Use of Prior Reviews

Applications for field tests or market releases in developing countries in many cases involve GMOs previously approved by national biosafety committees elsewhere in the world. The findings of these committees are a valuable resource because they can direct subsequent reviewers to specific areas of concern and indicate how these concerns might be addressed. Sharing documentation from prior reviews helps build familiarity with specific GM products, gives insight into management procedures, provides direction on additional information that may be needed for the current review or at later stages in the development process, and raises the confidence with which decisions are made.

The validity of conclusions from risk assessments conducted in other countries is limited, however, by the extent to which there are significant differences in environmental, ecological, and agronomic conditions. Existing biosafety data should be acceptable but are not necessarily sufficient for reviews conducted elsewhere, particularly in countries that are centers of origin or centers of diver sity for certain crop species. Local experts will need to evaluate the available data. They may request that additional data pertaining to local conditions be provided before approval can be given or that additional safety data be collected during the field-testing phase of a GM product with commercial potential. Regional environmental similarities and crop preferences may allow neighboring countries to share biosafety data and collaborate on environmental risk assessments for the region. This approach offers advantages in sharing biosafety costs and expertise within the region and reduces duplication of effort, yet leaves decision making to national authorities.

To facilitate access to previous biosafety review data, the Secretariat for the Cartagena Protocol on Biosafety will provide a clearing house2 for biosafety data that can be accessed by national scientific review and decision-making committees. This database will house information that addresses concerns about specific GM products in specific environments and methods to manage and monitor them. Parties to the protocol will be required to submit their biosafety information to the clearing house.

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