The congressionally enacted Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) is a comprehensive regulatory program for pesticides and herbicides enacted in 1972 and amended nearly 50 times between that time and 2012. The goal of FIFRA is to regulate the use of pesticides through registration.
The Environmental Protection Agency (EPA) is the primary regulatory agency of pesticides. Section 3 of FIFRA mandates that the EPA must first determine that the product “will perform its intended function without unreasonable adverse effects on the environment” before it is registered. The act defines adverse effects as “any unreasonable effects on man or the environment, taking into account the economic, social and environmental costs and benefits of using any pesticide.” To further this objective, Congress placed a number of regulatory tools at the disposal of the EPA. Congress also made clear that the public was not to bear the risk of uncertainty concerning the safety of a pesticide. To grant registration, the EPA must conclude that the food production benefits of a pesticide outweigh any risks.
To make the cost-benefit determination required to register a pesticide as usable, manufacturers must submit to the EPA detailed tests on the chemical's health and environmental effects. The burden rests on the manufacturer to provide the data needed to support registration for use on a particular crop. The pesticide manufacturer is required to submit certain health and safety data to establish that the use of the pesticide will not generally cause unreasonable adverse effects. Data required include disclosure of the substance's chemical and toxicological properties, likely distribution in the environment, and possible effects on wildlife, plants, and other elements in the environment.
FIFRA embodies the philosophy that those who would benefit from government approval of a pesticide product should bear the burden of proof that their product will not pose these unreasonable risks. This burden of proof applies both when initial marketing approval is sought and in any proceeding initiated by the administrator to interrupt or terminate registration through suspension or cancellation. Of course, while putting the burden on industry, the assumption is that industry will be honest in its research and reports.
FIFRA is a licensing law. Pesticides may enter commerce only after they are approved or registered. They must be evaluated against existing statutory risk/benefit standards. The administrator may take action to terminate any approval whenever it appears, on the basis of new information or a reevaluation of information, that the pesticide no longer meets the statutory standard. These decisions are made on a use-by-use basis since the risks and benefits of a pesticide vary from one use to another.
FIFRA is also a control law. Special precautions and instructions may be imposed. For example, pesticide applicators may be required to wear protective clothing, or the use of certain pesticides may be restricted to trained and certified applicators. Instructions, warnings, and prohibitions are incorporated into product labels, and these labels may not be altered or removed.
Licensing decisions are usually based on tests furnished by an applicant for registration. The tests are performed by the petitioning company in accordance with testing guidelines prescribed by the EPA. Requirements for the testing of pesticides for major use can be met only through the expenditure of several millions of dollars and up to four years of laboratory and field testing.
Major changes in test standards, advances in testing methodology, and heightened awareness of the potential chronic health effects of long-term, low-level exposure to chemicals that came into the marketplace between the 1970s and the early 2000s brought the need to update EPA mandates. Thus, Congress directed the EPA to reevaluate its licensing decisions through a process of re-registration. That means previous governmental approval does not necessarily mean continued governmental approval.
The EPA has the power to suspend or cancel products. Cancellation means the product in question is no longer considered safe. It must be taken off the commercial market and is no longer available for use. Suspension means the product in question is not to be sold or used under certain conditions or in certain places. This may be a temporary decision, usually dependent on further studies.
There may be certain products that, in the opinion of the administrator, may be harmful. However, no action is taken if and when the action is incompatible with administration priorities. The EPA administrator is responsible to the directives and priorities of the President and the executive branch. Thus, some regulatory decisions are political.
From 1978 to 1983, the General Accounting Office (GAO) and the House Subcommittee on Department Operations, Research and Foreign Agriculture of the Committee on Agriculture (DORFA Subcommittee) thoroughly examined the EPA's implementation of Section 18. Under the auspices of Chairman George E. Brown Jr. (D-CA), the DORFA Subcommittee held a series of hearings that revealed numerous abuses in the EPA's administration of Section 18. A report was issued in 1982 and reprinted as part of the Committee's 1983 Hearings.
The subcommittee found the number and amount of pesticides being applied under Section 18 had increased rapidly. This increase was primarily due to a significant number of Section 18 exemptions resulting from a failure to register chemicals under Section 3 of FIFRA in an appropriate timeframe. The DORFA committee pointed out that a chemical was often stalled in the Section 3 review process because of regulatory actions related to suspected human carcinogens. States would easily bypass this hold-up by requesting Section 18 action, which had more lenient risk assessment procedures.
The EPA practices changed little over the next eight years. In the spring of 1990, the Subcommittee on Environment of the House Science, Space and Technology Committee, chaired by James H. Scheuer (D-NY), investigated the EPA procedures under Section 18 of FIFRA and found, if anything, the problem had gotten worse. The report found that more than 4,000 emergency exemptions had been granted since 1973 for the use of pesticides on nonregistered crops. A large number of emergency exemptions had been repeatedly granted for the same uses for anywhere from 5 to 14 years. The House Subcommittee also found the EPA required less stringent testing procedures for pesticides under the exemption, putting companies that follow the normal procedure at a disadvantage. The subcommittee concluded that the large numbers of emergency exemptions arose from “the EPA's failure to implement its own regulations.”
Emergencies were defined by the subcommittee as “routine predicted outbreaks and foreign competition” and “a company's need to gain market access for use of a pesticide on a new crop, although the company often never intends to submit adequate data to register the chemical for use.”
As for the re-registration requirement, the subcommittee observed that Section 18 requests were frequently for older chemicals that the EPA had difficulty re-registering. As a result, these chemicals are often granted repeated exemptions for use even though they may be carcinogenic. This procedure offers little incentive for companies to develop alternatives that would be safer and instead creates a loophole by which dangerous chemicals are allowed to remain in use.
In 2003, Congress passed the Pesticide Registration Improvement Act (PRIA), which established registration service fees for the registration of pesticides under three programs: antimicrobials, biopesticides and pollution prevention, and the registration divisions. PRIA, along with the Pesticide Registration Improvement Renewal Act of 2007 (PRIA 2), sought to establish a more predictable registration review process and to create shorter review periods for less risky applications.
See also Environmental Protection Agency (EPA) ; Insecticide poisoning .
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Liane Clorfene Casten