fined conditions of exposure—for example, one in 10,000 humans will become ill given a certain set of circumstances. Hazard identification, dose-response assessment and exposure assessment are all essential elements of a risk assessment.

Standard toxicological human health risk assessment, despite problems of uncertainty and variability and the consequent difficulty in extrapolation, is science-based. Variability is the range of differences implicit in a natural population (such as the genetic variability in sensitivity to allergens); uncertainty is based on incomplete knowledge or data (such as inadequate surveys of genetic variability to allergens) or on measurement error.

Quantitative risk assessment is being used for not only cancer or toxicological risk assessment, but also for ecological risk assessment, microbial risk assessment, and other diverse types of assessment. In principle, quantitative risk assessment of transgenic pest-protected plants could be based on the methods of quantitative risk assessment if a hazard is detected. If adequate data were not available, the assessment could use uncertainty analyses, ranges of values, and extrapolation. However, until methods are adapted and applied to quantitative risk assessments for pest-protected plants, “relative hazard” ranking may be the best approach, recognizing that this is an interim solution and that quantitative risk assessment is the desired goal.

Because the fundamental elements of risk assessment, such as hazard identification, dose-response assessment, exposure assessment, and risk characterization, can also be applied to risk assessments for transgenic pest-protected plants, the committee found that

Health and ecological risk assessments of transgenic pest-protected plants do not differ in principle from the assessment of other health and ecological risks.


2.2.1 Introduction of Recombinant DNA-engineered Organisms Into the Environment (1987)

In 1987, the NAS published a summary of key issues related to the introduction of recombinant DNA-engineered (rDNA-engineered) organisms into the environment (NAS 1987). This brief white paper outlined the expected risks and benefits associated with all types of transgenic organisms, including bacteria, insects, fish, and crop plants. At the time, commercial field releases of transgenic organisms were still in the planning stages, and the impending “biotechnology revolution ” attracted en-

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