The FIFRA requires all pesticides to be registered with the EPA. Pesticides are then classified according to general or
35. The FIFRA was enacted in 1972 and is codified in the U.S. Code,
Vol. 7, sec. 136 et seq. It was amended in 1975, 1978, 1980, 1983, 1984, 1988 (major amendments, U.S. Public Law 100-532, 102 Stat. 2654) and 1990. The FIFRA regulations are found in the Code of Federal Regulations, Title 40, secs. 162-180.
restricted use (7 USC §136a). The EPA registers a pesticide if it determines that the pesticide does not create unreasonable adverse effects on human health and the environment. The registration process requires applicants to provide information on the product's chemistry, residue chemistry, toxicology, field reentry protection, aerial drift evaluation, effect on nontarget organisms, and product performance (40 CFR §158.20[c]).
Since the FIFRA regulates pesticide sale, distribution, and use, the scope of the act largely depends on the definition of the term pesticide. The FIFRA (§2[u], 7 USC §136[u]) defines a pesticide as "any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant. ..."
The FIFRA contains other definitions including explanations of the terms within the definition of pesticide. For instance, an understanding of the term pest is needed to apply the definition of pesticide. A pest is defined as "any insect, rodent, nematode, fungus, weed, or any other form of terrestrial aquatic plant or animal life or virus, bacteria, or other micro-organism (except [those] on or in living man or other living animals) which [the EPA] declares to be a pest ..." (FIFRA §2[t], 7 USC §136[t]). The EPA has promulgated regulations which clarify what is and is not a pesticide for the purposes of this statute.36
Section 3 of the FIFRA (7 USC §136a) requires persons to register pesticides with the EPA before they are sold or distributed within the United States. FIFRA's registration process allows the EPA to evaluate the risks of the pesticide being proposed. This evaluation is accomplished by examining application information.
Applicants must file a statement which includes:
The name and address of the applicant and the name of any other person who appears on the label of the pesticide
The name of the pesticide
A complete copy of the pesticide's label, instructions for its use, and a statement of all claims made of the pesticide
The complete formula of the pesticide A request that the pesticide be classified for general use, restricted use, or both (FIFRA §3[c], 7 USC §136a[c] )
36. See Code of Federal Regulations. Title 40, part 162.
Additionally, the EPA can request the applicant to include a full description of tests, test results, and other data associated with the pesticide. The EPA has guidelines stating the types of information which an applicant must submit to register a pesticide (FIFRA §3[c], 7 USC §136a[c]).37
The EPA generally registers a pesticide provided that:
The pesticide is what it is claimed to be in the application The applicant complies with labeling and other FIFRA application requirements The pesticide performs its function without unreasonable adverse effects to the environment The pesticide, when used "in accordance with widespread and commonly recognized practice," does not cause unreasonable adverse effects to the environment (FIFRA §3[c], 7 USC 136a[c]).
The EPA must weigh the economic, social, and environmental costs and benefits to determine whether a pesticide causes unreasonable adverse effects to the environment (FIFRA §2[bb], 7 USC §136[bb]). The applicant has the burden of providing all information needed by the EPA to determine if the pesticide meets the registration standard.
The FIFRA (§3[c], 7 USC §136a[c]) also provides for conditionally registered pesticides under limited conditions. The EPA allows conditional registration if the proposed pesticide is substantially similar to an existing registered pesticide and no unreasonable risks on the environment exist. The conditional registration requires the applicant to submit additional data on the pesticide.
Finally, the act provides for experimental use permits which can be issued by the EPA or an authorized state (FIFRA §5, 7 USC §136c; 40 CFR pt. 172). These permits allow the applicant to sell, distribute, and use the pesticide under restricted conditions until the pesticide is properly registered.
As part of the registration procedure, the EPA classifies a pesticide for general use, restricted use, or both (FIFRA §3[d], 7 USC 136a[d]). A pesticide is classified for general use if it does not cause unreasonable adverse effects on the environment when applied according to its instructions and applicable warnings.
A pesticide is classified for restricted use if its application likely causes unreasonable adverse effects on the environment without additional regulatory restrictions. If the EPA classifies a pesticide for restricted use based on a finding that "the acute dermal or inhalation toxicity of the pesticide presents a hazard to the applicant or to other persons," the pesticide can be applied only by or under the supervision of a certified applicator. The FIFRA (§11, 7 USC §136i) has procedures and requirements to become
37. The guidelines are published in the Code of Federal Regulations, Title 40, part 158.
a certified applicator which are implemented by the EPA or through a federally approved state certification program.
The EPA is required to cancel a registered pesticide five years after its registration unless the registrant requests to have the pesticide reregistered (FIFRA §6[a], 7 USC §136d[a]). Additionally, the EPA can issue an immediate suspension order to a registrant to prevent an imminent hazard (FIFRA §6[c], 7 USC §136d[c]).
Many pesticides were registered under the FIFRA prior to the 1972 amendments. However, those pesticides were not subject to any risk/benefit analysis prior to registration. Moreover, many registered pesticides also had insufficient warnings and labels. Section 4 of the FIFRA (7 USC §136a-l) requires that these pesticides and any pesticide issued before November 1, 1984, reregister with the EPA. The implementation of this process has been slow.
In 1978, Congress sought to facilitate the reregistration process by giving the EPA authority to obtain data from holders of existing registered pesticides (FIFRA §3[c][B], 7 USC §136a[c][B]). Registrants then have ninety days to provide evidence that they are taking steps to obtain the data. The EPA can issue a notice of intent to suspend the registration if the registrant fails to comply. This notice can lead to a full suspension of the pesticide which could last indefinitely or until the registrant complies with the request for data.
Congress amended the FIFRA in 1988 to improve the reregistration process. Congress adopted a new section 4 to the FIFRA which created the following five phases for reregistration:
Phase 1. Listing and prioritizing active ingredients of pesticides for reregistration Phase 2. Submission of notices of intent to reregister, and identification of and commitments to replace missing or inadequate data Phase 3. Submission of studies on the active ingredients of the pesticides Phase 4. Independent initial review by the EPA of submissions under phases 2 and 3, identification of outstanding data requirements, and request for additional data if necessary Phase 5. Review of data submitted, and appropriate regulatory action implemented (FIFRA §4, 7 USC §136a-l)
Additionally, Congress adopted a fee program to cover the expected costs of the new reregistration process (FIFRA §4[i], 7 USC §136a-l[i]).
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