Biosafety Regulation
Jos Bijman
Keywords:  Biosafety/Foodsafety; Developing countries (general); Policies/Programmes; Genetic engineering. 
Correct citation: Bijman, J. (1994), "Biosafety Regulation." Biotechnology and Development Monitor, No. 18, p. 14­15.

Biosafety regulation in most developing countries is still in its infancy. The ecological and economic importance of such regulation, however, is undoubted. Appropriate biosafety regulations are one of the prerequisites for a successful transfer of biotechnology to and among developing countries. Major issues in the debate on biotechnology regulation are the up­scaling of field trials, harmonization of regulations, and capacity building in developing countries.

Biosafety regulation is a tool for the safe deployment of biotechnology applications into the environment. It is a special form of environmental impact assessment, focusing on the direct biological consequences of applying genetically modified organisms (GMOs). As part of this assessment, the nature of the organism, the environment where the organism is to be released, and the species interaction are analyzed. Although biosafety concerns all GMOs, transgenic crop plants are one of the main targets for developing countries, at least in the short term. Field trials constitute a major part of the impact assessments of transgenic plants.

Field Trials
In most industrialized countries, biosafety regulations have been implemented since the mid 1980s, although significant regulatatory differences between some of these countries exist. Large experience has been built up, both in the regulatory process itself as in analyzing the environmental impact of transgenic crops through small­scale field releases. Up to December 1992, more than 1,180 small­scale field trials with transgenic plants have been conducted in the OECD countries. Beside assessing the environmental behaviour of the transgenic plants, these trials are also conducted to examine the expression of the newly introduced trait.
The traits most commonly tested in those trials are resistance to herbicides, viruses and insects, as well as some quality characteristics. Herbicide resistance alone accounts for 40 per cent of the total number of trials. This high percentage reflects both scientific and commercial interests. In research on transgenic crops, herbicide resistance genes are often used as marker genes for the selection of successfully modified plants. At the same time, commercial interest for herbicide resistance comes from agro­chemical companies seeking new markets or safeguarding the existing market shares for their herbicides.

Up­scaling of trials
Although a large number of small­scale field trials have been conducted, their outcome does not necessarily predict safety on a commercial scale. The ecological risks of transgenic crops depend on relatively rare events occasioned by the interaction of particular plants with a particular environment. According to a report of the US Union of Concerned Scientists (UCS), commercial use on a large scale vastly increases the opportunities for the rare harmful conjunctions of factors to occur:

The UCS report offers a framework and guidelines for analyzing the environmental risks of large­scale, commercial use of transgenic crops. The issue of up­scaling has also been discussed within the OECD. As a result, the OECD has developed a set of scientific principles for the environmental safety of the large­scale use of transgenic plants. These guidelines, which still have to be published, are intended for the regulatory agencies, scientists and industries. These guidelines contend that experience and knowledge gained by traditional plant breeding is essential. The more that is known about a given plant, its traits, its environment and their likely interactions, the easier risk/safety­analysis and subsequent risk­management will be.

Many NGOs and bilateral and multilateral agencies are presently involved in providing direction and assistance in developing appropriate regulations and technical expertise for implementing them (see also Monitor no. 10). A major issue in these international initiatives is harmonization of regulation. Harmonization means that regulatory requirements are made compatible and that reviews are made consistent with each other. This does not mean that all countries should have identical policies, priorities or strategies. The goal is uniformity in requirements for data collection and testing procedures, and the exchange of information. Eventually, the outcome of national regulations depends on public perceptions and public acceptance, as well as on cultural and institutional processes.
Harmonization of regulations has many advantages: (1) regulatory authorities may benefit from experiences in other countries, both on the organization and the content of risk analysis, (2) it may foster technology transfer as it installs confidence and simplifies the preparation of field trial applications, and (3) it may protect developing countries from being used as a testing ground for field trials that would not be permitted in other countries.

Developing countries
The overwhelming majority of developing countries, however, do not have regulatory or monitoring procedures in place, mainly because of lack of monetary and enforcement systems, and often inadequate institutional capacity. Notable exceptions are India and the Philippines, which established regulations and incorporated them in national laws. Others, such as Argentina, Bolivia, Brazil, China, Colombia, Costa Rica, Cuba, Indonesia, Malaysia, Thailand and Zimbabwe, either have ad hoc committees or are in a more or less advanced stage of drafting regulations. These ad hoc committees are generally set up to review field trial applications for transgenic plants. Although the number of field trials does not come near the above mentioned number in the OECD area, it is increasing steadily. In Latin America alone, over 60 field trials have been conducted in the last three to four years.

Co­ordination and capacity building
Most developing countries are still in a process of designing and implementing safety regulations. This stage offers opportunities for international co­ordination of national approaches. Such co­ordination is carried out by, for example, the Interamerican Institute for Cooperation on Agriculture (IICA), for several regions within Latin America, and the International Service for the Acquisition of Agri­biotech Applications (ISAAA) for selected regions. Harmonization issues also have been discussed at the African Regional Conference for International Cooperation on Safety in Biotechnology, held in Zimbabwe in October 1993 (see also Monitor no. 17).
The harmonization activities of IICA and ISAAA are largely a capacity building endeavour, since regulation is only as good as the people who develop and enforce it. Therefore, capacity building means (1) the training of those nationals who will be developing and implementing biosafety regulatory mechanisms, and (2) the sharing of experience with agencies that are already for many years involved in developing and implementing such regulations. This can be done, for example, through small but intensive workshops that would enable participants to receive hands­on experience relevant to the procedures and issues.
For transnational biotech companies there is also a clear interest in establishing and harmonizing biosafety regulation in developing countries. Firstly, if a regulatory system is in place, companies can share responsibility with regulatory authorities, in case something goes wrong. Secondly, supporting regulation may provide a chance to influence the content of the regulation. And thirdly, implementing and harmonizing regulation can avoid unfair competition from companies located in countries without strict safety regulation. Several international biotech companies contribute to the ISAAA initiative.

Screen: Newsletter on biosafety
The European Union decided recently to support a newsletter, Screen (Swift Community Risk Evaluation Effort Network), on the release and regulation of GMOs, to facilitate the flow of information between the national authorities of European countries, scientists and regulatatory bodies. In a later stage, the newsletter will focus on the safety of GMO­related foods and intellectual property protection.
Although the newsletter focuses on European countries, the discussed themes might also be of interest to other parts of the world. 
Screen is available free­of­charge. Recipients are expected to reciprocate by providing annually half a page describing their activities on biosafety. Applicants from outside Europe are evaluated on their activities in the field of biosafety. For more information, contact:

Dr. Gert E. de Vries
ProBio Partners
Meerweg 6
9625 PJ Overschild
The Netherlands
Phone: (+31) 5966 321
Fax: (+31) 5966 508

Risks versus benefits
The procedures for risk assessment of transgenic plants should provide scientific (often quantitative) information about the chance of an adverse effect (a hazard) to occur. Field trials (small­ and large­scale) are the main method for gathering this information. But there is always the next phase of weighing the outcome of these trials. This is the phase of balancing risks against benefits. In this balancing, ecological effects are only one of many items to be evaluated. Acceptance of risk depends on many factors, such as the expected benefits, the kind of products involved, the possibility to avoid the risks and the 'need' for new products or technologies. Also important are the perception of the public and the reliability of the agency providing information on risks and benefits.
The evaluation of potential risks against expected benefits may vary between different (groups of) countries. When application of biotechnology for food production is involved, industrialized countries can more easily afford to place higher priority on health and environmental quality, whereas developing countries have to be more concerned with the production and distribution of food. Thus, developing countries may be more inclined to accept certain ecological risks associated with biotechnology, if the application of this technology results in enhanced food supplies.
More often the dichotomy is not between "North" and "South", but between different groups of actors within industrialized and developing countries: Between entrepreneurs and consumers, and between biotechnologists and ecologists. As entrepreneurship is inherently a risk­taking activity, entrepreneurs may be more inclined to accept certain risks than consumers. Consumers can "wait and see"; if their risk perception of certain product is too high, they can decide not to buy that product. Biotechnologists focus on the genes of an individual plant, and stress that genetic engineering has opened a large range of options for improvement of plant production. Ecologists (and environmentalists) focus on the effect of transgenics on the ecosystem. While biotechnologists stress how much is known about the genetic make­up of a plant, ecologists stress the lack of information on the behaviour of the plant in often complex ecosystems.
It follows that acceptance of risk and the evaluation of risk against benefit is very much influenced by the position and interests of the actors involved. This also makes the discussion and decision­making on biosafety regulation a difficult issue.
Jos Bijman

S. Sumida (1994), "Plant Biotechnology Comes of Age". The OECD Observer, no. 185, Dec. 1993/Jan. 1994, p. 9­11.

A. F. Krattinger, W. Lesser and G. Mudge (1993), Implementation of Biosafety Regulatory Mechanisms under the Biodiversity Convention. Geneva: International Academy of the Environment.

J. Rissler and M. Mellon (1993), Perils amidst the Promise: Ecological risks of transgenic crops in a global market. Cambridge, MA: Union of Concerned Scientists.

Contributions to the Biotechnology and Development Monitor are not covered by any copyright. Exerpts may be translated or reproduced without prior permission (with exception of parts reproduced from third sources), with acknowledgement of source.


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