4 Federal Insecticide Fungicide and Rodenticide Act (FIFRA) RegistrationFIFRA allows for registration if a product will perform its intended function without unreasonable adverse effects on the environmentFIFRA is a risk/benefit statute What does this mean?
5 Federal Food Drug and Cosmetic Act (FFD&C) Establish tolerances – legal limit on residuesTolerances for pesticides are established by EPA under the FFD&C ActGeneral standard for tolerances is that there will be a reasonable certainty that no harm will result from residues of pesticides in food or feedIt is a risk statute What does this mean?
6 Food Quality Protection Act 1996 Sets a general standard for tolerances – a reasonable certainty that no harm will result from aggregate exposurePesticide Registration Improvement ActAmended FIFRA by requiring a registration service fee system
7 Unique Items to be Addressed in Registering an Aquatic Herbicide Fish tolerancesShell fish tolerancesIrrigated cropsSwimmersPotable water
8 Data Required to Register a Pesticide Efficacy dataHuman health dataResidue chemistry dataEnvironmental fate and transport dataEcological toxicity dataThere are approximately 140 studies requiredAll studies must be carried out under GLPWhat is GLP?Where does this data come from and who pays for it?
9 Efficacy data Required but only submitted for human health pesticides Defines use rates and use patterns
10 Human Health Data Required Acute toxicity studies –used to determine appropriate label precautionsChronic toxicity –used for long term exposure endpoints dealing with users and food exposure as well as labelingOncogenicity –Developmental toxicityGene mutation studiesRreproduction study (2 generation)
11 Residue Chemistry Data Utilized to Determine Dietary Exposure Chemical identityNature of residuesMagnitude of residuesAnalytical methods for residue detection
12 Acceptable RisksEPA uses a no observable adverse effect level (NOAEL) from the toxicology studies requiredDietary – EPA determines a reference dose (RfD) using the NOAEL for the most sensitive endpoint divided by an uncertainty factor (UF) of a minimum of 100Example – a NOAEL of 10 mg/kg/UF of 100 = a RfD of .10 mg/kgThe risk is acceptable as long as the exposure does not exceed the RfD
13 Carcinogenicity 1 in a million . Non-dietary – EPA determines toxicity end points of concern called “LOC” or level of concern using a 100 fold safety factorA 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 acceptableCarcinogenicity 1 in a million.
14 Pesticide Residues in Water EPA takes into account residues of a pesticide in drinking water via drinking water levels of concern (DWLOC’s)They are based on ten year annual peak concentrationExposure from drinking water levels is evaluated from an acute and chronic standpoint
15 Studies Required to Conduct an Ecological Risk Assessment There are two categories of data required:Environmental fate and transport studies –looking at fate and transport of pesticide and its degradatesEcological toxicity studies – looking at toxicity of the pesticide and its degradates
16 Environmental fate and transport studies Chemical DegradationMetabolism studiesVolatilityDissipationBioaccumulation in aquatic non-target organismsAccumulation in fish
17 Ecological Toxicity Studies Tests on avian speciesTests on mammalian speciesTests on aquatic speciesbluegill sunfishrainbow troutFreshwater invertebrate
18 Other StudiesBased on acute toxicity and if product is applied directly to water or will be transported to water at a given levelSubchronic testing of fish - Fish early life stage using fresh or estuarine fish speciesFull life cycle invertebrateMulti-generation test for fish
20 What does EPA do with all that data? Identifies hazards – for dietary and non-dietary exposureSelect toxicological endpoints – doses at which no adverse effects are observed in toxicology studiesDetermines exposuresDevelops label language and establishes tolerances
21 Label DevelopmentHuman Health and Environmental Data are used to develop:User safety precautionsProtective clothing (PPE)REI’s What is this?Specific hazard warningsEnvironmental safety warningsProduct container disposal directions
22 Label Development Directions for use Pesticide Classification Application rates and intervalsPHIMandatory vrs Advisory – Who cares and why?Use RestrictionsPesticide ClassificationGeneral UseRestricted Use
23 WHAT DOES ALL THIS MEAN ? THE LABEL IS THE LAW!!!! 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!!!!
24 Federal RegistrationUse of a pesticide requires an accepted Federal labelStill requires individual state registrationMust be used in accordance with its labeling“Use” includes handling, mixing, storage loading, transportation as well as actual use
25 State RegistrationStates 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:The use is not covered by necessary tolerancesThe use has been previously denied disapproved, suspended or canceled
26 Clean Water Act Pesticides in water As of April 9, 2011 NPDES permits are required for use of aquatic pesticidesCovers application to water or at water’s edge including irrigation ditches and canals
27 Registration ReviewTakes into account changes in science, public policy, and pesticide use practices over timeAll pesticides15-year cycle44 chemicals cases/yearUpdate reviews as neededRegistered pesticides continue to meet statutory standard of no unreasonable adverse effects
29 NPDES Short history NPDES and pesticides Not required by regulation FR 11/27/2006Court vacated EPA regulations – 1/7/2009As 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 oneEPA proposed general permits 6/2/2010Pesticides General Permit (PGP) if not covered under general permit an individual permit is required.Final Rule issued 10/31/2011- Handled in OW(1) mosquito and other flying insect pest control;(2) weed and algae control;(3) animal pest control; and(4) forest canopy pest control.
30 Major Aquatic Herbicides Registered prior to 1986 Herbicide Year General UseCopper s Algae2,4-D ester broadleafEndothall submersed plants algaeDiquat submersed &2,4-D amine broadleafGlyphosate emergent plantsFluridone submersed plants
31 New Aquatic Herbicides for Invasive Weed Control Between 1986 and 2002 there were no new aquatic herbicides registeredSince 2003 there have been 8 new aquatic herbicides registeredTriclopryImazapyrCarfentrazone-ethyl 2004PenoxsulamImazamoxFlumioxazinBispyraibac-sodiumTroprozne???
32 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 companiesIt 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 future32