Annotated Bibliography Entry

           

Reference: FAO/WHO 2001b
Title: Consultations and Workshops: Safety Assessment of Foods Derived from Genetically Modified Microorganisms
Authors: Report of a Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology, 24 –28 September 2001
Publisher: WHO and FAO, WHO Headquarters, Geneva, Switzerland
Publication details: 2001, 28p.

Summary
Conclusions
Recommendations
Table of Contents

 

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Summary

WHO and FAO have been organizing Consultations of this kind since 1990 to provide scientific and technical guidance to Member States and to the Codex Alimentarius Commission. Clear assessment and communication of scientific data is becoming increasingly important so that the scientific risk assessment process is accurately reflected in the risk management process. The issues of safety and nutritional assessment of foods derived from biotechnology would be even more important in the near future with the rapid development of new foods with potential benefits related to health.

FAO and WHO have embarked on an initiative to organize a series of scientific expert Consultations to provide scientific and technical advice to their Member States. The scientific advice derived from the Joint FAO/WHO Expert Consultations can be used by the Member States of FAO and WHO directly. It will also serve as the scientific foundation for the work of the Codex Alimentarius Commission in their deliberation on safety assessment guidelines for foods derived from biotechnology presently being developed by the Codex ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology.

FAO and WHO have to date organized two Expert Consultations. The first Consultation held in Geneva in June/July 2000 addressed the overall aspects of safety assessment of genetically modified foods of plant origin and responded to five specific questions raised by the First Session of the Task Force (FAO/WHO, 2000). The second Consultation held in Rome in January 2001 specifically addressed the allergenicity of foods derived from biotechnology (FAO/WHO, 2001).

FAO and WHO convened this Consultation to assess whether currently available approaches for assessing the safety of foods and food ingredients derived from genetically modified plants could be applied to genetically modified microorganisms (GMMs). The Consultation examines unique aspects to be considered in the safety assessment of foods produced with the aid of GMMs.

The safety and risk assessment of foods, including genetically modified foods, are generally considered within a framework of risk analysis. Within this framework, reference can be made to the use of precaution in risk management and risk assessment. Ongoing discussions within the Codex system will help guide these considerations further.

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Conclusions

1. The Consultation agreed that the safety assessment of GMMs should proceed on a case-by-case basis aided by a series of well-defined questions. The Consultation confirmed that a comparative approach, using the concept of substantial equivalence, provided a practical means of identifying similarities and differences between food produced with the aid of GMMs and their appropriate comparators. These differences would then be the focus of the safety evaluation.

2. The Consultation noted that there are intrinsic properties of microorganisms that require special consideration in the application of the concept of substantial equivalence. In particular, it noted that the food matrix in which GMMs may be consumed could influence its safety, thus the impact of the food matrix needs to be considered. It may therefore be necessary to apply the concept of substantial equivalence both to the GMM and to the food produced with the aid of GMMs. In doing this, it may be necessary to examine additional parameters such as pathogenicity and persistence in the mammalian host GI tract.

3. The Consultation noted that the potential range of GMMs in food included viable and non-viable microorganisms that may be consumed as such or may be integral components of foods. The Consultation noted that because of the wide range of products involved, the safety assessment needed to take into consideration the specific uses and exposures to the GMM being considered.

4. The Consultation noted that the use of microorganisms in food production is of great importance to the nutritional quality and safety of the food supply. Therefore, the evaluation of GMMs should encompass both safety and nutritional aspects.

5. The Consultation noted that microorganisms in the GI tract exert important effects on the immune system. While previous recommendations (FAO/WHO, 2001) relating to the allergenicity of new proteins expressed in GM plants can be used in the safety assessment of foods produced with the aid of GMMs, it must be noted that the possible effect of GMMs or their components on the immune system in the mammalian host requires additional consideration.

6. The Consultation noted that genetic material from food has the potential to transfer to gut microflora and to cells of the mammalian host in vivo. The safety concerns of such gene transfer need careful evaluation based on the properties of the GMM and its components.

7. The Consultation concluded that in developing a GMM for use in food production, vectors should be used which consist only of nucleotide sequences from microorganisms with a history of safe use in food. Any selectable markers should be carefully chosen and based on safe use. In particular, antimicrobial resistance marker genes should be avoided and not be present in the final GMM.

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Recommendations

1. It is recognized that the complex ecosystem of the human gastrointestinal tract is subject to increasing and successful analysis. It is recommended that this analysis should be enhanced, including examination of the ecological components of the GI tract, the prevailing selective conditions, and the effect of nutritional conditions and host factors on the interactions. These studies would provide the basis for improved risk assessment.

2. While a permanent life-long colonization of an adult by an exogenous microbe is apparently a rare event, strains can be recovered from the intestinal tract for weeks after the discontinuation of exposure through food. Whether a GMM is established in the GI tract or not, the possibility remains that it might influence the microflora and/or the mammalian host. The effects on the flora might relate to functions expressed or to horizontal gene transfer. There is a need to improve the methods for evaluating the function of microorganisms in the GI tract.

3. Fermentation provides a simple technique to produce food of high nutritional and hygienic quality. This technology is used globally and is especially important in developing countries. The continued improvement of such technologies could involve the use of GMMs. The Consultation recommended that FAO/WHO promote capacity- building efforts to support the needs of developing countries in improving and evaluating this technology.

4. The Consultation recognized the need for efficient communication of issues related to the development and safety evaluation of GMM food. Specific communication of the principles guiding the safety assessment to the public would enable efficient interaction and transparency in the evaluation process. The Consultation recommended that FAO/WHO coordinate the efforts to achieve this.

5. The Consultation noted that specific methodologies are available which enhance the safety of GMMs through an improved understanding of the biology of microorganisms. New technologies are developing rapidly with a potential to enhance the safety evaluation of GMMs, especially bacteria. These are described within the report and include molecular profiling. The Consultation encourages further development and validation of such methods.

6. The Consultation identified a number of aspects that it recommends should be taken into account in assessing the safety of food produced with the aid of GMMs. These include:
·        application of the concept of substantial equivalence to the GMM and foods produced from the GMM;
·        consideration of the techniques used for the development of the GMM – especially the history of safe use of host microorganisms and also of the microorganisms from which inserted gene(s) and vector(s) are derived – and avoidance of the use of antimicrobial resistance marker genes;
·        strain identification and characterization;
·        transfer of genetic material from the food to the gut microflora and mammalian host cells;
·        genetic stability of the GMM;
·        pathogenic potential of the GMM;
·        impact of the GMM on the human immune system; and
·        human exposure to the GMM and the effects of food processing, production and storage.

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FAO/WHO 2001b. Consultations and Workshops: Safety Assessment of Foods Derived from Genetically Modified Microorganisms.

Contents

1. Introduction 2

2. Background 2

3. Scope 3

4. Safety Assessment 5
4.1 General approach to safety evaluation 5
4.2 Aspects specific to microorganisms 7
4.3 Application of the concept of substantial equivalence to GMMs 7

5. Specific Food Safety Issues 8
5.1 Introduction 8
5.2 Techniques for genetic modification 9
5.2.1 Bacteria 9
5.2.2 Yeast and filamentous fungi 9
5.3 Strain identification and characterization 10
5.4 Gene transfer 10
5.4.1 Bacteria 10
5.4.2 Yeast and filamentous fungi12
5.5 Genetic stability 12
5.6 Pathogenic potential 13
5.7 Safety and nutritional assessment 13
5.8 Interactions between the GMM, the intestinal flora and the mammalian host 14
5.9 Exposure16
5.10 Impact on the immune system 17

6. Conclusions 17

7. Recommendations 18

8. References 20

Annex I: List of Participants 24
Annex II: Agenda Items and List of Consultation Room Documents 28

           

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Web site: http://www.who.int/fsf/Gmfood/index.htm