After debating Bill C-474, An Act respecting the Seeds Regulations (analysis of potential harm), the Standing Committee on Agriculture and Agri-Food (the Committee) decided to examine the status of the agriculture and agri-food biotechnology industry in Canada. The members hoped to gather information on the various stakeholders in the sector, the opportunities biotechnology creates for the Canadian agriculture and agri-food industry, and problems stakeholders encounter in developing biotechnologies. The Committee also hoped to determine what public policy is needed for the sector to be productive, competitive and innovative and to benefit the Canadian agriculture and agri-food sector.

The Committee held 10 public hearings between December 2010 and March 2011 in Ottawa and Guelph, Ontario; and Saskatoon, Saskatchewan. It heard researchers, corporations, agricultural organizations and groups representing members of the public interested in the impact of the development of biotechnologies. The Committee also visited public and private research institutions across the country.

This document is a summary of the issues discussed by the witnesses during the public hearings. Following a brief overview of the themes that were addressed during the public hearings, the summary presents ideas that were put before the Committee for each major theme.

THEMES ADDRESSED DURING THE HEARINGS

The witnesses began by sharing their vision of what biotechnologies are. Biotechnologies are more than transgenic crops and genetically modified organisms (GMOs). Many other biotechnological processes are used to improve plants and animals and also in agri-food and industrial processing. The dialogue with the members of the Committee covered the evolution of biotechnology, the benefits of biotechnologies in terms of agricultural innovation and the importance to the future of agriculture and agri-food around the world.

Much of the discussions focused on genetically modified crops because they have monopolized public debate on biotechnologies in recent years. The witnesses stated the advantages and disadvantages of GMOs for the environment, health and the Canadian economy. They talked about the importance of appropriate regulation and expressed their views on the direction regulations should take in Canada. Among the other issues raised were the coexistence of genetically modified crops and “conventional” or organic varieties and the need to initiate or renew dialogue between supporters and opponents of this technology.

Research and development issues were also discussed. The witnesses described their vision of research funding. They also identified the impact of regulations on research and development, in particular regulations on intellectual property and the approval of new products.

SUMMARY OF ISSUES — BIOTECHNOLOGY

A. Definition and Evolution

Biotechnology is broadly defined as scientific applications that involve the use of living organisms, or parts of living organisms, including individual genes, to provide new methods of production and make new products. It includes genetic engineering (GE), in which an organism’s genetic material is intentionally altered in a way that does not occur naturally, such as by the insertion of foreign genes, as well as a range of non-GE molecular techniques.

The witnesses differentiated conventional biotechnology (such as the use of yeast for fermentation) from modern biotechnology. Modern biotechnology comprises relatively recent methods that have made great strides in the past decade; examples include genomics, biofortification and molecular marking. The best-known modern technology is genetic engineering, which helps in the production of genetically modified organisms or GMOs.

There are clearly two views of the evolution of modern biotechnology. Some think that recent methods are an extension of older methods, while others think that the advent of genetic engineering brought about a more radical change:

• Some witnesses consider genetic engineering to be a fundamentally different process from other technologies because it can be used to introduce a foreign gene into an organism.
• Other witnesses believe that plant selection has always been based on the introduction of new characteristics, often with the help of methods that are far removed from nature like mutagenesis: they indicated that thousands of genes have been incorporated into crops from species with which they have no affinity in their natural state without the use of genetic engineering.

Although Canadian legislation uses a broad definition of biotechnology, some witnesses limited their comments on biotechnology to genetic engineering alone because in their opinion, biotechnology cannot be considered homogeneous. The witnesses underscored the confusion that may exist in the minds of the public between biotechnology and genetic engineering. Because biotechnology is more than GMOs, the reservations about biotechnology that were expressed pertained only about GMOs.

B. Examples of Technologies and Products

The witnesses described numerous methods used in modern biotechnology, such as genomics, proteomics, molecular marking, tissue culture, pyramidal gene arrangement, targeted induced local lesions in genomes (TILLING), targeted mutagenesis, genetic engineering and bio-informatics. These methods are applied at different stages of new product research and development.

For example, genomics is the study of the totality of the hereditary information of an organism, or the “genome,” which includes genes, also non-coding regions of DNA or RNA that may serve other functions and have effects on how genes are expressed. Tissue culture consists in growing identical plants from the cells of a single plant and accelerates the development of a new variety. Genetic engineering, meanwhile, consists in introducing a foreign gene into an organism’s genome.

New products can be developed using one or more of these methods. The witnesses talked about a number of products that are currently on the market or at the research stage:

• new crop varieties that have such properties as tolerance of drought or other stressors (cold and salt), disease resistance or the ability to use the nitrogen in soil more efficiently;
• food and food supplements, such as products fortified with Omega-3 fatty acid;
• drugs and vaccines; many existing drugs (insulin, for example) are genetically engineered;
• animals modified to meet production requirements; examples include a pig genetically engineered to excrete less phosphorus (Enviropig) and a salmon engineered to grow faster.

C. Role and Importance of Biotechnologies in Farm Production

Technological change has been at the core of growth in agricultural productivity for 150 years. Innovation is needed in order to increase farm productivity around the world and meet such challenges as a growing population, the need for water and climate change. Innovation is also essential in keeping the Canadian agriculture and agri-food industry competitive with countries that invest heavily in research and development.

Biotechnology can be credited with a large proportion of the innovations that have been made in Canadian agriculture. Many industries attribute their current success to innovation in general and biotechnology in particular: much of the development of soya, canola and pulses took place in Canada with the advent of new varieties.

However, whether the increase in yield over the past 10 years can be attributed to genetic engineering or other factors not developed by genetic engineering that may come into play is open to debate. For example, the pulse industry has developed many varieties using modern biotechnology, but not genetic engineering.

For many, biotechnology has an important role to play in improving agricultural productivity and creating new products. However, some think that we should try to invest as much effort and resources in agronomic research and organic farming methods.

Some believe that genetic engineering is not the answer to increased agricultural productivity and is not even necessary, because the same results can be obtained using other methods. Others, meanwhile, believe that genetic engineering is one of many tools and that it has its benefits but is not a miracle solution.

SUMMARY OF ISSUES — ADOPTION, PERCEPTION AND CONSEQUENCES

Much of the discussion during the hearings was devoted to GMOs and genetic engineering. The biotechnology debate focused primarily on consumer acceptance of GMOs and its repercussions down the road. There was conflicting evidence on many issues; that evidence is reported here without any indication of relative weight (many witnesses in favour of one argument, for example).

A. Adoption

GMOs have been widely used by Canadian farmers since the mid-1990s. For example, more than 80% of farmers on the Prairies use genetically modified varieties.

Canada ranks fifth in the world in areas seeded with GMOs. The other countries that have adopted this technology are the United States, China, South Africa, Argentina and Brazil. Inversely, some countries, such as the European Union countries and Japan, are still wary of these products.

B. Environmental and Health Benefits and Risks

GMOs have been in use since the mid-1990s, and there have been no proven cases of damage to health or the environment. A study of more than 500 independent research groups carried out by the European Commission showed that GMOs are as safe for health and the environment as other foods currently on the market. The Canadian Biotechnology Advisory Committee has also concluded that there are no scientific data indicating that genetically modified plants and foods create more health and environmental problems.

The risks are hypothetical and difficult to prove. It is therefore important to be vigilant and monitor human health and the environment after the products hit the market.

Health:

• Genetic engineering is a new frontier with long-term consequences that are still unknown. Studies have shown possible health effects, which is an indication that more research is needed. This refers to a very small number of studies not published in refereed journals, raised by a small number of witnesses. Further, several subsequent witnesses dismissed these studies as having little scientific credibility, the finding of which were contrary to a much larger body of work.
• Regulatory bodies are aware of the new studies and are evaluating them. Standardized research protocols are needed so that the results of studies can be replicated and confirmed beyond the shadow of a doubt.
• In terms of health risks, the key is to study which gene was introduced and what it produces, because the concept that natural products are better is false (there are many toxic natural substances), and it is also not true that GMOs are safer than other foods.
• People talk about the risk associated with GMOs but know little about the risks associated with many other substances found in food.

Environment:

• The biggest risk stems from the fact that a gene can easily pass from one variety to another or from one species to another. Once a gene has passed into a wild population, it can further spread and would be difficult if not impossible to contain.
• Some indigenous varieties of corn in Mexico have been found to be contaminated, and that could be a problem for the preservation of biodiversity in that country.
• Genetically engineered salmon could compete with wild species.
• GMOs are not environmental disasters. Some varieties have made it possible to adopt more environmentally friendly methods, such as minimum till cropping systems, and the decrease of the use of pesticides. Studies have shown, however, that the amount of pesticide applied to some crops has increased.

C. Agronomic and Economic Benefits and Risks

Farmers would not choose GMOs if there were nothing to gain. From an agronomic point of view, existing GMOs have been used to improve weed control and increase the use of zero tillage systems. Studies have shown that farmers have earned hundreds of millions of dollars from genetically modified canola since the product was introduced. It has increased the net income of the farmers who use it, primarily because the cost of some inputs (fuel, etc.) is lower.

The introduction of GMOs is not without risk, however: weeds that are resistant to some herbicides can emerge, for example, or private companies may increase their control of the seed supply, especially if they have the best stock of elite seeds. There could be an increase in dependency on inputs from outside the farm (licensed technology, patented seeds, etc.) and a rise in monoculture.

For some, controlling the seed industry is no different than controlling any other industry, such as banking, fertilizer and farm machinery. Farmers always have the option of not buying genetically modified varieties.

Market reaction is another risk, since access to genetically modified products on some international markets is a problem. Because some markets are wary, contamination of unmodified varieties can lead to market closures and heavy economic losses. The economy has already suffered as a result of the appearance of genes where they were not expected to be (Starlink corn, transgenic flax, etc.).

The dispersal of genes to organic farms is a major challenge for organic farming and limits the range of choices: organic farmers say they can no longer grow organic canola because they cannot guarantee that their product has not been contaminated by genetically modified canola.

If genetically engineered pork were approved for human consumption, consumers might shy away from pork products so they do not run the risk of eating genetically engineered pork. That would hurt the entire industry.

D. Regulation

Regulation is the foundation of the public’s trust in products. Two visions of Canada’s regulatory system were presented. On the one side are those who believe that biotechnology regulation in Canada is working and that we have one of the best regulatory frameworks in the world. There are areas that could be improved, but no drastic changes are needed. On the other, are those who think that the regulatory system needs to be reviewed and that the government must implement the recommendations made by the Royal Society of Canada in its 2001 report Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada. The witnesses discussed the following issues:

Scientific principles underlying the evaluation of new products: Some believe that the available scientific information shows that the current regulatory system is working. Since it is impossible to prove that there is no risk, the weight of scientific evidence has to be used, and measures have to be taken to ensure that new products pose no unacceptable risk to humans or the environment: when 1 study says one thing and 40 others say something else, we have to look at the weight of the evidence. Others believe that precautions have to be taken in regulating and approving new products; they oppose the principle on which current regulations are based, namely that genetically modified crops are by and large equivalent to conventional crops. They base their argument on a report from the National Research Center in the United States which says that we should reassess our study methods.

Need to evaluate products case by case: Canada regulates products, not the way they were obtained (technology), because a crop resistant to herbicides, for example, can be created using genetic engineering or conventional methods. Most of the witnesses support this approach, although some would like regulations that apply only to genetically engineered products. Everyone agrees, however, that each product has to be evaluated on its own merit. The point was also made that the current regulations give the same treatment to GMOs that essentially pose no risk as they do to GMOs that pose significant risks. Some are too regulated, and others are not regulated enough. Because every GMO poses a different risk, a multi-level regulatory system like the system currently used for drugs should be put in place. It was noted that there are no specific regulations for genetically engineered animals.

Trust in the system: The witnesses talked about the need to include as many stakeholders as possible in the regulatory process in order to ensure that the opinions of those who are in the field are heard. It was stated that people may get the impression that the regulatory system was designed to benefit companies, mainly because the government’s decision-making processes are kept secret and do not have any public input. On the other side of the coin, some witnesses stated that the system is sometimes too slow and costly for companies. It was pointed out that the government’s role is not to block these products or to promote them. The government is a third party; its role is to defend a regulatory system that protects the public’s health and the environment.

Need for greater transparency: Some witnesses stressed the need for transparency in regulatory decisions so that everyone has confidence in the system. They stated that regulatory authorities examine all new scientific data, but that information is not in the public domain. Neither the public nor independent scientists have access to the scientific data the government evaluates. For now, regulatory authorities are required by law to keep confidential any information produced by a commercial venture. The witnesses talked about the need to come up with ways of making scientific data accessible. Peers could review scientific protocols and replicate experiments, and that would improve the regulatory process.

Science and socio-economic factors: For some witnesses, regulations must be based solely on scientific elements which show that a new product poses no risk to health or the environment. Straying from that concept would make the regulatory process too unpredictable and would drive investors away. They suggest that non-scientific elements are often commercial obstacles that do not mesh with World Trade Organization (WTO) rules. For others, the introduction of genetically modified wheat showed that evaluating biotechnology based on scientific criteria alone is not without problems. The case of genetically modified alfalfa shows that some products can be an economic threat for some farmers but that regulations are not designed to take that into account. They make the point that evaluation of the socio-economic impact of new genetically modified crops should be included in the Canadian regulations. There are quantitative methods based on scientific data that can be used to properly evaluate technology. Other countries, such as Argentina, take that approach without impeding trade.

Labelling and monitoring: Some witnesses talked about the need for a mechanism for monitoring the environmental and health effects of products after they go on the market. A government initiative to set up a project to monitor genetically modified foods was launched and then abandoned. Some witnesses stated that mandatory labelling of genetically modified foods could help track potential problems.

E. Coexistence

Studies show that genetically modified crops spread toward conventional crops and it is impossible to guarantee that there is absolutely no contamination. Some crops are better suited to segregation than others because of their biological properties. For example, soy growers and exporters have been able to put in place segregation systems that enable them to supply their customers with different types of soy with specific properties. This means they can supply Asian and European markets with GMO-free or certified organic products. This could not be done with other crops, such as canola: organic or non-genetically modified canola can be grown only in geographically isolated areas, such as Prince Edward Island. Some fear that the methods used by GMO growers will prevail and it will no longer be possible to guarantee GMO-free crops. In their view, not enough thought has been given to systems for segregating GMO and GMO-free crops.

Cohabitation of different types of farming: The witnesses talked about the importance of finding ways for all types of farming (organic, genetically engineered, etc.) to coexist. New technologies can be used to improve segregation, and it was stated that regulatory agencies should encourage molecular geneticists to come up with methods of preventing gene transfer in nature. Regulatory authorities already require buffer zones in some cases, but that method is not always effective. The United States is currently considering imposing geographical restrictions and segregation distances for some crops.

The industry has (or is hoping to) put in place protocols for segregating crops. Generally, however, it is very costly to keep crops apart so that they do not mix. For now, growers who do not use GMOs are the ones who assume the cost and the task of implementing measures to guarantee effective segregation. The organic farming sector says that biotechnology developers and users should pay for and implement measures to guarantee successful coexistence that respect both farming systems. Biotechnology companies and farmers who grow GMOs should compensate organic farmers for the financial losses caused by the sudden appearance of GMOs in plants and seeds.

Organic farming: Organic farmers accept pesticide residue on their products but do not tolerate any GMO contamination. That is a standard the organic farming industry has imposed on itself and can be found in international organic standards. To prevent pesticide contamination, organic producers create buffer zones. They also have to provide affidavits from their neighbours in which they undertake to refrain from spraying in windy conditions, etc. It is easier to take measures to prevent contamination by pesticides than by GMOs. The organic farming industry has not reached consensus on GMO contamination (zero tolerance or acceptance of a certain level of contamination as is the case for pesticides). Stakeholders do not believe that European consumers will accept a small percentage of GMOs in their products.

Alfalfa: The organic industry is afraid that the introduction of genetically modified alfalfa will eradicate certified organic alfalfa. Some stakeholders have called for a moratorium on the approval of genetically modified alfalfa. Genetically modified alfalfa has received regulatory approval in respect of health and the environment. However, it cannot be sold in Canada because the variety in question has not been approved. Some witnesses stated that the company has indicated it will not seek approval in Canada as long as farmers do not ask for it, there is no clear and acceptable policy on coexistence, and there has been no full deregulation in the United States (the United States has deregulated GM alfalfa since the end of the Committee study).

International trade: Internationally, there is zero tolerance of the presence of unapproved genetic material. That is the current policy in Canada, the United States, Australia, Japan, Korea and all European Union countries. The policy can be attributed to the fact that if a variety has not been approved, it is not yet considered safe. To avoid a situation where a variety has been approved in one country but not in another, the industry has made a commitment to try to obtain approval in all major countries in which a product will be marketed. For example, a variety of canola cannot be marketed in Canada unless it has been approved in the country’s primary export markets. Others have stressed the importance of harmonizing approval processes so that producers can sell their products in countries where consumers are less amenable to biotechnology.

However, with the proliferation of varieties and properties, many stakeholders think it is unlikely that a zero tolerance policy will last. Efforts must therefore be made to find ways of adapting the tolerance rules to international trade. It was proposed that Canada take on a leadership role in the modernization of global regulations. The presence of small quantities of genetically modified crops in a given country should not impede the movement of products around the world. A policy aimed at managing the presence of traces or low levels of genes in products that growers would like to see approved in other countries would be good for international trade. Some witnesses stated that there are already international rules on the movement of GMOs: the Cartagena Protocol on Biosafety was established to manage the international transportation of modified living organisms. Canada signed the protocol but has never ratified it.

F. The Need for Dialogue

In the late-1990s, initiatives were taken to sit the various stakeholders down in one room. A number of authorities studied the issues related to biotechnology, in particular the Canadian Biotechnology Advisory Committee under the jurisdiction of Industry Canada and the Canadian General Standards Board’s Committee on Voluntary Labelling and Advertising of Foods that are and are not Products of Genetic Engineering. The groups that opposed the technology withdrew from these initiatives primarily because they were biased and favoured the industry.

The debate over GMOs is certainly not over, and the witnesses stated that they support dialogue among all the stakeholders because the public needs to be fully informed and the interests of the stakeholders are better defined and reconciled. The debate has to be broad enough to incorporate all segments of society. The debate has often been brought down by sensationalistic headlines (for or against) that have not served either cause. The type of media coverage can have a significant impact on the quality of the debate (United Kingdom, for example); the level of dialogue must be raised.

SUMMARY OF ISSUES — RESEARCH AND DEVELOPMENT

A. Funding

The witnesses noted the importance of investment by both the public and the private sectors. The industry has invested a great deal in biotechnology research, but only the big corporations can afford to invest heavily. Small companies have trouble raising capital. As a result, innovations are concentrated in a handful of companies and research is limited to a certain number of crops (e.g., canola, corn, soy), to the detriment of small grain crops and pulse. The private sector invests only in crops that are produced in large quantities and crops on which there is no research and development suffer.

Some witnesses remarked that public-sector spending on agricultural research has decreased in Canada, and that the decline has been accompanied by lower growth in agricultural productivity since the 1990s. The positive impact of public investment in research on agricultural productivity has been demonstrated. The involvement of the public sector also ensures independent research and investment in areas of the agricultural industry that are not as appealing to the private sector because they are too small or there is no product to market (for example, research on organic farming methods). The witnesses stated that China and many other countries invest heavily in public agricultural research.

The witnesses were adamant that agriculture remain a national research priority. They said they were disappointed by a number of recent decisions by grant-giving agencies. The National Science and Engineering Research Council (NSERC) has dropped “Quality and Novel Bioproducts” from its list of target areas for strategic grants, and the Networks of Centres of Excellence has not renewed its funding for the Advanced Foods and Materials Network (AFMNet).

Regarding the type of investment, the trend is toward short-term funding (one to three years). The witnesses stated that there is also a need for ongoing and permanent investment, particularly in basic research. They also talked about investing in research infrastructures and in what is known as the “death valley” of research, that area between a concept and an actual product; many good ideas die because there is no mechanism for moving them forward.

Almost all of the witnesses said that it is important to foster collaboration among the industry, producers, universities, governments and consumers. The food industry is fragmented at the national level, and research, too, is often dispersed. To help build partnerships, the government can, for example, provide the research infrastructure and thus attract corporations. According to the cluster theory, competitors will set up alongside each other. The witnesses talked about many partnerships they have formed, for example, pulse producers: the University of Saskatchewan, and the Saskatchewan Department of Agriculture signed an agreement to develop new varieties. The development of new products must begin with a discussion with clients. Historically, research was done without giving any thought to clients or users.

B. Research and Regulations

To encourage investment in research and development, regulations must be clear and foreseeable; otherwise there is a risk of researchers going elsewhere. The issues raised were:

Cost: The witnesses mentioned the very high cost of getting a new product approved. It costs hundreds of thousands of dollars over several years to get a GMO on the market. That favours big corporations and reduces competition. It is also not good for small companies.

Administration: The industry finds that approval generally takes longer in Canada than in other countries. More and more crops are being developed for industrial applications (bioplastic, etc.) or energy, and regulations must be adapted to that shift. Regulations must also be flexible enough to ensure that undue obstacles to innovation are not created.

Intellectual property: Intellectual property rules ensure return on investment. In the field of biotechnology, Canada’s legislative framework is equivalent to the frameworks established by our main partners. However, some aspects of the regulatory framework applicable to intellectual property create uncertainty that can undermine the investment climate. Intellectual property is not always evenly protected, and the practices used in research laboratories are not uniform.