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Health Canada Approval of Monsanto’s Genetically Engineered Corn NK603

Below are excerpts from Health Canada’s 2001 3-page summary of its decision to approve NK 603 which can be viewed at http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/roundup_ready_corn_603-mais_603_roundup_ready-eng.php

Health Canada approved Monsanto’s herbicide tolerant corn NK603 for human consumption in April 2001.

At that time, Health Canada said, “Health Canada’s review of the information presented in support of the food use of glyphosate tolerant 603 corn concluded that this corn does not raise concerns related to human food safety. Health Canada is of the opinion that products from 603 corn are as safe and nutritious as those available from current commercial field corn varieties.”

Health Canada said “The Department conducted a comprehensive assessment of line 603…”

Health Canada assessed the safety of eating NK 603 GM corn via animal feed and processed corn ingredients: “The 603 line of transgenic corn is not a sweet corn, but rather, a field corn intended mainly for use in animal feed. However, some human food uses are relevant for field corn. The 603 corn hybrids would typically be either dry- or wet-milled into various processed corn products.”

Health Canada reviewed documents provided by Monsanto (Health Canada does not conduct its own safety tests but relies on corporations to provide data on safety). These documents are not available to the Canadian public and are classified as Confidiential Business Information.

Health Canada’s 2001 summary of its decision to approve NK603 is 3 pages long and contains the categories: 1. Introduction; 2. Development of the Modified Plant; 3. Product Information; 4. Dietary Exposure; 5. Nutrition; 6. Safety (a. Potential Toxicity and b. Potential Allergenicity); 7. Conclusion. The following is Health Canada’s entire summary of its assessment for human safety.


a) Potential Toxicity:

An analysis of the amino acid sequence of the inserted CP4 EPSPS enzyme did not show homologies with known mammalian protein toxins and it is not judged to have any potential for human toxicity. Safety has also been demonstrated in an acute mouse gavage study by feeding with high doses of the purified protein.

b) Potential Allergenicity:

The CP4 EPSPS enzyme expressed in 603 corn does not possess characteristics typical of known protein allergens. There were no regions of homology when the sequence of this introduced protein was compared to the amino acid sequences of known protein allergens. Unlike known protein allergens, CP4 EPSPS is rapidly degraded by acid and/or enzymatic hydrolysis when exposed to simulated gastric or intestinal fluids (t1/2< 15 s in the gastric fluids; t1/2< 10 min. in intestinal fluids). The CP4 EPSPS protein is extremely unlikely to be allergenic.

The CP4 EPSPS enzyme also has a history of safe human and animal consumption, as it is also expressed in Roundup Ready® canola and soybean, which have been commercially available and have a history of safe use in Canada for over four years.”