Comments on NMFS 3rd Salmonid Biolo

Opinion on 12 Organophosphates

Emphasis on Ethoprop

July 15, 2010

Bayer CropScience

Tilghman Hall

Russell Jones

Iain Kelly

Matt Kern
15 July 2010 

Outline

 General Comments Jeopardy Decisions Effects Characterization  E-fate and Exposure
15 July 2010 

General Comments - Process Review period allowed for draft biological o

 30 day review period for applicants/registra

unacceptable for a 942 page document covactive ingredients

 75 days from draft to finalization unrealistic 

will NMFS have time to fully incorporate coreceived from the applicant and action age

 It is appropriate for NMFS to request a time 

extension
15 July 2010 

General Comments - Process The statement that “In order to ensure that EPA’s 

will not jeopardize listed species or destroy or advmodify critical habitat, NMFS’ analysis necessarily encompasses the impacts to listed Pacific salmonESUs/DPSs of all uses authorized by EPA, regarwhether those uses have historically occurredinconsistent with the statement that action is definreregistration

 With the action being reregistration then a clea

defined baseline should be developed that incldiscussion on the pesticide reduction in use thaoccurred for these compounds
15 July 2010 

General Comments - Process Utilization of expertise in the biological opin

development

 Parallel programs from State or other agen

were either ignored or dismissed – example

The Federal Caucus in the Columbia River B

salmon recovery

WA state water monitoring data

 How was the USDA or other agronomic exp

(i.e., State Agriculture Departments or exteoffices) used in the process?
15 July 2010 

General Comments - Process RPAs and RPMs

 Consultation handbook notes that the appli

should be given every opportunity to assist development of RPAs 

 Were other agronomic experts used in the 

development of RPAs or RPMs?

 Strongly recommend that a transparent pro

developed that allows stakeholder input into biological opinion and development of any appropriate RPAs or RPMs (as necessary)

 Was there or will there be an economic and 

feasibility analysis conducted on RPAs and 
15 July 2010 

General Comments – Data quality and transp

 Remains difficult to fully interpret how jeopardy d

were reached. Greater clarification and transparneeded

 NMFS states that data quality is considered whe

evaluating studies, but there is no documentation this was performed and the conclusions reached 

 Many cases cannot verify inputs or statements m

document – see written comments

 NMFS notes high uncertainty for many aspects o

exposure and effects characterization, as well as characterization, and uses this as justification for methodology used or not used in the opinion

 The Population modeling has high uncertainty and 

appears to be a cornerstone upon which the jeopadecisions are reached. Can you explain the reaso
15 July 2010 

General Comments – Data quality and transp

 Broad generalizations that cross all contam

and/or classes of chemistry are inappropriwithout proper context and citations

 Utilization of non-peer reviewed data or m

examples

 What is the status of the publication of pop

models and/or what type of peer-review haconducted?

 The NOAA 2009 data on the AChE inhibitio

not been reviewed nor available for review
15 July 2010 

Ethoprop Label Mitigation Summary

Labeled Uses

Wind Speed at 

Application (mph) Buffer (ft)1

Apps. per 

Season

Application 

Method2

Immediate Soil 

Incorporation3 S

EPA Reg. No. 264-457 (Granular)Beans (Snap & Lima) ----- ----- 1 ground mechanical Cabbage ----- ----- 1 ground mechanical Corn (Field & Sweet) ----- ----- 1 ground mechanical Cucumber ----- ----- 1 ground mechanical Mint ----- ----- 1 ground mechanical or irrigation Potatoes ----- ----- 1 ground mechanical EPA Reg. No. 264-458 (Spray)Cabbage (CA Only) 10 140 1 ground mechanical 

Hops 10 140 1 ground mechanical or irrigation 

Mint 10 140 1 ground mechanical or irrigation 

Potatoes 10 140 1 ground mechanical 

Sweet Potatoes 10 140 1 ground mechanical Ornamentals 10 140 1 ground mechanical 24(c) OR 060024- Sugar Beats(west of Cascade Mountains only) 10 140 1 ground mechanical 24(c) OR 090003- Easter Lilies (Curry Co. Only) 10 140 1 ground mechanical 24(c) OR 060010- Snap Beans 10 140 1 ground mechanical 24(c) CA-060007- Snap and Lima Beans 10 140 1 ground mechanical 

1to inland freshwater habitats 2applications made within 4 feet of ground3mechanical incorportion to 2-8 inches, irrigantion of 1 to 2 inches water4nozzles which produce medium or coarser spray droplets as per ASAE 572

Existing Ethoprop Label Mitigations
15 July 2010 

Hazard and Risk Characterization Topic

 Risk characterizations – Jeopardy decisio Effects data Mixtures Population modeling
15 July 2010 

NMFS Jeopardy Conclusions for Ethop

 Chinook-Sacramento River Winter-Run (Jeopardy and A

Modifications Determinations)

 Coho-Central California Coast (Jeopardy and Adverse M

Determinations)

 Steelhead-Southern California (Jeopardy and Adverse M

Determinations)

 NMFS then notes that the action as implemented under the 

remove the likelihood of jeopardy and adverse modification habitat

Given the extensive mitigation already on ethoprolabels, it is unclear what risk was identified for thESUs/DPSs (of the 28 evaluated) and where additmitigation for ethoprop may be warranted
15 July 2010 

Co-occurrence (land use and adverse e

Steelhead-Southern California DPS Endangered High (21), Medium (5), Low 

Coho-Central California Coast ESU Endangered Not Evaluated 

ESU Endangered High-entire area 

Chinook-Sacramento River Winter 

Run

Watershed Conservation 

Listing Value

Area 

Species Designation

 No maps or details on the co-occurrence anal

provided for evaluation

 NMFS stated where there is significant overla

use and salmon habitat there is a higher risk flikelihood of adverse effects

 For the 3 ethoprop jeopardy decisions percen

was low and therefore the decision criterion is 

 Reminder - ethoprop has no urban uses
15 July 2010 

Co-occurrence (land use and adverse e

 What is the cdetermining ov

 Is there a sland value? How did the distance from factor into thdeterminatio

 How did you mdetermination f"likelihood of aeffects”?

 NMFS used a classification of likelihood of ad

effects overlapping with co-occurrence with la
15 July 2010 

Co-occurrence (land use and adverse e

 Similar question
15 July 2010 

Ethoprop Toxicity

Species LC50 (ppb)

Rainbow Trout 13800Rainbow Trout 1850Rainbow Trout 1150Rainbow Trout 1020Geometric Mean (all studies)= 2339AChE Inhibition EC50 (ppb)Rainbow Trout (unpublished study) 90.6Species EC50 (ppb)Daphnia magna 93Daphnia magna 44Geometric Mean (all studies)= 64Salmonid (Rainbow Trout) Acute Toxicity DataFreshwater Invertebrate (Daphnia) Acute Toxicity Data

Conservative attribute All concentrations were 

for the entire exposure 

Juvenile salmonids we

(sensitive life stage)

Food is withheld during 

exposure periodToxicity values are signhigher than relevant mofor ethoprop

 When multiple toxicity values are available for the 

species it is appropriate to use a geometric mean values
15 July 2010 

Ethoprop Toxicity

 AChE values for the 12 Ops were discuss

opinion and were subsequently used in the population modeling, both citing a NOAA 2document. This study is not available for rmethodology or results and therefore seeminappropriate for regulatory use 

 For the risk characterization phase - expos

durations for EECs should be consistent wthose from the toxicity studies
15 July 2010 

Mixtures - Toxicity

 The BiOp raises strong concerns on potential syn

effects amongst pesticides particularly OPs

 We strongly disagree based on the following:

 It draws heavily on a single recent paper (Laetz et 

in which

 Authors state significant synergistic effects at high 

concentrations beyond those detected in the environ

 Synergistic effects at lower concentrations much les

– Baldwin at the 2009 SETAC meeting presented results 

synergy at lower concentrations – this paper is not disc

 Needs better dose response characterization 

 Mixtures do occur but generally at low concentratio

durations. The environmentally relevant concentrations the concentrations where the above stated paper found 

 Majority of the literature indicates that additivity is 

most common interaction of pesticides
15 July 2010 

Population and Organismal Modeling

 Model for Reduced Growth of Salmon

 Status of peer review of model unknown, t

appropriateness of use of model in questio

These models need to be peer-reviewed be

used in a regulatory process

 Has a sensitivity analysis on the model for 

parameters and assumptions been conduc

 Given the current available methods, it is u

why the models must rely on point estimate
15 July 2010 

Population and Organismal Modeling

 Difficult to assess how inputs and assumptions w

determined. For example:

 What is the justification for assuming density indepe Are exposure concentrations assumed to be the sam

watershed’s and habitats for all ESUs/DPSs? Are thassumed to be stable? How were they chosen? Whvalues in the range of the monitoring data chosen?

 What is the justification that 100% of the females rep

and/or 100% of subyearlings are exposed to an even

 How did the models account for opportunistic feedin

of salmon?

 Did the models examine the spatial and temporal as

salmon life histories and habitats? Why or why not?
15 July 2010 

Population and Organismal Modeling – clarifneeded

 Does this meaconcentrations would need to significantly efpopulation gro How was this used in the jeodecisions?
15 July 2010 

Population-Level Analysis

Please explain how these were determined based oavailable for ethoprop
15 July 2010 

Maximum Concentration Limits for RPA Elem

 NMFS provided the above table for maximum concentratio

salmonid habitat based on population model results

 Please explain the derivation of these values and where the

found in the biological opinion
15 July 2010 

Exposure and Environmental Fate Topi

 Monitoring Incorporation Persistence in Soil Soil Field Capacity Restriction Dimensions of Floodplain Habitat Monitoring Requirement
15 July 2010 

Monitoring

 NMFS emphasis on the peak values from 

monitoring data is unwarranted and mischaracterizes the exposure

 Monitoring values should always be placed 

perspective and should be used probabilis

 Ethoprop residues in samples in all three d

base sources cited by NMFS are all below maximum level of 20 ppb for salmon habit

 NAWQA: 5.75 ppb Washington: 0.27 ppb California: 1.1 ppb
15 July 2010 

NAWQA Ethoprop Data in CA, ID, OR, and W

Total 4803

1-5.75 4

0.1 - ≤ 1 ppb 33

0.01 - ≤ 0.1 153

≤ 0.01 ppb 117

Not detected 4494

Concentration Range (ppb) No. of Samp
15 July 2010 

NAWQA Ethoprop Data in CA, ID, OR, and W

99.9th 0.68

99th 0.07698th 0.0395th 0.016

Ethoprop Conce

(ppb)

Percentile

Given the low Koc of ethoprop, NMFS’s conover the NAWQA program’s use of filtered samples is not relevant for ethoprop. 
15 July 2010 

Ethoprop Analyses in Washington Data 

Total 1Residues not detected above the specified detection limit of 0.012-0.25 ppbResidues not detected 1Residues estimated: 0.0019-0.064 ppb Residues detected: 0.013-0.070 ppb Residues detected: 0.14-0.27 ppb 

Category and Concentration Range No. of 

(ppb)
15 July 2010 

Monitoring

 NMFS emphasis on detection in NC golf course i

seems inappropriate:

 Turf uses are no longer on the label Climate conditions are different Turf applications were not incorporated while incor

required for all current uses

 Therefore NMFS is not correct in its categorizatio

event as “associated with application methods coto current registered uses.”

 The water analysis associated with the incident is 

relevant for a salmonid analysis in the Pacific No

 References to this value should be eliminated or e

stated that it is not relevant
15 July 2010 

Incorporation

 The label requires all ethoprop application

incorporated into the soil

 By the application equipment  Immediately after application mechanically 

irrigation.

 Reduction of runoff due to incorporation

 Mechanical tillage: 25-80 percent Shanking into the soil or placing in the see

10-100 percent 
15 July 2010 

Incorporation

 The relatively low concentrations of ethoprop in s

water demonstrates that this incorporation is effeminimizing concentrations in surface water

 It is unclear how NMFS considered the incorpora

well as the existing required buffers, into the bioloopinion and decisions on jeopardy

 This should be explicitly stated

 Listing of input parameters for exposure assessm

required and needs to be added

 Formulation type, e-fate parameters, buffers, incor

droplet size, etc.
15 July 2010 

Cumulative Exposure Assessment

 NMFS modeled 3 scenarios (potatoes, citr

cherries) for various OP’s with the assumpthe different crops were grown on the samresulting in a cumulative exposure in the swater body

 Assumption is not valid, these crops would 

grown on same land at the same time

 Input parameters were not provided for GE

model to allow verification of the results
15 July 2010 

Persistence in Soil

 NMFS’s statement that ethoprop is persist

soil is not supported by field studies

 6 trials in the U.S. including one in Californ

two in Washington

 3 trials in the Netherlands

 All studies showed degradation rates of 0.

months
15 July 2010 

Persistence in Soil

 The degradation of ethoprop tends to incre

with increasing time and depth into the soi

 Potential explanations

Microbial adaptation to ethopropIncreased availability due to the general dec

inorganic matter with increasing depth 
15 July 2010 

Soil Field Capacity Restriction The restriction on applications when soil moisture is at field 

unnecessary

 Runoff occurs in response to rainfall This restriction in combination with restriction with the ra

events should be an “and” statement, not an “or” statem

 This restriction has the potential of increasing residues in ru

 This restriction may reduce the time between application 

rainfall producing runoff

 For example: The situation might be that a heavy rain oc

leaving the soil at field capacity for another week (the grhaving to delay his application), then the grower makes application and then in three days it rains causing runoffgrower had been able to make his application immediatefirst rainfall, there would have been an extra week for deand increased binding to the soil before the runoff event

 From an enforceability standpoint: is it clear what is meant b

storm event likely to produce runoff from the treated are

forecasted by NOAA/NWS, to occur within 48 h following ap

 What is likely? Will the NWS make such forecasts?
15 July 2010 

Floodplain Habitat Water Body Dimens

 NMFS has specified the dimensions of floo

habitat to be 1-2 m wide and 0.1 m deep

 This will require the development of a flow

water scenario for assessing potential concentrations in the floodplain habitat
15 July 2010 

Floodplain Habitat Water Body Dimens

 Example:

 1 inch runoff square 160 acre field 2 m wide and 0.1 m deep running along on

the field and draining the entire field

 The runoff is 100 times the volume of the s

 Therefore, a scenario with a static water b

these dimensions would not be appropriat
15 July 2010 

Monitoring Requirement

 The monitoring program should not be a 

theoretical exercise to:

 validate spray drift models indicate that residues can be present in ce

types of surface water bodies, when salmonot present

 Instead the monitoring should focus on 

concentrations in water bodies in which saare present during the actual times of sam
15 July 2010 

Monitoring Requirement

 The monitoring available to date indicate that the 

mitigations being requested are much more restrrequired to protect salmonids

 Bayer CropScience requests that EPA:

 draw on the considerable experience available wit

registrant community in designing such studies

 better utilize existing monitoring data, as well as co

spatial and temporal intersection of pesticides and species in the design of the study

 use the opportunity to design the study such that a

required mitigations can be refined 
15 July 2010 

Conclusions

 An extension for reviewing the document should 

pursued

 As registrants/applicants we need to have a valid

predictable, risk assessment and consultation pro

 Greater clarity is needed in some of the methods 

in how jeopardy decisions were reached

 More detailed assessment accounting for the tem

spatial components of the salmon life history and patterns can be conducted

 Exposure assessments need to be current and sp

the compound under evaluation

 Monitoring data shows that existing ethoprop miti

measures are effective and no additional measurprotect salmon are needed