Laws and Regulations
EPA regulates the use of pesticides under the authority of two federal statutes: the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA).
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides the basis for regulation, sale, distribution and use of pesticides in the U.S. FIFRA authorizes EPA to review and register pesticides for specified uses. EPA also has the authority to suspend or cancel the registration of a pesticide if subsequent information shows that continued use would pose unreasonable risks. Some key elements of FIFRA include:
- is a product licensing statute; pesticide products must obtain an EPA registration before manufacture, transport, and sale
- registration based on a risk/benefit standard
- strong authority to require data--authority to issue Data Call-ins
- ability to regulate pesticide use through labeling, packaging, composition, and disposal
- emergency exemption authority--permits approval of unregistered uses of registered products on a time limited basis
- ability to suspend or cancel a product's registration: appeals process, adjudicatory functions, etc.
The Pesticide Registration Improvement Act (PRIA) of 2003 establishes pesticide registration service fees for registration actions in three pesticide program divisions: Antimicrobials, Biopesticides and Pollution Prevention, and the Registration Divisions.
The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes EPA to set maximum residue levels, or tolerances, for pesticides used in or on foods or animal feed. FFDCA:
- mandates strong provisions to protect infants and children
- provides the authority to set tolerances in foods and feeds (maximum pesticide residue levels)
- also provides authority to exempt a pesticide from the requirement of a tolerance
- rule-making process required to set tolerances or exemptions
- before a registration can be granted for a food use pesticide, a tolerance or tolerance exemption must be in place
- mandates primarily a health-based standard for setting the tolerance--"reasonable certainty of no harm"
- benefits may be considered only in limited extreme circumstances, very unlikely
- pesticide residues in foods are monitored and the tolerances enforced by FDA (fruits and vegetables, seafood) and USDA (meat, milk, poultry, eggs, and aquacultural foods)
The Food Quality Protection Act of 1996 (FQPA) amended FIFRA and FFDCA setting tougher safety standards for new and old pesticides and to make uniform requirements regarding processed and unprocessed foods. FQPA:
- passed unanimously in both the House and Senate
- amended both FIFRA and FFDCA, significantly changing the way EPA regulates pesticides:
- establishes a single safety standard under FFDCA by which we are to set tolerances--not a risk/benefit standard (with some exceptions)
- assessment must include aggregate exposures including all dietary exposures, drinking water, and non-occupational (e.g., residential) exposures
- when assessing a tolerance, EPA must also consider cumulative effects and common mode of toxicity among related pesticides, the potential for endocrine disruption effects, and appropriate safety factor to incorporate
- requires a special finding for the protection of infants and children
- must incorporate a 10-fold safety factor to further protect infants and children unless reliable information in the database indicates that it can be reduced or removed
- establishes a tolerance reassessment program and lays out a schedule whereby EPA must reevaluate all tolerances that were in place as of August, 1996 within 10 years
- requires a minor use program and provides that special considerations be afforded minor use actions
- requires review of antimicrobial actions within prescribed timeframes
- EPA must now periodically review every pesticide registration every 15 years
- now required to set tolerances for use of pesticides under emergency exemptions (FIFRA Section 18)
The Endangered Species Act (ESA) of 1973 prohibits any action that can adversely affect an endangered or threatened species or its habitat. In compliance with this law, EPA must ensure that use of the pesticides it registers will not harm these species.
- Under the Endangered Species Act, EPA must ensure that use of pesticides it registers will not result in harm to the species listed as endangered or threatened by the U.S. Fish and Wildlife Service, or to habitat critical to those species' survival.
- EPA publishes a variety of notices in the Federal Register, including proposed and final regulations and notices about documents available for comment. You can receive emails from the pesticide program about announcements and Federal Register notices.
- The Code
of Federal Regulations (CFR) is a codification of the rules published
in the Federal Register by the Executive departments and agencies of the
Federal Government. The CFR is divided into 50 titles which represent
broad areas subject to Federal regulation, with environmental regulations
contained mainly in Title 40. Each volume of the CFR is revised once each
calendar year and updated on a quarterly basis, Title 40 is issued every
July 1. The official legal edition of the CFR is available from the Government Printing Office Website.
The lastest available CFR information may be obtained by referring to the e-CFR: Electronic Code of Federal Regulations. The information in the e-CFR is updated frequently. The e-CFR is an editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.
October 26, 2007 - EPA's pesticide registration data requirements have been restructured for 40 CFR Part 158.