AgBiotech Bulletin Volume 7, Issue 2 February, 1999 Published by AG-WEST BIOTECH INC. TABLE OF CONTENTS President's Column - The Potential Impact of the International Biosafety Protocol 5 Calgene Files Patent on Yellow-Seeded Canola 6 New Plant Breeders' Rights Regulations In Effect In Canada 6 State of the Biotech World 9 Saskatoon Genomics Initiative Could Revolutionize Canola Research The following interview with Dr. Derek Lydiate looks at the current state of the canola genomics initiatives underway in Saskatoon, and particularly at Agriculture and Agri-Food Canada's Saskatoon Research Centre. ABB: The AgBiotech Bulletin first interviewed you almost two years ago, several months before you assumed your position as head of molecular genetics at the Saskatoon Research Centre. At that time you outlined a number of new genomics initiatives being planned for canola. Is the work progressing as envisioned? D.L: I think its safe to say that the genomics possibilities in Saskatoon are coming together nicely. We always hope to do things quicker and bigger, but what we are doing already is not bad at all. I'll try to describe the eight areas where we have initiatives, but first, a definition of genomics may be in order. Genomics is a set of technologies that, when put together on an appropriate scale, can hugely accelerate the process of discovering what genes do. It is really a way of automating a lot of the steps in discovering genes and gene functions. Second, it's a technology built on the huge amount of data that's becoming available on the actual DNA sequences of genes. Some bacteria and yeasts have been completely sequenced. We now know all of their genetic information, which provides a picture of all of the activities the organism has to perform to function as an organism. The big efforts in genomics are the project to sequence the human genome, and the little plant Arabidopsis. We are particularly interested in Arabidopsis. ABB: Why is Arabidopsis so significant to your work, which is largely centered around canola? D.L.: There's a huge amount of similarity between the genetic makeup of canola and Arabidopsis. That's why the Arabidopsis sequencing project is changing the way we research canola. Over the next few years, the balance of where researchers get their most useful information will change. At the moment, if you want to find a gene that does a particular job you are still better off working out how to measure the performance of that job and then finding individual plants that differ in their performance. You then work backward to find the responsible gene. In the future, due to the Arabidopsis projects, there will be a wealth of information out there about genes and what those genes do. And we'll have the technologies to actually understand that information and integrate it. We call this bioinformatics. AAFC is an associate member of the NRC's Canadian Bioinformatics Resource (CBR), centered in Halifax. The CBR has assembled a package of programs that are useful for extracting information from DNA sequences, from protein sequences and protein structures. It also brings together easily accessible copies of all the major international databases that contain that information, and a whole suite of the programs that you use to analyze the information. Using informatics, the most efficient way to modify a crop like canola would be to use our understanding of the genetics of a plant like Arabidopsis. Using Arabidopsis as a model, we would identify the DNA sequence of the gene or group of genes that we think likely to be the ones that, for example, induce cold tolerance. We would then be able to identify the best candidate genes in canola, modify those and introduce them back into the plant. A high proportion of the time we will be able to make the plants better. That's what genomics is really about. It is a suite of technologies for being able to identify which genes are present in particular organisms; to identify which genes might be involved in particular processes; and then to get ideas about how you might want to change them. ABB: At what stage is AAFC, and the Saskatoon research community, on this work? D.L.: With Arabidopsis, we are making progress toward having all the really important resources being developed worldwide available to researchers in Saskatoon, and through us, to other researchers in Canada. These resources include access to the sequence data bases as well as access to the technologies to analyze those data bases to obtain needed information. The resources also include populations of Arabidopsis plants with disruptive insertions. We have thousands of lines, each with different disruptive insertion in a different gene. With this population, we can use molecular biology techniques and the sequence data to find out what happens when we disrupt a gene. We can work back very quickly to find the plant that already has the disruption and then determine whether it has the effect that we expect. We want to be able to screen the whole bank of mutants for a particular change in phenotype. Important changes in phenotype can be rather subtle. Designing a method so that you can screen tens of thousands of different lines to identify the few that show a change is very costly and very difficult. Now we can go to our mutant population and narrow the search down to the genes that we think are involved and start off with, say, five candidates. We then disrupt each of them and look at what happens. If we are right in one or two cases, we've got extremely good material to go on from. The other thing we are keen on doing is developing the Brassica resources needed to use the theoretical information from the Arabidopsis model in the actual crop plants. The bridge between Arabidopsis and Brassica is the key, so that the Arabidopsis work is not merely theoretical. ABB: How does AAFC work with other players in Saskatoon, such as PBI, to avoid duplication of activities? D.L.: The thing that's most important to us is that, as a community, Saskatoon has all the pieces needed to be really efficient and competitive. We're developing quite a good relationship with the Plant Biotechnology Institute (PBI), with the idea that the research developed by AAFC and PBI will be available to anyone else wanting to work on the Arabidopsis and canola platform here or in the rest of Canada. While we are moderately-sized players with regards to the international Arabidopsis effort, we can realistically expect to have a considerable international lead in the use of the Arabidopsis information in the modification of canola. With our work on the Arabidopsis-canola platform, we are well placed to be world leaders in Saskatoon at building up the genomics infrastructure for canola. We also have a range of expertise, in agronomy and entomology and so on. All of the people understand canola and what makes it successful and what limits its success. We need all of them to be able to channel the molecular biology so that it has a chance of doing something useful. ABB: Exactly how does the Arabidopsis effort apply to canola? D.L.: When you have all this sequence information from Arabidopsis it's very useful given that almost all the gene sequences are very similar to canola sequences. But if you actually want to modify canola, a lot of the time you need the actual canola sequences too. Jointly with PBI, we are embarking on quite a large-scale effort to get the DNA sequences of a high proportion of the genes in canola. With the Expressed Sequence Tags (EST) program in place, we can transfer the Arabidopsis information efficiently and start doing experiments in canola straight away, without the need to use lab experimentation to find the equivalent Brassica genes every time. With a good database, we can pinpoint a particular test tube where we already have the needed DNA. So it's simply a process of automating the parts that can be automated and then, in the future, maximizing the speed. Then when you have ideas or avenues for doing things, you can make lots of molecular shortcuts. One other aspect of this is the Brassica/Arabidopsis genome collinearity initiative. It is designed to work out the ways in which the genomes of Brassica and Arabidopsis are very similar because they have descended from a common ancestor. We are trying to understand the correlation of the chromosomal architecture that holds the genes in their relative positions. This is vitally important if you want to move from Arabidopsis to Brassicas quickly. We are fairly good at it, which gives us quite a jump in each individual project where we move from Arabidopsis to Brassicas. An additional element is the Brassica Microsatellite Consortium involving AAFC and 14 companies. The purpose of this is to develop a new generation of genetic markers that will be very useful for a range of research activities It will also change the unit cost of doing experiments. We'll be able to look at the exact genes that control the limiting steps in complicated plant processes like yield and cold tolerance. ABB: When are these technologies going to kick in? When will you begin to see results? And once the genomics technology is in place, what do you plan to do with it? D.L.: I expect that before the end of this calendar year we'll be doing experiments with a biological focus in ways that include the use of the genomics resources. Now to get really efficient exploitation of all this information, at the end of the day, we actually have to have a way of generating new variations in the canola plants. The only technology that we have at the moment is transgenic technology. This technology has international trade ramifications as well as consumer implications. It also has real scientific limitations. Transgenics is actually a very gross, unrefined tool for introducing variation into plants. I think it is reasonable to say that there's a practical limit to the degree of modification that you would want to introduce using this vehicle. Irrespective of the other broad considerations, scientifically and practically, it's not the way we want to go in the long run. ABB: What alternative technologies are available? D.L.: There are two other technologies we can use to modify genetic behaviour, both of which are much closer to what happens naturally. As a result, they remove almost all of the real fears associated with transgenic plants and, to my mind, most of the 'aesthetic' problems. One is to make use of pieces of DNA that 'hops' from place to place. All organisms have these transposable elements, which probably have an important evolutionary place in the ecological development of plants. There is a paradox that all living things want to be able to both maintain genetic or phenotypic uniformity in a stable environment and change quickly if the environment changes. One of the ways that organisms have been able to do that is by making the machinery that actually copies DNA to every generation operate with incredible fidelity. The normal process of making copies of genes from parents to children happens with hardly any errors. And then organisms also have these mobile elements. Most of the time the nuclear machinery prevents them from moving around very much. Under stress, however, they become much more active and generate new variations. We can follow, and to some extent regulate, the behaviour of these mobile elements. With molecular biology and DNA sequence information, you can actually use these elements to create variation. The project between PBI and AAFC, which is funded by AFIF, is generating a population in canola that will allow us to use these elements to produce new genetic alleles of canola. The other technology that can be used with genomics is gene replacement. It's akin to the technology people are trying to use to combat cancer and genetic lesions in humans. Nobody has it working well enough to be useful in plants yet, but what it should enable you to do is effectively design a new DNA sequence and introduce it into the existing copy of the gene. ABB: What are some practical applications for this technology? D.L.: One thing which we are very interested in doing with this is introducing cold tolerance in canola. If canola is sown very early, and if there is a warm spell followed by a cold snap, the plant can die. If, on the other hand, there had been a period of cold beforehand, the canola would have been acclimated. Canola already has the defence mechanism it needs to do this. We want to alter the regulatory machinery to turn on the control gene that activates the whole range of cold resistance genes. Then, if you did get a sudden cold spell, the plants would survive. That's the kind of thing we are actually starting to work on. Other people around the world are trying to do the same. This will be a key technology for really applying the genomics to plant modification. Another important resource we are in the process of building up is called the canola BAC library. This will be a physical library of different bacterial isolates, each containing a different piece of DNA from one of the chromosomes of canola. Over time, what we want to do is build up a library that will allow us to basically ride along chromosomes, pulling out the actual chromosomal piece that flanks or is related to the genes we are interested in. We have recently acquired the robotic equipment to mechanize this process. We'll also speed up the process of moving from having a genetic change we can see in canola to understanding what gene it was that caused that genetic change. It's a resource that will speed up the process of getting to individual canola genes that do individual things. ABB: What are the challenges involved in taking these initiatives forward? D.L.: With all of these elements in place, we have a very good environment in which to design the right sort of projects to make effective use of genomic information. In the last year, we have been trying to put together the suite of genomics resources that will really make things work. Quite a few of these are new and some have been up and running for a few months now. So we are getting close to the stage where there is a real prospect of us having everything workable. There are two real challenges for the future. We would definitely like to boost the muscle power on a number of these things and both AAFC and PBI are really quite keen on making sure that canola and Arabidopsis find their just place in Genome Canada (the national genomics initiative). The crop based applications for genomics, over the long run, will only outweigh the medical applications. Obviously, there are a lot of things you can do in plants that you can't do in people, a lot of experiments that you can't do in people, and a lot of ways that we can benefit society by improving the environment and agriculture. The other challenge is making sure that as these resources become available and exploitable, that we have the biologically-based projects in place to make use of them to do exciting things. The people here are really quite amenable to that and there is quite a lot of excitement about what we will be able to do when we get to the point that these technologies are really usable. For some of them that should be within this year. The Saskatoon Genomics-Bioinformatics Initiative The Saskatoon genomics-bioinformatics initiative is a collaborative effort involving Agriculture and Agri-Food Canada, the Plant Biotechnology Institute and other partners. Funding support for several elements of the initiative comes from the Agri-Food Innovation Fund (AFIF) and other sponsors. Initiative Partners - Insertion mutagenized B. napus AAFC and PBI, with funding support population from AFIF - Insertion mutagenized Arabidopsis AAFC and PBI population - Canola BAC library (B. napus) AAFC, with funding support from AFIF - EST sequencing program AAFC and PBI (Genes expressed in canola) - Brassica microsatellite consortium Consortium of AAFC and 14 companies - Brassica/Arabidopsis genome collinearity AAFC, with funding support from AFIF and the European Community - Gene replacement technology AAFC with funding from AFIF - Bioinformatics AAFC is an associate member of the NRC - Canadian Bioinformatics Resource (CBR) centered in Halifax Ag-West Board Member Profile Dr. P. Ashley O'Sullivan, a member of the Board of Directors of Ag-West Biotech, has been the Director of the Agriculture and Agri-Food Canada (AAFC) Saskatoon Research Centre since 1994. He is also responsible for managing research at the Research Branch facilities in Melfort and Scott. Dr. O'Sullivan graduated with a B.SC and a Ph.D. from University College Cork in Ireland. Following graduation, he moved back to Canada where he worked as a post-doctoral fellow in the Plant Sciences Department at the University of Alberta from 1973 to 1976. He then conducted research on new herbicides with Monsanto Canada until 1978. In 1978, Dr. O'Sullivan began work with AAFC as a weed scientist at the Lacombe Research Station. From 1985-87, he was seconded as Canadian Principal Advisor to the CIDA-sponsored Indo-Canadian drylands project, where he served as on-site team leader. In 1987, he was appointed Assistant Director and later Acting Director of the Lethbridge Research Station. In 1990, he became Director of the AAFC Research Station at Swift Current, Saskatchewan. In 1996, Dr. O'Sullivan received an APEX Leadership Award for his contribution to the Canadian Public Service. Regulatory Australia To Label Genetically Modified Foods The Australia-New Zealand Food Standards Council has decided to require all foods which have been genetically modified to be labeled as such. The decision by the Council, made up of Australia's and New Zealand's health ministers, runs counter to a recommendation from the Australia and New Zealand Food Authority. A spokesperson for the Australian Food Council described the decision as political, noting that Australia now has one of the most restrictive labeling policies in the world. However, the consumers association says that 90 per cent of Australians want to know if their food contains genetically modified material. A group called GeneEthics reports that it will now lobby to have genetically engineered foods banned unless direct benefits to consumers can be identified. Change of Date for Codex Meeting The dates of the next meeting of the Codex Committee on Food Labeling (27th Session) have been changed to April 26-30, 1999 in Ottawa. President's Column The Potential Impact of the International Biosafety Protocol by Peter McCann, President, Ag-West Biotech Inc. The Biosafety Protocol - which is likely to be signed next month in Columbia - is intended to regulate the movement across borders of living modified organisms (LMOs) that could adversely affect biodiversity. While Ag-West supports the intent of the Protocol, there is a real danger that it may create major barriers to agricultural trade. The impact of the Protocol will depend largely on the nature of the Advanced Informed Agreement (AIA) it requires. AIA calls for exporting nations to obtain advance agreement from the importing nation before shipping an LMO. Some parties to the Protocol are calling for AIA on every shipment. Another concern is the definition of LMO, which for some parties includes all products derived from LMOs. If the Protocol is applied broadly, the impact on Canada's agricultural trade could be devastating. According to agricultural economist Dr. Peter Phillips, Van Vliet Chair Professor at the University of Saskatchewan, the economic impact of the protocol would be devastating if the parties to the Protocol agree to a broad definition of LMOs. Dr. Phillips bases this view on an economic impact assessment he carried out for the Canadian Food Inspection Agency, in collaboration with Grant Isaac of the London School of Economics. The study considers the economic impact of various Protocol options. If the Protocol defines LMOs broadly, virtually all trade in agricultural commodities such as canola would fall under its provisions and be subject to severe restrictions. In the absence of an identity preservation system for genetically-modified crops, Phillips believes that the high costs of compliance with the Protocol would result in the elimination of trade with smaller national markets. With larger markets, the result would be increased costs and a disruption of the smooth flows of commodities. In short, the Protocol would amount to a very substantial trade barrier. On the other hand, if the protocol used a narrow definition of LMO, restricted to crops for deliberate release and required notification on the first shipment of a novel product only, it would amount to a 'small irritant.' Ag-West's position is that: - The scope of the Protocol should be limited to LMOs that may have an adverse effect on biodiversity. Decisions under the Protocol with respect to risk assessment should be transparent and based on science, rather than relying on considerations that are primarily socioeconomic or political. The Protocol should be limited to LMOs intended for deliberate release (planting), not cover non-viable products of LMOs, or commodities destined for processing or transit through a country. - The AIA procedure should apply to those LMOs that may have an adverse effect on biodiversity to ensure that organisms being released for the first time receive proper evaluation in advance. Countries should be free to accept or reject imports, but should respond to requests in a timely manner. - Mechanisms should be adopted to permit countries to make individual determinations as to which LMOs require advance consideration, to enter regional agreements to simplify procedures, or to exempt LMOs deemed safe. Documentation should only be required on the first transborder shipment. - Trade with non-parties to the Protocol should be accepted when those countries have adequate risk assessment procedures of their own in place. This is essential to Canada given that the United States is not a party to the Protocol. - Given that the importing country will be responsible for assessing the safety of LMOs, developing countries are requesting support to build their human resource and financial capacity to carry out these assessments. The costs of capacity building will be high and will fall to developed nations such as Canada. The cost of capacity building and, particularly, the cost to Canadians must be understood before an agreement is signed. Economic impact assessments should be carried out in order to prioritize countries for capacity building, and the regionalization of services should be studied. - The Protocol must support the protection of intellectual property and ensure that importing countries institute intellectual property regimes consistent with global norms. - The Protocol is also intended to cover liability in the event of damage occurring to biodiversity. However, the Protocol should not be used to hastily create a product liability regime for LMOs. Rather, liability should be considered under the provisions of the larger Convention on Biodiversity. Contact: Peter McCann at 306-975-1939; e-mail peter.mcann@agwest.sk.ca News Calgene Files Patent on Yellow-Seeded Canola Canadian researchers and seed companies are studying the possible implications of a recent U.S. patent on a yellow seeded canola mutant issued to Calgene Inc. of Davis, California. Calgene is owned by Monsanto Corporation. "We are currently analyzing the implications of this patent," says Dr. Bert Innes, Strategic Analyst with Agriculture and Agri-Food Canada in London, Ontario. "It appears that the claims of this patent may go beyond the particular mutant identified by Calgene to include all yellow seeded canola." Several lines of Brassica rapa are yellow seeds, says Innes. Yellow seeded canola, which has lower fibre and higher oil content, is being developed by a number of institutions and seed companies in Canada. "Certainly, AAFC has been working on yellow seeded canola for 20 years," says Innes. "So while the particular mutant may be novel and patentable, any claim to yellow-seeded canola in general gets into an area where there is significant prior work. In this case, the patent would not satisfy the requirement of novelty. The question is, how to interpret the scope of the patent. We will be watching this very carefully.' Contact: Dr. Bert Innes at 519-457-1470 ext 305. Ag Research Chair Established At U of S Research into new winter wheat varieties and environmentally friendly farming practices will get a boost thanks to the creation of a new research chair in ecological agriculture at the University of Saskatchewan. The non-profit conservation organization Ducks Unlimited Canada (DUC) announced today it will provide $500,000 over five years to establish the Eco-Agriculture Enhancement Chair. The Chair will expand the U of S Crop Development Centre's research into improved winter wheat varieties and sustainable, conservation-based farming. It will also help train graduate students. This is the first time DUC has funded a chair in agricultural research at a Canadian university. Dr. Brian Fowler, senior research scientist with the Crop Development Centre will hold the new Chair. Fowler, recognized internationally as the leading expert on winter wheat, will lead a research team in the U of S Department of Plant Sciences that will work with DUC to develop varieties that are more winter hardy and contribute to DUC's promotion of winter cereals to farmers. According to Ducks Unlimited, winter cereals have proven to provide valuable wildlife habitat. At present, only about 200,000 acres of Western Canadian farm land is planted with winter wheat. According to Fowler, increasing this figure by two or three times would help to establish markets for Canada's winter wheat crop. His seed breeding program, which has already developed six new winter wheat varieties since 1991, will work on developing winter-hardy, drought-tolerant, disease-resistant and higher-yielding winter wheat varieties that will be profitable for growers. Contact: Dr. Brian Fowler, Senior Research Scientist, U of S Crop Development Centre at 306-966-4973. Australian Canola Sales To Europe Rise Australia's status as the only country to guarantee non-genetically modified canola is creating a boom in that country's canola sales to Europe. The New South Wales Grains Board recently reported that it has sold the largest cargo of canola ever to leave Australia. The 57,500 tonne shipment valued at US$16.53 million contributed to an all-time shipping record of 350,000 to 400,000 tonnes in 1998. Legal Notes New Plant Breeders' Rights Regulations In Effect In Canada On December 23, 1998, amendments made to the Plant Breeders' Rights Regulations came into effect. The following summary is provided by Joy D. Morrow of Smart&Biggar, Ottawa. Under the new Plant Breeders' Rights Regulations, protection can now be sought for a new plant variety belonging to any species, excluding algae, bacteria, and fungi. Previously, applications for protection were accepted only for rape (canola), chrysanthemum, soybean, rose, potato, wheat, oats, dianthus, poinsettia, strawberry, barley, flax, apple, alfalfa, bean, pea, potentilla, cherry, pear, African violet, yew, grapevine, corn, maple, begonia, mustard, clematis, creeping red fescue, impatiens, lentil, pelargonium, timothy, Kentucky bluegrass, peach, plum, raspberry, spirea, blueberry, and viburnum. Those species for which plant breeders' rights protection was not previously available, i.e. those species not in the list given above, will be entitled to the transitional benefits prescribed in the new Regulations for 'recently prescribed categories,' for a period of 12 months terminating on December 23, 1999. The following prior sale activities now bar the grant of a valid Plant Breeders' Rights certificate: - A sale in Canada prior to the application filing date, or for applications for recently prescribed categories filed until December 23, 1999, a sale in Canada prior to August 1, 1990. - A sale outside of Canada of woody plants or their rootstocks six years prior to the application filing date, or, for applications for recently prescribed categories filed until December 23, 1999, a sale outside of Canada prior to August 1, 1984. - A sale outside of Canada of other than woody plants and their rootstocks four years prior to the application filing date, or, for applications for recently prescribed categories filed until December 23, 1999, a sale outside of Canada prior to August 1, 1986. The entitlement provisions in the statute and Regulations use the terms 'sold' and 'sale' with reference to the bar periods. Neither term is defined. However, the term 'sell' (referred to in the grant provisions) is defined broadly as: 'sell' includes agree to sell, or offer, advertise, keep, expose, transmit, end, convey or deliver for sale, or agree to exchange or to dispose of to any person in any manner for a consideration. We expect a court would look to this definition at least for guidance in interpreting the 'sale' bars to entitlement. For more information contact Joy Morrow at 613-232-2486; fax 613-232-8440; e-mail ottawa@smart-biggar.ca Deliver your message to the right audience. Send news and information to the Bulletin via fax 306-664-6615. Events February 23-26, 1999 Introductory Course In Risk Analysis For Agriculture And Food Venue: USDA Graduate School, Atlanta, GA. Details: An intensive four-day course, primarily for government professionals with little prior experience in risk analysis. It introduces basic nomenclature and covers the fundamental concepts of risk assessment, risk management, and risk communication. The tuition is US$495.00. Contact: Ms. Delikah Carter at 404-331-0606 or e-mail delikah_carter@grad.usda.gov June 9-11, 1999 AgBiotech World Forum '99 Venue: MGM Grand, Las Vegas, USA Details: An annual science-to-business conference and trade show. 1999 Theme: Getting your share of the huge new agbiotech opportunities. Contact: Patrick Canney, IBC USA Conferences, phone 508-804-5281 or e-mail pcanney@ibcusa.com June 19-23, 1999 Plant Biology Canada '99 Venue: Delta Bessborough Hotel, Saskatoon, SK Details: The annual meeting of the Canadian Society of Plant Physiologists will include three symposia: 1. Plant Biology in the Next Millennium; 2. Advances in the Biology of Plant Organelles; 3. Poplar: An Emerging System for Plant Biology and Biotechnology. Abstracts and papers are invited. Contact: Rosemarie Gallays, NRC/PBI, fax 306-975-5571, e-mail rgallays@pbi.nrc.ca July 27-30, 1999 Rendez-vous BioAtlantech 1999 Farm, Forests and Fish: Genomic Technologies Ð Mapping Tomorrow's Resources Venue: Fredericton Sheraton Hotel, Fredericton, New Brunswick Details: The conference will highlight significant scientific breakthroughs, high impact science, new directions, key questions, and emerging commercial opportunities in genomic technologies related to agriculture, aquaculture and forestry. Contact: BioAtlantech 1999, PO Box 636, Stn A Fredericton, NB E3B 5A6. Phone 506-444-2444; fax 506-444-5662; e-mail jgartley@fundy.net; website at www.bioatlantech.nb.ca SARAS Column Market Access Issues for Canadian Seeds by Bill Anderson Ph.D., Saskatchewan Ag-biotech Regulatory Affairs Service (SARAS) There are many factors affecting the commercialization of transgenic seed in international markets. Public acceptance issues, lack of internationally harmonized regulatory systems and data requirements, politicized regulatory systems, intellectual property rights, unclear and inconsistent labeling laws, and the current uncertainty cultivated by the United Nations Convention on Biological Diversity (CBD) Biosafety Protocol, all contribute to market access barriers for Genetically Modified Organisms (GMOs). When considering Canada's approach to regulating transgenic plants and the effect these regulations have on commodity markets in Canada, it is important to remember that all of the issues that effect market access for GMOs are interconnected and interdependent. Many developed countries with the capacity to evaluate risks for environmental release, feed and food uses of agricultural GMOs have developed regulatory systems based on scientific principles. It is important to note that the dialogue and cooperation among industry, public institutions and regulatory agencies helped develop these regulatory guidelines and set the standards for health and environmental safety. Despite the fact that many of these regulatory systems conduct risk assessments based on scientific principles, the approval of biotech products is ultimately controlled at the political level. International market access for GMOs is limited due to the lack of international harmonization of regulatory systems and data requirements. Most countries have adopted the Organization for Economic Co-operation and Development's (OECD) approach to assessing risks of GMOs which compares the transgenic plant to its traditional counterpart (if it has one). The concepts of familiarity and substantial equivalence are used to assess the potential environmental and health risks associated with the plant. All assessments for GMOs are done on a case by case basis. Canada regulates novel traits in plants. The means by which the plant incorporated this novel trait is irrelevant with respect to triggering Canadian regulation. However, the information required by regulatory agencies will differ depending on the ability to collect data for addressing a particular concern. The Canadian Food Inspection Agency (CFIA) is responsible for assessing environmental and feed safety data for plants with novel traits (PNTs). These data are collected from field trial plots. Regulators determine if there is a potential negative impact on the environment by assessing, among other concerns, whether there is increased weediness or out-crossing compared to the plant's traditional counterpart. If the plant is determined to be substantially equivalent to its traditional counterpart it can receive unconfined release permission. The CFIA is also responsible for variety registration. Food safety in Canada is assessed by Health Canada's Health Protection Branch. Regulators assess whether there have been substantive changes in the plant with regard to allergens or nutritional composition. In Canada, if a transgenic plant is determined to be 'substantially equivalent' to its traditional counterpart, and imparts no additional environmental or health risks, it can obtain full unconditional environmental release approval. The first transgenic varieties that received unconditional release approvals had agronomic traits incorporated (herbicide tolerance), and were therefore destined for the general grain handling system. There are no downstream benefits (values) added to the seed, and thus they do not warrant the cost of Identity Preserving (IP) or segregation from substantially equivalent non-GMO seeds. The trigger for regulation of a plant in Europe is the process used to create the variety (modern biotechnology-recombinant DNA technology). Developments in the EU regarding the granting of regulatory approvals for import, food and feed uses for transgenic crops have caused great concern among shippers and exporters of grain in Canada and other trading countries. Once a transgenic variety has entered the general grain-handling system, Canadian shippers and exporters are unable to provide the necessary affidavits required for compliance with EU Resolution 90-220, and are unable to guarantee that shipments of regular varieties do not contain any non-approved genetically modified seed. Shippers and exporters of crops want to ensure that transgenic crops that do not have regulatory approvals in all major markets do not gain entry into the bulk commodities system. The developments in the EU regarding the 'zero tolerance' approach presents a number of serious concerns for the agbiotech industry. It is important that strategies are developed in order to address the concerns of stakeholders, such as shippers and exporters of agbiotech products, to prevent major damage to the agbiotech community. Contact Bill Anderson at 306-975-1939 or e-mail Bill.Anderson@agwest.sk.ca Trends State of the Biotech World Almost 30 million hectares of genetically modified crops were planted worldwide in 1998, just 15 years after the first successful gene transfers ushered in the era of biotechnology. According to an article by Anne Simon Moffat in Science (Volume 282, Number 5397, pp. 2176 - 2178), more than half of the world soybean harvest and about a third of the corn harvest now comes from plants engineered with genes for herbicide or disease resistance. Half of all the canola grown in Canada is bio-engineered. Biotech foods are already ubiquitous: products from these commodities find their way into hundreds of foods, such as breakfast cereals, cooking oils, corn syrup, soft drinks, and candies. Table 1 indicates the global spread of biotech crops. Table 2 indicates the current status of the approval of biotech crops in Canada. Table 3 shows the estimated percentage of Canadian crops that are genetically engineered. Table 1: Area of Transgenic Crops Planted Worldwide Country millions of hectares planted 1997 1998 U.S.A. 8.1 20.5 Argentina 1.4 4.3 Canada 1.3 2.8 Australia 0.1 0.1 Mexico <0.1 0.1 Spain 0.0 <0.1 France 0.0 <0.1 South Africa0.0 <0.1 Total 11.0 27.8 Table 2. Status of Plants with Novel Trait That Have Been Approved for Use in Canada (These plants have been for one or more of the following: Novel Food Use, Novel Feed Use, Environmental Release and Variety Registration. Not all of these varieties are grown in Canada at this time.) Crop Number of Novel types approved traits approved Canola 13 Pollination systems control mechanism Glufosinate tolerant Glyphosate tolerant Glufosinate ammonium tolerant Imidazolinone tolerant Higher quantities of laurate and myristate High oleic/low linolenic acid Bromoxynil tolerant Tomato 3 Delayed ripening Potato 2 Colorado Potato Beetle resistant Corn 14 Imidazolinone tolerant European Corn Borer resistant Glufosinate tolerant Combined Corn Borer/glyphosate tolerant Sethoxydim tolerant Glufosinate ammonium tolerant Combined Corn Borer/glufosinate tolerant New hybrid system Glyphosate resistant Soybeans 1 Glyphosate tolerant Flax 1 Sulfonylurea tolerant Cotton Seed 3 Lepidopteran resistant Bromoxynil tolerant Glyphosate tolerant Wheat 1 Imidazolinone tolerant Squash 2 Virus resistant Source: Plant Biotechnology Office, Canadian Food Inspection Agency Table 3. Estimated percentage of Canadian crops that are genetically engineered Percentage Crop Genetically Engineered Reason Canola 50 Tolerates herbicides Corn 15 Tolerates herbicides Soybeans 30 Tolerates herbicides Potatoes 20 Resists pests (beetles) Tomatoes 0* Delayed ripening * Approved but not grown in Canada Source: University of Guelph, Department of Plant Agriculture Alliances VIDO and PharmaDerm/Helix Sign Agreement PharmaDerm Laboratories Ltd., a Saskatoon-based biopharmaceutical R&D firm and Helix BioPharma Inc. of Aurora, Ontario have announced an agreement with the University of Saskatchewan - Veterinary Infectious Diseases Organization (VIDO) to jointly share certain vaccine technology for both human and veterinary use. Helix will have exclusive rights to exploit human applications of the technology while VIDO will have exclusive rights to veterinary applications. Revenues will be allocated to Helix and VIDO according to a predetermined formula. VIDO, a leading Canadian veterinary-medical research organization with an international reputation for animal health, is developing vaccines that will induce a strong immunological response to disease-causing microbes. VIDO is noted for developing the first genetically engineered vaccine for animals. Helix is developing new injectionless vaccine delivery systems based on its proprietary lipid microencapsulation process. The technology is expected to increase patient compliance and help reduce the costs of infectious disease. Contact: Dr. Marianna Foldvari of PharmaDerm Laboratories Ltd. at 306-934-7471. Investment in Bioriginal BDC is investing $2.5 million in Bioriginal. Other investors include Manvest Inc. and Crown Life Insurance Company. Bioriginal focuses on the discovery, development and commercialization of naturally based supplements and herbs for the international markets of human health and nutrition, cosmetics and pharmaceuticals and pet food markets. Bioriginal is poised to capture significant market share as a supplier in this industry, which is currently valued at $10 billion. Rick Kulow, President of Bioriginal stated that, 'We are pleased to have BDC lead this syndication. The $9 million infusion of capital will be used for a facility expansion, including the development of an in-house laboratory, and for working capital to support our increasing sales.' Contact: Rick Kulow at 306-975-9256. CMDF to receive provincial tax credits in Saskatchewan Saskatchewan's Ministry of Economic and Co-operative Development has approved the Canadian Medical Discoveries Fund's (CMDF) application to receive provincial tax credits on the sale of units of the labour-sponsored venture capital fund in Saskatchewan. CMDF is prepared to invest Saskatchewan-based funds back into the province within 24 months after the end of the fiscal year in which the capital was raised. 'We are delighted that the Province of Saskatchewan has approved CMDF's application and look forward to working in partnership with the government to invest in the future of Saskatchewan and to create new leading edge biotechnology and life science companies in this great province,' said Dr. Calvin Stiller, Chairman and CEO and Founder of CMDF, who is a native of Saskatchewan. CMDF is not new to the Saskatchewan biotechnology scene, having made its initial investment in 1997 in Saskatoon-based Biostar Inc. The company develops of protein-based immunizing agents for humans and animals. Biostar's lead product is for prostate cancer therapy. Follow-on investments to date in Biostar are now in excess of $ 3.5 million. CMDF has assets in excess of $250 million and an investment portfolio of more than 40 companies. CMDF has targeted investments in early-stage companies because they offer the greatest opportunity to develop and commercialize outstanding Canadian science and provide the greatest profit potential for the shareholders. Resources The Biotechnology Directory 1999 The Biotechnology Directory 1999, edited by J. Coombs and Y.R. Alston, is published in association with Nature Biotechnology. It provides current and accurate information on more than 9000 biotechnology companies, universities and research institutes, Also included is a buyers guide to suppliers of related products, services and equipment. Contact: Grove's Dictionaries Inc, 345 Park Avenue South, 10th Floor, New York, NY 10010. Call 800-221-2123; fax 212-689-9106; e-mail grove@grovereference.com; website www.grovereference.com Users' Guide for Biotech SMEs The Users' Guide for SMEs in the Biotechnology Field identifies and explains the various European and national programs which can be of significant assistance to SMEs in the biotechnology field. It also identifies and explains sources of funding and provides a comprehensive and detailed listing of competent authorities, useful contacts, trade associations, etc. Contact: http://europa.eu.int/comm/dg03/publicat/bio/index0.htm SABIC Column Who Decides? By Lisa Jategaonkar, M.Sc. Manager, Saskatchewan Agricultural Biotechnology Information Centre (SABIC) The Western Canadian Wheat Growers recently organized a 'President's Roundtable' on 'Biotechnology Ethics or Economics: Who decides for the farmer?' as part of its 29th annual convention held in Saskatoon on January 6-8, 1999. Panelists included Jenny Hillard, vice president of the Consumers' Association of Canada (CAC); Jim Fischer, dairy producer and chairman of AgCare from Walkerton, ON; Lee Pengilly, farm manager of Circle J Resources in Sterling, Alberta; and Peter McCann, president of Ag-West Biotech Inc. Peter McCann described the potential benefits of biotech both for the farmer and the consumer. These include disease and pest-resistant crops and frost-tolerant crops. He described new food crops with altered oil profiles and reduced anti-nutritional components. He also described new applications in the area of genomics and edible vaccines. McCann pointed out that the industry is aware of several issues surrounding biotechnology, including outcrossing, ethical concerns, such as the use of animals for xenotransplantation, labeling and the potential for domination by multinational companies. Jenny Hillard opened by saying that biotechnology has been an issue with the CAC since 1988. Her association is very different from European consumer groups in that her organization's central issue was not the health and safety of biotechnology products, but the labeling of biotech foods. She said that very little information was available to make decisions on biotechnology. She felt that the Internet had a lot of misinformation on both sides, and that much of the scientific material available on biotechnology had created a mystique rather than practical information. Other issues of interest to the CAC include rBST, the terminator gene, and the long-term economic and health effects of biotechnology. She pointed out that many people do not accept the idea of animal genes in plants. She questioned whether we need biotechnology at all, given that we have abundant supplies of food available at a low price. She concluded by saying that ethics and economics are intertwined; if a consumer chooses not to buy for ethical reasons, then that affects the farmers' economics. Lee Pengilly said that government and industry are in bed together. She said that consumers have to be vigilant Ñ that we are part of an experiment in which the ecological effects are unknown. She indicated that some people have described biotechnology as the work of Satan. As an organic farmer, she is concerned that outcrossing will lead to a loss of her organic certification and the development of pest resistance. She also questioned who would be liable in these cases. Jim Fischer says he looks at his farm as a business, and in the management of this farm he is always looking at ways to increase yield and to obtain better crops. He said that knowledge of the gene is not good or evil, but how we use this knowledge will decide whether it has harmful or beneficial effects. He continued that biotechnology is not a magic bullet to solve the world's hunger problems. Fisher said that he often hears that biotechnology is not natural and pointed out that changes in crops are occurring all of the time; we need to evaluate these changes and move on to the next step. He feels that biotechnology will be applicable to some farmers but not to others and wants the option of evaluating the benefits and advantages of new crops himself. The four very different viewpoints presented to the Western Canadian Wheat Growers Convention seemed to reflect both the optimism and concerns of their membership. The audience of more than 200 farmers at the convention acknowledged that biotech crops have economic benefits, but also expressed concerns about their application. While farmers were optimistic about the benefits that biotechnology can bring, they want to be able to evaluate the relative advantages and disadvantages themselves. They also are aware that economics and ethics are highly intertwined. As Ms. Hillard pointed out, if consumers in foreign markets choose not to use biotechnology for ethical reasons, the farmer's bottom line is affected. Readers are welcome to discuss these issues at the Saskatchewan Agricultural Biotechnology Information Centre. Call 306-668-2660 to book your visit. People Watch Royal Bank Growth Corporation (RBCG) Dr. Murray McLaughlin has been appointed CEO of a new affiliate company of the Royal Bank Growth Corporation (RBCG). McLaughlin is a former President of Ag-West Biotech. The company will specialize in the commercialization of Canada's early-stage advanced agricultural technologies. Canadian Food Inspection Agency Dr. Morven McLean has been appointed Chief, Plant Biotechnology at the Canadian Food Inspection Agency (CFIA). Dr. McLean replaces Simon Barber who left the CFIA a year ago to work with the OECD. Dr. McLean was formerly with the Research Branch of Agriculture and Agri-Food Canada, as well as a private biotechnology company. Helix BioPharma Dr. Lorne Babiuk has been appointed to the Medical Advisory Board of Helix BioPharma Corp. Dr. Babiuk is a recognized authority in veterinary immunology and vaccines, having been the first to genetically engineer a vaccine for any animal species. Dr. Babiuk is a professor in the Department of Veterinary Microbiology at the University of Saskatchewan and the Director of the Veterinary Infectious Diseases Organization. We Welcome Your Input The AgBiotech Bulletin welcomes submissions of news, ideas and articles from subscribers. Information about new developments at your company or institution, notices about new products or resources, or observations about events and opportunities affecting the agbiotech industry will be considered for publication. Please put us on your mailing list for press releases and/or contact us directly regarding story ideas or submissions. Contact: The Signature Group Inc., 489 2nd Avenue North, Saskatoon, Saskatchewan Canada S7K 2C1; phone 306-934-1772; fax 306-664-6615; e-mail: siggroup@sk.sympatico.ca Visit Ag-West Biotech's Web Site! Ag-West's presence on the World Wide Web includes dozens of valuable features for the agbiotech community in Canada and around the world, including: - Downloadable, full-format versions of The AgBiotech Bulletin and The AgBiotech Infosource. - Dozens of informative articles provide current information on regulatory issues, intellectual property, economic development and the full range of issues covered in this newsletter. - Dozens of Connections will link you with economic development and funding agencies, biotech businesses in Saskatchewan and sources of biotech information around the world. Visit the Ag-West Web site at http://www.agwest.sk.ca Trade Links With The Ag-West Web Site! Interested in trading links with the Ag-West web site? Please contact Bill Anderson at Ag-West by e-mail at bill.anderson@agwest.sk.ca The AgBiotech Bulletin On-line is also available from the Ag-West Website at http://www.agwest.sk.ca