Pesticides – An Overview
Pesticides are chemical substances used to prevent, destroy, repel, or mitigate undesirable organisms such as weeds or harmful insects. The chemical control of pests has facilitated the industrialization of agriculture and has helped the United States reap a surplus of agricultural products. Used properly, pesticides by definition are inherently toxic to certain organisms. This inherent toxicity requires careful regulation to insure the safety of the public, the food supply, and the environment. The United States Environmental Protection Agency (EPA) is the primary entity charged with regulation of pesticides, although it works in conjunction with state agencies. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136-136y, establishes the general system of federal pesticide regulation, and the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. §§ 301-392, establishes the system to govern pesticides in food and feed. States are generally permitted to enact legislation that restricts pesticide use more than federal law requires. This overview focuses on FIFRA and FFDCA as amended by the Food Quality Protection Act of 1996 (FQPA), Pub. L. No. 104-170, 110 Stat. 1489.
The Office of Pesticide Programs (OPP) manages the regulations of all pesticides and establishes maximum levels of pesticide residue that can be found in food or feed crops. The OPP implements the FIFRA, PRIA 4, FQPA, FFDCA, and Endangered Species Act. In addition to the regulatory functions, the OPP provides information and coordinates with partners and stakeholders on issues ranging from worker protections to the misuse of pesticides.
Federal Insecticide, Fungicide, and Rodenticide Act
The EPA regulates pesticides through registration and labeling requirements. Pesticides may not be sold unless they are registered and labeled. As part of the registration process, manufacturers must submit scientific data on pesticide toxicity and environmental behavior. If a pesticide will be used on a food or feed crop, data must be supplied to identify scientific methods that will detect the pesticide or its residues on food and specify the acceptable amounts that may be present in the food.
A cost-benefit analysis of the scientific data based on environmental, societal, and economic variables is used by the EPA to determine the acceptable uses and conditions for use, if any, of the pesticide. The standard of analysis requires that the pesticide and its acceptable uses not cause harm to human health with reasonable certainty or pose unreasonable risks to the environment. Once registered, the manufacturer must prepare a label that meets EPA approval that explains the permissible uses and required conditions for use of the pesticides, including protections for workers. Pesticide label requirements preempt state and local laws, and application of a pesticide inconsistent with the label instructions is a violation of federal law.
In addition to general pesticide registrations, FIFRA authorizes procedures for temporary registrations, minor use registrations, experimental use registrations, special local registrations, and emergency use registrations. Temporary registrations are granted if evidence suggests that there would be no significant risk to the environment and if registration would be in the public’s best interest. Minor uses are pesticide applications on crops with fewer than 300,000 acres of total production in the United States. These pesticides play a major role in agricultural production and protect public health from disease vectors such as mosquitos, ticks, cockroaches, rats and disease-causing organisms. The small market for these pesticide minor uses does not provide the economic incentive for chemical manufacturers to continue to fund their registration. Minor use provisions in FIFRA expedite minor use registrations by reducing registration costs and coordinating EPA actions with the United States Department of Agriculture (USDA), the Department of Health and Human Services, and producer groups that benefit from the registration of the minor use. Experimental use registrations allow companies to conduct research with pesticides in order to develop the required data for the registration process, and they allow agricultural research institutions to conduct other scientific experiments with the pesticides. Special local use registrations allow states to add permissible uses to pesticide labels for special local needs within a state. Emergency use registrations, also called Section 18 registration, allow states or federal agencies to use new pesticides registrations or add uses to existing registrations in a defined geographic area for a specific length of time to control an emergency situation. The maximum duration of an emergency use exemption may be one year for specific or public health exemptions, three years for quarantine exemptions, or 15 days for crisis exemptions. The EPA evaluates and makes decisions on the requests for emergency exemptions within 45 days.
During registration, the EPA determines if a pesticide will be classified either as a general use pesticide or a restricted use pesticide. A general use pesticide is considered safe enough to be used by the general public. Restricted use pesticides can only be applied by certified users because they are considered more dangerous. Most states have developed programs approved by the EPA to train and certify applicators for restricted use pesticides.
Special review provisions in FIFRA allow the EPA to reevaluate registered pesticides. Registrants are required to submit new evidence if it suggests there may be adverse effects. If the EPA determines that there may be unreasonable risks associated with the pesticide, a special review may be initiated to repeat the analysis of a pesticide’s risks and benefits. Registrants may be required to submit additional data and undertake new studies to assist the review. After completion of the special review process, the EPA may continue the registration, amend the registration, or cancel the registration.
In addition to the special review process, reregistration of older pesticides is required to ensure that older registrations meet new scientific criteria. In addition to reregistering all pesticides approved before November 1, 1984, FIFRA also establishes periodic review with the goal that all pesticide registrations will be examined on a 15-year cycle. This 15-year review may lead to a special review in which the registration is amended or cancelled.
Cancellation of a pesticide registration makes future sale or distribution of the pesticide illegal but allows the sale and use of existing stocks if doing so would not violate the purposes of FIFRA. Specific procedures for cancellation or suspension decisions and their appeal are outlined in the Act.
Federal Food, Drug, and Cosmetic Act
The portions of the FFDCA that affect pesticides guide the establishment of tolerances for pesticides and their residues in food and feed. Foods that have residue amounts higher than allowable tolerances or where no tolerance has been specified are deemed to be adulterated and cannot be sold.
The tolerance level of pesticides and their residues in foods or feeds must be “safe.” The standard for “safe” requires that there be “a reasonable certainty of no harm.” This standard must be determined based on all potential exposure to individuals over their lifetimes, and special care is given to protect infants and children. Higher tolerances are allowed in only limited instances when greater harm to the public would occur from not using a pesticide. The higher tolerances are required to be “safe” for infants and children, not greater than 10 times more likely to cause cancer, and not more than twice the risk of a “safe” level over a lifetime. Although FIFRA allows states to enact tougher pesticide legislation, FFDCA preempts state pesticide tolerances and only permits lower tolerances in states that receive EPA approval based on special circumstances. Periodic review of established tolerances is required on a five-year cycle.
The Food and Drug Administration (FDA) and the USDA monitor and enforce the tolerances established by the EPA. EPA actions under FIFRA and FFDCA are coordinated. If a tolerance is revoked, the corresponding pesticide registration is revoked, and if a pesticide registration is revoked, the corresponding tolerance is revoked. If a tolerance is revoked, the FFDCA permits the continued sale of existing amounts of the food.
There are many other statutes that impact pesticides. The Endangered Species Act prohibits actions that have a negative impact on endangered species and their habitat. Under this statute, the EPA must ensure that its pesticide registrations do not threaten endangered species or their habitat.
The Safe Drinking Water Act provides for the protection of the nation’s drinking water. The development of standards and testing for pesticides and other chemicals in the water supply is required under the Act.
The Clean Water Act (CWA) regulates the discharge of pollutants into the waters of the United States. In certain instances pesticides may be deemed to be pollutants. Although some conflicting case law exists, the EPA has interpreted the CWA to mean that pesticides properly applied to surface waters according to all FIFRA requirments and label directions are not pollutants under the CWA and do not require a permit. A pesticide application into waters of the United States that did not follow all FIFRA requirements or label directions would be a pollutant and result in violations of both FIFRA and the CWA. Nonpoint source runoff of pesticides from agricultural lands is not generally regulated by the CWA. For more information on the Clean Water Act, please visit our Clean Water Act Reading Room.
For information concerning pesticides and their relationship to agricultural labor, please see the Labor Reading Room. For more information on FIFRA and other environmental statutes, please see the Environmental Law Reading Room.