response evaluation, exposure assessment, and risk characterization. 1 The definitions of those and other terms in the National Research Council's (NRC's) “Red Book” (NRC 1983) are widely used and generally accepted.

Hazard identification is “the determination of whether a particular chemical is or is not causally linked to particular health effects” (NRC 1983). Hazard is usually determined experimentally in controlled experiments with known doses. In the case of pest-protected plants, hazard would be the effect of a gene product (such as Bacillus thuringiensis (Bt) toxin, or a secondary plant product, such as a glycoalkaloid) which is expressed or changed as a result of genetic modification. The effects of gene flow or the effects on nontarget organisms could be considered potential hazards for ecological risk assessments.

Dose-response assessment is the determination of the relationship between the magnitude of exposure and the probability of occurrence of the adverse effect in question. Dose-response assessment can address the potency or severity of the hazard. For example, many substances lead to adverse effects only at high doses and might be regarded as posing less severe hazards. The relationship between dose and adverse effects for a particular hazard is reflected in the dose-response curve. In the case of pest-protected plants, some proteinase inhibitors require very high concentrations to cause adverse health effects (Ryan 1990). On the other hand, some plant glycoalkaloids cause adverse health effects at relatively low doses. This allows toxicants to be ranked according to “relative hazard” which is not the same as “relative risk.” Overall risk is the product of the likelihood of an adverse consequence and the severity of that consequence. Hazard severity, and probability and magnitude of exposure all contribute to the overall risk. The risks that may be posed by proteinase inhibitors and glycoalkaloids could be similar depending on the probability and magnitude of exposure.

Exposure assessment is the determination of the extent of exposure to a toxicant under any stated set of circumstances. In the context of pest-protected crops, exposure of nontarget species to a plant-pesticide might be considered for ecological risk assessment, and exposure of humans to a plant-pesticide for human health risk assessment. Exposure assessment of pest-protected plants should deal with such questions as how much of the toxicant humans consume, concentrations in the edible portions of the crop, and how often and how much nontarget insects consume.

Risk characterization considers all the above and is often reported as a quantitative assessment of the probability of adverse effects under de-

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Note that these essential steps may be categorized and/or termed differently in various risk assessment frameworks.



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