Federal regulation of genetically modified organisms
Petition: No. 125
Issue(s): Agriculture, compliance and enforcement, and science and technology
Petitioner(s): Jenn Robus
Date Received: 16 August 2004
Summary: This petition concerns the assessment and regulation of genetically modified organisms (GMOs) in Canada. The petitioner is primarily concerned about the regulation of plant biotechnology and asks specific questions about the following: how departments determine whether or not a plant with novel traits is safe; the regulations and policies governing farm borders and farmers' rights in areas where genetically modified crops are produced; departments' review and enforcement of policies on GMOs; and departments' approaches to addressing public concerns about GMOs.
9 August 2004
Commissioner of the Environment and Sustainable Development
Office of the Auditor General of Canada
240 Sparks Street
Re: Environmental Assessment and Plants with Novel Traits
Please consider this submission of an environmental petition under the Canadian Auditor General Act. Enclosed is the petition regarding the use of genetically modified organisms regulated by Canadian Federal Departments. The questions are directed at Agriculture and Agri-Food Canada, specifically the Canadian Food Inspection Agency, Health Canada, Environment Canada and Industry Canada.
Thank you for your time in responding to this issue of environmental concern, and I look forward to hearing from you.
[Original signed by Jenn Robus]
564 Patricia Drive
The Plant Biosafety Office is a division of the Canadian Food Inspection Agency and is responsible for regulating the environmental release of agricultural and horticultural crop plants with novel traits (PNT's) in Canada. They define a plant with novel traits, as a "plant variety/genotype possessing characteristics that demonstrate neither familiarity nor substantial equivalence to those present in a distinct, stable population of a cultivated species of seed in Canada and that have been intentionally selected, created, or introduced into a population of that species through a specific genetic change". This is usually done through recombinant DNA technology, and the testing as well as inspection of quality and sales of seeds is under the jurisdiction of the Department of Justice Canada's Seeds Act, under the Amendment in 2001 of Regulations Part V. The plants used in Canada for genetic modification purposes are canola, corn, wheat, soybean, potato and flax.
The CFIA is also responsible for assessing the potential risk of damaging environmental effects from genetically modified crops, as well as confined trials, unconfined release and seed variety registration. Scientists must consider the potential risk of the plants having an adverse effect on the natural habitat they will be introduced to, in the form of weeds, invasiveness, the cross of gene flow to surrounding plants, and the impact on non-target species as well as impact on biodiversity. When a developer wishes to market a plant, they must be able to supply all the information necessary to carry out an environmental safety assessment done by the CFIA to be approved before the crops can be taken out of the laboratory and into the field. The Plant Biosafety Office then implements a Decision Document and the release of the plants into Canadian fields is granted, with assessments taken periodically to continue evaluating the crops.
Environment Canada's Canadian Environmental Protection Act as renewed in 1999 has the goal of protecting the environment and contributing to sustainable development, as well as working with Health Canada to assess and regulate potentially toxic substances. Part 6, Animate Products of Biotechnology, in sections 104-115 of the CEPA 1999 outline requirements and assessments for biotechnological use in agriculture.
Under the Canadian Environmental Assessment Act (administered by the Canadian Environmental Assessment Agency) federal departments, agencies and crown corporations are required to conduct these assessments for proposed projects when the government is involved in either funding, permits, or licensing.
Currently, there is much concern surrounding the safety and assessment of genetically altered organisms, or plants with novel traits. The criteria for environmental assessment put forth by the CFIA state that potential risks of proposed biotechnology crops must be fully evaluated before release into the field is granted. As outlined in the CFIA guideline, developers must submit all information relative to their proposed plant to CFIA scientists. It is this self-evaluation and methodology of assessment that I wish to bring attention to.
With the role of the Commissioner of the Environment and Sustainable Development to assist Parliament and the Auditor General in monitoring department sustainable development strategies, this environmental assessment falls directly under the Commissioner's jurisdiction.
I am submitting the following questions under the petition act, to be directed at Agriculture and Agri-Food Canada, specifically the Canadian Food Inspection Agency, Health Canada, the Department of Justice Canada, Environment Canada and Industry Canada.
1. a. Where are the tests for proposed plants with novel traits performed and under whose authorization? If they are done by the corporation's scientists, how are they chosen and what training and qualifications must they have?
2. a. What exact studies do the CFIA scientists carry out to determine the safety of the plants on the health of the environment and of humans?
b. How exactly does the CFIA ensure accuracy of the reports submitted for environmental assessment if they do not perform the scientific procedures themselves?
c. What are the training qualifications for CFIA scientists assessing the information provided by the corporations in their environmental safety assessment? How are they chosen and what are are they trained in?
d. What are the consequences and penalties for corporations and developers of seeds who do not supply complete information about their seeds?
3. What are the regulations surrounding farm borders in areas of genetically altered crops mixed with organic crops?
a. What are the policies in place that stipulate the rights of the organic farmers to oppose cross-pollination from gene flow and subsequent contamination of plants with novel traits (as defined by the CFIA) into their organic crops?
b. What are the penalties for corporations and developers who do not comply with these policies?
c. How often are these policies reviewed and enforced? Please detail.
4. a. How frequently are the Decision Documents related to approved novel plants reviewed and reassessed?
b. Are the results shared with the corporation(s) and are suggestions made to them on improving their biotechnology? Please provide details.
5. How often does your department review its assessment requirements and what does it take to change policies in effect?
6. The CEAA requires federal departments to conduct assessments when the government is involved in the proposal. Are there proposals that do not involve government funding or permits? And how are these assessed?
7. Would the ministers concerned please provide details on the measures taken to evaluate the safety of a plant with novel traits? What exactly is the research that concludes these plants are safe to be consumed over the long term for human health and the environment? Please explain in detail what any effects are, either to humans or the ecosystem, and how they are being managed.
8. What are the ministries doing about the concerns raised by the public over the safety of genetically altered organisms?
a. What does each federal department do in terms of researching these public concerns? To what extent is this research shared with the public?
b. How does each federal department justify or defend their policies on the safety of genetically altered organisms?
I thank you again for your time in this matter, and look forward to hearing from you. Please feel free to contact me with any concerns surrounding this petition.
RESPONSE OF THE FEDERAL DEPARTMENTS AND
AGENCIES TO THE PETITION FILED
AUGUST 16, 2004, BY JENN ROBUS
UNDER THE AUDITOR GENERAL ACT:
Environmental, Livestock Feed, and Human Health Safety Assessments of Plants with Novel Traits
December 24, 2004
The Government of Canada defines biotechnology broadly as the application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural and modified forms. Canada has a unique regulatory approach for biotechnology products which considers the novelty of an organism as the trigger for regulatory review (e.g. the introduction of new genetic trait(s), change in an existing genetic trait(s) or new uses as a food or livestock feed), instead of how the product was developed. However, the criteria for novelty are specific to the product (e.g. plants, livestock feeds, fertilizers, etc) and are defined in the appropriate directives, regulations or guidelines. Novel organisms can be developed through various genetic modification techniques (e.g. traditional breeding, genetic engineering, mutagenesis, cell fusion, etc). As such, plants with novel traits (PNTs) are defined as new varieties of a species subject to regulatory oversight when they possess trait(s) novel to that species in Canada, i.e.:
In responding to this petition on the environmental, livestock feed, and human health safety assessments of PNTs, 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 in the topic of environmental, livestock feed, and human health safety assessments of PNTs.
The Government's response builds on previous responses to petitions submitted under the Auditor General Act, which provided an in-depth look at the existing regulatory framework for biotechnology in aspects covering health, environment, trade, and socio-economic questions, as they pertain to sustainable development in this country. Those responses provided an overview of the comprehensive way in which Canada regulates novel products. They also describe the "checks and balances" in the regulatory system, as well as such forward-looking developments as the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The specific questions related to the environmental, livestock feed, and human health safety assessments of PNTs presented in the petition are addressed in this response. The reader is invited to review previous petition responses, which are publicly available on Government of Canada Web sites, for information about the overall regulatory framework for biotechnology.
Canada has one of the safest, most effective regulatory systems for novel products in the world. In the 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 the Government must apply rigorous standards to the manner in which it regulates and monitors novel products, particularly as they relate to human and animal health and the environment. The Government 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 prestigious record for its science-based regulatory system - a system in line with principles laid out by organizations such as the World Health Organization (WHO), the Organisation for Economic Co-operation and Development (OECD), the United Nations Environment Programme (UNEP), the Food and Agriculture Organization (FAO), the International Plant Protection Convention (IPPC), the Codex Alimentarius Commission, and the Office International des Épizooties (OIE).
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 transparent dialogue with Canadians as it is also embodied in the Auditor General Act and the process for petitioning the Government on matters pertaining to the environment and sustainable development.
Table of Contents
On August 16, 2004, Jenn Robus (hereinafter referred to as the Petitioner) filed a petition (hereinafter referred to as the Petition) with the Commissioner of the Environment and Sustainable Development, pursuant to Section 22 of the Auditor General Act. The Petition contains questions relating to the environmental, livestock feed, and human health safety assessments of PNTs; specific questions are addressed in the body of this document.
The petition was received by the Auditor General's office on August 16, 2004. It was sent to the petitioned Ministers on behalf of their departments (hereafter referred to as the Ministers) on August 27, 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 August 27, 2004.
The petition process set out in Section 22 of the Auditor General Act is a means by which Canadians can express their views while seeking 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 of priority to the federal decision-making framework for biotechnology.
The Commissioner of the Environment and Sustainable Development forwarded the petition to the following Ministers for response:
However, a copy of this petition was forwarded to the Minister of Industry and the Minister of Justice and Attorney General of Canada for information purposes only. As appropriate, departments and agencies other than those specifically referred to in the question have provided input 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 (CFIA) and Agriculture and Agri-Food Canada (AAFC) in the context of this matter.
The Response of the Federal Departments and Agencies to the Petitioner
1. The Ministers of AAFC, Health, and the Environment are providing this document as a joint response to the Petitioner.
2. Providing a joint response illustrates the federal government's commitment to improve the 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 described in those responses.
3. Overall, the Ministers believe that Canada's existing regulatory system provides for the safety assessment and management of novel products, from the perspective of sustainable development. In previous petition responses (specifically petitions numbered 23, 34A & B, 38A & B, 44, 84, 85, 88, and 108) the Government of Canada has already provided information regarding:
4. In addition, several Acts and Regulations covering environmental and human health safety assessment of new substances were found to meet the criteria for notification and assessment in the Canadian Environmental Protection Act, 1999 (CEPA 1999). For example, the Seeds Act and regulations is listed in CEPA 1999's Schedule 4 indicating the Government's finding that the Seeds Act and Regulation's provisions for notification and assessment of plants with novel traits is comparable to that in CEPA 1999 for organisms that are products of biotechnology.
5. As a result of the above, Ministers have structured this document to focus on responses to the Petitioner's questions (refer to paragraphs 7 - 104).
6. Readers may refer to previous petition responses, which are publicly available on Government of Canada Web sites, for extensive background information about the regulation of novel products in Canada (refer to Annex A)
Responses to Individual Questions
Question 1a: Where are the tests for proposed plants with novel traits performed and under whose authorization? If they are done by the corporation's scientists, how are they chosen and what training and qualifications must they have?
Response to Question 1a:
7. Mandatory, pre-market environmental, livestock feed, and human health safety assessments are required before novel products are made available for any use in food or livestock feed, or for their unconfined environmental release. Health Canada is responsible for carrying out human health safety assessments on all products under the Food and Drugs Act (refer to the response to question 7 for more details). Within the CFIA, the Plant Biosafety Office (PBO) is responsible for environmental safety assessments of plants with novel traits (PNTs) while the Feeds Section is responsible for livestock feed safety and efficacy assessments. In doing so, CFIA environmental safety assessments evaluate the efficacy of livestock feeds and environmental safety of PNTs for unconfined environmental release and/or use as a livestock feed. In Canada, an important part of the development process is the confined research field trial stage involving the release of a PNT, for research purposes, under terms and conditions of confinement designed to minimize any impact the PNT may have on the environment. This stage provides product developers with the opportunity to evaluate the performance of PNTs, study their environmental safety, and address the criteria and information requirements considered in the food, livestock feed, and environmental assessments of PNTs.
8. The exact locations of confined research field trials are not released. The locations of such sites have always been considered to be confidential business information. The Access to Information Act (Sections 20 and 27) provides protection for confidential business information where it is properly demonstrated that the protection is necessary. As you may know, many trials in other countries involving PNTs have been vandalized. This potential for mischief creates an additional set of risks. However, provincial authorities are always notified prior to the authorization of a research trial in their respective provinces and are provided with a 30-day comment period. Also, the PBO strongly recommends that applicants notify neighbours that have land surrounding the trial site.
9. This being said, certain details concerning confined research field trials that are conducted are available on the CFIA Web site. Details provided include: crop species, breeding objective, general description of the novel
trait(s), the organization conducting the field trial(s), and the province(s) in which the trials were or are being conducted. A summary of these field trials is available on the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/triesse.shtml>.
10. Requests for permission to conduct confined research field trials and livestock feeding trials are either approved or denied by the Minister of Agriculture and Agri-Food after the Minister considers, pursuant to Subsection 111(1) of the Seeds Regulations and/or Subsection 4.3 (1) of the Feeds Regulations, all relevant matters. These relevant matters include, among others, evaluating the potential impact on and risk to the environment, including the potential impact on and risk to human and animal health, posed by the proposed unconfined environmental release and/or use as a livestock feed. After consideration of the request, the Minister may:
- authorize a confined release and/or a livestock feeding trial, and where necessary to minimize the risk, impose conditions for the management of potential risks to the environment
- refuse to authorize a confined release and/or a livestock feeding trial, where the proposed release poses an unacceptable risk to the environment and/or livestock health
11. In regard to training and qualifications required of product developers' scientists and how they are chosen, those details would need to be requested of individual product developers. While the nature of the confined research field trial is the responsibility of the product developers, the CFIA is responsible for regulating product developers' compliance with regulatory requirements. The CFIA inspection staff work closely with the product developers' field managers to assist them in maintaining their compliance.
12. For more information on confined research field trials and unconfined release of PNTs, visit the How To Apply For Confined or Unconfined Release of PNTs section of the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/enviroe.shtml#con>.
Question 2a: What exact studies do the CFIA scientists carry out to determine the safety of plants on the health of the environment and of humans?
Response to Question 2a:
13. The CFIA is primarily a regulatory body, and as such, is not mandated to validate the research of each novel product by testing them independently of the product developer when it conducts its safety assessments. However, in support of its sound, science-based regulatory system, the CFIA regularly commissions studies to build on its existing knowledge of biotechnology. These studies have focussed on potential impacts of novel agricultural products, regardless of the technique used to develop them. Various topics have been studied, for example:
- insect resistance and herbicide tolerance management
- plant molecular farming
- gene stacking
- biodiversity and agricultural ecosystem management
- agriculture and its impact on biodiversity in general
- alternative selection markers for transgenic plants
- gene flow and fertility
- detection of transgenes in livestock feed and livestock consuming such livestock feed
- allergenicity for occupational and bystander exposure (livestock feed related studies)
- transgenic livestock and bird safety assessments
14. Other examples can be found in the response to question 7 (refer to paragraphs 69-72).
15. For details on these studies, and other studies commissioned by various federal departments and agencies, refer to the Progress Reports of the Government of Canada's Action Plan in response to the Royal Society of Canada Expert Panel Report (refer to paragraphs 37-40 for background information on the report). Specifically, refer to the December 2002 (item 41), June 2003 (item 3), December 2003 (item 24) August 2004 (item 36) Progress Reports. Copies are available on Health Canada Web site at: <www.hc-sc.gc.ca/english/protection/novel_foods.html>.
16. Copies of several of these studies can be found on the CFIA Web site, for example:
- Herbicide Resistance Management Issues In PNTs, available at: <www.inspection.gc.ca/english/plaveg/bio/resist/disdoce.shtml>
- Final Report on the Ecological Impact of Bt Corn Pollen on the Monarch Butterfly in Ontario, available at: <www.inspection.gc.ca/english/plaveg/bio/bt/btmone.shtml>
- Responsible Deployment of Bt Corn Technology in Ontario, available at: <www.inspection.gc.ca/english/plaveg/bio/bt/btcormai2e.shtml>
- Potential Impacts of Plant Molecular Farming on Biodiversity, available at: <www.inspection.gc.ca/english/plaveg/bio/mf/mf_kirke.shtml>
- Selectable Marker Genes in Transgenic Plants, available at: <www.inspection.gc.ca/english/sci/biotech/trans/marmare.shtml>
Question 2b: How exactly does the CFIA ensure accuracy of the reports submitted for environmental assessment if they do not perform the scientific procedures themselves?
Response to Question 2b:
17. As previously stated, confined research field trials provide an opportunity for product developers to evaluate the performance of their PNTs under highly controlled conditions while minimizing their potential impact on the environment. In addition to this function, these field trials also yield specific information that product developers must collect and submit to the CFIA when applying for unconfined environmental release and/or use as a livestock feed prior to commercialization.
18. Similar to the approach used in the regulation of other products, such as pharmaceuticals, CFIA scientists use data submitted by the companies seeking unconfined approval of their products. There are CFIA directives that dictate what data must be submitted, and how CFIA scientists must examine the data. For example, Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits and Directive 95-03: Guidelines for the Safety Assessment of Livestock Feeds: Plant Sources provide guidance to applicants regarding what information must be provided in an application for unconfined environmental release and/or use as a livestock feed, including the Reviewers' Checklist for Analytical Techniques. Data must be of the same high quality as that required by scientific journals for publication and peer review. Documents such as the Reviewers' Checklist for Analytical Techniques and internal Standard Operating Procedures ensure consistency in the quality of the CFIA review. The data are thoroughly analysed, as are the rules used to ensure the validity of results. If the data is scientifically unsound, incomplete or inadequate, government regulators require that the product developer examine the shortcomings of their submission before the assessment can continue. For more information on the data requirements for environmental and livestock feed safety assessments, visit the CFIA Web site at: <www.inspection.gc.ca/english/sci/biotech/reg/datae.shtml>.
19. Each CFIA environmental and livestock feed safety assessment includes a review of the molecular biology data related to the inserted and/or modified gene(s) as submitted by the product developer. As well, a literature review and an internal peer review are conducted before a final authorization is granted. This molecular biology data is shared with Health Canada for use in their human health safety assessments. The CFIA also works closely with other regulatory bodies such as U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA-APHIS) so as to share experiences in the assessment of particular applications. Assessments are guided by knowledge of and familiarity with the non-modified counterpart; therefore, all results are reviewed in that context.
20. Government evaluators developed Directives 94-08, and 95-03 related to applications for unconfined environmental release and/or use as a livestock feed, respectively, based upon principles developed through technical and extensive stakeholder consultations. These guidelines were influenced by previous expert consultations carried out by the United Nations' WHO and FAO, and the OECD relative to regulating biotechnology products. The research commissioned by the CFIA discussed in the response to question 2a also provides scientific information used in the development of these guidelines.
21. Canada is not unique in using industry generated data as part of its environmental, livestock feed, and human health safety assessments. This method is considered to be a standard scientific method of evaluation, and is used by regulating authorities around the world. By using this system, product developers are responsible for their product. Government regulators are also able to contract studies or convene groups of experts to gain further advice and insights about specific types of products including research about their potential interaction with the environment. In addition to the information provided by product developers, government regulators use available peer-reviewed scientific literature and expert advice from the scientific community.
Question 2c: What are the training qualifications for CFIA scientists assessing the information provided by the corporations in their environmental safety assessment? How are they chosen and what are they trained in?
Response to Question 2c:
22. It is the excellence of our employees that gives Canadians confidence that the Government of Canada remains steadfast in its commitment to safeguard Canada's environment, livestock feed and food supply and the plants and animals upon which safe and high-quality food depends. Given the importance of these responsibilities, the challenge is to attract the most qualified people possible and to make sure they stay with us to exercise their skills to the benefit of all Canadians. To this end, the CFIA developed a human resources strategy that was published in 2003. A copy of this strategy is available on the CFIA Web site at: <www.inspection.gc.ca/english/hrrh/strat2003-08/strate.shtml>.
23. To be hired as an Environmental Release Assessment Officer within the PBO, specifically, applicants must meet the following qualifications:
- a degree from a recognized university with specialization in plant biology, plant ecology and molecular biology or biochemistry and molecular biology (preference may be given to candidates who possess a post-graduate degree)
- experience in critically evaluating scientific documents
- experience related to plant ecology or weed science and plant biotechnology
- experience in developing and interpreting technical regulations, policies and procedures
- experience in developing and implementing the biosafety regulation of PNTs
- knowledge of plant science, agricultural ecosystems in Canada, and developments in plant biotechnology (including related environmental issues)
- knowledge of Canadian regulatory framework for PNTs (including the Seeds Act and Regulations, general protocols, and the safety assessment process)
- ability to communicate effectively and exercise leadership in a team environment
- ability to manage and prioritize several projects
- ability to critically review and analyze scientific and technical submissions
- ability to develop effective interpersonal relations and use sound judgement
24. A selection process is held for those candidates who clearly demonstrate how they meet the above qualifications. Once candidates are selected, it takes about one year to train Environmental Release Assessment Officers, during which time they are paired with a more experienced staff member.
Question 2d: What are the consequences and penalties for corporations and developer of seeds who do not supply complete information about their seeds?
Response to Questions 2d:
25. Products are not approved until CFIA evaluators are satisfied that the application addresses all regulatory requirements, the science has been properly carried out, and no significant risks are found. If the data is scientifically unsound, incomplete or inadequate, government regulators require that the product developer examine shortcomings in their submissions before the assessment can continue. If any part of the information provided is insufficient, evaluators require the product developer to supply further studies or information.
Question 3: What are the regulations surrounding farm borders in areas of genetically altered crops mixed with organic crops? A) What are the policies in place that stipulate the rights of the organic farmers to oppose cross-pollination from gene flow and subsequent contamination or plants with novel traits (as defined by the CFIA) into their organic crops? B) What are the penalties for corporations and developers who do not comply with these policies? C) How often are these policies reviewed and enforced? Please detail.
Response to Question 3:
26. The CFIA's science-based environmental and livestock feed safety assessments assesses potential risks to the environment and livestock health caused by introducing a PNT into the environment, not potential risks related to the marketing of such crops. 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 PNT is found to pose a significant risk to the environment, it is not released in Canada. For details on the assessment criteria, refer to the Directive Dir94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits available on the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/dir/dir9408e.shtml>.
27. This being said, some representatives from the organic community are concerned about non-organic products commingling with organic products. Organic production rules are established by organic grower groups, who are aware that gene flow from crop production is not unique to crops derived through biotechnology and yet have still required zero tolerance for pollen flow from such crops. Organic farming systems acknowledge the possibility of spray or fertilizer drift from non-organic farming systems, and procedures are established to minimize this. Matters such as setting isolation distances are often dealt with through co-operative arrangements between neighbours. Grower organizations set quality criteria for agricultural commodities as part of their private membership requirements. These requirements may include the use of buffer zones between growers using different management approaches. Constitutionally, agriculture is a shared responsibility between the federal and provincial governments. Provinces and municipalities have authority to regulate land use within their jurisdiction and may set standards for agricultural commodities.
28. The Government of Canada, including CFIA and AAFC, has shown 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. Readers are invited to review the Standard on the Canadian General Standards Board Web site at: <www.pwgsc.gc.ca/cgsb/032_310/standard-e.html>.
Question 4a: How frequently are the Decision Documents related to approved novel plants reviewed and reassessed?
Response to Question 4a:
29. Once the environmental safety assessment for unconfined environmental release and/or use as a livestock feed is complete, a decision document is sent to the product developer. Following the product developer's receipt of the decision document, it is published on the CFIA Web site (also available in hard copy). Decision documents explain in detail what was reviewed to make the decision, and why certain conclusions were reached. The decision can be:
- to grant unconfined environmental release and/or use as a livestock feed
- to grant unconfined environmental release and/or use as a livestock feed with conditions (e.g. the PNT can only be grown in specific areas of Canada or insect resistance management plans need to be implemented, etc)
- to not allow unconfined environmental release and/or use as a livestock feed
30. Decision documents are available to the public in hard copy and can be viewed on the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/pbo/dde.shtml>.
31. Evaluators in regulatory departments and agencies in Canada and abroad acknowledge that because of the rapid pace of research advances, scientific knowledge should not be viewed as static. Any authorization for a PNT is subject to be reviewed if new information comes to light that indicates that an approved PNT could pose an unforeseen risk to the environment or human or livestock health. Any such new information on a product must be submitted, by law, to regulatory authorities. As a result, any person who has provided notification or received authorization under either the Feeds Regulations (Section 4.4) or the Seeds Regulations (Section 112) is required to immediately provide any new information to the CFIA for a re-evaluation of the potential impact on and risk to the environment or livestock health posed by its release. The Minister, on the basis of this new information, may amend the requirements of the original authorization where there is a change in the risk from that of the original release.
32. The Government of Canada may carry out post-market sampling, auditing, and testing, either as routine post-market surveillance for compliance with post-approval conditions or on a case-by-case basis, or may change its regulatory decisions, in response to additional information provided by the product developer, the public, or advances in scientific knowledge. Refer to paragraph 34 for an example of a post-market surveillance for compliance with post-approval conditions.
33. There have been occasions when new information has become available; however, based on this new information, there have been no changes in the outcome of the environmental and livestock feed safety assessments of any approved PNTs (or products derived from such crops) that have resulted in amendments to the regulatory requirements of the original authorizations at this time. This has been the case, regardless of the method used to produce the change to molecular make-up of the PNT (e.g., whether it is a product of modern recombinant DNA techniques or mutagenesis).
34. Amendments to the original requirements for insect resistance management (IRM) plans for Bt (Bacillus thuringiensis) technology-derived products provide an example of revisions to decision documents. Until 1998, companies marketed Bt technology-derived corn in Canada with different IRM plans for the European Corn Borer. In an effort to establish a consistent single IRM plan, which could be used as an industry standard, the CFIA made amendments to the requirements of Bt technology-derived PNTs effective January 1, 1999. This effort was led by the Canadian Corn Pest Coalition, an advisory group made up of academics, provincial extension staff, representatives from the biotechnology industry, and government scientists. The Coalition studied this question in detail and provided recommendations to the CFIA. Likewise, an IRM plan was developed for Bt technology-derived potatoes and the decision documents for these PNTs were also amended. In 2000 and 2002 , the CFIA audited every product developer marketing approved Bt technology-derived corn products to verify compliance with this regulatory requirement. The CFIA also audited every product developer marketing approved Bt technology-derived potatoes for compliance during the 2000 growing season. The decision documents describing these amendments to the requirements for Bt technology-derived corn and potatoes are available on the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/dde.shtml>.
Question 4b: Are the results shared with the corporation(s) and are suggestions made to them on improving their biotechnology? Please provide details.
Response to Question 4b:
35. As mentioned previously, once the environmental safety assessment for unconfined environmental release and/or use as a livestock feed is complete, a decision document is sent to the product developer. Following the product developer's receipt of the decision document, it is published on the CFIA Web site (also available in hard copy). As such, these decision documents are shared with the product developers and the public. Should a decision document be reviewed and reassessed, the same notification process would exist.
36. While the nature of the research related to the development of these products is the responsibility of the product developers, the CFIA is responsible for regulating product developers' compliance with regulatory requirements. Therefore, suggestions are not made on how product developers can improve their biotechnology. However, CFIA scientists are often contacted by industry representatives for information on, and explanations of, regulatory requirements related to the environmental and livestock feed safety assessments. As part of this interchange, the CFIA discusses the reasons why company data may be rejected or need to be clarified.
Question 5: How often does your department review its assessment requirements and what does it take to change policies in effect?
Response to Question 5:
37. As a vital step in the evolution of the regulatory system, the Government of Canada has sought input from expert panels, committees, the scientific community, and available scientific literature in order to incorporate expert scientific views into our continuously evolving regulatory system. The Royal Society of Canada Expert Panel on the Future of Food Biotechnology (the Panel), an expert panel established to examine future scientific developments in food biotechnology, and their resulting impact on regulation, has provided an example. In 2001, the Royal Society of Canada published a report entitled, Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada. The report provided recommendations for the regulatory system and outlined the scientific capacity required by the federal government to continue to ensure the safety of novel products. The report's 53 recommendations can be categorized under the following themes:
38. In response, the Government of Canada has published an action plan and accompanying progress reports. The action plan outlines the activities underway or recently completed by various departments and agencies, including:
- revise relevant documents and create new information materials explaining the regulatory system to the public
- update and refine protocols for safety assessment as science progresses and more advanced methods become available
- participate in international efforts and seek contributions from experts to develop and validate testing protocols and other tools to address biotechnology issues
- increase scientific and regulatory capacity with scientists trained in molecular biology, entomology, ecology, and other sciences related to plants, animals and the environment
- support research projects relevant to biotechnology issues
39. Since 2002 the Government of Canada has regularly posted progress reports on its action plan to address issues raised by the Royal Society of Canada report. The most recent progress report was issued in August 2004. The next update has been scheduled for December 2004. These documents have been posted on Health Canada's Web site at: <www.hc-sc.gc.ca/english/protection/novel_foods.html>.
40. The Government of Canada, as previously reported in the response to the Royal Society of Canada, is committed to the renewal of biotechnology legislation. Renewal may occur on a regularly scheduled basis (as provided for in legislation), or as needed, for instance to ensure that legislation evolves with scientific advances. As such, actions regarding some of the Panel's recommendations are in place or have been initiated in Canada. The regulatory framework must continue to evolve so that we maintain our high scientific standards and keep pace with new scientific discoveries, to assure that our food supply continues to be one of the safest in the world.
41. Each department has the responsibility to conduct in-house research to support their regulatory capacity and expertise in order for their regulatory decisions to reflect the latest scientific knowledge. At the same time, we recognize that new developments in regulatory research may be achieved through a variety of means including studies by:
- government research institutions working in partnership with regulatory departments and agencies
- external experts as part of on-going research within the academic community or as supported by levels of government, interest groups, agricultural stakeholders such as producers
- industry research supporting product development as may be published in the public domain i.e. reported in peer reviewed literature
programs to support the maintenance of genetic diversity and the funding of a national research program for the study of potential long-term effects
42. Health Canada is currently conducting a comprehensive review of its health protection legislation and is moving toward replacing existing statutes with a new health protection legislative regime, better adapted to modern technology and society. This proposal features elements such as fundamental values, guiding principles, greater transparency in the regulatory process, and a general safety requirement for all products. The detailed proposal, Health Protection Legislative Renewal, is available on the Health Canada Web site at: <www2.itssti.hc-sc.gc.ca/HPCB/Policy/LegislativeRenewal.nsf>.
43. For Environment Canada, the assessment requirements in the New Substances Notification Regulations NSNR (Organisms) are embedded in regulation. Therefore, a review of the assessment requirements for Organisms leads to regulatory amendments to effect any change. The process to review the NSNR (Organisms) has begun in 2004 to ensure that they continue to be effective and appropriate for the protection of the environment and human health.
44. In terms of safety assessments under the CEPA 1999, Health Canada shares the responsibility with Environment Canada for the safety assessment of new animate products of biotechnology. Section 139 of CEPA 1999 calls for a Parliamentary Review of the Act within five years of the enactment of the legislation to ensure that the law keeps pace with new and emerging developments in environmental and health science. A Parliamentary review of CEPA 1999 is planned to begin in March 2005.
45. The CFIA is committed to regular updating directives to keep pace with evolving science, technology and public values. For example, in October 2003, the PBO updated Directive 2000-07: Guidelines for the Environmental Release of Plants with Novel Traits within Confined Field Trials in Canada. Some of the amendments included:
- changes in restrictions on the size and number of confined research field trial locations
- changes for records and reporting of confined research field trials
- changes to isolation distances
- use of GPS (global positioning satellite) coordinates
- increases in monitoring frequency after the novel plants have been harvested, while the site is still subject to land-use restrictions
- further guidance on removing volunteer plants and related species before they flower
- the posting of summaries of authorized confined research field trials on the CFIA Web site
46. Interim amendments to Directive 2000-07:Guidelines for the Environmental Release of Plants with Novel Traits within Confined Field Trials in Canada created to provide requirements for PNTs intended for plant molecular farming (PMF) also serve as an example of the CFIA's review of its assessment requirements and the extent of consultation involved with such a process. PMF refers to a technology using plants to produce products other than food or livestock feed, such as pharmaceuticals. To date, there is no commercial PMF activity in Canada, but confined research field 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 Directive 2000-07: Guidelines for the Environmental Release of Plants with Novel Traits within Confined Field Trials in Canada, amendments available on the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/dir/dir0007ie.shtml>.
47. These amendments also describe a role for Health Canada in the human health safety assessment of these trials. Health Canada and the CFIA are working together to develop a mechanism through which Health Canada can provide advice to the CFIA as necessary. In this regard, a Memorandum of Understanding between CFIA and Health Canada is being developed.
48. In addition to reviewing applications for confined research field trials of PNTs intended for PMF, the PBO has also been developing directives specific to confined research field trials and commercial cultivation of these types of PNTs. As part of this activity, the CFIA hosted a broad, multi-stakeholder consultation focussing on the particular concerns associated with PMF 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 this, including a discussion report and proceedings, visit the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/mf/mf_cnsle.shtml>.
49. Prior to this technical consultation, the CFIA also held a Public Forum (October 2001) to provide opportunities for the public and stakeholders to learn about PMF and to express their views regarding the regulation of this technology. Input from these consultations has been incorporated in the previously mentioned interim amendments to Directive 2000-07. Information regarding this Forum has been made available on the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/mf/mf_fore.shtml>.
50. An important step in developing directives for safety assessments of PNTs intended for PMF involves examining whether these products and by-products can be adequately segregated from other commodities; specifically, those intended for the food and livestock feed chains. To discuss this, the CFIA hosted a technical workshop on March 2-4, 2004. Participants included representatives from industry, federal government (including Health Canada), agricultural and agribusiness associations, and experts in grain handling and identity preservation. As a result of the workshop, the CFIA, in collaboration with 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 PMF. As well, the CFIA continues to work with Health Canada to develop an appropriate regulatory pathway, leading to the development of directives. For more information on PMF, visit the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/mf/molecule.shtml>.
51. For further example, the CFIA has recently updated its directives and guidelines on PNTs (i.e. Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits) and livestock feeds derived from PNTs (Directive 95-03: Guidelines for the Safety Assessment of Livestock Feeds: Plant Sources). These updates reflect policy changes that are the result of advances in science and the CFIA's increased experience in regulating novel products. Consultation continues to be a key factor in the CFIA's development of regulatory policy.
52. New drafts of the above-mentioned directives were made available for a 60-day public comment period which was held from May 27 to July 25, 2003. Comments received were reviewed and considered in the writing of the final directives. The final versions of Directives 94-08 and 95-03 have been made available on the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/dir/dir9408e.shtml> and <www.inspection.gc.ca/english/anima/feebet/bio/dir95-03e.shtml> respectively.
53. These revised directives provide a detailed description of how the CFIA uses novelty as a regulatory trigger. The documents also include a definition of novelty, and clarify actions required in specific cases such as intraspecies/interspecies crosses, re-transformation and re-mutation of approved PNTs, and intentional gene stacking (i.e. insertion and/or modification of more than 1 gene) of PNTs. The documents also contain an expanded glossary. Directive 95-03: Guidelines for the Safety Assessment of Livestock Feeds: Plant Sources clarifies the use of substantial equivalence in livestock feed safety assessments.
54. Health Canada is currently completing its revision to the Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganism. A 75-day on-line public consultation was held between July and September 2003 to solicit comments and feedback on the proposed revisions as well as other issues (e.g. public involvement, transparency of process, and animal cloning). A summary report of the comments has been drafted and will be posted on Health Canada's website at: <www.novelfoods.gc.ca>. The revised guidelines are consistent with guidance documents recently developed at the international level and will also be posted on the Health Canada Web site once finalized.
55. The CFIA and Health Canada have adopted a policy of harmonized approvals (i.e. required assessment for all uses are completed at approximately the same time) to minimize the potential for products that have not been approved to enter into the Canadian environment, livestock feed and/or food supply. This policy is in place to minimize the risk of products that have not been approved from entering the Canadian environment, food and livestock feed supply. This policy is now included in the CFIA's revised directives 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits and 95-03: Guidelines for the Safety Assessment of Livestock Feeds: Plant Sources, as well as Health Canada's revised Guidelines for the Safety Assessment of Novel Foods.
Question 6: The CEAA requires federal departments to conduct assessments when the government is involved in the proposal. Are there proposals that do not involve government funding or permits? And how are these assessed?
Response to Question 6:
56. Proposals involving PNTs do not trigger the requirement to conduct an environmental assessment under the Canadian Environmental Assessment Act, 1999. However, all proposals involving PNTs - regardless of government involvement or not - are subject to the environmental, livestock feed, and human health safety assessments in accordance with the Acts and regulations discussed throughout this response. For more information on the Canadian Environmental Assessment Act, 1999 visit the Canadian Environmental Assessment Agency Web site at: <www.ceaa.gc.ca/013/act_e.htm>.
Question 7: Would the ministers concerned please provide details on the measures taken to evaluate the safety of a plant with novel traits? What exactly is the research that concludes these plants are safe to be consumed over the long-term, for human health and the environment? Please explain in detail what any effects are, either to humans or the ecosystem, and how they are being managed.
Response to Question 7:
Evaluating the Safety of PNTs
57. The paramount concern in regulating novel products is the health and safety of Canadians, animals and our environment. Several federal departments and agencies have responsibilities for the human health, animal 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, and Health of Animals Act), and Health Canada (e.g., under the Pest Control Products Act and the Food and Drugs Act) have these responsibilities. The aforementioned Acts (excluding the Food and Drugs Act) are listed in Schedule 4 of CEPA 1999, which means that these biotechnology products are not assessed under the regime set up under CEPA 1999. For novel living organisms not already falling within the purview of those Acts listed in Schedule 4 of CEPA 1999, Environment Canada and Health Canada assess these organisms under the CEPA 1999. Micro-organisms used in bioremediation and industrial enzyme production serve as examples of such a situation.
58. The CFIA provides documents on its Web site called directives that elaborate on and explain how the requirements in the various Acts should be fulfilled for PNTs; these include:
- Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits
- Directive 95-03: Guidelines for the Safety Assessment of Livestock Feeds: Plant Sources
- Directive 2000-07: Guidelines for the Environmental Release of Plants with Novel Traits Within Confined Field Trials in Canada
- Directive D-96-13: Import Permit Requirements for Plants with Novel Traits, and their Products
59. Health Canada's Guidelines for the Safety Assessment of Novel Foods outline the criteria it considers when assessing the human health safety of novel micro-organisms and plants for food use, as mandated by the Food & Drugs Act.
60. Elements of the Environment Canada safety assessments of micro-organisms and organisms other than micro-organisms, including imports of plant material with novel (new) traits intended for direct use as food, non-livestock feed, or for processing into food or industrial products and not covered by either the CFIA Seeds Act or the Feeds Act and Regulations, are discussed within the Guideline for Notification and Testing of New Substances: Organisms is available on the Environment Canada Web site at: <www.ec.gc.ca/substances/nsb/bioguide/eng/Bioguide_e.htm>.
61. Risks of harm to the environment, livestock health or human health posed by novel living organisms, or their genes, are assessed on a case-by-case basis. It typically takes between seven and ten years for the development, assessment and approval of novel products. If the novel living organism is found to pose no potential concerns to human, livestock 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).
62. In the case of PNTs, an environmental and livestock feed safety assessment conducted by the CFIA, would consider the following questions:
- Does the plant have the potential to become a weed of agriculture or to be invasive of natural habitats?
- Is there a potential for gene flow to wild relatives whose hybrid offspring may become more weedy or invasive?
- Does the plant have the potential to become a plant pest?
- Is there a potential impact on non-target organisms?
- Is there a potential impact on biodiversity?
- Is there a potential impact of the plant or plant products on livestock feed or food safety?
63. Health Canada's requirements for the human health safety assessment of any novel food are extremely rigorous. Health Canada's Guidelines for the Safety Assessment of Novel Foods outline the criteria it considers when assessing the human health safety of novel micro-organisms and plants for food use, as mandated by the Food & Drugs Act. Companies must ensure that their products fulfill these requirements, which include detailed documentation of testing results. The human health safety assessment involves determining how the food was developed; how its composition and nutritional quality compares to non-modified (or traditional) foods; and what potential the food has for being toxic or causing allergic reactions. If an evaluator determines that the data submitted is not sufficient, additional information and additional testing may be required. Each of the novel foods currently allowed for sale in Canada has undergone this rigorous safety assessment. Health Canada has concluded that these approved products do not pose a health or safety concern.
64. Novel products evaluated under the Food and Drug Act in terms of human safety also undergo an environmental assessment under the authority of the CEPA 1999 and its New Substances Notification Regulations (NSNR). The NSNR prescribe the information that must be submitted to the Minister of Environment. As part of Health Canada's mandate to improve and protect the health and safety of Canadians and its shared responsibility for the protection of the environment, Health Canada has established its own Environmental Assessment Unit (EAU) to conduct appropriate human health and, on behalf of Environment Canada, the environmental assessments of novel products which are regulated under the Food and Drugs Act. For clarification, the environmental assessment of PNTs by Health Canada 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. The CFIA is responsible for assessing the environmental impact of PNTs in the field under the Seeds Act.
Long-term Safety for Human Health and the Environment
65. The fundamental principle of the safety assessments of PNTs involves a scientific comparison of novel products to conventional products in order to determine whether they are no less safe than conventional products which have been safely part of the Canadian diet for a long time. CFIA and Health Canada refer to this concept as `substantial equivalence'. The comparative approach permits linking the composition of the new products to existing products with a history of safe use, permitting prediction of the long-term impact of the new products in the diet. Differences identified in the comparison are the focus of further detailed assessment.
66. Given that the application of genetic modification in and of itself does not necessarily introduce unique risks, the potential for long-term effects of these foods are no different than that for conventional foods which have been safely part of the Canadian diet for a long time. So far, many of the issues raised by foods resulting from the application of biotechnology are equally applicable to foods produced by conventional means. Potential food safety issues are those associated with toxic or allergenic compounds which are present already in the food supply. After ten years of reviewing the safety of genetically modified (GM) foods, Health Canada has not found any scientific evidence showing that GM foods are any less safe than their conventionally produced counterparts. Additionally, the foods that have been approved to date have involved the transfer of one or two genes which introduce a limited number of new traits, such as resistance to an insect or a plant virus.
67. This being said, in order to continue strengthening the environmental, livestock feed, and human health safety assessment process, the Government of Canada is expanding its database of knowledge through research.
68. Health Canada's Centre for Surveillance Coordination is working with relevant departments, the CFIA and external partners, nationally and internationally, to assess options for post-market surveillance of novel foods, including GM foods. This work follows from the outcomes of a global environmental scan, several consultations and an international conference on Post-Market Surveillance of GM Foods that was hosted by Health Canada in October 2002 to share global knowledge about the issues, challenges and opportunities surrounding this topic. It is expected that some future novel foods exhibiting more complex modifications (those with intentional nutritional modification for example), will likely require the implementation of a post-market monitoring mechanism. For example, such measures would be required when there are issues related to consumption by target populations, concerns about displacement of other foods, or upper safe levels of intake of the bioactive constituent. At this time, no products representing such true novelty to the food supply have been proposed for commercialization.
69. In responding to the recommendations of the Royal Society of Canada (also refer to paragraphs 37-40) regarding the regulation of novel foods in Canada, the Government of Canada noted that "we recognize the benefits of conducting long-term monitoring studies and research on the impact of GM organisms. We are taking additional measures to improve federal capacities in this area, including ecosystems effects research."
70. The Ecosystem Effects of Novel Living Organisms (EENLO) is an interdepartmental initiative led by Environment Canada in partnership with the CFIA, Natural Resources Canada, AAFC, Fisheries and Oceans Canada, the National Research Council, and Health Canada 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.
71. In February 2004, a workshop on EENLO was held involving experts from within and outside government. Building upon the work of those who participated, a pilot network is being initiated to enhance communications between researchers and aid in the generation of new knowledge and approaches.
72. AAFC conducts research on the health and environmental aspects of GM foods, plants and livestock feeds, and other novel food products in consultation or collaboration with the CFIA, Health Canada and Environment Canada. These three departments and agencies are the authorities who use the knowledge generated from this research to address issues related to safety. For example, AAFC, in consultation with CFIA, is conducting long-term research studies to examine and supplement current knowledge on the potential environmental impacts of GM crops including corn, potatoes and canola. The studies, initiated in 2000, will run for 12 years. The objective is to examine the potential environmental and economic impact of long-term production of crops with novel traits. Traditional cultivars of each crop are included for comparison purposes. Data is being collected on weed, disease, insect, and soil micro-organism populations, gene transfer, and production costs. 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.
73. As mentioned previously, any authorization for a PNT is subject to be revisited if new information comes to light that indicates that an approved PNT could pose an unforeseen risk to the environment or human or livestock health. Any person who has provided notification or received authorization under either the Feeds Regulations (Section 4.4) or the Seeds Regulations (Section 112) is required to immediately provide any new information to the CFIA for a re-evaluation of the potential impact on and risk to the environment posed by its release. The Minister, on the basis of this new information, may amend the requirements of the original authorization where there is a change in the risk from that of the original release.
74. If the PNT is found to pose no potential safety concerns to human, animal or environmental safety when compared to its traditionally developed counterparts in use in Canada, it will be considered safe to be released to the environment, used as a livestock feed or used as a food. However, there are situations where potential risks can be managed by imposing conditions that reduce the risk. For example, the CFIA requires product developers of herbicide-tolerant crops to include management plans when they submit an application for unconfined environmental release and/or use as a livestock feed. The CFIA would not authorize a PNT if it could produce herbicide tolerant hybrids that do not have effective or sustainable control options. As such, these management plans are designed to address:
- control of volunteer herbicide tolerant plants (e.g. if herbicide tolerant crops are planted one year, a farmer can expect a certain number of plants to regrow the next year as a result of seed shattering or seed spillage before or during the previous harvest)
- the selection of herbicide tolerance in weeds resulting from the potential continued application of the same herbicide in subsequent years
- crop management during the growing season, particularly where tolerance to multiple herbicides could arise from cross-pollination between related crops
- an efficient mechanism to allow farmers to report problems to the product developer
75. Bt crops provide another example of the need for management plans. Bt pest control products have long been used as foliar sprays in both conventional and organic production. As with other types of insecticides, there is the potential for the development of pest resistance to these products. The advent of PNTs which express Bt proteins also led to similar regulatory questions over the potential development of pest resistance following use of these Bt crops, if they were approved. For this reason, authorizations of Bt corn by the CFIA are conditional on the implementation of IRM plans and have been since 1999 (refer to paragraphs 34 for further details). These plans are designed to control the pest population from becoming resistant to the Bt proteins.
Question 8: What are the ministries doing about the concerns raised by the public over the safety of altered organisms?
Question 8a: What does each federal department do in terms of researching these public concerns? To what extent is this research shared with the public?
Response to Questions 8 & 8a:
76. Agricultural crops are at constant risk from insects, disease, and other environmental stresses that cause losses in yields. Areas of biotechnology such as genetic engineering could offer help to address concerns about pests, diseases, and other crop losses, such as drought and frost. However, despite these potential benefits, questions and concerns about agricultural biotechnology have been raised. To deal with these concerns, scientists and government regulators have taken steps to carefully assess all new novel products. Throughout the past 15 years, specific regulations have been implemented and will be revised and updated periodically. These actions have taken place in response to bona fide concerns raised by the public including respected scientists, lay-persons, and commercial interests. Therefore, before a product can be released into the environment or made commercially available it must be evaluated for safety based on data collected from extensive testing. This testing is conducted at the expense of the product developer, but it must meet data quality guidelines as determined by the Government of Canada.
77. In addition to this extensive testing, the Government of Canada strongly supports providing consumers with information to help them to make informed choices. If individuals are to make informed decisions, they also need meaningful, credible and truthful information as it relates to biotechnology and food. Specifically, the CFIA and Health Canada are actively seeking opportunities to provide the public with information on the safety of the Canadian regulatory system and the safety of the foods on the marketplace. This may be achieved through many means, including brochures, Web sites, information kits, education and awareness programs, and toll-free lines.
78. Under the Canadian Biotechnology Strategy (CBS), federal departments with a role in biotechnology are responsible for enhancing consumers' understanding of biotechnology and, in particular, the various environmental and health questions associated with novel products. For example, the CFIA Web site contains comprehensive information in plain language fact sheets that discuss various aspects of the government's regulation of novel products and in simplified decision documents that describe the CFIA's environmental and livestock feed safety assessments for certain PNTs (complete versions of the directives and decision documents are also available). These directives contain information on import permit requirements, confined field research trials, and unconfined environmental release and/or use as a livestock feed. This site has information on the novel products that have been approved so far in Canada, along with cooperative efforts made by industry and government to better manage novel products. The CFIA continues to evaluate its Web site, as well as its various other communications products, always with a view to improving public accessibility, readability and content.
79. Expert committees, such as Canadian Biotechnology Advisory Committee (CBAC) and the Royal Society of Canada's Expert Panel on the Future of Food Biotechnology, provide advice and recommendations that will help to strengthen the regulatory system for novel foods, and ensure that it continues to be open and transparent.
80. In 1999, the Government of Canada established CBAC to study social, economic, scientific, regulatory, and health aspects of biotechnology and to advise federal Ministers accordingly. The 21-member committee was drawn from the scientific, business, general public, ethics, and environmental communities. In the spring of 2001, CBAC held five consultations across Canada with industry stakeholders, academia, and civil society to discuss the regulation of novel foods. Government of Canada officials participated in each workshop to provide technical and regulatory information as required. CBAC released an interim report in August 2001, and Government of Canada officials met with CBAC members to comment on the report. Canadians were given until January 2002 to give their comments. CBAC's full report was released in August 2002 and is accessible through the CBAC Web site at: <www.cbac-cccb.ca>. The CBAC report, entitled Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada, provided recommendations for improving the regulation of novel foods in four areas:
81. The federal government is now developing a detailed response to the recommendations made in the report. Links to the CBAC report and information updates can be found Health Canada's (<www.novelfoods.gc.ca>) and the CFIA's Web sites (<www.inspection.gc.ca/english/sci/biotech/tech/reprape.shtml#cbac>).
82. The Royal Society of Canada's Expert Panel on the Future of Food Biotechnology also recommended that the regulatory system should become more transparent to the public. They recommend achieving this by including external scientists and experts in various aspects of regulation. The Panel also recommends that information regarding the assessments, and the decisions based on them, should be available to the public.
83. In addition to the recommendations themselves, the response to the Royal Society of Canada report provided an opportunity for various departments and agencies to more cohesively communicate their roles through the need to co-operatively draft and update the Internet-posted Government of Canada action plan. This inter-disciplinary, inter-departmental approach to communicating about the Government's regulation of novel products reminds us that even though promotional and regulatory functions are separate, departments and agencies can work together to more effectively inform Canadians about the regulatory system.
84. By making the federal approach accountable and transparent, the Government of Canada has ensured that the public has had the opportunity to fully participate in the development and implementation of the regulatory system, including policy formulation. We are committed to increasing the transparency and openness in the Canadian regulatory system, specifically related to the approval process, product information and how safety assessments are conducted. Several initiatives that aim to achieve these goals are underway.
85. For example, the Biosafety Clearinghouse was established under the Cartagena Protocol on Biosafety (the Protocol) as an internet-based tool that allows users to search domestic and international biosafety information. In addition to providing public access to biosafety information, it allows countries to exchange scientific, technical, environmental, and legislative information about living modified organisms (LMOs) produced through modern biotechnology. The Protocol is a supplementary agreement to the United Nations Convention on Biological Diversity. Health Canada, together with the CFIA, is assisting Environment Canada in the implementation of the Canadian Node of the Biosafety Clearinghouse (CNBCH). The CNBCH is a central portal to information on the Canadian regulatory system for LMOs and safety assessments conducted thereunder. The CNBCH is available on the Internet at: <www.bch.gc.ca>.
86. For further example, the CFIA and Health Canada launched their joint pilot "Notices of Submission" Project on October 21, 2003. With the launch of this project, the federal government is responding with a credible means of addressing the public's interest in a more transparent process of regulating novel products. Previously, only lists of approved products - along with their accompanying decision documents and directives - were posted on the CFIA and Health Canada web sites. To complement this practice, notices of new submissions are being posted on the CFIA web site. These notices describe products currently under review for approval and summarize the information used in their safety assessments. As such, this new initiative allows for public input during the approval process itself, rather than only after approval is given. Also, for the first time, the public has access to a list of safety-related scientific studies conducted on new products. For more information on this pilot project, visit the CFIA Web site at: <www.inspection.gc.ca/english/plaveg/bio/subs/subliste.shtml>. To receive e-mail notification of new submissions, join the notification subscription service at: <www.inspection.gc.ca/english/tools/listserv/listsube.shtml?biosub_biodem>. For more general information on how the CFIA is committed to regulatory transparency, visit the CFIA Web site at: <www.inspection.gc.ca/english/sci/biotech/trans/transe.shtml>.
87. The Government of Canada Regulatory Policy imposes a clear requirement on regulators, when developing regulations, that "Canadians [be] consulted, and that they have an opportunity to participate in developing or modifying regulations and regulatory programs".
88. As a regulatory department, Health Canada is actively engaged in involving the Canadian public in the development of policies and regulations. The Health Products and Food Branch (HPFB) evaluates the safety, quality and effectiveness of drugs, vaccines, medical devices, and other therapeutic products, and evaluates the safety and quality of the foods Canadians eat (also refer to paragraph 68). Many of the issues surrounding these products are often complex and require a balance of both strong scientific knowledge and views from the public in order to ensure that the Branch's policies and actions have the best possible impact on the lives of Canadians. In order to obtain the views of Canadians, HPFB undertakes many public involvement initiatives. These activities are coordinated by the Office of Consumer and Public Involvement (OCAPI). OCAPI is currently seeking public opinion on a new proposed Public Involvement Framework.
89. In addition, OCAPI has organized HPFB's Public Advisory Committee (PAC), composed of 16-20 involved Canadians which meet three times a year as a public/consumer involvement forum which advises on issues and initiatives as requested by HPFB. PAC is a component of HPFB's strategy to increase transparency and public involvement through the consultation process. Topics discussed at the latest PAC meeting included plant molecular farming, animal cloning, and Health Canada's Framework for Biotechnology. Further information about OCAPI, and minutes from previous PAC meetings, visit the Health Canada Web site at: <www.hc-sc.gc.ca/hpfb-dgpsa/ocapi-bpcp/index_e.html>.
90. For further example, as Health Canada is revising the Guidelines for the Safety Assessment of Novel Food Derived from Plants and Microorganisms, a consultation was set up to hear concerns from stakeholders and the public. Several other initiatives that aim to increase public involvement and transparency are also underway and are available on Health Canada web site at: <www.novelfoods.gc.ca>.
91. The CFIA also frequently engages the public in consultations to help develop guidelines and regulations for novel products. The CFIA consultation process includes conducting workshops, convening multi-stakeholder meetings, and distributing draft documents for the general public's review and comment. Another form of consultation that the CFIA uses information from is the citizens' conference, also known as a consensus conference. These consultations include discussion of technical and scientific matters. Some of the topics discussed include:
92. In addition to these consultations, a wide range of subject experts, representing academia, industry and non-government organizations, have participated in extensive commodity-specific consultations on technical and scientific matters.
93. Departments and agencies post information on the Internet about their intentions to consult with the public on a topic, and, in addition to providing "how to" information, often include discussion papers and other documents on the topic of concern. Public consultations are also advertised through newspapers ads and public service announcements. When technical consultations are held, invitations are sent out to various stakeholders. A list of CFIA consultations is available on the CFIA Web site at: <www.inspection.gc.ca/english/sci/biotech/consult/consulte.shtml>. As well, Health Canada's Web site has information about public consultation on novel foods. Please see <www.hc-sc.gc.ca/english/protection/novel_foods.html>.
Researching Public Concerns
94. Since 1999, the Federal Government's Canadian Biotechnology Secretariat and its partners have maintained a large-scale tracking program of public opinion research (POR). During that time, it has commissioned 12 public opinion surveys and more than 80 focus groups. In all, there are more than 18,000 data points available in what is North America's largest and most comprehensive investigation into attitudes about biotechnology and the public policy that surrounds it. The program is designed to produce two waves of research each year with a large tracking component and chapters of more intensive inquiry into specific issues like genetic privacy, GM food and stem cell research. Results have been remarkably consistent since the inception of the research program. For a comprehensive list of POR into biotechnology and related topics, please visit the Government of Canada's Bioportal Web site, specifically Public Opinion Research in the index of topics, at: <www.bioportal.gc.ca>.
Question 8b: How does each federal department justify or defend their policies on the safety of genetically altered organisms?
Response to Question 8b:
95. Canada has one of the most stringent regulatory systems in the world to protect human, animal and environmental safety. The OECD said this of Canada's regulatory system, "Canada has a mature and well-functioning system of regulatory governance . . . . More than thirty years of review and more than twenty years of innovation and reform have made Canada one of the most experienced of OECD countries in attempts to improve government capacities to assure high quality regulation." (Government Capacity to Assure High Quality Regulation: OECD Reviews of Regulatory Reform, Regulatory Reform in Canada, 2002, page 51). This report is on the OECD Web site at: <www.oecd.org/dataoecd/47/42/1960472.pdf>.
96. In 1993, the Government of Canada established the Federal Regulatory Framework for Biotechnology. This federal framework resulted from an agreement among federal regulatory departments on principles for an efficient, effective approach for regulating novel products. The following six principles were approved on the basis that they would assure that the practical benefits of novel products and processes would be balanced with the need to protect human health, animal health and the environment. The framework:
- maintains Canada's high standards for the protection of the health of workers, the general public and the environment
- uses existing legislation and regulatory institutions to clarify responsibilities and avoid duplication
- continues to develop clear guidelines for evaluating novel products which are in harmony with national priorities and international standards
- provides a sound scientific database on which to assess risk and evaluate products
- assures both the development and enforcement of Canadian biotechnology regulations are open and include consultation
- contributes to the prosperity and well-being of Canadians by fostering a favourable climate for investment, development, innovation and adoption of sustainable Canadian biotechnology products and processes
97. The six principles of the regulatory framework reflect that the Government of Canada's approach to assure safety in the use of biotechnology is fundamentally a cautious and sustainable one. In particular, the maintenance of Canada's high standards for the protection of human health, animal health, and the environment is carried out by federal regulatory departments and agencies without compromise. For new novel products, this means that these products will be assessed based on the established procedures for the identification of safety concerns relevant to the products. Biotechnology is defined under the Federal Regulatory Framework for Biotechnology and under a number of federal Acts and Regulations as "the application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms." As such, modification of products may be achieved through a number of techniques of biotechnology, including genetic engineering, cell fusion or mutation breeding (a technique that is considered a type of traditional breeding by some countries). Regardless of their method of production, in Canada, the resulting novel products are thoroughly scrutinized for their safety before they are permitted to be released into the environment or allowed to be sold in the marketplace.
98. Canada continues to build on its strong knowledge base in biotechnology regulation by actively working within international fora such as: the OECD, the IPPC; the United Nations Convention on Biological Diversity, the WHO, the United Nations Educational, Scientific and Cultural Organization (UNESCO), the UNEP, the FAO, the Codex Alimentarius Commission, and the World Trade Organization (WTO). Canada is one of the key architects of the international regulatory system of rules and standards, including those for novel products. This international system is transparent, rules-based and science-based, and contains mutually reinforcing elements.
99. The philosophy of the regulatory framework is that genetically engineered organisms are not fundamentally different from traditionally derived organisms and can be assessed using well-defined and understood principles of safety assessment. Each new product is therefore evaluated on its own merits and characteristics, while at the same time the processes used to develop the organisms are carefully considered. Because of the precise nature of the new techniques of biotechnology, we may in fact have more knowledge about genetically engineered organisms than about those that occur naturally. The approach to the safety assessment of novel foods taken by Canada is currently applied by regulatory agencies around the world in countries such as the European Union member states, Australia/New Zealand, Japan, and the United States.
100. The Government of Canada is confident that its regulatory system is strong and has made every reasonable effort to ensure that regulatory, compliance and enforcement mechanisms serve to protect Canadians, animals, and the environment regarding the uses of approved novel products in or imported into Canada.
101. Likewise, the Government of Canada remains committed to the continuous improvement of the regulatory system within the context of the existing regulatory framework for novel products. Canada will continue to seek and implement, as appropriate, advice from outside experts including:
- the Royal Society of Canada, whose Expert Panel on the Future of Food Biotechnology produced a report entitled Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada
- CBAC which released its final report entitled Improving the Regulation of Genetically Modified Foods and other Novel Foods in Canada
102. In the letter to present the CBAC report to the Government of Canada, the President of the CBAC committee wrote: "We found no evidence that GM foods, approved under the current regulatory system, pose any greater health or environmental risk than other foods in the marketplace". As mentioned previously, the complete report is available on the CBAC web site at: <cbac-cccb.ca>.
103. The Government of Canada agrees that novel products need to be regulated from a sustainable development perspective before they are introduced into Canada. It is important that their potential immediate and long-term impacts be understood. Canada's existing regulatory system clearly provides for the safety assessment and management of novel products from a sustainable development perspective. The Government of Canada has an ongoing commitment to good governance and stewardship for the protection of Canadians and the environment. The most widely accepted approach to safety assessment internationally is one that is based on science and that follows a step-by-step approach that is unbiased and predictable.
104. The Ministers named in this Petition remain committed to:
- an effective domestic regulatory system that embodies the concept of sustainable development as it seeks to protect the health of Canadians, and the environment; and
- the broader responsibilities of global stewardship, which Canada shares with other countries, to see that practical and effective measures to protect humans, biodiversity, and the environment are achieved through the design and operation of a science-based, rules-based, and transparent, internationally-recognized regulatory framework.
Annex A - Selected Internet Resources for Further Reading
Part 1 - Government Departments and other Organizations
Government of Canada
Agriculture and Agri-Food Canada
Canadian Biotechnology Strategy
Canadian Food Inspection Agency
Commission for the Environment and Sustainable Development
Part 2 - Response Topics
Confined Research Field Trials
Royal Society Progress Report and Commissioned Studies
Data Requirements for CFIA Environmental and Livestock Feed Safety Assessments
CFIA Human Resources
CFIA Directive 94-08
National Standard For Organic Agriculture
CFIA Decision Documents
CFIA Confidential Business Information
Royal Society Progress Report
Health Protection Legislative Renewal
CFIA Interim Amendments to Directive 2000-07
Plant Molecular Farming
Canadian Environmental Assessment Act
Guidelines for Notification and Testing of New Substances: Organisms
Questions 8 & 8a
Canadian Node of of the Biosafety Clearing House
Notice of Submission Pilot Project
CFIA Regulatory Transparency
Health Canada's Office of Consumer and Public Involvement
CFIA and Health Canada Consultations
Public Opinion Research
Organization for Economic Cooperation and Development - Report