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/ www.epa.gov/pesticides/