The Evolution of Domestic Law: FIFRA
The Federal Insecticide Fungicide and Rodenticide Act (FIFRA)
A number of different federal statutes address the ecological risks associated with pesticides in the US. The primary statute directly governing the regulation of pesticides is FIFRA. Several other statutes such as the Clean Water Act, the Endangered Species Act, the Migratory Bird Treaty Act, and the Organic Foods Production Act, indirectly address the ecological risks of pesticides and are discussed in the next chapter.
The most comprehensive federal law addressing pesticides is FIFRA.1 The primary federal law addressing toxic substances in general, the Toxics Substances Control Act (TSCA), explicitly excludes from its regulatory jurisdiction “any pesticide [as defined by FIFRA] when manufactured, processed, or distributed in commerce for use as a pesticide.”2 Although a version of FIFRA has been in place since 1910, the environmental movement of the 1960s directly led to substantial amendments to FIFRA that, for the first time, brought environmental considerations into the purview of the law. Brooks et al., provide a detailed exploration of the role that the ecological science of pesticides played in the development of environmental law in general and pesticide law in particular. According to Brooks et al., the 1968 Wisconsin DDT hearings, in which an environmental organization filed a petition with the Wisconsin Department of Natural Resources seeking a declaratory ruling that DDT was a pollutant, was one of the first attempts to use ecology “in a legal forum to promote environmental protection.”3 According to these authors, the Wisconsin DDT petition “rode on the fame of Rachel Carson’s Silent Spring written in 1962 and presented to a lay audience, a view of pollution as an unwelcome intruder in the “house of nature,” a complex ecosystem which magnified the effects of the pollutant.”4 Ecological concerns, including concerns with the manner in which DDT moved through the ecosystem, the way DDT bioaccummulated in the food chain, and the impact of DDT on individual bird species as well as on the community as a whole, dominated the testimony in the Wisconsin DDT hearings.5 These same ecological considerations later played a predominant role in the adoption of the 1972 amendments to FIFRA and in the subsequent cancellation of DDT by EPA.
In the US, EPA has the primary responsibility for regulating pesticides under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). Under FIFRA, EPA has the authority to regulate the sale, distribution, and use of pesticides in the US. FIFRA has its roots in the 1910 Insecticide Act, which marked Congress’ first attempt to regulate the sale and distribution of pesticides. The 1972 FIFRA amendments, which form the backbone of the current FIFRA, were not enacted as a new freestanding environmental protection initiative. Instead, the amendments were an attempt to integrate an environmental component into a then 60-year-old statute, the Insecticide Act of 1910.6 The Insecticide Act was designed to protect consumers from ineffective insecticide products and fraudulent claims about such products, which could cause crop losses. Environmental concerns did not play any role whatsoever in either the Insecticide Act of 1910 or its subsequent amendments in 1947. In fact, when President Truman signed the 1947 legislation7 amending the 1910 Act, the New York Times printed a small blurb in the “News on Food” section on page 26, describing it as a law to “color poisons.”8 At the time of its passage, the primary groups concerned about pesticides were farmers, whose interests in government were advocated by the United States Department of Agriculture (USDA). DDT was seen as a magic bullet against the pests and crop disease that cost farmers $360 million in 1945 alone.9 Passage of the Act and the 1947 amendments was non-controversial in large respect because there were few opponents to the concept of widespread pesticide application, much less well-organized opponents.10
Pesticide regulatory reform moved slowly, partially as result of the makeup of the primary regulating Congressional committees.11 Of particular importance was James Whitten, who chaired the subcommittee on agricultural appropriations for the House Appropriations Committee.12 As subcommittee chair, Whitten was called the “Permanent Secretary of Agriculture,” and held this post from 1947 until 1992.13 He encouraged the USDA to pursue the means necessary to eradicate pests and advocated widespread pesticide application to accomplish this goal.14
The first backlash against unremitting pesticide application was seen in the late 1950s with federal government campaigns against the gypsy moth and fire ants. Several groups complained about the gypsy moth program’s use of DDT suspended in oil, which led to high fish kills in northern states and, similarly, groups were concerned about the application of dieldrin in high concentrations to fight the so-called fire ant “threat.”15 The most dramatic public backlash began with the New Yorker magazine’s publication in 1962 of three articles by Rachel Carson arguing that pesticides were over used, despite the fact that their effects were poorly understood.16 The resulting public debate pitted scientist against scientist, arguing over the benefits of pesticide usage and the respective hazards.17 In the following years, pesticide regulation and reform came to the forefront and resulted in the 1964 FIFRA amendments, which required registration numbers for pesticides and eliminated the “protest registration,” which had allowed chemical makers to keep a product on the market while protesting cancellation.18 Of additional importance was that environmental values were discussed in the 1964 bill whereas in 1947 such issues had no influence in the resulting legislation.19
A major step in civilization was the domestication of food plants. With the birth of organized agriculture and the resultant concentration of crops and animals, the stage was set for outbreaks of pests. Until that time man had to search for food as did the pests. Afterword neither had to search; instead pest control became necessary. The welfare of an increasing human population requires intensified agriculture. This in turn enables the pests to increase, which necessitates the use of pesticides with their concomitant hazards. It thus seems inevitable that, as the population increases, so do certain hazards (p. 1).
The panel believes that the use of pesticides must be continued if we are to maintain the advantages now resulting from the work of informed food producers and those responsible for control of disease. On the other hand, it has now become clear that the proper usage is not simple and that, while they destroy harmful insects and plants, pesticides may also be toxic to beneficial plants and animals, including man.
The Act, which would become FIFRA, was significantly amended in 1972. FIFRA came into being in its current form after the nation’s experiences with DDT and other toxic pesticides.20 The effort to reform FFIRA responded in part to the delays EPA faced when it sought removal of certain pesticides from the market.21 Although the 1972 FIFRA amendments brought environmental concerns into the purview of pesticide regulation, such concerns were more of an afterthought to an already established consumer protection licensing program. In fact, the legislative history of the 1972 FIFRA makes clear that the amendments were not seen primarily as environmental in nature, but instead were seen as a balancing between the importance of pesticides to securing the nation’s food supply and the risks pesticides pose to man and the environment.22 The Senate Report explicitly noted the concern that “some [pesticides] may have long lasting adverse effects on the environment. Some may be taken up in the food chain and accumulated in man and other animals. Improperly used they may endanger bees and other useful insects, birds and other animals and their food supply.”23 The Report provides a historical guideline to federal pesticide legislation, starting in 1910 with the Federal Insecticide Act. The Committee noted that the 1910 Act aimed to prevent the sale or manufacture of adulterated or mislabeled insecticides or fungicides. In 1947 the original FIFRA, which repealed and replaced the 1910 Act, focused on pesticide registration and warnings. In 1954, the so-called “Miller Amendment” was added, requiring manufacturers to test their pesticide before it was to be used on food crops, and to provide data on the toxicity of the chemical. The information allowed the Federal Food and Drug Administration to set a limit on the amount of chemical residue permissible on the food crop when sold. In 1959, Congress further amended FIFRA to include new forms of agricultural chemicals (e.g., defoliants and desiccants). The impact of pesticides upon wildlife was not addressed, however, until the 1972 amendments.24 A 1963 Presidential Scientific Advisory Committee had recommended adding a pesticide’s impacts on fish and wildlife as a factor for registration (prior to 1972, the impact upon “useful vertebrates and invertebrates was the only environmental consideration in the registration process”).25
As is evident from FIFRA’s legislative history, the Act started as a classic consumer protection act aimed at ensuring that pesticide products were not mislabeled or adulterated. The 1972 revisions that brought environmental considerations into the purview of the Act were never the primary focus of the Act. Moreover, it is clear from FIFRA itself, as well as its legislative history and judicial interpretation, that economic and social considerations such as concerns for farmer profit, desire for cheap and safe food, and concerns over pest vector-borne public health diseases, are equally important to environmental considerations under the Act.26
FIFRA section 2(u) provides that the term “pesticide” means “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest ….”27 Under FIFRA, all pesticides that are sold or distributed in the United States must be registered by EPA.28 The primary standard for registration is that the pesticide be registered only if it will not cause an “unreasonable adverse effect on the environment.”29 Section 2(j) defines the term “environment” broadly to include “water, air, land, and all plants and man and other animals living therein and the interrelationships which exist among them.”30 Section 3(a) of FIFRA provides that EPA shall register a pesticide if it determines that, “when considered with any restrictions imposed, its composition is such as to warrant the proposed claims for it, its labeling and other material required to be submitted comply with the requirements of FIFRA; the pesticide will perform its intended function without unreasonable adverse effects on the environment; and when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.”31 FIFRA defines the term “unreasonable adverse effects on the environment” as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.”32 Accordingly, when making the determination of whether to register a pesticide, EPA must consider both the risks posed by the pesticide and the economic and social implications of using the pesticide. Although not expressly mandated by the statute, EPA has interpreted and consistently applied this standard as a cost/benefit balancing standard under which EPA weighs the costs or risks associated with the use of a pesticide against the economic and social benefits of the pesticide. It should be noted that cost/benefit terminology is used differently under FIFRA than in discussing most environmental regulation. Typically, in doing a cost/benefit analysis, the regulatory agency compares the costs of regulation (e.g., the cost of installing pollution controls) to the benefits of regulation (e.g., lives saved or cancers avoided). Under FIFRA, however, the “costs” are considered to be the costs of allowing the use of the pesticide (e.g., cancer deaths), whereas the benefits are considered to be the benefits of allowing the use of the pesticide (e.g., reduction in crop loss from pest insect damage).
A number of scholars have pointed out that although Congress did direct EPA to take into account economic factors, it did not explicitly mandate that EPA conduct a strict cost/benefit analysis.33 In fact, as Professor William Rodgers has argued, the legislative history of FIFRA suggests that adverse effects were not intended to be tolerated unless there are “overriding benefits” from the use of the pesticide.34 Despite the apparent intent of Congress in enacting FIFRA, for more than 30 years EPA has interpreted FIFRA to require a cost/benefit balancing, and this interpretation has been upheld by the courts.35
Although the registration standard requires EPA to determine that the pesticide “will perform its intended function” without unreasonable adverse effects on the environment,36 FIFRA expressly states that EPA shall not make any lack of essentiality a criterion for denying registration of any pesticide, and that where two pesticides meet the requirements for registration, one should not be registered in preference to the other. Specifically, the statute states “the Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where two pesticides meet the requirements of this paragraph, one should not be registered in preference to the other. In considering an application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy, in which event the Administrator may register the pesticide without determining that the pesticide’s composition is such as to warrant proposed claims of efficacy.”37 Accordingly, there is no requirement to demonstrate that a pesticide is necessary to control a particular pest to obtain a registration and the availability of alternative pesticides for the same use does not preclude registration. Moreover, FIFRA expressly authorizes EPA to waive all data requirements pertaining to efficacy and in fact EPA has, by rule, done so.38 Thus, as a practical matter in making registration decisions, EPA does not require any showing of the economic or social benefits to be derived from the pesticide, but instead assumes that such benefits will accrue.
One of the most significant aspects of FIFRA is that it requires an applicant for a pesticide registration to submit data to EPA. EPA evaluates the potential for risk for a particular pesticide using data, generally submitted by the registration applicant, specific to that pesticide. EPA’s data requirements are designed to evaluate the two components of risk: hazard and exposure. Data requirements are found at 40 CFR Part 158, and provide for the submission of data on health and environmental effects. The applicant for registration must bear the cost of gathering and generating the necessary data. To avoid duplicative data generation, the statute encourages the joint development of data and provides that applicants seeking to reach agreement on the terms of a data development arrangement may seek binding arbitration.39
Data already submitted to the agency to support an existing registration may be relied upon to support a new registration application provided the applicant for the new registration offers to pay compensation to the registrant who originally submitted the data. Data submitted to support a registration the first time a particular active ingredient is registered, is protected by the “exclusive use” provisions of FIFRA and cannot be considered by EPA to support additional registrations for a period of 10 years. In addition, FIFRA section 10 generally governs the disclosure of information submitted to EPA pursuant to FIFRA requirements. Section 10(d) provides that health and safety data must be made available to the public, except that section 10(g) prohibits disclosure of health and safety data to multinational pesticide producers except during public proceedings under law or regulation. Sections 10(b) and 10(d) provide that other confidential business information ordinarily may not be released, and provide specific protection for the formula and information on inert ingredients. Exemptions from these confidentiality protections are provided to avoid imminent public health risks. Additionally, the Administrator may determine that disclosure is in the public interest during a proceeding to determine whether a pesticide causes unreasonable adverse effects. Any such release of information is subject to procedural protections involving prior notice and opportunity for district court review.