- Manufacturer (or importer) has burden of proving safety and efficacy.
- “Safe” does not mean no-risk; it means the risk is not unreasonable, which depends on balancing of risks and benefits.
- Ongoing oversight through requirement of periodic reregistration, and mechanisms for cancellation and suspension.
There is a fundamental difference between pesticides and other toxic chemical products. Many chemical products have unwanted toxic side effects, but pesticides are meant to kill. It is their inherent poisonous nature that makes them valuable.
Pesticides provide tremendous benefits. They help protect us from vector-borne diseases, such as malaria and West Nile virus that are carried by mosquitoes. They help control vermin such as rats that are a danger to public health. They help protect crops from weeds, insects, and other pests, thus enabling America’s farm productivity.
But a poison that kills one species is likely to pose dangers to other species as well, including humans. Hence, governmental regulation of pesticides is more stringent than for most chemicals.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)1 is an old law, first adopted in 1947 and administered originally by the Department of Agriculture. Its original concern was the efficacy of pesticides—to protect farmers from snake oil salesmen. It was rewritten in 1972, soon after the Environmental Protection Agency was formed, and after Rachel Carson’s book Silent Spring2 alerted the public to the adverse effects of pesticides. FIFRA is now an environmental statute administered by the EPA. While it still addresses effectiveness, its main purpose is to protect health and the environment from unreasonable adverse effects. The act has been amended numerous times, sometimes making it more protective and sometimes less, in a push-pull between environmentalists on the one hand and pesticide companies and agricultural interests on the other.
FIFRA is the main federal statute regulating pesticides. In addition, there are some provisions in the Food, Drug, and Cosmetic Act (FDCA) relating to pesticide residue on foods and in the Occupational Safety and Health Act relating to the safety of workers who apply pesticides.
FIFRA regulates pesticides and pesticide devices. The act’s concept of “pesticide” is broader than you would probably expect, so some definitions may be useful.3
To avoid absurd extremes, EPA has designated two categories of instruments as exempt from FIFRA regulation as pest control devices. One is any device that depends mainly on the performance of the person using it, such as a flyswatter. The other unregulated category is for devices that (without using glue or pesticides) entrap vertebrate animals, such as an old-fashioned mousetrap baited only with cheese.
Devices are subject only to limited regulation under FIFRA, consisting mainly of truth-in-labeling requirements, reporting, and registration of the manufacturer with EPA. But FIFRA’s main provisions for product registration are not applicable. Caveat: Even though not regulated by FIFRA, state laws may impose requirements.
The basic approach of FIFRA is to require that all new pesticides be registered by the EPA before they can be distributed and sold.7 To obtain registration of a new pesticide, the burden is on the manufacturer to establish that the product will not pose unreasonable adverse risks to health and the environment. Typically, the manufacturer applying for registration must conduct extensive scientific testing to meet this burden.
Registration is essentially a license to sell a pesticide, but it is not a carte blanche license. The EPA can and does impose conditions on a product’s registration, including labeling and packaging requirements and restrictions on use. Each registration is specific for intended use and dosage. If a pesticide is intended for use on multiple types of crops, for example, or if it has variable dosages, the manufacturer must go through a separate registration process for each. This is largely because the safety and efficacy data may vary for different uses and doses.
FIFRA also regulates existing pesticides. They must be reregistered every fifteen years, with the same burden on the manufacturer to show there is no unreasonable risk.8 This avoids one of the major problems of the Toxic Substances Control Act (TSCA)—that is, older substances being grandfathered in without adequate review. Further, if evidence of unreasonable risk turns up at any time (not just during the reregistration process), the EPA can take a pesticide off the market.
Registration requirements mainly affect manufacturers (and importers). Regulations also apply to distributors and sellers, to the extent they cannot distribute or sell any pesticides that are not properly registered, or that have been ordered off the market by the EPA.
Criteria for Registration
The EPA will approve and register a pesticide only if it meets all of the following criteria9 to the EPA’s satisfaction:
- The product’s chemical composition warrants its claimed purpose.
- The label and other required materials provide appropriate warnings and other information.
- When used as intended, it will not have unreasonable adverse effects on health or the environment.
- When used in accordance with widespread and commonly recognized practice (which is not always the same as the intended use stated on the label), it will not generally cause unreasonable adverse effects on health or the environment.
In short, the EPA scrutinizes the product for efficacy, safety, and proper labeling.
A pesticide must be effective for its advertised purpose. The manufacturer is responsible to test for efficacy before the product is marketed. But the EPA does not routinely require the manufacturer to submit this test data, so long as the chemical composition is consistent with its claimed purpose and there are no red flags.10
Health and environmental safety have long since surpassed efficacy as the main emphasis of FIFRA. Note that safety is evaluated not just for intended use, but also taking into account any customary and widely recognized practice. The relationship between labeling and safety are discussed more in the following.
The label is a key part of pesticide regulation. The proposed label (including package inserts and other materials) must be submitted to the EPA for review, as part of the registration process. The EPA must be satisfied with the label before it will register the pesticide.11 The EPA scrutinizes the format as well as the content of a label—for example, to make sure an important warning is not buried in fine print. The label must appear exactly as approved—nothing may be added, deleted, or modified without approval.
Originally, FIFRA’s regulation of product labels was concerned primarily with making sure the claims were true—that the product was effective and buyers would get their money’s worth. Efficacy is still relevant, but now the main emphasis is on safety—avoiding harm to health or the environment.
A major function of the label is to translate the scientific data required for the registration process into specific directions and precautions. The label specifies how the product may be used, who can use it, where, how much, and how often. These directions on the label are not mere suggestions—they are legally enforceable. As stated on every pesticide label, “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.”12
All required text on the label must appear in English. However, the EPA may require, or the applicant may propose, the addition of a second language, if the EPA considers it necessary to protect the public. For example, in recognition that many of the agricultural workers in the United States come from Spanish-speaking countries, the EPA’s Worker Protection Standard for Agricultural Workers includes a requirement that certain parts of the label be written in Spanish as well as English. Under consideration is a petition by a farmworkers’ organization to require all of the required agricultural pesticide labels be bilingual. When a label is translated, all required label contents must appear in both languages.13
Manufacturer’s Burden of Proof
The burden of proof is on the manufacturer to satisfy the EPA that a new pesticide does not pose unreasonable risk for human health or the environment.14 The EPA will not grant registration until the manufacturer meets that burden. Commonly, this requires scientific testing that can take years and cost the manufacturer millions of dollars.
Contrast this to the Toxic Substances Control Act, under which chemicals can be freely marketed if the EPA does not act within ninety days, and the EPA can require testing only if it makes a formal risk determination. The treatment of pesticides under FIFRA is more like the treatment of pharmaceuticals under the Food, Drug, and Cosmetic Act (see chapter 13) with respect to the burden of establishing safety and efficacy.
Balancing of Risks and Benefits
Pesticides are inherently risky. In deciding whether to register a pesticide, the question the EPA addresses is not whether the product will pose a risk, but whether it will pose an unreasonable risk to health or the environment. To answer this question, the EPA conducts a risk assessment, balancing the product’s risks against its benefits. Specifically, FIFRA directs the EPA to take into account economic, social, environmental, and health costs and benefits.15
There are many factors that could weigh on the benefit side of the EPA’s risk assessment. Avoiding loss of crops from insect damage enables American agriculture to provide ample and affordable food—an example of an economic benefit. For a completely different example, consider the health benefit of a product that provides an effective alternative to a more dangerous pesticide.
Based on its risk assessment, the EPA can refuse to register a pesticide, or impose restrictions. FIFRA directs the EPA to adopt the least restrictive measures that are consistent with protecting health and the environment. For example, limiting the use of a pesticide to trained applicators would be less restrictive, and therefore preferable, to denying registration entirely.16
The risk assessment is somewhat different for two categories—public health pesticides and pesticide residues on food.
Public Health Pesticides
A public health pesticide17 is one used primarily for public health programs. One example would be antibacterials. Another type is pesticides intended to control “vector-spread” disease—such as Lyme disease that is spread by ticks or West Nile virus that is spread by mosquitoes. A public health pesticide is assessed somewhat differently than other pesticides, in that the risks of the product are weighed against the risks of the diseases it is intended to control.