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

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

Reminder FQPA = FIFRA + FFDCA

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

Impact of “Kids” Safety Factor 1X 3X 10X Size of Safety Factor * Population Adjusted Dose

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 R F F 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)

Impact of Cumulative Assessment R R R F R R R R R R R DW R F DW F 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

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

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

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

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

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

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

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

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

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.