epa and aquatic pesticide registration - no unreasonable adverse effects on man or the environment...
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EPA and Aquatic EPA and Aquatic Pesticide Registration -Pesticide Registration -
No Unreasonable No Unreasonable Adverse Effects on Man Adverse Effects on Man
or the Environmentor the EnvironmentDonald StubbsDonald Stubbs
OutlineOutline Applicable Federal StatutesApplicable Federal Statutes Data RequirementsData Requirements Label DevelopmentLabel Development Federal RegistrationFederal Registration State RegistrationState Registration NPDESNPDES Reregistration and Registration ReviewReregistration and Registration Review
Federal Food DrugFederal Food DrugAnd Cosmetic Act And Cosmetic Act
(FFDCA)(FFDCA)
Tolerance EstablishedTolerance Established Product RegisteredProduct Registered
Food Quality Protection ActFood Quality Protection Act(FQPA) (1996)(FQPA) (1996)
Federal Insecticide FungicideFederal Insecticide FungicideAnd Rodenticide ActAnd Rodenticide Act
(FIFRA)(FIFRA)
Applicable StatutesApplicable Statutes
Clean Water Clean Water ACTACT
Pesticide Pesticide RegistrationRegistrationImprovement Act Improvement Act (2004)(2004)
RegistrationRegistration FIFRA allows for registration if a product will perform FIFRA allows for registration if a product will perform
its intended function its intended function without unreasonable adverse without unreasonable adverse effects on the environmenteffects on the environment
FIFRA is a risk/benefit statute FIFRA is a risk/benefit statute What does this mean?What does this mean?
Federal Insecticide Fungicide and Federal Insecticide Fungicide and Rodenticide Act (FIFRA)Rodenticide Act (FIFRA)
Establish tolerances Establish tolerances – legal limit on residues – legal limit on residues Tolerances for pesticides are established by EPA Tolerances for pesticides are established by EPA
under the FFD&C Actunder the FFD&C Act General standard for tolerances is that there will be a General standard for tolerances is that there will be a
reasonable certainty that reasonable certainty that no harm no harm will result from will result from residues of pesticides in food or feedresidues of pesticides in food or feed
It is a risk statute It is a risk statute What does this mean?What does this mean?
Federal Food Drug and Cosmetic Federal Food Drug and Cosmetic Act (FFD&C)Act (FFD&C)
Food Quality Protection Act 1996Food Quality Protection Act 1996
Sets a general standard for tolerances – a Sets a general standard for tolerances – a reasonable certainty that no harm will result from reasonable certainty that no harm will result from
aggregate exposureaggregate exposure
Pesticide Registration Pesticide Registration Improvement ActImprovement Act
Amended FIFRA by requiring a registration Amended FIFRA by requiring a registration service fee systemservice fee system
Unique Items to be Addressed in Unique Items to be Addressed in Registering an Aquatic HerbicideRegistering an Aquatic Herbicide Fish tolerancesFish tolerances Shell fish tolerancesShell fish tolerances Irrigated cropsIrrigated crops SwimmersSwimmers Potable waterPotable water
Data Required to Register a Data Required to Register a PesticidePesticide
Efficacy dataEfficacy data Human health dataHuman health data Residue chemistry dataResidue chemistry data Environmental fate and transport dataEnvironmental fate and transport data Ecological toxicity dataEcological toxicity data There are approximately 140 studies requiredThere are approximately 140 studies required All studies must be carried out under GLPAll studies must be carried out under GLP
What is GLP?What is GLP?
Where does this data come from and who pays for it? Where does this data come from and who pays for it?
Efficacy data Efficacy data
Required but only submitted for human Required but only submitted for human health pesticides health pesticides
Defines use rates and use patterns Defines use rates and use patterns
Human Health Data RequiredHuman Health Data Required
Acute toxicity studies – Acute toxicity studies – used to determine appropriate label precautions used to determine appropriate label precautions
Chronic toxicity – Chronic toxicity – used for long term exposure endpoints dealing with used for long term exposure endpoints dealing with
users and food exposure as well as labelingusers and food exposure as well as labeling Oncogenicity –Oncogenicity – Developmental toxicityDevelopmental toxicity Gene mutation studiesGene mutation studies Rreproduction study (2 generation)Rreproduction study (2 generation)
Residue Chemistry Data Utilized to Residue Chemistry Data Utilized to Determine Dietary Exposure Determine Dietary Exposure
Chemical identityChemical identity Nature of residues Nature of residues Magnitude of residuesMagnitude of residues Analytical methods for residue detectionAnalytical methods for residue detection
Acceptable RisksAcceptable Risks
EPA uses a no observable adverse effect level EPA uses a no observable adverse effect level (NOAEL) from the toxicology studies required (NOAEL) from the toxicology studies required
Dietary – EPA determines a reference dose (RfD) using the Dietary – EPA determines a reference dose (RfD) using the NOAEL for the NOAEL for the most sensitive most sensitive endpoint divided by an endpoint divided by an uncertainty factor (UF) of a minimum of 100uncertainty factor (UF) of a minimum of 100
Example – a NOAEL of 10 mg/kg/UF of 100 = a RfD Example – a NOAEL of 10 mg/kg/UF of 100 = a RfD of .10 mg/kgof .10 mg/kg
The risk is acceptable as long as the exposure does not The risk is acceptable as long as the exposure does not exceed the RfDexceed the RfD
Non-dietary – EPA determines toxicity end points of Non-dietary – EPA determines toxicity end points of concern called “LOC” or level of concern using a 100 fold concern called “LOC” or level of concern using a 100 fold safety factorsafety factor
A ratio of the LOC to exposure is calculated – margin of A ratio of the LOC to exposure is calculated – margin of exposure (MOE)exposure (MOE)
If the MOEIf the MOE is less then or equal to the LOC the risk is is less then or equal to the LOC the risk is acceptableacceptable
Carcinogenicity 1 in a million Carcinogenicity 1 in a million
..
Pesticide Residues in WaterPesticide Residues in Water
EPA takes into account residues of a pesticide in drinking EPA takes into account residues of a pesticide in drinking water via drinking water levels of concern (DWLOC’s) water via drinking water levels of concern (DWLOC’s)
They are based on ten year annual peak concentrationThey are based on ten year annual peak concentration
Exposure from drinking water levels is evaluated from an Exposure from drinking water levels is evaluated from an acute and chronic standpointacute and chronic standpoint
Studies Required to Conduct an Studies Required to Conduct an Ecological Risk AssessmentEcological Risk Assessment
There are two categories of data required:There are two categories of data required:
Environmental fate and transport studies –Environmental fate and transport studies –looking at fate and transport of pesticide and looking at fate and transport of pesticide and its degradatesits degradates
Ecological toxicity studies – looking at Ecological toxicity studies – looking at toxicity of the pesticide and its degradatestoxicity of the pesticide and its degradates
Environmental fate and Environmental fate and transport studiestransport studies
Chemical DegradationChemical Degradation Metabolism studiesMetabolism studies VolatilityVolatility DissipationDissipation Bioaccumulation in aquatic non-target organismsBioaccumulation in aquatic non-target organisms Accumulation in fishAccumulation in fish
Ecological Toxicity Studies Ecological Toxicity Studies
Tests on avian species Tests on avian species Tests on mammalian speciesTests on mammalian species Tests on aquatic speciesTests on aquatic species
bluegill sunfishbluegill sunfish rainbow troutrainbow trout Freshwater invertebrateFreshwater invertebrate
Other StudiesOther Studies
Based on acute toxicity and if product is applied directly Based on acute toxicity and if product is applied directly to water or will be transported to water at a given to water or will be transported to water at a given levellevel
Subchronic testing of fish - Fish early life stage Subchronic testing of fish - Fish early life stage using fresh or estuarine fish speciesusing fresh or estuarine fish species
Full life cycle invertebrate Full life cycle invertebrate Multi-generation test for fishMulti-generation test for fish
PLANT TOXICITY TESTSPLANT TOXICITY TESTS
Terrestrial Plant TestsTerrestrial Plant Tests Seedling emergence Seedling emergence Vegetative vigorVegetative vigor
Aquatic Plant tests Aquatic Plant tests Green algaeGreen algae Blue-green cyanobacteriaBlue-green cyanobacteria Freshwater diatomFreshwater diatom Marine diatom Marine diatom Floating aquatic macrophyteFloating aquatic macrophyte
What does EPA do with all that data? What does EPA do with all that data?
Identifies hazards – for dietary and non-dietary Identifies hazards – for dietary and non-dietary exposure exposure
Select toxicological endpoints – doses at Select toxicological endpoints – doses at which no adverse effects are observed in which no adverse effects are observed in toxicology studiestoxicology studies
Determines exposuresDetermines exposures
Develops label language and establishes Develops label language and establishes tolerancestolerances
Label DevelopmentLabel Development Human Health and Environmental Data are Human Health and Environmental Data are
used to develop:used to develop: User safety precautionsUser safety precautions
Protective clothing (PPE)Protective clothing (PPE) REI’s REI’s What is this?What is this? Specific hazard warningsSpecific hazard warnings
Environmental safety warningsEnvironmental safety warnings Product container disposal directionsProduct container disposal directions
Label DevelopmentLabel Development
Directions for useDirections for use Application rates and intervalsApplication rates and intervals PHI PHI Mandatory vrs Advisory – Mandatory vrs Advisory – Who cares and why?Who cares and why? Use RestrictionsUse Restrictions
Pesticide Classification Pesticide Classification General UseGeneral Use Restricted UseRestricted Use
WHAT DOES ALL THIS MEAN ?WHAT DOES ALL THIS MEAN ?
You can use a pesticide labeled for aquatic You can use a pesticide labeled for aquatic use to control nuisance weeds without use to control nuisance weeds without causing causing unreasonable adverse effects on man unreasonable adverse effects on man or the environmentor the environment as long as you follow the as long as you follow the label directions.label directions.
THE LABEL IS THE LAW!!!!THE LABEL IS THE LAW!!!!
Federal RegistrationFederal Registration
Use of a pesticide requires an accepted Use of a pesticide requires an accepted Federal labelFederal label
Still requires individual state registrationStill requires individual state registration Must be used in accordance with its labeling Must be used in accordance with its labeling ““Use” includes handling, mixing, storage Use” includes handling, mixing, storage
loading, transportation as well as actual useloading, transportation as well as actual use
State RegistrationState Registration States may register an additional use of a States may register an additional use of a
federally registered pesticide product via 24(c) federally registered pesticide product via 24(c) of FIFRA. of FIFRA.
EPA reviews 24(c) registrations, and may EPA reviews 24(c) registrations, and may disapprove them if:disapprove them if: The use is not covered by necessary tolerances The use is not covered by necessary tolerances The use has been previously denied disapproved, The use has been previously denied disapproved,
suspended or canceledsuspended or canceled
As of April 9, 2011 NPDES permits are As of April 9, 2011 NPDES permits are required for use of aquatic pesticidesrequired for use of aquatic pesticides
Covers application to water or at water’s edge Covers application to water or at water’s edge including irrigation ditches and canalsincluding irrigation ditches and canals
Clean Water ActClean Water ActPesticides in waterPesticides in water
Registration ReviewRegistration Review
Takes into account changes in science, public policy, Takes into account changes in science, public policy, and pesticide use practices over timeand pesticide use practices over time
All pesticidesAll pesticides 15-year cycle15-year cycle 44 chemicals cases/year44 chemicals cases/year Update reviews as neededUpdate reviews as needed Registered pesticides continue to meet statutory Registered pesticides continue to meet statutory
standard of no unreasonable adverse effectsstandard of no unreasonable adverse effects
NPDESNPDES Short history NPDES and pesticidesShort history NPDES and pesticides
Not required by regulation FR 11/27/2006Not required by regulation FR 11/27/2006 Court vacated EPA regulations – 1/7/2009 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
EPA proposed general permits 6/2/2010 EPA proposed general permits 6/2/2010 Pesticides General Permit (PGP) if not covered under general permit an individual permit is required.
Final Rule issued 10/31/2011- Handled in OWFinal Rule issued 10/31/2011- Handled in OW (1) mosquito and other flying insect pest control; (1) mosquito and other flying insect pest control; (2) weed and algae control; (2) weed and algae control; (3) animal pest control; and(3) animal pest control; and (4) forest canopy pest control.(4) forest canopy pest control.
Major Aquatic Herbicides Major Aquatic Herbicides Registered prior to 1986Registered prior to 1986
HerbicideHerbicide YearYear General UseGeneral UseCopperCopper 1950s 1950s AlgaeAlgae2,4-D ester2,4-D ester 19591959 broadleafbroadleafEndothallEndothall 19601960 submersed plants algaesubmersed plants algaeDiquatDiquat 19621962 submersed & submersed & 2,4-D amine2,4-D amine 19761976 broadleafbroadleafGlyphosateGlyphosate 19771977 emergent plantsemergent plantsFluridoneFluridone 19861986 submersed plantssubmersed plants
New Aquatic Herbicides for Invasive New Aquatic Herbicides for Invasive Weed ControlWeed Control
Between 1986 and 2002 there were no new aquatic Between 1986 and 2002 there were no new aquatic herbicides registeredherbicides registered
Since 2003 there have been 8 new aquatic herbicides Since 2003 there have been 8 new aquatic herbicides registeredregistered TriclopryTriclopry 2003 2003 Imazapyr Imazapyr 2003 2003 Carfentrazone-ethylCarfentrazone-ethyl 2004 2004 Penoxsulam Penoxsulam 2007 2007 Imazamox Imazamox 20082008 Flumioxazin Flumioxazin 2010 2010 Bispyraibac-sodiumBispyraibac-sodium 2011 2011 Troprozne???Troprozne??? 2013 2013
The Model -- Research, Education The Model -- Research, Education and Collaborationand Collaboration
The increase in aquatic herbicide registrations were a The increase in aquatic herbicide registrations were a result of research, education and collaboration, and result of research, education and collaboration, and support by Florida’s Center for Aquatic and support by Florida’s Center for Aquatic and Invasive Plants, the U.S. Army Corps of Engineers, Invasive Plants, the U.S. Army Corps of Engineers, EPA, AERF and pesticide companiesEPA, AERF and pesticide companies
It is this type of collaboration and support that is needed It is this type of collaboration and support that is needed to ensure safe, adequate and appropriate aquatic to ensure safe, adequate and appropriate aquatic pesticides to deal with invasive pets in the futurepesticides to deal with invasive pets in the future
PLANT TOXICITY TESTSPLANT TOXICITY TESTS
AQUATIC PLANTS - 5 tests. AQUATIC PLANTS - 5 tests. Green algae - Green algae - Selenastrum capricornutumSelenastrum capricornutum Blue-green cyanobacteria - Blue-green cyanobacteria - Anabaena flos-aquaeAnabaena flos-aquae Freshwater diatom - Freshwater diatom - Navicula pelliculosaNavicula pelliculosa Marine diatom - Marine diatom - Skeletonema costatumSkeletonema costatum Floating aquatic macrophyte - Floating aquatic macrophyte - Lemna gibbaLemna gibba
TERRESTRIAL PLANT TESTSTERRESTRIAL PLANT TESTS
SEEDLING EMERGENCE – Environmental SEEDLING EMERGENCE – Environmental Concentration (EC)25 for % emergence, plant Concentration (EC)25 for % emergence, plant height, plant dry weight, and visual height, plant dry weight, and visual phytotoxicity, phytotoxicity, EC05 or NOAEC.EC05 or NOAEC.
VEGETATIVE VIGOR - EC25 for plant VEGETATIVE VIGOR - EC25 for plant height, plant dry weight, and visual height, plant dry weight, and visual phytotoxicity, phytotoxicity, EC05 or NOAECEC05 or NOAEC..