Macquarie Journal of International and Comparative Environmental Law
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Macquarie Journal of International and Comparative Environmental Law |
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DOUGLAS J R MOODIE[*]
Learn from me, if not by my precepts, at least by my example, how dangerous is the acquirement of knowledge, and how much happier that man is who believes his native town to be the world, than he who aspires to become greater than his nature will allow (Mary Shelley, Frankenstein 1818 Text)
We live in a world inundated with transformative technologies. One of those is the genetic modification of living organisms for food purposes. Huge increases in the acreage of genetically modified (‘GM’) crops have occurred since the mid 1990s.[1]
More than 175 million hectares worldwide have now had GM crops grown on them at one time or another.[2] This ‘first generation’ of GM food crops has consisted of plants with few and relatively straightforward trait changes. But this is likely to soon change.[3]
It has been estimated that ‘the global market for biotechnology applications will reach $50 billion annually by 2005 … and the strongest growth is projected for the agri-food sector’.[4]
The research and production emphasis in the international sphere, as in the domestic one, has so far been heavily geared to GM plants and the human food and livestock feed derived from those plants. Work involving GM animals lags far behind that involving plants.[5] Technical issues, including the greater complexities of animal biological systems, are in part responsible for this. The development of transgenic fish[6]
represents something of an exception to this situation. Research on transgenic fish commenced several decades ago and ‘has occurred at a very rapid pace’.[7] By 2000, as many as thirty-five different species of fish had been the subject of genetic manipulation.[8] The first transgenic fish research in Canada was focused on an antifreeze protein gene to permit the rearing of Atlantic salmon in the icy waters off Canada’s east coast.[9] The majority of Canadian research, however, has been on increasing growth rates, with almost all the effort directed at Atlantic and Pacific salmon.[10] This research has produced a genetically altered Atlantic salmon that has a growth rate reputed to be as much as 600% greater than its non-GM counterpart. Contrary to common perception, however, the GM Atlantic salmon at maturity is more or less the same size as a mature non-GM Atlantic salmon. The allure of enhanced growth rate is that the fish can be brought to market size more quickly, thus allowing for a significant increase in production within a fixed timeframe. Technological breakthroughs hold out the promise of revolutionizing the commercial production of salmon, and perhaps numerous other species. So far, though, transgenic fish remain at the pre-commercial stage.[11]
GM foods have fuelled significant discourse, in Canada and abroad, in recent years. Two major contemporary Canadian studies of biotech food regulation have resulted. In August of 2002, the Canadian Biotechnology Advisory Committee (‘CBAC’)[12]
issued a report on the regulation of GM foods in Canada. The CBAC Report followed almost two years of research, stakeholder and public consultations, and public comments on specific draft recommendations presented in an interim report published in August of 2001. The Royal Society of Canada (‘Royal Society’)[13] in early 2000 assembled an Expert Panel (‘Royal Society Expert Panel’) to provide advice on certain food biotechnology[14] regulatory issues. The Royal Society Expert Panel issued its report in January of 2001. The federal government published an action plan[15] in response to the Royal Society Report, as well as four (to November, 2003) progress reports[16] on that action plan.
The CBAC and Royal Society Reports, together with the ‘Action Plan’ and ‘Progress Reports’, represent intensive Canadian government sponsored initiatives to study the issues swirling around GM foods.[17] The heightened attention to GM foods in Canada in the past three years or so has been prompted by several factors. First, as already mentioned, recent leaps in biotechnology have the potential to soon make available a much greater array of GM foods, with more complex characteristics, than the world has previously known.[18] Second, there are growing economic[19] and social[20] forces urging the broad acceptance and usage of GM foods and food products. Third, there is a fast-evolving awareness among the consuming public of the presence of GM foods and food products in their diets, of the potential for significant increases in that presence, and of the health, environmental and social/ethical issues connected with GM foods and food products.[21]
The purpose of this article is to examine aspects of the Canadian regulation, present and prospective, of transgenic fish. The emphasis of the examination is on four inter-connected regulatory areas: food safety, environmental protection, consumer choice and trade. These areas generate, in the view of this author, the ‘tier one’ issues in respect of regulation. There are a number of ‘softer’ issues, such as the socio-economic and ethical implications of food biotechnology. These, however, tend to garner less attention in the GM food debate, especially in the international forum. These issues are consequently not ascribed much direct focus in this article. They do, however, come up tangentially from time to time, particularly in the discussions of ‘consumer choice’ aspects of GM food regulation.
Transgenic fish regulation in Canada presents as a discrete and valuable area of study for several reasons. The first is that research organizations with strong Canadian ties have been at the forefront of global efforts to develop the commercial potential of transgenic fish. A Massachusetts-based company called AQUA Bounty Technologies Inc (formerly A/F Protein Inc) with offices and manufacturing and research facilities in eastern Canada, has been identified as ‘leading the race to commercialize the growth enhanced GE [genetically engineered] fish’.[22]
The second is that Canada has an already significant aquaculture industry that is poised, some predict, to grow exponentially in future decades.[23]
Thirdly, the emergence of an explicit, broad discourse regarding GM foods creates a backdrop which inevitably will influence, one way or another, any integration of transgenic fish into Canada’s traditional aquaculture industry. This combination of factors suggests the Canadian experience, and the decisions ultimately made by Canada vis-à-vis commercial production of transgenic fish, will be both intrinsically interesting and of instructional value to other nations travelling similar paths.
The first part of this article considers the international background and the laws, policies and mechanisms developed and continuing to be developed by the global community to address food safety, environmental protection, consumer choice and trade issues relating to GM foods (and, particularly, transgenic fish). The second part turns to briefly look at Canada’s non-GM aquaculture industry. The third part of the article discusses the domestic regulatory situation for GM food products. What structures and procedures are currently in place? How have international initiatives and directives been incorporated, or hold promise to be incorporated, in the Canadian context? To what extent has the recent governmental and extra-governmental attention to GM food issues so far shaped Canada’s regulatory structures and procedures? How might one expect those structures and procedures to be affected, both by the formal government sponsored discourse and by broader societal forces and opinions? How might the answers to the foregoing ‘GM food’ questions vary, if at all, for transgenic fish?
The article ultimately attempts some conclusions on the sort of regulatory regime commercial transgenic fish producers might expect to face in Canada in 3-5 years, and beyond. It also offers some thoughts on the critical factors that may make the difference between a future multi-billion dollar industry and one that never gets off the proverbial drawing board.
The international context of GM food regulation is a complex one, involving various organizations each with its own unique mandate and agenda. The CBAC Report identifies a number of international bodies that are currently involved in ‘the coordination and regulation of biotechnology products’.[24] These include the Food and Agriculture Organization (‘FAO’), the World Health Organization (‘WHO’), the Codex Alimentarius Commission,[25] the World Trade Organization (‘WTO’), the Organization for Economic Co-Operation and Development (‘OECD’) and the Secretariat of the Convention on Biological Diversity.[26] These bodies ‘cover a spectrum of functions from … set[ting] science-based standards to … broader objectives such as food security, trade facilitation, environmental protection, and other social and political goals’.[27] It is the stated view of the CBAC that Canada demonstrates active participation in all these international bodies, and ‘at times lead[s] the efforts to develop international consensus on matters of science, governance and/or policy’.[28]
This plethora of international organizations, along with several expert panels and commissions in various states, in the last three years has produced numerous reports on regulatory issues related to GM foods.[29] Of the several international organizations involved with GM food regulation, three seem to be particularly conspicuous. They are: FAO, WHO and WTO.
The existing international regimes and procedures for monitoring and regulating food safety are extensive and well-established, though they do not much differentiate between GM and non-GM foods. It can be anticipated, therefore, that transgenic fish will be treated, at the international level, in a manner similar to that applied to any novel food product. International food safety regulation seems to have two facets: one is centred on the development and dissemination of food standards and guidelines; the other has a strong trade orientation. The precise interaction of these two facets is not an easy thing to discern.
The Codex Alimentarius Commission is at the heart of the food standards/guidelines facet of the international regulatory effort. The Codex Commission has been at its task for four decades. Its secretariat is provided by FAO and WHO. The Codex Commission is an intergovernmental body with 165 member countries.[30]
Its primary functions are stated to be ‘protect[ing] the health of consumers, ensur[ing] fair practices in food trade and promot[ing] the coordination of food standards’.[31] The explicit ‘food trade’ function indicates that the Codex Alimentarius Commission’s mandate may blur into those of WTO and its related bodies. It is not abundantly clear what the Codex Commission does, independent of the WTO regime, to ensure ‘fair trade practices in the food trade’. It may be that this trade aspect of the Codex Commission’s mandate is a holdover from a period before WTO took primary jurisdictional control over trade-related matters in the international forum. On the other hand, with the involvement of the Codex Commission in the establishment of global food labeling rules,[32]
there exists an inextricable connection with trade issues. Whether or not a product is labeled, and what is the content of that labeling, has a direct bearing on the international trade in that product.
FAO and WHO have furnished to the international community ‘expert scientific advice on the food safety aspects of foods derived from biotechnology since 1991’.[33]
FAO and WHO, through the Codex Alimentarius Commission, in 1999 established the ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology (the ‘CAC Task Force’). The purpose of the CAC Task Force is to consider the health and nutritional implications of biotech foods and, in particular, to:
develop standards, guidelines or recommendations, as appropriate, for foods derived from biotechnology or traits introduced into foods by biotechnology, on the basis of scientific evidence, risk analysis and having regard, where appropriate, to other legitimate factors relevant to the health of consumers and the promotion of fair trade practices.[34]
Again one sees the ‘fair trade practices’ angle occupying a central place. The CAC Task Force submitted interim reports to the Codex Commission in 2001 and 2002, and is expected to complete its work by late 2003 and provide a full report at that time.[35]
The joint FAO/WHO work on the human health evaluation of GM foods uses for its scientific foundation a series of expert consultations on the safety and nutritional aspects of such foods. These expert consultations are stated to be ‘completely independent from the inter-government negotiation process, and treat the subject from a pure scientific perspective’.[36]
They aim to furnish scientific advice, to review existing GM food assessment strategies and to offer recommendations on further research and evaluation needs.[37]
The structure, then, of the Codex Commission’s approach to the assessment of biotech foods starts with science oriented output from various expert consultative bodies. That output typically moves to the CAC Task Force, which uses it to help mould standards, guidelines, and recommendations for ultimate consideration by the Commission as a whole. The overall process seems comprehensive, if somewhat lumbering. And it is directed at constantly moving targets, as different foods with different characteristics produced through different means stream onto the stage. Ultimately, the Codex Commission does no more than gather and disseminate information and ‘develop standards, guidelines or recommendations, as appropriate, for foods derived from biotechnologies …’.[38] It is left to the governments of individual states to create and implement their own policies regarding these technologies. They can whole-heartedly embrace the Codex Commission’s standards, guidelines and recommendations, disregard them completely or use them with whatever modifications they consider appropriate.
Notwithstanding the non-binding status of the Codex Commission’s efforts, they are significant for a couple of reasons. First, the scientific information generated has a great deal of value for developing states that do not have the financial and/or technical means to do their own science. Even for states that do, the scientific information emanating from the Commission can serve as the basis for policy decisions or, at the least, for further independent research efforts. Second, the standards and guidelines set by the Codex Commission have persuasive international force because of the multilateral process involved and the level of expertise drawn upon. States that set up standards that substantially exceed those recommended by the Codex Commission do so at the risk of incurring domestic and/or international criticism for ‘overdoing it’. Conversely, states that have standards markedly below those suggested by the Codex Commission greatly increase the chances of domestic complaints and/or of actions abroad to block entry of their ‘substandard’ products. To the extent, therefore, the Codex Commission food safety assessment process is viewed as scientifically legitimate and independent of distorting factors (such as political ones), and that, by and large, seems to be the case at the present time, what it has to say about biotech foods will carry serious weight.
From an environmental perspective, the difficulty with transgenic fish is that no one yet has much idea what impact they might have on natural ecosystems. Regulatory initiatives are therefore to a large extent ‘grasping at shadows’. Some environmentalists suggest scenarios of catastrophic proportions. Greenpeace Canada, presently the most active Canadian environmental non-governmental organization (‘ENGO’) on the topic of GM food, considers the genetic alteration of fish to be ‘high risk technology with potentially disastrous consequences if the GE fish escape into the environment’.[39] Citing past experience with invasive species and specific research findings on transgenic fish, Greenpeace Canada has suggested, ‘even a single fertile GE fish could be sufficient to destroy a local population under certain circumstances’.[40] The Royal Society Expert Panel, not so dramatically disposed as Greenpeace, nevertheless underscored the serious dearth of information available. It concluded that:
[b]ased on the limited research that has been published to date … there is little, if any, empirical basis upon which one can reliably predict the outcome of interactions between wild and GM fish.[41]
And the complicating factor with this issue is the difficulty involved in achieving a satisfactory level of assurance, given the only real way of doing so is to engage in comprehensive field trials – inherently risky business.
The research to date on the overall effects of transgenesis on fish shows:
deleterious consequences to fish morphology, respiratory capacity, and locomotion associated with the introduction of growth hormone (GH) gene constructs in some transgenic variants of salmonids, notably Pacific and Atlantic salmon.[42]
The concern here is that transgenic fish that cannot swim, forage or breathe properly may not only have difficulty thriving in a fish farm setting, but if released into the environment, intentionally or not, could have detrimental effects on native populations through the exchange of genetic material (‘introgression’). Escapes from aquatic fish farms are common,[43] and so any rearing of transgenic fish in sea-based open netcages can be anticipated to result in environmental incursions of significant numbers of those fish. In addition to the concerns surrounding introgression, escaped transgenic fish might also have more direct and immediate ecosystem impacts through ‘hyper-predation’ (eating everything in sight) and migration to novel habitats.
The international concern with protecting the environment from adverse effects of GM fish has both general and specific aspects. On the general side, since at least 1992 the concept of ‘precaution’ has guided the international approach to environmental stewardship. What is now commonly referred to as the ‘precautionary principle’ or ‘precautionary approach’ was enshrined as, and seemingly popularized by, Principle 15 of the Rio Declaration on Environment and Development.[44] While the Rio Declaration was not the first time the idea of a principle of precaution found its way into an international agreement,[45] it certainly seems to have been energized by Rio. The broad acceptance of the Rio Declaration among states and the steady percolation of its concepts and principles downward into the strata of citizenry of those states, lends support to the suggestion that the Rio Declaration represented a kind of international ‘codification’ of the precautionary principle. In the decade since Rio, reference to the precautionary principle/approach in the international environmental arena has become increasingly common. Academics have noted the precautionary principle’s incorporation ‘in virtually every recently adopted treaty and policy document related to the protection and preservation of the environment’.[46] Even some of the international judiciary has taken ‘precaution’ into its lexicon.[47]
Notwithstanding the broad international acceptance of the ‘precautionary principle’, there remains uncertainty as to precisely what it embodies. It is said to represent a ‘better safe than sorry’ attitude and approach. It has generated voluminous literature, with legal scholars to-ing and fro-ing on its precise meaning and utility. There is no consensus; indeed the views of academia on the precautionary principle seem to span the spectrum. Some commentators have categorized it as a tool of great import in ongoing efforts to protect the environment; while others have dismissed it as too loose and ambiguous to be of any real use.[48]
Specific rules and standards aimed at protecting the environment from possible negative ramifications of transgenic fish have emerged and/or evolved in the international forum. Bodies charged with creating and promulgating these rules and standards have adopted ‘precaution’ as their mantra. Each of the North Atlantic Salmon Conservation Organization (‘NASCO’),[49]
the International Council for the Exploration of the Seas (‘ICES’),[50]
and the UN Food and Agriculture Organization has gotten directly involved in the business of safeguarding the seas from unwanted infiltration by GM fish. In 1997 the Council of NASCO, being its governing body, agreed to certain guidelines relating to the development of transgenic salmon.[51] The NASCO Guidelines obligate Convention parties to, among other things, ‘take all possible actions to ensure that the use of transgenic salmon, in any part of the NASCO Convention Area, is confined to secure, self-contained, land-based facilities’ and to ‘advise the NASCO Council of any proposal to permit the rearing of transgenic salmonids and provide details of the proposed method of containment and other measures to safeguard the wild stocks’.[52] In September 1995 ICES enacted its Code of Practice on the Introductions and Transfers of Marine Organisms,[53]
which requires that ‘wherever feasible, initial releases of GMOs be reproductively sterile in order to minimize impacts on the genetic structure of natural populations’.[54] The Royal Society Report noted that the:
Working Group of ICES that deals specifically with transgenic organisms issued, in 1997, a qualifying recommendation that ‘[u]ntil there is a technique to produce 100% sterilization effectiveness, GMO[s] should not be held in or [in] connection with open water systems.[55]
The ICES Code also imposes a requirement to notify member countries prior to the intentional environmental release of a genetically modified organism (‘GMO’), encourages establishment of strong domestic measures to protect ecosystems from harmful effects of releases of GMOs and urges members to undertake research to evaluate the effects on the environment of released GMOs. The Code of Conduct for Responsible Fisheries[56] was adopted on 31 October 1995 by the Conference of the United Nations Food and Agriculture Organization. The FAO Code is a non-mandatory instrument that sets out various principles and standards applicable to the conservation, management and development of global fisheries.[57] It is intended to provide a ‘framework for national and international efforts to ensure sustainable exploitation of aquatic living resources in harmony with the environment’.[58] A segment of the FAO Code relates specifically to aquaculture development. One article speaks directly to the issue of protection of the environment from the potentially adverse effects of genetically altered organisms.[59] The ICES Code, NASCO Guidelines and FAO Code constitute non-binding, general obligations on the Canadian government to defend ecosystems and biodiversity from any possible negative implications of transgenic fish. They do not have the ‘force of law’ behind them in the sense they would if embodied in a convention. Having said that, there exists not insignificant moral compunction on Canada to adhere to these rules and guidelines in shaping its domestic approach to regulating transgenic fish.
The Biodiversity Convention[60] and the Cartagena Protocol,[61]
contrary to the ICES Code, NASCO Guidelines and FAO Code, do constitute legally binding obligations on a state upon ratification by that state. The Biodiversity Convention was ratified by Canada in 1992, and as of December 2003 had 188 parties.[62] The Biosafety Protocol entered into force in August 2003.[63] Canada, however, has yet to ratify the Protocol.[64]
The primary purposes of the Biodiversity Convention are:
the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.[65]
The Convention in Article 8 imposes several general obligations that impact on possible future releases of transgenic fish into the environment. Paragraph 8(d) commits Convention parties to ‘[p]romote the protection of ecosystems, natural habitats and the maintenance of viable populations of species in natural surroundings’ and paragraph 8(h) has parties agreeing to ‘[p]revent the introduction of, control or eradicate those alien species which threaten ecosystems, habitats or species’. It is paragraph 8(g), however, that is a ‘direct hit’ in terms of transgenic fish and the environment. It reads:
Each Contracting Party shall, as far as possible and as appropriate … [e]stablish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking into account the risks to human health …
This provision, directly on topic as it may be, is nevertheless so vague as to be capable of multiple interpretations and a wide range of implementary measures.
The Biodiversity Convention, being and intended to be a framework agreement, is noteworthy, at least as far as the present discussion is concerned, not so much for itself as for the biosafety protocol developed under it. The objective of the Cartagena Protocol, stated in its Article 1, is to try to insulate the environment from genetically engineered organisms that might cause harm to it.[66] To what extent does the Protocol affect transgenic fish, particularly their development and production within Canada? The impact is not, at least not directly, that significant. In the view of this author the Protocol is something of a ‘red herring’ when it comes to transgenic fish. First, the Protocol is a trade-based agreement, aimed at controlling the ‘transboundary movement … of all living modified organisms that may have adverse effects on … biological diversity’.[67] The Preamble of the Protocol, at paragraph 9, specifically acknowledges that ‘trade and environment agreements should be mutually supportive with a view to achieving sustainable development’. The Protocol is not much concerned with domestic aspects of biotechnology.[68] Its real focus is the regulation of transboundary shipments of living modified organisms (‘LMOs’) and the impact of those LMOs on recipient states. Second, the Protocol’s orientation, though it does not say so expressly, is to LMOs of the plant world. Plant seeds have the significant feature of being capable of ‘transferring or replicating genetic material’ long after having been detached from their host. They have a post-harvest period during which their categorization as ‘living modified organisms’ is preserved, and they therefore are squarely caught by the Protocol. Transgenic fish, on the other hand, are not ‘living modified organisms’ after having been harvested. Post-harvest, they cease to be ‘living’ as they no longer have the capability of ‘transferring or replicating genetic material’. They become a non-living commodity that is outside the ambit of the Biosafety Protocol. They maneuver around the Protocol’s net. This makes sense given the focus of the Biosafety Protocol on protecting biodiversity from unwanted and uncontrolled infiltration by GM organisms. A dead fish is not a threat to ecological balance. If this view of the application of the Biosafety Protocol is correct,[69] from the Canadian perspective it likely exempts the bulk of future transgenic fish production, certainly at least transgenic salmon, since the industry by all accounts would be geared to the domestic grow-out of fish to market maturity, rather than just the development and production (and transboundary shipment) of eggs, fry and smolt.
To be clear, though, the Biosafety Protocol would have full application to the export of living transgenic fish, regardless of the stage of maturity, from Canada to another country. If the purpose of the export is to achieve the ‘intentional introduction into the environment of the Party of import,’ then the ‘advance informed agreement (AIA) procedure’, referred to in Article 7(1) and described in Articles 8, 9, 10 and 12, becomes applicable.[70] The Protocol is also applicable should Canada be designated as the ‘Party of import’ of living transgenic fish. There seems to be ample protective scope within the Protocol to fend off any unwanted incursions of transgenic fish.[71]
Notwithstanding that the Protocol may have limited relevance to the internal rules regarding the rearing and handling of transgenic fish, Canadian regulators will still have to be cognizant of its framework and requirements. Article 2(1) obligates each ‘Party’ to the Protocol to ‘take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol’. Beyond this over-arching legal duty, practicalities will probably dictate a substantial degree of conformity between specific Protocol obligations (assuming eventual ratification) and Canada’s domestic regulatory regime.[72]
Embedded in many of the debates regarding GM food products, both inside and outside Canada, are concerns about the consuming public having full, accurate and readily available information about those foods. The concerns often seem to be vocalized in demands for mandatory labeling of GM foods. Labeling, however, is only one aspect of the ‘consumer choice’ side of GM food regulation. Indeed, labels come only at the end of a much larger process of scrutinizing a particular GM food for health and environmental safety. Both the CBAC Report and the Royal Society Report put substantial emphasis on regulatory transparency and public involvement in the GM food approval process, and on improved information dispersal to support consumer choice.[73] These areas of emphasis seem to be reflective of international trends. The CBAC Report comments that ‘[i]nternationally, biotechnology regulatory systems are evolving toward increased transparency, often with enhanced opportunities for public input’.[74] Public notification and request for comments procedures are in place, although they vary somewhat, in the United States, Australia and New Zealand.[75] The situation in the United States is noteworthy because it seems to be somewhat skewed in favour of the proprietary interests of biotech developers. The Food and Drug Administration (‘FDA’) in the United States has control of both the food safety and environmental implications of commercialization of transgenic animals.[76]
The FDA’s review process has attracted some criticism for being excessively ‘closed’.[77] At the other end of the spectrum is the European Union, which has more of a focus on openness and public involvement, and less on protecting commercial rights. By way of example, the European Parliament, in February of 2001:
adopted a directive concerning the deliberate environmental release of GMOs that requires assessment reports to be made public and that the public be given an opportunity to comment before the field trials and market approval.[78]
Notwithstanding the differences in current national approaches, at least in principle there does not seem to be too much debate at the international level on the value, vis-à-vis GM foods, of increasing the role of citizen participation in policy formulation, of regularizing and making more transparent the functions of government, and of improving public awareness and the quantity and quality of information made available. These are all viewed as worthwhile objectives, details of implementation to be worked out state-by-state depending on cultural idiosyncrasies, funding availability, and similar factors. It is labeling that stirs up the real dust when one assesses ‘consumer choice’ issues related to GM foods.
As of mid 2002, thirty-five states had mandatory labeling laws in place for GM foods.[79] These states included China, Australia, Japan, Norway, Switzerland and the fifteen states comprising the European Union.[80]
The addition of China, as of 1 July, 2002,[81] to the list of states requiring compulsory labeling of GM food and food products is notable because of the large Chinese population and the resulting implications for its trading partners.[82]
While some ENGOs declare that labeling of GM foods ‘is fast becoming the de facto international standard,’[83] this in fact is something of an exaggeration. There exists powerful international opposition to the drive to force mandatory labeling for all GM foods and food products. The Greenpeace organization points to the United States as the ringleader of the anti-labeling countries. There is no doubt current US policy stands staunchly opposed to mandatory labeling. In response to a draft document (tentatively called Proposed Draft Guidelines for the Labeling of Foods and Food Ingredients Obtained Through Certain Techniques of Genetic Modification/ Genetic Engineering) circulated for a 2002 meeting of the Codex Committee on Food Labeling (‘CCFL’), the United States went on the record as saying:
[f]oods derived from biotechnology are not inherently less safe than other foods … [and] … the United States strongly believes that the Committee should hold in abeyance any further discussion on mandatory process-based labeling until more comprehensive information is available regarding the implications of such labeling, particularly information relating to the costs and impact on international trade.[84]
The position of the United States on mandatory labeling is supported by Argentina and Canada.[85] Those three countries account for 96% of the world’s transgenic crop production.[86] Some environmental interest groups assert that the US/Argentina/ Canada triumvirate opposes mandatory labeling primarily to protect domestic producers/exporters of GM foods.[87] Of course there is truth in this. There are real, significant costs and trade implications associated with mandatory labeling. Most biotech foods currently in commercial production are of the first generation variety and have been on the market for years. What is the point, the triumvirate asks, of forcing producers to spend large amounts of money to re-label? Not only that, the warning label perception would be likely to drive down consumption of explicitly identified GM foods. The common position of the US, Argentina and Canada is not bereft of logic. In the absence of actual health and environmental risks, they say, there is no compelling reason to mark GM foods, and several good reasons (all commercial) not to.
There are clearly deep divergences of opinion in the international forum in connection with the need for mandatory labeling of GM foods. They reflect the complexities of the larger GM food debate. Once a GM food product is assessed and determined to be safe (both for human consumption and the environment), it may be asked why then differentiate between that food and its non-GM equivalent? The answer is framed firmly as a ‘right to know’. Labeling advocates suggest that any adverse implications of GM foods, notwithstanding the most rigorous contemporary testing, may only be identifiable after a long period of time. Consumers who want to avoid those possible implications altogether, it is argued, have the right to do so. There are also members of the public who oppose GM foods on ethical, religious or similar ‘conscientious objector’ grounds. They, too, labeling proponents say, have the right to choose not to consume GM foods.
The consumer choice regulatory issues vis-à-vis GM foods are essentially reducible to a classic contest between commercial interests, on the one hand, and the right of the consuming public to complete information so as to enable thoroughly informed decisions, on the other. The more expansive the information requirements, the more will be the costs and the less will be the profits of the GM food producers. And those GM food producers are, at present, concentrated in a very small number of countries, led by the United States. This has caused a split in the international community between those states favouring full consumer information (including mandatory labeling) and those in opposition. The latter camp includes the GM food producers, such as the US, as well as countries heavily dependent on the GM producing states. The former camp includes the non-GM food producers, who have the luxury of being able to promote consumer rights without having to face serious adverse economic consequences from taking such a policy position.[88] Consumer mobilization, often sparked by efforts of ENGOs, also plays a part in the policy-making decisions of states.[89]
The GM food discourse in the international community highlights two significant conclusions relative to issues of consumer choice.
First, there is currently gridlock within the Codex Alimentarius Commission as to how to proceed with mandatory labeling. This situation is likely to continue for the foreseeable future. The CCFL[90] ‘operates by consensus according to general Codex rules that remain surprisingly undefined’.[91] The United States, Argentina, Canada and others have taken advantage of this situation to drag out labeling discussions year after year. There is no reason to believe this will soon end. The US at present has little incentive to change tactics. The CCFL process permits, almost encourages, interminable procedural maneuvering. Even if that process was amended so as to permit CCFL to formulate recommendations on labeling of GM foods, and the Codex Commission accepted those recommendations, it would not necessarily mean that uniform global labeling practices would follow. No enforcement mechanisms exist for Codex standards. States and non-state entities are free to adopt them, or not. Yet the standards promulgated by the Codex Commission, as indicated previously in this article, do have substantial persuasive force in the international community, and may be adverted to in trade disputes. There exists, as a consequence, strong incentive on the part of GM food producing states to defer for as long as possible the day when the Codex Commission becomes directly seized of the issue. That certainly seems to be the strategy of the US and like-minded states as they continue to hamstring the CCFL process.
The second conclusion about the consumer choice issues highlighted by the contemporary international GM food discourse is that there is still insufficient overall concern about GM foods to bump that discourse to the next level of intensity. First generation GM food products have been with us for a substantial period of time, and have so far presented as nothing other than benign. No broad-based cause for concern therefore exists. This may change when more advanced GM food products, including transgenic fish, near market entry. This approaching wave of next generation GM foods is one of the factors prompting the many studies, internationally and domestically, of regulatory issues. The level of debate over mandatory labeling and other consumer choice issues will undoubtedly heighten as the next generation GM food wave grows nearer. For the present, however, governments generally seem to have ample leeway to formulate domestic policies to accommodate their respective states’ commercial interests with ‘softer’ demands for enhanced consumer information and input.
Trade issues are closely intertwined with food safety and consumer choice (especially labelling) issues. Trade disputes may develop when, for instance, one state adopts laws requiring mandatory identification of domestically consumed GM foods. Exporters to that state are then compelled to incur costs in making their product labels conform, and also face potential reduction of demand for those products ‘stigmatized’ with GM labels. To what extent can a state require incoming GM food products to be labeled as such? That is the critical question. The CBAC answers it, in part, as follows:
Trade agreements allow countries to mandate labeling for reasons of health and safety and to disclose the nutrient content of the product. Labeling for other reasons may be considered a non-tariff barrier to trade.[92]
A state that wishes to export a GM food product must be cognizant of potential barriers and restrictions. To the extent an exporter has a product barred from entry to another state, or has conditions and/or restrictions imposed on that export, international trade rules and regimes come into play. Similar considerations apply to a state wishing to bar or restrict the entry into it of GM food products. With different states taking varying positions on GM foods (and sometimes on types of GM foods), there arises significant potential for abusive application of trade restrictions. A state may move to bar/restrict entry of a GM food product on the ostensible basis of alleged human health and/or environmental safety concerns. Given the many unknowns regarding GM foods, however, such a move could as easily be rooted in disguised protectionism as a genuine concern about health and safety implications.
A state that erects barriers to, or imposes restrictions on, GM food imports may have its actions questioned under international trade agreements to which it is a party. Such agreements may be bilateral or regional multilateral, such as the North American Free Trade Agreement (‘NAFTA’)[93]
or more broadly multilateral. The purpose of this section is to do no more than provide an overview of those elements of the multilateral trade regime that impact most directly on GM foods. The focus is on the agreements falling under the jurisdiction of WTO. Three of the main WTO agreements are the Agreement on the Application of Sanitary and Phytosanitary Measures (the ‘SPS Agreement’) the Agreement on Technical Barriers to Trade (the ‘TBT Agreement’) and the General Agreement on Tariffs and Trade (the ‘GATT’).[94]
Both the SPS Agreement and the TBT Agreement entered into force with the establishment of WTO on 1 January, 1995.[95]
The original GATT dates from 1947.[96] The GATT was updated in 1994 (the ‘1994 GATT’) and became one of the WTO agreements upon the establishment of WTO at the beginning of 1995.[97] The GATT initially was both an agreement and an institution. The GATT institution was superseded by WTO as the world umbrella organization for international trade. The 1994 GATT, the SPS Agreement and the TBT Agreement are applicable to all WTO members.[98] As of April, 2003, that membership totaled 146.[99] The WTO agreements therefore have extensive applicability.
Of the various WTO agreements, it is perhaps the SPS Agreement that is most relevant to international trade in GM foods (and transgenic fish).[100] The SPS Agreement sets out rules relating to the interaction of trade restrictions with human food safety and animal and plant health standards.[101] Its focus is to ensure that consumer protection and disease prevention measures adopted by states, to the extent they inhibit inflow of food products, are capable of reasonable justification. To put it another way, such measures cannot just be contrivances aimed at protecting domestic food producers or otherwise interfering, unwarrantedly, with the free international flow of food products. The definition of ‘sanitary or phytosanitary measure’, included in Annex A of the SPS Agreement, broadly covers any measure applied:
to protect human … life or health … from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs.[102]
The process of genetic engineering is not expressly referenced, nor does it have to be. It is the traits and effects of GM foods that are important, not necessarily the process by which those foods are created.
The SPS Agreement permits states to use different standards and methods of inspecting food products. However, the Agreement strongly encourages international harmonization.[103] In terms of human health standards, the Codex Alimentarius Commission is expressly identified[104] as the international organization of primary import. WTO member states are obligated to participate fully, to the extent of their resources, in the Codex Commission’s development and promotion of food standards, guidelines and recommendations.[105]
Countries are permitted to use measures that result in higher standards than those in general international application only if there is scientific justification for doing so or such higher standards are based on approaches that are not arbitrary or inconsistent. There is, though, a heavy emphasis in the SPS Agreement on the application of scientific evidence and criteria, ‘taking into account risk assessment techniques developed by the relevant international organizations’, and on the minimization of negative trade effects. To the extent relevant scientific evidence is insufficient, Article 5(7) entitles a member state to provisionally adopt sanitary or phytosanitary measures based on ‘available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members’. There is, then, some latitude provided to states to enable them to proceed cautiously in the face of uncertainty. This seems to constitute approval of a ‘precautionary approach’, although the need for scientific back-up is never far removed. A member implementing provisional measures in the face of ‘insufficient scientific evidence’ has an onus to:
seek to obtain the additional information necessary for a more objective assessment of risk and [to] review the sanitary or phytosanitary measure accordingly within a reasonable period of time.[106]
Article 7 and Annex B of the SPS Agreement deal with the issue of transparency. These provisions obligate members to notify others of changes in their measures and to provide detailed information on the measures they impose. Any attempt by a member state to set up a disguised restriction on trade would therefore be challenging to uphold.
For GM foods, the application of the SPS Agreement will make an interesting case study. The scientific uncertainty swirling around GM foods suggests that states wishing to restrict GM food imports, based on genuine concerns about human health impacts, may have considerable ability to do so. Only as evidence accumulated by scientific bodies increases (assuming it is benign), and international standards become broadly harmonized, might states continuing to zealously restrict imports of GM foods encounter problems with the enforceability of their measures. In the event of a dispute between states, the WTO’s full range of dispute settlement procedures comes into operation (Article 11 of the SPS Agreement). These include formal consultation, good offices, conciliation, mediation and arbitration.
Although trade disputes involving GM foods have so far been rare,[107]
the labeling area may turn out to be the more fruitful one for such disputes. Rather than imposing an outright ban on GM foods, which ban a state might have difficulty upholding in adjudication, the tactic of choice may be to set up a mandatory labeling system. Even for a GM food which, based on a preponderance of evidence, is of little risk to human health, there will always (at least for the foreseeable future) exist some uncertainty. Let individual consumers make the final choice, say wary importing states. Whether this type of approach is based on genuine concern for health and safety, or is a disguised trade barrier, would have to be discerned on a case-by-case basis. European labeling rules that impede the export from North America of GM foods may provide the first good opportunity for the WTO dispute settlement regime to grapple with the complexities of GM food trade issues.[108] Other WTO food dispute decisions may, of course, help shape the outcome of those that develop specific to GM food products.[109]
Before leaving the discussion of some of the trade issues facing GM foods, it is appropriate to return briefly to the Biosafety Protocol. As discussed earlier, the Protocol is a strange hybrid that aims at trade facilitation in concert with environmental protection. As such, it does not apply significant restrictions to many GM foods being moved between states. That is because such foods are not considered to pose an environmental threat if they are destined simply to be consumed or contained. Also, if a GM food is non-living, a harvested salmon for example, the Protocol appears not to apply. As far as transgenic fish are concerned, only fish being moved alive across state boundaries would therefore be subject to the Protocol. It seems to be for other international agreements, particularly the SPS Agreement, to regulate any future international trade in GM foods of the non-living aquatic variety.
The Canadian aquaculture industry is, as mentioned earlier,[110] already fairly substantial. Finfish dominate, and the preponderance of those finfish is salmon. British Columbia (on the Pacific side of the country) and New Brunswick (on the Atlantic side) are, by far, the largest Canadian aquaculture producers, together accounting for 84% of national industry revenues in 2001. The Office of the Commissioner for Aquaculture Development, which comes under the auspices of the federal Department of Fisheries and Oceans (‘DFO’), reports that Canadian finfish production, as forecast by the Canadian Aquaculture Industry Alliance, is expected by 2006 to double from existing levels.[111]
Growth of salmon farming in Canada has not occurred without controversy. On the Pacific coast, in particular, heated debate has run for years about the environmental impacts of using open netcages for farming salmon in coastal waters.[112] The anti-netcage lobby[113] categorizes open netcage aquaculture as a heavy industry that ‘uses publicly owned coastal waters to support intensive private feedlot operations that dump drug-laced sewage into the ocean’.[114]
Opponents criticize netcage farming on a number of bases, including several tied to environmental impacts. The allegations include that:
• crowded conditions make disease and parasitic infections prevalent, which diseases and parasites can transmit to wild stocks via escaped fish and/or farm waste;
• antibiotics and other drugs to prevent/treat diseases and parasites are dumped directly into netcages, and some of those drugs filter through into the natural environment;
• raw fish waste continuously flows out of the netcages into the open ocean contaminating proximate shellfish beds and other marine habitats (and blood and offal from the slaughter of market-ready fish are also deposited into the ocean); and
• escaped Atlantic salmon, which is the species of choice for British Columbia farms, threaten native stocks of Pacific salmon through competition for food and/or breeding
The anti-netcage lobby asserts that the detrimental effects of coastal netcage farming are more than just abstractions, but have real and lasting negative consequences, particularly for those who depend on wild fisheries for food and livelihood. These segments of society include First Nation peoples, commercial salmon fishers and eco-tourism operators. The solution, as far as the anti-netcage forces are concerned, is elimination of all open netcages and their replacement by closed containment systems that treat sewage and prevent escapes and disease transfers, or by secure, land-based fish rearing facilities – both costly alternatives compared to traditional netcages.
The disagreements swirling around salmon aquaculture in British Columbia led to the imposition of a moratorium in 1995 on the establishment of new farms (but not on the expansion of existing operations). That moratorium was lifted on 12 September, 2002. During the 7½ years of the moratorium a number of reports were commissioned to study the issues relating to netcage salmon farming. The most notable of those was a report[115]
resulting from a Commission of Inquiry headed by the Honourable Stuart Leggatt, a retired BC Supreme Court judge. The Leggatt Inquiry Report was issued in November of 2001. The recommendations of the Leggatt Inquiry Report include the removal of all netcage salmon farms from the marine environment by 1 January, 2005 and the application of the ‘precautionary principle’ to the regulation of the salmon farming industry.[116]
It is not the point of this article to expound in any detail on the conventional Canadian aquaculture industry. Two general points do, however, bear relevance. The first is that the industry is large and growing quickly, but compared to the scale of aquaculture in certain other parts of the world is still quite miniscule. This suggests a likely trend toward further rapid growth, especially given Canada’s vast marine resource base, technological sophistication and capital availability. To the extent bio-engineered fish can be used to exploit this growth potential, they will inevitably have enthusiastic proponents. The second point is that the existing industry is not without problems and controversies. The potential commercial introduction of transgenic fish adds a whole new layer to that. However, transgenic fish might also help furnish practical solutions to some of the entrenched issues connected to conventional fish farming methods.
Canada’s existing structures and procedures relating to food regulation involve several federal departments and agencies, each with its own general area of responsibility (although there is some overlap). There is presently no separate and distinct responsible body or procedural approach for GM food products. Health Canada occupies the central role in assuring the safety of Canada’s food supply,[117] and has charge of labeling matters relative to health and safety issues.[118] The Canadian Food Inspection Agency (CFIA)[119] and Environment Canada also play key parts in the regulation of food.
The current human food safety assessment process used by Health Canada apparently is unique. The CBAC Report states that Canada ‘is the only country where regulatory oversight is triggered by “novelty” rather than “process”’.[120] By ‘novelty’ it is meant that a particular food product has novel characteristics compared to existing approved food products. The fact that those novel characteristics are the result of genetic modification is irrelevant. Process, in other words, does not matter. The Canadian approach is therefore anomalous. In contrast to this, ‘some form of “process-triggered” regulation is the rule in all other countries that have developed regulatory systems for GM foods’.[121] Because the initial stage of the Canadian approach to food regulation is fairly sweeping, regulators have invoked ‘unique terminology and definitions’.[122]
Health Canada’s regulatory jurisdiction regarding food safety and related matters comes from the Food and Drugs Act[123] and the regulations made thereunder. The three primary foci for food assessments, whether GM or non-GM foods, are toxicity, allergenicity and nutritional content.[124] GM foods fall under the Novel Food Regulations.[125] These regulations establish ‘important background criteria,’[126] but the ‘more instructive document is that entitled Guidelines for the Safety Assessment of Novel Foods (Health Canada, 1994)’.[127] These Guidelines expressly adopt a threshold test based on comparative analysis. The Canadian approach to the safety assessment of a novel food product therefore starts (and may end) by examining certain attributes of that product against ‘those of its traditional counterpart’. The technical jargon for this is ‘substantial equivalence’. It is identified as lying ‘[a]t the heart of Health Canada’s safety assessment process,’[128] and it comes in for considerable scrutiny and commentary in both the CBAC Report and the Royal Society Report.[129]
Environment Canada, under the Canadian Environmental Protection Act, 1999 [130] (‘CEPA’), maintains ‘overall responsibility for performing environmental risk assessments of new substances manufactured or imported into Canada, including organisms produced through biotechnology’.[131] If, however, an equivalent environmental assessment is mandated by other legislation, Environment Canada is relieved of its responsibility under CEPA. This is how CFIA became responsible for assessing GM plants and their effects on the environment and biodiversity. In a similar usurpation of Environment Canada’s role as the overseer of environmental assessments, DFO is in the midst of developing new regulations under the Fisheries Act[132] to permit it to conduct assessments of all ‘transgenic aquatic organisms’.[133]
Environment Canada administers the CEPA regulations (the New Substances Notification (NSN) Regulations[134]) that pertain to GM organisms. The NSN Regulations require that:
all ‘new’ substances, including products of biotechnology, are reported and assessed for their potential to adversely affect human health and the environment before being manufactured in Canada or imported across its borders.[135]
The NSN Regulations ‘call for information to be provided by the proponent about many aspects of the modified organism’s biological and ecological niche, and concerning potential or actual environmental impacts of its unconfined release’.[136] The Royal Society Report assesses the ‘information requirements as listed in the CEPA regulations [as] quite substantial’.[137] However, it qualifies that comment, further on, by concluding:
based on interviews with Environment Canada officials … the CEPA Regulations have no explicit data requirements for information pertaining to the potential effects on conservation and biodiversity posed by GM animals.[138]
The Royal Society Expert Panel categorized this as ‘a significant weakness in the current legislation’[139] that leaves the:
existing regulatory framework … ill-prepared, from an environmental safety perspective, for imminent applications for the approval of transgenic animals for commercial production.[140]
As things currently stand in Canada, then, any application for the environmental release of transgenic fish would be processed by Environment Canada under the NSN Regulations, such as they are. But until a release into the environment is actually intended, the existing environmental protection regulations do not kick in.
As mentioned above, DFO is drafting new regulations under the Fisheries Act specific to ‘transgenic aquatic organisms’. That work was still ongoing at the time of writing this article.[141] The work follows two major regulatory initiatives undertaken by DFO in the late 1990s. They are the:
• National Code on Introductions and Transfers of Aquatic Organisms;[142] and
• Draft Policy on Research with, and Rearing of, Transgenic Aquatic Organisms (‘DFO Draft Policy’).
The DFO National Code was disseminated in January of 2002. However, that final version appears to have been made inapplicable to transgenic aquatic organisms.[143] Indications are that the DFO Draft Policy has been left to wither, as present effort is directed to completion of the Fisheries Act regulations.[144] The DFO Draft Policy was, in any event, intended only ‘to be used on an interim basis, until specific Regulations are enacted …’.[145] The motivation for the quick preparation of the DFO Draft Policy, according to the Royal Society Report, was the expectation of imminent application for approval of production of transgenic fish, which expectation was premised on the application filed in the US in early 2000.[146] Given its status as the precursor to the Fisheries Act regulations-in-progress, the DFO Draft Policy retains some relevance despite its current dormant state.[147] The primary criticism of the DFO Draft Policy leveled by the Royal Society Expert Panel was in respect of DFO’s recommendations therein in support of the possible use of sterilization techniques to protect the environment from transgenic fish.[148]
The domestic regime in place in respect of consumer choice aspects of Canadian food regulation has already been touched on. It is intertwined with food safety, reduces for the most part to labeling matters, and is in the hands of Health Canada and CFIA.
Trade aspects of the Canadian approach to food regulation are not so much anchored in the domestic regime. With Canada’s perspective on GM foods being a predominantly outward one, trade-related issues are directed and fueled more by what goes on outside Canadian borders than within them. Bilateral and multilateral agreements to which Canada is a party therefore tend to be viewed by it as ‘swords’ rather than ‘shields’, at least in so far as GM foods go. The WTO agreements are especially significant. The low-restriction trade philosophy generally espoused in those agreements aligns well with Canada’s natural disposition, as one of the world’s leading food producers (both GM and non-GM), to promote the free transborder flow of food products. Lobby groups, particularly in the agriculture and agri-food industries, work with federal departments (most notably International Trade) to try to minimize restrictions on GM foods moving out of Canada. GM food producers have a double hurdle. First they must get their products approved domestically. Then they need to comply with varying external requirements. As those external requirements become more numerous and complex, producers become more disinclined to grapple with them.[149] They turn their focus to markets of less resistance. This is the plight of the GM food producer in Canada, one that will be inherited by those working with transgenic fish.
International harmonization of standards would undoubtedly be enormously beneficial to Canadian exporters of GM foods. To the extent health and labeling matters can be addressed at the global level, trade issues specific to GM foods recede. This, of course, is easier said than done. The debate over mandatory labeling indicates how entrenched the sides can be. The position taken by Canada in CCFL discussions shows its appreciation of the economic concerns of domestic producers of GM foods. However, calls for labeling from other domestic sources, together with a coalescing of international opinion (particularly in the European Community), highlight the volatility of the situation. There can be little doubt that trade issues will proliferate so long as food safety and consumer choice debates rage on. The latter largely control the former.
So how do transgenic fish fit into the existing Canadian regulatory regime, especially in respect of food safety, environmental protection, consumer choice and trade? The answer is relatively straightforward. At this point no special arrangements have been made for transgenic fish. The new Fisheries Act regulations will address the environmental implications associated with research and rearing of transgenic aquatic organisms. Precisely how this is done remains to be seen. Except for this activity in the area of environmental protection no other aspect of the Canadian regulatory regime applicable to GM foods differs materially for transgenic fish. The regime is geared towards plants and seeds, however very little tweaking would be necessary in order to accommodate food products made from transgenic fish. Such products would have to undergo the same food safety and nutrition assessments, based on whatever standards are ultimately accepted for GM foods generally, and would also be affected by the same consumer choice issues as other GM foods. As already alluded to, however, the current Canadian regulatory regime is likely headed for substantial modification.
With attitudes evolving and initiatives developing around GM foods at the international level, as well as domestically, the big question for Canadian transgenic fish producers is how will all this affect existing regulatory structures and procedures, and to what extent can and will those structures and procedures, in turn, be adapted to accommodate commercial production of transgenic fish? The previous section of this article, for example, made reference to new Fisheries Act regulations being drafted for transgenic aquatic organisms. The precise shape those regulations take will reflect the level of Canada’s commitment to safeguard the environment from such organisms. The discussion in this section returns to each of the regulatory areas of food safety, environmental protection, consumer choice and trade to offer some specific comments on what may be in store for transgenic fish farmers in Canada.
The issue of GM food safety is a deceptively complex one. At its heart is the question: ‘How safe is “safe”?’ The answer to that ultimately depends on the perspective of the poser of the question. As indicated in the first part of this article, there is no international consensus to use for guidance. Viewpoints span the spectrum, ranging from FAO which endorses ‘substantial equivalence’[150] and generally promotes the careful use of GM foods to help address the immediate needs of global hunger, to some developed states which use a broad brush in categorizing GM foods as inherently risky and unnecessary.[151] Canada, as an active member of the international community, must factor in these viewpoints in shaping its own approach to regulating the safety aspects of GM foods.
Canada is a ‘major importer and exporter of primary, intermediate and final food products,’[152] and the gradual infiltration of GM products into the global food supply therefore has significant ramifications for Canadian producers and consumers. As the world continues to shrink, Canada cannot, even if it wanted to, insulate its internal policies from those developing outside its borders. The astute tactic is therefore to use all reasonable means to affect what is evolving on the international scene. There appears to be broad recognition and acceptance of this approach in government. The indications are everywhere. A good example is Canada’s very active involvement in the efforts of the Codex Alimentarius Commission to develop internationally accepted standards for the safety and identification of GM foods. In the labeling context, the CBAC has noted the importance of taking this type of internationalist approach.[153]
Indeed, the significance of synchronizing Canada’s domestic GM food policies with those of the rest of the world is a recurring theme in both the CBAC Report and the Royal Society Report. International trends, approaches and initiatives are continually referred to and examined for relevance to Canada.
The emergence of the precautionary principle is perhaps the most noteworthy of those international developments.[154] The CBAC Report and the Royal Society Report advocate the employment of considerable caution in Canada’s development of standards of assessment for ‘next generation’ GM foods.[155] The Royal Society Report recommends:
the precautionary regulatory assumption that, in general, new technologies should not be presumed safe unless there is a reliable scientific basis for considering them safe.[156]
The CBAC Report recommends:
regulatory authorities take a precautionary approach to all stages of development and commercialization of a GM food (laboratory research, confined field trials, pre-market risk assessment and post-market surveillance …).[157]
Both Reports support the maintenance and strengthening of a risk-based approach to the assessment of GM foods based on rigorous scientific testing and evaluation, and pre-scheduled reviews of product approval decisions.[158] The Royal Society Expert Panel recommends that CFIA ‘develop detailed guidelines describing the approval process for transgenic animals intended for … food production …’.[159] All of this suggests more demanding and regimented assessment procedures for new GM foods than have been applied to ‘first generation’ products.[160] And the Reports recommend that the developers of biotech foods bear the burden (and cost) of ‘carry[ing] out the full range of tests necessary to demonstrate reliably that they do not pose unacceptable risks’.[161]
Transgenic fish producers will be caught by this toughened future regime. Canadian policy makers have difficult choices ahead.[162] There will be a natural predilection to look to broadly accepted international standards. The Codex Alimentarius Commission will be key. Canada undoubtedly will continue its strong participation in the work of the Codex Commission, and will probably adopt standards for GM foods as sanctioned by that organization. The reasons for this prediction are twofold. First, given the competing mandates of the Codex Commission itself (protection of human food safety and promotion of fair, free-flowing international trade and, indirectly through FAO, of world food security), the GM food standards advocated by the Commission are likely to strike a reasonable balance. For Canada, faced with similar pressures, the path of least resistance, and the one easiest to justify to domestic parties with interests in the regulation of GM foods, may be one that runs parallel to that of the Codex Commission. Second, as a leading global producer and exporter of GM foods, Canada will be strongly influenced to go with safety standards that are at least as rigorous as those of the Codex Alimentarius Commission. That strategy will probably keep Canada ‘on side’ in respect of its own international trade commitments, and provide to it serious ammunition in any trade disputes that may arise with states taking extreme protectionist stances.
The great uncertainty regarding the environmental effects of transgenic fish has led to a relatively high degree of consensus amongst all interested parties on the need to take meaningful steps to protect marine ecosystems. Fish obviously live in an environment very different from, say, canola. They also reproduce differently, self-propel and are carnivorous. A host of unique environmental issues consequently come into play for fish. This prompted the only recommendations in either the CBAC Report or the Royal Society Report directed specifically at transgenic fish.[163]
The central recommendation of the Royal Society Report, at least in so far as transgenic fish are concerned, is that it would be ‘prudent and precautionary to impose a moratorium on the rearing of GM fish in aquatic facilities’.[164] This recommendation is based on:
the paucity of scientific data and information pertaining to the environmental consequences of genetic and ecological interactions between cultured and wild fish …;
the difficulty … in being able to use laboratory research to predict environmental consequences reliably …; and
the unpredictable nature of complex pleiotropic effects of gene insertions.
In addition to the moratorium, the four other substantive recommendations of the Royal Society Report relating directly to transgenic fish, all of an environmental protection nature, are that:
[a]pproval for commercial production of transgenic fish be conditional on the rearing of fish in land-based facilities only …;
[r]eliable assessment of the potential environmental risks posed by transgenic fish can only be addressed by comprehensive research programs devoted to the study of interactions between wild and cultured fish …;
[p]otential risks to the environment posed by transgenic fish must be assessed not just case-by-case, but also on a population-by-population basis …; and
[i]dentification of pleiotropic, or secondary, effects on the phenotype resulting from the insertion of single gene constructs be a research priority … .[165]
Canada’s existing international commitments, both moral and legal, serve only to reinforce the positions vocalized by the Royal Society Expert Panel. It would be very difficult for Canada to adopt anything but an environmentally protectionist position on transgenic fish. To do otherwise would run afoul the obligations encapsulated in the Biodiversity Convention, the Biosafety Protocol (assuming ratification), the ICES Code, NASCO Guidelines and FAO Code. From the perspective of transgenic fish developers, much energy must surely now be focused on creating efficient and foolproof sterility techniques. To the extent those developers can offer 100% sterile GM smolt and fry to rearing facilities, many of the environmental concerns unique to transgenic fish melt away. Guaranteed sterility also puts back into play the possibility of raising transgenic fish in ocean-based nets or cages, a more economically attractive alternative to fish farmers. It does not, however, completely clear the way for ocean-based facilities. Environmental concerns still exist regarding sterile fish released into natural ecosystems. An issue paper on transgenic fish recently published by the Pew Initiative on Food and Biotechnology[166] summarizes the concerns as follows:
Even if sterility could be assured, release of triploid fish into the environment presents certain hazards. Triploids of some species, while sterile, still have enough sex hormones in their bloodstream to enter into normal courtship and spawning behaviour. Escaped sterile triploid fish could interfere with the reproduction of wild relatives by mating with fertile wild adults would be reproductive interference of declining, threatened, or endangered species.[167]
It will be interesting to see what emerges in the new Fisheries Act regulations. If those regulations should take anything but an ultra cautious approach to protecting the environment, the ire of many will be aroused and Canada’s commitment to its international obligations will be called into question.[168]
Both the CBAC and the Royal Society Expert Panel grappled extensively with the new reality of how best to uphold the consuming public’s right to full information and choice when it comes to GM food products. One of the four themes of the CBAC Report is ‘Information and Consumer Choice’. The Royal Society Report similarly includes a discussion on the pros and cons of mandatory labeling. Indeed, the whole ‘consumer choice’ issue, for practical purposes, very much boils down to a matter of labeling. To label or not to label is the question. The CBAC Report suggests that it would be premature for Canada to adopt a mandatory labeling scheme prior to ‘an agreed-upon Canadian standard [being] developed and tested’.[169] The Report also reiterates that, whether voluntary or mandatory, a ‘single internationally accepted standard is highly desirable and perhaps essential in the longer run’.[170] The CBAC Report recommends that Canada ‘establish a voluntary labeling system for foods with GM content based on a set of clear labeling criteria, derived from a broadly accepted standard’.[171] The Report further recommends enhancement of Canada’s ‘continuing effort, in concert with other countries, to develop a harmonized approach to labeling in regard to GM foods … .’[172] The Royal Society Expert Panel also supported a voluntary system of GM food labeling.[173]
The labeling debate is not simply a matter of having the ‘right to know’, as some environmental groups (such as Greenpeace Canada) argue.[174] It is intimately connected to both trade and food safety issues. On the one hand, detailed labels have the potential to obviate some food safety issues. For example, a GM food product to which a small section of the population may be allergic could be properly identified as such and still allowed to enjoy broad market distribution (similar to how nut products are currently handled). On the other hand, to the extent Canada’s labeling laws are out of step with those of its major trading partners, serious economic woes will certainly ensue. In this respect, the position of the United States is critical. It is difficult to imagine Canada adopting labeling rules different from the rules of the US.
The CBAC recommended that any voluntary labeling system be subjected to review in five years to determine whether it has in fact given consumers an adequate degree of choice.[175] If it has not, other approaches, including mandatory labeling, would then be assessed. The Canadian Council of Grocery Distributors and the Canadian General Standards Board are apparently in the process of together developing a Canadian standard for the voluntary labeling of GM foods.[176]
All things considered, it seems quite probable that Canada will see a voluntary labeling system in place for GM foods within the not-too-distant future. Mandatory labeling is liable to be many years off, if ever, unless there is some drastic and unforeseen occurrence, such as the US changing its stance or the Codex Alimentarius Commission deciding to support mandatory labels (and, given CCFL politics, the latter is extremely unlikely without the former). There is no good reason to believe that the approach to labeling for transgenic fish will be any different from that generally applicable to GM foods. As a new product, transgenic fish producers will have no recourse to the argument that they cannot absorb the costs of re-labeling. In fact, it can be anticipated that GM fish farmers may, from the outset, embrace labeling as a means of pre-emptively defusing at least one of the controversies associated with their product.
It is obvious from the discussions and recommendations of the CBAC and the Royal Society Expert Panel that both those bodies were very sensitive to the economic repercussions that would flow from any sharp change in domestic policies affecting trade in GM food products. Of particular concern, of course, is the substantial export market in ‘first generation’ foods that already exists. As a world leader in GM food production, and also as a pioneer in research and development of ‘next generation’ GM foods, Canada has a great deal to lose from domestic regulations that do not dovetail with international requirements. As such, at least judging from the CBAC and Royal Society Reports, any revamping of Canada’s regulatory regime for GM foods must involve a continual questioning of the impact on trade obligations and relationships.
Trade issues are not driving the current GM food discourse in Canada. It is health, environment and consumer choice concerns which act as catalysts. Trade is just along for the ride. However for every health, environmental and consumer choice policy proposal, there almost inevitably is an implication for Canadian trade. Canada’s obligations under numerous international agreements, the WTO agreements being the most important, trigger a need for constant vigilance in respect of domestic initiatives. Federal government departments like Industry, Agriculture and Agri-Food, and International Trade have mandates not only to protect Canadian exports, but also to try to augment them at every opportunity.
When it comes to trade issues, the Canadian strategy relative to the export of GM foods is two-pronged. First, do not let domestic tinkering adversely impact on the economic benefits derived from exports. Second, do whatever can be done within international organizations to regularize rules and standards to protect and enhance the free outflow of Canadian products. It is significant that Canadian policy formulation to date in respect of application of the precautionary principle has a distinct pro-trade bias.[177] On the import side, there does not seem to be great concern that Canadian consumers might be exposed to unsafe GM products from abroad or Canadian producers to a flood of cheap imports. The combination of international and domestic safeguards makes these scenarios seem unlikely, at least for the time being. Besides, as one of the world’s handful of major GM food developing countries, there are few other states with the capacity to target Canada with GM products.
Transgenic fish appear destined to be caught in the slipstream of general Canadian trade policy relating to GM foods.
The one thing that can be said with certainty about the existing regulatory regime for GM foods in Canada is that it will see many significant changes in the next several years. Technological advances, if nothing else, will compel change. Other forces are at play, though, besides technology. There is growing consumer awareness at home and GM conservatism abroad. There is the reality of economic gain and the potential of enhanced world food security (forces sometimes, oddly enough, running on parallel courses in the GM food debate). There are concerns about ethics, religion and globalization. There is a broad commitment to ensure human-made organisms do not run amok in the natural world, causing perhaps irreparable damage. Canadian policy makers must sort through all this and come up with a plan that strikes a balance between the protection and promotion of multiple domestic interests and the honouring of multiple international commitments. The task is a formidable one.
Transgenic fish, whose technology is just emerging from the pipeline, find themselves in the middle of the GM food fray. Such fish, or products made from them, will be treated with at least as much caution and trepidation as ‘next generation’ GM foods derived from plants. A Canadian producer of transgenic fish can therefore anticipate encountering difficulties on many fronts; so much so, in fact, that it seems doubtful such a product will land on grocery shelves any time soon.
The main impetus to commercial production of GM fish is economic - the promise of hefty profits. Lined up in opposition are the various non-economic factors discussed in this article. To the extent the economic incentive is strong, some or all non-economic factors may be mitigated or overcome. It is like bowling: the larger and more powerful the economic ball, the more readily non-economic pins can be scattered. That seems to be the way of the modern regulatory state. Humans follow their innovative urges (often tied in with profit seeking) far and wide, usually reined in only by laws designed to buffer their fellows and the (shared) environment from the worst consequences of those urges. If not for those urges, of course, most of us would still be leading ‘short and brutish’ lives. Improvement of the human condition is a laudable and never-ending quest, but care and consideration are necessary counter-balances – particularly when pursuit of profit is the central motive underlying a specific ‘improvement’ effort.
The primary economic attribute of transgenic fish is their extraordinarily enhanced growth rates.[178] The raw profit potential is enormous. That expedited growth, though, does not necessarily translate into pure profit. Faster growing fish bring significantly higher costs: fish feed, labour and transportation, to name just some. And then there are the capital start-up costs. Land-based rearing facilities, if mandated, do not come cheap (even if government helps out, which is the Canadian way). The cost of research and development has to be recuperated, and the costs associated with obtaining regulatory approvals must be offset. When the product goes to market, chances are it will have a ‘GM’ label on it. Sales may, as a result, not be so robust as hoped. And the price fetched for GM fish, compared to the ‘natural’ counterpart, is likely to be lower, perhaps substantially. Then there are the costs and headaches of dealing with the export of such a product to recipient states that may be just as happy not to have it. Ultimately, the economic ‘ball’ represented by transgenic fish may not be large enough, or have sufficient steam behind it, to knock over many (or any) non-economic ‘pins’.
There are two big ‘wild cards’ for the nascent Canadian transgenic fish industry. One is essentially technological, the other geopolitical.
On the technology side, it has been noted that GM research has the potential to make fish that have positive attributes other than enhanced growth. The growth-enhanced salmon already developed apparently are more efficient feeders than their non-GM cousins.[179] This has important environmental implications, since most fishmeal is made from small wild fish without much market appeal. It is generally accepted that it takes more than a pound of wild fish, reduced to feed, to produce every pound of farmed fish. That raises ‘concerns that aquaculture might fail to yield a net gain of fish protein for the world’.[180] There is obviously something inherently disturbing about this. If it is accurate, it means the fish farm that is often viewed as friendly to the wild fishery is actually directly contributing to its ongoing depletion. GM fish, if they are more efficient at feed conversion than non-GM fish, could help reverse this negative impact on wild stocks (assuming that overall production remains constant, which, of course, is not what GM fish producers have in mind – expedited growth cycles are supposed to bring large increases in the total amount of farmed fish brought to market).
Aside from the feed conversion factor, GM technology could result in fish that are in several ways truly more benign vis-à-vis the natural environment. A GM fish could be produced efficiently using grain-based fishmeal, thus resulting in a very positive impact on wild fish. A GM fish could be produced that is disease resistant, thus reducing or eliminating the need to feed antibiotics to farmed fish and thereby rendering them more ‘organic’. Similarly, a more ‘organic’ fish would be one that is genetically programmed to handle pests (such as sea lice), bringing about reduction or elimination of the application of pesticides to farmed fish. The right combination of genetic tinkering could, hypothetically, create a fish that is something of an environmental ‘superhero’. If such a scenario should unfold, it would surely strengthen the position of transgenic fish proponents.[181]
On the geopolitical side, the key word is ‘America’. For Canadian GM fish producers, the United States has the potential to add much critical mass to the economic ‘ball’, and to propel it down the lane with considerable force.[182] The size of the American market, the apparent lack of widespread aversion to GM foods (unlike in Europe) and the existing degree of integration of the two economies, makes the US consuming public the logical target of the Canadian-based GM fish producer. After all, Americans already account for the bulk of Canada’s annual aquaculture exports.[183] And the FDA application submitted in 2000[184] means American approval may predate any Canadian approval eventually sought. In fact, with a green light for transgenic fish in the US, full Canadian approval perhaps becomes secondary. Transgenic fish rearing facilities in Canada could service the US market, turn a healthy profit and be disinclined to get caught up in a Canadian system that is not as ‘producer friendly’ as the American one. This, however, will generate even more pressure for Canadian regulatory authorities to align themselves with the US approach. Such pressure would become particularly acute with the passage of time and no evidence of significant adverse effects by transgenic fish on human health or the environment.[185]
The American situation therefore seems to be central both to Canada’s future transgenic fish production industry and to the tone and content of its evolving regulatory regime for transgenic fish.[186] The Canadian market is not large enough to itself overcome the many issues attached to GM fish. Other potentially lucrative markets, such as those of Europe, are presently too problematic. The regulatory path in Canada is strewn with numerous impediments. Policy makers can equivocate around ‘precaution’ indefinitely, and may do so. Only political will can clear the path. Political will is most often fueled by economics. Without a strong push from the economic side, which in all likelihood must be an American push, Canadian-produced transgenic fish probably will be swimming many circles for years to come.
This may be seen as a good or bad thing, depending on one’s perspective and the relative weight one assigns to economic versus non-economic factors. If a guess had to be ventured, it would be that economics (perhaps strengthened by GM food’s promise to enhance global food security and any future technological breakthroughs) ultimately will come out victorious and transgenic fish will leap into the North American food supply. A finding of adverse health implications will stop this process in its tracks. Otherwise, human faith in its ability to self-regulate and control risks likely will prevail. Of course, history shows that humankind is not particularly adept at self-regulation. The ecosystem threats possibly presented by transgenic fish represent an area of focused concern. Regulation can never fully corral human greed, ignorance and carelessness. With only a few transgenic fish perhaps having the capacity to cause serious, irreversible disruption in the world’s oceans, it seems environmental protection may in the long run be the one significant piece of the regulatory puzzle that proves the most difficult to fit snugly into place. Canadians tend to give environmental issues a relatively high priority. One can therefore anticipate insistence upon rigorous steps to protect the environment from any negative impacts of transgenic fish.
[*] Assistant Professor, Dalhousie University, Faculty of Law, Halifax, Nova Scotia, Canada. Research support was provided by AquaNet, a Centre of Excellence Network for Aquaculture in Canada, based at Memorial University, and funded by the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada through Industry Canada. I would like to thank Professor David VanderZwaag for his helpful comments on and criticisms of the work that forms the basis of this article. A modified version of this article is to be included in David VanderZwaag and Gloria Chao (eds), Aquaculture Law and Policy: Towards Principled Access and Operation (forthcoming in 2004).
[1] ‘The International Service for the Acquisition of Agri-biotech Applications estimates that the global area of transgenic crops in 2001 was about 53 million hectares, a more than 30-fold increase since 1996, grown by 5.5 million farmers in 13 countries.’ – Canadian Biotechnology Advisory Committee, Report to the Government of Canada Biotechnology Ministerial Coordinating Committee, Improving the Regulation of Genetically Modified Foods in Canada (2002) 5, online: http://www.cbac-cccb.ca/epic/internet/incbac-cccb.nsf/vwapj/cbac_
pdf/$FILE/cbac_report_e.pdf (date accessed: 17 December 2003) [CBAC Report].
[2] Ibid 34.
[3] ‘With the expected availability of genomic information for many species in the next few years, the floodgates of genetic modifications could open and release on the market an unprecedented variety of genetically enhanced products.’ – Royal Society of Canada, Expert Panel Report on the Future of Food Biotechnology, Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (2001) 14 online: http://www.
rsc.ca/foodbiotech
nology/GmreportEN.pdf (date accessed: 06 March 2003) [Royal Society Report].
[4] Ibid.
[5] CBAC Report, above n 1, 24-25.
[6] There are variations on the definition of ‘transgenic’. The following is taken from the ‘Definitions’ section of Canada’s National Code on Introductions and Transfers of Aquatic Organisms (2002) online: http://www.dfo-mpo.gc.ca/science/aquaculture/code/prelim._e.htm
(date accessed: 01 December 2003) [DFO National Code]: ‘Transgenic organisms – Organisms bearing within their DNA, copies of novel genetic constructs introduced through recombinant DNA technology. This includes novel genetic constructs within species as well as interspecies transfers. Such organisms are usually (but not always) produced by micro-injection of DNA into newly fertilized eggs.’
[7] CBAC Report, above n 1, 25.
[8] Royal Society Report, above n 3, 25, 26. There exist various novel gene constructs that have been, or probably will be, the subject of finfish research. Genetically superior fish could have characteristics such as improved growth rates, feed conversion efficiencies, disease resistance, cold and freeze resistance, tolerance to low oxygen levels and the ability to utilize low-cost or non-animal protein diets (ibid 27).
[9] Ibid 27.
[10] Ibid.
[11] The ‘first application to be made in North America for the commercial production of a transgenic fish … was made in early 2000 in the United States [to the Food and Drug Administration] …’ (Royal Society Report, above n 3, 27). As of July, 2003, that application remained active, with assessment work ongoing and no decisions having been made. Also as of July, 2003, no parallel application had been submitted in Canada (personal communication, 11 July 2003, from E Entis, CEO of AQUA Bounty Technologies Inc, below n 22).
[12] The CBAC is a creation of the Government of Canada. It is a body comprised of independent experts whose mandate it is to assist the federal Government in the formulation of public policy on various biotechnology matters. Advice from the CBAC flows to the Biotechnology Ministerial Coordinating Committee, which consists of the federal ministers of Industry, Agriculture and Agri-Food, Health, Environment, Fisheries and Oceans, Natural Resources and International Trade (CBAC website: http://www.cbac.cccb.ca
).
[13] The Royal Society of Canada, The Canadian Academy of the Sciences and Humanities, is a national body of distinguished scholars and scientists. As of November 2003 it consisted of about 1800 Fellows. The Royal Society’s main goal is the promotion of learning and research in the natural and social sciences and in the humanities. One of the functions of the Royal Society is to provide independent expert advice, typically to government, on public policy issues through its program of Expert Panel reports (Royal Society website: http://www.rsc.ca).
[14] Article 2 of the United Nations Framework Convention on Biodiversity, 5 June, 1992, UN Doc UNEP/bio. Div/N7-INC.514, reprinted in (1994) 31 ILM 818, online: http://www.biodiv.org
/default.aspx [‘Biodiversity Convention’] defines ‘biotechnology’ as ‘any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use’.
[15] Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report’ (2001) online: http://www.hc-sc.gc.ca/english/pdf/RSC_response.pdf (date accessed: 9 March 2003) [‘Action Plan’].
[16] ‘Progress Report – Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report’ (2002) online: http://www.hc-sc.gc.ca/english /pdf/royalsociety/progress_report.pdf [‘Progress Report #1’]; ‘Progress Report – Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report’ (2002) online: http://www.hc-sc.gc.ca/english/pdf/royalsociety/progress_report_may.pdf [‘Progress Report #2’]; ‘Progress Report – Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report’ (2002) online: http://www.hc-sc.gc.ca/english/pdf/royalsociety/DecProgReportE.pdf [‘Progress Report #3’]; ‘Progress Report – Action Plan of the Government of Canada in response to the Royal Society of Canada Expert Panel Report’ (2003) online: http://www.hc-sc.gc.ca/english/protection/ royalsociety/progress_report_june.html [‘Progress Report #4’] [Progress Report #1, Progress Report #2, Progress Report #3 and Progress Report #4, ‘Progress Reports’].
[17] In Canada, the GM food controversy has manifested itself in several ways. The CBAC Report, above n 1, 11, chronicles the developments on the domestic front during the period of its project. These included a Private Member’s Bill (Bill C-287) to amend the Food and Drugs Act, RSC 1985, c F-27, to require the labeling of GM foods. The Bill was defeated in the House of Commons. There have also been numerous developments on the international front that have helped to foment, and have partially driven, the domestic debate.
[18] CBAC Report above n 1, 10.
[19] ‘At present, a relatively small number of companies hold the vast majority of plant biotechnology patents and an increasing share of the GM food market. This market dominance and concentration of economic power is seen by some as a source of diminished self-sufficiency in food production and a threat to the sovereignty of some underdeveloped countries. Others regard this industrial structure as a necessity due to the time and expense involved in developing products from the research stage through regulatory approval’ (ibid 44).
[20] ‘Biotechnology provides powerful tools for the sustainable development of agriculture, fisheries and forestry, as well as the food industry. When appropriately integrated with other technologies for the production of food, agricultural products and services, biotechnology can be of significant assistance in meeting the needs of an expanding and increasingly urbanized population in the next millennium.’ – United Nations Food and Agriculture Organization, ‘FAO Statement on Biotechnology’ (2000) online: http://www.fao.org/biotech/stat.asp (date accessed: 18 December 2003) [‘FAO Biotechnology Statement’].
[21] Much of the increased public awareness of GM foods and food products and the issues related to them have been catalyzed and focused by environmental non-governmental organizations like Greenpeace Canada. Greenpeace Canada in the last couple of years has showcased GM foods as one of its top issues. It recently launched a website to inform consumers of the products on their grocery shelves that contain GM ingredients (http://www.greenpeace.ca ).
[22] See, eg: J van Aken, ‘Genetically Engineered Fish: Swimming Against the Tide of Reason’ (2000) 5 online: http://www.greenpeace.ca/e/campaign/gmo/documents/swimming_ 12_00.pdf (date accessed: 4 December 2003) [‘Swimming Against the Tide’]. The website of AQUA Bounty Technologies Inc is http://www.aquabounty.com
(date accessed: 18 December 2003).
[23] ‘The [aquaculture] industry reported total operating revenues of $704.5 million in 2001 … Of that, finfish, mostly salmon, accounted for $602.0 million, or almost 90% of total sales … During the last decade, the export market has consistently expanded, driven in large part by demand for salmon in the United States. In 2001, the value of aquaculture exports, which totaled $444.3 million, increased 17% from the previous year, more than triple 1992 levels.’ – Statistics Canada-Agriculture Division, ‘Aquaculture Statistics, 2001’ (2002) 2 online: http://www.statcan.ca (date accessed: 17 March 2003). The predicted growth of Canada’s aquaculture industry is premised on several factors, including: (1) the availability of large marine areas for exploitation by commercial aquaculture interests; (2) the willingness of small, often isolated communities to embrace aquaculture production facilities, particularly in light of decreased participation in traditional fisheries and the paucity of other localized economic opportunities; (3) the proximity of a huge, increasingly health-conscious US market; and (4) active encouragement, sometimes manifesting as undisguised promotion, of aquaculture by both federal and provincial governments. Much of the governmental support for aquaculture flows from the perceived economic benefits associated with the industry, which benefits are often tied into the first three of the preceding factors (availability of marine areas, support of local communities and positive market features) by both industry proponents and government spokespeople. At the federal level in Canada, aquaculture is promoted by the Office for the Commissioner of Aquaculture Development, which falls under the auspices of the Department of Fisheries and Oceans. Aquaculture is also promoted at the provincial level in most provinces. In Nova Scotia, by way of example, it is championed by the Department of Agriculture and Fisheries. Even a cursory review of the websites for these two government departments (http://www.gov.ns.ca/nsaf/aquaculture/radac/index.ht
and http://www.ocad-bcda.gc.ca/ehome.html
, respectively) discloses that development of the industry, in the pure economic sense, occupies the central and paramount policy position for these particular departments. The Nova Scotia Department’s website states, for instance, that ‘[a]quaculture offers one of the best opportunities for economic development in coastal areas … [and] [t]he government strongly supports the development of this sustainable long term industry’. – ‘Regional Aquaculture Development Advisory Committees (RADACs) – Background Information’ 1 (date accessed: 16 March 2003).
[24] CBAC Report, above n 1, 9.
[25] The Codex Alimentarius Commission was created in 1963 by the Unitied Nations Food and Agriculture Organization and the World Health Organization to ‘develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme’. The stated primary purposes of the Joint FAO/WHO Food Standards Programme are ‘protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations’ – online: http://www.codexalimentarius .net (date accessed: 15 March 2003).
[26] CBAC Report, above n 1, 9. Lesser known international bodies include the Secretariat of the International Plant Protection Convention and the International Office of Epizootics (also known as the World Animal Health Organization) (ibid). Additionally, there are bilateral and regional initiatives. These include, by way of example, ‘the network on plant biotechnology for Latin America and the Caribbean (REDBIO) which involves 33 countries’. (FAO Biotechnology Statement, above n 20, 3).
[27] Ibid.
[28] Ibid. Other commentators, such as Greenpeace Canada, vocalize a more cynical view of Canada’s activities at the international level: ‘Canada is one of the world’s worst countries in blocking action on labeling GE [genetically engineered] food … Canada, the US and Argentina are determined to force the world to eat GE food without knowing it – because they grow 96 percent of the world’s GE crops.’ – Greenpeace Canada, ‘Greenpeace in Halifax for Global Meeting on Genetically Engineered Foods’ (2002) online: http://www.greenpeace.ca
(date accessed: 16 October 2002) [‘Halifax Codex Meeting’].
[29] Ibid 12.
[30] FAO Press Release, ‘FAO Stresses Potential of Biotechnology but Calls for Caution’ (2000) online: http://www.fao.org/WAICENT/OIS/PRESS_NE/PRESSENG/2000/pren0017.htm
(date accessed: 15 March 2003).
[31] Ibid.
[32] ‘The Codex Alimentarius Committee on Food Labeling is a United Nations committee which … held its first meeting in 1996 with a mandate to establish guidelines for the labeling of foods derived from biotechnology.’ – Greenpeace Canada, Press Release, ‘What is Codex Alimentarius?’ (2002) online: http://www.greenpeace.ca/e/index.php
[filed under ‘Press Releases’] (date accessed: 18 December 2003).
[33] Codex Alimentarius Commission, ‘FAO/WHO Food Safety Assessments of Foods Derived from Biotechnology’ online: http://www.codexalimentarius.net/biotech.stm
(date accessed: 16 March 2003).
[34] Codex Alimentarius Commission, ‘Biotechnology and Food Safety – The Codex ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology’ online: http://www.fao.org/es/ESN/food/risk_biotech_taskforce_en.stm
(date accessed: 16 March 2003).
[35] Ibid.
[36] Codex Alimentarius Commission, ‘Biotechnology and Food Safety – FAO/WHO Work on the Safety Evaluation of GM Foods’ online: http://www.fao.org/es/ESN/food/risk_biotech_en.stm
(date accessed: 16 March 2003).
[37] Codex Alimentarius Commission, ‘Biotechnology and Food Safety – FAO/WHO Expert Consultations’ online: http://www.fao.org/es/ESN/food/risk_biotech_consultations_en.stm
(date accessed: 16 March 2003).
[38] FAO Biotechnology Statement, above n 20, para 11.
[39] van Aken, above n 22, 3.
[40] Ibid 5.
[41] Royal Society Report, above n 3, 156. ‘The effect of genetic interactions on the viability and persistence of wild fish populations will depend on the degree to which individuals are adapted to their local environment, on the genetic differentiation between wild and cultured individuals, on the probability and magnitude of outbreeding depression (ie, a fitness reduction in hybrids from matings between individuals from two genetically distinct populations) and on the size of potentially affected wild populations relative to their carrying capacities …’ (ibid 152).
[42] Ibid 87.
[43] An ‘estimated 32,000 to 86,000 farmed Atlantic salmon escaped from netpens into British Columbia waters between January and September 2000’ (ibid 151).
[44] Rio Declaration on Environment and Development, 13 June 1992, UN Doc.A/CONF.151/5/Rev.1, reprinted in (1992) 31 ILM 874 online: http://www.unep. org/unep/rio.htm (date accessed: 4 May 2003) [‘Rio Declaration’]. Principle 15 states: ‘In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.’
[45] According to A Jiordan and T O’Riordan, ‘The Precautionary Principle in Contemporary Environmental Policy and Politics’ in C Raffensperger and J A Tickner (eds), Protecting Public Health and the Environment (1999) 19-21 [‘Precautionary Principle in Contemporary Policy/Politics’] the precautionary principle had its genesis in the former West Germany in the early 1970s, picked up some impetus from the 1972 UN Conference on the Human Environment held in Stockholm, gathered force in Europe in the 1980s, and by 1993 had been ‘accepted as a fundamental guiding principle of EU environmental policy’.
[46] D Freestone and E Hey, ‘Origins and Development of the Precautionary Principle’ in D Freestone and E Hey (eds), The Precautionary Principle and International Law: The Challenge of Implementation (1996) 41.
[47] See, eg: the dissenting opinion of Sir Geoffrey Palmer in New Zealand v France [1995] ICJ 288 wherein he stated 413, that ‘the precautionary principle … may now be a principle of customary international law relating to the environment’.
[48] Jiordan and O’Riordan, above n 45, 22; ‘… the Precautionary Principle still has neither a commonly accepted definition nor a set of criteria to guide its implementation … While it is applauded as a “good thing”, no one is quite sure about what it really means, or how it might be implemented. Advocates foresee precaution developing into “the fundamental principle of environmental protection policy at [all] scales”. Skeptics, however, claim its popularity derives from its vagueness; that it fails to bind anyone to anything or resolve any of the deep dilemmas that characterize modern environmental policy making.’ [emphasis in original] [references deleted]. One excellent commentary that makes a strong argument in favour of the use of the precautionary principle to harmonize the ‘two fundamentally different conceptions of GM technology’ (‘… these conceptions [being] the Frankenstein and the Better Living through Chemistry narratives’) is J S Applegate, ‘The Prometheus Principle: Using the Precautionary Principle to Harmonize the Regulation of Genetically Modified Organisms’ (2001) 9 Ind J Global Legal Stud 207, 208.
[49] NASCO was established under the Convention for the Conservation of Salmon in the North Atlantic Ocean, online: http://www.nasco.int/convention.htm
(date accessed: 03 December 2002) [‘NASCO Convention’] which Convention entered into force on 1 October, 1983. ASCO has as its object the ‘conservation, restoration, enhancement and rational management of salmon stocks … [in] the [North] Atlantic Ocean. – ‘About NASCO’, online: http://www.nasco.int/about.htm
(date accessed: 03 December 2002). The parties to the Convention are Canada, Denmark (in respect of the Faroe Islands and Greenland) the European Union, Iceland, Norway, the Russian Federation and the US.
[50] ICES is an organization the modern incarnation of which was established in 1964 by the Convention for the International Council for the Exploration of the Sea, 12 September 1964, online: http://www.ices.dk/index.asp
(date accessed: 3 December 2002) [‘ICES Convention’]. The primary objective of the ICES is to coordinate and promote marine research in the North Atlantic. – ‘About Us – ICES’ online: http://www.ices.dk/aboutus/aboutus.asp
(date accessed: 5 December 2002). ICES has nineteen member countries, including Canada and the US (ibid).
[51] The NASCO Guidelines for Action on Transgenic Salmon, CNL(97)48 [‘NASCO Guidelines’] can be found online at http://www.nasco.int, filed under ‘Resolutions’ (date accessed: 21 December 2003), being Annex 5, 21 to NASCO Resolution CNL(03)57 – ‘Resolution to Minimise Impacts from Aquaculture Introductions and Transfers and Transgenics – The Williamsburg Resolution’.
[52] Ibid.
[53] Code of Practice on the Introductions and Transfers of Marine Organisms, online: http://www.ices.dk/pubs/itmo.pdf
(date accessed: 6 December 2002) [‘ICES Code’].
[54] Ibid para (c) of Section V.
[55] Royal Society of Canada, above n 3, 166.
[56] Code of Conduct for Responsible Fisheries online: http://www.fao.org/fi/agreem/codecond/ ficonde.asp#9 (date accessed: 13 November 2002) [‘FAO Code’].
[57] Ibid, Preface.
[58] Ibid.
[59] ‘[E]fforts should be undertaken to minimize the harmful effects of introducing … genetically altered stocks used for aquaculture … into waters, especially where there is a significant potential for the spread of such … genetically altered stocks …’ (ibid, Article 9.3.1)
[60] Article 2 of the United Nations Framework Convention on Biodiversity, above n 14.
[61] Cartagena Protocol on Biosafety to the Convention on Biological Diversity, 29 January 2000, online: http://www.biodiv.org/biosafety/default.aspx
[‘Biosafety Protocol’, ‘Cartagena Protocol’ or ‘Protocol’].
[62] Article 2 of the United Nations Framework Convention on Biodiversity, above n 14.
[63] Cartagena Protocol on Biosafety to the Convention on Biological Diversity, above n 61.
[64] The discussion of the Protocol in this article assumes its ultimate ratification by Canada. Canada signed the Protocol on 19 April 2001 but, according to the website of the Office of Biotechnology of the Canadian Food Inspection Agency, is still assessing the implications of ratification (online: http://www.inspection.gc.ca/english/sci/biotech/enviro/portoce.shtml
- date accessed: 21 December 2003).
[65] The United Nations Framework Convention on Biodiversity, above n 14 at Article 1.
[66] ‘In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on the Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.’
[67] Cartagena Protocol on Biosafety to the Convention on Biological Diversity, above n 61 at Article 4. Paragraphs (g) and (h) of Article 3 provide the following key definitions: ‘“[l]iving modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology’; ‘“[l]iving organism” means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids’.
[68] Articles 1 and 4 do, though, speak of the Protocol applying generally to the ‘use’ and ‘handling’ of LMOs in the broad context of the ‘conservation and sustainable use of biological diversity’. Parties to the Protocol would therefore, ostensibly, have to ensure conformity of their internal rules and practices with the requirements of the Protocol. The language used in Article 2(2) in fact is broader than that of Articles 1 and 4. Article 2(2) says that ‘Parties shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account risks to human health’ [emphasis added]. The use of the word ‘reduces’, however, renders this provision somewhat weaker than it otherwise would have been.
[69] It is supported by the comments of K Buechle in ‘The Great, Global Promise of Genetically Modified Organisms: Overcoming Fear, Misconceptions, and the Cartagena Protocol on Biosafety’ (2001) 9 Ind J Global Legal Stud 283, 286, 287: ‘The Protocol only deals with LMOs, not processed LMOs. As article 3(h) makes clear, a living organism is one that can replicate genetic material. Once an LMO has been processed, it is no longer capable of replicating genetic information … “GM product” or “GM food” may refer to an LMO or to a processed food product that would not fall under the [Biosafety Protocol] LMO definition.’
[70] The AIA procedure is a fairly onerous one and calls for the written prior consent of the state to which the genetically modified product is being exported. Most exporters of LMOs will, one assumes, seek to avoid application of the AIA procedure whenever possible. For transgenic fish, the way around it is to stipulate that the fish are ‘destined for contained use undertaken in accordance with the standards of the Party of import’ per Article 6(2), in which case the AIA procedure is deemed not to apply. Outside the AIA procedure, the Protocol is not nearly so onerous. Shipments of LMOs ‘destined for contained use’ would mandate adherence to certain notification and identification requirements, but would not need the advance written agreement of the state of import. What is or is not ‘destined for contained use’ may be open to some interpretive creativity. First of all, the word ‘destined’ has an element of subjectivity to it, as well as a temporal limitation. An LMO transported from one country to another, even with the genuine intention of having it kept fully and securely contained, may at a later point in time be removed from that containment. Second, the wording of Article 6(2) leaves itself open to exploitation by unscrupulous parties who structure an LMO shipment to be for ‘contained use’, knowing full well that the LMO, once shipment is complete, may be contained inadequately or not at all. Finally, the Protocol’s definition of ‘contained use’ is itself somewhat malleable.
[71] Article 10 sets out the AIA decision procedure. Article 11 deals with LMOs intended for direct use as food or feed, or for processing. The ‘food/feed’ referred to in Article 11 must either be, or contain, an LMO. Examples would be GM grain, whether intended for direct or processed human consumption, or for livestock feed, and GM animals shipped alive across national borders to be butchered at the place of destination. Articles 10(6) and 11(8) contain precautionary principle language that leaves much discretion with the ‘Party of import’. Article 26 of the Protocol also contains express wording permitting a state, in ‘reaching a decision on import under this Protocol or its domestic measures implementing this Protocol’, to take into account ‘socio-economic considerations’ (so long as consistent with other international obligations of the state). To the extent Articles 10 and/or 11 are somehow found to be insufficiently flexible to support a state’s decision on an import, which seems unlikely, Article 26 would be available to offer justification for that decision. Such a decision could, therefore, under the terms of the Protocol, be taken either on ‘scientific’ or ‘non-scientific’ grounds (or both).
[72] The necessity for ‘contained use’ of certain LMOs, as discussed in note 70, is a good example of this. Strong containment requirements for LMOs, whether those LMOs are sterile or not (according to the definition), represent one means of minimizing risks from LMOs no matter what their source.
[73] Recommendations 4.1, 4.9, 6.1 and 7.2 of the Royal Society Report, above n 3, all concern ways of enhancing transparency and the provision of assessment information to the public. Regulations 2.1 to 2.10 and 6.1 to 6.3 of the CBAC Report, above n 1, all concern increasing public involvement in the decision-making process and the transparency of that process, as well as the improvement of information flow to consumers to support their purchasing choices.
[74] CBAC Report, above n 1, 20.
[75] Ibid 20-21.
[76] Pew Initiative on Food and Biotechnology, Future Fish: Issues in Science and Regulation of Transgenic Fish (2003) 46 online: http://www.pewagbiotech.org
(date accessed: 1 December 2003) [Future Fish].
[77] ‘Only after the FDA grants a new animal drug application may it release [data and] information [related to the application]. Even then, it makes public only portions of the file. The practical effect is that even after the FDA approves an application, much of the information submitted as part of that application, or any earlier underlying information from an investigational application, remains undisclosed. This closed process may have merit for protecting the intellectual property involved in the traditional human or animal drug approval. When applied to transgenic animals, however, it blocks public consideration of, and input into, a range of policy issues that go beyond technical and scientific considerations of safety. In particular, questions about what constitutes an acceptable level of environmental risk are at least as much policy questions as they are scientific questions … This lack of transparency and public participation in the new animal drug approval process significantly challenges an agency hoping to retain public confidence in its decision-making process’ (ibid 52).
[78] Council Directive 2001/18/EC, repealing Council Directive 90/220/EEC, as cited in CBAC Report, above n 1, 21.
[79] Greenpeace Canada, ‘Halifax Codex Meeting’, above n 28.
[80] Greenpeace Canada, ‘China Gets Mandatory GE Labeling While Canadians Still Guess What They’re Eating’ (2002) online: http://www.greenpeace.ca
(date accessed: 16 October 2002) [‘China Gets Mandatory Labeling’].
[81] Ibid.
[82] In the world of food labeling politics, there is a great deal that hinges on critical mass. With a market as big as China’s, mandatory label identification of GM products means some ripple effect is unavoidable. Exporters doing significant business in China will be compelled to change the labels on their products destined for that market, and the prohibitive costs associated with running different product lines (in terms of labeling) might then prompt a decision to use GM labels even on products shipped to states without mandatory labeling legislation (or consumed in the state of production). To the extent a particular state’s food exporters have to conform their product labels to fit the requirements of recipient states, the government of that state must consider the relative costs and benefits of adopting similar requirements. Greenpeace Canada, in ‘China Gets Mandatory Labeling’, ibid, reported that, in connection with the Chinese move, Thailand, Malaysia, Indonesia and the Philippines were all discussing the compulsory labeling of GM foods and food products.
[83] Greenpeace Canada, ‘China Gets Mandatory Labeling’, above n 80.
[84] Quoted in B Kneen, ‘CODEX and the Politics of Labeling’ article prepared for CropChoice, 16 April 2002) 4 online: http://www.greenpeace.ca
(date accessed: 15 November 2002) [‘Politics of Labeling’].
[85] Ibid 3.
[86] Ibid.
[87] Greenpeace, in particular, sees the issue in much starker terms. It assumes, until presented with convincing proof to the contrary, that GM foods are potentially dangerous. This approach runs contrary to the stated US position, which stresses the ‘inherent safety’ of approved biotech foods. Groups in favour of mandatory labeling consider US-led opposition to labeling to be nothing short of a conscious strategy to permeate the world with GM organisms such that, eventually, there would be no practical means of differentiating between GM and non-GM foods. This, goes the theory, not only saves GM food producers costs in the short term, but insulates them from liability in the long term should their products turn out to have adverse consequences: ‘… the strategy of the biotech industry and its government partners, particularly in the US and Canada, has been to contaminate the global food system as fast and as extensively as possible and then say, it is too late to label … The biotech industry is desperate to kill the call for traceability (of which Europe is the major advocate). The industry simply does not want to take responsibility for its products or to accept liability.’ (ibid 1, 7).
[88] One exception to this is China. It accounts for 3% of worldwide transgenic crops. – CBAC Report, above n 1, 5.
[89] The campaign of Greenpeace Canada offers a study in progress of how this works (above n 21). Despite the Greenpeace Canada activities, however, there seems to be little evidence so far of any significant increase in the level of public concern over GM foods, at least not to the extent of forcing mandatory labeling.
[90] Canada, it should be noted, is ‘both host country and chair’ of CCFL – Kneen, ‘Politics of Labeling’, above n 84, 1.
[91] Ibid.
[92] CBAC Report, above n 1, 41.
[93] North American Free Trade Agreement (1993) 32 ILM 289 (reprinted 1 January 1994) online: http://www.nafta-sec-alena.org/DefaultSite/index.html
(date accessed: 4 December 2003).
[94] Other WTO agreements having potential implications for trade in GM products include the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’) and the Agreement on Agriculture. These are two of the many WTO agreements that resulted from the 1986-1994 Uruguay Round of multilateral trade negotiations. The TRIPS Agreement recognizes the wide international variance in the protection and enforcement of intellectual property rights and the absence of any set of over-arching principles. It therefore endeavours to look at relevant principles of intellectual property agreements and of GATT itself, with a view to providing adequate principles, enforcement measures and dispute settlement mechanisms for the international community to be able to use. The patentability of transgenic fish technology likely will be affected by the TRIPS Agreement. The Agreement on Agriculture generally aims at providing a workable framework for the long-term reform of agricultural trade and domestic policies, so as to achieve a stronger nexus to market forces (ie, by the reduction of subsidies and other tariff and non-tariff barriers to trade). To the extent aquaculture is categorized as ‘agriculture’, transgenic fish may be affected by the general reforms that are the objective of the WTO Agreement on Agriculture. Full texts of all of the WTO agreements referred to in this article, along with explanatory notes, can be found at the following WTO website: ‘WTO Documents - Legal Texts: http://www.wto.org/english/docs_
e/docs_e.htm.
[95] WTO, Understanding the WTO Agreement on Sanitary and Phytosanitary Measures (1998) 1-2, online: http://www.wto.org/english/tratop_e/sps_e/spsund_e.htm
(date accessed: 5 January 2003) [hereinafter ‘Understanding the SPS Agreement’].
[96] Ibid 1.
[97] Ibid 1-2.
[98] Ibid 1-3.
[99] WTO, ‘Membership’, online: http:www.wto.org (date accessed: 2 April 2003).
[100] At the Uruguay Round of Multilateral Trade Negotiations, which resulted in the establishment of the WTO, states expressed concern about the need for clear rules regarding the use of sanitary and phytosanitary measures affecting trade. It was recognized that sanitary and phytosanitary measures, because of technical complexity, could be ‘particularly deceptive and difficult barrier[s] to challenge’. – ‘Understanding the SPS Agreement’, above n 95, 3. The SPS Agreement was thus born. It built on previous GATT rules aimed at the use of unjustified sanitary and phytosanitary measures to protect trade. But it was more directed. Other WTO agreements continue to have health and safety elements. Article XX of the GATT 1994, for instance, permits a WTO member to put its public health and safety and domestic environmental objectives ahead of its general responsibility not to erect trade barriers or invoke discriminatory trade measures. But it is the Sanitary and Phytosanitary Agreement that now seems to be front and center in terms of formulating specific rules regarding food trade restrictions attributable to health and safety concerns.
[101] The TBT Agreement, by contrast, allows states to impose barriers to trade which are more technical in nature, rather than having as their primary purpose the protection of human health, animals and plants. The TBT Agreement is complementary to the SPS Agreement since its focus, at least in terms of food labeling requirements, is on food safety matters. The TBT Agreement comes into play for transgenic fish because it governs labeling relating, for instance, to whether a product was produced in an environmentally friendly way, or is GM or has GM ingredients. The TBT Agreement also covers nutrition claims and concerns (provided they are of a non-safety nature).
[102] The full text of the SPS Agreement can be found, directly, at: http://www. wto.org/english/docs_e/docs_e.htm
.
[103] Article 3 of the SPS Agreement deals specifically with matters of harmonizing sanitary and phytosanitary measures: ‘Members shall base their sanitary and phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement …’
[104] Article 3(4) of the SPS Agreement.
[105] Article 12 of the SPS Agreement establishes a Committee on Sanitary and Phytosanitary Measures, the main objective of which is to ‘develop a procedure to monitor the process of international harmonization and coordinate efforts in this regard with the relevant international organizations’.
[106] Article 5(7) of the SPS Agreement.
[107] To the end of 2002, only one WTO case directly involved an attempted import ban on a GM food. That case dates from 2000 and was between Thailand and Egypt. Egypt banned the import of canned tuna from Thailand that had been processed in soybean oil made from GM soy. Thailand objected to the ban, alleged that Egypt was in contravention of its obligations under the GATT 1994 and the SPS Agreement, and requested formal consultations through the WTO to resolve the situation. This particular trade dispute does not appear to have progressed beyond the consultation stage. – WTO Dispute Settlements, ‘Egypt – Import Prohibition on Canned Tuna with Soybean Oil – Request for Consultations by Thailand’ (2000) Document No. 00-3889 online: http://www.wto.org/english/tratop_e/dispu_e/dispu_e.htm#disputes
(date accessed: 9 April 2003).
[108] CBAC Report, above n 1, 42.
[109] The 1998 ‘Beef Hormone Decision’ of the WTO Appellate Body (Appellate Body Report, GATT Doc WT/DS26/AB/R (1998) as cited in and discussed in L Hughes, ‘Limiting the Jurisdiction of the Dispute Settlement Panels: The WTO Appellate Body Beef Hormone Decision’ (1998) X The Georgetown Int’l Envtl Law Review 915) is a good example of how interpretive guidelines for the SPS Agreement are being developed. The Appellate Body, ibid 919, ‘confirmed the right of Members to set their own levels of health and environmental protection,’ while at the same time applying some reasonable scientific justification or risk assessment. Precisely what would pass as reasonable, however, was still a somewhat open question since harmonization of sanitary and phytosanitary measures on the basis of international standards had yet to occur – ibid 920. The Appellate Body suggested that, so long as such international standards continued to evolve, states would have a fair degree of latitude within which to maneuver. The application of a precautionary approach could not, however, be used by states to justify a blanket prohibition. There would always have to be some sound scientific/risk assessment basis to support a state’s decision to restrict entry of a food product from another state. The Appellate Body’s ‘confusion and hesitation in applying the precautionary principle’ is worrisome to some commentators – ibid. This ‘confusion/hesitation’ may, though, have been misinterpreted. It could perhaps be better described as deference to the strong trade promotion elements of the SPS Agreement. The tension between domestic health/environmental protection and free-flowing international trade is, after all, the crux of the SPS Agreement. One state’s caution is another’s trade barrier. It will take more dispute decisions to enable a very precise determination of where lies the bright line of separation. And even then, as scientific information accrues and specific standards develop, the line will be a shifting one.
[110] Statistics Canada-Agriculture Division, above n 23.
[111] Office of the Commissioner for Aquaculture Development, ‘Canadian Aquaculture Industry Profile’ online: http://www.ocad-bcda.gc.ca/eaquaculture.html
(date accessed: 11 December 2003).
[112] Contrary to the situation in British Columbia, no great environmental tumult has plagued the salmon farming industry on Canada’s east coast. The explanation for this would seem to lie in the divergent factors at play. Most of Atlantic Canada’s salmon farms are located along the New Brunswick side of the Bay of Fundy, where the powerful tides (reputedly the highest in the world) may function to disperse farm waste more effectively than on the west coast. The stocks of wild salmon are much smaller on the east coast, such that there is no commercial fishery and only a very limited sport fishery. And the wild salmon of course are Atlantic, so there is no concern with cross-breeding between wild and farmed salmon. Also, the economic benefits of aquaculture may register more strongly with Atlantic Canadians, set against a backdrop of historic and persistent economic under-development, exacerbated in the fishery sector by the collapse of traditional stocks in the 1990s. Finally, smaller First Nation communities, traditionally less dependent than their west coast counterparts on salmon and other fishery resources, have had less incentive to throw their weight behind any organized opposition to fish farming.
[113] The lead of the anti-netcage lobby in British Columbia has been taken by the David Suzuki Foundation.
[114] David Suzuki Foundation, ‘Salmon Farming’ online: http://www.davidsuzuki.org/ Oceans/Fish_Farming/Salmon/
(date accessed: 11 December 2003) [‘Salmon Farming’].
[115] Report and Recommendations of the Honourable Stuart M Leggatt, Clean Choices, Clear Waters: The Leggatt Inquiry into Salmon Farming in British Columbia (2001) online: http://www.davidsuzuki.org
, filed under ‘Oceans and Sustainable Fishing/Publications’ (date accessed: 21 December 2003) [Leggatt Inquiry Report].
[116] Ibid 23.
[117] Health Canada is solely responsible for assessing the safety of foods for human consumption, including GM foods and other novel foods, and for allowing them to be sold in Canada. It is responsible for implementing the provisions of the Food and Drugs Act that relate to public health, safety and nutrition; for establishing policies and standards for the safety and nutritional quality of foods sold in Canada; and for assessing the effectiveness of CFIA activities related to food safety … - CBAC Report, above n 1, 8.
[118] Health Canada is responsible for labeling in respect of health and safety matters, while CFIA ‘handles general food labeling policies and regulations not related to health and safety …’ ibid.
[119] The thrust of CFIA’s efforts, at the risk of oversimplification, is on the farm. CFIA looks after ‘regulating GM plants, assessing their impact on the environment and biodversity, including the possibility of gene flow and impact on non-target organisms, and is responsible for ensuring livestock feed safety, including feed composition, toxicology, nutrition and dietary exposure … CFIA operates under the powers of the Seeds Act, the Plant Protection Act, the Feeds Act, the Fertilizer Act, and the Health of Animals Act. It also shares some responsibilities with Environment Canada under the Canadian Environmental Protection Act (CEPA), and with Health Canada under the Pest Control Products Act (PCPA) and the Food and Drugs Act’ – Royal Society Report, above n 3, 35. CFIA is said to be the first government agency typically encountered by a person or corporation wanting to introduce a new GM crop plant. Much of CFIA’s work involves assessing the environmental impacts of GM plants. This is done in large part through confined field trials.
[120] CBAC Report, above n 1, 5.
[121] Ibid 6. The CBAC Report also notes that the Biosafety Protocol’s definition of LMO emphasizes process (ibid).
[122] Ibid ‘Rather than referring to GM plants or GM foods, the guidelines and regulations refer to plants with novel traits and novel foods, respectively. The regulations define a novel food as any food that does not have a history of safe use as a food, or has been manufactured or packaged in a way not previously applied to that food and that causes a significant change in the food’s properties. A third category of novel foods is GM foods, including foods derived from mutagenesis.’ (ibid) [emphasis added].
[123] RSC 1985, c F-27, as amended.
[124] Royal Society Report, above n 3, 44-86.
[125] Food and Drugs Regulations, Division 28, CRC c 870.
[126] Royal Society Report, above n 3, 37.
[127] Ibid ‘These guidelines (as opposed to regulations) specify that a guiding principle in the safety assessment is based on a “comparison of molecular, compositional and nutritional data for the modified organism to those of its traditional counterpart”. They suggest that data should be provided on dietary exposure, nutrient composition, anti-nutrients, and nutrient bio-availability. If concerns still remain following this analysis, “toxicity studies would be required as necessary, on the whole food, food constituent or specific component in question”. Finally, using data supplied by the applicant, Environment Canada and Health Canada consult together to decide whether a product is “toxic” to the environment and human health…’ (ibid).
[128] CBAC Report, above n 1, 8.
[129] The ‘substantial equivalence’ concept apparently was ‘formulated by the [Organization for Economic Cooperation and Development (‘OECD’)] in 1993 [and] was the result of consultations with some 60 experts from 19 countries on methods to assess the safety of GM foods’. (CBAC Report, ibid 25).
[130] SC 1999, c 33, as amended.
[131] CBAC Report, above n 1, 7.
[132] RSC 1985, c F-14, as amended.
[133] CBAC Report, above n 1, 7. To the extent transgenic fish remain at the research and development stage, all work done ‘within a contained setting such as a laboratory or greenhouse is not currently subject to regulatory oversight and authorization in Canada … [although the] Canadian Institutes of Health Research have guidelines designed to prevent the environmental release of GMOs [and] [m]ost research institutions – both public and private – have their own codes of conduct and oversight committees.’ (ibid).
[134] SOR/94-260 [NSN Regulations].
[135] CBAC Report, above n 1, 9.
[136] Royal Society Report, above n 3, 38.
[137] Ibid 39.
[138] Ibid 165.
[139] Ibid.
[140] Ibid.
[141] Personal communication, 21 November 2003, from I Price, Department of Fisheries and Oceans, Ottawa. Ms Price advised that the ‘hard science’ base for the risk assessment process relative to transgenic aquatic organisms was still being created, and that the new regulations were anticipated to be made publicly available, in draft form, in the spring of 2004.
[142] Canada’s National Code on Introductions and Transfers of Aquatic Organisms, above n 6.
[143] This notwithstanding the fact that early versions of the DFO National Code, including the one critiqued by the Royal Society Expert Panel, did cover GM fish. Evidently DFO had a late change of heart, or a realization that the DFO Draft Policy or pending Fisheries Act regulations would be the better place to deal with transgenic aquatic organisms. Section 1.1.4 of the final version of the DFO National Code states that ‘[i]ssues related to … transgenic aquatic organisms are not covered by this Code’. [bold underlined portion in original].
[144] Personal communication, 2 December 2002, from L Stewart, Communications Adviser, Office of the Commissioner for Aquaculture Development, Department of Fisheries and Oceans, Ottawa: ‘I understand … that the policy document “Research with, and Rearing of, Transgenic Aquatic Organisms” is no longer in use as it is out of date and … we are moving to regulations instead.’
[145] Royal Society Report, above n 3, 163.
[146] Above n 11, see particularly the discussion of the application made to the Food and Drug Administration.
[147] DFO will not, however, release the DFO Draft Policy for public viewing. Its content can therefore only be discerned, and then not in any comprehensive fashion, through comments offered by the Royal Society Expert Panel.
[148] The Royal Society Expert Panel compared the DFO Draft Policy position against the ICES Code and NASCO Guidelines, as well as making its own assessment of the practical risks of using sterility techniques as the sole means of insulating the environment from transgenic fish. The Royal Society Report expresses skepticism about the ‘mitigative utility of rendering GM fish sterile in aquatic facilities’ (ibid 170) largely because ‘existing techniques for effecting sterility are not 100% effective’ (ibid 166) but also because of the ‘considerable uncertainty associated with … the consequences of ecological interactions between [sterilized fish] and wild fish’ (ibid 160). Its conclusion is that sterilization is an insufficient means, at this point in time, of ensuring environmental protection from transgenic fish.
[149] The detailed reporting and compliance obligations stipulated under the Biosafety Protocol likely explain Canada’s reluctance, thus far, to ratify the Protocol. Canada is caught in something of a bind vis-à-vis the Protocol. On the one hand, Canada ratified the Biodiversity Convention more than a decade ago and is, generally speaking, a strong supporter of international initiatives directed at preserving and protecting the environment. On the other hand, from Canada’s export-oriented viewpoint, the Biosafety Protocol serves little more than to erect additional obstacles to the transborder movement of Canadian GM food products. As already discussed, however, for transgenic fish producers the Biosafety Protocol likely does not present as a significant concern.
[150] The debate around the virtues and shortcomings of substantial equivalence symbolizes much of the larger debate about the degree of scrutiny appropriate for GM foods. Substantial equivalence essentially stands for the proposition that if a GM food product looks, feels, tastes and acts the same as its non-GM counterpart, no more need be done. It is a relatively simple procedure that appeals both to commercial producers of GM food products and international agencies focused on global food security issues. The CBAC Report, above n 1, 54 and accompanying text, cites several joint FAO/WHO reports, and an OECD report, which apparently endorse substantial equivalence as an assessment tool. The problem with substantial equivalence as an assessment technique is that it is perceived by some as ‘subjective, inconsistent and pseudo-scientific’ (ibid 25 - footnotes deleted), in effect a shortcut endorsed by those who, for whatever reasons, want to avoid the application of ‘hard science’ in assessing GM foods.
[151] In Norway, by way of example, not only must a proposal to produce GM fish guarantee no adverse effect on the environment, but any such production must also be able to show tangible positive results – see Section 10 of The Act relating to the production and use of genetically modified organisms (Gene Technology Act), Act No 38 of 2 April 1993.
[152] CBAC Report above n 1, 41.
[153] ‘The development of an international labeling standard, accepted by all of Canada’s trading partners, is the surest way to obviate the negative consequences of mandatory labeling while providing meaningful consumer choice. It would be highly advantageous for Canada to actively promote the development of such a standard.’ (ibid, 42).
[154] Recognition of the growing international development and application of the precautionary principle prompted the federal government to recently complete a broad inter-departmental consultation process regarding the principles that should underpin the application of the precautionary principle by Canadian regulators. Those consultations generated a ‘Discussion Document’ in September of 2001 – Privy Council Office, 2001, A Canadian Perspective on the Precautionary Approach/Principle, Discussion Document, http://www.pco-bcp.gc.ca/ raoics-srdc/docs/precaution/Discussion/discussion_e.htm (date accessed: 7 December 2003) [Discussion Document on Precaution]. The Discussion Document on Precaution concludes that the ‘precautionary approach/precautionary principle is a distinctive approach within risk management that primarily affects the development of options and the decision phases, and is ultimately guided by judgment, based on values and priorities’ (ibid 4) [references deleted]. Vague as this is, the Discussion Document on Precaution does offer some comments that suggest development of a pragmatic Canadian approach to the precautionary principle. One comment, ibid 5, recognizes that it is ‘legitimate for decisions to be guided by society’s chosen level of protection against risk’. This suggests the possibility of broad commercialization of GM foods, so long as risk assessment has been done to a level that is acceptable to society generally, and/or that identification standards are adopted that provide consumers with a real ability to choose (and so avoid potential risks). Another series of comments repeatedly stresses the need to apply a ‘sufficiently sound or credible scientific basis’ (ibid 10-11) [emphasis added] in the decision-making procedures relating to GM foods. This suggests an inclination to promote a scientific approach to assessment of GM foods that is reasonable, but not perversely stringent. Again, though, where the precise lines are to be drawn is open to debate. The Discussion Document on Precaution also makes a point of carefully emphasizing that the precautionary principle is an international phenomenon that is constantly evolving and, importantly, affects Canada’s vital interests (economic and otherwise). Canada should, it says, therefore make it a high priority to try to shape the precautionary principle to ensure it fits Canadian reality, including in the area of GM foods.
[155] The CBAC Report, above n 1, 5, notes the relatively large number of ‘first generation’ GM approvals to the time of the Report: ‘To date, Health Canada has authorized 52 novel (42 transgenic) foods for marketing in Canada, and the Canadian Food Inspection Agency (CFIA) has authorized 39 plants with novel traits (31 transgenic) for unconfined environmental release. Forty GM crops (31 transgenic) have been approved for use in livestock feeds, including some not grown in Canada, such as cotton.’ The CBAC also noted, however, at 27, that it ‘found no evidence to indicate that substantial equivalence has been used as a decision threshold to exempt GM foods from appropriate regulatory oversight’. The implication from this is that assessment of first generation GM products has been, overall, adequate – but the level of assessment for next generation products will have to be intensified.
[156] Royal Society Report, above n 3, Recommendation 8.1, 206.
[157] CBAC Report, above n 1, Recommendation 3.2, xv.
[158] See, eg: CBAC Report Recommendations 3.1, xv and 3.6, xvi, and Royal Society Report Recommendation 7.1, 191.
[159] Royal Society Report, above n 3, Recommendation 5.1, 105.
[160] The Action Plan issued by the Canadian government in response to the Royal Society Report confirms the support of the government for a precautionary approach to biotech food consistent with Principle 15 of the Rio Declaration. One wonders what else the federal government possibly could have said. Of course it is cautious about approving products that might possibly hurt Canadians and/or their environment. But is that traditional caution equivalent to application of the ‘precautionary principle’? That is the core question.
[161] See, eg: Royal Society Report, above n 3, Recommendation 8.2, 206.
[162] Because of the divergent interests involved in the GM food debate, and the fact that government is pulled in multiple directions, many of the recommendations of the CBAC and the Royal Society Expert Panel focused on independence, transparency and accountability in the future regulation of GM foods. Two of the CBAC Report’s eight categories of recommendations, for instance, are ‘Structure, organization and operation of the federal food regulatory system’ and ‘Transparency and public involvement’. Regardless what assessment standards are ultimately adopted, the Reports emphasize that there must be absolute public confidence that those standards be applied fully and consistently in every case.
[163] The CBAC Report has little in it pertaining directly to transgenic fish. It is, overall, very much plant and crop oriented. It also followed the Royal Society Report, temporally speaking, and the CBAC therefore consciously endeavored not to duplicate what had been covered in the Royal Society Report. One CBAC Recommendation (3.4, xvi) may have implications for transgenic fish research facilities. It encourages ‘government [to] undertake a study to evaluate the effectiveness of existing guidelines covering experimental work with genetically modified organisms in laboratories and greenhouses … with a view to determining the need for national guidelines or statutory measures.’
[164] Royal Society Report, above n 3, Recommendation 6.13, 170 [emphasis added].
[165] Ibid Recommendations 6.14-6.17, 170.
[166] Future Fish, above n 76.
[167] Ibid 27-28.
[168] The Government of Canada’s Action Plan in response to the Royal Society Report, above n 15, indicates agreement with the need to keep reproductively capable transgenic fish and aquatic organisms in secure land-based facilities.
[169] CBAC Report, above n 1, 42.
[170] Ibid.
[171] Ibid Recommendation 7.1, xviii.
[172] Ibid Recommendation 7.4, xviii.
[173] Royal Society Report, above n 3, 226. Only where there are identified health risks or significant nutritional changes does the Royal Society Expert Panel recommend compulsory labels.
[174] ‘[R]easons why consumers might choose to consume or avoid GM foods include perceived or potential health risks or benefits, perceived or potential environmental risks or benefits, a fundamental ethical opposition to genetic modification of any kind, religious beliefs, food quality and price, broader societal concerns (such as globalization, food security issues and concentration of corporate power), and lack of confidence in the regulatory system.’ – CBAC Report, above n 1, 38.
[175] Ibid Recommendation 7.2, xviii.
[176] WTO, ‘Understanding the WTO Agreement on Sanitary and Phytosanitary Measures’ above n 95 and accompanying text.
[177] The Discussion Document on Precaution, above n 154, 23, recommends that where more than one precautionary measure reasonably meets specified criteria, ‘the least trade-restrictive measure should be applied … This is especially important in terms of international trade where disciplines and mechanisms exist for other States to challenge the nature and impact of precautionary measures.’
[178] Genetic engineering can be used to alter any number of traits. In fish, however, the focus of research has been on growth enhancement and cold-water tolerance. To the extent transgenic fish are restricted to controlled land-based facilities, the ability to tolerate cold water becomes irrelevant. It is, in any event, the trait of greatly enhanced growth that has generated most of the interest in transgenic fish and pushed them to the verge of commercialization.
[179] Future Fish, above n 76, 7.
[180] Ibid 16.
[181] Some of the possible future advantages of transgenic aquaculture are discussed in Future Fish, ibid 34. Perhaps the single most important non-economic factor relative to a Canadian transgenic fish industry is the perfection of a practical and effective mass sterilization technique. Such a technique not only would neutralize much (though not all – see above n 167 and accompanying text) of the concern on the environmental side, thus removing from the lane one of the stickier non-economic ‘pins’, but at the same time would significantly reduce production costs (by enabling the use of ocean cages/nets), thus increasing the size and velocity of the economic ‘ball’. Sterilization therefore has the potential to effect a tipping of the regulatory scales for transgenic fish.
[182] In one sense, therefore, the Canadian situation may be a somewhat anomalous one and perhaps may not provide to other states quite as much guidance and instruction as was intimated at the beginning of this article.
[183] See n 23.
[184] See n 11.
[185] The regulatory harmonization between the two countries also would make it difficult for Canada to stand on the sidelines while the US proceeded with commercial production of GM fish. If those fish are deemed safe for consumption by US citizens, Canadian regulators would be hard-pressed to hold to the position that Canadians should have a higher or different standard of safety applied to them. Cross-border shopping would, practically, make it impossible to prevent at least some transgenic fish being eaten by Canadians.
[186] The American situation itself is extremely interesting in the way it seems to be evolving. Future Fish, above n 76, for instance, is quite critical of the regulatory regime that has emerged in the United States to deal with transgenic fish. The core concern seems to be that there exists some built-in bias in favour of rights of property and profit. That is, the big business interests pushing GM fish may bulldoze over other ‘lesser’ interests. One of the recommendations of Future Fish is therefore increased public participation and accountability regarding the US regulatory approval process.
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