Presentation on theme: "Pesticide Regulatory Process"— Presentation transcript:
1 Pesticide Regulatory Process Barbara MaddenU.S. Environmental Protection AgencyOffice of Pesticide ProgramsRegistration DivisionMarch 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 FFDCAUnder FIFRA, OPP conducts worker and ecological risk assessments to support the following regulatory actions:Section 3 - RegistrationsSection 5 – EUPsSection 18 – Emergency ExemptionsSection 24(c) – Special Local NeedsUnder 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 ActCreated time frames for completion of registration actionsProvided fee waiver/exemptions provisions for small businesses, minor uses, IR-4 and state & federal agencies
5 IR-4 and PRIASame 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 PRIAA section 3 label amendment including a complete application package must be submitted with any IR-4 petition including:All registration formsProposed LabelsNotice of Filing (NOF)All packages must pass a 21 day screenOnce petitions are sent into review if it is determined there are data deficiencies, a 75-day deficiency letter is sent to the registrant.
9 TeffThe 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 ResiduesExposure includes food, water and residential exposuresResidue 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 chemicalAcuteShort-termIntermediate-termChronic (cancer and non-cancer)Cumulative risk – chemical classA 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 RegulationAttempt to establish tolerances for crops with Codex MRLS at the same levelEPA and IR-4 are working together to revise the existing crop groups in 40 CFR
13 Websites and ContactsPublic Dockets for Pesticide DecisionsPesticide Registration Improvement Act (PRIA)Reduce Risk Web SiteSection 18 Web SiteInerts Web SiteRD Contacts ListWork Plan Web SiteChemical Fact Sheets Web Site24(C) Web SiteIR-4 Web Site