The Biosafety Files, a new link in biosafety information

by

Niels Louwaars, Willem Brandenburg, Luud Gilissen, Gijs Kleter and Jaap Wagenaar

Risk assessment by a competent authority should precede the release of genetically modified organisms (GMOs) into the environment and food chain. Capacity building to ensure comprehensive risk assessment is a major challenge for governments, especially those in developing countries. Access to scientifically verified biosafety information is an obvious field for international cooperation that several online initiatives are seeking to address. The Biosafety Files described here is a new Dutch contribution to risk assessment capacity.

Risk evaluation
As with all new technologies, governments have an active role to play in avoiding negative side effects of new technologies on health, the environment, economy and culture. The Cartagena Protocol on Biosafety (CPB) provides a general framework, in which basic principles have been agreed upon, such as the precautionary principle, the principle of substantial equivalence and the case-by-case/step-by-step approach to risk assessment.
Governments have to provide for a competent authority, which guides the introduction of GMOs in the environment and/or the food chain. Approval of release is based on a risk evaluation, which consists of three separate activities:

• thorough technical analysis of all potential effects,
• analysis of what effects may imply hazards to the environment and/or health,
• consideration of which hazards are perceived by the public and the government as risks, and of the balance between expected negative and positive effects.

Governments need to have access to substantial human capacity in order to perform this important task properly. The analysis of effects requires a thorough understanding of the technologies applied (DNA-constructs), of reproductive biology and ecology, and of various aspects of food science and health. Data assessment, analysis of effects, and hazard identification are scientific activities that need fully trained scientists, who can do their job with a sound scientific and technical background, and a critical mind to formulate relevant questions.
Values become important in the second analysis, for assessing whether effects may be considered risks. For example, possible transfer of a herbicide resistance gene in oilseed rape to wild relatives that occur in the same area may be considered a serious risk as weeds may quickly create super-weeds. However, possible transfer of a gene to change oil qualities in the same crop, may not be considered so much of a risk if the principle is followed that every added foreign gene carries a fitness reduction 'cost'.
In the latter phase, the risk-benefit analysis will trigger a political decision on whether or not to accept certain risks through full or partial release. Competent authorities should require the applicant to provide extensive research data on environmental and health effects of the GMO, similar to release requirements for medicinal products. The national authority has to be able to scrutinise this information, and to identify possible gaps. Gaps that may be filled by the applicant or through public research.

Capacity requirements - training and information needs.
Developing countries have limited human resources in these new fields of science. The first biotechnologists in a country are generally employed in research rather than regulatory services, yet countries may regularly receive applications for release of genetically modified (GM) crops.
Training programmes on the regulatory aspects of GMOs are few and have to combine regulatory and technical aspects in order to prepare participants for their important task. Several international organisations have been active in this field for several years organising ad-hoc training sessions or providing those organised by others with information (see box below for the most active organisations). Several national organisations have been active in specific countries and programmes, such as the Stockholm Environmental Institute (SEI, Sweden) and their East African partners in the East African Regional Programme and Research Network for Biotechnology, Biosafety and Biotechnology Policy Development (BIO-EARN), an Indo-Swiss Collaboration in Biotechnology, and a Netherlands programme Implementation of national Biosafety frameworks in pre-accession countries of Central and Eastern Europe.
Next to the human resources and the physical facilities to perform biosafety-related research, authorities particularly require access to information. Not all information is so location-specific that extensive research needs to be performed in each country. Pooling biosafety information is a very effective means of international cooperation. It reduces the dependency of competent authorities on information supplied by the (commercial) applicant, and it may provide the newest data on any new product. A prerequisite is that such information is publicly available to ensure critical scrutiny. Several such information systems have been developed.
ICGEB has a biosafety database with a large number of links to other sources of biosafety information, UNIDO's Biosafety Information Network and Advisory Service (BINAS) has its own system called DTREE and information is available in various national information systems, such as the Hungarian Database of Environmental Releases of GMOs. ISAAA is distributing useful information which has been developed in close cooperation with industry. All these sources have been set up to create a more transparent situation but all have their specific merits and drawbacks.

The Biosafety Files
Several available databases are not very systematic and difficult to search, limited to either environmental or food safety aspects, or they are linked with information that is clearly biased, promoting the widespread use of GMOs. Wageningen University and Research Centre is working on an easy-to-use information system with only scientifically reviewed information, containing as much raw data as possible, to make it independent of bias caused by the results of earlier analysis. The Centre will host this system at http://www.biosafety.nl under the name Biosafety Files.
The biosafety files currently consists of three interlinked databases: Gene Files, Botanical Files and Food Files. It thus combines knowledge on the DNA-level, the crop level and the product level.

• The Gene Files is a database with generic information on genes, promoters and selection sequences. It provides a clear basis for analysis as a source of synonyms and primary information on the relevant sequences. The information can be used directly all over the world.
• The Food Files contains information on food safety aspects of GM crops, including composition analysis, animal tests, potential allergenicity of novel proteins, and stability of foreign DNA and proteins. Combining this generic safety data with local consumption patterns will allow for the assessment of risks at a local level. These local consumption patterns may be obtained from other databases. As such, the food files need to be interpreted in the framework of the United Nations Codex Alimentarius and the European Union Novel Food Regulations.
• The Botanical Files provide data on the possibility of a crop to outcross with wild and weed relatives and with conventional landraces and other varieties of the same crop plant. These files are based on maps that are developed by local botanists using their national or regional flora and information from researchers (especially breeders). Currently, botanical files are developed in Europe and Eastern Africa. The files provide a multiple-entry method of analysis where a specialist checking a particular application can find basic information on the gene, the crop and food safety. There are also plans to introduce information on animal GMOs as well.
  Currently, the Wageningen UR Biosafety Files are under construction. The authors welcome comments on the concepts in this article and the Biosafety Files, which will be in operation by April 2002.

Niels Louwaars*, Willem Brandenburg, Luud Gilissen, Gijs Kleter and Jaap Wagenaar,
* Wageningen University and Research Centre, Plant Research International, PO Box 16, 6700 AA Wageningen, The Netherlands.
Phone +31 317 477 003, Fax +31 317 418 094,
Email: n.p.louwaars@plant.wag.ur.nl

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