Annotated Bibliography Entry

Reference: Canada CBAC 2002
Title: Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada. Report to the Government of Canada Biotechnology Ministerial Coordinating Committee, Canadian Biotechnology Advisory Committee.
Authors: Canadian Biotechnology Advisory Committee
Publisher: Canadian Biotechnology Advisory Committee, 240 Sparks Street, Room 561 E, Ottawa ON K1A 0H5 Canada
Publication details: August 2002. 92p.

Summary
Structure of the Report
Issues
Recommendations
Conclusion
Table of Contents

 

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Summary

CBAC is an independent expert advisory body created by the Government of Canada to assist it in the formulation of public policy on a range of biotechnology subjects. It provides advice to the Biotechnology Ministerial Coordinating Committee, which consists of the federal ministers of Industry, Agriculture and Agri-Food, Health, Environment, Fisheries and Oceans, Natural Resources and International Trade.

History of the GM Foods Project

At our inaugural meeting in October 1999, we identified the regulation of genetically modified foods (GM foods) as a priority subject for study. We identified three main areas of interest: the science base supporting regulatory processes; the organization and governance of regulatory systems; and social and ethical considerations in regulating GM foods. In early 2000, the ministers of Health, Agriculture and Agri-Food, and Environment asked the Royal Society of Canada to convene an Expert Panel to provide the federal government with advice on the scientific capacity required by Canada’s regulatory system to ensure the safety of new food products being developed through biotechnology. In view of the Expert Panel’s mandate, we decided to focus our attention on strengthening regulatory structures and processes, and on approaches to assessing the social acceptability of GM foods.

The project proceeded in three phases. In Phase 1, we commissioned background research by experts to identify issues and options in specific areas. A bibliography of research reports and other relevant documents reviewed in the course of our deliberations is presented in Annex 4. In Phase 2, national stakeholder and public consultations were conducted, based on a Consultation Document outlining 10 topics for discussion. These discussion topics are listed in Annex 2.

Phase 3 began in August 2001 with the publication of an Interim Report Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada. In it, we presented several draft recommendations and introduced the Acceptability Spectrum, a consultation tool intended to foster a meaningful dialogue on the acceptability or non-acceptability of certain GM foods and feeds (see Annex 6). Canadians were invited to comment on the report, and 160 submissions were received, mostly from consumers and interested citizens (see Annex 2 for a summary of the responses).

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Structure of the Report

The report begins with a brief reference to the ethical principles guiding CBAC’s work. This is followed by a discussion of the science, governance and regulation of GM foods in Canada, a look at some of the recent policy developments in Canada and around the world, and an outline of some of the economic, environmental and socio-ethical elements of the GM foods debate.

The major portion of the document discusses our eight recommendations, organized under four themes:

• Good Governance

• Precaution

• Information and Consumer Choice

• Social and Ethical Considerations.

In preparing this report we took into account recent events in Canada and abroad. These include technological, legislative or regulatory developments as well as reports issued by various advisory bodies. We took special note of the Report of the Expert Panel of the Royal Society of Canada and the government’s response to it. Discussion of the Expert Panel’s recommendations in areas that are germane to our own deliberations is included in the relevant sections of this report.

Seven annexes are provided at the end of this report. Annex 1 lists the research and companion documents that CBAC commissioned or prepared to help inform its deliberations on GM foods. Annex 2 is a summary of the written input that CBAC received on the Interim Report. Annex 3 presents an introduction to possible second and third generation GM foods and the questions they raise. This annex originally appeared in the Interim Report and has been updated for this report. Annex 4 is a bibliography of related reports. Annex 5 is a Policy Analysis Matrix that summarizes — for three scenarios — the relative impact of labelling GM foods on a number of public policy issues. Annex 6 outlines a framework to consider the acceptability of GM foods and work to date on this framework. Annex 7 is a letter to CBAC from the Exploratory Committee that was established to develop the framework.

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Issues

The issues involved in the production, regulation and marketing of GM foods are complex. Positions are polarized. There are those who believe that modern biotechnology has provided and will provide significant benefits for both farmers and consumers. They are opposed by those who hold that it is only the inventors of genetically modified products who are likely to benefit significantly, while the population as a whole may have to bear unacceptable risks to health and the environment. There are also sharp differences of opinion concerning the implications of agricultural biotechnology for developing countries. Some see it as a means of considerably enhancing food supplies in vulnerable regions of the world, while others fear that it will lead to the exploitation of both growers and consumers in impoverished countries.

The fact that there are divergent views on such a complex issue is not surprising. Nor should it be a reason for failure to take action that is in the public interest — namely, to capture the benefits of biotechnological innovation while providing reasonable protection against potential harms. Our findings and recommendations in this regard fall under four themes: good governance, precaution, information and consumer choice, and social and ethical considerations.

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Recommendations

Recommendation 1. Structure, organization and operation of the federal food regulatory system

Good governance is essential for creating and maintaining a regulatory regime that protects the health and safety of citizens and of the environment. As well, it inspires confidence in its efficiency and effectiveness. Good governance entails both legislated accountability and a commitment to transparency, and effective separation of regulatory functions from other potentially conflicting functions of government.

The multiple responsibilities of the federal government relative to foods, as in many other areas, include both regulatory and promotional functions. In fulfilling these responsibilities, steps must be taken to ensure that these functions are not in conflict. Moreover, given that several departments and agencies participate in food regulation, sometimes with overlapping responsibilities, we recommend that their roles and functions be closely coordinated.

While an independent, coordinated and efficient regulatory system is of prime importance, so too is the trust of the public and stakeholders in that system. To this end, we urge the government to enhance the system’s accountability and communication to the public, including creation of a single authoritative spokesperson to oversee and coordinate the communication of government policies and practices with regard to GM foods.

Recommendation 2. Transparency and public involvement

The federal government should improve the ways it communicates with, and involves, the public in the regulation of GM foods and the development of associated policies. The government does not provide clear information explaining how GM products are regulated and decisions are made, the roles of the regulatory bodies, or the information considered during safety assessments. Federal regulators need to be more active and transparent in publicly communicating such matters, including the scientific basis for regulatory decisions. While we recognize that regulators are restricted in disclosing “confidential business information,” measures should be taken to ensure that the maximum amount of appropriate information is made public.

The public should have greater opportunity for involvement in policy development and decision making concerning GM products and an opportunity to comment on proposed decisions regarding specific products. Moreover, given that the science supporting the safety assessment of GM foods should be able to withstand the scrutiny of independent experts, we urge that mechanisms be created to allow for greater inclusion of the views of outside experts as individuals or as members of scientific advisory panels.

We recognize that implementing these measures will require a fundamental shift in the approach taken by regulators to transparency and decision making. However, we consider these steps essential for building public confidence in the food regulatory system and in the risk assessment and risk management of applications of new technologies. We also believe that they will help to fill the desire on the part of consumers for easy access to reliable information about GM foods.

Recommendation 3. Precautionary elements

All but one of our members support Canada’s current approach in which all plants and foods with novel traits are subjected to rigorous regulatory assessments rather than treating GM plants and foods as a separate category. The committee also supports the use of substantial equivalence as a guide to identifying the differences between conventional and novel crops so that such differences can be rigorously assessed to determine their implications for health and environmental safety. We also endorse the precautionary approach to risk management currently utilized in Canada, an approach that has been shown both nationally and internationally to be an essential component of good regulatory practice. We urge that this approach be used in all stages of a product’s life cycle, from initial laboratory research and field trials, through pre-market assessment, to use and disposal.

Research and development of GM organisms has been taking place for nearly 30 years with no evidence as yet of harm to human health or the environment. Nevertheless, we urge an examination of existing standards to ensure that such research is being conducted in a precautionary manner. These activities are currently governed solely by guidelines. We recommend a study to determine whether the guideline approach is effective or whether stronger measures are required, particularly with regard to the propagation of GM plants in greenhouse facilities.

As part of its precautionary approach, government should introduce a long-term program of research into GM and other novel organisms that are part of the food chain. A systematic approach is required to evaluate new research data and to ensure that they are used when warranted to modify approval decisions, revise risk mitigation measures and determine whether and when a plant or food has been in commercial production long enough to no longer be considered “novel.” In addition to this ongoing process, regulators should be authorized to initiate a mandatory re-evaluation of product approvals after a pre-determined period following initial product approval (say, every 10 years) — if warranted on the basis of a review of new information provided by the proponent (developer) of the product, the public or external experts.

Recommendation 4. Evaluation and monitoring of long-term health impacts

GM foods currently in the marketplace have arguably undergone greater regulatory scrutiny than their conventional counterparts. Nevertheless, in keeping with a precautionary approach, it is prudent to establish programs to determine whether there are any long-term adverse or beneficial effects attributable to these foods that are not revealed in pre-market assessments. This requires much more information about food consumption patterns than is now available for either conventional or GM foods. This lack makes it difficult to estimate the quantitative significance of GM foods in the Canadian diet. This challenge is but one of many inherent in designing and implementing an effective post-market surveillance system for GM foods. It is noteworthy that no country currently has such a system in place.

Generalized surveillance in an attempt to link population health outcomes with the consumption of foods categorized by source, whether GM, organic or other food categories, is unlikely to be feasible or cost-effective, given the difficulty of controlling for confounding variables. However, post-market monitoring to detect specific adverse or beneficial effects and their relationship to exposure to a particular GM food may be feasible. In this regard, Health Canada’s recent initiative to develop new surveillance methodologies and approaches for monitoring long-term health effects related to the consumption of GM and other foods is noteworthy.

We recommend that the government strengthen its commitment to basic research into long-term health effects related to the consumption of specific foods, including GM products. We also recommend that it initiate a significantly expanded program to obtain comprehensive food consumption data for both conventional and GM foods, and that this new information be incorporated into regulatory decisions and risk management strategies.

Recommendation 5. Environmental stewardship

The current approach to the assessment of environmental risk and ecosystem impacts of GM plants could be improved. There is a need for increased investment in research into both the short- and long term impacts of GM and other novel crops on the environment.

Currently, environmental impacts are primarily assessed using small-scale confined field trials that may be too small in area to detect impacts that would appear in larger areas or too short in duration to detect effects that would emerge in the longer term. The ability to assess the environmental impacts of large scale planting of transgenic crops is also hampered by the lack of baseline data on the environmental impacts of agriculture generally. These and other gaps need to be addressed if the monitoring of bioagricultural practices is to be effective. We also note that studies into the environmental impact of GM crops must examine not only the potential risks but also the potential benefits and how the risks can be minimized and benefits maximized.

Because the experimental field testing phase presents the greatest challenge to risk management, it is essential to ensure the effectiveness of isolation zones to mitigate cross-pollination, and to use detection techniques to ensure traceability should plant material accidentally escape. We urge that auditing programs be implemented at both the field-testing and post-approval stages to ensure compliance. We also urge the creation of an independent panel to review and recommend ecologically meaningful experimental protocols and performance indicators to be monitored for each new class of GM organism introduced into the environment.

The implementation of an ecosystem approach to environmental assessments would benefit from exploiting the potential for making wider use of ecological expertise in the risk assessment process and for international collaboration in ecosystem research. This potential should be systematically investigated and the results of the investigation, together with results of background studies already undertaken by government, published as soon as possible.

 

Recommendation 6. Improved information to support consumer choice

Government departments and agencies are making progress in improving the quality and quantity of information they make available about GM and other novel foods, but much remains to be done. A centralized consumer food information service is needed to provide information on all aspects of foods and food production, including relevant laws and regulations, research and development activities, current scientific knowledge, perspectives on ethical and social issues, and ways citizens can help develop policies. We also urge that information be developed that is tailored for use by specific groups, including health care professionals and other intermediaries such as nutritionists, teachers and the media.

Recommendation 7. Labelling

We note that the mandatory labelling of GM foods is already required for health and safety reasons. CBAC recommends that the federal government adopt a voluntary system for labelling GM foods for matters other than health and safety. The majority of CBAC members believe that Canada should begin with a voluntary labelling system for GM foods to allow time for testing the system’s adequacy and efficiency and to develop an accepted international standard; to provide consumers who wish to purchase GM-free products with the ability to identify them; to lim it costs; and to avoid trade action where a mandatory labelling scheme would contravene trade agreements. The dissenting member, is strongly in favour of proceeding directly to mandatory labelling, and notes that a majority of respondents to our Interim Report urged a mandatory system.

We emphasize that before any labelling system, whether voluntary or mandatory, can be introduced, an effective, agreed-upon standard is essential. The Canadian Council of Grocery Distributors and the Canadian General Standards Board are currently developing such a standard following extensive consultations. We recommend that once a Canadian standard has been developed and agreed upon, it be implemented via a voluntary system and that the system be widely communicated to the public. We recommend that it be evaluated in five years to determine whether it gives consumers sufficient choice concerning the foods they purchase and, if not, that alternatives, including mandatory labelling, be considered. Concurrently, the government should enhance its cooperative efforts with other countries to develop a harmonized approach to labelling, with special emphasis on the development of an internationally accepted standard.

Recommendation 8. Other social and ethical considerations related to GM foods

The government is called upon to consider the important social and ethical issues that are not explicitly taken into account in the regulatory approval system or in the development of policy on GM foods. These are complex matters involving principles of justice and beneficence (doing or producing good), respect for cultural diversity and traditional knowledge, religious convictions and beyond.

The principles of justice and beneficence require that due consideration be given to the distribution of harms and benefits within and between societies. With regard to the genetic modification of plants for food production, we must therefore be concerned about distributive justice, not only within Canada but also between developed and developing countries. Distributions of economic and technological power, of biological resources and the ability to exploit them, and of proprietary rights to traditional knowledge are issues that must be addressed through international cooperation.

We found that dialogue between those who support GM crops and foods and those against them is hindered by a lack of suitable tools to consider systematically, and evaluate on an ongoing basis, the social and ethical factors that influence public acceptability of a specific food or technology. We recommend that approaches and mechanisms be developed to facilitate dialogue on social and ethical issues, to support initiatives for clarifying the issues and options, and to develop suitable policies.

To this end, we are supporting an initiative involving an Exploratory Committee composed of members from industry and non-governmental organizations in developing a tool called the Acceptability Spectrum to facilitate dialogue on complex issues such as those raised by GM foods.

We conclude that no scientific evidence exists to suggest that GM plants and foods currently in the market pose any greater health or environmental risk than other foods. This does not mean that one should take these products or the underlying technology used to develop them lightly. There is a need not only to develop methods for long-term surveillance of health and environmental impacts, but also to ensure that regulatory processes are able to deal effectively with the more complex products on the horizon. The incorporation of ethical considerations into public policy on biotechnology in general, and on GM and other novel foods in particular, poses a continuing challenge for government and is an important topic in CBAC’s ongoing program of activities. We look forward to the government’s response to our findings and recommendations.

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Conclusion

This report marks the completion of our original project plan pertaining to the regulation of GM and other novel foods in Canada. However, we will continue to take an active interest in matters pertaining to GM foods, including developments in the areas of regulation, the monitoring of long-term health and environmental effects, labelling, and integration of social and ethical considerations into public policy discussions and decision making. We will report on these matters as the need arises. We will also:

·        meet with interested parties, both inside and outside government, to discuss and explain our recommendations concerning the regulation of GM and other novel foods

·        cooperate with federal agencies on their work programs to address our recommendations

·        continue to facilitate the Exploratory Committee’s work on the pilot project on the Acceptability Spectrum, including the refinement and testing of the tool, the methodologies for using it and examining its scope for application in wider consultation settings

·        undertake a watching brief on national and international matters pertaining to the regulation of GM foods

·        monitor public opinion research concerning GM foods

·        continue to sponsor research and background studies on specific topics pertaining to GM foods

·        report on important developments, including progress in the implementation of our recommendations

·        closely monitor developments in the labelling of GM foods and, in particular, should a voluntary labelling scheme be adopted, whether or not the scheme provides consumers with a reasonable range of choice in the foods they purchase.

GM foods will continue to evolve and take on new dimensions that offer both promise and possible risks. Our recommendations are designed to maximize the former and minimize the latter. We look forward to the government’s response to our findings and recommendations.

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Table of Contents

 

Executive Summary viii 

Recommendations xii 

Introduction 1  
Who We Are; History of the GM Foods Project; Structure of This Report

Ethical Context of CBAC’s Work 2

GM Foods: Science, Governance and Regulation 3  
The Science Behind GM Foods; Global Impact of GM Foods; Canada’s Approach to Regulating Novel Foods; Regulatory Structures and Processes; International Aspects of Regulation; Implications of Future Foods for the Regulatory System

Recent Developments in Public Policy 11  
National; International

The Debate about GM Foods 13  
Economic Issues; Environmental Impacts; Ethical and Social Considerations; Public Confidence in Regulatory Regimes

Observations and Recommendations 14

Theme 1: Good Governance  
Recommendation 1. Structure, organization and operation of the federal food regulatory system 14  
Recommendation 2. Transparency and public involvement 9

Theme 2: Precaution  
Recommendation 3. Precautionary elements 23  
Recommendation 4. Evaluation and monitoring of long- term health impacts 29  
Recommendation 5. Environmental stewardship 33

Theme 3: Information and Consumer Choice  
Recommendation 6. Improved information to support consumer choice 37  
Recommendation 7. Labelling 38

Theme 4: Social and Ethical Considerations  
Recommendation 8. Other social and ethical considerations related to GM foods 43

Conclusion 48

Annexes  
1. CBAC Publications, Commissioned Reports and Companion Documents 49  
2. Summary of the Written Input to the Interim Report 51  
3. The Future of Food Biotechnology 62  
4. Bibliography 69  
5. Policy Analysis Matrix — Labelling of GM Foods 71  
6. Facilitating a Policy Dialogue on Genetically Modified Foods and Feeds in Canada 73  
7. Letter to CBAC from the Exploratory Committee 91

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Web site: http://www.cbac-cccb.ca