EPA and Aquatic Pesticide Registration - No Unreasonable Adverse Effects on Man or the Environment Donald Stubbs

Outline Applicable Federal Statutes Data Requirements Label Development Federal Registration State Registration NPDES Reregistration and Registration Review

Applicable Statutes Food Quality Protection Act Clean Water ACT (FQPA) (1996) Clean Water ACT Pesticide Registration Improvement Act (2004) Federal Food Drug And Cosmetic Act (FFDCA) Federal Insecticide Fungicide And Rodenticide Act (FIFRA) Tolerance Established Product Registered

Federal Insecticide Fungicide and Rodenticide Act (FIFRA) Registration FIFRA allows for registration if a product will perform its intended function without unreasonable adverse effects on the environment FIFRA is a risk/benefit statute What does this mean?

Federal Food Drug and Cosmetic Act (FFD&C) Establish tolerances – legal limit on residues Tolerances for pesticides are established by EPA under the FFD&C Act 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 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?

Efficacy data Required but only submitted for human health pesticides Defines use rates and use patterns

Human Health Data Required 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 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 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

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 factor 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 .

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 concentration Exposure from drinking water levels is evaluated from an acute and chronic standpoint

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 degradates Ecological toxicity studies – looking at toxicity of the pesticide and its degradates

Environmental fate and transport studies Chemical Degradation Metabolism studies Volatility Dissipation Bioaccumulation in aquatic non-target organisms Accumulation in fish

Ecological Toxicity Studies Tests on avian species Tests on mammalian species Tests on aquatic species 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 Terrestrial Plant Tests Aquatic Plant tests Seedling emergence Vegetative vigor Aquatic Plant tests Green algae Blue-green cyanobacteria Freshwater diatom Marine diatom Floating aquatic macrophyte

What does EPA do with all that data? Identifies hazards – for dietary and non-dietary exposure Select toxicological endpoints – doses at which no adverse effects are observed in toxicology studies Determines exposures Develops label language and establishes tolerances

Label Development Human Health and Environmental Data are used to develop: User safety precautions Protective clothing (PPE) REI’s What is this? Specific hazard warnings Environmental safety warnings Product container disposal directions

Label Development Directions for use Pesticide Classification Application rates and intervals PHI Mandatory vrs Advisory – Who cares and why? Use Restrictions Pesticide Classification General Use Restricted Use

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!!!!

Federal Registration 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 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: The use is not covered by necessary tolerances The use has been previously denied disapproved, suspended or canceled

Clean Water Act Pesticides in water 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 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 Short history NPDES and pesticides 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 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 OW (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 Year General Use Copper 1950s Algae 2,4-D ester 1959 broadleaf Endothall 1960 submersed plants algae Diquat 1962 submersed & 2,4-D amine 1976 broadleaf Glyphosate 1977 emergent plants Fluridone 1986 submersed plants

New Aquatic Herbicides for Invasive Weed Control Between 1986 and 2002 there were no new aquatic herbicides registered 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 32

PLANT TOXICITY TESTS AQUATIC PLANTS - 5 tests. 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 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.