Annotated Bibliography Entry

Reference: Canada CBAC 2001
Title: Improving the regulation of Genetically Modified Foods and Other Novel Foods in Canada – Interim Report of the Canadian Biotechnology Advisory Committee to the Biotechnology Ministerial Coordinating Committee. 
Authors: Canadian Biotechnology Advisory Committee (CBAC)
Publisher: Canadian Biotechnology Advisory Committee, 240 Sparks Street, Ottawa, Ontario, K1A OH5, Canada
Publication details: August 2001. 70p.

Summary
Observations, Findings and Draft Recommendations
Recommendations
          Good Governance
         Information and Choice
         Social and Ethical Considerations
Table of Contents

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Summary

Canada’s current regulatory system has been effective in its primary objective of ensuring the safety of the nation’s food supply. As the tempo of development of new food products by genetic modification of plants and animals has accelerated, public interest in the capacity of the regulatory system to keep pace with future developments has grown.

This document is an Interim Report of the Canadian Biotechnology Advisory Committee (CBAC) to the Government of Canada on the regulation of genetically modified (GM) food. It covers the first two phases of a three-phase project that CBAC has undertaken on this important topic. The primary objective of the project is to identify improvements in the structure and function of the regulatory system that would position it to successfully meet current and future challenges.

Phase 1 of the project began in the summer of 2000. It consisted of collecting and analyzing information on the regulatory, social, economic, ethical, legal and environmental elements of GM foods. A number of background papers on GM foods were commissioned. Reports of other expert groups including the report of the Royal Society of Canada Expert Panel on the Future of Food Biotechnology were reviewed.

Phase 2 consisted of three key activities, all designed to garner input of Canadians concerning the regulation of GM foods. The first was the release in March 2001 of a Consultation Document soliciting input from Canadians. The second involved a series of multi-stakeholder workshops held in April 2001 in five cities across Canada. The third was a review in May 2001 of existing public opinion research reports related to GM foods. Reports on these three activities are available on the CBAC Web site.

Phase 3 of the GM foods project begins with the release of this Interim Report. CBAC is inviting feedback on this report and will be accepting input until January 31, 2002. At the conclusion of Phase 3, following the comment period, CBAC will submit its final report to the Government of Canada.

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Observations, Findings and Draft Recommendations

The Interim Report begins with a brief description of the context for CBAC’s project on GM foods and the process by which it has been conducted. This is followed by a summary of Canada’s system for regulating GM foods. The ethical context within which CBAC considered the main issues of contemporary interest and relevance is identified.

The phrase “GM foods” refers generally to food produced from genetically engineered plants and animals using recombinant DNA technology. It became evident in our deliberations that while some aspects of food regulation may be particular to GM foods (e.g. some aspects of the risk assessments), many of the issues involved  and many of our observations and recommendations apply to all plants, crops and animals with novel traits. Indeed, under Canada’s regulatory system, GM foods are part of the broader category of novel foods. We support this more comprehensive approach, and we have therefore formulated many of our draft recommendations in the context of novel foods in general. In addition, in some cases, our analysis and recommendations have potential implications for certain general features of the food regulatory system, food policy and environmental regulation. Our recommendations seek to identify the situations where wider application may be warranted.

Ten issues are at the heart of CBAC’s analysis, consultations and draft recommendations. They are:

• transparency
• separation and independence of regulatory functions
• ensuring safety during research and development activities
• opportunities for public involvement
• post-market monitoring for risks and benefits
• capability and capacity in the regulatory system
• information provision
• labelling
• environmental stewardship
• broader social and ethical considerations.

These issues are discussed under three overarching themes:

• good governance
• information and choice
• social and ethical considerations.

CBAC’s current thinking regarding GM foods is presented as draft recommendations. These consist of five general and twenty-four specific recommendations. They target a number of structural and operational features of the regulatory system as well as key challenges related to public information, informed choice and environmental stewardship. We also identify a sixth area in which we intend, as part of Phase 3 of our project, to develop additional insight and recommendations concerning social and ethical issues related to the regulation of GM foods.

The draft recommendations presented below reflect core values and principles for the protection of health and the environment, individual autonomy, transparency, integrity and accountability of the regulatory system, and sustainability of food production. We believe an understanding of the ten issues and effective application of their associated recommendations, once finalized, will contribute to a more accountable, knowledge-based and cautious food regulatory system.

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Recommendations

Good Governance

1. Structure, Organization and Operation of the Federal Food Regulatory System

Observations: The federal food regulatory system relies on a number of regulatory bodies, some being more active on issues pertaining to GM and other novel foods than others. The bodies interact but are not highly integrated. Within their specialized spheres, they address similar issues and concerns but generally do not do so in a concerted or sufficiently transparent manner. Health Canada and the Canadian Food Inspection Agency (CFIA) function more closely than other parts of the system, but coordination with the other parts appears weak. There is no individual leader or spokesperson for food safety matters at the federal level for either GM and other novel foods or for food in general. GM and other novel foods are currently a small part of the overall food safety systems, but this may change in the near future. The degree to which the regulatory function remains independent from the government’s promotional activities is not clearly described.

Draft Recommendation 1: CBAC recommends that the federal government enhance the structure, organization and operation of the federal food regulatory system for GM and other novel foods. It should adopt a series of measures to further systematize and integrate its different regulatory bodies, and to clarify the separation of government’s regulatory role from its promotional activities. We also recommend that an assessment be undertaken to determine whether it would be advantageous to apply this recommendation more widely to the entire Food Safety System.

Specifically, we recommend the following measures:

1.1 Appointing a chief safety officer for GM and other novel foods. This person will become the focal point and spokesperson on all federal GM and other novel food safety matters - related to human health as well as environmental safety – and will coordinate activities of the individual regulatory bodies. This officer will chair a new assistant deputy minister (ADM) committee on GM and other novel food safety regulation (see below). This person will be appointed ex officio member of all rulings committees operated by regulatory bodies within the food regulatory system.

1.2 Establishing a committee at the ADM level to oversee GM and other novel food safety regulation for Canada. Representatives will be from federal regulatory bodies involved in the assessment and approval/registration of products of biotechnology and related inspection and enforcement activities (at a minimum, Health Canada, the Canadian Food Inspection Agency, Environment Canada, and Fisheries and Oceans Canada). The committee’s responsibilities will include ensuring effective interdepartmental and interagency coordination and communication, and planning and analysis activities. Specific functions would address:

• Coordination and communication of product assessments as well as proposed and final regulatory decisions.

• Coordination of communication activities and tools aimed at external audiences.

• Elimination of gaps and counterproductive overlaps in the regulatory system.

• Evaluation of the adequacy of the existing guidelines covering experimentation involving recombinant DNA and other forms of genetic modification. This function should be pursued to determine the ability of existing guidelines to ensure health and environmental safety during research and development activities, the extent to which they are applied by researchers in public and private organizations, and whether further action, including greater regulatory scrutiny or a single national standard for research and development is needed to protect health and the environment.

• Management of the government’s scientific and technical expertise. The aim would be to ensure that it is maintained and built up where necessary, and is adapted in anticipation of future regulatory needs, following periodic evaluation of new research findings and market trends.

• Preparation and publication of standard operating procedures (SOPs) to clearly describe the delegation of decision-making authority, the strategies in place to insulate officials from inappropriate influence, the procedures and rationale for engaging nongovernmental experts and expert panels in regulatory processes, the policies regarding the preparation of decision documents for public review prior to final decision making, and the details regarding rulings committees and other elements of internal reviews.

• Examination of opportunities for ongoing improvement of risk assessment and risk management activities, and of inspection and enforcement capacity in relation to more complex, newer generation products. This function should be conducted with a view to ensuring routine monitoring for compliance with conditions of approval associated with the production of plants with novel traits or novel foods.

1.3 Ensuring effective independence of regulatory functions from the industry and trade promotion functions of the federal government. CBAC recommends that the federal government carefully scrutinize its internal operations and relationships with stakeholders, and modify them where needed. All communications and communication materials should be assessed, and specific attention should be paid to the involvement of regulators in the negotiation of international policy and trade rules. These measures should be undertaken to ensure the highest degree of integrity and independence in the conduct of regulatory functions, to avoid exacerbating the perception of mandate conflict, and to ensure an appropriate role for regulatory officers in international activities. For those regulatory bodies that do not already have in place a standing committee through which all proposed decisions on GM foods and other novel foods must be vetted, CBAC considers it essential to establish one.

1.4 Having the Auditor General of Canada monitor and publicly report on regulatory bodies involved in assessments and decision making related to foods sold in Canada, with emphasis on the independence of regulatory functions, and the effectiveness of standard operating procedures.

 

2. Evaluation of Long-term Health and Environmental Impacts

Observations: The federal government conducts research related to GM foods. Work is also under way internationally. However, a number of additional tools and programs are needed to effectively assess and anticipate long-term health and environmental impacts associated with GM and other novel food.

Draft Recommendation 2: CBAC recommends that the federal government launch a significant effort related to the monitoring of long-term health and environmental impacts associated with GM foods and other novel foods.

This activity involves the following measures:

2.1 Requiring the inclusion of effective detection methodologies for transgenes as part of the application process for requesting approval of novel products.

2.2 Developing food consumption data in order to improve the risk assessment process. Providing a greater understanding of potential exposure to certain foods would assist in the identification of populations that may be at higher than normal risk and in monitoring for long-term effects of certain food consumption patterns.

2.3 Ensuring that new scientific or technical information is taken into account within a reasonable time frame. This objective could be achieved by including in product approvals a preset deadline before which a reassessment of any new information related to the product or otherwise relevant to its risk assessment is conducted.

2.4 Introducing a broad-based program of long term research into GM organisms that are part of the human food chain. This task would improve our scientific knowledge of health and environmental harms as well as benefits of the products in question. Leadership should be shown in studying crops for which Canada is a global leader (e.g. canola, identity preserved soy, durum wheat, flax and malt barley). International collaboration and information sharing as well as programs for developing similar information on other novel foods are also recommended.

3. Transparency

Observations: While there is a desire within the federal government to be more transparent in its regulatory functions, constraints (and possibly legal impediments) remain. There is insufficient emphasis on transparency. The communication of information related to the regulation of GM and other novel foods has not been highly effective.  

Draft Recommendation 3: CBAC recommends that the federal government become more effective and transparent in communicating all features of the GM and other novel food regulatory system, including the scientific basis for regulatory decisions related to human and environmental health and safety.

We recommend the following measures:

3.1 Continuing to involve the Canadian public in the development of laws, regulations, policies and programs related to the Canadian food regulatory system.

3.2 Improving information and communications about the federal food regulatory system.

Decision trees could clearly describe the regulatory authorities, responsibility centers and relevant laws, activities, stages of risk assessments and decision processes, progression through the regulatory system, relevant time lines, mechanisms to resolve differences of opinion, and opportunities for public input at various stages.

3.3 Maintaining a readily accessible public record of the GM and other novel food products currently under review as well as the status of the assessment.

3.4 Communicating GM and other novel food risk assessments and proposed regulatory decisions systematically through published documents. This would include a 45-day comment period for public input on the proposal. This should be followed by a final decision document, amended as appropriate, based on the input received. (Minimum topics to be covered in these documents are listed in the full report.)

3.5 Making publicly available the detailed scientific and technical data reviewed by the government in conducting human health and environmental safety assessments of GM foods and other novel foods. For this purpose, a review should be conducted to ensure an accurate interpretation of existing provisions in the Access to Information Act. As well, consideration should be given to any necessary amendments to applicable laws and regulations. The disclosure requirements should not, however, include details such as how to construct and manufacture the product, as this could significantly jeopardize a company’s competitiveness. Furthermore:

• The information should be available for products sold in Canada and for products being proposed for market approval.

• Existing provisions in the Access to Information Act should not be viewed as requiring the government to keep confidential any technical or scientific data that have not been kept strictly confidential by the owner of the data (e.g. if the data have been made public or are available to the public as a result of the product being approved in another country).

• Consideration should be given to any necessary amendments to applicable laws and regulations in order to allow the release of the data.

3.6 Re-examining pollen drift and reassessing the buffer zones currently applied to field studies of GM crops and other plants with novel traits. Information on pollen drift should be required in all submissions for approval of plants with novel traits. Growers within five kilometres of a field study involving GM crops should have access to more detailed information, on request, in order to protect their own crop production. Otherwise, the detailed location of trials conducted on GM crops and other plantswith novel traits in the field (“field studies”) should not be released because of the risk of damage through vandalism. Further study is needed to better understand the characteristics and risks associated with GM products.

3.7 Publishing, on an annual basis, information on government inspection programs, findings related to compliance with measures concerning GM products, the frequency of

3.8 Publishing, on an annual basis, information on the government’s research program and research results related to health and environmental safety aspects of GM foods, plants and feed, and other novel products.

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Information and Choice

4. Information and Informed Choice

Observations: Canadians want easy access to reliable and complete information regarding food including GM and other novel foods. The current information sources are criticized for being unreliable, incomplete, overly technical or otherwise ill-suited to the needs of the general public. Canadians also want to be able to choose whether or not to buy GM foods. Consumer choice can be influenced by health and environmental concerns as well as by principles, beliefs and values. Labelling is currently required for such health concerns as the presence of an allergen or a significant nutritional change. Current laws allow voluntary labelling if it is not misleading. However, the absence of a systematic and reliable standard for labelling food regarding whether or not it is derived from genetic modification prevents labelling claims such as “GM free” from being verified. Other countries are putting forth various forms of voluntary or mandatory labelling policies.

Draft Recommendation 4: CBAC recommends that the federal government put in place mechanisms to help Canadians make informed choices about the foods they consume. The government should allocate new and additional resources for providing Canadians with a centralized service for accurate and comprehensive information on GM and other novel foods, the food regulatory system, and food standards and regulations. The government should also ensure the development of an approach to labelling foods regarding genetic modification that, combined with the information service, is effective in helping Canadians make informed food choices.

We recommend the following measures:

4.1 Establishing a centralized food information service as the primary avenue through which the government provides food-related information, including on GM and other novel foods, to Canadians. The service should reflect effective cooperation among all parts of government with roles related to food regulation, food research, food policy and consumer affairs. The information disseminated for the most part should originate in the federal government, and should always be unbiased. The organization and operation of the service should be based on a comprehensive strategy. Funding for related government communication and information activities should be consistent with the strategy.

4.2 Developing, as part of this strategy, reliable information for use by health care professionals and other intermediates (such as doctors, nurses, nutritionists, dieticians, teachers, community workers, consumer associations, civil society groups and the media).

4.3 Developing a labelling system for foods with GM content and continue to work on an

• Develop a set of clear labelling criteria regarding the GM content in food. Further effort could be placed on the ongoing labelling initiative of the Canadian General Standards Board and Canadian Council of Grocery Distributors.

• Ensure that any label statements regarding genetic modification are verifiable, and that programs and techniques are in place to ensure their validity.

• Implement the labelling standard voluntarily, at least initially, in order to test its adequacy and effectiveness, and widely promote its use so that people have real opportunities to make informed choices.

• Continue to work with other countries in international fora to develop a harmonized international approach for labeling regarding genetic modifications.

• Depending on the success of this approach — and especially if it fails to provide Canadians with sufficient choice regarding the food they consume — further consideration should be given to a mandatory labelling scheme.

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Social and Ethical Considerations

5. Environmental Stewardship

Observations: Currently, there are no binding international standards for environmental assessments for GM or other novel foods. Work is under way and progress is being made in identifying “best practices.” Nonetheless, CBAC believes there is room for improvement in the current approach to environmental assessments for research into long-term impacts and the degree to which ecosystem effects are being considered.

Draft Recommendation 5: CBAC recommends that the federal government strengthen its

environmental stewardship over GM foods, other novel foods and the organisms from which foods are derived. A comprehensive national research program related to long-term impacts, improved environmental assessments of regulated products and the use of conservative standards of safety as the basis for product approvals is needed.

We recommend the following measures:

5.1 Establishing a well-supported and collaborative national research program to improve

5.2 Exploring over the short term and implementing options for integrating a stronger ecosystem perspective into environmental risk (safety) assessments of GM and other novel foods. A report of options should be developed and released publicly within a year. Key elements would include national and international research collaboration needs and the potential for making better use of ecological expertise.

5.3 Strengthening over the medium term the environmental assessments of novel foods and GM processes used in food production through a stronger ecosystem perspective and peer review of experimental design and data. Independent panels should be utilized to recommend ecologically meaningful experimental protocols for each new class of GM introductions. This task would require building a strong base of expertise to cover key ecological and environmental concerns, such as environmental persistence of GM organisms, effects on biogeochemical cycles, reproductive biology such as pollen flows, harmful effects of horizontal gene transfer, diminution of biodiversity, insect resistance to GM insecticidal products and cumulative effects.

5.4 Taking a precautionary approach to ensure a conservative safety standard for environmental and health concerns related to GM and other novel foods. This does not imply, however, a zero-risk approach. Special concern should be taken with regard to potentially catastrophic kinds of risks. Under circumstances where it is appropriate to use substantial equivalence as a framework to structure the safety assessment of novel foods, it is necessary to ascertain whether the composition of the plant has been changed in any way. Examples are the introduction of new hazards into food, an increase in the concentrations of inherently toxic constituents, a decrease in the expected nutrient content, or the introduction of unwanted characteristics such as antibiotic properties into natural ecosystems.

5.5 Assessing the implications and suitability of recommendations 5.1 to 5.4 above for broader application throughout the environmental regulatory system.

 

6. Other Social and Ethical Considerations Related to GM Foods

Observations: The debate over GM foods is polarized between those supporting the application of biotechnology (e.g. rDNA technology) to foods and those against it. The search for common ground between advocates of different views is hindered by the lack of suitable tools to systematically consider and evaluate on an ongoing basis the social and ethical factors that influence public acceptability of specific food. CBAC will continue to consider the health and environmental safety, ethical, social, economic and broader societal considerations that influence people’s acceptability of different kinds of GM foods. Attention will be focussed on developing methods to enable meaningful dialogue on these factors and to better identify the criteria and values at play in people’s evaluation of specific foods. Guidance in relation to this aspect of the GM foods debate — in particular, a mechanism for addressing social and ethical factors that influence the public’s acceptability of specific foods — is being developed for CBAC’s final report (See CBAC 2002). 

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Table of Contents 

Executive Summary 2

Introduction 10

The Setting and the Consultation Process 11

GM Foods, Other Novel Foods and the Canadian Regulatory System 13
Benefits and Concerns 14
The Advent of Food Safety Assessments 15
The Regulatory System 16
Implications of Future Foods for the Food Regulatory System 19

The Ethical Context 21

Key Issues Related to the Regulation of GM Foods 22

Theme 1: Good Governance 23
Issue 1 — Transparency 23
Issue 2 — Separation and Independence of Regulatory Functions 26
Issue 3 — Ensuring Safety During Research and Development Activities 27
Issue 4 — Opportunities for Public Involvement 28
Issue 5 — Post-market Monitoring for Risks and Benefits 30
Issue 6 — Capability and Capacity in the Regulatory System 32
Draft Recommendations Regarding Good Governance 33

Theme 2: Information and Choice 38
Issue 7 — Information Provision to Support Informed Choice 38
Issue 8 — Labelling 39
Draft Recommendations Regarding Information and Choice 41

Theme 3: Social and Ethical Considerations 43
Issue 9 — Environmental Stewardship 43
Issue 10 — Broader Social and Ethical Considerations 44
Draft Recommendations Regarding Social and Ethical Considerations 49

Moving Forward from Here 51
Refining the Federal Food Regulatory System 51
A National Food Policy 51
Next Steps 51

Annexes
A — Members of the Canadian Biotechnology Advisory Committee 52
B — CBAC Publications, Commissioned Reports and Companion Documents 53
C — Feedback on an Appropriate Ethical Context 55
D — Royal Society Panel Recommendations 58
E — The Future of Food Biotechnology 65

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Web site: http://www.cbac-cccb.ca/english/workplan/listDocs.aro?type=5