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

2. Outline Applicable Statutes for Pesticide Registration Applicable Statutes for Pesticide Registration Legal Ways to Apply Pesticides Legal Ways to Apply Pesticides Data required for a Dietary Risk Assessment Data required for a Dietary Risk Assessment Data required for an Ecological Risk Assessment Data required for an Ecological Risk Assessment How EPA Uses A Risk Assessment How EPA Uses A Risk Assessment Registration Review Registration Review Notes on - MCLs and NPDES Notes on - MCLs and NPDES Aquatic Herbicide Successes Aquatic Herbicide Successes

3. Federal Food Drug And Cosmetic Act (FFDCA) Tolerance Established Product Registered Food Quality Protection Act (FQPA) (1996) Federal Insecticide Fungicide And Rodenticide Act (FIFRA) (1947) Applicable Statutes Pesticide Registration Improvement Act (2004)

4. Registration Registration FIFRA allows for registration if a product will perform its intended function without unreasonable adverse effects on the environment. 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. FIFRA is a risk benefit/statute. FIFRA takes into account economic, social and environmental costs and benefits. FIFRA takes into account economic, social and environmental costs and benefits. Federal Insecticide Fungicide and Rodenticide Act (FIFRA)

5. Tolerance setting Tolerance setting Tolerances for pesticides are established by EPA under the FFD&C Act. 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. 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. It is a risk statute. It does not take into account economic, social or environmental costs and benefits. It does not take into account economic, social or environmental costs and benefits. Federal Food Drug and Cosmetic Act (FFD&C)

6. Food Quality Protection Act 1996  Set a general standard for tolerances – a reasonable certainty that no harm will result from aggregate exposure  Periodic pesticide registration  Endocrine disruptors – development and implementation of a comprehensive screening program  Special provisions for infants and children  Use of percent of crop treated for chronic dietary risks

7. Pesticide Registration Improvement Act (PRIA) FIFRA was amended by requiring a registration service fee system FIFRA was amended by requiring a registration service fee system EPA review time frames were established for all actions EPA review time frames were established for all actions Extending time frames is by mutual consent Extending time frames is by mutual consent EPA retains discretion to expedite any action EPA retains discretion to expedite any action

8. Example Action* Decision Time Fee** (Months) (Months)RD New ai food use $569,000 New ai food use 24 $569,000 New ai nonfood use $395,000 New ai nonfood use 21 $395,000 New food use $60,000 New food use 15 $60,000 New non food use $24,000 New non food use 15 $24,000 Amendment (change $4,000 Amendment (change 4 $4,000 in labeling) * 58 PRIA action codes for RD **Rounded to nearest 1,000

9. Legal Ways to Use a Pesticide Section 3 –federal registration Section 3 –federal registration Section 5 –experimental use permit Section 5 –experimental use permit Section 18 –emergency use Section 18 –emergency use Section 24 (c) –state registration Section 24 (c) –state registration

10. Federal Registration Pesticide product label is federal license for use of a pesticide Pesticide product label is federal license for use of a pesticide Still requires individual state registration Still requires individual state registration Product must be used in accordance with its labeling Product must be used in accordance with its labeling “Use” includes handling, mixing, storage loading, transportation as well as use “Use” includes handling, mixing, storage loading, transportation as well as use Registrations are reviewed every 15 years Registrations are reviewed every 15 years

11. Permit required if testing over 1 surface acre of water Permit required if testing over 1 surface acre of water Gather data for registration Gather data for registration Crop destruct, temporary tolerance or limit use of water Crop destruct, temporary tolerance or limit use of water Authorized for 1 to 2 years Authorized for 1 to 2 years Permit not required if testing 1 or less surface acre of water Permit not required if testing 1 or less surface acre of water Experimental Use Permit Aquatic Uses

12. Emergency Use Authorizes an unregistered pesticide use to state or federal agencies for: Authorizes an unregistered pesticide use to state or federal agencies for: Significant economic loss or Significant economic loss or Significant risk to threatened or endangered species or Significant risk to threatened or endangered species or Prevent the introduction or spread of a new pest or Prevent the introduction or spread of a new pest or Control a pest that will cause a significant risk to human health Control a pest that will cause a significant risk to human health Must be an urgent, non routine situation Must be an urgent, non routine situation Authorized for 1 to 3 years Authorized for 1 to 3 years

13. State Registration States may register an additional use of a federally registered pesticide product States may register an additional use of a federally registered pesticide product “Additional use" is broadly defined “Additional use" is broadly defined EPA reviews 24(c) registrations, and may disapprove them if: EPA reviews 24(c) registrations, and may 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, suspended or canceled The use has been previously denied disapproved, suspended or canceled

14. Unique Items to be Addressed in Registering an Aquatic Pesticide Fish tolerances Fish tolerances Shell fish tolerances Shell fish tolerances Irrigated crops Irrigated crops Swimmers Swimmers Drinking water Drinking water

15. Data Required for a Dietary Risk Assessment Human Health Data Human Health Data Acute toxicity studies Acute toxicity studies Subchronic toxicity testing Subchronic toxicity testing Chronic toxicity Chronic toxicity Oncogenicity Oncogenicity Developmental toxicity Developmental toxicity

16. Human Health Data continued Human Health Data continued Gene mutation studies Gene mutation studies Two generation reproduction study Two generation reproduction study Structural chromosomal aberration study Structural chromosomal aberration study Depending on use pattern and results of Depending on use pattern and results of studies additional studies may be required studies additional studies may be required

17. Data Required for a Dietary Risk Assessment Residue Chemistry Data Residue Chemistry Data Chemical identity Chemical identity Nature of residues Nature of residues Magnitude of residues Magnitude of residues Analytical methods for residue detection Analytical methods for residue detection

18. What does EPA do with all this Data? It conducts a human health risk assessment to evaluate the likelihood that adverse human health risk may occur as a result of exposure to a pesticide via direct or indirect contact, or by ingestion of treated foods. It conducts a human health risk assessment to evaluate the likelihood that adverse human health risk may occur as a result of exposure to a pesticide via direct or indirect contact, or by ingestion of treated foods. It does this by determining It does this by determining What hazards need to be addressed - commonly referred to as toxicity endpoints of concern What hazards need to be addressed - commonly referred to as toxicity endpoints of concern

19. Determining the no adverse effect level for those hazards identified Determining the no adverse effect level for those hazards identified Studies are run at various levels to try and ensure an effect and no effect level Studies are run at various levels to try and ensure an effect and no effect level Apply these no effect levels to various exposure scenarios Apply these no effect levels to various exposure scenarios Example Example Dietary – liver effects (increased liver weight) at 5000 mg/kg but not 1000 mg/kg

20. Acceptable Risks EPA uses the no adverse effect level from the toxicity endpoints to determine acceptable risks. Dietary – EPA determines a reference dose (RfD) using the no adverse effect level for the most toxic endpoint divided by an uncertainty factor (UF) generally 100. (1000/100=10) The risk is acceptable as long as the exposure does not exceed the RfD. Carcinogenicity 1 in a million.

21. Water Water Drinking Water Levels of Concern (DWLOC) are determined based on the remaining percent of RfD after food is taken into consideration. Drinking Water Levels of Concern (DWLOC) are determined based on the remaining percent of RfD after food is taken into consideration. Exposure from drinking water levels are looked at from both an acute and chronic standpoint. Exposure from drinking water levels are looked at from both an acute and chronic standpoint. Allowable water levels are compared to the DWLOC. Allowable water levels are compared to the DWLOC.

22. Studies Required for an Ecological Risk Assessment There are two categories of data required: There are two categories of data required: Environmental Fate and Transport Studies – looking at fate and transport of a pesticide and its degradates. Environmental Fate and Transport Studies – looking at fate and transport of a pesticide and its degradates. Ecological Toxicity Studies –looking at toxicity of the pesticide and its degradates. Ecological Toxicity Studies –looking at toxicity of the pesticide and its degradates.

23. Fate and Transport Assessments  Tells us where and how the pesticide moves in the environment.  How long a pesticide will persist.  What degradation products are produced and in what quantities.  How much is likely to reach ground water and/or surface water.

24. Chemical Degradation Hydrolysis Hydrolysis Photolysis Photolysis Photodegradation in water Photodegradation in water Photodegradation on soil Photodegradation on soil Photodegradation in air Photodegradation in air

25. Metabolism Metabolism studies are used to determine the brake down products from organisms metabolizing the parent pesticide product. There are four types of fate metabolism studies: Aerobic Soil Metabolism Aerobic Soil Metabolism Anaerobic Soil Metabolism Anaerobic Soil Metabolism Anaerobic Aquatic Metabolism Anaerobic Aquatic Metabolism Aerobic Aquatic Metabolism Aerobic Aquatic Metabolism

26. Mobility and Bioaccumulation Volatility- looks at dissipation thru evaporation Volatility- looks at dissipation thru evaporation Dissipation studies - determine the extent of dissipation and mobility of pesticide residues under actual use conditions. Dissipation studies - determine the extent of dissipation and mobility of pesticide residues under actual use conditions. Aquatic field dissipation Aquatic field dissipation Terrestrial field dissipation Terrestrial field dissipation Forest field dissipation Forest field dissipation Bioaccumulation in aquatic non-target organisms Bioaccumulation in aquatic non-target organisms Leaching Leaching Accumulation in fish Accumulation in fish

27. Ecological Toxicity Studies Tests on avian species Tests on avian species Tests on mammalian species Tests on mammalian species Tests on aquatic species Tests on aquatic species Estuarine/marine fish Estuarine/marine fish Estuarine/marine invertebrate Estuarine/marine invertebrate Warm water fish Warm water fish Cold water acute fish Cold water acute fish Freshwater invertebrate Freshwater invertebrate

28. Other Studies Based on acute toxicity and if product is applied directly to water or will be transported to water at a given level Sub Chronic Testing of Fish Sub Chronic Testing of Fish Full Life Cycle Invertebrate Full Life Cycle Invertebrate Multi-generation Fish Study Multi-generation Fish Study Case-by-case basis based on outcome of other studies, fate characteristics and use pattern

29. PLANT TOXICITY TESTS Aquatic plants Aquatic plants Terrestrial plants Terrestrial plants Seedling emergence Seedling emergence Vegetative vigor Vegetative vigor

30. How do We Use These Risk Assessments? We use the data and risk assessments to develop labeling language. We use the data and risk assessments to develop labeling language. User Safety Precautions User Safety Precautions Environmental Safety warnings Environmental Safety warnings Product Container Disposal Product Container Disposal Directions for Use Directions for Use Pesticide Classification Pesticide Classification The label is the Law

31. WHAT DOES ALL THAT MEAN ? You can use a pesticide labeled for aquatic use to control nuisance pests without causing unreasonable adverse effects on man or the environment, as long as you follow the label directions.

32. MCL The Office of Water is responsible for setting MCLs The Office of Water is responsible for setting MCLs A MCL is a maximum contaminant level A MCL is a maximum contaminant level A MCL is set at a level at which there is no known or anticipated threat to a human A MCL is set at a level at which there is no known or anticipated threat to a human It is an enforceable level It is an enforceable level There are MCL’s for some aquatic pesticides There are MCL’s for some aquatic pesticides If a MCL exists for a chemical OPP uses it in its risk assessments If a MCL exists for a chemical OPP uses it in its risk assessments

33. NPDES Short history NPDES and pesticides Short history NPDES and pesticides Not required by regulation FR 11/27/2006 Not required by regulation FR 11/27/2006 Court vacated EPA regulations – 1/7/2009 Court vacated EPA regulations – 1/7/2009 EPA proposed general permits 6/2/2010 EPA proposed general permits 6/2/2010 Final Rule issued 10/31/2011 (handled in OW) Final 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.

34. Registration Review Registration Review Registration Review Applies to all pesticides Applies to all pesticides On a 15-year cycle On a 15-year cycle The process is set by rule The process is set by rule Science reviews are updated as needed Science reviews are updated as needed Adds to what we know about the chemicals Adds to what we know about the chemicals

35. New Aquatic Herbicides for Invasive Weed Control Prior to 1986 -- 7 or 8 major aquatic herbicides registered Prior to 1986 -- 7 or 8 major aquatic herbicides registered From1986 to 2003 no new aquatic herbicides registered From1986 to 2003 no new aquatic herbicides registered Since 2003-- 5 new aquatic herbicides registered Since 2003-- 5 new aquatic herbicides registered Triclopry (Renovate) 2003 Triclopry (Renovate) 2003 Imazapyr (Habitat) 2003 Imazapyr (Habitat) 2003 Carfentrazone-ethyl (Stingray) 2004 Carfentrazone-ethyl (Stingray) 2004 Penoxsulam in Florida 2007 Penoxsulam in Florida 2007 Imazamox (Clearcast ) 2008 Imazamox (Clearcast ) 2008 Flumioxazin 2010 Flumioxazin 2010 Bispyraibac-sodium 2011 Bispyraibac-sodium 2011

36. 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 adequate and appropriate aquatic pesticides to deal with invasive pets in the future.

37. Thank you!