Pesticide Regulatory
Process
Barbara Madden
U.S. Environmental Protection Agency
Office of Pesticide Programs
Registration Division
March 16, 2011
1
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)
2
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.
3
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
4
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.
5
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.
6
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.
7
8
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.
9
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
10
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.
11
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
12
Websites and Contacts
Public 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/
13
Questions?
Thank you.
14