Topics
Protecting the food supply
Asignificant aspect of the public's response to products of biotechnology is concern about the food they eat. In its mandated role to protect Canada's food supply and the health of plants and animals, the Canadian Food Inspection Agency (CFIA) conducts safety assessments for the environmental release of plants, feed, seed, and veterinary biologics - including those derived through biotechnology. In doing so, the Agency establishes that products developed from these agricultural commodities are safe for Canadian consumers, animals, and the environment. Through independent inspections and research, the CFIA also enforces food safety and nutritional quality standards established by Health Canada.
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Science: the foundation of public safety
The key to reliable regulation for consumer protection is sound science. The CFIA has undertaken numerous research initiatives to enhance its detection and identification capacity for various biotechnology-derived products, including plants with novel traits (PNTs) and novel livestock feeds.
The Agency has commissioned several studies to build on its existing knowledge of biotechnology. These studies have focused on potential environmental impacts of novel agricultural products, whether they have been derived through mutagenesis, recombinant DNA, or any other biotechnology techniques. The research studies include the effect of Bt. corn pollen on monarch butterflies, herbicide resistance management for PNTs, the movement of canola pollen in the environment, and computer modelling that predicts pollen flow.
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Learning from independent experts
Biotechnology is not static but a constantlyevolving field that demands continual upgrading of the regulatory system in order to keep pace with emerging developments. The CFIA is committed to adapting its regulatory system to be able to respond to future needs and the ongoing challenges of agricultural biotechnology. To assist with this task, it draws on the knowledge and expertise of recognized experts in the field.
Two groups of independent experts, the Royal Society of Canada (RSC) and the Canadian Biotechnology Advisory Committee (CBAC), were engaged by the federal biotechnology ministers to provide recommendations on how to best enhance Canada's regulatory system in this fast-changing environment.
In February 2001, the Royal Society of Canada released to federal ministers and the public the report of its expert scientific panel's recommendations, entitled Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada.
In response, government departments and agencies released an action plan in November 2001 to address the RSC's 53 recommendations. To date, four progress reports have been published, outlining the key milestones achieved for each of the elements in the action plan. The fifth progress report of the Royal Society is scheduled for release in December 2003.
Similarly, in August 2002, CBAC released its final report, entitled Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada. The government departments responding to this report are in the process of finalizing a coordinated response.
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Information for sound decisions: labelling systems
In addition to enforcing health and safety labelling requirements set by Health Canada, the CFIA is also responsible for the development of general food labelling policies and labelling regulations not related to health and safety. As well, the Agency is directly involved in domestic and international discussions about labelling of biotechnology-derived foods.
As a technical advisor, the CFIA has contributed to the development of a domestic voluntary labelling standard for biotechnology-derived foods, an initiative being led by the Canadian General Standards Board (CGSB). The committee responsible for the standard held its 11th meeting in May 2003 to discuss outstanding issues. The standard was revised and a third ballot was issued in the summer of 2003. Consensus was reached on the draft standard by the committee, and if approved by the Standards Council of Canada, a national standard could be published as early as February 2004.
Canada is also involved with the Codex Alimentarius Commission task force that develops international standards for food safety. The Commission is responsible for developing standards, guidelines and other similar texts to protect consumers' health and to ensure fair trade practices in global food trade. It also promotes the coordination of food standards work done by international government and non-governmental organizations. The CFIA has been involved in several Codex initiatives, providing pivotal leadership to ongoing discussions of labelling at the Codex Alimentarius Committee on Food Labelling and participation in the task force on Foods Derived From Biotechnology.
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Strengthening international understanding and co-operation
As a responsible member of the world community and global leader in biotechnology, Canada has worked hard over the past five years to contribute to the international regulatory framework. The CFIA and other government bodies are members of several international organizations that deal with the regulation of products derived through biotechnology.
These organizations include: the Asia-Pacific Economic Cooperation (APEC) forum, the World Health Organization (WHO)/Food and Agriculture Organization (FAO) Codex Alimentarius Commission Committee on Food Labelling (CCFL), and the Organisation of Economic Co-operation and Development (OECD). The CFIA has enhanced its efforts to contribute to, and support the work of, these global bodies.
In addition, Canada is a signatory to the Cartagena Protocol on Biosafety. Although a non-party, Canada has continued to work in the international arena to help clarify the provisions of the Protocol. This level of international participation gives the Agency the opportunity to communicate its commitment to a science-based approach to biotechnology, while contributing to sound international policy.
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Rigorous and responsive regulatory system
The Government of Canada is committed to ensuring that its regulation of foods derived from biotechnology is appropriate for the state of the science and the types of products that are being developed through research. To that end, it allocated $90 million in Budget 2000 specifically to enhance the regulatory system for products derived through biotechnology.
An annual investment of $10 million in the regulatory system for biotechnology-derived products has enabled the CFIA to continue to strengthen its "safety first" regulatory approach to keep pace with the next generation of scientific discoveries. This funding has allowed the CFIA to:
- increase capacity for monitoring, inspection, surveillance and enforcement by carrying out training to update the skills of its current staff
- increase capacity to enhance the CFIA's ability to provide good policy to meet current challenges and anticipate future challenges before they appear
- generate research to underpin regulation by acquiring new tools, methodologies and knowledge for risk assessment, risk management and monitoring
- strengthen international regulatory cooperation and harmonization by negotiating international agreements and by designing standard-setting protocols
- maintain and heighten the public's confidence in Canada's regulatory system while continuing to improve its communications with the public and stakeholders
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Early successes
Biotechnology is an ever-expanding science that has posed several challenges to the Agency since its creation in 1997. Although the Agency is still new, its highly qualified and dedicated employees have consistently proven themselves equal to these challenges, forcefully responding to Canadians' safety and information needs, and playing a strong role in the national and international arenas of agricultural biotechnology.
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Enhancing regulatory rigour: improving and evolving
Protecting consumers, animals and the environment is the CFIA's top priority, which is reflected in the rigour of its regulatory system. The Agency is committed to incorporating new knowledge arising from advances in science and its increasing experience in regulating products of biotechnology within the regulatory system.
The CFIA is updating its regulatory directives and guidelines on plants with novel traits (Regulatory Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits) and livestock feeds derived from plants with novel traits (Regulatory Directive 95-03: Guideline for the Assessment of Livestock Feed from Plants with Novel Traits).
With respect to specific types of new products (one example being molecular farming), the CFIA has completed the Interim Amendment to Directive 2000-07 for Confined Research Field Trials of PNTs for Plant Molecular Farming to explicitly state appropriate terms and conditions for confined research field trials of plants with novel traits for molecular farming.
In regards to animal biotechnology, the CFIA has been involved in several important initiatives. In 1998, the CFIA and other departments hosted the "Consultation on Regulating Livestock Animals and Fish Derived from Biotechnology," which was attended by representatives from non-governmental organizations, industry, industry associations, university communities, First Nations and government, as well as interested individuals. The purpose of the consultation was to seek advice and identify areas where improvements could be made to Canada's existing regulatory system dealing with livestock animals and fish derived through biotechnology, and to raise awareness of the technology, its use and applications.
In 2003, some 45 participants, including representatives of stakeholder groups (biotechnology companies, livestock breeders, university researchers and the Canadian Council on Animal Care) and government (Agriculture and Agri-Food Canada, Environment Canada, Health Canada, and Industry Canada), attended a CFIA-organized focus group aimed at providing stakeholders and regulated parties with a forum to discuss the current status and anticipated developments in the regulation of animal biotechnology in Canada. It also provided an opportunity to formulate recommendations on the future role of the CFIA in the regulation of animal biotechnology.
The CFIA is working with Environment Canada, as well, providing scientific expertise to draft notification guidelines for the regulation of livestock animals that are products of biotechnology under the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999.
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Reaching out to the public
Canadians feel strongly about having access to credible information as it relates to foods available in the marketplace. Because of its commitment to openness and transparency, the CFIA has not only maintained, but heightened the public's confidence in Canada's regulatory system while continuing to improve its domestic and international communications with the public and stakeholders alike.
The CFIA has frequently engaged the public in consultations to help develop guidelines and regulations for biotechnology-derived agricultural products. These consultations have included workshops, multi-stakeholder meetings, online feedback forms and draft documents for review and comment, along with independent reviews by experts.
To date, some of the topics discussed have been:
- regulations and safety assessments for biotechnology-derived products
- labelling of biotechnology-derived foods
- plant molecular farming
Enhanced understanding helps consumers to formulate their own views about biotechnology in Canada and the global marketplace. An important area of public information surrounds the labelling of genetically modified (GM) foods. The Agency has developed a range of tools that enable Canadians to access the most up-to-date information as well as the opportunity to respond and ask questions.
The CFIA has committed itself to increasing the public's access to, and understanding of, the regulation of all biotechnology-derived products. Some of these activities include:
- posting more information on the CFIA Web site
- designing information products, such as consumer fact sheets, that are written in "plain language"
- developing information kits
- designing a poster that provides an overview of some of the agricultural biotechnology regulation milestones that have occurred over the last 15 years
In addition, the CFIA, on behalf of several other government departments, led responses to a number of petitions submitted under section 22 of the Auditor General Act to the Commissioner of the Environment and Sustainable Development. The responses to these petitions were made available to the public on the CFIA Web site well before this level of transparency applied to all petitions.
On October 21, 2003, the CFIA launched the Notices of Submission Project, in conjunction with Health Canada. These notices will describe the product - a new Plant with Novel Trait (PNTs), or novel feed or food derived from a PNT - and summarize the information provided for its safety assessment.
The launch of this project means that, for the first time in Canada, the public will be notified of new biotechnology crop, feed and food product submissions while they are under review. As well, it is the first time the public will have access to a list of scientific studies conducted on new products regarding safety, and they may provide input on scientific matters relevant to the safety assessment of each new product submission.
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Demonstrating effective programs management: responding to StarLink™
The CFIA's inspection functions include border inspections for biotechnology-derived products that have not been approved for safety in Canada. StarLink™ corn - approved in the U.S. for animal feed and industrial purposes, but not for human consumption - is one such product. It has not been approved in Canada for any purpose and therefore cannot be imported.
The CFIA, the Canadian Grain Commission, as well as the Canada Customs and Revenue Agency undertook a major joint initiative to keep StarLink™ corn from entering the country. They worked together to verify that shipments had appropriate documentation, proving no StarLink™ content, and to sample shipments on a random basis. Between October 2001 and December 2002, approximately 60,000 shipments of whole grain corn from the U.S. were reviewed. In December 2001, the government issued a detailed response to the Greenpeace Canada petition. The response gave an overview of the comprehensive way that Canada regulates biotechnology-derived foods and in what ways the regulatory system continues to evolve to meet challenges such as those posed by the StarLink™ case.
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Working with world partners to develop "smart standards"
The CFIA participates in several international organizations and discussions on a range of matters related to its mandate, and frequently helps to develop Canada's position on these issues. The CFIA participates in the OECD's Working Group on Harmonisation of Regulatory Oversight in Biotechnology. The main task of this working group is to achieve harmonization in countries' regulation of biotechnology, focusing on environmental safety.
Also, in 2000, CFIA became the Shepherd of the Research, Development, and Extension of Agricultural Biotechnology (RDEAB) Sub-Group of APEC. This sub-group was formally established to be a place for member economies to discuss regulatory transparency, discuss capacity building, encourage the development of effective communications and further technical cooperation and information exchange.