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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 Data Requirements
Label Development Federal Registration State Registration NPDES Reregistration and Registration Review

3 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

4 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?

5 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?

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 Shell fish tolerances Irrigated crops Swimmers Potable water

8 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?

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 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)

11 Residue Chemistry Data Utilized to Determine Dietary Exposure
Chemical identity Nature of residues Magnitude of residues 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 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 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 .

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 concentration 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: 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

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

17 Ecological Toxicity Studies
Tests on avian species Tests on mammalian species Tests on aquatic species bluegill sunfish rainbow trout 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 Full life cycle invertebrate Multi-generation test for fish

19 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

20 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

21 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

22 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

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 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

25 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

26 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

27 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

28 Thank you!

29 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.

30 Major Aquatic Herbicides Registered prior to 1986
Herbicide Year General Use Copper s Algae 2,4-D ester broadleaf Endothall submersed plants algae Diquat submersed & 2,4-D amine broadleaf Glyphosate emergent plants Fluridone submersed plants

31 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 Imazapyr Carfentrazone-ethyl 2004 Penoxsulam Imazamox Flumioxazin Bispyraibac-sodium Troprozne???

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 32

Green algae - Selenastrum capricornutum Blue-green cyanobacteria - Anabaena flos-aquae Freshwater diatom - Navicula pelliculosa Marine diatom - Skeletonema costatum Floating aquatic macrophyte - Lemna gibba

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.

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