FQPA: “It’s a Good Thing” (for Kids)

1. FQPA:“It’s a Good Thing”(for Kids) Penelope A. Fenner-Crisp, PhD, DABT (USEPA, retired) Presented at the 2007 Society of Toxicology Regulatory and Safety Evaluation Specialty Section Charlotte, NC March 26, 2007

2. Why? • Implementation of the FQPA directives is leading to a reduction in exposure to pesticides possessing a greater degree of hazard concern

3. Reminder FQPA = FIFRA + FFDCA

4. FFDCA • When setting or (re)assessing tolerances, EPA is to: • Apply an extra 10X safety factor to assure the protection of infants and children; • Assess total pesticide exposure from all non-occupational sources: diet, drinking water, residential and other non-occupational sources • Assess effects of exposure to multiple pesticides with a common mechanism of toxicity

5. Impact of “Kids” Safety Factor P A D* R f D 1X 3X 10X Size of Safety Factor * Population Adjusted Dose

6. Impact of Aggregate Assessment The “Risk Cup” = the PAD R R F DW DW R F F F F F F F F F F F F F F F F F F F F F F R F F F F Food residues (F) alone (pre-FQPA) Food Residues (F) + Drinking Water Residues (DW) Food residues (F) + Drinking Water Residues (DW) + Residential Residues (R)

7. Impact of Cumulative Assessment R R R F R R R R R R R DW R F F DW F R R R R F F F F F F DW T F F F F F F R F F F F R F F R F

8. Cumulative Risk Assessment Decisions • Chlorinated triazines (3) and Chloroacetanilides (2) meet safety standard • Organophosphates • From > 40 in 1996 to 32 today • Cancelled/phased out substantial number of residential uses • Cancelled/phased out > 50 uses on kids’ foods

9. FIFRA • Tolerance Reassessment • Reregistration • Expedited Review for Reduced Risk Pesticides • Registration Renewal

10. FIFRA-Tolerance Reassessment • All existing tolerances to be reassessed by August 3, 2006 • Accomplishments as of August 2006: • Focused on the “Worst First:” OPs, Carbamates, Group B, Cq carcinogens, RfD exceeders, high hazard inerts • Completed assessment of 9637 of 9721 tolerances for ~470 food use pesticides and high hazard inerts • Recommended revocation of 3200 tolerances • Recommended modification of 1200 tolerances • Confirmed safety of 5237 tolerances

11. FIFRA-Reregistration • FQPA mandated completion of reregistration (for the fourth time) • Accomplishments as of August 3, 2006: • Completed 559 of 566 reregistration eligibility decisions for food-use pesticides • Remaining 54 non-food use cases to be completed by October, 2008. • ~4400 of ~17,600 individual pesticide end-use product registrations cancelled

12. FIFRA-Reduced Risk Pesticides • FQPA formalized 1992/3 guidance for expedited registration review of reduced risk (RR) conventional pesticides • Areas of criteria supporting definition of RR • Human Health • Non-target organisms (birds and fish) • Potential for groundwater contamination • Lower use rates, less frequent application • Low pest resistance potential • Compatibility with IPM • Efficacy

13. RR Human Health Effects Factors • Very low mammalian toxicity • Toxicity generally lower than alternative (10-100x) • Displaces chemicals that pose high concern (e.g., the OPs, Probable carcinogens) • Reduces exposure in occupational settings

14. RR Pesticide Actions:1994-2006 • Number of active ingredients reviewed: 70 • Number of new actives: 47 • Number of OP alternatives*: 28 • Number of new uses granted: 668 • Number of new uses granted for OP alternatives: 260 * 1999- first year of expedited review of OP Alternatives

15. FIFRA-Registration Renewal • FQPA mandates periodic review of pesticide registration • 15-year review cycle • Procedural regulations in place (August, 2006) • Schedule for FY07-FY10 issued (October, 2006) • Covers conventional, antimicrobial, biochemical, microbial pesticides

16. I’m Maggie. I’m 2 weeks old I’m Drew. I’m 11 years old Our Grandma says that FQPA is a good thing for infants and kids like us.