Guelph, Ontario
October 29, 2002

Roundup Ready soybeans have been genetically modified to tolerate in-crop applications of Roundup herbicide. A single gene derived from a common soil bacterium has been inserted into the soybean. The gene produces a version of a plant enzyme that is normally blocked by glyphosate, the active ingredient in Roundup herbicide. The bacterial version of the enzyme is naturally tolerant to glyphosate, allowing the soybeans to continue to grow after being sprayed with the herbicide, while other weeds are killed and offering producers a new tool for weed control.

Canada's Novel Food Regulations require developers of novel foods, including foods derived from biotechnology, to notify the Health Canada prior to the sale or advertising for sale of the novel foods, in Canada. The required safety assessment of food developed using genetic modification includes the evaluation of the process used to develop it; the comparison of its characteristics to that of the traditional counterpart; the nutritional quality and the potential for the presence of any toxicants or anti-nutrients; and the potential allergenicity resulting from any proteins introduced into the food. This assessment provides assurances that the safety of a novel food is equivalent to similar foods already available in the Canadian marketplace. Once reviewed by Health Canada, these foods can enter the marketplace in the same manner as traditional foods and be subjected to the same post-market standards applicable to all foods sold in Canada. Mandatory labelling would be required for genetically modified foods where safety concerns such as allergenicity and compositional or nutritional changes are identified. In this situation, labelling will be required to alert consumers or susceptible groups in the population.

Health Canada's Guidelines for the Safety Assessment of Novel Foods (including those foods developed from genetic modification) are based upon scientific principles developed through expert international consultation with agencies such as the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) and the Organisation for Economic Co-operation and Development (OECD). The approach to the safety assessment of biotechnology-derived foods taken by Canada is currently applied by regulatory agencies around the world in countries such as the European Union, Australia/New Zealand, Japan, and the United States.

Health Canada conducted an extensive assessment of the soybeans according to the Guidelines for Safety Assessment of Novel Foods. In 1996, Health Canada approved Roundup Ready soybean for human food use. The assessment compared Roundup Ready soybeans with the commercial variety from which they were derived, as well as with other commercial varieties of soybeans. The inserted gene in the soybean produces a new enzyme, a protein which is easily digested by both humans and animals. Health Canada determined that, apart from minute levels of the introduced protein, there was no difference between the genetically altered soybeans and other commercial varieties. The insertion of genetic information into these soybeans to confer glyphosate tolerance caused no difference in the composition or nutritional quality of the soybeans. Health Canada stated that assessments for potential allergenicity or potential toxicity did not raise concerns.

In Canada, the Plant Biosafety Office of the Canadian Food Inspection Agency (CFIA) is responsible for the regulation of plants with novel traits, including those derived from genetic engineering, with respect to environmental safety. The CFIA carries out safety assessments to evaluate new agricultural products for their efficacy and the safety of the worker/bystanders, animals and the environment. The CFIA is also involved in post-approval inspection.

Environmental release in Canada of plants with novel traits requires authorization by the CFIA. Authorizations are issued only after an environmental risk assessment has been conducted by the Plant Biosafety Office, under the Seeds Act. When a developer wishes to release into the environment a plant with a novel trait, they must provide detailed information about the novel trait, the method used to introduce the novel trait into the plant and any risks of adverse environmental effects resulting from the release of the plant into the environment, must be provided. Potential adverse effects could include the plant becoming a weed of agriculture or invasive of natural habitats; novel traits passing to wild relatives through gene flow; the plant or its gene products adversely effecting non-target organisms (including humans); and the plant's impact on biodiversity.

The CFIA reviewed the data and information submitted by the developer of Roundup Ready soybeans and compared it with unmodified soybean counterparts. In 1995, CFIA concluded that neither the inserted gene nor its resulting gene product and associated novel trait confer any intended or unintended ecological advantage, or environmental impact, to Roundup Ready soybean. The potential for transfer of the herbicide-resistance trait to other soybean plants is very low, due to the biology of the species. There is no potential for transfer to wild relatives. In addition, CFIA has concluded that the novel gene and its corresponding trait do not in themselves raise any concerns regarding the safety or nutritional composition of this line as animal feed.

In Ontario, estimates for 2002 plantings from sales figures and commodity groups, show that 40-50% of soybeans are genetically engineered, up from 25-30% in 2001. According to research commissioned by the Canola Council of Canada, over 80% of canola growers used genetically modified varieties in 2000, predominately Roundup Ready canola, as part of a no- or minimal-till system. This has helped reverse decades of soil erosion, but no-till systems require a relatively benign, broad spectrum weed-killer like Roundup. Planting herbicide tolerant canola resulted in a 29% reduction of chemical use. The broad spectrum of weeds controlled by glyphosate, the active ingredient in Roundup, means that soybean growers no longer need to make as many multiple applications with combinations of herbicides. As a result of the widespread substitution of one active ingredient application for an application that might include three or four active ingredients, U.S. soybean growers made 16 million fewer herbicide active ingredient applications in 1998 in comparison with 1995. A 19% reduction occurred in the number of herbicide active ingredient applications made to the average treated soybean acre. Glyphosate is known for its low toxicity and has been used for nearly 30 years without any harm to beneficial insect populations. Honeybees are not harmed by Roundup, as shown by studies mandated by the U.S. Environmental Protection Agency and the World Health Organization. The International Organization for Biological Control deemed Roundup less harmful than various other herbicides. Glyphosate biodegrades easily, breaking down into naturally occurring substances relatively quickly compared to other herbicides. Contamination of groundwater and field run-off is unlikely as the herbicide binds to soil particles.

For more information, please contact Dr. Douglas Powell at (519)821-1799.

Information Sources

AGCare. (2002, July 15) Press Release: Ontario use of biotech crops on the increase again.

Canadian Food Inspection Agency. (2002). Plant Biosafety Office. Retrieved October 29, 2002, from
http://www.inspection.gc.ca/english/plaveg/pbo/pbobbve.shtml

Canadian Food Inspection Agency. (2001). The Safety of Biotechnology derived food crops. Retrieved October 29, 2002, from http://www.inspection.gc.ca/english/ppc/biotech/safsal/safsale.shtml

Canadian Food Inspection Agency. (2001). Decision Document DD95-05: Determination of Environmental Safety of Monsanto Canada Inc.'s Glyphosate Tolerant Soybean (Glycine max L.) Line GTS 40-3-2. Retrieved October 29, 2002, from http://www.inspection.gc.ca/english/plaveg/pbo/dd/dd9505e.shtml#A17

Health Canada. (2002). Food Program: Novel Foods and Ingredients. Retrieved October 29, 2002, from
http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_novel_foods_and_ingredient.html

Gianessi, L.P., & J.E. Carpenter (2000). Agricultural Biotechnology: Benefits of Transgenic Soybeans. National Center for Food and Agricultural Policy, Washington, DC