Annotated Bibliography Entry

Reference: OECD 2000b.
Title: Report of the Task Force for the Safety of Novel Foods and Feeds
Authors: Organisation for Economic Co-operation and Development (OECD)
Publisher: OECD Publications, 2, rue Andre-Pascal, 75775 Paris Cedex 16, France
Publication details: May 2000. 72p

 

Summary
          Conclusion
Table of Contents

 

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Summary

The techniques of genetic modification are having a major impact on the development of new varieties of crops, vegetables and fruits, starting with major trading commodities such as maize, rice, soybean – whether for human consumption or as livestock feed. There are systems in place in the majority of OECD countries for the safety assessment of genetically modified (GM) foods and feeds. Most participants in the OECD’s Task Force for the Safety of Novel Foods and Feeds work in national ministries or agencies whose responsibility is to ensure consumer safety.

Regulatory bodies in some of the OECD countries have approved approximately 40 GM foods, and more approvals are expected in the future. The main issues addressed by food safety assessors are the implications on human health, including the impact of genes which code for antibiotic resistance, the identification of toxicological or allergenic properties of new food components introduced through genetic modifications; and nutritional impacts.

Safety assessors use a number of internationally established scientific principles, including substantial equivalence, in their work. Although substantial equivalence is not the only such principle, there is detailed description given in the report, partly because it was a concept elaborated at the OECD, and partly because there is high level of interest in the topic at the present time.

The concept is that the most practical approach to determining the relative safety of a new food is to consider whether it is substantially equivalent to analogous traditional foods - if such foods exist. Initially, this concept was applied to organisms of terrestrial origin; later it was concluded that, with certain caveats, the principle of substantial equivalence could also be applied to products of aquatic biotechnology.

It was recognised that while substantial equivalence might be determined relatively easily in some cases, in others, a product might be determined to be substantially equivalent except for the novel trait. There might also be cases where a product was so novel that the concept of substantial equivalence could not be usefully applied. Steps were taken in 1996 towards identifying strategies that could establish the safety of food produced by biotechnology when there is no acceptable counterpart for comparison and substantial equivalence cannot be applied. In considering this topic, attention was given to experiences with novel foods from nonbiotechnological sources (such as irradiated foods).

By 1997, several OECD countries had gained experience with safety assessment of foods derived through modern biotechnology. Their experience was examined for the effectiveness of the application of substantial equivalence in safety assessment. The methods used in the nutritional and toxicological evaluation of new foods, particularly those methods to access protein toxicity, were also addressed. It was concluded that the determination of substantial equivalence provides equal or increased assurance of the safety of foods derived from genetically modified plants, as compared with foods derived through conventional methods.

Much experience has been gained in the safety assessment of the first generation of foods derived through modern biotechnology, and those countries that have conducted assessments are confident that those GM foods they have approved are as safe as other foods. Nevertheless, some have raised concerns about the adequacy of existing test methods. For example, more standardised procedures to establish substantial equivalence are needed, as well as improved methods to assess the allergenicity of proteins new to the diet (together with their digestibility and toxicity) taking regional differences in diet into account. In this respect the Task Force has recognised the need for capacity-building to assess the safety of novel foods as a priority activity. This is the reason why work continues internationally on the development of Consensus Documents on individual crop species. Food and feed safety assessors should address these issues. In this context it is important to note that the concept of substantial equivalence is being addressed in a number of international fora and will need to be kept under review.

Looking at regional and national experience, the report states that there are differences in risk analysis among OECD countries. One example is that the application of the concept of substantial equivalence is not necessarily identical in regional and national legislation. It is evident that differences exist in risk management and the way other legitimate factors (such as socio-economic and ethical concerns) are taken into account.

A major issue for the future is the development of strategies for managing the safety assessment of the “next generation” of GM products (i.e. those expected to be marketed during the next decade). One category of these new products, agronomic applications, includes crop varieties with the ability to withstand specific environmental stresses. For example, researchers are developing new varieties that can resist drought, salt or heat stress.

A second category of new products, food and public health applications, includes crop varieties with improved levels of specific nutrients. An example is the new “golden rice” variety that expresses a Vitamin A precursor.

A third category, medical applications, includes fruits and vegetables (such as bananas or potatoes) that are being genetically modified to produce edible vaccines or novel forms of pharmaceuticals.

A fourth category, industrial and environmental applications, refers to new crop plants being developed for use in the production of textiles, fuel oils, or other forms of industrial chemicals, as well as methods of bio-remediation and waste control.

These “next generation” products will raise additional food safety issues for several reasons. Perhaps most importantly, some will involve more complicated modifications (with several genes) than the “first generation” products. Since this will make the application of established principles such as substantial equivalence even more difficult, evaluating these products’ safety is likely to require that more sophisticated testing strategies and methods be developed. Even in the case of products (i.e. medical and industrial) not intended to be consumed as food, safety assessors need to be certain that effective measures are in place to keep these products from entering the food chain. In preparation for the new generation of GM products, food safety assessors should keep the concept of substantial equivalence under review and should continue to exchange experience with the development of new testing methods and strategies as well as harmonising data needs.

This report shows that some differences exist among OECD countries. One issue on which there is disagreement concerns the detection of any possible long-term effects through post-market surveillance. Post-market surveillance implies the continuing need to monitor GM foods’ impact on human health following marketing. Some OECD countries believe that, because new food products should not be placed on the market until safety of the product has been established, there is no scientific basis on which to require special surveillance for foods derived using modern biotechnology. For other countries, postmarket surveillance is one of the ways to demonstrate the absence of possible long-term or unintended effects that might result from the consumption of a novel food or feed. Safety assessors should continue to review this issue by evaluating feasibility studies related to post-market surveillance.

Although food safety assessment is based on sound science, there is a clear need for increased transparency and for safety assessors to communicate better with the public. Much progress has already been made in this regard. For example, some authorities invite public comments on safety evaluations and some publish the results of the work of their advisory committees. (In this context, the Internet has become a powerful tool for disseminating safety information.) Some authorities have included consumer representatives on committees responsible for safety assessments. However, more could be done in this area. An important first step would be for authorities to compare experiences, with a view to developing “good practices” for public involvement in safety assessments. Safety assessors in different countries should continue to exchange experiences on mechanisms for public involvement in the safety assessment process. OECD’s BioTrack Online site should be further developed, to ensure that this information is readily available.

A number of references are made to the work of other intergovernmental organisations, particularly FAO, WHO and that of the Codex Alimentarius Commission. The Task Force, which works with these organisations to ensure an effective global system for food safety assessment, welcomes their participation in its work. It also welcomes the work of the Inter-Agency Network for Safety in Biotechnology (IANBses eleven intergovernmental organizations*

(*CGIAR, CBD, ICGEB, FAO, OIE, OECD, UNCTAD, UNDP, UNIDO, WHO, WTO)

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Conclusion

The Task Force is currently focusing on further efforts to promote continued international harmonisation in the field of safety assessment of products of modern biotechnology. The main area of work at this time is the development of Consensus Documents that provide information on critical parameters of food safety and nutrition for each food crop. A number of other Task Force activities are under way - including those related to capacity-building – which are also designed to promote harmonisation.

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OECD 2000. Report of the Task Force for the Safety of Novel Foods and Feeds

Table of Contents

Executive Summary  4

An Introduction to OECD’s Task Force   6

Chapter I Scientific Issues 8  
A. What is Biotechnology? 8
A.1. Comparison of classical and modern biotechnology 8
A.1.1. Micro-organisms   8                                                                            
A.1.2. Plants  9                                                                                 
A.1.3. Animals 10                                                                                              
A.2. Types of modified foods entering the market 10                                
A.2.1. Micro-organisms 10                                                                              
A.2.2. Plants  11                                                                                                 
A.2.3. Animals 11                                                                                            
A.2.4. Animal feeds 11                                                                                      

B. What are the Novel Food and Feed Safety Issues?  12
B.1. The safety of new proteins in food toxicity and allergenicity 13
B.2. The safety of whole foods: altered expression of natural toxicants and Antinutrients 15
B.3. The safety of whole foods: nutritional changes 16
B.4. The safety of whole foods: unexpected changes in food composition relevant to human health  16
B.5. Gene transfer: potential impacts on human health (e.g. antibiotic resistance markers) 17                                                                    

Chapter II Current Approaches and Experiences in the Safety Assessment of Foods Derived through Modern Biotechnology 20

A. Internationally Established Scientific Principles 20
A.1. The new gene  20
A.2. The new protein 20
A.3. Other food components 21
A.4. Additional effects 21
A.5. Substantial equivalence 21
B. Regional and National Experience 24

Chapter III Current Needs and Future Challenges 25

A. Introduction 25                                                                                         
B. Adequacy of Existing Assessment Methods  26                                            
C. Allergenicity 28                                                  
D. New Products and Future Developments  29
D.1. Developments in modern biotechnology 29
D.2. Agronomic applications 29
D.3 Food quality and public health  30
D.4. Medicinal applications 30
D.5. Industrial applications 30
D.6. Challenges posed by the “new generation” of GM products 31
D.7. Genetically modified animal feeds 32
E. The Feasibility of Using Post-Market Surveillance to Assess Impacts on Human Health 32
F. Communication with the Public on Approaches to Safety Assessment 34

References  36

Annex 1: National Experiences Contributed by Member Countries  39

Annex 2: List of Participants in the Task Force for the Safety of Novel Foods and Feeds  63

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