To the editor:

Miller and Conko's commentary (Nat. Biotechnol. 18, 360, 2000) criticizes the Cartagena Protocol on Biosafety for the following operative provision implementing the precautionary principle: “lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism (LMO) on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the LMO … in order to avoid or minimize such potential adverse effects1.”

Consequently, decision making may take into account scientific uncertainty on a case-by-case basis: The Party of import can approve, with or without conditions, or prohibit the import. Except in a case in which consent is unconditional, a decision shall set out the reasons on which it is based. Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the LMO in the receiving environment.

The particular relevance to risk management is highlighted by a recent communication from the European Commission2 seeking to establish guidelines for applying the precautionary principle beyond biosafety. Where action is deemed necessary, measures should be (1) proportional to the chosen level of protection, (2) nondiscriminatory in their application, (3) consistent with similar measures already taken, (4) based on an examination of the potential benefits and costs of action or lack of action, (5) subject to review, in the light of new scientific data, and (6) capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment. In conclusion, adequate handling of the precautionary principle outlined in the biosafety protocol could contribute to a well-balanced mechanism for the transboundary movement of LMOs.