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AGBIOS is a Canadian company dedicated to providing public policy, regulatory, and risk assessment expertise for products of biotechnology. AGBIOS has worked with federal departments and agencies on issues of policy and regulation pertaining to genetically modified and other novel foods, crops, and forest tree species. The Company also provides experience and expertise to commercial enterprises seeking regulatory approval of biotechnology products, and to other public and private sector groups seeking clarification of issues associated with the development and utilization of biotechnology processes and products.Our website offers access to a database of safety information on all genetically modified plant products that have received regulatory approval, information on the implementation of biosafety systems, including case studies for food and environmental safety assessments, and a searchable library of biosafety-related citations in key topic areas.

Executive Summary: Global Review of Commercialized Transgenic Crops: 2002, Feature: Bt Maize Clive James ISAAA Brief No. 29 Download[PDF Size: 347266 bytes]Highlights from the 2002 review of transgenic crops commercialization.Agronomics and Sustainability of Transgenic Cotton in Argentina Qaim, M.; Cap, E.J.; deJanvry, A.; AgBioForum 6(1&2): 41-47. Download[PDF Size: 213838 bytes]Transgenic Bt cotton can halve pesticide application rates in Argentina while significantly increasing yields. Yield effects are bigger than in other countries, due to the current low levels of insecticide use. Although smallholder farmers are not currently using the technology, gross benefits are predicted to be highest for them. Biological model simulations show that rapid resistance buildup in pest populations appears to be unlikely if minimum non-Bt refuge areas are maintained.PREVIEW: Global Status of Commercialized Transgenic Crops: 2003, Executive Summary. C. James ISAAA Brief No. 30, 2003. Download[PDF Size: 315133 bytes]In 2003, the global area of transgenic crops continued to grow for the seventh consecutive year at a sustained double-digit growth rate of 15% compared with 12% in 2002. The estimated global area of GM crops for 2003 was 67.7 million hectares; this includes a provisional conservative estimate of 3 million hectares of GM soybean in Brazil (the final hectarage could be significantly higher), officially approved for planting for the first time in 2003. It is noteworthy that a double-digit rate of 10% growth in GM crops was sustained in 2003, even excluding the Brazilian hectarage. The 67.7 million hectares of GM crops in 2003, equivalent to 167 million acres was grown by 7 million farmers in 18 countries, an increase from 6 million farmers in 16 countries in 2002. The increase in area between 2002 and 2003 of 15% is equivalent to 9 million hectares or 22 million acres.Impacts on U.S. agriculture of biotechnology-derived crops planted in 2003: An update of 11 case studies Sankula, S. & Blumenthal, E. National Center for Food and Agricultural Policy Download[PDF Size: 463274 bytes]In a follow-up to an earlier study, the National Center found that the six biotechnology-derived crops planted in 2003 (canola, corn, cotton, papaya, squash and soybeans) produced an additional 5.3 billion pounds of food and fiber and increased farm income $1.9 billion. The biotechnology-derived crops also reduced the use of pesticides by 46.4 million pounds.The economic status and performance of plant biotechnology in 2003 Runge, C.F. & Ryan, B. University of Minnesota Download[PDF Size: 1922410 bytes]The study provides a detailed view of biotechnology's value at the farm level and beyond the farm gate, where the crops — and the research and development that creates them — generate additional jobs, income and investment in the agrifood chain and public and private research community.Agriculture in the developing world: Connecting innovations in plant research to downstream applications Deborah P. Delmer PNAS 102(44): 15739-15746 Download[PDF Size: 313505 bytes]Enhancing agricultural productivity in those areas of the world bypassed by the Green Revolution will require new approaches that provide incentives and funding mechanisms that promote the translation of new innovations in plant science into concrete benefits for poor farmers. This article is an attempt to analyze both the constraints and the opportunities presented by the challenge to translate new discoveries in plant sciences into successes in agriculture for the benefit of the poor of the world.BiosafetyThe Biosafety Protocol: The Real Losers are Developing Countries Frances B. Smith Briefly, vol 4(3), National Legal Center for the Public Interest Download[PDF Size: 107466 bytes]An analysis of the Biosafety Protocol by Francis B. Smith, Executive Director of Consumer Alert and of a new organization, International Consumers for Civil Society. Ms. Smith follows the biotech issue closely, and was in Montreal throughout the negotiations.A conceptual framework for implementing biosafety: linking policy, capacity, and regulation. McLean, M.A., Frederick, R.J., Traynor, P.L., Cohen, J.I. & Komen, J. ISNAR Briefing Paper No. 47 Download[PDF Size: 305169 bytes]The conceptual framework clarifies critical decision points in the development of a national biosafety system, systematically examines choices among policy options, and delineates some of the scientific and social dimensions of these options.Environmental ImpactPreliminary report on the ecological impact of Bt corn pollen on the Monarch butterfly in Ontario M.K. Sears, D.E. Stanley-Horn & H.R. Mattila Prepared for the Canadian Food Inspection Agency and Environment Canada Download[PDF Size: 130617 bytes]The majority of the pollen fell within a few meters of the corn field (approximately 90% falls within 5 meters). On average, pollen counts on leaves were lower than those known to be toxic to neonates less than one week following peak pollen shed (though the range of values included densities that approached the LD50 determined in our experiments). Further, only 5 meters from the field, pollen counts on milkweed leaves were close to zero.Field deposition of Bt transgenic corn pollen: lethal effects on the monarch butterfly L.C. Hansen, J.J. Obrycki Oecologia Download[PDF Size: 153794 bytes]Further studies on the supposed effects of Bt corn pollen on the Monarch butterfly, based largely on laboratory observations.Absence of toxicity of Bacillus thuringiensis pollen to black swallowtails under field conditions C. L. Wraight, A. R. Zangerl, M. J. Carroll, and M. R. Berenbaum Proceedings of the National Academy of Sciences Download[PDF Size: 95323 bytes]A field study was performed to assess whether mortality of early instar black swallowtails was associated either with proximity to a field of Bt corn or by levels of Bt pollen deposition on host plants. It was concluded that Bt pollen of the variety tested was unlikely to affect wild populations of black swallowtails, thus suggesting that at least some potential nontarget effects of the use of transgenic plants may be manageable.The release of genetically modified crops into the environment. Part II. Overview of ecological risk assessment. Anthony J. Conner, Travis R. Glare, Jan-Peter Nap The Plant Journal Download[PDF Size: 269312 bytes]Despite numerous future promises, there is a multitude of concerns about the impact of GM crops on the environment. Key issues in the environmental assessment of GM crops are putative invasiveness, vertical or horizontal gene flow, other ecological impacts, effects on biodiversity and the impact of presence of GM material in other products. These are all highly interdisciplinary and complex issues. A crucial component for a proper assessment is defining the appropriate baseline for comparison and decision.Resistance to Bt toxin is surprisingly absent from pests. J.L. Fox Nature Biotechnology, 21 (9), 958-959. Download[PDF Size: 373688 bytes]Defying the expectations of scientists monitoring transgenic crops such as corn and cotton that produce insecticidal proteins derived from Bacillus thuringiensis (Bt), target insect pests have developed little or no resistance to Bt crops thus far, according to USDA-funded scientists.EthicsThe Tragedy of the Commoners: Biotechnology and its Publics Ambuj Sagar, Arthur Daemmrich and Mona Ashiya Nature Biotechnology Vol 18, January 2000 Download[PDF Size: 203324 bytes]The sustainable development of biotechnology will require a renewed focus on stakeholders and their needs. This, in turn, demands a clearer understanding of public concerns as well as attention to issues of institutional structure and representation in decision-making processes. [PDF Format 198 KB]Ethical Aspects of Agricultural Biotechnology Cambridge Biomedical Consultants EFB Task Group on Public Perceptions of Biotechnology, European Commission Download[PDF Size: 336142 bytes]The report is the work of leading scientists, ethicists and experts in the patenting and regulatory fields concerned with applications of biotechnology in the agricultural and food areas from throughout Europe. The intention in the report has been to produce a clear, concise and balanced distillation of these studies in non-technical language for ease of understanding and use.The use of genetically modified crops in developing countries Nuffield Council on Bioethics Download[PDF Size: 672891 bytes]The Council's Report, Genetically modified crops: ethical and social issues, provoked considerable discussion in 1999. Now, four years on, the Council has decided to produce a follow-up Discussion Paper, focusing specifically on the role of GM crops in developing countries.Food Security2020 Global Food Outlook: Trends, Alternatives, and Choices International Food Policy Research Institute Download[PDF Size: 88592 bytes]This report shows just how, and how much, certain policy decisions and social changes will affect the world’s future food security. It projects the likely food situation in 2020 if the world continues on more or less its present course, and it then shows how alternative choices could produce a different future.Forseeable ScienceHarvest on the Horizon: Future Uses of Agricultural Biotechnology The Pew Initiative on Food and Biotechnology Download[PDF Size: 729251 bytes]This report, the first published by the Pew Initiative on Food and Biotechnology, provides an illustrative overview of what could be the “next generation” of genetically engineered agricultural products. This report is intended to underscore the broad scope of current agricultural biotechnology research and to illustrate some of its potential uses, many of which are dramatically different than those commercially available today.Gene FlowGene flow in the environment – genetic pollution? G.R. Squire, N. Augustin, J. Bown, J.W. Crawford, G. Dunlop, J. Graham, J.R. Hillman, B. Marshall, D. Marshall, G. Ramsay, D.J. Robinson, J. Russell, C. Thompson & G. Wright Annual Report of the Scottish Crop Research Institute, 1998/99 Download[PDF Size: 357552 bytes]Biological invasions have had profound effects on human society from the earliest times. The spread of the black death in the Middle Ages, the devastations of potato blight, the effects on indigenous species by grey squirrels, dutch elm disease and flat worms have all been seen as detrimental to man or the environment. Others are seen as bringing benefits: most of our crops evolved elsewhere in the world and many culinary and medicinal herbs were brought to Britain by the Romans. Perhaps the greatest invasion is the import of vast numbers of exotic plants to gardens and greenhouses. Ecological invasions are an intrinsic part of ecology and evolution and we only consider them bad if they impoverish our health, livelihood or living conditions. [PDF Format 349K]Gene stacking in herbicide tolerant oilseed rape: lessons from the North American experience. J. Orson English Nature Reports No. 443 Download[PDF Size: 114120 bytes]It is concluded that herbicide tolerant gene-stacked volunteers of oilseed rape would be inevitable in practical agriculture in the UK. It is recommended that more emphasis would have to be placed upon post-harvest cultivations in order to minimise volunteer populations in subsequent crops. However, it is considered that there would be little impact on other agricultural practices if only genetically modified (GM) varieties tolerant to glyphosate (Roundup Ready) or glufosinate (Liberty Link) were introduced into the UK.Absence of detectable transgenes in local landraces of maize in Oaxaca, Mexico (2003–2004) S. Ortiz-Garcia, E. Ezcurra, B. Schoel, F. Acevedo, J. Soberon and A. A. Snow PNAS Early Edition, August 2005. Download[PDF Size: 387305 bytes]A systematic survey was conducted of maize seeds from 870 plants in 125 fields and 18 localities in the state of Oaxaca during 2003 and 2004 for the presence of transgene sequences. More than 153000 seeds were tested by PCR for the presence of two transgene elements from the 35S promoter of the cauliflower mosaic virus and the nopaline synthase gene (nopaline synthase terminator) from Agrobacterium tumefaciens. There was no evidence of either the 35S CaMV or NOS transgene sequences in this survey, which indicates that the frequency of transgenic seeds from maize grown in the sampled region was near zero in 2003 and 2004.Public PerceptionBiotechnology and the European public George Gaskell et al. Nature Biotechnology 18: 935-938. Download[PDF Size: 137118 bytes]The latest European sample survey of public perceptions of biotechnology reveals widespread opposition to genetically modified (GM) food in much of Europe, but public attitudes to medical and environmental applications remain positive.Cloning and its discontents — a Canadian perspective Edna F. Einsiedel Nature Biotechnology 18: 943-944. Download[PDF Size: 131266 bytes]Public attitudes to Dolly the sheep may mirror the perception of biotechnology as a whole.Changing attitudes to biotechnology in Japan Darryl Macer and Mary Ann Chen Ng Nature Biotechnology 18: 945-947. Download[PDF Size: 123248 bytes]Support for biotechnology in Japan is declining, although it remains higher than the US or Europe.US public opinion divided over biotechnology? Susanna Hornig Priest Nature Biotechnology 18: 939-942. Download[PDF Size: 549880 bytes]Although a majority of US citizens remain supportive, opposition to biotechnology is on the rise.RegulationThe EU-U.S. Biotechnology Consultative Forum Final Report Download[PDF Size: 125874 bytes]A panel of experts, 10 each from the US and EU, were charged to consider the full range of issues of concern in crop biotechnology and provide their views and assessments of potential risks and benefits.Economic Impact Study: Potential Costs of Mandatory Labelling of Food Products Derived from Biotechnology in Canada KPMG Consulting Download[PDF Size: 449847 bytes]This report presents the findings from an exploratory investigation of the potential economic impacts if Canada were to introduce mandatory labelling of food products containing ingredients from biotechnology and non-biotechnology. The findings presented are based on a program of interviews with a limited number of Canadian industry participants at each level in the supply chain for grain and oilseed products plus a review of relevant secondary research.International Comparison of Regulatory Frameworks for Food Products of Biotechnology Donald J. MacKenzie Prepared for the Canadian Biotechnology Advisory Committee (CBAC), December 2000. Download[PDF Size: 394755 bytes]This document provides a comparison of the regulatory frameworks in Argentina, Australia, Japan, the United Kingdom and the United States. The objective is to situate Canada internationally with respect to the regulation of agricultural biotechnology products and highlight best practices in a manner that will help CBAC identify issues related to the governance and organization of Canada’s regulatory system.Food Safety, Labelling, and the Role of Science: Regulating Genetically-Engineered Food Crops in Canada and the United States E. Moore ECPR Joint Sessions Workshop on the Politics of Food, April 14-19, 2000, Copenhagen. Download[PDF Size: 113801 bytes]The paper examines the nature of the policy networks in both countries surrounding the issue of food safety risks in an effort to determine why there are differing policy responses, given the implications for policy capacity.Questions and Answers on the Regulation of GMOs in the EU European Commission Download[PDF Size: 58711 bytes]Information on how GMOs are currently regulated within the EU and the impact of Directive 2001/18, which is scheduled to come into force on 17 October 2002.Improving the regulation of genetically modified foods and other novel foods in Canada. Canadian Biotechnology Advisory Committee Interim report to the government of Canada biotechnology ministerial coordinating committee. Download[PDF Size: 218578 bytes]Applying the Precautionary Principle to Genetically Modified Crops Indur M. Goklany Center for the Study of American Business, Policy Study No. 157, August 2000. Download[PDF Size: 223763 bytes]A framework for applying the precautionary principle is developed and then, based on a brief survey of the public health and environmental costs and benefits of GM crops, the framework is applied to the broad range of consequences of a ban on GM crops.Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada Royal Society of Canada: Expert Panel on the Future of Food Biotechnology Download[PDF Size: 794289 bytes]In November, 2000 Health Canada’s Health Products and Foods Branch approached the Royal Society of Canada with a request to commission an Expert Panel to provide advice to ensure the safety of new food products being developed through biotechnology. The Society agreed to do so, and this report represents a consensus of the panel.The release of genetically modified crops into the environment. Part I. Overview of current status and regulations. Jan-Peter Nap, Peter L. J. Metz, Marga Escaler, Anthony J. Conner The Plant Journal Download[PDF Size: 184320 bytes]Regulatory approaches in Europe and North America are essentially different. In the EU, it is based on the process of making GM crops; in the US, on the characteristics of the GM product. Many other countries are in the process of establishing regulation based on either system or a mixture. Despite these differences, the information required for risk assessment tends to be similar. Each risk assessment considers the possibility, probability and consequence of harm on a case-by-case basis.Model Act: Proposed provisions for a transparent, effective and workable biosafety regulatory framework. Stanley H. Abramson (Arent Fox Kintner Plotkin & Kahn, PLLC), Laura M. Reifschneider (International Environmental Resources) Download[PDF Size: 185018 bytes]The Model Act is designed to assist developing countries that may need to introduce new administrative and legal frameworks for environmental safety with respect to the import, export and use of living modified organisms within their territories. It is based on provisions found in existing and well-functioning biosafety regulatory schemes around the world that have been amended and shaped in accordance with actual experience in the field.Exporting Precaution: How Europe’s Risk-Free Regulatory Agenda Threatens American Free Enterprise Lawrence A. Kogan Washington Legal Foundation Download[PDF Size: 821489 bytes]The Monograph first defines the precautionary principle and then explains how international bureaucrats and influential activist groups are using it as a vehicle to diminish America’s competitive position in the world economy and advance special interest agendas hostile to free enterprise and technology. Activists have made their deepest inroads in areas such as genetically enhanced foods and climate change, and Mr. Kogan provides an extensive analysis to those efforts, including a discussion of state and regional programs. The Monograph concludes with an insightful philosophical discussion of the precautionary principle’s broader international legal, political, and economic impact.SafetySafety issues associated with the DNA in animal feed derived from genetically modified crops. D.E. Beever & C.F. Kemp Nutrition Abstracts and Reviews Series B: Livestock Feeds and Feeding Download[PDF Size: 109089 bytes]There is a growing body of scientifically valid information available that indicates no significant risk associated with the consumption of DNA or the resulting proteins from the GM crops that are registered in any of these countries. Based on the safety analyses required for each crop, consumption of milk, meat and eggs produced from ani-mals fed GM crops should be considered to be as safe as traditional practicesSeeds of Opportunity: An assessment of the benefits, safety, and oversight of plant genomics and agricultural biotechnology N. Smith Committee on Science Subcommittee on Basic Research Download[PDF Size: 211553 bytes]The report, Seeds of Opportunity, concludes that there is no significant difference between plant varieties created using agricultural biotechnology and similar plants created using traditional crossbreeding. It recommends that regulations at U.S. Department of Agriculture and proposed regulations at the Environmental Protection Agency targeting biotechnology products be changed to focus on the characteristics of a plant, not the process used to develop it.Transgenic Plants and World Agriculture Royal Societies Report Joint Report of Science Academies from Brazil, China, India, Mexico, United States, the Third World Academy of Sciences and the UK Royal Society Download[PDF Size: 52723 bytes]Leading scientists have urged private corporations and research institutions to share their know-how on GM technology in order to help alleviate the problem of growing world hunger.Bacillus thuriengensis plant-pesticides. US Environmental Protection Agency (September 2000). United States EPA EPA Release Download[PDF Size: 694658 bytes]This document contains the executive summary, scientific assessment of human health and environmental risks, and insect resistiance management. [678K]Assessment of Scientific Information Concerning StarLink™ Corn FIFRA Scientific Advisory Panel SAP Report No. 2000-06 Download[PDF Size: 82550 bytes]Report of the FIFRA Scientific Advisory Panel Meeting, November 28, 2000, held at the Holiday Inn Rosslyn Hotel. A Set of Scientific Issues Being Considered by the US Environmental Protection Agency Regarding the Scientific Safety Assessment of StarLink Corn.Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn Centers for Disease Control and Prevention Download[PDF Size: 399686 bytes]Summary of CDC's epidemiological investigation into cases of suspected allergenic reaction to Cry9C protein possibly present in foods containing event CBH351 (StarLink) maize. The findings did not provide any evidence that the reactions that the affected people experienced were associated with hypersensitivity to the Cry9c protein.Safety of Genetically Engineered Crops Rene Custers, Editor Flanders Interuniversity Institute for Biotechnology Download[PDF Size: 1649358 bytes]For each of the issues surrounding the safety assessment of genetically modified foods (e.g., toxicity, vertical gene flow, non-target effects, allergenicity and horizontal gene transfer), the report contains a review written by a notable scientific expert.Genetically modified plants for food use and human health — an update. The Royal Society, London Policy Document 4/02 Download[PDF Size: 565457 bytes]In 1998 the Royal Society issued the report Genetically modified plants for food use. The Society periodically issues updates on reports (recent examples include updates on bovine spongiform encephalopathies and stem cells) and the following update, which is based on research published in the last three years, specifically addresses human health aspects of genetically modified foods and the principle of substantial equivalence.Nutritional and Safety Assessments of Foods and Feeds Nutritionally Improved through Biotechnology ILSI Food Biotechnology Committee Task Force Comprehensive Reviews in Food Science and Food Safety Download[PDF Size: 737681 bytes]This document provides the scientific underpinnings and recommendations for assessing the safety and nutritional effects of crops with improved nutritional qualities. It includes terms and definitions for describing such products, identifies the key safety and nutritional challenges, and introduces potential approaches and methods to address those challenges.Modern Food Biotechnology, human health and development: an evidence based study Food Safety Department World Health Organization Download[PDF Size: 830377 bytes]The study reviews evidence in several broad areas related to genetically modified foods, including currently available products, the assessment of risks and benefits, the broader impact on societies and the existing regulatory capacity in countries.Genetically modified crops in the EU: food safety assessment, regulation, and public concerns Ariane König, Gijs Kleter, Walter Hammes, Ib Knudsen and Harry Kuiper (Editors) RIKILT — Institute of Food Safety Download[PDF Size: 1101219 bytes]Overarching report Entransfood, the European network on safety assessment of genetically modified food crops. ENTRANSFOOD provided a platform for participants from a wide range of different perspectives and disciplines to interact and to explore the interdependence of scientific, regulatory, and societal aspects of introducing GM food crops. Project participants and sponsors consider ENTRANSFOOD a trial model to inform future deliberations on how to structure multidisciplinary research projects on questions relating to risk.Socio-EconomicsThe Global GM Market: Implications for the European Food Chain Brookes, G., Craddock, N., Kniel, B. Commissioned by Agricultural Biotechnology Europe Download[PDF Size: 694215 bytes]This report examines the feasibility and cost implications of delivering and maintaining ‘GM avoidance’ policies in the EU food and feed supply chains. In the next 1-3 years, supply availability of non-GM material in the key soybean and derivative sector is likely to decline and the price differential between GM and non-GM material widen. This will make the continued absorption of additional non-GM related costs very difficult for any user sector with high levels of (non-GM) soybean/derivative usage because of the adverse impact on profitability.