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Pesticide Regulatory Process

Barbara Madden

U.S. Environmental Protection Agency

Office of Pesticide Programs

Registration Division

March 16, 2011

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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)

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Statutes 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.

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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

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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.

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.

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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.

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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.

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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

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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.

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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 180.41

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Websites and ContactsPublic Dockets for Pesticide Decisions

http://www.regulations.gov/search/Regs/home.html#home

Pesticide Registration Improvement Act (PRIA) http://www.epa.gov/pesticides/fees/

Reduce Risk Web Site http://www.epa.gov/pesticides/health/reducing.htm

Section 18 Web Site http://www.epa.gov/opprd001/section18

Inerts Web Site http://www.epa.gov/opprd001/inerts

RD Contacts List http://www.epa.gov/opprd001/contacts_rd.htm

Work Plan Web Site http://www.epa.gov/opprd001/workplan

Chemical Fact Sheets Web Site http://www.epa.gov/opprd001/factsheets

24(C) Web Site http://www.epa.gov/opprd001/24c

IR-4 Web Site http://ir4.rutgers.edu/

Questions?

Thank you.

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