Transcript Pesticide Registration Federal

EPA and Aquatic
Pesticide Registration No Unreasonable
Adverse Effects on Man
or the Environment
Donald Stubbs
Outline
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Applicable Federal Statutes
Data Requirements
Label Development
Federal Registration
State Registration
NPDES
Reregistration and Registration Review
Applicable Statutes
Food Quality Protection Act
(FQPA) (1996)
Clean Water ACT
Pesticide Registration
Improvement Act (2004)
Federal Food Drug
And Cosmetic Act
(FFDCA)
Tolerance Established
Federal Insecticide Fungicide
And Rodenticide Act
(FIFRA)
Product Registered
Federal Insecticide Fungicide and
Rodenticide Act (FIFRA)
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Registration
 FIFRA allows for registration if a product will perform
its intended function without unreasonable adverse
effects on the environment
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FIFRA is a risk/benefit statute What does this mean?
Federal Food Drug and Cosmetic
Act (FFD&C)
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Establish tolerances – legal limit on residues
Tolerances for pesticides are established by EPA
under the FFD&C Act
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General standard for tolerances is that there will be a
reasonable certainty that no harm will result from
residues of pesticides in food or feed
It is a risk statute What does this mean?
Food Quality Protection Act 1996
 Sets a general standard for tolerances – a
reasonable certainty that no harm will result from
aggregate exposure
Pesticide Registration Improvement
Act
 Amended FIFRA by requiring a registration
service fee system
Unique Items to be Addressed in
Registering an Aquatic Herbicide
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Fish tolerances
Shell fish tolerances
Irrigated crops
Swimmers
Potable water
Data Required to Register a
Pesticide
Efficacy data
 Human health data
 Residue chemistry data
 Environmental fate and transport data
 Ecological toxicity data
 There are approximately 140 studies required
 All studies must be carried out under GLP
What is GLP?
Where does this data come from and who pays for it?
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Efficacy data
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Required but only submitted for human
health pesticides
Defines use rates and use patterns
Human Health Data Required
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Acute toxicity studies –
used to determine appropriate label precautions
Chronic toxicity –
used for long term exposure endpoints dealing with
users and food exposure as well as labeling
Oncogenicity –
Developmental toxicity
Gene mutation studies
Rreproduction study (2 generation)
Residue Chemistry Data Utilized to
Determine Dietary Exposure
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Chemical identity
Nature of residues
Magnitude of residues
Analytical methods for residue detection
Acceptable Risks
EPA uses a no observable adverse effect level
(NOAEL) from the toxicology studies required
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Dietary – EPA determines a reference dose (RfD) using the
NOAEL for the most sensitive endpoint divided by an
uncertainty factor (UF) of a minimum of 100
Example – a NOAEL of 10 mg/kg/UF of 100 = a RfD
of .10 mg/kg
The risk is acceptable as long as the exposure does not
exceed the RfD
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Non-dietary – EPA determines toxicity end points
of concern called “LOC” or level of concern using a
100 fold safety factor
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A ratio of the LOC to exposure is calculated – margin of
exposure (MOE)
If the MOE is less then or equal to the LOC the risk is
acceptable
 Carcinogenicity 1 in a million
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Pesticide Residues in Water
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EPA takes into account residues of a pesticide in drinking
water via drinking water levels of concern (DWLOC’s)
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They are based on ten year annual peak concentration
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Exposure from drinking water levels is evaluated from an
acute and chronic standpoint
Studies Required to Conduct an
Ecological Risk Assessment
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There are two categories of data required:
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Environmental fate and transport studies –
looking at fate and transport of pesticide and
its degradates
Ecological toxicity studies – looking at
toxicity of the pesticide and its degradates
Environmental fate and
transport studies
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Chemical Degradation
Metabolism studies
Volatility
Dissipation
Bioaccumulation in aquatic non-target organisms
Accumulation in fish
Ecological Toxicity Studies
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Tests on avian species
Tests on mammalian species
Tests on aquatic species
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bluegill sunfish
rainbow trout
Freshwater invertebrate
Other Studies
Based on acute toxicity and if product is applied directly
to water or will be transported to water at a given
level
 Subchronic testing of fish - Fish early life stage
using fresh or estuarine fish species
 Full life cycle invertebrate
 Multi-generation test for fish
PLANT TOXICITY TESTS
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Terrestrial Plant Tests
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Seedling emergence
Vegetative vigor
Aquatic Plant tests
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Green algae
Blue-green cyanobacteria
Freshwater diatom
Marine diatom
Floating aquatic macrophyte
What does EPA do with all that data?
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Identifies hazards – for dietary and non-dietary
exposure
Select toxicological endpoints – doses at which
no adverse effects are observed in toxicology
studies
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Determines exposures
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Develops label language and establishes
tolerances
Label Development
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Human Health and Environmental Data are
used to develop:
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User safety precautions
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Protective clothing (PPE)
REI’s What is this?
Specific hazard warnings
Environmental safety warnings
Product container disposal directions
Label Development
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Directions for use
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Application rates and intervals
PHI
Mandatory vrs Advisory – Who cares and why?
Use Restrictions
Pesticide Classification
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General Use
Restricted Use
WHAT DOES ALL THIS MEAN ?
You can use a pesticide labeled for aquatic
use to control nuisance weeds without
causing unreasonable adverse effects on man
or the environment as long as you follow the
label directions.
THE LABEL IS THE LAW!!!!
Federal Registration
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Use of a pesticide requires an accepted
Federal label
Still requires individual state registration
Must be used in accordance with its labeling
“Use” includes handling, mixing, storage
loading, transportation as well as actual use
State Registration
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States may register an additional use of a
federally registered pesticide product via 24(c)
of FIFRA.
EPA reviews 24(c) registrations, and may
disapprove them if:
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The use is not covered by necessary tolerances
The use has been previously denied disapproved,
suspended or canceled
Clean Water Act
Pesticides in water
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As of April 9, 2011 NPDES permits are
required for use of aquatic pesticides
Covers application to water or at water’s edge
including irrigation ditches and canals
Registration Review
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Takes into account changes in science, public policy,
and pesticide use practices over time
All pesticides
15-year cycle
44 chemicals cases/year
Update reviews as needed
Registered pesticides continue to meet statutory
standard of no unreasonable adverse effects
Thank you!
NPDES
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Short history NPDES and pesticides
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Not required by regulation FR 11/27/2006
Court vacated EPA regulations – 1/7/2009
As a result discharges to waters of the U.S. from the application of pesticides
will require NPDES permits. This was not a science issue but a legal one
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EPA proposed general permits 6/2/2010
Pesticides General Permit (PGP) if not covered under general permit an
individual permit is required.
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Final Rule issued 10/31/2011- Handled in OW
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(1) mosquito and other flying insect pest control;
(2) weed and algae control;
(3) animal pest control; and
(4) forest canopy pest control.
Major Aquatic Herbicides
Registered prior to 1986
Herbicide
Copper
2,4-D ester
Endothall
Diquat
2,4-D amine
Glyphosate
Fluridone
Year
1950s
1959
1960
1962
1976
1977
1986
General Use
Algae
broadleaf
submersed plants algae
submersed &
broadleaf
emergent plants
submersed plants
New Aquatic Herbicides for Invasive
Weed Control
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Between 1986 and 2002 there were no new aquatic
herbicides registered
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Since 2003 there have been 8 new aquatic herbicides
registered
 Triclopry
2003
 Imazapyr
2003
 Carfentrazone-ethyl
2004
 Penoxsulam
2007
 Imazamox
2008
 Flumioxazin
2010
 Bispyraibac-sodium
2011
 Troprozne???
2013
The Model -- Research, Education
and Collaboration
The increase in aquatic herbicide registrations were a
result of research, education and collaboration, and
support by Florida’s Center for Aquatic and
Invasive Plants, the U.S. Army Corps of Engineers,
EPA, AERF and pesticide companies
It is this type of collaboration and support that is needed
to ensure safe, adequate and appropriate aquatic
pesticides to deal with invasive pets in the future
PLANT TOXICITY TESTS
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AQUATIC PLANTS - 5 tests.
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Green algae - Selenastrum capricornutum
Blue-green cyanobacteria - Anabaena flos-aquae
Freshwater diatom - Navicula pelliculosa
Marine diatom - Skeletonema costatum
Floating aquatic macrophyte - Lemna gibba
TERRESTRIAL PLANT TESTS
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SEEDLING EMERGENCE – Environmental
Concentration (EC)25 for % emergence, plant
height, plant dry weight, and visual
phytotoxicity, EC05 or NOAEC.
VEGETATIVE VIGOR - EC25 for plant
height, plant dry weight, and visual
phytotoxicity, EC05 or NOAEC.