The U.S. Supreme Court has ruled that in reviewing the order of a public health agency, the courts should not second-guess the underlying scientific basis of the agency’s decision. This is a well-established principle, extending back to a 1905 case involving smallpox immunizations. The litigant tried to argue that he should not be subjected to smallpox vaccination because it was dangerous. [Jacobson v. Massachusetts, 197 U.S. 11 (1905) .] The court ruled that it would not second-guess the expertise of the agency in requiring the vaccination. To successfully attack an agency’s expert decision making, it must be shown that the agency acted “arbitrarily or capriciously,” which means that the agency acted without a rational basis for its decision. To defeat such a challenge, the agency must present a proper record explaining the factual and legal basis for its actions. If the record documents a proper basis for the agency’s decision, the regulated entity challenging the decision will not be permitted to bring in experts to dispute the agency’s findings. If the agency presents a proper record, and stays within its statutory bounds, the courts are very reluctant to overturn agency actions.

Most cases challenging agency scientific decision making are brought because the agency took an action. In rare cases, an agency may be successfully sued for failing to act. In one case, the Secretary of the Department of Health and Human Services refused to promulgate a rule banning the interstate shipment of unpasteurized milk. A group of public interest groups, including the American Academy of Pediatrics, sued the agency, arguing that such a rule was necessary to protect the public’s health. The agency record showed that FDA scientists had built an overwhelming record that unpasteurized milk posed a threat to the public health. The court found that the Secretary was acting arbitrarily and capriciously in refusing to promulgate the rule, and ordered her do so. [ Public Citizen v. Heckler, 653 F. Supp. 1229 (D.D.C. Dec. 31, 1986) ]