responsibility for administering FIFRA, and the states play an important role in enforcing the act. Under FIFRA, the term pesticide is defined as “any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest” [7 U.S.C. § 136 (u)(1)].
Pursuant to FIFRA Section 3(a), a pesticide may not be sold or distributed in the United States without a license, known as a registration, from EPA. To obtain a FIFRA registration, an applicant must demonstrate, among other things, that the pesticide will “perform its intended function without unreasonable adverse effects on the environment” [§ 136a (c)(5)(C)] and that when the pesticide is “used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment” [§ 136a (c)(5)(D)]. FIFRA defines environment as “water, air, land, and all plants and man and other animals living therein and the interrelationships which exist among these” [§ 136 (j)]. It defines the phrase 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” [§ 136 (z)(bb)(1)]. In other words, when deciding whether a particular pesticide meets the standard for registration, EPA must consider the economic and social benefits of using the pesticide and the risks to humans and the environment posed by its use. EPA has interpreted the “unreasonable adverse effects on the environment” standard to require a balancing of costs and benefits in which EPA weighs the costs to human health and the environment resulting from pesticide use against social and economic benefits, such as the benefits of mitigating disease vectors and reducing crop damage.
To obtain a registration, an applicant must provide data demonstrating that its pesticide does not cause unreasonable adverse effects. FIFRA does not mandate that any particular tests be conducted or that any particular type of data be submitted to obtain a registration. However, FIFRA Section 3(c)(2)(A) directs EPA to publish guidelines “specifying the kinds of information which will be required to support the registration of a pesticide” and directs EPA to revisit and revise these guidelines “from time to time.” Pursuant to that section, EPA has promulgated rules in 40 C.F.R. Part 158 that establish data requirements for demonstrating that a particular pesticide product meets the standard for registration. Excerpts from Part 158 are provided in Appendix A of the present report. EPA has also developed a series of test guidelines that specify methods for conducting the studies that will generate the data to support registration.
Many of the data requirements in Part 158 address general information about a pesticide, such as its chemical composition and chemical and physical properties. Other data requirements focus on mammalian testing that can be used to evaluate the human health effects of pesticide exposure. Most important for purposes of this report, Part 158 includes a number of sections related to environmental risk, including risks to species that are not the targets of the pesticide (that is, nontarget species). For example, Subpart G requires avian oral toxicity testing, avian dietary toxicity testing, and avian reproduction testing and might require wild-mammal toxicity testing and simulated or actual field testing. Addi-