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Laws
FIFRA | PRIA
| FFDCA | FQPA | ESA
| 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
(743 KB, 106 pgs 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. (140 KB)
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.
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