1. Pesticide Regulatory Process
Barbara Madden
U.S. Environmental Protection Agency
Office of Pesticide Programs
Registration Division
March 16, 2011

2. Statutes Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Federal Food Drug and Cosmetic Act (FFDCA)
Food Quality Protection Act (FQPA)
Pesticide Registration Improvement Act (PRIA)
Endangered Species Act (ESA)

3. Statutes Section 3 - Registrations Section 5 – EUPs
FQPA amended both FIFRA and FFDCA
Under FIFRA, OPP conducts worker and ecological risk assessments to support the following regulatory actions:
Section 3 - Registrations
Section 5 – EUPs
Section 18 – Emergency Exemptions
Section 24(c) – Special Local Needs
Under FFDCA, OPP conducts human health aggregate risk assessments. FFDCA also provides the basis for the endocrine screening program.

4. PRIA PRIA was passed on March 23, 2004 and reauthorized in 2007
Fee-for-Service Act
Created time frames for completion of registration actions
Provided fee waiver/exemptions provisions for small businesses, minor uses, IR-4 and state & federal agencies

5. IR-4 and PRIA
Same registration process as other section 3 registrations – same PRIA deadlines.
Label Amendments submitted with IR-4 petitions are exempt from PRIA fees provided the application is solely associated with the tolerance petition submitted by IR–4 and is in the public interest.
Minor Use Team in the Registration Division coordinates the review of IR-4 petitions for conventional pesticides.

6. Revised Public Interest Finding
Label Amendments submitted with IR-4 petitions are exempt from PRIA fees provided the application is solely associated with the tolerance petition submitted by IR–4 and is in the public interest.
In 2007 the Deputy Office Director announced that the IR-4 Public Interest Finding would be revised.
No final determination on how the revised public interest finding will read has been made and talks between EPA and IR-4 are still ongoing.

7. Impact of PRIA
A section 3 label amendment including a complete application package must be submitted with any IR-4 petition including:
All registration forms
Proposed Labels
Notice of Filing (NOF)
All packages must pass a 21 day screen
Once petitions are sent into review if it is determined there are data deficiencies, a 75-day deficiency letter is sent to the registrant.

9. Teff
The HED ChemSAC decision for 2,4-D and Dicamba on teff only determined that residue field trial data were not needed for teff and that the existing tolerance (residue data) on wheat could be extrapolated to establish a tolerance for teff.
However, a petition with all of the supporting documentation still had to be submitted to the EPA, risk assessments conducted and the required safety finding must be made before tolerances can be established for residues of 2,4-D and Dicamba on teff.

10. Risk Assessment Risk = Hazard X Exposure
Exposure = Consumption X Residues
Exposure includes food, water and residential exposures
Residue field trial data supplied by IR-4 is one component in this equation providing inputs for exposure to food

11. FFDCA Safety Finding Reasonable Certainty of no harm finding
Aggregate risk – individual chemical
Acute
Short-term
Intermediate-term
Chronic (cancer and non-cancer)
Cumulative risk – chemical class
A Federal Register Notice must publish to establish a tolerance stating this finding has been made.

12. Ongoing Projects of Minor Use Team
Joint review projects with the Pesticide Management Regulatory Agency (PMRA)
Work share projects with California Department of Pesticide Regulation
Attempt to establish tolerances for crops with Codex MRLS at the same level
EPA and IR-4 are working together to revise the existing crop groups in 40 CFR

13. Websites and Contacts
Public Dockets for Pesticide Decisions
Pesticide Registration Improvement Act (PRIA)
Reduce Risk Web Site
Section 18 Web Site
Inerts Web Site
RD Contacts List
Work Plan Web Site
Chemical Fact Sheets Web Site
24(C) Web Site
IR-4 Web Site

14. Questions? Thank you.