Pesticide regulation in the United States is primarily a responsibility of the Environmental Protection Agency (EPA). In America, it was not till the 1950s that pesticides were regulated in terms of their safety. The Pesticides Control Amendment (PCA) of 1954 was the first time Congress passed guidance regarding the establishment of safe limits for pesticide residues on food. It authorized the Food and Drug Administration (FDA) to ban pesticides they determined to be unsafe if they were sprayed directly on food. The Food Additives Amendment, which included the Delaney Clause, prohibited the pesticide residues from any carcinogenic pesticides in processed food. In 1959, pesticides were required to be registered.
In 1970, President Richard Nixon created the EPA and shifted control of pesticide regulation from the US Department of Agriculture (USDA), the US Department of the Interior (DOI), and FDA to the newly created agency. 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. In 1972, the Federal Environmental Pesticides Control Act (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.
Current law requires the EPA to consider the "ingredients of the pesticide; the particular site or crop on which it is to be used; the amount, frequency, and timing of its use; and storage and disposal practices." The EPA looks at what the potential human health and environmental effects might be associated with the use of the pesticide. The company that wishes to register the pesticide must provide data from various test that are done using EPA guidelines. These tests include: acute toxicity test (short-term toxicity test) and chronic toxicity test (long-term toxicity test). These tests evaluate: whether the pesticide has the potential to cause adverse effects (including cancer and reproductive system disorders) on humans, wildlife, fish, and plants, including endangered species and non-target organisms; and possible contamination of surface water or ground water from leaching, runoff, and spray drift. The registration process can take upwards of 6 to 9 years, and the cost of registration for a single pesticide is in the range of millions of dollars.
Background
In most countries, pesticides must be approved for sale and use by a government agency.Willson, Harold R (February 23, 1996), Pesticide Regulations . University of Minnesota. Retrieved on 2007-10-15. In the US, EPA is responsible for regulating pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Food Quality Protection Act (FQPA). Studies must be conducted to establish the conditions in which the material is safe to use and the effectiveness against the intended pest(s). The EPA regulates pesticides to ensure that these products do not pose adverse effects to humans or the environment. Pesticides produced before November 1984 continue to be reassessed in order to meet the current scientific and regulatory standards. All registered pesticides are reviewed every 15 years to ensure they meet the proper standards. During the registration process, a label is created. The label contains directions for proper use of the material in addition to safety restrictions. Based on acute toxicity, pesticides are assigned to a Toxicity Class.
Some pesticides are considered too hazardous for sale to the general public and are designated restricted use pesticides. Only certified applicators, who have passed an exam, may purchase or supervise the application of restricted use pesticides. Records of sales and use are required to be maintained and may be audited by government agencies charged with the enforcement of pesticide regulations. These records must be made available to employees and state or territorial environmental regulatory agencies.
The EPA regulates pesticides under two main acts, both of which were amended by the Food Quality Protection Act of 1996. In addition to the EPA, USDA and FDA set standards for the level of pesticide residue that is allowed on or in cropsStephen J. Toth, Jr., Pesticide Impact Assessment Specialist, North Carolina Cooperative Extension Service, "Federal Pesticide Laws and Regulations." March, 1996. Retrieved on February 25, 2011. The EPA looks at what the potential human health and environmental effects might be associated with the use of the pesticide.
Additionally, EPA uses the National Research Council's four-step process for human health risk assessment: (1) Hazard Identification, (2) Dose-Response Assessment, (3) Exposure Assessment, and (4) Risk Characterization.
History 1910 Congress passed the first law regulating pesticides, the Federal Insecticide Act, in 1910. Its focus was protecting farmers from fraudulent claims.Susan Wayland and Penelope Fenner-Crisp. “Reducing Pesticide Risks: A Half Century of Progress.” EPA Alumni Association. March 2016.
1940s FIFRA was enacted in 1947 and was a collaboration between the federal government and the chemical industry. It resulted from the increase in pesticide production during and after World War II. At that time, the concern about pesticides was related to pesticide efficacy and producer honesty. FIFRA was passed as a "truth in labeling" law. The goal of the legislation was to maintain pesticide standards while allowing new pesticides to enter the market quickly. The 1947 legislation was an example of an "iron triangle," made up of the House Committee on Agriculture, the USDA, and the pesticide industry. The legislation required that pesticide formulas be registered with USDA, and that the pesticide labels were accurate. The legislation was not intended to enact an active regulatory system; it was to enable the creation of a stable marketplace. The political climate in the US prevented major changes to the regulation due to the public's relative lack of concern, USDA's administration of the law, and agricultural interests in congress.
1950s Committee hearings in 1950-51, led by Congressman James Delaney of New York, were the first instance of government hearings concerning pesticide safety. The hearings resulted in two amendments to the Federal Food, Drug and Cosmetic Act: The Pesticides Control Amendment (PCA) and the Food Additives Amendment (FAA). These two amendments resulted in FDA involvement in pesticide regulation. The PCA of 1954 was the first time Congress passed guidance regarding the establishment of safety limits for pesticide residues on food. PCA authorized the FDA to ban pesticides they determined to be unsafe if they were sprayed directly on food. The Food Additives Amendment, which included the "Delaney Clause," prohibited the pesticide residues from any carcinogenic pesticides in processed food. In 1959, FIFRA was amended requiring that pesticides be registered.
1960s In 1962, The New Yorker published a series of essays by Rachel Carson, later published in book form as Silent Spring, that publicized the negative effects of pesticide use on wildlife. This, along with new evidence that pesticides could have negative impacts on human health, helped spur the creation of the modern environmental movement. Several government agencies, such as the Public Health Service, the Fish and Wildlife Service, and the President's Science Advisory Committee, found evidence that pesticides were negatively affecting human health. There were attempts throughout the 60's to pass legislation reforming FIFRA. The proposals included: moving FIFRA authority from the USDA to the FDA, providing greater public access to pesticide registration data, and mandating better interagency cooperation. None of these proposals gained enough support to pass in both the House and Senate. However, Congress passed an amendment to FIFRA in 1964 allowing the USDA to suspend or cancel a pesticide's registration in order to "prevent an imminent health hazard".
1970s In 1970, President Richard Nixon created the 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 re-registered 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 re-registration process was beset by difficulties throughout the 1970s. FEPCA required the re-registration process to be complete by 1976; however EPA did not begin re-registration until the fall of 1975. Shortly after beginning the re-registration process, congressional investigations revealed that the EPA was taking shortcuts that undermined the purpose of re-registration. 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 re-registration program in August 1976. EPA did not restart re-registrations until 1978.
1980s Following the 1980 election of President Ronald Reagan, industry groups attempted to get amendments to FIFRA passed. The pesticide industry was primarily interested in three things: less public access to industry data, longer exclusive use periods, and the right to sue over use of manufacturer data without the manufacturer's permission. Environmental groups prevented the amendments from passing with help from labor groups that had become concerned about the safety of pesticide workers. Until the late 1980s short term reauthorizations of FIFRA were passed, but no changes to the law were enacted.