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 today’s 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 pesticide’s 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 EPA’s 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/