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Workshop on Adventitious Presence
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| 1. | Introduction | |
| 2. | Participating organizations | |
| 3. | Background discussion paper | |
| 4. | Opening remarks | |
| 4.1 | Blair Coomber, Director General, International Trade Policy Division, AAFC | |
| 4.2 | Glyn Chancey, Director, Plant Products Division, CFIA | |
| 5. | Presentations | |
| 6. | Participants’ input | |
| 6.1 | Issues, challenges and opportunities | |
| 6.2 | Strategies and approaches | |
| 6.2.1 Strategies and approaches for the grains, oilseeds and special crops sectors 6.2.2 Strategies and approaches for the seed sector 6.2.3 Strategies and approaches for all sectors |
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| 7. | Conclusion | |
Adventitious presence, or AP, is defined here as "the unintended, technically unavoidable presence of genetically engineered material in an agri-food commodity." It is a complex issue with cross-cutting implications for regulations, marketing approaches, international trade and all members of the crop value chain.
The Government of Canada has initiated a dialogue with Canadian agri-food sector stakeholders on the implications of AP, i.e. the unintended technically unavoidable presence of genetically engineered material in agri-food commodities.
To this effect, a discussion paper "Industry and Government Perspectives on Adventitious Presence of Products of Genetic Engineering in Seeds, Grains, Oilseeds and Special Crops" was commissioned in early Spring 2004. The paper was tabled for discussion with a limited number of agri-food sector stakeholders in Winnipeg in June 2004, and was subsequently posted on Agriculture and Agri-Food Canada website. The paper provided an overview of AP in Canada and concerns expressed by stakeholders such as export market disruption due to AP in grain, and the implications of AP for seed production.
To continue the dialogue, Agriculture and Agri-Food Canada (AAFC) and the Canadian Food Inspection Agency (CFIA) invited stakeholders from throughout commodity value chains to a "Workshop on Adventitious Presence with emphasis on events approved in both Canada and its export markets".
The objectives of the workshop, organized jointly by the Canadian Food Inspection Agency and Agriculture and Agri-Food Canada, were threefold:
The workshop was designed to provide a forum for stakeholders to share an overview of AP, current and expected future impacts of AP, and potential mitigation of impacts of AP on seed, grain and oilseed production and trade. It is a step toward development of a strategy to address AP issues in Canada.
Workshop participants included approximately 65 government and private stakeholders from across Canada and from Mexico, the United States, Switzerland and the United Kingdom. Participating organizations are listed in Section 2. Participants were provided a background discussion paper that set the context for the workshop agenda. Summaries of the participants’ extensive input in identifying AP issues and considering mitigation approaches are included in this report.
AAFC and CFIA recognize that AP of GE material that has not been granted health and safety regulatory approvals in Canada and/or its export markets is also of concern to stakeholders. AP of unapproved material directly involves health and safety regulators, both domestically and internationally, as well as other government departments and private stakeholders, and must be closely linked with import policies. Issues of unapproved AP can only be addressed appropriately in a wider forum that includes Canadian and international bodies responsible for food, feed and environmental safety of GE material, and other stakeholders involved in import of agricultural commodities, and were therefore not the main focus of this workshop.
AAFC and CFIA will carefully consider the recommendations of workshop participants with respect to AP of approved GE material, and will continue to work with other government departments and domestic and international stakeholders to address AP of unapproved material.
Agriculture and Agri-Food Canada (AAFC):
Alberta Agriculture
American Seed Trade Association
Association of Official Seed Certifying Agencies
BIOTECanada
Canada Grains Council
Canadian Federation of Agriculture
Canadian Food Inspection Agency (CFIA):
Canadian Seed Trade Association
Canadian Seed Growers' Association
Canadian Special Crops Association
Canadian Grain Commission
Canadian Organic Growers
Canola Council of Canada
Comisión Intersecretarial de Bioseguridad y Organismos Genéticamente
Modificados (CIBIOGEM Mexico)
CropLife Canada
Environment Canada
Foreign Affairs Canada
Health Canada
Inland Terminal Association of Canada
International Seed Federation
International Trade Canada
Ministère de l'agriculture, des pêcheries et de l'alimentation du
Québec
National Farmers Union
National Millers Association
Ontario Corn Producers Association
Ontario Soybean Growers
Ontario Ministry of Agriculture and Food
Organic Agriculture Centre of Canada
Pulse Canada
Saskatchewan Mustard Growers Association
Saskatchewan Organic Directorate
UK Department for Environment Food and Rural Affairs
UNDP-GEF National Coordinator of Biosafety Project, Mexico
University of Manitoba
University of Saskatchewan
USDA-Agricultural Marketing Service
USDA-Biotechnology Regulatory Service
USDA-Foreign Agriculture Service
Mr. Coomber welcomed participants on behalf of Agriculture and Agri-Food Canada (AAFC) and noted that the topic of Adventitious Presence (AP) is of great importance to industry, regulators, policy makers, marketers and consumers. Participants at the workshop represent a broad range of Canadian stakeholders, as well as representatives of Mexico, the United States, Switzerland and the United Kingdom. He noted that the purpose of the workshop was to increase understanding and awareness of AP among stakeholders to help ensure that future direction on issues related to AP is based on a common approach and a common vision.
He provided an overview of AP and some of the issues from Agriculture and Agri-Food Canada’s perspective.
AP is part of crop production and grain handling, and has been since long before the introduction of genetic engineering (GE) technology. However, the sensitivities around this new "class" of products have brought adventitious presence under the spotlight.
From a broad federal government perspective, innovation is a main driver of sectoral growth and global competitiveness. AAFC is committed to ensure that Canadian crop and animal producers have access to technologies that contribute to the production of a safe, nutritious and affordable food supply. These technologies include GE crops that have, through scientific evaluation, been deemed to be safe and nutritionally equivalent or superior to conventionally bred crops. AP stems from our ability to apply scientific knowledge and technological innovation to the production of food.
From AAFC’s perspective, AP raises a number of specific challenges, domestic and international. The Canadian agricultural sector needs to be positioned to meet increasing market specifications, and as a result access global markets. Furthermore, the treatment of AP in international fora should not lead to discrimination against Canadian products of innovation.
AAFC supports the development of policy, regulation, and good agricultural practices that support both producers who deliberately choose production of GE crops and those who deliberately choose to avoid them.
Industry must play a key and constructive role in developing solutions to the challenges posed by AP, and AAFC is committed to working collaboratively with all stakeholders to address the challenges posed by AP.
The question of AP arises in a number of fora including, from an environmental perspective, in a context of the Biosafety Protocol. The federal government is committed to work toward achieving a predictable multilateral environmental agreement for the safe and responsible transboundary movement of living modified organisms. In this context we are working very closely with all stakeholders to promote the development of predictable and pragmatic rules necessary for the Canadian agriculture and agri-food sector to remain competitive and maintain access to the international markets.
For some stakeholders, AP of unapproved GMOs is of great concern. Mr. Coomber emphasized that while the focus of the workshop would be on AP of approved GE seeds and crops, the issue of unapproved events would also likely be raised, as the approval status can change when Canadian crops are shipped to foreign markets. The work done on approved events will help to establish a framework for progressing on unapproved events.
In closing, Mr. Coomber noted that AP is a complex issue, with several cross-cutting implications on regulations, marketing approaches, international trade and technical trade rule setting. By creating a better understanding of these issues and implications across stakeholder groups, it will be possible to collectively set a clearer path forward that encompasses both industry and government perspectives.
Mr. Chancey welcomed participants on behalf of the Canadian Food Inspection Agency (CFIA), and noted that there is a rich and diverse group of people representing a wide range of stakeholder interests both from within and outside of government.
The subject of the workshop – genetically engineered events that have been approved in both Canada and its export markets – is indicative of the specific complexities of AP and the importance of clearly defining the issues to be addressed. Sensitivities regarding GE technology have created a business and public policy environment that, rightly or wrongly, recognizes differences in seed or grain quality and safety based on whether or not it is produced through genetic engineering.
The issue of the adventitious presence of genetically engineered products is extremely complex, with both product marketing and quality concerns and health and safety issues inextricably mixed in the public debate and in the reality of doing business. From a regulatory perspective, this creates particular challenges, from the definitional and policy perspective to the practical aspects of ensuring public confidence in the science-based regulatory regime.
For this stakeholder workshop, AP is defined as "the unintended, technically unavoidable presence of genetically engineered material in an agri-food commodity." The CFIA is a partner in the workshop because of its role in the regulation of novel varieties, including regulated genetically engineered varieties, for environmental safety and livestock health and safety. CFIA’s assessment framework in this regard is firmly routed in science and is focussed strictly on health and safety issues.
The CFIA is also a partner in this workshop initiative in its role as Canada’s seed regulator. CFIA has a mandate that includes a mixture of health and safety, plant protection, and seed certification. These responsibilities, which include oversight of seed varietal purity and identity, have numerous complexities and challenges and are inextricably linked to AP. Canada’s bulk commodity handling system, the system of regulatory approvals, and enforcement, compliance and certification systems are also inextricably linked and a thorough understanding of these systems is fundamental to developing the options for addressing the challenges associated with AP.
Today, we are ready to move forward in one area of the broad, complex issue of adventitious presence, focusing on the aspects relating to GE material that has been granted regulatory approvals in both Canada and its export markets. In these cases, AP can cause trade disruptions and other challenges where there are quality or marketing requirements for seed or grain related to its GE status. For example, Roundup-tolerant soybeans are approved for planting in many countries. In certain countries, they are approved for food and feed purposes only, in some countries there may be mandatory labelling thresholds, and certain customers or markets may have additional specification requirements.
A standard or specification does not exist in a vacuum. It is firmly rooted in a series of procedures to measure the specific characteristics of concern. In the sampling and sub-sampling of seed or grain, in the handling and preparation of material to be tested, in the methods and procedures for testing, in the reporting and interpretation of results, and in the application of tolerances to second and subsequent test results – all of these need to be understood and accepted by both buyers and sellers. And in the absence of reliable, practical and internationally agreed upon systems and testing methods, absolute guarantees are not possible – only qualified assurances.
This workshop of AP of approved events is part of a larger process of developing and clarifying Canadian domestic policy that also includes efforts to address AP of GE material that has not been granted regulatory approval in either the importing or the exporting country. This is clearly an important area of concern for many stakeholders. Clarifying issues around AP of varieties that are not approved in Canada or the destination country will continue to require extensive analysis, policy development and refinement, and consultation with domestic and international government regulators as well as importers and exporters. This is a work in progress.
The CFIA is undertaking efforts to strengthen its consultative framework to support the operation of its specific regulatory mandates. The Seed Sector Review and the proposed permanent consultative framework is a key example, as is the industry-government committee on AP and coexistence to be reconvened by the CFIA this year.
In closing, Mr. Chancey emphasized the importance of the workshop as an opportunity for government to hear stakeholders’ views and experiences around these issues and to collectively develop approaches to address these challenges today and into the future.
The following presentations provided context for the workshop discussions:
Gord Harrison, InterSect Alliance Inc., provided an overview of stakeholder perspectives on the issues and implications of AP.
Dale Adolphe, Vice Chairman Canada Grains Council and Chairman, Canada Grains Council Biotechnology Committee, spoke about the impact of AP on production, handling, and export of grain, oilseeds and special crops.
Bernard Le Buanec, Secretary General, International Seed Federation, looked at AP and its implications for changes to international seed standards and seed production systems.
For copies of any of these presentations, please contact the CFIA’s Plant Production Division.
The following are comments raised by one or more participants. Note that consensus was not necessarily reached on any of these comments.
Drawing on the presentations, their experience and the perspectives of their sectors, participants considered (i) the ways in which AP is currently an issue and the extent of those issues, (ii) how AP issues may continue in the future, and (iii) new issues that may emerge in the future. For this discussion, AP included approved and unapproved GE material in domestic and international markets.
(i) Most participants noted that adventitious presence is currently a significant issue for many sectors, as Canadian products may be restricted from existing markets or entering new markets and opportunities may be lost. For example, adventitious presence of GE canola in mustard may result in the loss of access to European Union markets. In the corn industry, shipments of sweeteners derived from glyphosate-tolerant varieties may be rejected by European markets. For the organic sector, adventitious presence may result in lost markets and revocation of organic certification. There are also issues related to varietal purity, traceability, labelling and end use (food vs. feed vs. industrial uses).
It was noted that the complexity of issues related to adventitious presence depends greatly on how adventitious presence is defined. For example, most markets test for same species adventitious presence (e.g., GE corn in corn shipments, GE soybeans in soybean shipments); however, adventitious presence of GE canola in mustard or wheat also raises concerns. Similarly, there are significant differences between health and safety issues related to unapproved GE material and trade issues related to approved material.
A participant cautioned that care must be exercised when using terms such as "contaminated," especially in reference to grain. It was noted that, as set out in the Canada Grains Act, grain is considered contaminated only if an unapproved event is present; presence of approved events does not result in contaminated grain. Other terminology concerns raised by participants included the use of "co-existence" and "containment."
Some participants noted that there are liability issues associated with adventitious presence, particularly for growers. It was suggested that knowledge of economic risk, communication and contract negotiation skills will be increasingly important as this issue will likely continue and become more complex in the future.
There were also concerns raised that organic production costs may increase if crop rotation options are reduced and/or new agronomic management methods and testing are needed.
(ii) Participants noted that many of the issues associated with adventitious presence will continue in the future. Some participants suggested that strict regulations are needed to prevent adventitious presence consequences from worsening. Other participants noted that Canadian standards regarding adventitious presence need to be well balanced to maintain our competitive advantage and market access, while not limiting innovation or farmers’ ability to utilize innovation.
(iii) It was noted that new issues will emerge as new technology develops, including containment and confinement issues associated with large-scale plant molecular farming operations and liability/responsibility issues. The impact of these issues will be affected by the level of consumer acceptance of products containing GE material, and consumer confidence in the regulatory framework. Communication and education are important to raise public awareness of risks and benefits of GE products and of the roles of government and industry.
Some participants noted the importance of synchronous approvals amongst different government departments and trading partners. It was suggested that validated detection methods should be made more available as a requirement of a submission for approval.
The need for international harmonized standards was raised. Some participants felt that there is a high level of standardization around health and safety assessments, for example the food safety assessment requirements under the Codex Alimentarius of the FAO and WHO. Environmental assessments were seen to be less amenable to harmonization, due to geographical, ecosystem, climate and other factors affecting agriculture and the environment.
Internationally standardized testing methods are also needed, especially to detect unapproved events. It is important that testing methods are cost effective (not an economic burden on producers).
It was suggested that the seed certification process move toward an approach that allows GE presence to be considered separately from traditional varietal purity, rather than including AP status as part of offtypes. It was noted that this may be necessary only for certain markets, and that there would be new costs associated with separate testing.
The current Canadian regulatory system related to adventitious presence was seen by some participants to be working well in terms of risk assessments. Further development is needed in the area of risk management, especially as the next wave of bioengineered products emerges. Risk communication needs to be improved, as it affects consumer acceptance and confidence. Data collection and management around both approved and unapproved events also needs to be improved. It was suggested that a study be undertaken to determine the extent and scope of issues associated with adventitious presence, particularly those related to loss of markets/opportunities.
The view was expressed that government has a role to establish thresholds/standards along the value chain and to ensure that quality management systems are in place to assure those thresholds. It was suggested that thresholds and standards must be set much higher than what is actually required, as mistakes will inevitably occur. Some participants felt that government, industry and the research community should continue to take a leadership role at the global level, particularly with Canada’s key trading partners. In addition, Canada should work with developing countries to help them gain from our lessons learned.
Some workshop participants felt that while adventitious presence cannot be avoided, it may be managed by building on the IP (identity preservation) experience and strengths. A participant noted as an example an industry-led, non-legislated IP program for food grade soybeans which has enabled exports to Europe and Japan. Managing AP includes setting a rational balance between a de facto zero tolerance and what can be achieved by industry practically and cost-effectively. Industry should have the flexibility to meet market demands.
Building on these issues, participants considered the short- and long-term challenges and opportunities that emerge for industry and government. For this discussion, participants were directed to focus on challenges and opportunities related to events approved in both Canada and its export markets.
Again, issues around the use of terms were raised. A participant advised that the term "adventitious presence" should always be qualified with either "approved" or "unapproved." The term "zero tolerance" is another example. It was noted that "zero tolerance" does not appear in any Act or Regulations, and that its use has resulted in misinformation and unscientific expectations.
There is a fear that markets will be lost due to customer perception of Canada’s inability to limit AP. A key challenge noted by some participants is the potential for occurrence of unknown adventitious presence levels in seed, which could jeopardize well-established, market driven IP markets such as the food grade non-GM soybean market. This is compounded by the limitations of current testing methods which do not provide quantitative measures. For example, a strip test that returns positive for GE presence could result in the shipment being rejected, even though the actual level of AP, which may be within the acceptable amount, is unknown.
Similarly, the potential co-mingling of different species within a shipment is a concern. For example, a wheat shipment (there are no GM wheats) in which canola is found (there are GM canolas) could result in loss of market and erosion of customer confidence.
Another key challenge is the lack of harmonized international regulations and requirements for thresholds, testing methods, quality assurance protocols, risk assessments, etc. Therefore, it is important to be aware of the standards of other countries and markets.
In looking to the future, there will be a need to balance government’s regulatory responsibility with industry’s ability to meet "reasonable and rational" expectations along the value chain as well as those of end-use customers. This may require a new industry/ government partnership, and possibly a new governance model. It was noted that reasonable and rational customer expectations may be achieved through improved communication about risks, the technology, production practices, and merits/benefits of products, to create understanding and acceptance. This is a key challenge, however, given the level of consumer scepticism and mistrust.
Building on the suggestion in the previous discussion that an IP approach may be an answer to AP challenges, some participants noted that evidence will be needed to demonstrate that IP systems meet customers’ requirements. It cannot be assumed that a government’s standards will satisfy the customer – customer/market demands may be more stringent than those set by the regulatory authority.
Some participants felt that the next wave of biotechnology will likely be much more difficult to detect, and thereby to regulate. Liability challenges will also continue in the future.
Participants noted that some of these challenges offer opportunities for industry and government. For example, an opportunity exists to "sell science" to others who are just starting on their regulatory framework for AP. New testing methods, production designs, non-GE products, new industrial bioproducts, and GE products that focus on outputs (i.e., to meet customer demand) rather than inputs, were other suggested opportunities.
The following are comments raised by one or more participants. Note that consensus was not necessarily reached on any of these comments.
Participants developed recommendations to explore or pursue in response to the challenges and opportunities that had been identified.
6.2.1 Strategies for the grain, oilseed and special crop sectors
Some participants felt that add-back of foreign material should be phased-out; an industry-government voluntary approach is preferred. However, other participants opposed this.
The applicability of IP systems to AP issues was again raised. As the current IP systems are considered effective, some participants felt that these should be strengthened and expanded.
Another strategy suggested by some participants was for the government to consider certifying production processes to minimize or control AP, rather than setting AP thresholds which may not meet the requirements of all markets. This approach would be similar to the seed certification process, and would include production protocols and quality standards (e.g., requirements for crop isolation, control of volunteers, equipment use and cleaning, etc.).
Other suggestions included:
6.2.2 Strategies for the seed sector
The seed sector is generally well prepared to deal with AP, as it has had strong success and experience with its seed certification system and quality control procedures. Participants noted that there is a need for the seed sector to monitor changing market conditions and remain flexible and responsive to those changes. The sector should continue to monitor for AP, follow established practices, encourage good on-farm record keeping, and more widely communicate information about the quality control procedures that exist. It was suggested that the Seed Sector Review could provide a suitable communication vehicle.
It was also suggested that there is an opportunity for the proposed seed sector consultative process to build consensus around a science-based, global centre for the development of certified reference materials.
Voluntary protocols could be established for GE testing of seed of varieties grown for specific markets, e.g., GE-free soybeans. Existing Canadian Seed Growers’ Association (CSGA) provisions for additional certification requirements could also be used to ensure low levels of AP in seed.
Some participants suggested that developers of new GE varieties should seek regulatory approvals in all markets that would be affected by AP of the variety.
6.2.3 Strategies that would support all sectors
Some participants noted that AP of approved events should be positioned as a marketing/industry issue rather than as a safety issue. AP needs to be perceived interdepartmentally as a trade issue, beyond health and safety regulatory concerns.
A communication strategy should be developed to facilitate a common understanding among value chain members, including customers, of the system capabilities to deliver a practical level of purity (GE or non-GE). This would include a coordinated information exchange and knowledge building mechanism to better communicate the risk assessment process, the safety of products on the market, and Canadian standards in relation to the standards of other countries, and to build confidence in the system. However, it was also noted that millions of dollars have already been spent on this type of communication, with little effect.
Some participants felt that developers should be assisting in control of AP from new events by developing and promoting risk management strategies for growers as well as appropriate testing methods. This raised concerns regarding liability issues. Developers should also ensure that their submissions are done in a synchronous manner across regulatory authorities and with countries with regulatory frameworks in place. While this may be ideal, it was noted that it is a highly unrealistic expectation.
Although the international harmonization of standards is desirable, some participants felt it is unlikely to be attained given the track record to date. The question was raised as to the appropriate forum for international coordination on standards, methodology, certified reference material, for example, Codex Alimentarius, Organization for Economic Development and Cooperation (OECD) and International Seed Testing Association (ISTA). It was suggested that OECD might be most appropriate for food/feed areas, and International Plant Protection Convention (IPPC) for environmental issues [particularly plant health].
Canada has the international credibility required to take a leadership role on a number of fronts, including:
It was suggested that Canada and industry work together to develop and establish thresholds that are reasonable and practical, and promote those to international fora. The development process should take an approach that considers all perspectives – developer, producer, exporter, importer, negotiator.
Stakeholder input in the development of policy and regulations is an ongoing commitment of AAFC and CFIA. The issues raised and comments received at this workshop help create an improved understanding among industry and government stakeholders of the issues and implications related to adventitious presence, particularly related to material approved for environmental, feed and/or food use in both Canada and its export markets. AAFC and CFIA are working with the Canadian Grain Commission in considering each of the recommendations made by participants of this workshop, particularly those related to the role of government.
As part of the Government of Canada’s ongoing initiative on adventitious presence, AAFC and CFIA will continue to work with other government departments, international partners and public stakeholders in addressing the larger, more complex issues of adventitious presence of material that has not been granted environmental, feed and/or food use approvals.
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