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Understand how the FQPA directives are enhancing safety for children by reducing pesticide exposure and implementing safety factors. Learn about the impact on aggregate assessment and cumulative risk, alongside regulatory decisions and accomplishments as of 2006. Discover actions taken for reduced-risk pesticides, reregistration, and registration renewal under FIFRA.
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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 P A D* R f D 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 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)
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
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.