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 Factor1X 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 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)

7. Impact of Cumulative AssessmentR 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

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
* 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.