Highlights of Halifax Roundtable on GM Food

Highlights Document
Workshop on Genetically Modified Food

Prepared by the Canadian Biotechnology Advisory Committee

April 9, 2001

Consultation Participants

Stakeholders

Theresa Glanville – Mount Saint Vincent University
Bruce Gray – NS Agricultural College
Margaret Miller – Bio-East
Shirlyn Coleman – NB Department of Agriculture, Fisheries and Aquaculture
Laurie Curry – Food and Consumer Products Manufacturers (a.m. only)
Danny Hendricken – National Farmers Union
Todd Dupuis – Atlantic Salmon Federation
Etienne Dako – University of Moncton
Garth Fletcher – Ocean Science Centre
Eugene Tan – Copper McDonald
David Sangster – NS Department of Agriculture
Jeanne Cruikshank – Canadian Council of Grocery Distributors
Geordie Ouchterlony – NS Organic Growers Association
Della Erith – NS Food Growers Association
Marian MacKinnon, Professor, School of Nursing at UPEI
Judith Fraser Arsenault – Mount Saint Vincent University

Technical Resources
Karen McIntyre – Health Canada
Stephen Yarrow – CFIA

Canadian Biotechnology Advisory Committee
Françoise Baylis

Art Hanson
Suzanne Hendricks
Peter Phillips

Canadian Biotechnology Secretariat
Kelly Brannen
Suzanne Fortin

Media Relations
Carl Martin

Facilitation Team
Lyle Makosky
Jean Ogilvie
Elaine Gaudet
Yvon Gauvreau
Sebastien Malherbe

Stakeholder Workshop Objectives

The current series of stakeholder workshops on Genetically Modified (GM) food has two main objectives:

• To enable stakeholders to explain positions and rationale on key issues, propose and respond to promising policy directions, and describe benefits and consequences of preferred directions.
• To enable stakeholders to identify trade-offs in policy options and values or principles that could underpin decision making.

Themes/Issue Areas

In order to effectively address the various themes and issues and identify and discuss potential ways ahead, stakeholders were divided into four break-out groups. Each group was invited to focus on one theme (i.e., theme A, B, C or D) during the first break-out group session. Theme E was discussed by each group during a second set of break-out groups. Each discussion group was created using a “stakeholder mix” approach, meaning each group ought to have a mix of the perspectives represented (e.g., NGO/Consumer Group, Government, Industry, Academia and Health Industry).

Theme A: Good Governance

• Transparency
• Opportunities for public involvement

Theme B: Information provision

• Information provision to support informed choice
• Labelling

Theme C: Risk and Benefit Considerations

• Environmental stewardship
• Post-market monitoring for risks and benefits

Theme D: Regulatory System

• Separation and independences of regulatory functions
• Capability and capacity in the regulatory system
• Ensuring safety during research and development activities

Theme E: Social and Ethical Considerations

• Broader social and ethical considerations

For background information on these issues, please refer to the consultation document entitled “Regulation of Genetically Modified Food” available on the CBAC web site at www.cbaccccb. ca. For each of these themes and issues, the text below summarizes the preferences and other views expressed by participants in the session. The information should not be considered to represent consensus positions of the participants.

Theme A - Good Governance

Transparency and opportunities for public involvement

The group discussing Theme A agreed on the need for factual and accurate product information being communicated/released (made public) ahead of time – before a product is approved by regulators. The information disseminators (although these were not yet identified) should be held accountable for the accuracy of the information and encouraged to use it for educational purposes. Releasing the information ahead of time allows for public dialogue and feed-back as well as time for independent assessment. It should be holistic and should include information on social, ethical, economic and scientific impacts.

Two possibilities are being put forward for the release of product information for products submitted for regulatory review. The first is to release all information as it becomes available. The second possibility involves two stages: releasing information on the application for approval along with the reasons for product development at the time of submission, and releasing the remainder of the information at the time the decision is made.

Possible implications of the group’s proposed new process

• Potentially time consuming.
• Enables a better understanding of the regulatory process.
• Provides for informed choice on the part of the public.
• Demonstrates democracy.
• Could be a disincentive/hindrance for small companies.
• A major risk associated with releasing product information too early in the regulatory process is that it may change; this may affect the accuracy of the product information that is in the public domain.

The underlying values which could assist in developing policy in this area are as follows:

• Autonomy – commitment to pursue informed choice and promote the required conditions to allow Canadians to pursue their fundamental values and interests.
• Knowledge – understanding the information and its implications and ramifications.
• Accountability – whoever makes the decisions based on factual information needs to be able to justify them.
• Respect for diversity – be creative and innovative when it comes to GM foods.
• Beneficence – show the benefits associated with GM foods and not just the risks; show these from a regional, national and international perspective.

Theme B - Information Provision

Additional Challenges

As well as the challenges identified in the CBAC consultation document, the group noted that the environment is very fast moving – British Columbia is tabling legislation with regard to mandatory labelling and there is a private members bill on mandatory labelling in the federal system. The group also identified as challenges the huge volume of information to sift through, and the lack of clarity around what consumers really want to know with respect to GM foods.

Labelling

Canada has to be part of the international process with regard to labelling, and have the credibility to take a lead in such a process.

With respect to domestic approaches to labelling, there are two possible paths. Labelling of GM foods could be based on the current system – labelling with regard to the risk of the product for consumers. Or, it could take a relatively new direction and label for the process that went into the production of the food (similar to organic food labelling). There was a preference expressed for the latter model on the grounds that it enabled consumers to make food choices based on ethical considerations of GM food processes. The recognized consequence of this choice was that it could entail increased costs to consumers. A study done in Australia and cited in B.C. has shown that the increase to consumers may be around 0.1%, which was considered an acceptable trade-off for labelling.

If the labelling system were voluntary, it would probably develop like organic foods – companies would elect product differentiation to sell into niche markets (“Guaranteed GM-free”). The problem here is that it would still not be promoting consumer choice, since the majority of foods would go unlabelled. On the other hand, there was agreement that given a lack of certainty around what consumers want to know, it was premature to think about a mandatory system of labelling. (What would go in the label?) There were also concerns about overall price increases on the part of producers and distributors as well as consumers. The key value around labelling has to be to protect and enable consumer choice.

Information

There is a pressing need to have a consolidated information base on GM foods available to interested parties, one that includes information from all sources – government, industry, research etc. The ideal model would be an agency at arms-length from government, one designed to ensure the neutrality of information, but there is a question around who would pay. The next best option would be to house it with Health Canada, where credibility around matters of biotechnology is seen by the group to be high. Another option may be Consumer Affairs, or advice could be sought from consumer groups about where to locate such a resource.

There is also a pressing need for expanded opportunities for members of the public to engage in conversations around GM foods as a way of becoming better informed, and able to make better food choices and provide better direction to government. According to Group A, a key reason why this hasn’t happened is that neither government nor industry has dedicated resources to play this information provision role. Informing the consumer has been an afterthought, and there is now a need to play catch-up. The key source of information for consumers had been the media and this is not enough. CBAC as a model for engaging public dialogue is a good one in its focus on informing a wider public, and in its selection of a balanced group of members, but its influence is limited.

The underlying values which could assist in developing policy in this area are as follows:

• Informed choice – provide product content to enable the consumer to decide whether or not to acquire it.
• Long-term safety – both related to human health as well as the environment.
• Trust in government – the government needs resources in order to either live up to and/or redevelop the public’s trust.
• Safe cheap food - food that is affordable and accessible to all.
• Fariness/level playing field – don’t single out GM foods.

Theme C - Risk and Benefits Considerations

Environmental stewardship

The current knowledge base related to GM food needs to be strengthened through additional research. Currently the vast majority of research being done is funded by industry. In order to create some balance in GM food research, there is a need for additional government-led GM food research, in part because of the responsibility government carries to ensure the safety of food available to Canadians.

The group was not completely clear about the applicability of the life cycle approach to GM food. It was perceived as an interesting alternative approach since it considers potential impacts from a broader perspective, and as a result these impacts are considered more thoroughly.

The regulatory process cannot work in a vacuum, as it needs to consider and include what is happening internationally. We need to ensure assessments are both strong and thorough since they are needed in order to make appropriate decisions. These assessments need to include more comprehensive indicators (e.g. of potential impacts of GM foods) and attach some clear liability and accountability to the regulatory process.

With the potential threats GM foods pose to the environment, more resources need to be llocated to long-term environmental studies in order to evaluate these potential impacts.

Related concerns:

• Currently the public does not trust either industry (because of a potential bias) or government research (because government is perceived as making decisions based on industry pressure).
• The life cycle approach is perceived as potentially slowing down the assessment process.
• The assessment may identify key safety information too late in the process.
• Even though Canada needs to consider what is happening internationally, it must maintain its independence regarding food safety.
• Participants were unsure whether the technology currently exists to adequately evaluate/predict the potential environmental impacts of GM foods.

Post-market monitoring of risks and benefits

In general there is a requirement for new detection methods for novel traits or genetic material in GM products. It is important to ensure detection of GM characteristics (in particular) in processed food, in order to allow freedom of choice by the consumer. The crucial need for appropriate labelling is reinforced by the lack of adequate/accurate detection methods.

The use of special audits was recognized as a way to verify the efficiency of “special conditions” being imposed on industry by the regulators, as a condition of approval. Additionally it raises public confidence in the regulatory system.

Currently there is no clear or accurate way to assess the consumption rate of GM foods in Canada. Developing an estimate will require a creative approach. Additionally, there is a need to track and publish annual GM food data (e.g., usage, sales, export), as this information is necessary to clearly identify and understand the potential ramifications of GM foods. This data would also contribute to increased public confidence in the Canadian food system and avoid potential backlashes.

Canada should spend/invest whatever resources are required in order to address the following:

• It may be very difficult to detect genetic material in GM products as it implies testing, monitoring and other follow-up mechanisms.
• With regards to “special audits”, who should pay for them?
• It may be very difficult to track consumption of GM foods especially in the case of processed foods. At best it may only be possible to get rough estimates.
• Who will be responsible for the tracking and publication of the annual GM food data? As well, who will be tasked with funding of this initiative?

The underlying values which could assist in developing policy in this area are as follows:

• Sustainability – consider long-term social, economic and environmental impacts.
• Objectivity – look at the whole picture; balance the perspectives, both positive and negative.
• Diversity – maintain biodiversity, economic diversity and choice diversity.
• Nature ethics – work with and not against nature.
• Safety – be very careful in regard to potential health implications.
• Balance – balance competing needs.

Theme D - Regulatory System

Separation and independence of regulatory functions

There needs to be a clear separation of the regulatory and promotional functions within the federal system. While there appears to be reasonable separation at this time, there is a need for additional public information regarding the regulatory process, including how it works and the effectiveness and rigour of the separation. To ensure confidence and trust, the government also needs to demonstrate that its regulatory process does not accept all GMF submissions, but is rigorous enough to reject a demonstrable number on health and safety grounds. The government also needs to demonstrate that there is sufficient publicly funded research to ensure objectivity and independent analysis of risks. We should also emphasize public research geared towards alternatives i.e., organic farming.

Related concerns:

• Canadian food export markets could be compromised by importing countries that do not accept GM foods and hence reject Canadian products that are perceived to mix GM and non-GM food.
• Any public advertising should separate the promotional and regulatory sponsor/agency.
• There is a concern that industry funded research is setting the agenda and limiting the ability to conduct objective research on risks and impacts.
• There is a perception that every product submitted is accepted and given approval by the regulatory bodies. There is a need to demonstrate/communicate the rigours of the regulatory process as well as to provide the public with information related to rejected products.

Capability and capacity in the regulatory system

The scientific and technical capacity of the regulatory system may currently be sufficient, however further development will likely be required as a result of greater and more complex demands expected in the near future. Canada should also pursue a shared regulatory agenda with other countries to allow each to focus on areas of regulatory competency using common standards (without it reducing or effecting Canadian standards), thereby improving our combined capacity. In addition we should draw upon domestic and external capacity (e.g., draw upon certified laboratories and outside peer reviews).

Related concerns:

• We are unsure if universities will educate/graduate a balance of both applied and theoretical research experts, given industry pressure for applied vocations. With fewer graduates with areas of pure research, the regulatory system will have fewer candidates to draw upon in filling future human resources needs.
• A rigorous comparison of the U.S. and Canadian systems should be undertaken before pursuing either harmonization of the current regulatory system or the development of a joint regulatory system.

Ensuring safety during research and development activities

There is a need to develop guidelines and standards covering research and development activities (prior to the regulatory review of products) and to find a way to incorporate them in the regulatory system, although not necessarily within the regulations themselves (except in the case of special risks), and to develop a program for monitoring performance against these standards/guidelines.

Related concerns:

• Requires the maintenance of an audit trail both by the researcher and those monitoring

The underlying values which could assist in developing policy in this area are as follows:

• Science based – a world class, highly skilled, science based regulatory regime that is objective, non-biased, independent and uses research as the methodology for product review.
• Transparent – a regulatory system that is open, accessible and that communicates how the process works as well as the resulting decisions.
• Focus on health, safety, and environmental sustainability – a concern/focus on health and safety of food and an emphasis on a safe and sustainable environment.
• International compatibility – collaborate with other countries to advance harmonization and common standards, without compromising acceptable standards for health and safety.
• Ethical – a regulatory policy environment that incorporates ethical considerations/conduct/people, that is based in part on the principle of a moral obligation not to do harm, and to be held accountable for that principle.

Theme E - Social and Ethical Considerations

During the afternoon break-out sessions participants began by discussing broader social and ethical questions as they relate to GM foods. Following this, the groups were asked to react, discuss and provide feedback on an acceptability/non-acceptability spectrum framework that has been introduced and that has evolved over the course of the stakeholder workshops on GM food. Under this framework, GM products would be analysed and placed on a spectrum ranging from acceptable to unacceptable (i.e. banned). GM products would be characterised either as: acceptable; acceptable with conditions; unacceptable at the present time (i.e. moratorium - unacceptable until more is known or a given standard is met); or, not acceptable under any circumstances. Products or groups/classes of products could be analysed against criteria and placed in an appropriate location on the spectrum. Consideration could be given to health and environmental safety, social issues, ethical issues and broader societal implications. Products could move from one category to another when more is known/validated or threshold standards are met. The approach would be developed outside of the existing regulatory process – which is science and risk based. The various possible mechanisms for implementing this framework would need to be explored, including the relationship and complementarity of this activity with the regulatory system and with the broader governance structure.

Group A

Challenges

• Making policy/regulatory processes generic to all current and future GM foods.
• Limited knowledge on the part of some producers who see GMOs coming but cannot predict the market. As a result, they are fearful and continue with their current practices.
• Unclear consumer demand in terms of: variety, quality, safety and enhanced nutrition of food.
• The intellectual, philosophical and emotional ability and capacity to deal with ethical considerations.
• Finding one clear ethical definition of Canadian society composed of diverse culture, habits, sports, preferences, religions, diets etc.
• Determining the value associated with the use of a product.

Potential Ways Ahead

• Parliament should determine ethical guidelines for regulators to work with.
• An acceptability/moratorium spectrum may be a component of the guidelines.
• In considering an acceptability/moratorium spectrum the following should be taken into account:
  • The value given to the use of a product
  • The weight given to each category within the spectrum
  • Applying the framework requires a body of persons with expertise in each of the dimensions (ethical, social, health, safety, environmental and corporate).
  • It also requires ethical guidelines set by parliament
  • Two options: the spectrum is guided by a government decision-making body and implemented before proponents invest too much; or, an advisory body guides the application of the policy which is implemented by government departments.

Group B

Challenges

In addition to the challenges raised in CBAC’s consultation document, the break-out group identified some additional ones. Traditionally, research has been funded by government.

Increasingly, industry is taking the lead in research, with the resulting questions – who is setting the research agenda, and for what purposes. Another major challenge is that we are short on trained ethicists with a background in biotechnology, and on biotechnology scientists with some training in ethics.

The group noted that we have not always been successful in getting the right people to the table to talk about these issues (note the boycott of the CBAC process by some environmental groups).

Potential Ways Ahead

The group felt that the regulatory system should be maintained as a process based on scientific principles. Social and ethical concerns are so divergent that considering them in a regulatory framework would create “chaos”.

Social and ethical considerations should be worked out in the policy/political arena and should provide broad guidelines to a regulatory framework.

Like the subject of abortion, this discussion is going to be multi-dimensional, engaging the media, Parliament, public consultation, and the courts. A concern with respect to public consultation is whether the public is informed enough to contribute substantively to the discussion at this time. If we ground our approach to public consultation in a process of public education, we could look forward to more informed public engagement. A suggestion with respect to public education is that we begin this in the schools with ethical considerations as part of the science curriculum.

Another way forward in terms of supporting social and ethical considerations is the possibility of creating an ethical review process that has more teeth (the current process based on the Tricouncil approach doesn’t really have the ability to impact on industry research, since it is only a guideline and the only sanction is removing public funding). The suggestion was made that government should undertake an ethical review as a condition of granting a patent. Also, this ethical review process should extend to plant research, the argument being that since humans ingest foods, we need to know what the long-term repercussions are on our bodies and the environment.

The group also recommended opening up a process to invite public input into official review processes in order to express opinions around whether novel foods should be approved or not (similar to the U.S. system)

In reviewing the spectrum framework as a tool for engaging discussion around GM foods, there were mixed reactions among participants. Some were unclear on how and with whom it could be used, and what would happen to the results. Others felt that it was useful in allowing people to place themselves along the spectrum, and that it could be used in a number of ways, including getting public input into specific products or processes.

Group C

Challenges (general)

• There is a lack of public involvement in this debate and the public has a very limited understanding of the GM issues.
• The general trend is an “end of the tap” approach; meaning that we focus on finding solutions to address problems instead of considering the overall system.
• Complexity of the GM issues and technical language.

Possible Ways Forward

• Social and ethical issues must be considered but they do not have to be an integral part of the regulatory framework (e.g. product-by product risk based decisions).
• Special attention should be put on creating a reliable source of unbiased and sound information (similar to the Food Biotech Communication Network) in order to help address the current lack of education.
• Explore the applicability of a model similar to the Canadian environmental assessment process which includes social and economic impacts as well as elements of public participation.

Reactions to the GMF Acceptability/Non-acceptability Spectrum Framework

• Overall the group found the proposed framework concept appealing. It provides more options and alternatives. It serves as an educational mechanism for the proponents. It would allow and encourage public debates regarding social acceptability of GM food products.

Group D

Challenges

The group felt that social and ethical considerations should be considered within the regulatory policy environment but should not be a part of the current scientifically based product review process at this time. To develop a social and ethical framework requires that we define and understand the aspects that should be incorporated within the term “social”. A starting point could be to look at food from two perspectives and to outline the social considerations for each as follows:

• Food as societal necessity (“grow to live”):
  • The meaning of food in our society
  • The effect on the quality of life for both consumer and animal
  • The effects on agriculture.
  • The source, integrity and knowledge of the food source and production path.
  • Sustainability of communities.
  • Freedom of choice for consumers.
  • Values and objectives for food as a necessity and life sustaining element.
  
  
  
• Food as a produced commodity (“live to grow”):
  • The effects on agribusiness.
  • Environmental impacts.
  • Sustainability of industry.
  • Freedom of choice for producers and farmers.
  • Transfer of technology e.g., IP rights.
  • Opportunities for employment and education in the food sector.
  • Values/objectives for food as a commodity.
  • Impact on trading practices of other nations (the dependencies created both with external sources and within own communities).
  • Value/economic benefits of food in our economy.

Potential Ways Ahead

• Hold broad consultations with the public and stakeholders to develop inputs into the framework (multiple sectors, multiple age groups).
• Develop and apply a mechanism (e.g., national group of Canadians with a range of age profiles) to design a social and ethical framework based on the public dialogue.
• Take the framework to parliament for collective direction.

Reactions to the GMF Acceptability Spectrum

General

• There is still a need to articulate why GM foods should or should not be pursued in our society i.e., the rationale and benefits need to be articulated as well as risks and benefits.
• Some are still concerned about the need to look at alternative forms of food development.
• The spectrum should incorporate both risks and benefits.

Likes

• Helpful and worth pursuing.
• Useful vocabulary and starting point.
• Good tool for discussion.

Dislikes

• Will be very difficult to create.
• Hard to find an objective group with the time to give input and develop this.

Other questions

• Can this spectrum incorporate the vulnerabilities of the technology and the concern for irreversibility of impacts?
• How do we incorporate other practices with the same/similar benefits?

Summary of key values

Participants discussed values and principles related to governance and the regulatory system. The following were raised and most widely supported:

Values for shaping the regulatory system

Top five:

• Transparent
• Science based
• Accountability
• Autonomy
• Focus on health safety and environmental sustainability

Other values discussed in groups and supported by some, but not selected as most important include:

• Beneficence
• International compatibility
• Knowledge
• Ethical
• Caution
• Justice

Values for shaping policy choices

Top six:

• Sustainability
• Objectivity
• Fairness/Level playing field
• Safety (tied)
• Informed choice (tied)
• Long term safety (tied)

Other values discussed in groups and supported by some, but not selected as most important include:

• Diversity
• Beneficence
• Trust in government
• Justice
• Autonomy
• Caution
• Safe cheap food
• Nature ethics
• Balance
• Knowledge

Closing ideas and guidance to CBAC

This section outlines the final three or four suggestions made by participants as final thoughts/advice for future consideration by CBAC. These suggestions should not be considered to be consensus views of any of the groups.

Consultation

• Need to find a way to consult and/or incorporate the viewpoints of non-governmental organizations who boycotted the current process. Additionally, try to understand their underlying issues, why they boycotted, and what to do in order to overcome these issues.
• Include the entire country in the consultation process. Move to a provincial consultation.
• Ensure you have comprehensive contact lists and communicate with potential participants ahead of time.
• Provide all Canadians with an opportunity to be heard e.g., hearings, written/oral submissions.
• Find out if Canadians in fact want to pursue the GM foods agenda.
• Educate the public through the use of 90 second slots on TV, schools.

General

• Find acceptable ways to consider social and ethical issues apart from the regulatory framework.
• Use a precautionary approach with respect to human health and the environment.
• Re-evaluate why we are producing GM foods. Is it simply because we can? Is it because this is what producers or consumers want?
• Inform the public about the regulatory process.
• There is a need for short and long-term government-conducted scientific studies/research (independent testing).
• Make sure to insist that appropriate resources be dedicated to education and public information.
• Keep the process transparent and educate the public.
• Stop moving forward with GM foods and return to the natural way of producing food.

Please note that similar reports from each of the five CBAC stakeholder workshops on The Regulation of GM Foods, conducted across Canada from April 2nd to April 10th 2001, will be posted on the CBAC web site. As well, results from all five workshops will be integrated into a single roll-up report that will also be available on the CBAC web site by the end of the month.

Please visit the CBAC web site at www.cbac-cccb.ca or call the CBAC toll-free number at 1-866-748-2222 for additional information or documentation related to this or other CBAC projects.