Annotated Bibliography Entry

Reference: Canada Royal Society Report 2001
Title: Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada
Authors: Expert Panel on the Future of Food Biotechnology, The Royal Society of Canada
Publisher: The Royal Society of Canada, 283 Sparks Street, Ottawa, Ontario, K1R 7X9, Canada
Publication details: January 2001. 245p

Summary
Recommendations
          Concerning Underlying Policies & Principles Guiding Regulation of Agricultural Biotechnology
          Concerning Regulations and Guidelines
         Concerning the Regulatory Process
         Concerning Scientific Capacity for the Regulation of Food Biotechnology
Table of Contents 

 

Back to Canada Page

 

Summary

This Report is a response to a request to the Royal Society of Canada from Health Canada, the Canadian Food Inspection Agency and Environment Canada that an Expert Panel be assembled to provide advice on a series of questions related to the safety of new food products being developed through the use of new genetic engineering technologies. The Terms of Reference asked the Panel “to provide Health Canada, the Canadian Food Inspection Agency and Environment Canada with advice on our regulatory system and the scientific capacity that the federal government requires into the 21st century to ensure the safety of new food products being developed through biotechnology”. The Panel was specifically charged to address the following issues:

To forecast:

·  The types of food products being developed through biotechnology that could be submitted for regulatory safety reviews by Health Canada and/or the Canadian Food Inspection Agency over the next 10 years;

·  The science likely to be used to develop these products; and

·  Any potential short- or long-term risks to human health, animal health and the environment due to the development, production or use of foods derived from biotechnology.

To assess approaches and methodologies developed in Canada and internationally to evaluate the safety of foods being developed through biotechnology, including those being developed by the World Health Organization, the Food and Agricultural Organization and the Codex Alimentarius Commission.

To identify:

·  The scientific capacity that will be needed to ensure the safety of new foods derived from biotechnology, including human resources for research, laboratory testing, safety evaluation, and monitoring and enforcement; and

·  Any new policies, guidelines and regulations related to science that may be required for protecting human health, animal health and environmental health.

This Report addresses these issues in the following way.

Chapter 1 clarifies the Panel’s interpretation of its mandate and the Terms of Reference. It attempts to delineate clearly the range of scientific and non-scientific issues that fall within its mandate, those that fall clearly outside it, and those related issues that need to be addressed to provide comprehensive answers to the questions posed by the mandate. Chapter 1 also summarizes the process by which the Panel produced the Report.

Chapter 2 responds to the mandate to forecast the future directions in the development of agricultural biotechnology. It does so by summarizing the scientific developments that have led to the current status of application of the technology. It identifies the social and scientific dynamics driving its current development, and points to technological developments that are likely to bring new applications of biotechnology. Many of the themes summarized in Chapter 2 are developed in greater detail in subsequent chapters dealing with specific health and environmental risks.

Chapter 3 summarizes the system currently in place for the regulation of agricultural biotechnology in Canada. The chapter recommends implementation of an independent process for auditing of the scientific and ethical aspects of regulatory decision making.

Chapter 4 is the first of three chapters that conduct the scientific identification of the short- and long-term risks the Panel found to be most important for regulatory concern in Canada. It focuses on the direct risks to human health posed by genetically modified (GM) food. Part 1 of Chapter 4 considers the specific problems related to the use of the classical risk assessment methodologies for the assessment of toxicological risks from GM foods, especially the assessment of the safety of whole foods. Part 2 focuses on the critical issues related to the identification of potential allergens in GM foods, and makes recommendations for strengthening the scientific capacity for identifying and assessing the allergenicity of new or unexpected proteins in GM foods. Part 3 points to the need to consider the impacts of genetic engineering modifications on the nutritional value of the resulting food.

Chapter 5 considers the potential direct impacts of genetic engineering upon the health and welfare of agricultural animals, as well as the indirect impacts upon wild animals. Part 1 identifies the risks associated with the genetic modification of fish and farm animals themselves, while Part 2 focuses upon the risks associated with GM feeds, feed additives and metabolic modifiers administered to food-producing animals. Chapter 5 makes a variety of recommendations for the more rigorous assessment of the impacts upon animal health and welfare, genetic diversity and sustainability, as well as upon human consumers of GM animals and animal products.

Chapter 6 identifies what the Panel considered to be the most significant potential risks to various aspects of the natural environment posed by agricultural biotechnology. The chapter is divided into four parts, each dealing with the impacts of potential gene flow upon different sectors of the natural environment — microorganisms and soil microflora, wild and non-GM plants, target and non-target insects, and wild fish. Recommendations following each of these sections identify a series of more refined environmental assessments that need to be added to the Canadian regulatory process to protect more adequately important environmental values.

Chapter 7 introduces a series of three final chapters that deal with critical methodological approaches and assumptions underlying current and proposed regulatory practices in the area of agricultural biotechnology. Chapter 7 is an in-depth analysis and critique of one of the most controversial concepts invoked in both national and international regulatory contexts — that of “substantial equivalence”. The Panel finds the use of “substantial equivalence” as a decision threshold tool to exempt GM agricultural products from rigorous scientific assessment to be scientifically unjustifiable and inconsistent with precautionary regulation of the technology. The Panel recommends a four-stage diagnostic assessment of transgenic crops and foods that would replace current regulatory reliance upon “substantial equivalence” as a decision threshold.

Chapter 8 focuses upon the current debate over the validity and relevance of the “precautionary principle” in the regulation of agricultural biotechnologies. Many national and international regulatory bodies (including Canada) have adopted the “precautionary principle” as a regulatory axiom. In this chapter, the Panel lays out an understanding of the principle it considers to have both scientific and regulatory validity, and recommends its use as an axiom of Canadian regulatory policy. The Panel finds the use of “substantial equivalence” as a standard of safety (as opposed to a decision threshold in assessment of risk) to be, in general, a precautionary standard.

Chapter 9 raises a series of issues the Panel identified during its deliberations that it considered to be of critical importance in maintaining the integrity of science upon which the regulation of agricultural biotechnology should be based, and in maintaining public confidence in the regulatory processes. Part 1 of the chapter raises serious concerns about the undermining of the scientific basis for risk regulation in Canada due to the following factors:

·  the conflict of interest created by giving to regulatory agencies the mandates both to promote the development of agricultural biotechnologies and to regulate it;

·  the barriers of confidentiality that compromise the transparency and openness to scientific peer review of the science upon which regulatory decisions are based; and

·  the extensive and growing conflicts of interest within the scientific community due to entrepreneurial interests in resulting technologies and the increasing domination of the research agenda by private corporate interest.

In Part 2 of Chapter 9, the Panel considers the scientific basis for mandatory labelling of genetically engineered food products, and establishes guidelines for mandatory and voluntary labelling on the basis of health risks. The Panel recognizes that there are broader social, political and ethical considerations in the debate about mandatory labelling of GM foods that lie outside the Panel’s specific mandate, so this discussion is not intended to provide a comprehensive answer to the issue of mandatory labelling.

Back to top

Recommendations

Summary of the Royal Society of Canada Expert Panel’s Recommendations

In light of its investigations, the Panel made the following recommendations. The rationale and complete text of these recommendations are found at the end of each major section of the Report.

Recommendations Concerning Underlying Policies and Principles Guiding the Regulation of Agricultural Biotechnology

7.1 The Panel recommends that approval of new transgenic organisms for environmental release, and for use as food or feed, should be based on rigorous scientific assessment of their potential for causing harm to the environment or to human health. Such testing should replace the current regulatory reliance on “substantial equivalence” as a decision threshold.

7.2 The Panel recommends that the design and execution of all testing regimes of new transgenic organisms should be conducted in open consultation with the expert scientific community.

7.3 The Panel recommends that analysis of the outcomes of all tests on new transgenic organisms should be monitored by an appropriately configured panel of “arms-length” experts from all sectors, who report their decisions and rationale in a public forum.

8.1 The Panel recommends the precautionary regulatory assumption that, in general, new technologies should not be presumed safe unless there is a reliable scientific basis for considering them safe. The Panel rejects the use of “substantial equivalence” as a decision threshold to exempt new GM products from rigorous safety assessments on the basis of superficial similarities because such a regulatory procedure is not a precautionary assignment of the burden of proof.

8.2 The Panel recommends that the primary burden of proof be upon those who would deploy food biotechnology products to carry out the full range of tests necessary to demonstrate reliably that they do not pose unacceptable risks.

8.3 The Panel recommends that, where there are scientifically reasonable theoretical or empirical grounds establishing a prima facie case for the possibility of serious harms to human health, animal health or the environment, the fact that the best available test data are unable to establish with high confidence the existence or level of the risk should not be taken as a reason for withholding regulatory restraint on the product.

8.4 As a precautionary measure, the Panel recommends that the prospect of serious risks to human health, of extensive, irremediable disruptions to the natural ecosystems, or of serious diminution of biodiversity, demand that the best scientific methods be employed to reduce the uncertainties with respect to these risks. Approval of products with these potentially serious risks should await the reduction of scientific uncertainty to minimum levels.

8.5 The Panel recommends a precautionary use of “conservative” safety standards with respect to certain kinds of risks (e.g. potentially catastrophic). When “substantial equivalence” is invoked as an unambiguous safety standard (and not as a decision threshold for risk assessment), it stipulates a reasonably conservative standard of safety consistent with a precautionary approach to the regulation of risks associated with GM foods.

9.1 The Panel recommends that Canadian regulatory agencies and officials exercise great care to maintain an objective and neutral stance with respect to the public debate about the risks and benefits of biotechnology in their public statements and interpretations of the regulatory process.

9.2 The Panel recommends that the Canadian regulatory agencies seek ways to increase the public transparency of the scientific data and the scientific rationales upon which their

9.3 The Panel recommends that the Canadian regulatory agencies implement a system of

9.4 The Panel recommends that the Canadian Biotechnology Advisory Commission

Back to top

 

Recommendations Concerning Regulations and Guidelines

4.1 The Panel recommends that federal regulatory officials in Canada establish clear criteria regarding when and what types of toxicological studies are required to support the safety of novel constituents derived from transgenic plants.

4.3 The Panel recommends that, in view of the availability of suitable alternative markers, antibiotic resistance markers should not be used in transgenic plants intended for human consumption.

4.8 The Panel recommends that approvals should not be given for GM products with human food counterparts that carry restrictions on their use for non-food purposes (e.g. crops approved for animal feed but not for human food). Unless there are reliable ways to guarantee the segregation and recall if necessary of these products, they should be approved only if acceptable for human consumption.

5.1 The Panel recommends that the Canadian Food Inspection Agency (CFIA) develop

6.10 The Panel recommends that companies applying for permission to release a GM organism into the environment should be required to provide experimental data (using ecologically meaningful experimental protocols) on all aspects of potential environmental impact.

6.11 The Panel recommends that an independent committee should evaluate both the experimental protocols and the data sets obtained before approvals of new plants with novel traits are granted.

6.12 The Panel recommends that standard guidelines should be drawn up for the longterm monitoring of development of insect resistance when GM organisms containing “insecticidal” products are used, with particular attention to pest species known to migrate over significant distances.

6.13 The Panel recommends that a moratorium be placed on the rearing of GM fish in aquatic netpens.

6.14 The Panel recommends that approval for commercial production of transgenic fish be conditional on the rearing of fish in land-based facilities only.

Back to top

 

Recommendations Concerning the Regulatory Process

4.2 The Panel recommends that regulatory authorities establish a scientific rationale that will allow the safety evaluation of whole foods derived from transgenic plants. In view of the international interest in this area, the Panel further recommends that Canadian regulatory officials collaborate with colleagues internationally to establish such a rationale and/or to sponsor the research necessary to support its development.

4.6 The Panel recommends development of mechanisms for after-market surveillance of GM foods incorporating any novel protein.

4.7 The Panel recommends that the appropriate government regulatory agencies have in place a specific, scientifically sound and comprehensive approach for ensuring that adequate allergenicity assessment will be performed on GM foods.

4.9 The Panel recommends that all assessments of GM foods, which compare the test material with an appropriate control, should meet the standards necessary for publication in a peer-reviewed journal, and all information relative to the assessment should be available for public scrutiny. The data should include the full nutrient composition (Health Canada, 1994), an analysis of any anti-nutrient and, where applicable, a protein evaluation such as that approved by the United Nations Food and Agriculture Organization (FAO).

4.10 The Panel recommends that protocols should be developed for the testing of future genetically engineered foods in experimental diets.

4.11 The Panel recommends that the Canadian Nutrient File should be updated to include

5.2 The Panel recommends that the approval process for transgenic animals include a rigorous assessment of potential impacts on three main areas:
1) the impact of the genetic modifications on animal health and welfare;
2) an environmental assessment that incorporates impacts on genetic diversity and sustainability; and
3) the human health implications of producing disease-resistant animals or those with altered metabolism (e.g. immune function).

5.3 The Panel recommends that the tracking of transgenic animals be done in a manner similar to that already in place for pedigree animals, and that their registration be compulsory.

5.4 The Panel recommends that transgenic animals and products from those animals that have been produced for non-food purposes (e.g. the production of pharmaceuticals) not be allowed to enter the food chain unless it has been demonstrated scientifically that they are safe for human consumption.

5.6 The Panel recommends that the use of biotechnology to select superior animals be balanced with appropriate programs to maintain genetic diversity, which could be threatened as a result of intensive selection pressure.

5.8 The Panel recommends that changes in susceptibility of genetically engineered plants

5.9 The Panel recommends that a data bank listing nutrient profiles of all GM plants that potentially can be used as animal feeds be established and maintained by the federal government.

5.10 The Panel recommends that university laboratories be involved in the validation of the safety and efficacy of GM plants and animals.

5.11 The Panel recommends that Environment Canada and the Canadian Food Inspection Agency establish an assessment process and monitoring system to ensure safe introductions of GM organisms into Canada, according to the intent of the Canadian Environmental Protection Act.

6.1 The Panel recommends that all ecological information on the fate and effects of transgenic biotechnology products on ecosystems required under existing regulations should be generated and made available for peer review.

6.2 The Panel recommends the carrying out of exhaustive, long-term testing for ecological effects of biotechnology products that pose environmental risks, especially with respect to persistence of the organism or a product of the organism, persistent effects on biogeochemical cycles, or harmful effects resulting from horizontal gene transfer and selection.

6.3 The Panel recommends that, in evaluating environmental risks, scientific emphasis should be placed on the potential effects of selection operating on an introduced organism or on genes transferred to natural recipients from that organism.

6.5 The Panel recommends that the history of domestication, and particularly the time period and intensity of artificial selection, of GM plants should be taken into account when assessing potential environmental impacts. Species with a short history of domestication should receive particularly close scrutiny because they are more likely to pose environmental risks.

6.6 The Panel recommends that environmental assessments of GM plants should pay particular attention to reproductive biology, including consideration of mating systems, pollen flow distances, fecundity, seed dispersal and dormancy mechanisms. Information on these lifehistory traits should be obtained from specific experiments on the particular GM cultivar to be assessed, not solely from literature reports for the species in general.

6.7 The Panel recommends that environmental assessments of GM plants should not be restricted to their impacts on agroecosystems but should include an explicit consideration of their potential impacts on natural and disturbed ecosystems in the areas in which they are to be grown.

6.8 The Panel recommends that research data from experiments conducted by industry on the potential environmental impacts of GM plants used in Canadian Environmental Protection Agency assessments should be made available for public scrutiny.

6.16 The Panel recommends that potential risks to the environment posed by transgenic fish be assessed not just case-by-case, but also on a population-by-population basis.

Back to top

 

Recommendations Concerning Scientific Capacity for the Regulation of Food Biotechnology

4.4 The Panel recommends that the Canadian government support research initiatives to increase the reliability, accuracy and sensitivity of current methodology to assess allergenicity of a food protein, as well as efforts to develop new technologies to assist in these assessments.

4.5 The Panel recommends the strengthening and development of infrastructures to facilitate evaluation of the allergenicity of GM proteins. This could include development of a central bank of serum from properly screened individuals allergic to proteins which might be used for genetic engineering, a pool of standardized food allergens and the novel GM food proteins or the GM food extracts, maintenance and updating of allergen sequence databases, and a registry of food-allergic volunteers.

5.5 The Panel recommends that federal and provincial governments ensure adequate public investment in university-based genomic research and education so that Canada has the capacity for independent evaluation and development of transgenic technologies.

5.7 The Panel recommends that a national research program be established to monitor the long-term effects of GM organisms on the environment, human health, and animal health and welfare.

6.4 The Panel recommends that a detailed analysis be undertaken of the expertise needed

6.9 The Panel recommends that a federally funded multidisciplinary research initiative be undertaken on the environmental impacts of GM plants. Funds should be made available to scientists from all sectors (industry, government and university) with grant proposals subject to rigorous peer review.

6.15 The Panel recommends the establishment of comprehensive research programs devoted to the study of interactions between wild and cultured fish. Reliable assessment of the potential environmental risks posed by transgenic fish can be undertaken only after extensive research in this area.

6.17 The Panel recommends that identification of pleiotropic, or secondary, effects on the phenotype resulting from the insertion of single gene constructs into GM organisms be a research priority.

7.4 The Panel recommends that Canada develop and maintain comprehensive public baseline data resources that address the biology of both its major agroecosystems and adjacent biosystems.

7.5 The Panel recommends that Canada develop state-of-the-art genomics resources for each of its major crops, farm animals and aquacultured fish, and use these to implement effective methodologies for supporting regulatory decision making.

 

Back to top

Table of Contents 

Executive Summary vii
Summary of the Expert Panel’s Recommendations x
Recommendations Concerning Underlying Policies and Principles Guiding the Regulation of Agricultural Biotechnology x
Recommendations Concerning Regulations and Guidelines xi
Recommendations Concerning the Regulatory Process xii
Recommendations Concerning Scientific Capacity for the Regulation of Food Biotechnology xiv

1. Introduction 1
The Expert Panel 1
Mandate and Terms of Reference 1
Terms of Reference 1
Interpretation of the Terms of Reference 2
Health and Environmental Risks 4
Socio-Economic Risks 5
Philosophical/Metaphysical Risks 6
Scientific and Extra-Scientific Issues in Risk Analysis 7
Panel Procedures 9
A Note on Terminology 11
References 13
Note 13

2. The Past, the Present and the Future 14
Introduction 14
The Origins of Genetic Engineering 14
Our Food Production System Relies on Few Genetically Selected Species 15
Direct Gene Transfer Within and Between Species 16
Selecting a Transformed Plant 18
Current Products and Future Developments 19
GM Plants 19
GM Microbes 23
GM Animals 24
Fish 25
Means of introducing transgenes into fish 25
Development of growth hormone gene constructs for commercial food production 27
Future applications 27
Shellfish and Aquatic Plants 28
Farm Animals 28
Need for a Broader Research Agenda 29
References 30

3. The Regulatory Environment 34
Introduction 34
Canadian Regulation of Food Biotechnology 35
Overview 35
Canadian Food Inspection Agency 35
Health Canada 37
Environment Canada and Protection of the Environment 38
References 40
Figure 3.1 40
Figure 3.2  42

4. Potential Human Health Impacts 44
Introduction 44
PART 1: TOXICANT ASSESSMENT 44
Resistance Factors 49
Recommendations 50
References 51
PART 2: THREATS TO HUMAN HEALTH FROM ALLERGENS IN GM FOODS 53
Mechanisms and Allergic Responses in Food Allergy 53
The Increasing Problem of Food Allergies 54
The Transfer of Allergens by Genetic Modification 55
Potential Risks of Allergenic GM Foods 56
Food Allergens: How Much Is Too Much? 56
What Are the Most Common Food Allergens? 57
Can Genetic Modification Increase the Risk of Development of Food Allergy? 58
Can We Accurately Assess or Predict the Allergenicity of a Protein? 60
Approach to Allergenicity Assessment 61
Source of Donor Gene 61
Comparison with Known Allergens 62
In Vitro and In Vivo Immunologic Analysis 63
In Vitro Assays 63
In Vivo Studies 64
Physicochemical Characteristics 66
Prevalence of allergy to the donor protein 67
Potential Changes in Host Allergenicity 68
Other Considerations in Allergenicity Assessment 68
An Example of the Evaluation Process to Assess Allergenicity 69
Summary 71
Recommendations 73
References 75
PART 3. NUTRITION ISSUES 82
Introduction 82
Impacts of Genetic Engineering 82
Testing 83
Recommendations 85
References 86

5. Considerations in the Use of Biotechnology in Animal Production Systems 87
Introduction 87
PART 1. GENETICALLY MODIFIED ANIMALS 87
Potential Threats to Animal Health and Welfare 87
Fish 87
Changes in muscle cellularity, muscle enzyme activity and gene expression 87
Changes in gross anatomy 88
Changes to swimming ability and foraging behaviour 88
Other pleiotropic effects 89
Farm Animals 89
Changes in muscle cellularity, muscle enzyme activity and gene expression 91
Increased incidence of mutations and other pleiotropic effects 92
Altered nutritional and welfare needs of transgenic animals 92
Creation/Strengthening of Animal Commodification 93
Reservoirs of Pathogens or Antibiotic-resistant Microflora 93
Loss of Animal Genetic Resources 94
Recommendations 95
References 96
PART 2. GENETICALLY MODIFIED FEEDS, FEED ADDITIVES AND METABOLIC MODIFIERS ADMINISTERED TO FOOD-PRODUCING ANIMALS 99
Potential Novel Threats to Food Quality and Safety 99
Potential Novel Threats to Animal Health or Welfare 100
Metabolic Enhancers 100
Vaccines 101
Microbially Derived Feed Supplements and Additives 101
Potential Threats from Concentration of GM Products in the Animal’s Food Stream 103
Recommendations 105
References 106

6. Environmental Risks 107
Introduction 107
PART 1: MICROORGANISMS IN BIOTECHNOLOGY AND THE ENVIRONMENT 107
The Microbial Species Concept 108
The Diversity of Microorganisms in the Natural Environment 108
Direct Effects of GMOs on Soil Microflora 109
Lateral Gene Transfer 111
Transfer of Antibiotic Resistance Genes 113
The Importance of Evaluating Selection 114
Recommendations 116
References 117
PART 2: GM PLANTS 121
Environmental Risks 121
Could GM Plants Become Invasive? 121
Gene Flow Between GM Crops and Wild Plants 123
Spread of Transgenes in Wild Plants 127
GM Crops and Biodiversity 129
Regulatory Implications 131
Future Research 132
Recommendations 135
References 136
PART 3: ENVIRONMENTAL IMPACT: AN ENTOMOLOGICAL PERSPECTIVE 139
Resistance in the Targeted Pest Species 139
Impact on Other Herbivores Attacking the Same Host Plant 141
Impact on the Natural Enemies of Herbivores 142
Impact on Other Non-Target Insects in the Habitat 144
General Conclusions 145
Other GM Organisms for Insect Control 146
Recommendations 147
References 148
PART 4: POTENTIAL ENVIRONMENTAL RISKS RESULTING FROM INTERACTIONS BETWEENWILD AND CULTURED FISH 150
Salmonid Aquaculture and the Incidence of Escape Events in Canada 152
Genetic Interactions Between Wild and Cultured Fish 152
Local Adaptation in Fish 152
Genetic Differences Between Wild and Cultured Fish 152
Hybridization and Outbreeding Depression in Fish 154
Ecological Interactions Between Wild and Cultured Fish 154
Interactions Between Wild and Non-Transgenic Cultured Fish 154
Interactions Between Wild and Transgenic Fish 156
Evaluating the Environmental Safety of Genetically Modified Fish 157
Experimental Facilities and Evaluation Protocol 157
I. Genetic Introgression 158
II. Ecological Interactions 158
III. Fish Health 159
IV. Changes to Environmental Health Effected by Aquaculture Farms 159
Density-dependent Effects and Population Viability 159
Sterility of Genetically Modified Fish 160
Induction of Triploidy 160
Sterility as a Mitigative Tool to Minimize Potential Environmental Risks 160
Regulatory Implications 162
DFO National Code on Introductions and Transfers of Aquatic Organisms 162
DFO Draft Policy on Research with, and Rearing of, Transgenic Aquatic Organisms 162
Proposed Aquatic Organism Risk Analysis 163
Critique of Current Regulatory Framework and Proposed Risk Aquatic Organism Analysis 165
CEPA (Canadian Environmental Protection Act) 165
Sterility of Transgenic Fish 166
Aquatic Organism Risk Analysis 166
Future Research 168
Public Perception of Environmental Risks Posed by Cultured Fish 168
Recommendations 170
References 171

7. Substantial Equivalence as a Regulatory Concept 177
Introduction 177
The Origins of “Substantial Equivalence” 177
How Have New Crop Varieties Normally Been Approved? 178
How Have Transgenic Crops Been Treated in This Context? 179
How Well Has “Substantial Equivalence” Been Accepted? 179
The Role of the “Substantial Equivalence” Concept in the Canadian Regulatory Process 180
“Novelty” Versus “Equivalence” 180
How Do the Products of Genetic Engineering Differ from the Conventionally Derived Products? 183
What Are the Anticipated Consequences of “Precise” Single Gene Modifications? 184
Is This Simple Linear Model Valid? 184 |
Assessing the Significance of Differences 186
Building Better Evaluation Capacity 186
Level One - DNA Structure 187
Level Two - Gene Expression 187
Level Three - Protein Profiling 188
Level Four - Metabolic Profiling 189
Can “Substantial Equivalence” Become Scientifically Rigorous? 189
Recommendations 191
References 192

8. The Precautionary Principle and the Regulation of Food Biotechnology 194
Introduction 194
Current Status 194
Controversies Surrounding the Precautionary Principle 195
Interpreting the Principle 197
Recognition of Scientific Uncertainty and Fallibility 197
Presumption in Favour of Health and Environmental Values 198
Proactive Versus Reactive Approaches to Health and Environmental Values 200
Burden of Proof and Standards of Evidence 201
Standards of Acceptable Risk (Safety) 204
Implications for the Regulation of Food Biotechnology 205
Recommendations 206
References 208
Notes 210

9. Issues in the Science-based Regulation of Biotechnology 211
PART 1: MAINTAINING THE INTEGRITY OF RISK ASSESSMENT SCIENCE 211
Regulatory Conflict of Interest 211
Confidentiality Versus Transparency in Canadian Regulatory Science 212
Validation of the Science 214
Increasing Commercialization of University Scientific Research in Biotechnology 215
Recommendations 218
References 219
PART 2: LABELLING OF GENETICALLY MODIFIED FOODS 220
Current Labelling Policies on GM Foods 220
Socio-Political and Ethical-Philosophical Concerns 223
Health Basis for Mandatory Labelling 224
Conclusions on Mandatory Labelling 225
Voluntary Labelling 226
References 228

Glossary 229

Acronyms and Abbreviations 240

Member of the Expert Panel 242      

 

Web site: PDF of full report available at  http://www.rsc.ca/foodbiotechnology/GMreportEN.pdf

 

Back to top