What is harmonisation of regulatory oversight?
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Modern biotechnology is changing fast and is beginning to have a major impact on agriculture and the environment. Increasing the efficiency of safety assessment and promoting transparency in the exchange of information are among the key aims of the OECD.
The 1990s have seen a rapid increase in the development of genetically modified products, many of which are destined for release into the environment. So far, most of the products being developed consist of major crops, such as maize, wheat and soya bean. Well over 40 types of crop plant species have been genetically modified to exhibit a variety of traits, including resistance to various insect pests and disease and tolerance to certain herbicides. Through modern biotechnology quality characteristics have improved, reducing spoilage.The majority of OECD member countries have developed – or are in the process of developing – their own systems to assess the environmental and health safety of these new varieties. In some countries, the system is inscribed in a specific law regulating the use of biotechnology products. In others, the regulation might be a part of legislation, for example, on environmental protection.A few countries have preferred a more voluntary approach to control.There are country differences in terms of who controls what. In some it is the job of the health ministry to ensure safety assessment, while in others that job goes to agriculture or environment ministries. Sometimes, it is a shared responsibility among ministries or agencies. Where there is similarity between approach it is the underlying technical information which regulatory authorities use to assess safety.Three aspects of GMOsTypically, three aspects of a genetically modified product are examined: the biological characteristics of the crop species under consideration; the specific trait introduced through the modification – for disease resistance, for instance- – and third, the potential impact on human health and the -environment. Of these three aspects, the first two – the information on the bio-logy of the crop species and the characteristics of the introduced trait – are generally the same from country to country. And it is here that much of the OECD’s work on harmonisation is focused.The main aim is to facilitate the development of consensus documents by its member countries. These documents focus on information either on the bio-logy of a specific crop plant species or on introduced novel traits. They include technical information which is relevant to the safety assessment of biotechnology products and are intended to be mutually acceptable among OECD countries.Through its Working Group on Harmonisation of Regulatory Oversight in Biotechnology, the OECD collates scientific evidence that is useful for environmental safety assessment, but it makes no overall judgement as to the environmental safety of these plants or genetic engineering processes. This is because all GM plants are evaluated on a case by case basis, helped by field trials. A key part of the evaluation is to consider the environment into which the plant is introduced.What risk?
One example is the environmental safety assessment of a genetically modified variety of oilseed rape (Brassica napus). The task there is to understand the possibility for the development of hybrids between the cultivated variety and its wild relatives. The question asked is whether such hybrids might lead to the intro-gression of novel traits into the related wild species. If so, the related species risk becoming weedy and more invasive of other natural ecosystems.This possibility is especially important for the locations where the species originally evolved, their so-called -centres of -origin.The OECD’s consensus document on oilseed rape reports on the ability of cultivated varieties of oilseed rape to ‘hybridise’ with wild relatives. However, because there is a wide variation in the distribution of wild relatives around the world – and the potential environmental impact can differ from one place to another – the actual safety assessment itself remains the responsibility of the national authorities themselves to carry out.One major advantage of the OECD’s collective approach to compiling safety information is that it avoids duplication in assessment, which means significant savings for the regulatory authorities involved. Literally thousands of genetically modified crop varieties are currently being tested (or have been tested) in small-scale field trials, before they are grown at a commercial scale. Normally, each of these trials requires a separate safety notification in each country and these field tests have already represented over 100 different combinations of plants and traits.Government and industry see savings in approval procedures too. It is a gradual, though reliable, process. And based on it, a number of GM plant varieties have been approved for commercial growing by regulatory agencies in the United States, Argentina (a non-OECD country), Canada, Australia and Japan. However, very few have been approved and grown in Europe.Whatever line different countries take on biotechnology, the value of harmonisation of regulatory oversight will remain the same. It provides a -common baseline and an evolving set of references to help form policy judgements about the environment in the fast changing world of modern biotechnology.©OECD Observer No. 216, March 1999