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

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Presentation on theme: "EPA and Aquatic Pesticide Registration - No Unreasonable Adverse Effects on Man or the Environment Donald Stubbs."— Presentation transcript:

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

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

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) Applicable Statutes Clean Water ACT 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 What does this mean? FIFRA is a risk/benefit statute What does this mean? Federal Insecticide Fungicide and Rodenticide Act (FIFRA)

5 Establish tolerances – legal limit on residues Establish tolerances – legal limit on residues 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 What does this mean? It is a risk statute What does this mean? Federal Food Drug and Cosmetic Act (FFD&C)

6 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

7 Unique Items to be Addressed in Registering an Aquatic Herbicide Fish tolerances Fish tolerances Shell fish tolerances Shell fish tolerances Irrigated crops Irrigated crops Swimmers Swimmers Potable water Potable water

8 Data Required to Register a Pesticide Efficacy data Efficacy data Human health data Human health data Residue chemistry data Residue chemistry data Environmental fate and transport data Environmental fate and transport data Ecological toxicity data Ecological toxicity data There are approximately 140 studies required There are approximately 140 studies required All studies must be carried out under GLP All studies must be carried out under GLP What is GLP? What is GLP? Where does this data come from and who pays for it?

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

10 Human Health Data Required Acute toxicity studies – Acute toxicity studies – used to determine appropriate label precautions Chronic toxicity – Chronic toxicity – used for long term exposure endpoints dealing with users and food exposure as well as labeling Oncogenicity – Oncogenicity – Developmental toxicity Developmental toxicity Gene mutation studies Gene mutation studies Rreproduction study (2 generation) Rreproduction study (2 generation)

11 Residue Chemistry Data Utilized to Determine Dietary Exposure 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

12 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 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 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

13 Non-dietary – EPA determines toxicity end points of concern called “LOC” or level of concern using a 100 fold safety factor 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) A ratio of the LOC to exposure is calculated – margin of exposure (MOE) If the MOEis less then or equal to the LOC the risk is acceptable If the MOE is less then or equal to the LOC the risk is acceptable  Carcinogenicity 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) 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 They are based on ten year annual peak concentration Exposure from drinking water levels is evaluated from an acute and chronic standpoint Exposure 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: There are two categories of data required: Environmental fate and transport studies – looking at fate and transport of pesticide and its degradates 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 Ecological toxicity studies – looking at toxicity of the pesticide and its degradates

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

17 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 bluegill sunfish bluegill sunfish rainbow trout rainbow trout Freshwater invertebrate Freshwater invertebrate

18 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 Subchronic testing of fish - Fish early life stage using fresh or estuarine fish species Full life cycle invertebrate Full life cycle invertebrate Multi-generation test for fish Multi-generation test for fish

19 PLANT TOXICITY TESTS Terrestrial Plant Tests Terrestrial Plant Tests Seedling emergence Seedling emergence Vegetative vigor Vegetative vigor Aquatic Plant tests Aquatic Plant tests Green algae Green algae Blue-green cyanobacteria Blue-green cyanobacteria Freshwater diatom Freshwater diatom Marine diatom Marine diatom Floating aquatic macrophyte Floating aquatic macrophyte

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

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

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

23 WHAT DOES ALL THIS MEAN ? 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!!!! THE LABEL IS THE LAW!!!!

24 Federal Registration Use of a pesticide requires an accepted Federal label Use of a pesticide requires an accepted Federal label Still requires individual state registration Still 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 loading, transportation as well as actual use “Use” includes handling, mixing, storage loading, transportation as well as actual use

25 State Registration States may register an additional use of a federally registered pesticide product via 24(c) of FIFRA. 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: 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

26 As of April 9, 2011 NPDES permits are required for use of aquatic pesticides 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 Covers application to water or at water’s edge including irrigation ditches and canals Clean Water Act Pesticides in water

27 Registration Review Takes into account changes in science, public policy, and pesticide use practices over time Takes into account changes in science, public policy, and pesticide use practices over time All pesticides All pesticides 15-year cycle 15-year cycle 44 chemicals cases/year 44 chemicals cases/year Update reviews as needed Update reviews as needed Registered pesticides continue to meet statutory standard of no unreasonable adverse effects Registered pesticides continue to meet statutory standard of no unreasonable adverse effects

28 Thank you!

29 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 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 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.

30 Major Aquatic Herbicides Registered prior to 1986 HerbicideYearGeneral Use Copper 1950sAlgae 2,4-D ester1959broadleaf Endothall1960submersed plants algae Diquat1962submersed & 2,4-D amine1976broadleaf Glyphosate1977emergent plants Fluridone1986submersed plants

31 New Aquatic Herbicides for Invasive Weed Control Between 1986 and 2002 there were no new aquatic herbicides registered Between 1986 and 2002 there were no new aquatic herbicides registered Since 2003 there have been 8 new aquatic herbicides registered Since 2003 there have been 8 new aquatic herbicides registered Triclopry2003 Triclopry2003 Imazapyr 2003 Imazapyr 2003 Carfentrazone-ethyl2004 Carfentrazone-ethyl2004 Penoxsulam 2007 Penoxsulam 2007 Imazamox 2008 Imazamox 2008 Flumioxazin 2010 Flumioxazin 2010 Bispyraibac-sodium 2011 Bispyraibac-sodium 2011 Troprozne??? 2013 Troprozne??? 2013

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 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

33 PLANT TOXICITY TESTS AQUATIC PLANTS - 5 tests. AQUATIC PLANTS - 5 tests. Green algae - Selenastrum capricornutum Green algae - Selenastrum capricornutum Blue-green cyanobacteria - Anabaena flos-aquae Blue-green cyanobacteria - Anabaena flos-aquae Freshwater diatom - Navicula pelliculosa Freshwater diatom - Navicula pelliculosa Marine diatom - Skeletonema costatum Marine diatom - Skeletonema costatum Floating aquatic macrophyte - Lemna gibba Floating aquatic macrophyte - Lemna gibba

34 TERRESTRIAL PLANT TESTS SEEDLING EMERGENCE – Environmental Concentration (EC)25 for % emergence, plant height, plant dry weight, and visual phytotoxicity, EC05 or NOAEC. 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. VEGETATIVE VIGOR - EC25 for plant height, plant dry weight, and visual phytotoxicity, EC05 or NOAEC.


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