Federal Insecticide, Fungicide and Rodenticide Act (1972)
Federal Insecticide, Fungicide and Rodenticide Act (1972)
The Environmental Protection Agency (EPA) is the primary regulatory agency of pesticides. The EPA's authority on pesticides is given in the Congressionally-enacted Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)—a comprehensive regulatory program for pesticides and herbicides enacted in 1972 and amended nearly 50 times over the years. The goal of FIFRA is to regulate the use of pesticides through registration.
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 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 is a licensing law. Pesticides may enter commerce only after they are approved or "registered following an evaluation against statutory risk/benefit standards." The Administrator may take action to terminate any approval whenever it appears, on the basis of new information or a re-evaluation 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.
FIFRA embodies the philosophy that those who would benefit by government approval of a pesticide product should bear the burden of proof that their product will not pose 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.
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.
However, major changes in test standards, advances in testing methodology, and the heightened awareness of the potential chronic health effects of long-term, low-level exposure to chemicals which have come into the marketplace within the past several decades have brought the need to update EPA mandates. Thus, Congress directed that the EPA reevaluate its licensing decisions through a process of re-registration. That means if the government once approved a certain product for domestic use, it does not mean the EPA can be confident today that its use can continue.
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. But no action is taken if and when the action is incompatible with administration priorities. That is because the EPA administrator is responsible to the directives and priorities of the President and the executive branch. Thus, some regulatory decisions are political.
There is a statutory way to avoid the re-registration process. It is called Section 18. Section 18 under FIFRA allows for the use of unregistered pesticides in certain emergency situations. It provides that "the Administrator may, at his discretion, exempt any Federal or State agency from any provisions of this subchapter if he determines that emergency conditions exist which requires such exemption. The Administrator, in determining whether or not such emergency conditions exist, shall consult with the Secretary of Agriculture and the Governor of any state concerned if they request such determination."
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 Chair George E. Brown, Jr., (D-CA) the DORFA Subcommittee held a series of hearings which revealed numerous abuses in 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 that "the rapid increase in the number and volume of pesticides applied under Section 18 was clearly the most pronounced trend in the EPA's pesticide regulatory program." According to the Subcommittee report, "a primary cause of the increase in the number of Section 18 exemptions derived from the difficulty the Agency had in registering chemicals under Section 3 of FIFRA in a timely manner." The DORFA committee stated: "Regulatory actions involving suspect human carcinogens which meet or exceed the statute's "unreasonable adverse effects" criterion for chronic toxicity often become stalled in the Section 3 review process for several years. The risk assessment procedures required by States requesting Section 18 actions, and by EPA in approving them, are generally less strict. For example, a relatively new insecticide, first widely used in 1977, was granted some 140 Section 18 emergency exemptions and over 300 (Section 24c) Special Local Needs registrations in the next four years while the Agency debated the significance to man of positive evidence of oncogenicity in laboratory animals."
The EPA's 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 (Chair: James H. Scheuer, D-NY) investigated the EPA's procedures under Section 18 of FIFRA and found if anything, the problem had gotten worse. The report states: "Since 1973, more than 4,000 emergency exemptions have been granted for the use of pesticides on crops for which there is no registration." A large number of these emergency exemptions have been repeatedly granted for the same uses for anywhere from fourteen, to ten, to eight, to five years. The House Subcommittee also found that the EPA required less stringent testing procedures for pesticides under the exemption, which put 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."
The Subcommittee identified "emergencies" 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: "The EPA's reliance on Section 18 may be related to the Agency's difficulty in re-registering older chemical substances. Often, Section 18 requests are made for the use of older chemicals on crops for which they are not registered. These older chemicals receive repetitive exemptions for use despite the fact that many of these substances may have difficulty obtaining re-registration since they have been identified as potentially carcinogenic. Thus, by liberally and repetitively granting exemptions to potentially carcinogenic substances, little incentive is provided to encourage companies to invest in the development of newer, safer pesticides or alternative agricultural practices."
The report concluded, "...Allowing these exemptions year after year in predictable situations provides 'back-door' pre-registration market access to potentially dangerous chemicals.#x201D;
[Liane Clorfene Casten ]
U.S. Environmental Protection Agency. Federal Insecticide, Fungicide, and Rodenticide Act: Compliance-Enforcement Guidance Manual. Rockville, MD: Government Institutes, 1984.
"EPA Data Is Flawed, Says GAO." Chemical Marketing Reporter 243 (January 11, 1993): 7+.
"Controlling the Risk in Biotech." Technology Review 92 (July 1989): 62–9.