History of the Food and Drug Administration
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the "United States Pharmacopoeia" or the "National Formulary". The act also banned "misbranding" of food and drugs. The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.
Pesticide regulation in the United States
In 1970, President Richard Nixon created the Environmental Protection Agency (EPA) and shifted control of pesticide regulation from USDA, DOI, and FDA to the newly created EPA. By this time public awareness of potential human health and environmental health effects had increased. In addition, some members of congress began to express concerns about the adequacy of pesticide regulation. The growing public concern created political pressure for pesticide regulation reform. These changes contributed to an environment that enabled an overhaul of pesticide regulation. FIFRA was amended in 1972 by the Federal Environmental Pesticides Control Act (FEPCA). FEPCA required manufacturers of new pesticides to perform a variety of tests to prove that the pesticide did not have "unreasonable adverse effects" on human health or the environment. Already registered pesticides were to be reregistered using these new requirements. The EPA was given the authority to refuse registration to any pesticide it concluded had risks for humans, wildlife, and/or the environment that outweighed the pesticide's benefits. In addition, pesticide registration data was required to be made available to the public after a pesticide had been registered. Pesticides that had been registered prior to 1972 could only be banned after a special review board was convened and determined the pesticide was hazardous. If this occurred, the indemnity clause of FEPCA required the EPA to compensate pesticide manufacturers, distributors, and users for the value of any unused stock they possessed. FEPCA also required EPA to review the registration data from pesticides registered prior to 1972, but did not appropriate funds for the task.
The reregistration process was beset by difficulties throughout the 1970s. FEPCA required the reregistration process to be complete by 1976; however EPA did not begin reregistration until the fall of 1975. Shortly after beginning the reregistration process, congressional investigations revealed that the EPA was taking shortcuts that undermined the purpose of reregistration. EPA was confirming the presence of registration data rather than determining whether the data was adequate. Shortly after this was revealed, an investigation into Industrial Bio-Test Laboratories (IBT) found that it had been routinely falsifying tests. IBT was the nation's largest independent laboratory that conducted toxicity tests. The EPA and the Canadian Department of Health and Welfare determined that "only about 10% of the over 2000 IBT studies which had been submitted in support of pesticide registrations were valid." After these two setbacks, EPA suspended its reregistration program in August 1976. EPA did not restart reregistrations until 1978.