Risk Assessment is Subjective

Although risk assessment ideally should be objective and unbiased, the process is necessarily affected by the unavoidable biases and limitations of individual reviewers - their education, work experience, social values, and cultural background. External factors such as policy decisions at local, regional, or national levels, and public perceptions and attitudes likewise color the context for biosafety committee deliberations. These factors will affect reviewers' comprehension, analysis, and judgment.

Objective biosafety assessments should be based on the best science available. (As we discussed earlier, decision making on the use of GMOs also takes into account various nonsafety factors such as economic impact, dietary and nutritional needs, religious and social values, and the like.) In reality, however, other influences will creep into the assessment process. For example, national policy determinations on the institutional home of biosafety and type of regulatory instrument employed (e.g., regulations under the ministry of environment vs. biosafety legislation in the ministry of agriculture) will shape assessment objectives and the configuration of review panels. Figure 1 (page 8) suggests a balanced influence of these factors on risk assessment, but this is rarely obtained in practice. It is much more likely that one or two of these factors will dominate the decisions that will be made.

This is certainly so when dealing with biological materials and their potential interactions in the environment. The number of possible permutations and combinations will easily challenge the most talented assessor. Whether risk assessment methodology is considered a "scientific activity" or an "analytical tool," understanding and using it may be the only acceptable means for making determinations for the safe development and use of biotechnology products.

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