Developing a Policy for Low-Level Presence (LLP): A Canadian Case Study
Agricultural biotechnology research and adoption is increasing. It is estimated that by 2015 there will be a three- to four-fold increase in the number of commercialized biotech products. Also increasing are the complications with international trade given the wide range of acceptance and regulatory capabilities currently in practice globally, specifically, the increasing low-level presence (LLP) of biotech products that have received full regulatory approval in one or more countries but not in the country of import.
Canada, recognizing the impact of LLP on international trade, is taking a leadership role. Using a government-industry collaborative model, the Canadian government is developing a domestic regulatory policy to manage LLP from imports and building international collaborations to raise awareness of the impacts of LLP on trade globally.
This article details the collaborative government-industry process and the current status of the draft domestic LLP policy and international engagement.
Key words: agriculture biotechnology, Canada, international trade, low-level presence (LLP), stakeholder collaboration, genetically modified, policy.Introduction
One of the current greatest challenges is how to feed our growing global population and to do so in a more sustainable manner. By 2030, the United Nations predicts there are likely to be 1.7 billion more mouths to feed (United Nations Secretariat, Department of Economic and Social Affairs [DESA], 2009). A population set to exceed 8 billion by 2030 brings with it the need to meet growing caloric demand.
Biotechnology or genetic modification (GM) is one tool available to increase agricultural production. Modern agriculture using plant biotechnology has doubled the production of world food calories since 1960. Farms can grow more on each hectare than ever before. In the 1980s, one hectare of arable land produced 1.8 tonnes of food annually on average. Today, one hectare produces 2.5 tonnes of food (United Nations Environment Programme [UNEP] Global Environment Outlook, 2007).
Farmers are also realizing economic gains from plant biotechnology. From 1996 to 2008, biotech crops have increased global farm incomes by $52 billion due to enhanced crop productivity and more efficient farming techniques. In 2008 alone, the direct global farm income benefit from biotech crops was $9.4 billion, and more than half of these income benefits have been realized by farmers in developing countries (Brookes & Barfoot, 2010).
This increased productivity has led to a rapid global adoption of the technology. According to the 2011 International Service for the Acquisition of Agri-biotech Applications (ISAAA) biotech crop report, the outlook for biotech crop adoption points to continued growth with current global biotech adoption at 16.7 million farmers in 29 countries, with 160 million hectares planted.
However, the adoption of biotech crops has not occurred uniformly across the globe and regulatory approaches are diverse. Since biotech crops were first commercialized in the mid-1990s, global approvals and acceptance have varied, ranging from rapid adoption in countries such as the United States, Canada, and Argentina, to low adoption and even GM moratoria in some European, Asian, and African countries.
Even in countries with well-established regulatory systems for biotech crops, approval timelines and duration of authorizations differ from country to country. These differences can lead to asynchronous authorizations among key trading countries, which can potentially affect international trade (Table 1).
Table 1. Asynchrony of first approvals of GM crops (for any use) between the United States and the European Union, status in early 2009.
International trade may be further impacted if a minute amount of a biotech crop already authorized and produced in one country is detected in an importing country that has not yet approved the product and does not have a regulatory process in place to deal with low-level presence (LLP).
Low-level presence does not have one universal definition, but for the purposes of this article, the definition is taken from a presentation by the Government of Canada entitled, “Low-Level Presence Policy Review and International Engagement” (Bergeron, 2012).
An understanding of the differences between biotech crops for food, feed, and processing (FFP) and those used as seed for planting is important in the development of a LLP policy. While all biotech products are assessed for their safety to humans, animals, and the environment, seed is intended for planting and therefore risk assessments (RA) need to focus on the potential environmental impacts. Food, feed, and products for processing—while they could in some cases be whole and act biologically as seeds—are generally destined for consumption and are not intended to be planted. In this article, LLP is specific to grain and used in reference to food, feed, and process products (FFP), unless specifically referred to as LLP in seed.
While there is an enormous infrastructure dedicated to the bulk handling and movement of grain and seed from farms to consumers around the world, even the most sophisticated infrastructure cannot prevent different crops or crop varieties from potentially coming into contact with one another. As an example, in 2009, a shipment of soybeans from the United States was put into quarantine before it could enter Europe, where there is a zero-tolerance policy for traces of unapproved GM products (Wager & McHughen, 2010). Dust particles of a GM corn (MON88017), which received full safety approval by both Canadian and United States regulatory authorities and was given full commercial release for production and consumption in both countries, accidentally made it into the shipment of soybeans somewhere in the transportation process. These traces of fully approved corn dust caused the soybean shipment to be quarantined, triggering significant economic losses.
Several researchers have analyzed the potential economic impact of LLP on the agri-food sector, especially for its impact on the European agri-food industry where there is a zero tolerance policy (Brookes, 2008; Freitag, Minol, & Stein, 2011; Kalaitzandonakes, 2011; Landmark Europe, 2009). One study (Landmark Europe, 2009) estimates the potential cost of an LLP incident involving EU-unauthorized GM maize from the United States could cost between 5 and 46 million Euros, not including potential indirect costs such as supply shortages or plant shutdowns.
In the future, incidents of LLP are expected to increase as the pipeline for new GM crops increases, as seen in Table 2 (Stein & Rodríguez-Cerezo, 2010). Countries such as China and India are close to commercializing new domestically developed GM crops that, although intended for domestic use, could end up inadvertently in shipments destined for international trade and enter other countries, including Canada, as LLP.
Table 2. Events in commercial GM crops and in pipelines worldwide, by crop.
Canada, recognizing the challenge of effectively managing the international trade of biotechnology-derived products and minimizing the trade impacts caused by the low-level presence of GM products which have been approved in one or more countries but not in the country of import, has been working on a domestic LLP policy and is leading international engagement on this important issue.
Canadian Political Engagement
In 2009, a GM flax variety, Triffid, was found in shipments bound for European ports. Following a red alert, trade of all Canadian flax with the European Union was halted. Triffid flax represents a prime example of LLP in that the variety, while never commercially grown and then de-registered in 2001, had received a full food, feed, and environmental approval in both Canada and the United States. But with Europe’s zero threshold for unauthorized GM events, all flax shipments were stopped.
The impact on Canadian flax producers was significant, estimated at approximately $30 million (Ryan & Smyth, 2012). This situation, while causing substantial economic harm, had a positive effect by raising the political awareness of the importance of LLP and its impact on international trade. Canada’s Minister of Agriculture, the Honorable Gerry Ritz, acknowledged the importance of the flax trade to Canadian producers, understood the concept of LLP, and recognized how a regulatory policy to deal with LLP could assist the trade of GM products internationally.
The Canadian Government, after discussions with importing countries, also realized that its own LLP system was inadequate to manage shipments entering Canada that may contain traces of GM crops that have not had a full approval in Canada. Driven by senior political support, Canada started working on a domestic LLP policy (described later in this article).
The Canadian Government further supported international engagement of this issue at the 36th Cairns Group (CG) Ministerial meeting in Saskatoon, Saskatchewan on September 9, 2011. The following quote by Minister Ritz is taken from an Agriculture and Agri-Food Canada (AAFC) news release (2011) and highlights this commitment:
Starting in 2007, prior to the Triffid flax issue, the industry recognized that LLP was going to be a key issue with respect to the international trade of products of plant biotechnology. The Canadian agricultural value chain came together—under the Canada Grains Council and supported financially by AAFC through the Advancing Canadian Agriculture and Agri-Food (ACAAF) program—to produce a report on “Creating an Environment for the Successful Commercialization of Canadian Crop Innovation” (Canada Grains Council, 2008). This report, which highlights 26 recommendations to increase agricultural innovation aimed at both industry and governments, was endorsed by more than 50 Canadian organizations including researchers and crop developers, primary producers, grain handlers and marketers, as well as end-use processors. The recommendations in the report encompass innovation from “mind to plate” and LLP was identified as a key limiting factor.
As a result of the collaborative approach to the development of the report and to facilitate the implementation of the report’s recommendations, the Grains Innovation Roundtable (GIRT; AAFC, n.d.) was formed in 2009 with the assistance of AAFC. The strength of this roundtable process was the cross-sectoral involvement of the industry sitting alongside senior officials from the Canadian government regulatory departments. Together, participants delved deeper into the issues identified and strategized on methods to create solutions that would be acceptable to both government and the industry.
The 26 recommendations identified in the original report were divided and covered by five working groups, each with a set of co-chairs and interested participants. The five groups included
The TPWG consisted of approximately 20 members representing a range of sectors and organizations experienced with regulatory and political challenges affecting international trade of innovative crops and products, as well as regulatory experts from the Canadian Food Inspection Agency (CFIA), AAFC, Health Canada, and the Market Access Secretariat (MAS).
The TPWG started by undertaking a comprehensive review of the current regulatory system—the Acts and Regulations which govern GM crops—in order to fully understand its benefits and limitations, and if and where regulatory changes might be required. As part of this analysis, a LLP scenarios subgroup was formed to test several specific examples and their implications on current regulations and guidelines. Part of the strength of this process was the involvement of Canadian regulators—not to provide direction per se, but to help the group understand the impact of its suggestions on current acts and guidelines and determine whether existing acts would need to be changed or whether suggestions could be put into place by regulatory changes. Following this extensive review, the TPWG proposed a framework for a LLP policy in Canada.
Canadian Regulatory Agency Engagement
In response to the Government of Canada’s commitment to develop a domestic LLP policy, an Interdepartmental Assistant Deputy Ministers (ADMs) Committee on Trade in GMOs was initiated in 2010. Comprised of ADMs from AAFC, Health Canada, Department of Foreign Affairs and International Trade (DFAIT), the Canadian Grain Commission, and Environment Canada, this high-level committee was mandated to address market access issues involving GM crops while ensuring the continued protection of human and animal health and the environment in Canada.
The committee’s work plan consisted of several complementary activities, including the development of an issues paper analyzing domestic and international LLP management approaches, an assessment process identifying priority sectors and countries involved, an international engagement strategy for advocating trade-friendly approaches for managing LLP, and the development of a domestic LLP policy.
To facilitate appropriate information exchange between the TPWG and the Interdepartmental ADM Committee, representatives from the multi-department secretariat supporting the ADM Committee participated in the TPWG.
The value of the government-industry roundtable approach is that it provided a forum for the open exchange of ideas working towards a mutual goal. It helped to increase communication and understanding from all perspectives, reduced the chances of misunderstanding through a ‘ping-pong’ approach, and increased time and efficiency.
Recognizing the value of this roundtable, and continuing to build on the work in this area, AAFC organized a permanent (and renamed) Grains Roundtable (GRT) with an inaugural meeting occurring March 17-18, 2011 in Winnipeg, Manitoba. At this meeting, the TPWG was changed to the Market Access Working Group (MAWG) to expand its focus, and a biotech sub-working group chaired by Janice Tranberg was formed to focus on biotech-specific issues, including LLP.
Under the initial GIRT, the TPWG produced a report that defined the agreed upon scope, objectives, principles, and approach for a LLP policy for Canada. On September 16, 2010, several members of the GIRT Steering Committee and TPWG co-chairs were invited to the the Interdepartmental ADM Committee to present the Proposed Framework for Canada’s Future LLP Policy, as summarized in Table 3.
Table 3. Proposed framework for Canada’s future LLP policy.*
The key objective of the proposed approach included increasing predictability for grains and seed exporters/importers, minimizing trade disputes, and reducing “emergency-like” responses. The new approach is intended to increase public confidence in the system and minimize potential negative impacts on trade.
In making recommendations to the government, the TPWG felt it was important to stress that a ‘one-size-fits-all’ approach would not work. Instead, a tool-kit approach was envisioned, which would be flexible enough to fit current and new innovative technologies and crops in the ag-biotech industry.
Canadian Domestic LLP Policy Development
The Government of Canada is proactively looking to enhance its regulatory system to manage LLP while protecting human and animal health and the environment, and minimizing the impact on innovation and trade.
Through the Interdepartmental ADM Committee, a series of options for the creation of a domestic LLP policy for Canada was drafted and sent out for initial consultation in September 2011. Approximately 180 invitations were sent to stakeholders, including developers, grower groups, grain handlers, and organic and food industries, asking for their input. Stakeholders were able to provide their feedback in two ways: written and in-person consultations. The in-person consultations occurred in six locations across Canada (Ottawa, Toronto, Montreal, Halifax, Winnipeg, and Saskatoon).
The draft consultation laid out three potential approaches which were not mutually exclusive and could be used in combination. The three draft approaches are graphically outlined in Figure 1.
Figure 1. Canadian draft LLP policy management flow chart.
January 25, 2012 draft by Janice Tranberg (CropLife Canada).
Taking the information gathered from the consultations, the Government of Canada’s Interdepartmental working group was tasked with looking at the domestic LLP policy directions and implementation considerations to refine the policy. Work continues with the industry through the GRT MAWG Biotech sub-working group on specific issues, including refining a potential action level and identifying a measurement of uncertainty associated with this level; this measurement is based on science and assures consistent results.
Regarding the two threshold-related proposals, the Canadian Government recognizes that the establishment of a risk management decision (RM) and threshold is separate from the risk assessment (RA) process and takes into account separate factors. Officials are considering the establishment of an expert committee to make recommendations on the thresholds, using information from the risk assessment which will be conducted within the Canadian government regulatory system. The government is also considering a threshold approach based on crop type as opposed to GM event-by-event, realizing that event-specific thresholds would create significant cost implications if different thresholds were introduced for different events that could be within the same commodity.
A second draft of Canada’s domestic policy for LLP, modified using information captured in the first consultation, was made available for consultation from November 6, 2012, to January 19, 2013, after this article was written and submitted for publication.
Increasing global hectares of biotech crops highlights the increasing potential for LLP incidents in Canada and abroad. The Canadian Government, recognizing this as a global issue, clearly sees the need to raise awareness internationally.
Championing this issue, Canada held the first international workshop on LLP in Vancouver, Canada on March 21-23, 2012, hosting senior government representatives from 15 countries.1 The meeting was in response to Minister Ritz’s commitment at the Cairns Group Ministerial Meeting in September 2011 that Canada would facilitate discussions with the international community on the effective management of LLP in agricultural imports.
To open the workshop, industry and government representatives from the 15 countries came together to discuss the challenges of LLP, starting with the perspective of the seed and trait developer, to the farmer growing the crops, to segregation by the grain handlers and complications of multi-jurisdictional transportation, and finally the importers’ and end-use processors’ ability to secure stable supply chains. While certain aspects differed between geographies and the stage within the value chain, two consistent messages became clear.
At the government-only meetings, senior representatives from the 15 countries explored opportunities to work collaboratively on the issue of LLP, with the understanding that finding global solutions to facilitate the management of LLP will reduce the likelihood of trade disruptions and increase transparency and predictability of trade. Participants reviewed and provided their intent to an International Statement on LLP and collaborated on a work plan to move this issue forward. The six main elements of the work plan include
At the conclusion of the Vancouver meeting, the goal of building awareness and connections among participating countries was met, laying the foundation for future collaboration. Argentina will host a follow-up meeting, which is set to take place in Buenos Aires in September 2012.
The number of GM crops developed, cultivated, and traded is expected to increase globally over the next few years, as reported by the Joint Research Council of the European Commission (Stein & Rodríguez-Cerezo, 2010). Due to the fact that many of these new GM crops are anticipated to be developed for domestic use only and global regulatory submissions and approvals may not occur, an increase in LLP incidents is anticipated.
A proactive approach by Canada to establish a domestic LLP policy could minimize trade disruptions resulting from imports coming into Canada inadvertently containing LLP, which would be beneficial to all sectors of the seed and grain industry. Potentially being the first country to fully develop and employ a LLP policy would also provide an example for other countries to follow on the management of LLP globally.
Establishing a domestic LLP policy prior to or in concert with Canada’s key trading partners will enable Canada to encourage trading partners to establish LLP policies that reflect consistent, science-based factors and which would assist in mitigating future incidences of LLP.
As a result of the leadership Canada has shown, both through the development of a draft domestic policy for LLP and through its work to encourage international engagement, this issue is recognized globally. Work continues in Canada and abroad with the goal to minimize or prevent future trade disruptions associated with the unintentional LLP of GM crops in trade.
1 Argentina, Australia, Brazil, Canada, Chile, Costa Rica, Indonesia, Mexico, New Zealand, Paraguay, Philippines, Russia, United States, Uruguay, and Vietnam.
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Suggested citation: Tranberg, J. (2013). Developing a policy for low-level presence (LLP): A Canadian case study. AgBioForum, 16(1), 37-45. Available on the World Wide Web: http://www.agbioforum.org.
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