Current and Future Trends in Harmonization in Europe and Internationally

JIRCAS international symposium series
ISSN 13406108
NII recode ID (NCID) AA1100908X
Full text
In the European Community (EC), harmonization of approaches to safety was achieved by two legally binding directives, adopted in 1990. Since their adoption, the experience gained with both the contained use of genetically modified microorganisms and the deliberate release of genetically modified organisms has led to considerable advances in the regulatory framework, including a recent proposal for amendment of the contained use directive, the adoption of reduced information requirements and a first simplified procedure in the EC for plant R & D releases, and the development of consensus documents in the OECD. The ability to identify low risk applications will enhance the trend towards increasing differentiation of regulatory requirements.
The need for harmonized approaches to safety at the international level is urgent as GMO products are starting to be traded internationally. The adoption of the UNEP International Technical Guidelines for Safety in Biotechnology represents a major step forward in establishing an international biosafety framework. Together with UNEP's capacity-building program, the decision by the second Conference of the Parties to the Convention on Biological Diversity to develop a biosafety protocol, and other international and regional activities, this framework will play a key role in the development and uptake of biotechnology applications.
Modern biotechnology is an enabling technology across a very wide spectrum of sectors, from the production of pharmaceuticals and foods, to the use of organisms in the environment for clean-up. For this reason it is a key technology of the present and of the future. The trade in products developed using modern biotechnology, an increasing number of which contain living organisms such as seeds, will be on a world scale. Against that backdrop, it is clear that any controls should as far as possible be based on a harmonized approach in order to avoid the creation of trade barriers. But the first question to be asked is why controls are needed at all.
There has been wide recognition that the use of genetic modification techniques does not necessarily produce organisms that will pose risks to humans or the environment. Indeed, in most cases when only a small number of known and specific traits are inserted, the resulting organism will behave predominantly in the same way as the organism from which it is derived. Nonetheless, some degree of caution is appropriate because the introduced trait or genetic material could produce a significant change in behavior and because organisms introduced into different environments sometimes behave differently. The approach taken in most countries which have put controls into place has been to assess the risk of damage to human health or the environment and to decide on the measures that are necessary to reduce the risks to a low or negligible level.
There has been a clear trend in the type and scale of applications of modern biotechnology. The 1970s and 1980s saw the development from small scale contained uses to large and commercial scale uses. From the mid-1980s, we have had small scale releases of GMOs into the environment and now commercialization of GMO products which are intended to be used in the environment.
The regulatory controls adopted by the European Community in 1990 reflected this trend and the consequent difference in experience about the way various GMOs behave in different circumstances. Two legally binding directives apply to biotechnology activities: the Contained Use of Genetically Modified Microorganisms, and the Deliberate Release into the Environment of Genetically Modified Organisms.
The Contained Use Directive requires that only a risk assessment be carried out for small-scale operations involving GMOs that do not pose any risk to humans or the environment. For larger scale and commercial operations of such GMOs, and small-scale uses of more hazardous organisms, prior notification to the competent authority is required. Large-scale commercial operations involving hazardous organisms require prior consent from the authority. This hierarchy of controls reflects the clear aim of the directive to provide maximum oversight for those operations considered to be most risky. We have seen two main consequences of this approach: firstly, safety is fully provided for, and secondly, industry and research have been encouraged to work with low risk applications. This is borne out by the numbers for the UK, and for the EC as a whole: there have been no accidents which have threatened to affect human health or the environment up till now, and of the estimated 20,000 projects undertaken at any one time in the UK, the percentage of low risk activities to the total is about 95%. In particular, in a large industrial scale there are no activities notified in the UK involving more hazardous organisms; all such activities involve low risk organisms.
As regards contained uses, the Community policy operates essentially at national level. There is little exchange of information between the competent authorities about individual activities, except when activities could be reasonably foreseen to affect another Member State as a result of an accident. Regular meetings of the authorities facilitate harmonized implementation of the directive throughout the Community.
Since the Contained Use Directive came into force, there has been a steep increase in the number of individual activities: As an indication, in the UK there has been a 170% increase in the numbers of notifications in the first half of this year as compared with a similar period in 1993. Experience in other EC countries has been similar. On this basis, in the White Paper on Growth, Competitiveness and Employment published in 1993, the European Commission proposed that it might be appropriate in the near future to consider amending the directive to take account of the experience gained, both in the EC and elsewhere. Accordingly, discussions are now taking place between the Member States of the Community and the Commission about a proposal to amend the Contained Use Directive. The proposal incorporates the internationally adopted approach of 4 containment levels, it is more strictly risk-based and it adjusts the triggers for the different regulatory requirements to reflect the experience gained.
Creator Helen K. Marquard.
Publisher Japan International Research Center for Agricultural Sciences
Available Online
Issue 5
spage 287
epage 292
Language eng

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