Pesticide Reregistration and Special Reviews1
Frederick M. Fishel2
Ever since the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988, the US Environmental Protection Agency (EPA) has been conducting a comprehensive review of pesticides that were first registered with the EPA prior to November 1984. The purpose of this review is to consider the effects of these older pesticides on human health and the natural environment and to decide on future use of these pesticides. The EPA examines health and safety data for these pesticide's active ingredients and determines whether these substances are eligible for reregistration. To be eligible, a pesticide must have a substantially complete database and must not cause unreasonable risks to human health or the environment when used in accordance with the directions and precautions included on the pesticide's EPA-approved label.
In 1996, FIFRA was further amended by the Food Quality Protection Act (FQPA), which requires that all pesticides approved by the EPA must meet new safety standards. These standards have become stricter over the years as the ability to evaluate the potential harmful effects of pesticides has increased. The EPA must be able to conclude “with reasonable certainty” that no harm will come to infants, children, or other sensitive individuals exposed to pesticides. All pesticide exposures from food, drinking water, and home and garden use must be considered in determining allowable levels of pesticides in food. The cumulative effects of pesticides and other compounds with common mechanisms of toxicity also must be considered.
Through the reregistration program, the EPA is ensuring that older pesticides meet contemporary standards for health and safety, as well as product-labeling requirements, and also ensuring that risks associated with these pesticides are moderated. In addition, the FQPA has created a new program that requires the EPA to review every registered pesticide on a 15-year cycle. As a result of this requirement, the public always will have assurance that pesticides are being reviewed by the EPA periodically to meet current scientific and regulatory standards.
In addition to pesticide reregistration requirements, when the EPA discovers that the use of a registered pesticide may result in unreasonable adverse effects on people or the natural environment, the EPA may then initiate the Pesticide Special Review process. Unlike the reregistration and registration review processes, the special review usually involves intensive review of just one or possibly a few potential risks or concerns. The review involves evaluating existing data, acquiring new information and/or studies, assessing the identified risk, and determining appropriate risk-reduction measures.
Criteria that determine the need for a special review include the following:
Acute toxicity to humans or domestic animals.
Potential chronic or delayed toxic effects in humans.
Potential hazards to non-target organisms.
Risk to the continued existence of any threatened or endangered species.
Risk of destruction or other adverse modification of a critical habitat of any threatened or endangered species.
Any other adverse effect to humans or the environment that may outweigh the benefits that justify initial or continued registration.
The EPA's decision to undertake a special review of a pesticide does not necessarily mean that the pesticide poses unreasonable risks and will be canceled. A special review may conclude with a determination that the pesticide does not pose such risks or that safe use of the pesticide requires additional risk-reduction measures, including possibly labeling changes or discontinuation of certain previously approved uses for the pesticide.
As required by federal regulations, EPA sends the producers of a pesticide, as well as the registrants, a private notification that the Agency is considering a Notice of Special Review. Issuing this private notification begins the pre-special review phase of the process. The registrant is then allowed a short period of time to dispute the validity of the Agency's concerns. If, after notifying the registrants and receiving their response, the Agency tentatively determines that use of the pesticide does not pose a significant risk, EPA issues a Federal Register (FR) notice that explains the reasons for its decision. This notice also announces the availability of the public docket, which includes the pre-special review notification and all written information received in response to the notification. The FR notice also solicits public comment, after which the Agency makes a final decision regarding whether to initiate a special review. The Agency's final decision is published in an FR notice, announcing the initiation of a special review or, as a final determination, not to initiate a special review.
Fishel, F.M. 2008. EPA Approval of Pesticide Labeling. PI167. Gainesville: University of Florida Institute of Food and Agricultural Sciences http://edis.ifas.ufl.edu/pi203 (accessed January 2013).
Olexa, M.T., and Z. Broome. 2011. Handbook of Florida Water Regulation: Food Quality Protection Act. FE589. Gainesville: University of Florida Institute of Food and Agricultural Sciences. http://edis.ifas.ufl.edu/fe589 (accessed January 2013).
This document is PI218, one of a series of the Agronomy Department, UF/IFAS Extension. Original publication date October 2009. Revised February 2013. Reviewed March 2019. Visit the EDIS website at https://edis.ifas.ufl.edu for the currently supported version of this publication.
Frederick M. Fishel, professor, Agronomy Department, and director, Pesticide Information Office; UF/IFAS Extension, Gainesville, FL 32611.
The Institute of Food and Agricultural Sciences (IFAS) is an Equal Opportunity Institution authorized to provide research, educational information and other services only to individuals and institutions that function with non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, marital status, national origin, political opinions or affiliations. For more information on obtaining other UF/IFAS Extension publications, contact your county's UF/IFAS Extension office.
U.S. Department of Agriculture, UF/IFAS Extension Service, University of Florida, IFAS, Florida A & M University Cooperative Extension Program, and Boards of County Commissioners Cooperating. Nick T. Place, dean for UF/IFAS Extension.