 1998).

Global agreement has been reached on what constitutes proper safety assessment of foods derived from GE/GM plants, yet such suggested studies have not been carried out on GM Bt maize (or any other GE/GM crop approved in the US):

Earlier this year, the Codex Alimentarius Ad Hoc Task Force on Foods Derived from Biotechnology reached agreement on a "Draft guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants" (ALINORM 03/34, Appendix V, pp. 61-73). This document is at Step 8 of the Codex procedure, which means that all 35 countries, including the U.S., at the meeting in Yokahama, Japan agreed on this document and recommended that it be adopted by the full Codex Alimentarius Commission. This is important because in the case of trade disputes, the World Trade Organization considers that, in terms of food safety, the standards or guidelines of Codex Alimentarius are deemed the global science-based standard and, thus, immune to trade challenges, i.e. they are not considered to be a "non-tariff trade barrier." At present, the U.S. has not subjected GE/GM maize to the complete safety assessment laid out in this document.

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