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) [FIFRA (109 pp, 288k, About PDF)] 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.

Endangered Species Protection Program 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. Find our more on the Endangered Species Protection Program

Regulations

The Federal Register Environmental Documents section contains the full-text of selected Federal Register documents issued from the EPA or other Federal Agencies that concern environmentally related issues, and beginning in October, 1994. These documents are further divided by topics such as Pesticides, Endangered Species, and Environmental Meetings. There are also topic specific daily listservs which will deliver the documents directly to your email box.
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.

October 26, 2007 - EPA's pesticide registration data requirements have been restructured for 40 CFR Part 158.

e-CFR: Electronic Code of Federal Regulations - (e-CFR) is a currently updated version of the Code of Federal Regulations (CFR). It is not an official legal edition of the CFR. 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.

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