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

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 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

33. 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

34. 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.