Federal Insecticide, Fungicide and Rodenticide Act, United States
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), is one of two major federal pesticide statutes which the U.S. Environmental Protection Agency (EPA) is responsible for implementing. FIFRA governs the sale and use of pesticide products within the United States.
The other major statute is the Federal Food, Drug, and Cosmetic Act (FFDCA), which limits pesticide residues on food in interstate commerce (including imports).
Pesticides are broadly defined in FIFRA Section 2(u) as chemicals and other products used to kill, repel, or control pests. Familiar examples include pesticides used to kill insects and weeds that can kill, reduce the yield, and sometimes harm the quality of agricultural crops, ornamental plants, forests, wooden structures, and also pastures. But the broad definition of “pesticide” in FIFRA also applies to products with less familiar “pesticidal uses.” For example, substances used to control mold, mildew, algae, and other nuisance growths on equipment, in surface water, or on stored grains are pesticides. The term also applies to disinfectants and sterilizing agents, animal repellents, rat poison, and many other substances. EPA estimates that as of May 2003, there were about 19,107 pesticide products currently in use. (Note 1.) These all are regulated under FIFRA, but approximately 6,502 pesticide products used in food production also are regulated under the FFDCA.
FIFRA directs EPA to restrict the use of pesticides as necessary to prevent unreasonable adverse effects on people and the environment, taking into account the costs and benefits of various pesticide uses. FIFRA requires EPA to regulate the sale and use of pesticides in the United States through registration and labeling ([[Draft:Federal_Insecticide,_Fungicide_and_Rodenticide_Act,_United_States#Notes|Note 2). The act prohibits sale of any pesticide in the United States unless it is registered and labeled to indicate approved uses and restrictions. It is a violation of the law to use a pesticide in a manner that is inconsistent with the label instructions. EPA registers each pesticide product for each approved use. For example, a product may be registered for use on green beans to control mites, as a seed treatment for cotton, and as a treatment for structural cracks. In addition, FIFRA requires EPA to reregister older pesticides based on new data that meet current regulatory and scientific standards. Establishments that manufacture or sell pesticide products must register with EPA. Facility managers are required to keep certain records and to allow inspections by federal or state regulatory officials.
History of FIFRA
Federal pesticide legislation was first enacted in 1910. It aimed to reduce economic exploitation of farmers by manufacturers and distributors of adulterated or ineffective pesticides. Congress did not address the potential risks to human health posed by pesticide products until it enacted FIFRA in 1947. The U.S. Department of Agriculture (USDA) was responsible for administering the pesticide statutes during this period. However, responsibility was shifted to the EPA when that agency was created in 1970. Broader congressional concerns about long- and shortterm toxic effects of pesticide exposure on people who applied pesticides (applicators), wildlife, nontarget insects and birds, and on food consumers, subsequently led to a complete revision of FIFRA in 1972. The 1972 law completely replaced the original 1947 law, and is the basis of current federal policy. Substantial changes were made in 1988 (P.L. 100-532) to accelerate the reregistration process, and again in 1996 (P.L. 104-170). The 1996 amendments facilitate registration of pesticides for special (so-called “minor”) uses, reauthorize collection of fees to support reregistration, and require coordination of regulations implementing FIFRA and the FFDCA.
Authorization for appropriations for FIFRA expired on September 31, 1991, although appropriations bills have continued to provide funding to implement the law. The Food Quality Protection Act of 1996 did not reauthorize FIFRA. However, authority in FIFRA to issue and enforce regulations, is, for the most part, permanent, and is not affected by the lack of authorization.
|Table 1. Federal Insecticide, Fungicide, and Rodenticide Act and Amendments (codified generally as 7 U.S.C. 136-136y)|
|Year||Act||Public Law Number|
|1947||Federal Insecticide, Fungicide, and Rodenticide Act||P.L. 80-104|
|1964||Federal Insecticide, Fungicide, and Rodenticide Act Amendments||P.L. 88-305|
|1972||Federal Environmental Pesticide Control Act||P.L. 92-516|
|1975||Federal Insecticide, Fungicide, and Rodenticide Act Extension||P.L. 94-140|
|1978||Federal Pesticide Act of 1978||P.L. 95-396|
|1980||Federal Insecticide, Fungicide and Rodenticide Act Amendments||P.L. 96-539|
|1988||Federal Insecticide, Fungicide, and Rodenticide Amendments of 1988||P.L. 100-532|
|1990||Food, Agriculture, Conservation, and Trade Act of 1990||P.L. 101-624|
|1991||Food, Agriculture, Conservation and Trade Amendments of 1991||P.L. 102-237|
|1996||Food Quality Protection Act (FQPA) of 1996||P.L. 104-170|
Source: Congressional Research Service. Note: The current FIFRA statute was established by P.L. 92-516, which completely replaced (by amendment) the original 1947 legislation.
Registration of Pesticide Products
When pesticide manufacturers apply to register a pesticide active ingredient, pesticide product, or a new use of a registered pesticide under FIFRA Section 3, EPA requires them to submit scientific data on toxicity and behavior in the environment. EPA may require data from any combination of more than 100 different tests, depending on the potential toxicity of active and inert ingredients and degree of exposure. To register a pesticide use on food, EPA also requires applicants to identify analytical methods that can be used to test food for residues of active ingredients, certain inert ingredients, and their breakdown products and to determine the amount of residue that could remain on crops, as well as on (or in) food products, assuming that the pesticide product is applied according to the manufacturers’ recommended rates and methods.
Based on the data submitted, EPA determines whether and under what conditions the proposed pesticide use would present an unreasonable risk to human health or the environment. If the pesticide is proposed for use on a food crop, EPA also determines whether a “safe” level of pesticide residue, called a “tolerance,” can be established under the Federal Food, Drug, and Cosmetic Act. A tolerance must be established before a pesticide registration may be granted for use on food crops. If registration is granted, the agency specifies the approved uses and conditions of use, including safe methods of pesticide storage and disposal, which the registrant must explain on the product label. FIFRA requires that federal regulations for pesticide labels pre-empt state, local, and tribal regulations. Use of a pesticide product in a manner inconsistent with its label is prohibited.
EPA may classify and register a pesticide product for general or for restricted use. Products known as “restricted-use pesticides” are those judged to be more dangerous to the applicator or to the environment. Such pesticides can be applied only by people who have been trained and certified. Individual states and Indian tribes generally are responsible for training and certifying pesticide applicators.
FIFRA Section 3 also allows “conditional,” temporary registrations if:
- the proposed pesticide ingredients and uses are substantially similar to currently registered products and will not create additional significant environmental risks;
- an amendment is proposed for additional uses of a registered pesticide, and sufficient data are submitted indicating that there is no significant additional risk; or
- data requirements for a new active ingredient require more time to generate than normally allowed, and use of the pesticide during the period will not cause any unreasonable adverse effect on the environment and will be in the public interest.
EPA has long coordinated pesticide registrations for food uses under FIFRA with tolerance setting under the FFDCA. The Food Quality Protection Act of 1996 (FQPA; P.L. 104-170) codified this policy. Thus, if EPA revokes a residue tolerance under FFDCA, it cancels the FIFRA pesticide registration for that food use. Similarly, if a pesticide registration for use on a food crop is canceled, EPA also cancels the residue tolerance for food. However, just as FIFRA allows continued use of remaining pesticide stocks after a registration is canceled, FFDCA allows continued commerce in commodities legally treated with a pesticide. Thus, EPA does not immediately revoke the tolerance for the pesticide residue when it cancels the corresponding registration.
Any person who has registered a pesticide may petition EPA proposing establishment of a tolerance or an exemption for that pesticide to permit its use on food-related crops (Note 3). Tolerance petitions must include information about pesticide application rates, measured concentrations of pesticide residues on the food after the pesticide has been applied according to directions on its label, and safety of pesticide use on food crops. The FFDCA requires EPA to respond to each petition by establishing a tolerance or exempting the pesticide from the requirement. If the pesticide will not leave residues above an established safe level, EPA will register the pesticide for use on that food product and set the tolerance level by issuing a regulation. EPA tolerances for pesticide residues preempt state and local restrictions on food, if the state and local restrictions are based on lower residue levels. States may petition for an exception if the EPA-set residue level threatens public health.
The FFDCA, Section 408, as amended, requires EPA to assess safety in terms of total exposure to the pesticide (that is, to the concentration of pesticide allowed by the tolerance, together with all other dietary and non-food exposures for which there is reliable information) as well as to other pesticides that have the same toxic effects on people. No quantitative standard of safety is established by law, but the Committee on Commerce noted in its report on the bill that became the FQPA that EPA should continue setting standards to ensure safety as it had in the past:
... the Committee expects that a tolerance will provide a ‘reasonable certainty of no harm’ if the Administrator determines that the aggregate exposure to the pesticide chemical residue will be lower by an ample margin of safety than the level at which the pesticide chemical residue will not cause or contribute to any known or anticipated harm to human health. The Committee further expects, based on discussions with the Environmental Protection Agency, that the Administrator will interpret an ample margin of safety to be a 100-fold safety factor applied to the scientifically determined ‘no observable effect’ level when data are extrapolated from animal studies. - U.S. House, Committee on Commerce, Food Quality Protection Act of 1996, H.Rept. 104-669, part 2, 104th Congress, 2nd sess., 1996, p. 6.
In determining a safe level, the FFDCA directs EPA to take into account many factors, including available information on dietary exposure to pesticides among infants and children. FQPA strictly limited the nature and influence of benefits considered in tolerance setting under Section 408 of the FFDCA. As amended, Section 408 allows EPA to maintain or modify existing tolerances (but not to establish new tolerances) at higher than “safe” residue levels only if the pesticide use avoids other greater risks to consumers, or is necessary to avoid significant disruption in domestic production of an adequate, wholesome, and economical food supply. Such higher tolerance levels may be set only for pesticides that are potential carcinogens (or have some other health effect) for which there is no known level of exposure at which no harm is anticipated (known as a non-threshold effect).
The higher tolerance level allowed for such pesticide residues must be “safe” for infants and children, as well as with respect to health effects for which there is a known threshold (that is, a level below which exposure is known to be harmless). The higher cancer (or other non-threshold) risk posed by the tolerance on an annual basis may not be more than 10 times the risk at a “safe” level of exposure and not more than twice the risk of a “safe” level over a lifetime.
For non-threshold effects, the House Commerce Committee provided additional guidance for establishing a level of residue that should be considered “safe.”
In the case of a nonthreshold effect which can be assessed through quantitative risk assessment, such as a cancer effect, the Committee expects, based on its understanding of current EPA practice, that a tolerance will be considered to provide a ‘reasonable certainty of no harm’ if any increase in lifetime risk, based on quantitative risk assessment using conservative assumptions, will be no greater than ‘negligible.’ It is the Committee’s understanding that, under current EPA practice, ... EPA interprets a negligible risk to be a one-in-a-million lifetime risk. The Committee expects the Administrator to continue to follow this interpretation. - U.S. House, Committee on Commerce, Food Quality Protection Act of 1996, H.Rept. 104-669, part 2, 104th Congress, 2nd sess., 1996, p. 6.
The “safe” standard applies to both raw and processed foods, and requires EPA to consider cumulative and aggregate exposure to pesticides in food, drinking water, air, and consumer products. Congress directed EPA to reevaluate all existing tolerances against this standard before August 2006.
FFDCA directs the FDA in the Department of Health and Human Services and USDA to monitor pesticide residue levels in food in interstate commerce and to enforce tolerances through their food inspection programs. USDA is responsible for inspecting meat and poultry; FDA inspects all other foods. States also may monitor pesticide residues in food sold within their jurisdictions.
Public Disclosure, Exclusive Use, and Trade Secrets
FIFRA Section 3 directs EPA to make the data submitted by the applicant for pesticide registration publicly available within 30 days after a registration is granted. However, applicants may claim certain data are protected as trade secrets under FIFRA, Section 10. If EPA agrees that the data are protected, the agency must withhold those data from the public, unless the data pertain to the health effects or environmental fate or effects of the pesticide ingredients. Information may be protected if it qualifies as a trade secret and reveals:
- manufacturing processes;
- details of methods for testing, detecting, or measuring amounts of inert ingredients; or
- the identity or percentage quantity of inert ingredients.
Companies sometimes seek to register a product based upon the registration of similar products, relying upon the data provided by the original registrant that are publicly released. This is allowed. However, Section 3 of FIFRA provides for a 10-year period of “exclusive use” by the registrant of data submitted in support of an original registration or a new use. In addition, an applicant who submits any new data in support of a registration is entitled to compensation for the cost of data development by any subsequent applicant who supports an application with that data within 15 years of its submission. If compensation is not jointly agreed upon by the registrant and applicant, binding arbitration can be invoked.
Most pesticides currently registered in the United States are older pesticides and were not subject to modern safety reviews. Amendments to FIFRA in 1972 directed EPA to “reregister” approximately 35,000 older products, in order to assess their safety in light of current standards. The task of reregistering older pesticides has been streamlined by reviewing groupings of products having the same active ingredients, on a generic instead of individual product basis. For food-use pesticides, EPA is evaluating a pesticide’s eligibility for reregistration at the same time the agency is reassessing the tolerance for that pesticide under the FFDCA. The FQPA requires EPA to reassess pesticides posing the greatest risks first. Many of the 35,000 pesticide products will not be reviewed and their registrations will be canceled, because registrants are not requesting reregistration. At least 14,000 products are no longer in use. Nevertheless, the task for registrants and EPA remains immense and costly.
To accelerate the process of reregistration, Congress, in 1988 amendments to FIFRA, imposed a 10-year reregistration schedule. To help pay for the additional costs of the accelerated process, Congress directed EPA to require registrants to pay fees for reregistration and registration of pesticide ingredients and products. Exemptions from or reductions in fees are allowed for minor-use pesticides, public health pesticides, and small business registrants. The 1996 amendments to FIFRA extended EPA’s authority to collect certain fees through FY2001. Congress extended authority for fees annually through appropriations legislation since FY2001. The Omnibus appropriations legislation signed January 23, 2004 (P.L. 108-199) modified the types and amounts of fees that EPA could collect potentially through FY2008.
EPA continues to evaluate the safety of pesticides after they are registered as new information becomes available. FIFRA requires registrants to report promptly any new evidence of adverse effects from pesticide exposure. If evidence indicates that a registered pesticide may pose an unreasonable risk, EPA may initiate a special review of available information to reevaluate the risks and benefits of each registered use. FIFRA also authorizes EPA to require registrants to conduct new studies to fill gaps in scientific understanding to assist risk assessments. As a result of a special review EPA may conclude that registration is adequate, needs amendment, or should be canceled.
Canceling or Suspending a Registration
If a special review or reregistration evaluation finds that a registered use may cause “unreasonable adverse effects,” EPA may amend or cancel the registration (Note 4). FIFRA also allows registrants to request cancellation or amendment of a registration to terminate selected pesticide uses. Requesting voluntary cancellation sometimes reflects a registrant’s conclusion that the cost of additional studies is not worth the expected benefit (that is, profit) from sales if the registration is maintained.
If a registration is canceled for one or more uses of a pesticide, FIFRA does not permit it to be sold or distributed for those uses in the United States, although for a specified period of time, U.S. farmers may use remaining stocks, and commerce may continue for commodities that were legally treated with the pesticide. FIFRA allows registrants to appeal an EPA decision to cancel a registration. An appeal initiates a lengthy review process during which the product may continue to be marketed. However, if there is threat of an “imminent hazard” during the time required to cancel a registration, FIFRA authorizes EPA to suspend registration. Suspension orders, which also may be appealed, stop sales and use of the pesticide. In the event of suspension and cancellation, FIFRA Section 15 directs EPA to request an appropriation from Congress to compensate anyone who owned any of the pesticide and suffered any loss due to the suspension or cancellation. The registrant of the suspended and canceled product is responsible, however, for all of the transportation and disposal costs, and most storage costs.
Use of Unregistered Pesticides
FIFRA also allows for unregistered use of pesticide products in special circumstances. Section 5 allows experimental use permits for purposes of research and to collect data needed to register a pesticide. Section 18 allows “emergency exemptions” from the provisions of FIFRA to be granted to federal or state agencies, for example, if there is a virulent outbreak of a disease that cannot be controlled by registered products. In addition, Section 24(c) permits states to allow additional uses of a federally registered product to meet “special local needs.”
Generally, EPA enforces FIFRA requirements. However, FIFRA Section 26 gives primary enforcement authority for pesticide use under FIFRA to states that have adequate enforcement procedures, laws, and regulations primary authority, including inspection authority. EPA is authorized by Section 27 to rescind a state’s primary enforcement responsibility if it is not being carried out.
FIFRA Section 11 authorizes EPA to form cooperative agreements with states, giving them the responsibility for training and certifying applicators of restricted use pesticides. States also may initially review and give preliminary approval to applications for emergency exemptions and special local needs registrations, (although under some conditions FIFRA allows EPA later to deny state-approved applications).
Section 9 authorizes inspections by EPA and authorized state officials of pesticide products where they are stored for distribution or sale. Section 13 authorizes EPA to issue orders to stop sales and to seize supplies of pesticide products. Civil and criminal penalties for violations of FIFRA are established in Section 14, while Section 15 provides indemnity payments for end users, distributors, and dealers of pesticides when registrations are suspended and canceled.
Federal district courts are authorized in Section 16 to review EPA final actions and omissions when action is not discretionary. People adversely affected by an EPA order may file for judicial review of the order following a hearing. But, FIFRA does not authorize citizen suits against violators.
Export of Unregistered Pesticides
FIFRA does not give EPA the authority to regulate domestic production for export of unregistered pesticides, even if U.S. registration has been canceled for health or environmental reasons. However, FIFRA does require exporters to prepare or pack pesticides as specified by the purchaser and in accord with some of the FIFRA labeling provisions. For example, exporters must translate warning information into the language of the destination. FIFRA also requires exporters of unregistered pesticides to obtain the purchaser’s signature on a statement acknowledging that the pesticide is unregistered and cannot be sold in the United States. EPA is required to notify governments of other countries and international agencies whenever a registration, cancellation, or suspension of any pesticide becomes or ceases to be effective in the United States.
- Bergeson, Lynn L. FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act). Basic Practice Series. American Bar Association. 2000. 150 p.
- U.S. Library of Congress, Congressional Research Service. Pesticide Legislation: Food Quality Protection Act of 1996 (P.L. 104-170). CRS Report 96-759 ENR. Washington, DC. Sept. 11, 1998. 31 p.
- Exceptions are noted in 40 CFR 152.20, 152.25, and 152.30.
- Ingredients in pesticide products are categorized as active or inert. Active ingredients are those that are intended to control the pest, while inert ingredients are used to deliver the active ingredients effectively to the pest. Inert ingredients often are solvents or surfactants and often comprise the bulk of the pesticide product. Some inerts are known to be toxic, and some are known to be harmless, but EPA lists most in the category “inerts of unknown toxicity”.
- That is, use on food crops, animal feed crops, or food products directly (e.g., grains, fruits, or vegetables after harvest).
- Registrations also may be canceled under other conditions, for example, if data are not submitted in response to EPA’s request for additional information to maintain a registration, or if a registrant fails to pay the maintenance fee.
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Note: The first version of this article was drawn from material prepared for the Congressional Research Service by Linda Schierow.