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Regulatory Processes for Pesticides
Mark HartmanAntimicrobials Division (AD)
Office of Prevention, Pesticides and Toxic SubstancesUnited States Environmental Protection Agency
Program Goals
Protect public health and the environment from pesticide risks.
Ensure pesticide users have access to appropriate tools.
Main Statutes
Federal Insecticide, Fungicide and Rodenticide Act (FFIRA)
Food Quality Protection Act (FQPA)
Federal Food, Drug and Cosmetic Act (FFDCA)
Pesticide Registration Improvement Act (PRIA)
Regulatory Framework
Registration
Reregistration
Registration Review
Registration Gateway to the marketplace Granting license necessary to use a pesticide in the
U.S.• New active ingredients• New uses• New products• Amended products
Goal – Ensure that new pesticides/use patterns do not pose risk of concern to human health or the environment
Pesticide Reregistration
Ensures older pesticides meet today’s standards
Scope – Pesticides initially registered before November 1984
Goal – Mitigate risks of concern without disrupting agriculture, public health, other vital uses
Registration Review
15-year review cycle for all pesticides
Implementation projected to begin in 2007
General Process
Data Collection
Risk Assessment
Risk Management
Regulatory Decision
Data
EPA has authority under FIFRA to require data to support a registration– Toxicity
– Product and Residue Chemistry
– Ecological Effects
– Environmental Fate
– Exposure
– Efficacy
Other available data is also reviewed
FIFRA Framework
Consider wide range of risks– Food– Occupational– Water resources– Residential – Terrestrial and aquatic organisms– Endangered species
Acceptable risk standard (“unreasonable adverse effects”)
FQPA Framework
FQPA introduced new safety standard, “reasonable certainty of no harm”
Consider and assess:– Aggregate exposure– Cumulative effects of pesticides with a
common mechanism of toxicity– Effects on infants and children– Endocrine effects (program in early stages)
Public Participation Process
Provides framework for stakeholder and public involvement in reregistration
Offers consistent, defined, predictable opportunities for public involvement
Gives EPA flexibility to tailor the process to each pesticide’s uses and risks
Tailored Approach
6-phase full process for pesticides with complex uses and issues; significant risk mitigation needed
4-phase modified process for pesticides with limited uses and risks; nominal risk mitigation needed
Low risk process for pesticides requiring little or no risk mitigation
Public Process: Phases 1-3
Phase 1: Registrant "Error Only" Review
Phase 2: EPA Considers Error Comments
Phase 3: Release of Risk Assessment for Public Comment
Phase 4
EPA considers public comments received during Phase 3, revises the risk assessments as necessary, prepares a preliminary benefits characterization (if needed) and works on risk reduction options
With input from other EPA offices, other agencies and stakeholders, EPA develops a risk management decision
Get Involved Early
EPA encourages stakeholders and the public to use our schedules and the public participation process
Plan to get involved early in reviews of pesticides of interest
See EPA’s website for pesticide information and contacts
Triclosan as a Pesticide
First registered in 1969 22 currently registered products Major use patterns
– Hard surface disinfection and sanitization– Materials preservatives (textiles etc.)– Coatings– Swimming pool water systems
Triclosan Process
Tentative Reregistration Decision Date of 9/07
Data review and risk assessment development to begin late in 2006
Information on EPA Website
EPA Office of Pesticide Programs www.epa.gov/pesticides/