Regulatory Processes for Pesticides

1
Regulatory Processes for Pesticides

• Mark Hartman
• Antimicrobials Division (AD)
• Office of Prevention, Pesticides and Toxic
  Substances
• United States Environmental Protection Agency

2
Program Goals

• Protect public health and the environment from
  pesticide risks.
• Ensure pesticide users have access to appropriate
  tools.

3
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)

4
Regulatory Framework

• Registration
• Reregistration
• Registration Review

5
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

6
Pesticide Reregistration

• Ensures older pesticides meet todays standards
• Scope Pesticides initially registered before
  November 1984
• Goal Mitigate risks of concern without
  disrupting agriculture, public health, other
  vital uses

7
Registration Review

• 15-year review cycle for all pesticides
• Implementation projected to begin in 2007

8
General Process

• Data Collection
• Risk Assessment
• Risk Management
• Regulatory Decision

9
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

10
FIFRA Framework

• Consider wide range of risks
• Food
• Occupational
• Water resources
• Residential
• Terrestrial and aquatic organisms
• Endangered species
• Acceptable risk standard (unreasonable adverse
  effects)

11
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)

12
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 pesticides uses and risks

13
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

14
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

15
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

16
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 EPAs website for pesticide information and
  contacts

17
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

18
Triclosan Process

• Tentative Reregistration Decision Date of 9/07
• Data review and risk assessment development to
  begin late in 2006

19
Information on EPA Website

• EPA Office of Pesticide Programs
  www.epa.gov/pesticides/