Overview. This Act establishes an extensive regulatory system for controlling the sale, distribution and application of pesticides. Pesticides must be registered with the Administrator of the U.S. Environmental Protection Agency, who is given authority to suspend or cancel registrations for pesticides which cause unreasonable adverse effects on the environment. The Act also requires that pesticides be labeled in an approved manner and makes it unlawful for anyone to use the pesticide in a manner inconsistent with its labeling. Other provisions of the Act provide for registration of establishments producing pesticides, certification of pesticide applicators, regulations to promote safe storage and disposal, and the issuance of stop sale orders, recall orders and other enforcement measures, as well as authority to delegate enforcement of pesticide use restrictions to the states. The Act was amended extensively by the Food Quality Protection Act of 1996, which added provisions regarding minor use pesticides, antimicrobial pesticides, public health pesticides, reduced risk pesticides, and integrated pest management.
Selected Definitions. Administrator: Administrator of the U.S. Environmental Protection Agency. Animal: all vertebrate and invertebrate species, including man and other mammals, birds, fish and shellfish. Certified applicator: an individual who is certified under the Act to use or supervise the use of pesticides classified for restricted use. Device: an instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling or mitigating a pest or other form of plant or animal life, but not including equipment used for the application of pesticides when sold separately therefrom. Environment: includes water, air, land and all plants and man and other animals living therein, and the interrelationships among them. Imminent hazard: a situation which exists when continued use of a pesticide during the time required for cancellation proceedings would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered or threatened by the Secretary under the Endangered Species Act of 1973. Minor Use: Use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health where the total U.S. acreage for the crop is less than 300,000 acres or the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and one of several conditions are met, such as where the alternatives to the pesticide pose greater risks to the environment or human health. Pest: any insect, rodent, nematode, fungus, weed or other form of terrestrial or aquatic plant or animal life or virus, bacteria or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares a pest under the Act. Pesticide: (1) a substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest, (2) a substance or mixture of substances intended for use as a plant regulator, defoliant or desiccant, as those terms are defined in the Act, or (3) a nitrogen stabilizer, also defined in the Act. Protect health and the environment: protect against any unreasonable adverse effects on the environment. Unreasonable adverse effects on the environment: (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of a pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on food inconsistent with federal law. § 136.
Pesticide Registration. The Act prohibits the distribution or sale of unregistered pesticides, with limited exceptions, and establishes procedures for registering pesticides with the Administrator of the U.S. Environmental Protection Agency. Registration procedures require that the applicant submit a statement and supporting data, including the proposed labeling and directions for use of the pesticide, and that the Administrator determine whether the pesticide should be classified for general or restricted use. Pesticides classified for restricted use may only be applied under the direct supervision of a certified applicator or subject to other restrictions imposed by regulation.
After considering any restrictions placed on a pesticide's use, the Administrator must register it if: its composition warrants the proposed claims for it; its labeling and other required material comply with the Act; it will perform its intended function without unreasonable adverse effects on the environment; it will not generally cause unreasonable adverse effects on the environment when used in accordance with widespread and commonly recognized practice. However, conditional registration under special circumstances is allowed.
The 1996 amendments to the Act provide for an expedited review process in cases where the use of the pesticide proposed by the application may reasonably be expected to reduce the risk of pesticides to human health, reduce the risk of pesticides to nontarget organisms, reduce the potential for contamination of ground water, surface water, or other valued environmental resources, or broaden the adoption of integrated pest management strategies or make them more available or effective. The 1996 amendments also include a number of special registration and date submission provisions to expedite registration of minor use pesticides, establish new labeling and registration requirements for antimicrobial pesticides and provide for separate consideration of public health pesticides.
The 1996 amendments require that the Administrator establish a procedure for periodic review of registrations. The goal is to review a pesticide's registration every 15 years. § 136a.
Amendments to the Act passed in 1988 required the Administrator to re-register registered pesticides which contained active ingredients contained in pesticides first registered before November 1984. The statute sets forth detailed instructions and procedures for the re-registration process. § 136a-1.
Pesticide registrations are valid for a five-year period and are canceled at the end of the period unless an applicant requests that the registration be continued. If at any time it appears that a pesticide or its labeling or other required material does not comply with the Act or that it generally causes unreasonable adverse effects on the environment when used in accordance with widespread and commonly recognized practice, the Administrator may issue notice of intent to cancel the registration or change the classification of the pesticide or to hold a hearing to consider the pesticide's cancellation or change of classification. At least 60 days prior to sending notice to the registrant or making public such notice, the Administrator must provide the Secretary of Agriculture a copy of the notice and an analysis of the impact on the agricultural economy.
If the Administrator determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings, the Administrator may suspend the registration of the pesticide after notice and, if requested, after an expedited hearing. The requirement of notice to and consultation with the Secretary of Agriculture would be waived under the circumstances. In an emergency, the Administrator may issue a suspension order before notifying the registrant. § 136d.
Establishments producing pesticides or active ingredients used in producing pesticides must be registered. If requested by the Administrator for the purpose of issuing a stop sale order under the Act, producers must inform the Administrator of the names and addresses of recipients of the pesticide in question. § 136e.
Experimental Use Permits. The Act allows the Administrator to issue experimental use permits if the applicant needs the permit in order to accumulate information necessary to register the pesticide. Use of the pesticide in this case is under the supervision of the Administrator and is subject to the terms and conditions specified in the permit. If the pesticide contains a chemical which is not in previously registered pesticides, the Administrator may require that studies be conducted to detect whether use of the pesticide under the permit may cause unreasonable adverse effects on the environment. Notwithstanding these provisions, the Administrator may issue experimental use permits for one year to any public or private agricultural research agency or educational institution which applies for a permit. The Administrator may authorize states to issue experimental use permits under terms and conditions imposed by regulation. § 136c.
Records and Inspections. The Act authorizes promulgation of regulations requiring producers, registrants and applicants for registration to maintain pertinent books and records and make them available for inspection and copying. For enforcement purposes, a producer, distributor, carrier, dealer or other person who sells or offers for sale, delivers or offers to deliver a pesticide or device subject to the Act shall, upon request of an officer or employee of EPA or of a state or political subdivision designated by the Administrator, permit inspection and copying of all records showing the delivery, movement or holding of the pesticide or device. EPA and the state are also authorized to enter at reasonable times places where pesticides or devices are held for distribution or sale for the purpose of inspecting and obtaining samples. For purposes of determining compliance with the Act, they may also enter a place where a pesticide, the registration for which has been suspended or canceled, is being held. Warrants may be issued to enforce the Act and seize pesticides violating the Act. §§ 136f and 136g.
Data submitted by applicants under the Act may be marked as trade secrets or commercial or financial information and submitted separately. Disclosure is prohibited if the Administrator determines that the information is privileged or confidential, with limited exceptions. For example, information concerning production, distribution, sale or inventories of a pesticide otherwise entitled to confidential treatment may be disclosed in connection with a public proceeding to determine whether a pesticide, or pesticide ingredient, causes unreasonable adverse effects on health or the environment, if disclosure is necessary in the public interest. All information concerning the objectives, methodology, results or significance of a test or experiment and information concerning the effects on any organism or the behavior of the pesticide in the environment, including data on safety to fish and wildlife, humans and other mammals, plants, animals, and soil, and studies on persistence, translocation and fate in the environment, and metabolism, must be available for disclosure to the public. § 136h.
Certified Applicators. As a general rule, restricted use pesticides must be applied by or under the direct supervision of a certified applicator. The Administrator may either approve a state plan for applicator certification or conduct a certification program in the state. Standards prescribed by the Administrator for applicator certification shall include provisions for making instructional materials concerning integrated pest management techniques available to individuals at their request but may not require instruction or competency in such techniques. When establishing or approving standards for certification, the Administrator is to establish separate standards for commercial and private applicators and may not require that private applicators (persons applying pesticides on property they own or rent or on property of another but without compensation) take competency tests, maintain records or file reports. However, under amendments to the Act adopted in 1990, the Secretary of Agriculture was directed to require certified applicators to maintain records comparable to records maintained by commercial applicators in each state. These records must be made available, upon request, to federal or state agencies dealing with pesticide use or a health or environmental issue related to the use of pesticides, as well as to health professionals needing the information in order to provide treatment or first aid to a person exposed to the pesticide. The 1990 amendments direct the Secretary and the Administrator to survey the records maintained under the law to develop and maintain a data base sufficient to enable them to publish annual reports on agricultural and nonagricultural pesticide use. §§ 136, 136a, 136i and 136i-1.
Unlawful Acts and Enforcement. The Act makes it unlawful, for example, to distribute or sell unregistered pesticides, to use a registered pesticide in a manner inconsistent with its labeling, to submit false information, or to violate an order of the Administrator issued under the Act, and provides for certain exemptions. Remedies of the Administrator include issuance of stop sale, use, or removal orders, seizure of the pesticide and the assessment of civil penalties. Knowing violations of the Act also subject the violator to criminal penalties. §§ 136j, 136k and 136l.
The Act authorizes the Administrator to make indemnity payments to persons who own any quantity of a pesticide immediately before the Administrator issues a notice of intent to suspend, if the registration is suspended and later canceled and the person suffers losses by reason of the suspension or cancellation. Indemnification is not required where the person had knowledge of facts that showed that the pesticide did not meet requirements for registration and yet continued thereafter to produce the pesticide without giving timely notice of the facts to the Administrator. In addition, no indemnity payments can be made unless a specific line item appropriation is made for the payment. Provision is also made for indemnification of end users, dealers and distributors under certain circumstances. § 136m.
Judicial Review. In cases where no hearing is held, refusal of the Administrator to cancel or suspend a registration or to change the classification of a pesticide can be reviewed in federal district court. Orders issued after hearing are subject to judicial review in the U.S. Court of Appeals. Actions to enforce, and to prevent and restrain violations of the Act, can be taken in federal district court. § 136n.
Miscellaneous Provisions. The Act contains provisions on a range of pesticide-related activity. The Act sets standards for pesticides being exported from and imported into the U.S. It authorizes the Administrator to exempt a federal or state agency from the provisions of the Act if emergency conditions exist. §§ 136o and 136p.
The Administrator is authorized to promulgate regulations relating to pesticide storage, disposal and transportation and may require registrants to provide information on methods for safe storage and disposal of the pesticide under consideration. The Act directed the Administrator to adopt, by 1992, regulations for the design of pesticide containers to promote safe storage and disposal. Also by 1992, the Administrator was to adopt regulations setting procedures and standards for removing pesticide residue from containers prior to disposal, although the Administrator could exempt products intended solely for household use from the regulations. These provisions do not affect the authority or requirements concerning pesticide containers under the Solid Waste Disposal Act (also known as the Resource Conservation and Recovery Act).
The Administrator may order recall of a pesticide, the registration of which has been suspended and canceled, when necessary to protect health or the environment. Voluntary recall may also be encouraged in cases where recall of a voluntary nature would be safe and effective. The Act outlines the procedures to be followed in the case of recall. § 136q.
Regulations, Research and Monitoring. The Administrator is authorized to undertake research, including research by grant or contract, to carry out the Act and required to conduct research into integrated pest management in coordination with the Secretary of Agriculture. In the 1970's, the Administrator was also directed to formulate and revise periodically a national plan for pesticide monitoring, in cooperation with other federal, state and local agencies, and to undertake monitoring activities to implement the Act and the plan, including monitoring in air, soil, water, man, plants and animals. § 136r.
The 1996 amendments to the Act require that the Secretary of Agriculture, in cooperation with the Administrator, implement research, demonstration, and education programs to support the adopted of integrated pest management. The Secretary and the Administrator must also make information on integrated pest management widely available to pesticide users, including federal agencies. Federal agencies are now required by the Act to use integrated pest management techniques in carrying out pest management activities. § 136r-1.
The Act authorizes the Administrator to adopt regulations to carry out the Act and sets forth special procedures for the adoption process. Before issuing regulations, the Administrator must consult with the Secretary of Agriculture and, in the case of public health pesticides, with the Secretary of Health and Human Services. §§ 136s and 136w.
The Act also authorizes the Administrator, after notice and opportunity for hearing, to: declare a pest any form of plant or animal life which is injurious to health or the environment; identify any pesticide which contains any substance in quantities highly toxic to man; establish standards for safe packaging; specify classes of devices subject to the Act; adopt regulations requiring pesticides to be colored or discolored as appropriate; determine and establish suitable names to be used in ingredient statements. In addition, the Administrator is directed to identify, in cooperation with the Secretary of Agriculture, pests that must be brought under control and to cooperate with the Secretary's research and implementation programs for the control of pests that reduce quality and the economical production and distribution of agricultural products to domestic and foreign consumers. § 136w-3.
The Administrator must cooperate with federal, state and local agencies in carrying out the Act and securing uniformity of regulation and may enter into cooperative agreements with states and Indian tribes to delegate authority to cooperate in enforcement, develop cooperative enforcement programs, and train and certify applicators. The Act also encourages the Administrator to use the services of cooperative state extension services to inform and educate pesticide users about accepted uses and regulatory requirements. §§ 136t and 136u.
Authority of States. States may regulate the sale or use of a federally registered pesticide or device in the state so long as the regulation does not permit any sale or use prohibited by the Act. However, states may not impose requirements for labeling or packaging in addition to or different from those required by the Act. A state may provide registration for additional uses of federally registered pesticides formulated for use within the state to meet special local needs. § 136v.
The Administrator may give a state primary enforcement responsibility for pesticide use violations if it has adopted adequate pesticide laws and regulations and meets other requirements set forth in the Act. If a state with primary enforcement responsibility is not adequately enforcing pesticide use regulations, the Administrator may rescind that responsibility, in whole or in part. §§ 136w-1 and 136w-2.