The Canadian Grain Commission is responsible for establishing and maintaining Canada’s grain quality standards, for both GM and non-GM grain. It is neutral on the merits of using genetic engineering to create new varieties of grain. Its role is not to decide whether the product of a given technology is inherently safe or unsafe but to provide the services and regulations that assure that its client’s quality certification requirements are met.
The role of the CGC in the registration of crops is through participation on the Prairie Registration Recommending Committee for Grain (PRRCG). This body and its various subcommittees make recommendations on variety registration to the Canadian Food Inspection Agency.
Although this registration process is slated for amendment, it can be generally stated that for those crops that are registered on the basis of merit, lines must be shown to exhibit quality and disease resistance characteristics, for example, that merit support for their registration.
For wheat to be registered "Kernel Visual Distinguishability," (KVD) a line must resemble the class that it belongs to and be clearly distinguishable from wheat of other classes. GM lines must meet the merit requirements for a crop in the same way as conventional lines.
When a developer wishes to release into the environment a plant with novel traits (PNT) under unconfined conditions, such as marketing the PNT, information required to undertake a full environmental safety assessment must be provided to the Plant Biosafety Office. Novel traits that may impact human/animal health must be assessed for safety, prior to variety registration, by the Office of Food Biotechnology, Health Canada, whose guidelines are based on internationally accepted principles, and were developed in consultation with other government agencies, consumers and industry.
Canada must address the marketing challenges presented by the development and production of GM grains and oilseeds. With increasing consumer concerns about the relative safety of GM grains and oilseeds, some countries have established, and others are establishing GM labeling requirements that will mean that GMOs will have to be traceable from farm to table. Market developments such as these mean that the ability to segregate GM and non-GM varieties will become critical to maintaining Canada’s international market share.
Since GM varieties usually are not visually distinguishable from non-GM varieties, this adds to the pressures on the visual grading system and intensifies the need to find an alternative method of segregation. One means of segregating GM from conventional grains could be through the application of Identity Preserved (IP) systems. Such systems are currently operating in Canada alongside the bulk handling system.
These programs have been successful in segregating grains with specific qualities or traits from their bulk commodity counterparts. Familiar IP programs include, the Warburtons wheat variety specific program, the CWB’s AC Navigator durum program, and non-GM soybean programs in eastern Canada.
Warburtons, for example, has over the last several years operated an IP program in Manitoba and eastern Saskatchewan to ensure that it receives specified varieties of red spring wheat. Farmers are paid a premium for growing these varieties, and the program has proved very successful.
Under current circumstances, however, the varieties grown for this program do not pose a threat to the bulk handling system because they are eligible for a recognized wheat class. Leakage of grain from the IP system into the bulk handled commodity wheat will have no adverse effect on the quality of the bulk-handled wheat. On the other hand, leakage of IP GM wheat, even in small amounts, may be of concern for processors in countries that regulate the marketing and labeling of food and feed products derived from GMOs.
As another example, nearly 30% of the Ontario soybean crop is sold using IP systems that were primarily implemented to help soybean exporters market non-GM food grade soybeans in Japanese and European markets. IP programs such as these are relatively small in volume, and it remains to be determined if the Canadian system could handle more and larger volume IP programs in a GM and non-GM world. Two-way risk of contamination becomes much more of an issue under such conditions.
More than ever, as the number of GM varieties that are grown increases, the demand for third party certified IP systems is expected to grow. In response to industry demand, the CGC and the Canadian Seeds Institute (CSI) began negotiations to develop a national program to audit and certify IP systems.
Created in 1997, the CSI is a not-for-profit, industry-led organization officially recognized by CFIA to provide specific quality assurance services to the seed industry. The partnership will bring together the CGC’s experience in grain testing and the CSI’s experience in process certification. The union also combines the CGC’s internationally recognized expertise in grain testing and the CSI’s experience in process certification.
The Canadian Soybean Exporters Association (CSEA), already has asked the CGC and CSI to audit their processes and practices for the IP soybean program. The CSEA saw value in having the CGC-CSI provide this service because of their respective domestic and international reputations as credible and unbiased third parties. This third-party certification is provided through CGC’s Bayport regional office as a pilot for this developing initiative.
The IP auditing service itself is patterned after the ISO certification process and includes a desk audit of procedures, an on-site audit, spot-checks throughout the year, and audit reports.
From the CGC perspective, the development of objective technologies that will allow varieties, classes, types or characteristics to be identified rapidly, simply, inexpensively, accurately and reproducibly will sustain the long-term success of IP systems. Consequently, the CGC is focusing resources on the development of such tests. We also are putting additional resources into the development of rapid testing technologies for the identification of varieties. Such technologies also will be applicable to the identification of GM grains. When these reliable tests become available, the CGC will offer these as part of its testing services.
Along with technical initiatives, we also are working with the grain industry to design guidelines for identity preservation systems. In response to the demands of their clients, these systems will facilitate segregation of parcels of grain that are visually indistinguishable from one another.
DETECTION AND MONITORING
The development of objective technologies that will allow GM and non-GM varieties to be identified quickly, inexpensively and accurately is critical to a successful IP system.
Ideally, testing methods as well as sampling procedures should be internationally approved to minimize discrepancies in test results. The CGC is focusing resources on the development of such tests with hopes to obtain international recognition for the protocols it develops.
Testing must be done at point of export since it is too expensive to correct problems if tests are conducted at point of unload. To ensure an efficient loading operation, testing would be best performed well in advance of loading grain to a vessel. Testing a load should only be for certification purposes, whereas testing for control will have to be performed well in advance of loading.
Testing after loading a vessel is not acceptable. It is very expensive to discharge loaded cargo and even more expensive to deal with out-of-specification cargo that has already reached its destination. Essentially, once the grain is on the vessel, the die is cast. It is too late to economically and effectively correct a GM contamination problem at that point.
Tests, therefore, will need to be fast and inexpensive, and have detection levels that will allow for effective application of whatever tolerances or specifications are established by the marketplace or through regulation in importing countries. As more GM varieties become registered and as the need to segregate and meet customer tolerances increases, there will be an increasing need for verifiable quantitative GM test methods.
ROUNDUP READY SOYBEANS
Currently, the CGC uses commercially available biochemical testing technology to provide accurate detection of the protein that confers the Roundup Ready (RR) trait in soybeans. This service is being used by the soybean industry in eastern Canada. The detection of the RR protein is marketed in two formats, as an ELISA plate and as a test-strip. ELISA, which is short for Enzyme-Linked Immuno-Sorbant Assay, is the standard for most antibody-based tests. Test kits are available from various companies but they all are based on antibody binding and subsequent visualization of the novel protein in the seed that confers the RR trait.
The GMO soybean certification program used by the CGC illustrates the utility and complementary use of two different testing protocols as part of a non-GMO IP program. For soybeans, a rapid stick-test assay is used to detect the presence/absence of GMOs during grain delivery. Both the test strip and the ELISA plate are acceptable for detecting the presence/absence of GMO soybeans in Canada. Since the ELISA plate test has been validated and accepted in the E.U., this format is preferred for export shipment analysis.
The strip test, which is faster and less expensive, is designed for field-use and provides strictly a positive/negative detection for the presence of the RR protein, so it is useful at delivery. This strip format does not offer the same quality as the ELISA test in terms of accuracy and sensitivity, and it has not received approval and validation by the E.U. For soybeans, either ELISA plate or DNA-based testing is used, and in some cases both are required (E.U.).
There are recognized limitations to protein-based technology such as ELISA, which means that they are not applicable in all cases. For example, there are uncertainties in the correlation between protein expression and % GM content. In addition, protein-based techniques are not event specific.
DNA-based tests, on the other hand, can be event specific. For this reason, they will be the tests of choice for quantification of specific events, possibly in specific varieties. This sort of technology is being rapidly developed through medical research, which is using detection platforms called microarrays, or gene chips. With this technology, hundreds if not thousands of samples may be DNA-fingerprinted automatically on a chip the size of a postage stamp. DNA-based GMO detection using quantitative (real-time) PCR also shows promise because of its superior accuracy and precision.
In the case of StarLink, lateral flow strip tests for detection of the Cry9C gene in maize is available for testing along with Bt9 ELISA plate test kits. Any U.S. maize delivered to a licensed elevator in Canada must be certified as testing negative for StarLink, based on testing three sub-samples, each containing 800 kernels, using lateral flow testing methodology. All sub-samples must test negative. Official testing and certification must be conducted by the United States Department of Agriculture, Grain Inspection, Packers and Stockyards Administration, Federal Grain Inspection Service (FGIS), or their licensed agents.
CANOLA AND WHEAT
GM Canola varieties represent a significant proportion of production in Canada. These varieties are approved in Canada and are accepted by the major importers such as Japan. Consequently, segregation of GM from non-GM canola currently is not an issue and the development and application of testing procedures has not received the same interest as seen for other crops.
Roundup Ready (RR) wheat is currently under development in a joint project between AAFC (CRC) and Monsanto, with a potential commercial release date of 2004-2005. One major concern associated with the introduction of GM wheat is that it might be approved for commercialization in Canada and or the U.S. but remain unapproved for major export customers. Indications are that handling of RR wheat, if it were registered in Canada, would initially be through application of an IP program.
One essential component of such an IP program would be monitoring of bulk handled wheat for the presence of leaked RR wheat. Appropriate GM testing procedures need to be developed for this purpose.
For the grain-handling industry, a rapid assay would be needed to facilitate the testing of grain without slowing the system down. At the same time, testing would have to be accurate and reproducible if cargo certification is requested by buyers. Serological detection and diagnostic techniques such as strip and possibly ELISA plate tests could be used for monitoring grain delivery in the country. For the reasons noted above, however, DNA-based procedures would be best for quantitative detection of RR wheat in support of cargo certification. Such technology will also prove useful for variety identification purposes to determine variety composition in grain shipments.
The Seeds Act and Regulations is the federal legislation, administered by the Canadian Food Inspection Agency (CFIA), governing the testing, inspection, quality and sale of seeds, and therefore variety registration in Canada. The Seed Section is responsible for the administration of the Seeds Act and Regulations, Parts I, III and IV.
The Plant Biosafety Office of the CFIA is responsible for the regulation of plants with novel traits (PNTs) in Canada. PNTs are defined as those plant varieties/genotypes that are not considered "substantially equivalent," in terms of their specific use and safety both for environment and for human health, to plants of the same species in Canada, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity.
Substantial equivalence, in turn, is defined as the equivalence of a novel trait within a particular plant species, in terms of its specific use and safety to the environment and human health, to those in that same species, that are in use and generally considered as safe in Canada, based on valid scientific rationale.
Plants in Canada are regulated on the basis of the traits expressed and not on the basis of the procedure used to insert the traits. Consequently, plants with novel traits may be developed through conventional breeding, mutagenesis or recombinant DNA techniques (GMO).
Safety assessments are required for all PNTs intended for importation and for environmental release in Canada. Safety assessments of livestock feeds and foods derived from biotechnology are the responsibility of the CFIA’s Feeds Section.