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Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

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The objective of FIFRA is to provide federal control of pesticide distribution, sale, and use. All pesticides used in the United States must be registered (licensed) by EPA. Registration assures that pesticides will be properly labeled and that, if used in accordance with specifications, they will not cause unreasonable harm to the environment. Use of each registered pesticide must be consistent with use directions contained on the label or labeling.

Summary of Federal Insecticide, Fungicide, and Rodenticide Act

Agriculture-Specific Requirements

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Overview of FIFRA

The first pesticide control law was enacted in 1910. This law was primarily aimed at protecting consumers from ineffective products and deceptive labeling. When the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was first passed in 1947, it established procedures for registering pesticides with the U.S. Department of Agriculture and established labeling provisions. The law was still, however, primarily concerned with the efficacy of pesticides and did not regulate pesticide use.

FIFRA was essentially rewritten in 1972 when it was amended by the Federal Environmental Pesticide Control Act (FEPCA). The law has been amended numerous times since 1972, including some significant amendments in the form of the Food Quality Protection Act (FQPA) of 1996. In its current form, FIFRA mandates that EPA regulate the use and sale of pesticides to protect human health and preserve the environment.

Since the FEPCA amendments, EPA is specifically authorized to: (1) strengthen the registration process by shifting the burden of proof to the chemical manufacturer, (2) enforce compliance against banned and unregistered products, and (3) promulgate the regulatory framework missing from the original law.

FIFRA provides EPA with the authority to oversee the sale and use of pesticides. However, because FIFRA does not fully preempt state/tribal or local law, each state/tribe and local government may also regulate pesticide use.

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Tolerances and Exemptions

Before EPA can register a pesticide that is used on raw agricultural products, it must grant a tolerance or exemption. A tolerance is the maximum amount of a pesticide that can be on a raw product when it is used and still be considered safe. Under the Food, Drug, and Cosmetic Act (FDCA), a raw agricultural product is deemed unsafe if it contains a pesticide residue, unless the residue is within the limits of a tolerance established by EPA or is exempt from the requirement. The FDCA requires EPA to establish these residue tolerances. 

Tolerances and Agriculture
Food or feed residues that lack tolerances or have residues exceeding the established tolerances are subject to seizure, and the applicators or agricultural producers are subject to prosecution under FIFRA if misuse is found.

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Registration of New Pesticides

Under FIFRA Section 3, all new pesticides (with minor exceptions) used in the United States must be registered by the Administrator of EPA. Pesticide registration is very specific; it is not valid for all uses of a particular chemical. Each registration specifies the crops/sites on which it may be applied, and each use must be supported by research data. Ordinarily, the manufacturer (domestic or foreign) of the pesticide files an application for registration. The application process often requires the submission of extensive environmental, health, and safety data.

Conditional registration may be given to some new pesticides while EPA obtains the data needed to make a full analysis of the product. After a pesticide is registered, the registrant must also notify EPA of any newly uncovered facts concerning adverse environmental effects (FIFRA Section 6(a)(2)). Exit EPA In addition, EPA is required to periodically review pesticide registrations, with a goal of review every 15 years. Variations of the registration requirements exist for "minor use pesticides," "antimicrobial pesticides," and "reduced risk pesticides."

Data Requirements for Registration
The categories of data required include the product’s chemistry; environmental fate; residue chemistry; dietary and non-dietary hazards to humans; and hazards to domestic animals and nontarget organisms (40 CFR Part 158).

Under the "product chemistry" category, applicants must supply technical information describing the product’s active and inert ingredients, manufacturing or formulating processes, and physical and chemical characteristics.

Data from "environmental fate" studies are used to assess the effects of pesticide residues on the environment, including the effect on nontarget organisms and their habitat.

Residue chemistry information includes the expected frequency, amounts, and time of application, and test results of residue remaining on treated food or feed.

Information under "hazards to humans, domestic animals, and nontarget organisms" includes specific test data assessing acute, subchronic, and chronic toxicity, skin and eye irritation potential, and potential exposure by various routes (i.e., oral, dermal, inhalation).

All studies must be conducted under conditions that meet Good Laboratory Practice (GLP) standards (40 CFR Part 160). Guidelines for studies of product chemistry, residue chemistry, environmental chemistry, hazard evaluation and occupational and residential exposure can be found in 40 CFR Part 158.

Registration Criteria
To register a pesticide, the Administrator must find the following to be true:

Unreasonable Adverse Effects on the Environment
FIFRA defines an "unreasonable adverse effect on the environment" as "(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of the pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under Section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a)." Exit EPA

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Special Local Needs (24(c)) Registrations

Under the authority of Section 24(c) of FIFRA, states may register an additional use of a federally registered pesticide product, or a new end-use product to meet special local needs. EPA reviews these registrations, and may disapprove the state registration if, among other things, the use is not covered by necessary tolerances, or the use has been previously denied, disapproved, suspended, or canceled by the Administrator, or voluntarily canceled subsequent to a notice concerning health or environmental concerns.

States have been granted the authority by FIFRA to issue special local needs registrations under certain conditions, while EPA is responsible for overseeing the general program. States may register a new end-use product for any use, or an additional use of a federally registered pesticide product, if the following conditions exist:

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Emergency Exemption From Registrations (Section 18)

Section 18 of FIFRA authorizes EPA to allow states to use a pesticide for an unregistered use for a limited time if EPA determines that emergency conditions exist. Most requests for emergency exemptions are made by state lead agricultural agencies, although the United States Department of Agriculture and United States Department of Interior also request exemptions.

Emergency Exemption Process
The process generally takes place as follows. Growers in particular regions identify a problem situation that registered pesticides will not alleviate. The growers contact their state lead agency (usually the state department of agriculture) and request that the agency apply to EPA for a Section 18 emergency exemption for a particular use. Requests are most often made for pesticides that have other food uses registered. The state agency evaluates the requests and submits requests to EPA for emergency exemptions they believe are warranted. The uses are requested for a limited period of time (no longer than 1 year), to address the emergency situation only. To be as responsive as possible to the states and growers, EPA attempts to make decisions on the requests within 50 days of receipt.

If the emergency appears valid and the risks are acceptable, EPA approves the emergency exemption request. EPA will deny an exemption request if the pesticide use may cause unreasonable adverse effects to health or the environment, or if emergency criteria are not met. As a matter of course, a state may withdraw an exemption request at any point in the process.

Tolerances for Emergency Exemptions
Under the Food Quality Protection Act (FQPA), enacted on August 3, 1996, EPA must establish formal tolerances (maximum allowable residue levels) to cover all pesticide residues in food, even residues resulting from emergency uses. Tolerances established for emergency exemption uses are time-limited to correspond to the use season. In establishing a tolerance, EPA must make the finding that there is "reasonable certainty that no harm" will result to human health from aggregate and cumulative exposure to the pesticide, as required by the new FQPA health-based standard. Establishment of these tolerances, with their expiration dates, are published in the Federal Register.

Crisis Exemptions
If a need is immediate, a state agency may issue a crisis exemption that allows the unregistered use for 15 days. The state notifies EPA of this action before issuing the crisis exemption, and EPA performs a cursory review of the use to ensure that there are no concerns. If concerns are noted, EPA confers with the state, and under extreme cases may not allow a crisis to be declared. If the state follows up the crisis exemption with an emergency exemption request, or has already submitted one, the use may continue under the crisis exemption until EPA has made a decision on the request. If the state does not also submit an emergency exemption request, EPA must still establish the appropriate tolerance(s) for the crisis use.

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Flow chart of emergency exemption process

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Restricted-Use Classification and Certification of Applicators

Under FIFRA, registrations and product labeling may restrict uses of pesticides. Each registration specifies the crops/sites on which it may be applied, and each use must be supported by research data. As a part of the pesticide registration, EPA must classify the product or some uses of the product as "restricted use" if they may cause unreasonable adverse effects even when used as directed on the product labeling.

Restricted-use pesticides are limited to use by pesticide applicators who are certified, or to people under the supervision of a certified applicator. Under FIFRA, states/tribes that choose to certify pesticide applicators can submit a state/tribal plan to the EPA Administrator. The Administrator approves the plan if it meets a number of conditions contained in FIFRA Section 11(a)(2) Exit EPA. In states/tribes that do not develop their own plan for applicator certification, EPA (or in the case of tribes, the state within which the tribe is located) administers an applicator certification program. The EPA program must also meet the conditions of FIFRA Section 11(a)(2).

Certification and Agriculture
Certification and training regulations require pesticide applicators to meet certain training requirements before they apply pesticides labeled "for restricted use." The purpose is to assure proper application of the pesticide and to ensure that restricted-entry provisions protecting the health of applicators and farm workers are met.

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Reregistration of Pesticides

Due to concerns that much of the safety data underlying pesticide registrations becomes outdated and inadequate, FIFRA Section 4 requires that registrations be reviewed every 15 years and requires EPA to reregister all pesticides that were registered before 1984. The goal is to update labeling and use requirements and reduce potential risks associated with older pesticide active ingredients -- those first registered when the standards for government approval were less stringent than they are today. This comprehensive reevaluation of pesticide safety in light of current standards is critical to protecting human health and the environment.

As of 1996, EPA has made reregistration decisions on more than 130 pesticides, leaving fewer than 250 to be reviewed. More than 200 other pesticides (and 20,000 pesticide products) have been cancelled since reregistration began.

Reregistration Eligibility Decision (RED) documents contain the results of EPA's regulatory reviews of pesticides initially registered before November 1, 1984. To be eligible for reregistration, a pesticide must be found not to cause unreasonable risks to people or the environment when used in accordance with its approved labeling. All registered pesticides also must meet the safety standard of the Food Quality Protection Act (FQPA), which became effective on August 3, 1996. Under this new law, EPA must consider the potential for increased susceptibility of infants and children to the toxic effects of pesticides. The Agency also must reassess existing tolerances (maximum pesticide residue limits in food), considering aggregate exposure to pesticide residues from many sources and the cumulative effects of pesticides and other compounds with common mechanisms of toxicity.

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Labeling Requirements

Labeling requirements control when and under what conditions pesticides can be applied, mixed, stored, loaded or used, fields can be reentered after application, and crops can be harvested. Requirements are also imposed on container specifications and disposal.

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Cancellation and Suspension of Pesticide Registrations

EPA can cancel a registration if it is determined that the pesticide does not comply with any of the substantive requirements of FIFRA (Section 6). Exit EPA EPA initiates a cancellation through a notice of intent either (1) to cancel its registration or change its classification, or (2) to hold a hearing to determine whether or not its registration should be canceled or its classification changed.

Before issuing a notice of intent, EPA must notify the Secretary of Agriculture, who provides comments within 30 days on the cancellation’s economic effects. If comments are not received within 30 days, EPA can publish its intent to cancel or change the classification of a registration in the Federal Register and notify the registrant. If comments are received with 30 days, EPA can issue the notice of intent 60 days after notifying the Secretary of Agriculture. Within 30 days the registrant can correct the problem, or a person adversely affected by the notice can request a hearing to present evidence and argue their case. After the hearing, EPA decides either to cancel the registration, revoke the notice to cancel, or place new restrictions on the registration.

In cases where EPA believes that an "imminent hazard" would exist if a pesticide were to continue to be used during the cancellation proceedings, EPA may use an emergency order to suspend the pesticide registration and thereby the sale, distribution, and use of the pesticide. An "imminent hazard" is defined as an unreasonable adverse effect on the environment or an unreasonable hazard to the survival of a threatened or endangered species. The administrator then has 90 days to issue a notice of intent to cancel the registration or change its classification before the emergency order expires.

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Pesticide Imports and Exports

FIFRA requires that imported pesticides be subject to the same requirements of testing and registration as domestic products. When imported pesticides arrive in the United States, FIFRA Section 17 Exit EPA requires the Secretary of the Treasury to notify the EPA and to provide samples upon request. If an import seems to be in violation of FIFRA, the pesticide may be barred from admission, and the Secretary of the Treasury must refuse to deliver the pesticide to the consignee. If the consignee fails to export the pesticide within 90 days of receiving notice of the refusal of admission, the pesticide will be destroyed. The consignee is responsible for paying for the storage, cartage, and labor on pesticides refused admission or delivery.

Exports of pesticides, however, are excluded from most parts of FIFRA (Section 17).Exit EPA Producers of exported pesticides are subject to recordkeeping requirements and certain procedures, labeling, and data requirements of FIFRA related to the safe storage, disposal, handling, and transportation of the pesticides. In addition, if a pesticide is not registered in the United States, the exporter must obtain a statement from the foreign purchaser acknowledging its unregistered status before the product can be shipped.

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Registration of Pesticide-Producing Establishments

FIFRA (Section 7) requires that establishments producing pesticides Exit EPA register with EPA. Registered establishments must report the types and amounts of pesticides they produce. The Act also gives EPA inspection authority and enables the agency to take enforcement actions against facilities that are not in compliance with FIFRA.

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