Normally when scientific data is used rationally in decisions that affect society, it is done in the context of specific rules and procedures. For example, the law requires the Commissioner of the Food and Drug Administration to determine that a drug is efficacious before it can be sold, and a formal procedure exists whereby a proponent of a drug can determine, in advance, what exactly needs to be done in order to demonstrate that drug is efficacious. The rules constrain the judgment of the decision-makers at FDA and, in particular, they specify what kind of evidence indicates that a drug is, in fact, efficacious.

Federal law regarding the use of pesticides provides another example. The law requires that pesticides be safe and non-injurious to the general population, and the factual determination whether a given pesticide meets the legal requirements is made pursuant to a set of rules and a procedure that are known, in advance, to all participants in the application process.

The Director of the NIEHS, in contrast, was effectively hamstrung because the law required him to determine whether powerline EMFs affect human health, but it provided no methodology or standards by which the Director could make such a judgment. The question simply cannot be answered on the basis of laboratory and epidemiological data and biophysical analysis alone, and these were the only resources potentially available to the Director. These issues are discussed below in detail.