The risk assessment and risk management process, as it has evolved over the past decade, is
complex and often idiosyncratic; that is, procedures vary on a case-by-case basis depending on the
country, the agency charged with oversight, the mandates of the relevant statute, and the specifics
of the proposed trial. Increasingly, we are becoming aware that the consideration of biological
hazard is complex. Any activity which introduces living organisms or the products of living
organisms into new environments deserves, and may legally require, consideration of possible
hazard and level of risk. One must consider the hazards to all species and their habitats.
Inappropriate handling of a plant pathogen may well clearly undesirable consequences. Examples
of adverse impacts of release or escape of animals, plants, and microorganisms demonstrate the
often dramatic effects of ignorance of the hazards of such incidents. The introduction of the kudzu
vine in the southern USA and the rabbit in Australia continue to pose problems as does the
mongoose in Hawaii.
Research to estimate the hazard and exposure, assessment and characterization to combine the
factors, and a management decision based on the scientific and legal options available. Risk
management and risk control are closely related - attempts to provide containment and mitigation
procedures that can be used to conduct tests more safely or to provide some assurance that the
product can be controlled, contained or eradicated, based on acceptable legal options.
Biosafety regulation should facilitate instead of prohibit biotechnology development.
Considerations of risk versus safety are of paramount importance, but biosafety regulations should
also consider their impact on safe technology transfer, economic competitiveness, international
harmonization and global needs and acceptance. Biosafety regulation should be developed and
applied in a strategic manner. Ideally, 'strategic regulation' is based on identifiable science-based
triggers that are consistent, easily understood and transparent. Strategic regulation is flexible and
dynamic (the USA has adapted its regulation 4 times and now includes field tests on notification
and a non-regulated status transgenic plants) and meets domestic and international needs.
