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

Thank you!Thank you!

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..