Research

Genetically modified plants for food use and human health - an update
The Royal Society (UK)
February 2002

Summary
In 1998 the Royal Society published a report, Genetically modified plants for food use, which concluded that the use of genetically modified (GM) plants had the potential to offer benefits in agricultural practice, food quality, nutrition and health, but that there were several aspects of G M technology that required further consideration. The Royal Society appointed a group of experts to update this report based on research since 1998. This update focuses on the effects that GM foods might have on human health and the use of the principle of substantial equivalence in GM food safety testing.

Few, if any, GM food products are currently available to buy in Europe and the UK. Commercial varieties produced elsewhere, in the USA and Canada for example, are designed to confer resistance to pests and to produce tolerance to specific herbicides. Over the next decade biotechnology will be aimed at improving many qualities of crops, including nutrition and agronomic performance. We support the continuation of research in this area as valuable in itself and as the only way to assess the true potential of G M plants.

We endorse the conclusions of the 21 st report of the Royal Commission on Environmental Pollution (1998) that scientific assessments must inform policy decisions but cannot pre-empt them, and that public opinion must be taken into account throughout. We believe that the public debate about GM food must take account of wider issues than the science alone. We also wish to stress the importance of informing debate with sound science.

We have some concerns about the regulatory processes governing the development and use of GM plants. We agree with the FAO/WHO 2000 report that the criteria for safety assessments should be made explicit and objective and that differences in the application of the principle of substantial equivalence, for example in different Member States of the European Union, need to be resolved. We welcome the development of consensus documents by the OECD' for different crops so that the principle of substantial equivalence can be applied uniformly. It may not be necessary or feasible to subject all G M foods to the full range of evaluations, but those conditions which have to be satisfied should be defined.

In the future safety assessments of GM and non-GM foods could make use of various new profiling techniques. Long-term research is required before these techniques can be applied. We recommend that research should continue to develop such technologies and thereby define the 'normal' compositions of conventional plants. We welcome the funding initiatives already put in place by the European Union Framework V programme and the UK's Food Standards Agency. Collaboration between the chemical industry, academia and regulators to develop techniques and share reference data will help ensure that agreement is reached on interpretation of results and use of new technologies.

One potential application of GM technology is to improve the nutritional quality of crops. It is possible that GM technology could lead to unpredicted harmful changes in the nutritional status of foods (MRC, 2000). Such alterations might also occur in the course of conventional breeding. Nutritional assessments are made as part of the safety assessment of G M crops, but more detailed guidelines would be beneficial. Vulnerable groups such as infants need special guidelines. To date no GM food for use in infant products has been submitted for approval. Detailed guidelines and legislation already exist for infant formulas and follow-on foods but it is not clear how they interact with G M food regulations. Therefore we recommend that both the Government and the European Commission should ensure that these two sets of regulations are complementary. Guidelines such as those described by COMA (1996) for nutritional assessment of infant formulas and more recently by Aggett etal. (2001) should be adopted for both novel and GM foods.

There is at present no evidence that G M foods cause allergic reactions. The allergenic risks posed by G M plants are in principle no greater than those posed by conventionally derived crops or by plants introduced from other areas of the world. One shortcoming in current screening methods, which applies to both conventional and G M foods, is that there is no formal assessment of the allergenic risks posed by inhalation of pollen and dusts. We therefore recommend that current decision trees be expanded to encompass inhalant as well as food allergies.

Plant viral DNA sequences are commonly used in the construction of the genes inserted into GM plants, and concern has been expressed about this. Having reviewed the scientific evidence we conclude that the risks to human health associated with the use of specific viral DNA sequences in G M plants are negligible.

One concern associated with G M foods is the possibility that genes introduced into GM plants might become incorporated into the consumer's genetic make-up. Since the Royal Society's 1998 report various papers have been published on this topic. The results need to be viewed in the context of a normal diet, which for humans and animals comprises large amounts of DNA. This DNA is derived not only from the cells of food sources, but also from any contaminating microbes and viruses. Given the very long history of DNA consumption from a wide variety of sources, we conclude that such consumption poses no significant risk to human health, and that additional ingestion of GM DNA has no effect.

Conclusions and recommendations
We recognise the valuable potential and current impact of plant biotechnology on the quality of food and its importance in the development of new crops. We support continuation of research on GM plants as valuable in itself and as the only way to assess the true potential of GM plants. However, the Royal Society recognises the concerns expressed with regard to the technology and believes that these should continue to be addressed through collaboration and dialogue between industrialists, public sector scientists, regulatory authorities and non-government organisations. It is important that the public debate about GM food takes account of wider issues than the science alone, but we wish to stress the importance of informing debate with sound science.

We agree with the FAO/WHO 2000 consultation that the criteria for safety assessments of G M foods should be made explicit and objective and that differences in the application of substantial equivalence, for example in different Member States of the European Union, need to be resolved (OECD, 2000).

Therefore we welcome the development of consensus documents for different crops by the OECD, which will help to facilitate the uniform application of substantial equivalence. We believe that the risks to human health associated with the use of specific viral DNA sequences in GM plants are negligible. Given the very long history of DNA consumption from a wide variety of sources, it is likely that such consumption poses no significant risk to human health, and that additional ingestion of GM DNA has no effect.

We have the following recommendations.
Safety assessments should continue to consider potential effects of the transformation process. The phenotypic characteristics to be compared between foods derived from GM plants and their conventional counterparts should be defined. It may not be necessary or feasible to subject all G M foods to the full range of evaluations but those conditions that have to be satisfied should be defined.

Research should be undertaken to develop modern profiling techniques and to define the 'normal' compositions of conventional plants. The working group welcomes the funding initiatives already put in place by the European Union Framework V programme and the UK's Food Standards Agency (FSA).

The biotechnology industry should collaborate with academia and regulators to develop and share suitable reference data sets. This will help ensure that the new technologies are wisely applied and that agreement is reached on the appropriate interpretation of the data that they will generate.

The UK Government should review the enforcement of the regulations on infant foods and GM foods to ensure these regulations are complementary.

The European Commission should consider the use of novel and GM foods in infant foods as part of its review of Directive 91/321/EEC that covers infant formulas and follow-on foods.

The current decision trees used to assess allergy should be expanded to encompass inhalant as well as food allergies.

In the longer term, should GM foods be re-introduced into the market in the UK, we suggest that the Food Standards Agency considers whether post-marketing surveillance should be part of the overall safety strategy for allergies, especially of high-risk groups such as infants and individuals in 'atopic' families.