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Human, social, and environmental impacts of genetic engineering

Petition

3972 West 33rd Ave
Vancouver BC
V6N 2H8

March 31, 2004

Johanne Gélinas
Office of the Auditor General
and the Commissioner of the Environment and Sustainable Development
Attention: Petitions
240 Sparks Street
Ottawa ON
K1A 0G6

Dear Ms. Gélinas,

I am writing to express my concerns about the social, health, and environmental consequences of genetic engineering. This relatively new and untested technology poses a serious threat to sustainable development in Canada. I am submitting this letter under the Auditor General Act.

1. Background

As a way of introducing this topic, perhaps it is useful to consider the distinction between genetic engineering (GE) and traditional breeding. Simple genetic manipulations have been used for hundreds of years by farmers and scientists. Ever since Gregor Mendel's experiments on pea plants, humans have been breeding plants and animals for desirable characteristics. The fairly recent advent of genetic engineering, however, brings a radical change to this traditional technique. Unlike breeding, genetic engineering often involves crossing genes between unrelated species. For example, a bacteria gene can be inserted into a tomato's DNA to help extend its shelf life. Under natural conditions, only organisms of the same species can interbreed. The blending of genetic material from different species is thus entirely unnatural.

The long term health and environmental consequences of this technology are unknown. Given this uncertainty, it would be best to use the precautionary principle when dealing with GE. This view is supported by scientists and other experts. In their report, Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, the Royal Society of Canada states: "where there are scientifically reasonable theoretical or empirical grounds establishing a prima facie case for the possibility of serious harms to human health, animal health or the environment, the fact that the best available test data are unable to establish with high confidence the existence or level of the risk should not be taken as a reason for withholding regulatory restraint on the product." The report goes on to say that "...the prospect of serious risks to human health, of extensive, irremediable disruptions to the natural ecosystems, or of serious diminution of biodiversity, demand that the best scientific methods be employed to reduce the uncertainties with respect to these risks. Approval of products with these potentially serious risks should await the reduction of scientific uncertainty to minimum levels."

2. Human Health

Genetic engineering poses serious risks to human health. These include allergic reactions, increased toxicity, spread of genetic material from crops manipulated to produce pharmaceuticals and the problems associated with increased pesticide applications.

There are numerous examples of GE products yielding unanticipated results. For instance, in a May 2002 briefing Greenpeace notes that "yeast which had been genetically engineered to improve alcohol fermentation unexpectedly had up to 30 times the concentration of methylglyoxal (a highly toxic compound) compared to the control non-GE strain." A great deal of uncertainty surrounds the health effects of GE. Scientific studies have shown cases of increased toxicity levels and unexpected allergic reactions.

Experiments are underway to use genetically modified plants to produce prescription drugs such as vaccines, industrial enzymes, blood thinners, growth hormones, and contraceptives. This use of GE is particularly troubling. What would happen if, for example, a rice plant modified to produce a growth hormone cross pollinated with a non-GMO rice plant? Once a pharmaceutical-producing plant is released into the environment, there is little that can be done to prevent genetic contamination. If the pharmaceutical-producing gene were to leak into food crops or into the wider environment the consequences would likely be severe.

Genetically engineered foods pose a risk to health in a third, more indirect way. Contrary to the claims of the biotechnology corporations, the use of GE crops has, in many cases, increased dependence on pesticides and other chemicals. The health risks of pesticides are widely recognized. These toxins have been linked to various cancers, as well as disorders of the neurological and immune systems. Charles Benbrook of the Northwest Science and Environmental Policy Center notes that "herbicide use on Roundup Ready soybean acres is gradually rising as a result of weed shifts, late-season weed escapes leading to a buildup in weed seed banks, and the loss of susceptibility to glyphosate in some weed species." With time, crops such as Roundup Ready canola with become increasingly resistant to applications of Roundup. As a consequence, larger applications or stronger chemicals will be needed. This means that genetically engineered crops will often contain higher concentrations of pesticides than non-GE crops.

Health Canada's website states that it "conducts a thorough safety assessment of all biotechnology-derived foods to ensure that a novel food is safe and nutritious." However, because of the nature of genetic modification, some of the effects of biotechnology may only become evident in the long term. Given this, it is best to proceed cautiously.

3. Sustainable Farming

Genetically modified seed, like all seed, cannot be easily contained. Seed is distributed by the wind, by animals and in water. Thus, seed planted in one location can, by natural forces, be disseminated over a large area. In effect, this spread of GMO seed onto other land is pollution. The proliferation of genetically modified crops threatens the viability of organic agriculture. If an organic farm is contaminated with genetically engineered material, its organic status is threatened. Thus the use of genetically engineered crops violates the right of farmers to use organic methods.

Seed saving is an ancient agricultural practice. Farmers traditionally save a portion of their harvest to plant for the following year. Over time, this practice allows a crop to become adapted to the conditions of a particular area. However, this practice conflicts with the realities of the biotechnology industry. Biotechnology corporations forbid farmers who purchase seed from saving some of their crop for future planting. Furthermore, biotechnology corporations are trying to limit the right of all farmers to save seed. Farmers who have not purchased seed but are found to have GMO plants (regardless of how these plants were seeded) could be prevented from saving seed in future years. The fact that a corporation can control a living entity, in this case a modified variety of canola, has serious implications.

The "Terminator gene" presents another serious threat to sustainable agriculture. This genetic modification prevents a plant from reproducing thereby forcing farmers to purchase seed every year. If a plant containing this gene were to spread into the surrounding environment, the effects could be very serious. In theory, this gene could be spread to conventional crops or wild plants, threatening their ability to reproduce. The United States Department of Agriculture has already licensed the Terminator gene. The Canadian government should take a strong stand and prevent the release of this technology.

4. Environmental Effects

There are a variety of environmental risks associated with genetic engineering. By combining genetic material from unlike species, genetic engineering essentially creates new organisms. When genetically engineered crops are planted there is a risk that GE material will contaminate wild plants. The consequences of this type of pollution are unknown. The long term effects of genetic pollution could include harm to plants, insects and animals and a loss of biodiversity. Concerns about the environmental effects of genetic engineering have been voiced by various scientific experts. The Canadian Association of Physicians for the Environment, in their Statement on Genetically Modified Organisms in the Environment and the Marketplace state:

We have real concerns about the relationships among living organisms. We are concerned about what it means to introduce what are essentially newly created species, some of which contain a chimeric blend of genes from entirely different creatures, into our world. We have seen the effects of chemical and nuclear contamination of the environment, and have real fears that biological contamination with newly minted organisms may be even more threatening to the natural order. We urge caution.

Since GE is still relatively new the long term consequences of this technology are uncertain. Genetic engineering poses a risk to human health, agriculture and the environment. Given the uncertainty and the risks, the precautionary principle should be employed when dealing with GE.

5. Petition Request

I would like answers to the following questions:

What is Health Canada's position regarding the use of genetically engineering crops to produce pharmaceuticals? What measures will Health Canada take to demonstrate that such crops do not pose a risk to human health in the long term?

What is the position of Agriculture Canada and Health Canada with regard to the use and licensing of the Terminator gene?

What will the Canadian government do to ensure that the rights of farmers to save seed take precedence over the right of corporations to make a profit?

What measures are Health Canada and Agriculture Canada taking to limit the ability of corporations to manipulate, patent and control life forms? What assurance can these departments give that such measures are sufficient to protect the health, rights, and livelihood of the general public?

What steps is Agriculture Canada taking to protect small scale organic farmers from the risks posed by genetic engineering?

Given the serious threat posed by genetic contamination, what actions will Environment Canada take to protect wild areas and biodiversity?

According to an Ipsos-Reid survey conducted in 2001, 87% of Canadians want all genetically modified foods labelled. Given the widespread popular support for mandatory labelling why has this not yet been done?

Thank you for your attention. I look forward to your response.

Sincerely,

[Original signed by Anna Kirkpatrick]

Anna Kirkpatrick

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Joint Response: Agriculture and Agri-Food Canada, Environment Canada, Health Canada, Industry Canada

RESPONSE OF THE FEDERAL DEPARTMENTS AND
AGENCIES TO THE PETITION FILED
April 7, 2004 BY A RESIDENT OF CANADA
UNDER THE AUDITOR GENERAL ACT:

Social, Health and Environmental Concerns of Genetic Engineering

August 20, 2004

Minister of Agriculture and Agri-Food
Minister of the Environment
Minister of Health
Minister of Industry

Foreword

In responding to this petition on social, health and environmental concerns of genetic engineering, federal departments and agencies have worked together, contributing their collective knowledge and expertise. The result is a considered, integrated response relevant to all Canadians who are interested generally in biotechnology-derived products, and specifically in the topic of genetically engineered crops.

This response builds on responses to previous petitions submitted under the Auditor General Act, which provided an in-depth look at the existing regulatory system for biotechnology - aspects covering health, the environment, trade and socio-economic questions, as they pertain to regulation and sustainable development in this country. Those responses provided an overview of the comprehensive manner in which Canada regulates developers' products and a description of the "checks and balances" in the system. The specific questions related to genetically engineered crops presented in the petition are addressed in this response. Readers are invited to review previous petition responses which are publicly available at: </domino/petitions.nsf/english>. Readers are also invited to review Annex A, which provides a list of selected internet resources for further reading on the topics related to this Petition.

Canada has one of the most effective regulatory systems for biotechnology products in the world. In the renewed Canadian Biotechnology Strategy, which was developed following extensive public consultations, the Government of Canada expressed its goal of being a world leader in the responsible development of biotechnology. This means that Canada applies rigorous standards to the manner in which it regulates and monitors biotechnology-derived products, particularly as they relate to human and animal health and the environment. Departments will continue to assure Canadians that the products and processes of biotechnology are subject to the highest standards of scientific testing for health, safety and environmental impact.

Internationally, Canada has a long and prestigious record for its science-based regulatory system - a system that is in line with principles laid out by organizations such as the World Health Organization, the Organisation for Economic Co-operation and Development, the United Nations Environment Programme, the Food and Agriculture Organization, the International Plant Protection Convention, the Codex Alimentarius Commission, and the Office Internationale des Épizooties.

One of the fundamental principles of the 1993 Federal Regulatory Framework for Biotechnology is that the development of Canadian biotechnology regulations be open and include consultation with Canadian citizens. Canadian values must be at the heart of the public discussion on biotechnology. It is in this light that the Government of Canada welcomes and values a genuine dialogue with Canadians on this subject.

Table of Contents

Foreword

Table of Contents

Department and Agency Acronyms

Background

The Response of the Federal Departments and Agencies to the Petition

Question 1:

Question 2:

Question 3:

Question 4:

Question 5:

Question 6:

Question 7:

Concluding Remarks

Annex A - Internet Resources

Department and Agency Acronyms

Background

On April 7, 2004, a resident of Canada (hereinafter referred to as the Petitioner) filed a petition pursuant to Section 22 of the Auditor General Act. The petition deals with the topic of genetically engineered (GE) crops and the potential risks they pose to human health and biodiversity in Canada (hereinafter referred to as the Petition).

The petition process set out in Section 22 is a means by which Canadians can express their views and seek more information on matters of federal policy in the context of the environment and sustainable development. The Government of Canada wishes to assure the Petitioner and other Canadians that responsible stewardship of human health, biodiversity and the environment is a central priority to the federal decision-making framework for biotechnology.

The main focus of the Petition concerns the potential impacts of GE crops, used for food and pharmaceutical purposes, on human health, sustainable farming and the environment, and the role of the federal government in regulating such crops, including labelling. The Petition was specifically directed by the Commissioner of Environment and Sustainable Development (CESD) to the following Ministers on behalf of their departments (hereinafter referred to as the Ministers) for response:

In consideration of questions which make reference to patents, the CESD has also directed the Petition to the Minister of Industry.

It should be noted that in some responses, departments and agencies other than those specifically referred to in the question have provided input, as appropriate, given the particular subject matter of the question and the individual department's or agency's mandate. It should also be noted that where the Petitioner refers to "Agriculture Canada," a response is provided that reflects the roles and responsibilities of the Canadian Food Inspection Agency, the Canadian Grain Commission, and Agriculture and Agri-Food Canada in the context of this matter.

The Petition was received by the Auditor General's office on April 7, 2004. It was sent to the Ministers on April 23, 2004. For this reason, the 120 days allowed for the government to respond to the Petition, as expressed in the Auditor General Act, began on April 23, 2004.

The Response of the Federal Departments and Agencies to the Petition

Introduction

The Ministers of Agriculture and Agri-Food, Environment, Health and Industry have provided this document as a joint response to the Petitioner, a resident of Canada.

Providing a joint response is consistent with the federal government's commitment to improve its management and co-ordination of matters related to biotechnology and the environment as reflected in several previous petition responses, as well as other joint work referenced in those responses.

Overall, the Ministers believe that Canada's existing regulatory system, which is science-based, provides for the risk assessment and management of biotechnology-derived products from a sustainable development perspective. In previous responses to petitions, the Government of Canada has already provided information regarding:

Readers may refer to previous petitions for extensive background information on regulating biotechnology in Canada at: </domino/petitions.nsf/english>.

Additional information concerning the federal government's approach to matters related to biotechnology, including GE crops, can be found at the Canadian Biotechnology Strategy (CBS) website: <http://biotech.gc.ca>. In particular, readers may wish to review the chapters dealing with Agriculture and Agri-Food Canada, the Canadian Food Inspection Agency, Environment Canada, Health Canada, and Industry Canada, in the document entitled "Biotechnology Transforming Society: Creating an Innovative Economy and a Higher Quality of Life" which can be found at the CBS site.

Response to Questions of the Petition

Question 1: What is Health Canada's position regarding the use of genetically engineering [sic] crops to produce pharmaceuticals? What means will Health Canada take to demonstrate that such crops do not pose a risk to human health in the long term?

Response to Question 1:

1.  The Petitioner makes indirect reference to plant molecular farming (PMF), a technology using plants to produce products other than food or animal feed, such as pharmaceuticals. As such, these plants are considered to be plants with novel traits (PNTs). Specifically, PNTs are those with a new trait or characteristic which (1) is not present in organisms of the same species that already exist in Canada or (2) is expressed outside the normal range of similar existing traits already in the species. The Petitioner also makes reference to Health Canada's position regarding this technology. However, the response also includes input from the CFIA, as both Health Canada and the CFIA have responsibilities for the safety assessments of novel products.

2.  Mandatory, pre-market safety assessments are required before novel products are made available for any use whether in food or feed, or for their environmental release. Health Canada is responsible for carrying out human health and food safety assessments on all products under the Food and Drugs Act (e.g. food, drugs) while the CFIA has the lead responsibility for carrying out environmental safety assessments for PNTs, new livestock feeds, new fertilizers and new veterinary biologics, including those derived from biotechnology. However, Health Canada is also responsible for conducting the environmental safety assessments of food products regulated by the Food and Drugs Act. These assessments are undertaken by the Environmental Assessment Unit of the Healthy Environment and Consumer Safety Branch, in accordance with the Canadian Environmental Protection Act, 1999 (CEPA 1999). The purpose of the Health Canada environmental safety assessment is to ensure that these food products, once in commerce, do not pose a threat to the environment, or to human health indirectly through entry into the environment. Health Canada is currently in the process of developing Environmental Assessment regulations more specific to all the products regulated under the Food and Drugs Act.

3.  On-going consultations with stakeholders, the PMF sector and other members of the government regulatory community are priorities as the Government of Canada continues to develop its policy framework for PMF.

4.  Health Canada's approach to regulation is product-based, where the method of manufacture is an important consideration. Most, if not all, of the pharmaceuticals produced by PMF would be considered biologics (i.e. therapeutic products produced in biological systems) under the Food and Drugs Act administered by Health Canada, and would be evaluated by the Biologics and Genetic Therapies Directorate. As with all biologics regulated by Health Canada, any medical product produced by PMF would be evaluated on a case-by-case basis using a science-based approach.

5.  Health Canada has extensive experience in the challenges posed by regulating biologics, such as those produced by genetically modified yeast in bioreactors, or vaccines produced in eggs. For all biologics, evaluation of the manufacturing process is a critical factor in the evaluation of the final product for sale. Pharmaceuticals produced by PMF will have to meet the same high standards of quality, safety and efficacy as biologics manufactured by other means. The onus will be on the PMF industry to prove that its products can be produced consistently and safely to Health Canada's standards before product approvals are granted.

6.  To date, there is no commercial PMF activity in Canada, but confined research trials have been conducted under the authority of legislation administered and enforced by the CFIA. Until the Government of Canada completes a review of its policy on PMF, authorizations for confined research field trials are granted according to the interim amendments to regulatory directive Dir2000-07, available at: <http://www.inspection.gc.ca/english/plaveg/bio/dir/dir0007ie.shtml>. Confined field trials provide the opportunity to evaluate these PNTs under highly controlled conditions while limiting their impact on the environment and preventing their introduction into the food and feed systems until they are fully assessed.

7.  In addition to reviewing applications for confined research field trials, the CFIA has been developing regulatory directives specific to field testing and commercial cultivation of PNTs for PMF. As part of the development of these new regulatory directives, the CFIA hosted a broad, multi-stakeholder consultation focusing on the particular concerns associated with confined research field trials of PNTs for pharmaceutical production in fall 2001. Participants included public interest groups, agriculture and agribusiness, industry, academia, and various departments and agencies from different levels of government. The CFIA also invited comments from interested Canadians on the issues discussed during the consultation through a questionnaire posted on the Agency's website. For further details on the multi-stakeholder consultation, including a discussion report and proceedings, please visit: <http://www.inspection.gc.ca/english/plaveg/bio/mf/mf_cnsle.shtml>.

8.  Prior to this technical consultation, the CFIA also held a Public Forum on PMF (October 2001) to provide opportunities for the public and stakeholders to learn about PMF and to express their views and concerns regarding the regulation of this technology. Further information regarding the Public Forum on PMF has been made available at: <http://www.inspection.gc.ca/english/plaveg/bio/mf/mf_fore.shtml>. Input from these consultations has been incorporated in the previously mentioned interim amendments to regulatory directive Dir2000-07.

9.  An important step in developing a regulatory framework involves examining whether these products and by-products can be adequately segregated from other commodities; more specifically, those intended for the food and feed chains. The Canadian Grain Commission (CGC), as the Canadian regulator for grains destined for export, is also concerned with these products being segregated from the current Canadian grain handling system by an effective segregation system. To address this issue, the CFIA hosted a technical workshop on March 2-4, 2004 to discuss the segregation and handling of potential commercial PMF products and by-products. Participants included representatives from industry, federal government, agricultural and agribusiness associations, and experts in grain handling and identity preservation. As a result of this workshop, the CFIA, in collaboration with colleagues from the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, has drafted and solicited advice on how best to expand the table of contents for a code of best agricultural practices for PNTs for PMF. As well, the CFIA will continue to work with Health Canada to develop an appropriate regulatory pathway, leading to the development of regulatory directives.

10.  For further information on PNTs for PMF, please visit: <http://www.inspection.gc.ca/english/plaveg/bio/mf/molecule.shtml>.

Question 2: What is the position of Agriculture Canada and Health Canada with regard to the use and licensing of the Terminator gene?

Response to Question 2:

11.  Currently, the "terminator gene", a gene causing seed sterility, is not used in conjunction with any GE product in Canada. Neither Health Canada nor the CFIA has reviewed or authorized any novel products containing the "terminator gene", and AAFC has no current plan to license the technology. "Terminator genes" are not used in any commercial seed varieties available in Canada.

12.  It is important to reiterate that Canada regulates novel products regardless of how they are produced. Specifically, novel products are those with a new trait or characteristic which (1) is not present in organisms of the same species that already exist in Canada or (2) is expressed outside the normal range of similar existing traits already in the species. Novel products, therefore, are not distinguished by how they are produced. Rather, the focus is on the characteristics that the products express (i.e. the technique is secondary to the qualities of the product). Under current legislation, any products expressing the "terminator gene" would be subject to the same comprehensive regulatory and scientific review as any other novel product in order to determine whether it would be approved for use in Canada, if ever this technology were to be submitted for regulatory consideration.

13.  For example, if a "terminator gene" was used in the development of a novel food, the gene would be evaluated for safety according to criteria in Health Canada's Guidelines for the Safety Assessment for Novel Foods. The assessment would examine the potential allergenicity and toxicity of the gene product and the potential for horizontal gene transfer to other organisms. Under current legislation, any pharmaceutical product derived from plants containing the "terminator gene" would be evaluated on a case-by-case basis as a biologic under the Food and Drugs Act, and would be expected to meet the same standards for safety, efficacy and quality as biologics produced by other means.

14.  The environmental assessment performed by Health Canada under CEPA 1999 on products covered by the Food and Drugs Act would be performed on the food, pharmaceutical or industrial substance itself, which can be the harvested plant, but not on the plant in the field containing the "terminator gene". The CFIA is responsible for assessing the impact on the environment of plants covered by the Seeds Act.

15.  Readers are directed to the following website for a series of fact sheets on the regulatory and assessment systems for novel products: <http://www.inspection.gc.ca/english/sci/biotech/reg/rege.shtml>.

Question 3: What will the Canadian government do to ensure that the rights of farmers to save seed take precedence over the right of corporations to make a profit?

Response to Question 3:

16.  Canada's laws and regulations, such as the Patent Act and Competition Act, help to make sure that the Canadian marketplace is fair and competitive, for farmers and for large and small corporations. Constantly, the Government objective is to ensure that an appropriate balance is maintained between protecting intellectual property rights and facilitating a competitive supply of products for Canadian consumers.

17.  For example, the development of new plant and seed varieties is currently protected under section 5 of the Plant Breeders' Rights ("PBR") Act. Implicit within the PBR Act is a farmer's privilege: farmers who purchase seeds from the PBR holder are entitled to grow a crop from those seeds, and are further entitled to save new seeds from that grown crop to use for planting any future crops in the farmers' fields. Seed developers may, in some cases, be entitled to seek patent protection for their innovations. A recent Supreme Court of Canada ruling (Monsanto Canada Inc v. Schmeiser) clarifies that farmers' privilege does not supercede the rights of patent holders in Canada. This balance between the farmer's privilege and the rights of patent holders does not reduce the amount of choice found within the agriculture sector. Farmers will continue to evaluate whether a specific seed will give them the best return on their investment, taking into account whether its use will require them to purchase new seed each year. As an example, most of the commercial corn crop produced in Canada, and a large percentage of Canada's annual canola crop, is produced using hybrid seeds that require farmers to purchase new seeds for planting each year.

18.  For more information on Supreme Court of Canada judgments, readers are invited to review the following website: <http://www.scc-csc.gc.ca>.

19.  The federal Government recognizes that biotechnology is an issue of significant public interest. This is why it has established the Canadian Biotechnology Advisory Committee (CBAC), an independent body, to provide Ministers with advice on matters related to biotechnology. The CBAC has undertaken a review of the scientific, ethical, social and economic dimensions of the patenting of multi-cellular inventions, i.e., higher life forms. It has also engaged in consultations with the Canadian public, stakeholders and experts. On the basis of its research and consultations, CBAC published, in June 2002, a report entitled Patenting of Higher Life Forms and Related Issues, a copy of which is available on the CBAC internet website at: <http://www.cbac-cccb.ca>; or by calling toll free at 1-866-748-2222. This report contains 13 recommendations. One of these recommendations particularly pertains to the inclusion of a farmer's privilege in the Patent Act. In consideration of the CBAC's recommendations, Industry Canada officials are currently working with other departments to analyze these and other issues.

Question 4: What measures are Health Canada and Agriculture Canada taking to limit the ability of corporations to manipulate, patent and control life forms? What assurance can these departments give that such measures are sufficient to protect health, rights, and livelihood of the general public?

Response to Question 4:

20.  The Government of Canada is committed to maintaining a balanced patent regime that provides appropriate incentives for innovation, while protecting Canadians' values and ensuring that they have access to the latest scientific information and technologies. Innovation in the area of biotechnology is especially important for our society due to its potential to generate important new drugs, medical therapies and food production techniques.

21.  Patents are an effective tool for encouraging innovation because they provide an incentive for individuals and companies to invest their time and money in developing novel inventions in return for an exclusionary, time-limited right. This right is balanced by the requirement that the invention be fully disclosed to the public within 18 months of the patent application filing date. Once the information is disclosed, anyone can use it to develop new and different innovations.

22.  As mentioned in paragraph 19, the CBAC published, in June 2002, a report entitled Patenting of Higher Life Forms and Related Issues. This report contains 13 recommendations, which are currently under review by the Government.

23.  Canada only grants patents for inventions that meet the criteria outlined in the Patent Act; they must be new, non-obvious to an expert in the field of technology to which the invention pertains and useful. As a result, patents cannot be granted in Canada on products and processes as they exist in nature.

24.  Lower life forms (i.e., single-celled organisms) have been patented in Canada for over 20 years. Contrary to the patent practices of our major trading partners, Canada does not currently grant patents on whole plants (or seeds) or animals. The Supreme Court of Canada confirmed that Canada's current Patent Act does not allow for the patenting of higher life forms.

25.  Canada's Patent Act is administered by Industry Canada, and as such, Health Canada's role in the drafting and implementation of the Patent Act is to advise Industry Canada on the impact of the Patent Act and any proposed changes to it, on health issues under the authority of Health Canada.

26.  From an AAFC perspective, Canada's success in agriculture has long depended on the sector's ability to innovate and make use of new scientific applications. Advances in food science and technology have the potential to usher in a wide variety of new products that serve a diversity of important purposes, which could bring benefits to Canadians' quality of life and to the economy.

27.  In the agriculture sector, producers need to have access to a wide range of technologies and production techniques with the potential benefits of improving returns, conserving natural resources (such as soil and water), and creating more flexibility in the management of their operations. Many producers have expressed to government the importance of encouraging further innovation in these areas.

28.  The Government of Canada is committed to protecting the health and environment of Canadians through a rigorous health and safety process for all agriculture products, including those derived through biotechnology. For example, Health Canada and CFIA perform safety assessments on food products and agricultural products.

29.  The CFIA is responsible for the regulation of a number of agricultural products derived through biotechnology, including plants, animal feeds, fertilizers and veterinary biologics. As such, mandatory, pre-market safety assessments are required before novel products are made available for any use whether in food or feed or their environmental release.

30.  For crops developed through biotechnology, the CFIA assesses the potential risk of adverse environmental effects and authorizes import permits, confined trials, unconfined release and variety registration. More specifically, a series of regulatory requirements must be satisfied in a stepwise manner, as follows: (1) the first environmental review for field trials, (2) the second environmental review prior to commercialization, (3) a feed safety review, (4) a food safety review, and (5) variety registration (for most field crops). The regulatory system requires the co-operation of applicants while maintaining and enforcing precautionary measures to enhance the safety and efficiency of the food system. For more information, please consult the website mentioned in paragraph 15 on the federal regulatory and assessment systems for novel products.

31.  In addition, the Government of Canada takes seriously the concerns about the implications of patents on food security, especially on developing countries. By way of example, Canada was one of the first countries to ratify the International Treaty on Plant Genetic Resources for Food and Agriculture, available at: <http://www.fao.org/ag/cgrfa/itpgr.htm>. This Treaty will facilitate the conservation of and access to the world's plant genetic resources and improve global food security. Canada also supports the flexibility available in the Agreement on the Trade-Related Aspects of Intellectual Property Rights allowing World Trade Organization members to individually determine whether they will exclude from patentability plants or animals. For more information on this agreement, please visit: <http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm>.

32.  The CGC, in recognition of the development and registration of GE grains in Canada, does provide services to farmers and the grain industry to maintain the integrity of the quality assurance system in Canada by (1) evaluating end use quality of GE grains and making recommendations to ensure that they conform to existing established quality standards; and (2) developing and validating methods for the identification and testing of GE grains as needed by industry.

Question 5: What steps is Agriculture Canada taking to protect small scale organic farmers from the risks posed by genetic engineering?

Response to Question 5:

33.  The Government of Canada, including AAFC, recognizes that there is a demand for organic products. For Canadian organic farmers to successfully compete in this market, it is important that they be supported with research and promotion, and provided with the tools, such as a world-class national standard and conformance system, which will assure continued international market access and consumer confidence.

34.  In terms of research, AAFC has a strong commitment to organic agriculture. For example, AAFC pioneered research into Integrated Pest Management (IPM) with investments in research that span over 40 years (some of the earliest IPM research conducted in the world was undertaken by horticultural entomologists working for the Canadian Department of Agriculture in the 1950s and 1960s). In 2003-2004, the total investment in IPM alone under the Environment National Science program exceeded $11 million. Similarly, a whole science theme under AAFC's Sustainable Productions Systems National Science Program is devoted to the study of organic agriculture and receives substantial annual financial support. Agriculture and Agri-Food Canada was also very instrumental in the creation, in 2001, of the Organic Agriculture Centre of Canada (OACC), whose vision is to strengthen the science and practice of organic agriculture in Canada. The OACC conducts, coordinates and disseminates producer-oriented research and education. Over $1 million has been extended to the OACC since 2001 and contributions are continuing.

35.  The commitment of AAFC to the organic sector extends to promotion and development. Financial support in excess of $4 million was provided from 1998-2004 under several programs including the national and regional Canadian Adaptation and Rural Development (CARD) programs and initiatives under Canada's International Business Strategy. Further information can be found on the CARD website: <http://www.agr.gc.ca/policy/adapt/index_e.phtml>.

36.  The Advancing Canadian Agriculture and Agri-Food (ACAAF) program is a new, five-year, $255 million program aimed at positioning Canada's agriculture and agri-food sector at the leading edge to seize new opportunities. ACAAF was launched in April 2004 as a successor to the CARD Fund, and will continue CARD's innovative and cooperative approach to funding projects at the national, multi-regional and regional level. This program is available to support organizations such as the OACC. Further information can be found on the ACAAF website at: <http://www.agr.gc.ca/acaaf >.

37.  The Government of Canada, including CFIA and AAFC, has shown further support for organic farming through the development of the voluntary National Standard for Organic Agriculture. The Standard, ratified in April 1999 by the Standards Council of Canada, is currently being updated under financial sponsorship from AAFC. It outlines principles for organic agriculture that endorse sound production and management practices to enhance the quality and sustainability of the environment and ensure the ethical treatment of livestock. Readers are invited to review the Standard at: <http://www.pwgsc.gc.ca/cgsb/032_310/standard-e.html>.

38.  The CFIA is committed to enhancing the safety of food produced, sold or imported into Canada, contributing to the health of animals, and protecting the plant resource base. Any potential risks caused by introducing a novel crop, including those derived from biotechnology, into the environment are assessed through the CFIA's environmental safety assessment process. This process addresses five key aspects: 1) altered weediness potential, 2) potential for outcrossing, 3) altered plant pest potential, 4) impacts on non-target organisms, and 5) impact on biological diversity. If a novel crop, including those derived from biotechnology, is found to pose a significant risk to the environment, it is not released in Canada. Readers are referred to the Regulatory Directive entitled Draft Safety of Plants with Novel Traits available at: <http://www.inspection.gc.ca/english/plaveg/pbo/pbobbve.shtml>.

39.  The National Standard of Canada for Organic Agriculture provides guidance on buffer zones to also address the issue of spray and fertilizer drift:

Buffer zones must be sufficient in size or other features to prevent the possibility of unintended contact with prohibited substances and are to be set by the operator on a case-by-case basis according to local needs and conditions and recommendations by a certification body. (National Standard for Organic Agriculture, Section 6.9)

40.  The Canadian Identity Preserved Recognition System (CIPRS) is a new tool for industry to provide assurance of specific grain quality attributes to domestic and international buyers of grain, including grain produced under pesticide free production regimes. The CIPRS is a joint project of the CGC and the Canadian Seed Institute, a not-for-profit organization established by Canadian seed associations. For more information on CIPRS, please visit: <http://www.grainscanada.gc.ca/prodser/ciprs/ciprs1-e.asp>.

Question 6: Given the serious threat posed by genetic contamination, what actions will Environment Canada take to protect wild areas and biodiversity?

Response to Question 6:

41.  Although the question specifically makes reference to Environment Canada, a broader response is provided. Several other federal departments and agencies have responsibilities for the human health and environmental risks of novel living organisms, including agricultural biotechnology products. Most notably, the CFIA (e.g. under the Feeds Act, Fertilizers Act, Seeds Act, Health of Animals Act), and Health Canada (e.g., under the Pest Control Products Act) have these responsibilities. For novel living organisms not regulated under the aforementioned Acts, for example, microorganisms used in bioremediation and industrial enzyme production. Environment Canada and Health Canada regulate these organisms under the CEPA 1999. As a note, the aforementioned Acts are listed in Schedule 4 of CEPA 1999 meaning these Acts and Regulations provide equivalent provisions for notification and assessment for potentially adverse effects on human health or the environment before import, manufacture or sale of the novel living organism.

42.  Risks of harm to the environment or human health posed by novel living organisms, or their genes, are assessed on a case-by-case basis. If the novel living organism is found to pose no potential concerns to human or environmental health when compared to its traditionally developed counterparts in use in Canada, it can be imported or manufactured in Canada for the notified use (e.g., release in the environment). When necessary, potential risks can be managed by imposing conditions that control or reduce the risk (e.g. prohibiting the release or limiting the release to a confined area).

43.  In the case of plants with novel traits, an environmental safety assessment, conducted by the CFIA, would consider the following questions:

44.  The Petitioner's question raises the issue of genetic contamination, or 'outcrossing' - the potential for genes to move from a genetically engineered plant to a wild relative. It is true that genes can be transferred from one plant of a species to another plant of the same species, and in some cases to a closely related but different plant species. This is a normal process that occurs naturally when plants of the same species pollinate one another or, in rare cases, pollinate a closely related plant of another species. Just as this can happen between non-genetically engineered plants, it can also happen between genetically engineered plants and non-genetically engineered plants. However, the transfer of pollen alone is not enough to permit gene flow as the genetic material in the pollen can only be transferred if:

45.  Environmental risk assessment guidelines require that the potential for outcrossing be evaluated on a case-by-case basis. This process takes into account the plant species, its biology and ecology in Canada, and the introduced novel trait. For the most part, genetically engineered plants that have been approved for release in Canada do not have wild relatives in Canada, including corn and soybeans.

46.  Canola plants of any variety, including herbicide-tolerant canola plants, can outcross with their same-species relatives and with a few related plants of other species, such as rapeseed. If a trait for herbicide tolerance were passed onto a weed, it does not mean that the weed would become a more difficult pest; it means that the weed would be tolerant to a specific herbicide (referred to as a herbicide tolerant volunteer). As such, there have been claims that the transfer of traits from plants with novel traits to wild relatives could create "superweeds" that are harder to control and more invasive. There have also been claims that gene flow from herbicide tolerant varieties to non-herbicide tolerant varieties could create "superweeds". The CFIA requires developers of herbicide tolerant varieties to implement stewardship plans for controlling any herbicide tolerant volunteer plants using other management practices, such as tillage or the use of alterative herbicides. To date, the CFIA's environmental safety assessments have concluded that while gene flow is possible, it does not result in increased weediness or invasiveness of wild relatives.

47.  AAFC supports regulators by carrying out research and providing advice regarding novel crops. In addition to its involvement in the risk assessment process, Environment Canada continues to develop a federal research strategy to generate knowledge to understand the potential long-term ecosystem effects of novel living organisms. The knowledge to be generated through the results of this research will be considered in both policy and regulatory decision making processes to ensure that these organisms contribute to an environmentally sustainable future.

Question 7: According to an Ipsos-Reid survey conducted in 2001, 87 percent of Canadians want all genetically modified foods labeled. Given the widespread popular support for mandatory labeling why has this not yet been done?

Response to Question 7:

48.  The Canadian Food Inspection Agency and Health Canada each have responsibility for food labelling policies under the Food and Drugs Act. The CFIA also has additional responsibilities under the Consumer Packaging and Labelling Act, as well as under other relevant legislation.

49.  Health Canada is responsible for setting food labelling policies regarding health and safety matters. For example, mandatory labelling of all foods, including genetically modified foods, is provided for in the legislation in respect of foods that have significant nutritional or compositional changes, or where potential health and safety risks exist that could be mitigated through labelling. The label must indicate, for example, the presence of a known allergen or the nature of a nutritional or compositional change. In regards to enforcement of these policies, the CFIA is responsible for enforcing all food labelling regulations under the authority of the Food and Drugs Act and the Consumer Packaging and Labelling Act.

50.  The CFIA also administers and enforces non-health and safety labelling requirements. These requirements apply to all foods, not only biotechnology-derived foods. Specifically, these non-health and safety labelling requirements refer to consumer protection against misrepresentation and marketplace deception with respect to food labelling, packaging and advertising and for prescribing basic food labelling and advertising requirements for all foods (e.g. listing of food ingredients and components, product claims, mandatory information and statements, etc).

51.  Current legislation prescribes what can be said on food labels so consumers are provided with essential information about nutrition, composition, and substances that may have safety implications for particular segments of the population. Therefore, because there are no potential health and/or safety concerns or significant nutritional or compositional changes, the fact that the process of genetic engineering was utilized need not be identified on the label. However, food products can be voluntarily labelled to highlight information of interest to consumers - as long as the information is truthful and not misleading. This also applies to biotechnology-derived foods in the sense that a food manufacturer may voluntarily choose to label its product as "a product of genetic engineering" or "not a product of genetic engineering". In not prohibiting such labelling, the government is recognizing the consumer's desire for more information that is not related to the safety of the product.

52.  In 1999, the Canadian Council of Grocery Distributors requested that the Canadian General Standards Board (CGSB) establish a process to develop a national standard for voluntary labelling of foods and food ingredients that are, or are not, products of genetic engineering. The Canadian government has been supportive of the CGSB process to develop common voluntary standards.

53.  The official adoption of the Standard for Voluntary Labelling and Advertising of Foods That Are and Are Not Products of Genetic Engineering as a National Standard of Canada, by the Standards Council of Canada, was announced on April 15, 2004. The release of this Standard means that consumers could start to see more labels on some food ingredients and food items indicating whether or not they are a product of genetic engineering. The voluntary National Standard provides guidance that will assist consumers in making informed choices about GE or non-GE foods, while allowing the agri-food industry the flexibility it needs to make appropriate business decisions in response to market demands.

54.  The Standard for Voluntary Labelling and Advertising of Foods That Are and Are Not Products of Genetic Engineering can be viewed at: <http://www.pwgsc.gc.ca/cgsb/032_025/standard-e.html>. This standard is also available, without charge, in hard-copy format. You can request a copy from the CGSB Sales Centre (Sales Centre, Canadian General Standards Board, Gatineau, Québec, K1A 1G6).

55.  Finally, the Standing Committee on Agriculture and Agri-Food tabled its report on the labeling of biotechnology-derived foods entitled Labelling of Genetically Modified Foods and its Impacts on Farmers, in June 2002. This report can be accessed from the following website: <http://www.parl.gc.ca/InfoComDoc/37/1/AGRI/Studies/Reports/agrirp23-e.htm>. The Government's response to the four recommendations in this report was tabled in the House of Commons in October 2002 and can be accessed from the following website: <http://www.agr.gc.ca/cb/biotech/gm_e.phtml>.

56.  For further information on labelling of novel foods in Canada, please refer to: <http://www.inspection.gc.ca/english/sci/biotech/labeti/labetie.shtml> or visit the websites listed in Annex A under Food Labelling.

Concluding Remarks

The Ministers named in this Petition remain committed to:

Annex A - Selected Internet Resources for Further Reading

Part 1 - Government Departments, Agencies and other Organizations

Government of Canada
<http://www.gc.ca>

Agriculture and Agri-Food Canada
<http://www.agr.gc.ca>

Canadian Biotechnology Strategy
<http://biotech.gc.ca>

Canadian Food Inspection Agency
<http://www.inspection.gc.ca>

Canadian Grain Commission
<http://www.grainscanada.gc.ca>

Commission for the Environment and Sustainable Development
</domino/oag-bvg.nsf/html/environment.html>

Environment Canada
<http://www.ec.gc.ca>

Health Canada
<http://www.hc-sc.gc.ca>

Industry Canada
<http://www.ic.gc.ca>

Supreme Court of Canada
<http://www.scc-csc.gc.ca>

Part 2 - Response Topics

A.  Plant Molecular Farming

General Information
<http://www.inspection.gc.ca/english/plaveg/bio/mf/molecule.shtml>

Public Forum on Plant Molecular Farming
<http://www.inspection.gc.ca/english/plaveg/bio/mf/mf_cnsle.shtml>
<http://www.inspection.gc.ca/english/plaveg/bio/mf/mf_fore.shtml>

Regulatory Directive
<http://www.inspection.gc.ca/english/plaveg/bio/dir/dir0007ie.shtml>

B.  Patenting of Higher Life Forms

Canadian Biotechnology Advisory Committee
<http://www.cbac-cccb.ca>

Supreme Court of Canada
<http://www.scc-csc.gc.ca>

International Treaty on Plant Genetic Resources for Food and Agriculture
<http://www.fao.org/ag/cgrfa/itpgr.htm>

Agreement on the Trade-Related Aspects of Intellectual Property Rights
<http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm>

C.  Regulation of Products of Agricultural Biotechnology

Canadian Food Inspection Agency
<http://www.inspection.gc.ca/english/sci/biotech/reg/rege.shtml>

D.  Organic Farming

Canadian Adaptation and Rural Development
<http://www.agr.gc.ca/policy/adapt/index_e.phtml>

Advancing Canadian Agriculture and Agri-Food
<http://www.agr.gc.ca/acaaf>

National Standard for Organic Farming
<http://www.pwgsc.gc.ca/cgsb/032_310/standard-e.html>

Draft Revision of Regulatory Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits
<http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9408de.shtml>

Canadian Identity Preserved Recognition System (CIPRS)
<http://www.grainscanada.gc.ca/prodser/ciprs/ciprs1-e.asp>

CFIA - Plant Biosafety Office
<http://www.inspection.gc.ca/english/plaveg/pbo/pbobbve.shtml>

E.  Food Labelling

National Institute for Nutrition
<http://www.inspection.gc.ca/english/corpaffr/newcom/1999/19990423e.shtml>

Royal Society of Canada
<http://www.inspection.gc.ca/english/sci/biotech/tech/royale.shtml>

Canadian Biotechnology Advisory Committee
<http://cbac-cccb.ic.gc.ca/epic/internet/incbac-cccb.nsf/en/ah00186e.html>

Codex Alimentarius Committee on Food Labelling
<http://www.inspection.gc.ca/english/sci/biotech/labeti/cae.shtml>

Standing Committee on Agriculture and Agri-Food Report on Labelling of Genetically Modified Food and its Impact on Farmers
<http://www.parl.gc.ca/InfoComDoc/37/1/AGRI/Studies/Reports/agrirp23-e.htm>

Government Response to the Standing Committee on Agriculture and Agri-Food Report on Labelling of Genetically Modified Food and its Impact on Farmers
<http://www.agr.gc.ca/cb/biotech/gm_e.phtml>