The Biosafety Files, a new link in biosafety information


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

Correct citation: Louwaars N., Brandenburg W., Gilissen L., Kleter G. & Wagenaar J. (2002), "The Biosafety Files, a new link in biosafety information." Biotechnology and Development Monitor, No. 49, p. 13-14.

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:

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.


Training on the regulatory aspects of GMOs

OECD Organisation for Economic Co-operation and Development http://www.olis.oecd.org/bioprod.nsf
ICGEB International Centre for Genetic Engineering and Biotechnology http://www.icgeb.trieste.it/~bsafesrv
IBS International Service for National Agricultural Research Service http://www.isnar.org/ibs
AgBiotech Biotech InfoNet http://www.biotech-info.net
ISAAA International Service for the Acquisition of Agri-biotech Applications http://www.isaaa.org
UNEP United Nations Environment Programme http://www.unep.org
UNIDO United Nations Industrial Development Organization - Biosafety Information Network and Advisory Service http://binas.unido.org/binas/
IAC International Agricultural Centre http://www.iac.wageningen-ur.nl/


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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