BioSafety Journal Pontificia Universidad Católica de Valparaíso ISSN: 1366 0233 Vol. 2, Num. 1, 1996

 BioSafety 
Volume 2 (Paper 1), May 22nd 1996
Online Journal, URL - http://bioline.bdt.org.br/by

Editorial: Development of the International Technical Guidelines for Biosafety.

Brian Kirsop

Biostrategy Associates, Stainfield House, Stainfield, Bourne, Linc, UK PE10 0RS

Received May 19th 1996 Accepted May 21st 1996

Code Number: BY96001
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At Rio de Janeiro in 1992, during the course of the Earth Summit and specifically in relation to Agenda 21 (1), governments agreed (2) to consider international cooperation on safety in biotechnology. This matter was discussed further at the first (3) and second (4) Conferences of the Parties (COP) - meetings of those governments which have signed the Convention on Biological Diversity (CBD) - in 1994 and 1995. At the 1995 meeting (4), held in Jakarta, it was agreed (2) that a Biosafety Protocol should be developed. An Open-Ended Ad Hoc working group of Experts was established to do this and will meet for the first time in July 1996. This group was instructed; (3) to follow the principles set out in the reports of earlier working group of experts in Biosafety (5,6,7). The contents of a Protocol are thus not yet agreed, though it will certainly focus on the transfer of "living modified organisms resulting from modern biotechnology" (4), across national boundaries. This reflects the belief that such organisms may have adverse effects on the conservation and sustainable use of biological diversity.

Realistically, it was accepted that the development of a Biosafety Protocol would take some time. The working group created to develop the Protocol has been asked to report by 1998. The COP at Jakarta therefore stressed that an interim mechanism was required and identified the International Technical Guidelines, which the United Nations Environmental Programme (UNEP) was developing, as suitable for this purpose. It also agreed that these Guidelines could be useful in implementing a Biosafety Protocol, once this had been developed. Thus, in both the short and the longer term, the UNEP Guidelines will be a significant feature of international, as opposed to country or regional, regulation of the transfer of modified organisms across national boundaries.

This account of the Guidelines is written because a final draft has been agreed for presentation to the next meeting of COP at Buenos Aires in 1996. A first version was written by a small group of experts in regulatory matters (6), was considered by a larger expert group (7) and was subjected to review by regional groups. Finally there was a global consultation meeting in December 1995 which discussed the modifications proposed at the earlier meetings and developed the final draft (8).

In the Guidelines, the term "organisms with novel traits " is used instead of "living modified organisms resulting from modern biotechnology"; the latter terminology was used in Agenda 21 and in the Biodiversity Convention (2). The glossary of terms present in the Guidelines defines "organisms with novel traits" as "organisms produced by genetic modification and whose resultant genetic make-up is unlikely to occur in nature. These do not include organisms obtained by conventional techniques and traditional breeding methods." The Guidelines are thus, in common with many other regulatory documents, concerned with genetically modified organisms (GMOs).

The Guidelines are necessarily more widely based than regulatory documents produced in other countries and communities, because they are intended to apply world wide, including areas where the necessary technology to apply them is not well developed. Previous Guidelines intended for international use, such as those produced by OECD (9,10) , havedefined the requirements for control but have not specifically addressed this issue. Section VI of the Guidelines, entitled Capacity Building, notes that "the implementation of the Guidelines depends on the availability of human and financial resources, information, institutional and/or infrastructural capacities at national regional and international levels" and that "Such resources and capacities are currently either not available or are not adequate in a number of countries at various levels." The Guidelines therefore include a number of recommendations intended to lead to increased capacity to apply them and also outline collaborative measures which would assist in their application in the interim period.

The Guidelines fall into discrete sections. Firstly, Chapter 1 introduces the topic and in 17 paragraphs sets out the basis on which they have been developed. Although earlier versions emphasized the importance of socio-economic factors in assessing the environmental impact of biotechnology, the present document (para 16) declines to address these issues.

Chapter 2 sets out general principles and considerations and bases the Guidelines firmly on the principles of risk assessment and risk management. It notes that the concern about some organisms produced by modern biotechnology is that their genetic make-up is unlikely to develop naturally. However, it also notes that the risks associated with environmental release of others, which are "well known agricultural crop plants in well known agricultural environments, will in most cases be the same in kind as those associated with the parent organisms and can be dealt with satisfactorily by comparable mechanisms".

Chapter III sets out the factors which must be taken into account in assessing the risks to human health and the environment from organisms with novel traits. It discusses risk assessment and then risk management but reserves detailed discussion of these to annex 3.

Chapter IV considers the mechanisms at national and regional level which will provide for safety. The significance of the existence of, or of access to, strong mechanisms for control and oversight is emphasized and the obligations of those wishing to transfer across boundaries, those requesting transfer and of authorities are clearly set out. Public participation via access to the information on which decisions are based is emphasized, again in accordance with the principles outlined in Agenda 21.

Chapter 5 is a key section for it discusses collaborative mechanisms at the international level which will assist countries and regions to make informed decisions, exploiting information supply and exchange where appropriate. It notes that it will be necessary to establish or designate "focal points" for the receipt of biosafety-related information and that confidential commercial information needs to be protected.

A section of major significance relates to supply of information related to transboundary transfer of organisms with novel traits. The basic principle is that any such transfer should require the "user" to provide information to "the user or appropriate focal points in the receiving country." This is especially significant to those countries without well developed mechanisms for oversight of such transfer. A crucial definition is that of user as "Any persons, institutions or organisations (including companies) responsible for the development, production, testing, marketing and distribution of organisms with novel traits" (Members of the general public are not regarded as users except in special circumstances.)

There are two situations regarding the need for information in connection with transfer across boundaries:

a) where information may be transferred together with the organism and

b) where information must be provided ahead of transfer of the organism to focal points or other oversight centres and where eventual transfer is subject to "advanced informed agreement."

The first situation is appropriate when organisms are to be used in containment, as for example in research and development (but not on the industrial scale - see below) or for storage in collections. The information provided should allow the receiving country to undertake a risk assessment. Where storage in collections is concerned, the required information may consist of the identity and possible hazards of the organism, together with relevant information on appropriate storage procedures.

Where prior informed agreement is required, examples of the information which would need to be supplied are given. Focal points in receiving countries are asked to make clear the precise information needed to those wishing to transfer organisms.

It should be noted that contained use on the industrial scale is subject to the prior informed agreement mechanism, though contained use for smaller scale work is not. This is because the release of large quantities of organism by accident or routine may have adverse effects on human health and the environment.

The Guidelines contain various other points which those intending to transfer organisms with novel traits will need to consider and for this reason, the full text of the Guidelines is given below. As a generalisation, the Guidelines as a whole fit well into the pattern already established in countries where the control of GMOs is well established and to have made valuable proposals for mechanisms which will allow countries with a less well developed infrastructure to handle the problems of transboundary transfer of such organisms.

REFERENCES

1 UNCED, 1992. Agenda 21

2 UNEP, 1992. Convention on Biological Diversity, June 5, 1992

3 UNEP, 1994. Report of the First Meeting of the Conference of the Parties to the Convention on Biological Diversity

4 UNEP, 1995. Report of the Second Meeting of the Conference of the Parties to the Convention on Biological Diversity

5 Fritze, Dagmar, 1995. Biosafety policy developments under the Convention of Biological Diversity: a Report of a Meeting of Experts in Madrid, July 1995. BioSafety,Volume 1, Paper 9 (BY95009), September 15th 1995. Online Journal, URL - http://bioline.bdt.org.br/by

6 UNEP, 1995. Report, panel of experts on biosafety,

CDB/Biosafety Panel/5/L.1

7 UNEP, 1992. Report of the Open Ended Ad Hoc Group of Experts on Biosafety, UNEP/CBD/COP/2/7.

8 UNEP, 1996. International Technical Guidelines for Safety in Biotechnology, UNEP/Global Consultation/Biosafety/4

9 OECD, 1986. Recombinant DNA Safety Considerations, Paris.

10 OECD, 1992. Safety Considerations for Biotechnology, Paris

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