Regulatory decision‐making often faces the question of what is an appropriate level of evidence. For instance, which approach is better suited to regulate potentially toxic chemicals: obtaining the best—most complete, most accurate, and so on—information that science is able to produce on each individual compound or relying on more basic knowledge to quickly assess a wide range of compounds? The first one would appear as the obvious answer, but, given the time and resource constraints under which regulators often operate, it may not be the most efficient one. Gathering the most complete and accurate scientific information means that regulatory agencies would be able to deal with only a limited number of substances. In contrast, by limiting the required evidence, they might be able to regulate many more substances albeit at the risk of sometimes making wrong decisions.
The key issue is how to establish the appropriate level of evidence for regulatory purposes and to choose the scientific methodologies best suited for generating this evidence.
This is a typical dilemma faced by regulatory agencies in many areas, and the example above is the cause of ongoing controversy among regulators, manufacturers, environmentalists, and public health advocacy groups. The key issue is how to establish the appropriate level of evidence for regulatory purposes and to choose the scientific methodologies best suited for generating this evidence.
Another example shows how the same dilemma befalls the field of benefit assessment. Many foods with health claims assert that certain ingredients will confer health benefits for consumers, beyond the nutritional characteristics. Again, what is the appropriate regulatory strategy: to analyze the product in question using the most accurate and complete scientific methodologies at hand, even if that means that only a small number of products will achieve authorization? Or recurring to basic or incomplete scientific information, to …
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