Highlights of Saskatoon Roundtable on GM Food

Highlights Document
Workshop on Genetically Modified Food

Prepared by the Canadian Biotechnology Advisory Committee

April 4, 2001

Consultation Participants

Stakeholders

Robert Morgan – POS Pilot Plant Corp
Roy Button – Saskatchewan Canola Development Commission
Grant Isaac – Biotechnology Management – University of Saskatchewan
Myka Sinchuk – Biotech Alberta
Ed Palmer – Agricore
Graham Scoles – Head, Department of Plant Sciences – University of Saskatchewan
Michael Mehta –Department of Sociology – University of Saskatchewan
Bryan Harvey – Coordinator of Agricultural Research – University of Saskatchewan
Walter Yarish – Chairman, Agricultural Biotech Steering Committee – Alberta Agriculture, Food and Rural Development
Margaret Crowle – Consumer Association of Canada
Peter McCann – Ag-West Biotech Inc.
Lisa Jategaonkar – NRC-BPI
Wilf Keller – NRC-BPI
Jonathan Greuel – Saskatchewan Wheat Pool
Alan McHughen – Crop Development Centre – University of Saskatchewan
Doug Billet – Saskatchewan Agriculture and Food
Steve Meister – Aventis CropScience
Laurie Curry – Food and Consumer Products manufacturers of Canada
Deborah Straw – Dow AgroScience

Technical Resources
Louise Laferriere – Canadian Food Inspection Agency
Mireille Prud’homme – Health Canada

Canadian Biotechnology Advisory Committee
Suzanne Hendricks
Dr. Mary Alton Mackey
Dr. Peter Phillips

Canadian Biotechnology Secretariat
Roy Atkinson
Kelly Brannen
Suzanne Fortin

Media Relations
Carl Martin

Facilitation Team
Lyle Makosky
Jean Ogilvie
Elaine Gaudet
Jeff Moffett
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

Information related to field trials should continue to be made available to the public, however the location of field trials should remain confidential because of a risk of vandalism

Strive to obtain agreement from developers for the release of GM food data, as long as a reevaluation of what was confidential at the time of the decision is performed. There is a need to maintain a balance between what is confidential and what is released to the public.

Communicate product decisions immediately – as soon as they are made. Standardised information sharing strategies should be defined and adopted (e.g., internet, newspaper, TV, radio...) and the accessibility of this information should be promoted.

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

• Social optimisation – a new social contract taking into account multiple stakeholders, minimizes social friction and maximizes social cohesiveness, trust, stability, efficiency and accountability.

Theme B - Information Provision

Information provision and labelling

In addition to the challenges raised in the CBAC Consultation Document with respect to information and labeling, three key challenges were raised by the participants. Firstly, there are problems of enforceability with respect to labeling standards. They require testing methodologies that are not necessarily in place. In the absence of adequate testing methodologies, labelling could result in conveying false or misleading information to consumers. A second issue is that we really don't know enough about what the Canadian consumer is asking for. We need to conduct quantitative research, which includes qualitative aspects, i.e. market simulations, including looking at the cost-benefit trade-offs from the perspective of consumers.

A third key issue is the question of what is the optimal way of communicating information to consumers and the role/purpose of labelling. Would the labelling of GM foods be for reasons of health and safety or to enhance consumer choice? Two key ways forward were proposed with respect to information. There is a clear need for a central, authoritative, credible information resource. The value of this would be an added level of comfort for the consumer (whether or not they choose to use it; access needs to be provided). The information base should include information about the technology and its products, and about the regulatory process as a whole. (A model to look to which is working very well is Health Canada's Pest Management Regulatory Agency with its on-line access to information about specific products. A potential starting point could be Health Canada's Canadian Health Network.) One risk of this suggestion is that there are cost implications, and the timeliness and accessibility of the information would be critical. It is important to ensure that we don't create a bureaucratic "island". It was also suggested that this source of information should be harmonized with the U.S. system (where many Canadians now get information). The second way forward suggested with regard to information is to develop an integrated information strategy among all the players in the regulatory system and involving the Canadian public.

Some players now (such as Health Canada) do not participate in media interviews if they are considered a "debate". This prevents good information from getting to the public. With respect to labelling, in the domestic context, the group focused on the challenge that we have not yet defined the purpose of labelling, or determined what consumers really want. This is the first step. Next steps revolve around the question of whether labeling should be voluntary or mandatory. The preferred way forward was to participate actively in the development of international standards (including the CODEX work), and use this as a standard in Canada.

Canada could then add more detailed or rigorous standards, but they would have to be voluntary in order to avoid international trade sanctions.

While the suggestion is for voluntary, vs. mandatory labeling, there is an assumption that a voluntary standard will be universally adopted by industry, giving it an effect that may be considered to be the equivalent of mandatory labeling. The point was made that industry will not agree to labeling based on "the presence of" (e.g. GM material) as consumers immediately take this to be a warning about the food. A possible alternative is negative labeling such as "non-GM food". Whatever direction labeling takes, determining what consumers want, and acknowledging that there will be a cost factor, is important.

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

• Integrity – labelling aligned with overall integrity of system.
• Credibility – appropriate people, expertise available to system.
• Public participation (Informed public) – ability to make informed choices.
• Transparency – people understand the system is working in their best interest.
• Safety of food supply – consumer confidence through a strengthened regulatory system.
• Fairness – high quality low cost foods that are safe and accessible.

Theme - C Risk and Benefits Considerations

This section encompasses two subject areas and their real/perceived challenges:

• Environmental Stewardship
• Post-market monitoring

In this theme area, the way forward involved a series of activities. The following discussion outlines the “story line” that was followed in the group’s discussion, that is to say, the group discussed the risks and relative benefits of each activity.

Environmental stewardship

For reasons of public good and commercialisation of products, the knowledge base must be strengthened. The increased level of knowledge will benefit both industry and the public. Because both benefit, both should contribute to the funding of this research. In areas where fiscal restraint is an issue, Canada should build on an already existing international knowledge base, in addition to maintaining and developing knowledge that is unique to Canada.

An international approach to the risk assessment process is possible, however an international approach to risk management touches on issues of each nation’s autonomy and sovereignty. As a starting point, an international body could collaborate, with individual members providing either process expertise and/or commodity expertise.

The proposed Life Cycle Approach is theoretically sound, however potential costs raise issues of feasibility. A significant and practical challenge of this approach would be the definition of meaningful beginning and end points in order to confine a potentially infinite process. The approach could cause or create an insatiable need for assessment information. Requiring basic elements supplemented by additional voluntary components could be commercially viable.

The GM crop assessment process and issues are linked to the Life Cycle Approach. Requirements that raise costs could put small researchers/companies out of business, and could further drive industry consolidation.

Post-market monitoring of risks and benefits

Proposing additional post-market studies related to monitoring for risks and benefits assumes that the current pre-market assessment process isn’t sufficient. As well, in the current system, products are assessed on the basis of novel traits. Proposing post-market studies for GM foods seems to mean that we will start assessing on a GM product basis (on the basis of the manufacturing process). This approach would create trade barriers.

If products are deemed safe and/or approved, the purpose of detection methods seems unclear. However, it is certain that trade partners will require detection methods to meet their approval processes. Of course, the processes must be cost effective and reasonable so as to minimize negative impacts.

With respect to auditing for conditions imposed for reasons of safety, an internal audit process combined with third party audits can be effective. Nonetheless, reasonable audit levels and “special conditions” require better definition.

It is challenging to effectively monitor GM food consumption given that there is no traceability/labelling. A good starting point would be the monitoring of general consumption trends. Monitoring raises the issue of whether or not this is a good or even strategic investment.

Participants noted that requiring organisations to provide information on sales, usage, import or export of GM food for subsequent publication may not be relevant or practical. This type of data may be useful for market development, but may not necessarily be of general public interest. In some cases, this type of information may be considered proprietary and may raise additional administrative issues related to the collecting of the information.

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

• Equitability – Fair distribution of benefit and burden
• Accountability – Definition of objectives and responsibilities
• Knowledge – Collaboration/sharing within domestic and international scientific communities, to best use and integrate knowledge as well as to bridge the perception reality gap.
• Stability/Confidence – Balancing social responsiveness with reasonableness and sound thinking.
• Social benefits – Utilizing new technologies to benefit Canadians economically and with respect to health and well being.

Theme D - Regulatory System

Separation and independence of regulatory functions

The current separation is sufficient and the regulatory role is satisfactorily independent. There is, however, a need to communicate how the system works to enhance public confidence and overcome misperceptions or a lack of information related to the system. The possibility of creating a separate ministerial reporting structure would wrongly imply a problem and would be counterproductive. We should consider the role of a third party advisor like CBAC to monitor and advise on the independence of the regulatory functions.

Capability and capacity in the regulatory system

There is a need for greater capacity in the regulatory system to handle future demand, to retain confidence, and ensure there are not unacceptable delays. Outside expertise (both domestic and international) should be accessed to add capacity. The current range of regulations should be reviewed to determine whether they are still relevant and critical to safety and health, in order to provide a more effective regulatory system and reduce the burden of excessive regulations – all this in order to provide a more effective regulatory approval.

Ensuring safety during research and development activities

Currently existing guidelines for R&D are well fashioned and in use. We should establish the principle that regulatory oversight should match the organism’s level of risk. Thus, the R&D guidelines on products at risk could be refocused to match the level of risk. This raises the question of equivalent regulatory oversight of non-genetic research practices in plants. As a starting point, there is a need to define the process (principles, products affected...) and identify either the solution or a need for new guidelines.

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

• Science based – based on sound accepted scientific principles and identified risk, and not incorporating social and ethical considerations.
• Transparent – the regulatory process and results are open, accessible and understandable.
• Product based – hazards and risks are associated with things not histories (i.e., final product and not how it was made).
• Verifiable – reproducible, consistent, non-arbitrary, with 3rd party oversight that reaches the same conclusions.
• Workable – regulatory process that produces a result and decision without undue time delay and is accessible to smaller companies and institutions.

Theme E - Social and Ethical Considerations

Group A

Challenges

• Separate social and ethical issues into separate categories, as the current regulatory system cannot deal with ethical considerations. However, provisions are required for ethical considerations (e.g. do not certify GMF as organic).
• Educating the public on the product/process distinction.
• Accessing information is very difficult and ineffective.
• Creating the mechanism to cover competing opinions.
• Dealing domestically with public perceptions in other countries.

Potential Ways Ahead

• The current framework needs to include the impact that would result from not approving a product, delaying its approval or fast tracking its approval. It would be useful to have a framework or checklist against which to measure/consider product, so that its social acceptability can be ascertained before research and financial resources are invested.
• A totally separate entity could be created at arms length from current science-based regulatory bodies. This entity would be multi-stakeholder, well funded, autonomous and accountable.
• Passing the safety assessment for products is not enough. A mechanism should be developed for assessing social considerations these products may have, and should be performed on a case by case basis.
• The framework should include two levels of social impact assessment. The first would be a voluntary assessment, conducted by industry. The second assessment would take place immediately following the safety assessment. The framework needs to clarify distinctions among consumers, producers, and other stakeholders, and regional differences.

Group B

Challenges

• We have the tendency to focus more on the risks in GM foods (e.g. Royal Society report) than the benefits. This could result in keeping beneficial products off the market.

Potential Ways Ahead

• Social ethical considerations should not be included in regulations (a science based system should not and can not be based on socio-ethical considerations). However, the regulatory framework should be supported by a policy framework that does consider social and ethical dimensions.
• One of the key themes discussed was related to the preparedness of the Canadian public to understand and make choices about biotechnology. A lot of work needs to be done in training our professionals (dieticians, physicians, etc.).
• In terms of an appropriate forum for handling social and ethical issues, the recommendation was made that there should be more science expertise in policy positions in government, balancing the current preponderance towards economic (and other types of) expertise. The Health Minister Alan Roch’s Advisory Board may also be a viable example of a forum in which social and ethical aspects of biotechnology can be worked out.
• There is a “scale of concerns” that we can identify. Of low concern seem to be plant to plant initiatives. Of greater concern are transgenic initiatives from animal to plant, and of greatest concern is anything involving human genes. The suggestion is that as our knowledge increases with respect to plant to plant applications, our comfort level may grow in other areas.
• Suggestions for next steps in public consultations include focusing on the opinion leaders – Dieticians of Canada, Consumer Association, College of Physicians and Surgeons, MLA’s.

Group C

Overview discussion

• Social and ethical issues are not unique to the GM food issue. Although, a transformative technology is new and unique; society can expect more of this type of social and ethical debate.
• Ideally, the social and ethical debate would be engaged early in the process. This did not occur with GM foods.
• Although some social and ethical issues are currently considered within the regulatory process, broader ethical and social issues should not be considered as part of the regulatory process. Broader social and ethical issues should be dealt with at “arms length”, not by the scientific community.

After a discussion regarding the complexity of the social and ethical question as it relates to GM foods, CBAC introduced a framework to facilitate and organise a discussion of important issues regarding the acceptability or non-acceptability of GM food.

In 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 (that could be developed) and placed in an appropriate location on the spectrum. Products could move on the spectrum as more is known/validated or threshold standards are met.

Reactions to the GMF Acceptability/Non-Acceptability Spectrum Framework

• Three categories of criteria may be required: science, non-science (social and ethical), broad social/ethical or societal.
• This framework will be necessary to deal with future technologies.
• Defining positions on the spectrum (e.g., acceptable, somewhat acceptable, etc.) will be challenging.
• The use of the word moratorium should not be so politically incorrect that it cannot be used. Differences between stakeholders will not be so irreconcilable.
• The process should not be technology-centred.
• The process will deal with communications issues and open up the unfocused dialogue that is raging within the current context.
• The new framework should engage both stakeholder groups and the public.
• Non-participation will affect stakeholder credibility.
• Criteria will need to be defined before creating a new body that deals with these social/ethical issues.
• Once the framework is defined, who would be involved and who will manage the process?

Group D

Challenges

• Social and ethical issues should not have a place in the current scientifically based regulatory system.
• How do you differentiate between GM foods and other research and products that derive from scientific processes and may result in mutated or altered products?
• What is the standard for acceptability of a food product (e.g., as safe as an organically grown product?).
• “Identity preservation” will likely become a dominant requirement of the future.
• The key question is the safety of food. This question needs to be addressed first and foremost by the regulatory process.
• The social and ethical questions regarding GM foods may be less of a concern to the public.
• As social and ethical questions grow in prevalence and increase in the consciousness of the public, the debate will reach a point where policy makers may respond by adopting a policy stance (e.g. if they do not have a tangible framework to work with).

Potential way ahead

• Social/ethical considerations must be kept separate from the regulatory process. Not maintaining them separate may generate never-ending debates.
• Determine the relative impacts of social and ethical considerations, and whether our society is prepared to accept the various types of products.
• Before granting a product final approval, provide the public an opportunity to take an in depth look and comment on the results in a public response period.
• CBAC needs to focus on the tangible issues of health and safety and be the guardian of the public good.

Reactions to the GMF Acceptability/Non-Acceptability Spectrum Framework

The spectrum concept referred to in Group C (above) was also presented and reviewed in Group D.

Likes (aspects the group found attractive)

• Useful construct to consider.
• Provides a vocabulary to talk about GM foods “acceptability”.
• Could be helpful if it was advisory (but should not be used as a gate in the regulatory chain).
• Could bring divergent views to the table to pursue these questions.

Dislikes/Concerns (aspects the group was concerned about)

• The category “acceptable with conditions” will potentially raise questions with the public who will be concerned that the product is not completely safe, given the presence of the word “conditions”. Also raises questions about who monitors the conditions, who is liable, etc.
• Should this not also apply to the acceptability of non-GM foods/products, and where does this lead to?
• It may only address a small set of the social and ethical questions.

Summary of key values

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

For shaping the regulatory system

Top five:

• Science based
• Product based
• Transparent
• Social optimisation
• Workable

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

• Accountable
• Verifiable
• Justice
• Autonomy
• Respect for diversity
• Knowledge

For shaping policy choices

Top five:

• Safety of food
• Informed public
• Equitability
• Societal benefits
• Integrity (tied)
• Knowledge (tied)

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

• Stability/confidence
• Accountability
• Transparency
• Knowledge
• Credibility
• Justice
• Autonomy
• Respect for diversity
• Caution

Closing ideas and guidance to CBAC

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

General

• Continue with public workshops as they provide good opportunities for discussion.
• CBAC needs to focus predominantly on food health and safety related issues.
• CBAC has to increase its visibility.
• NGOs seem to be detaching themselves from CBAC. As a result, CBAC needs to increase its efforts to encourage their involvement.
• Analyse what you currently have in place in terms of regulations. Once the analysis is completed, look at what regulations are still relevant/appropriate and eliminate or modify inappropriate ones.

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.