So what is ‘biotechnology’? A quick look at the word suggests a technology that is based upon bio-logy, the study of living things, and this is reflected in the definition which first appeared in the 1982 OECD publication Biotechnology: - International Trends and Perspectives and which is still accepted today: ‘the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services’.
The definition is broad, and like some of the -others found in the pages of this Spotlight, could be interpreted to encompass growing, tending and caring of animals and plants used for food. It could also be interpreted to mean -using microbes for processing foods such as yoghurt, cheese or beer; or using microbes to produce health products and drugs, such as antibiotics. The definition is also broad enough to encapsulate the use of microbes and plants for improving industrial processes and for cleaning up chemical spills. Today biotechnology is widely taken to mean genetic engineering, although some experts prefer to call this ‘modern’ biotechnology, seeing it as a sub-discipline.Apart from defining biotechnology, the same 1982 International Trends and Perspectives report contained a number of recommendations. One of them states that for the public to have confidence in the products of modern biotechno-logy, governments must have proper mechanisms in place to regulate their safety.From assessment to practice
Since 1980 OECD member countries have worked together on many biotechnology projects, including the publication in 1986 of Recombinant DNA: Safety Considerations. Also known as the ‘Blue Book’, this import-ant work dealt with that specific biotechnology of ‘genetic engineering’, also called genetic modification. Genetic engineering is scientifically applied to living organisms that are used, or whose products are used, across the various industrial and agro-foods sectors. Some, for instance genetically modified bacteria pro-ducing human insulin for treatment of diabetes, and human growth hormone, were already approved in 1986.The importance of biotechnology and microbiology in industry is gaining recognition every day (see Salomon Wald’s article, p. 32). However, it is not so much these industrial applications, but rather the use of genetically modified organisms (GMOs) in food crops and their poss-ible environmental effects which are increasingly raised as an issue of intense public and political debate -today.The 1986 Blue Book, the first OECD publication to respond to the 1982 recommendation for safe regulation, put forward key safety concepts for development and commercialisation of GMOs, including genetically modified plants for agricultural use. They covered advice on risk assessment; agriculture and the environment; and how to build our understanding of the behaviour of the GM plant.These principles, for example, on safe small-scale field testing of GM plants, were developed by hundreds of experts from OECD countries and they have been used as the basis of Member country GMO regulation.While all this was going on, private and public research institutions were already beginning to use genetic engineering to develop crop plant -varieties with novel traits for farmers and the food processing industry. The first field test was conducted in Belgium in 1986, and since then many thousands have taken place all over the world. The first commercial approval in 1992 was in the United States. It was for a genetically engineered tomato that could be harvested ripe, rather than green on the vine, and could still be packaged, shipped and sold before it went too soft and rotten. Since then a number of genetically modified crop plants have been approved for commercialisation, mostly in North America and Latin America, where they are now grown extensively.
Whether the cultivation of GMO crop plants endangers the environment or contributes to its safety is a matter of growing public debate. There are questions being asked about chemical fertiliser use and the possible effects of GM crops on bird, animal and wildflower -species. Regulating for the safety of new food crops requires a good understanding of the environmental behaviour of the traditionally developed varieties.That is why regulatory agencies have been using the OECD’s biosafety principles to compare the GMO plants with their unmodified ‘traditional’ counterparts (see article by Mark Cantley, p. 21).Fortunately, -thanks to the OECD’s science-based case studies, there is a lengthy history of crop plant development and breeding to draw upon. In 1993 the OECD published a work on Traditional Crop Breeding Practices and more recently experts from Member countries, through the Working Group on Harmonisation of Regulatory Oversight in Biotechnology (see article by Peter Kearns, p. 24), have embarked on developing and publishing on a number of specific crop plant and tree species.How new is novel food?
Most of the genetically modified crop plants commercialised to date have new attri-butes (novel traits) for the farming sector. That is why they are often refered to as new foods. Novel herbicide tolerance and pest and disease resistance are the major ones, yet in reality they are not new to crop plant varieties. Plant breeders have for decades been searching among crop species and their relatives and selecting genes that incorporate such traits into new crop varieties. What is new is the higher level of precision in genetic modification, thanks to the improved technologies available today. Furthermore, the market place has become extremely demanding. Growers every-where have long demanded greater consistency from plant breeders. So have food processing companies, retailers and indeed final consumers themselves. All have been seeking consistent uniformity and quality in their food. GM food was one response to these calls.What also makes novel food different is regulation. The trigger for biosafety regulation is clearly process-defined. Genetically engineered plants are regulated whereas their traditionally developed counterparts are not. Some -interested parties see this as a con-tradiction and warn against over-regulation which would unfairly undermine the development of the GM food industry. Others insist that we are dealing with new processes which need to be better understood, so it is perfectly normal to apply as many specific risk and safety assessments as necessary to achieve public confidence. These are important differences of opinion which a balanced, objective, review would help to overcome.©OECD Observer No 216, March 1999