Comments on NMFS 3rdSalmonid BiologicalOpinion on 12 OrganophosphatesEmphasis on EthopropJuly 15, 2010Bayer CropScienceTilghman HallRussell JonesIain KellyMatt Kern15 July 20102OutlineGeneral CommentsJeopardy DecisionsEffects CharacterizationE-fate and Exposure15 July 20103General Comments - ProcessReview period allowed for draft biological opinion30 day review period for applicants/registrants isunacceptable for a 942 page document covering 12active ingredients75 days from draft to finalization unrealistic – howwill NMFS have time to fully incorporate commentsreceived from the applicant and action agency?It is appropriate for NMFS to request a timeextension15 July 20104General Comments - ProcessThe statement that“In order to ensure that EPA’s actionwill not jeopardize listed species or destroy or adverselymodify critical habitat, NMFS’ analysis necessarilyencompasses the impacts to listed Pacific salmonidESUs/DPSs of all uses authorized by EPA, regardless ofwhether those uses have historically occurred.”isinconsistent with the statement that action is defined asreregistrationWith the action being reregistration then a clearlydefined baseline should be developed that includes adiscussion on the pesticide reduction in use that hasoccurred for these compounds15 July 20105General Comments - ProcessUtilization of expertise in the biological opiniondevelopmentParallel programs from State or other agencieswere either ignored or dismissed – examples:The Federal Caucus in the Columbia River Basin –salmon recoveryWA state water monitoring dataHow was the USDA or other agronomic experts(i.e., State Agriculture Departments or extensionoffices) used in the process?15 July 20106General Comments - ProcessRPAs and RPMsConsultation handbook notes that the applicantshould be given every opportunity to assist in thedevelopment of RPAsWere other agronomic experts used in thedevelopment of RPAs or RPMs?Strongly recommend that a transparent process bedeveloped that allows stakeholder input into thebiological opinion and development of anyappropriate RPAs or RPMs (as necessary)Was there or will there be an economic andfeasibility analysis conducted on RPAs and RPMs?15 July 20107General Comments – Data quality and transparencyRemains difficult to fully interpret how jeopardy decisionswere reached. Greater clarification and transparency isneededNMFS states that data quality is considered whenevaluating studies, but thereis no documentation on howthis was performed and the conclusions reachedMany cases cannot verify inputs or statements made in thedocument – see written commentsNMFS notes high uncertainty for many aspects of theexposure and effects characterization, as well as riskcharacterization, and uses this as justification formethodology used or not used in the opinionThe Population modeling has high uncertainty and yet itappears to be a cornerstone upon which the jeopardydecisions are reached. Can you explain the reasoning?15 July 20108General Comments – Data quality and transparencyBroad generalizations that cross all contaminantsand/or classes of chemistry are inappropriatewithout proper context and citationsUtilization of non-peer reviewed data or models -examplesWhat is the status of the publication of populationmodels and/or what type of peer-review has beenconducted?The NOAA 2009 data on the AChE inhibition hasnot been reviewed nor available for review15 July 20109Ethoprop Label Mitigation SummaryLabeled UsesWind Speed atApplication (mph) Buffer (ft)1Apps. perSeasonApplicationMethod2Immediate SoilIncorporation3Spray Nozzel Size4EPA Reg. No. 264-457 (Granular)Beans (Snap & Lima)----- ----- 1 ground mechanical NACabbage----- ----- 1 ground mechanical NACorn (Field & Sweet)----- ----- 1 ground mechanical NACucumber----- ----- 1 ground mechanical NAMint----- ----- 1 groundmechanical orirrigationNAPotatoes----- ----- 1 ground mechanical NAEPA Reg. No. 264-458 (Spray)Cabbage (CA Only)10140 1 ground mechanicalmediumHops10140 1 groundmechanical orirrigationmediumMint10140 1 groundmechanical orirrigationmediumPotatoes10140 1 ground mechanicalmediumSweet Potatoes10140 1 ground mechanicalmediumOrnamentals10140 1 ground mechanicalmedium24(c) OR 060024- Sugar Beats(west ofCascade Mountains only)10140 1 ground mechanicalmedium24(c) OR 090003- Easter Lilies (CurryCo. Only)10140 1 ground mechanicalmedium24(c) OR 060010- Snap Beans10140 1 ground mechanicalmedium24(c) CA-060007- Snap and Lima Beans10140 1 ground mechanicalmedium1to inland freshwater habitats2applications 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 572Existing Ethoprop Label Mitigations15 July 201010Hazard and Risk Characterization TopicsRisk characterizations – Jeopardy decisionsEffects dataMixturesPopulation modeling15 July 201011NMFS Jeopardy Conclusions for EthopropChinook-Sacramento River Winter-Run(Jeopardy and AdverseModifications Determinations)Coho-Central California Coast(Jeopardy and Adverse ModificationsDeterminations)Steelhead-Southern California(Jeopardy and Adverse ModificationsDeterminations)NMFS then notes that the actionas implemented under the RPA willremove the likelihood of jeopardyand adverse modification of criticalhabitatGiven the extensive mitigation already on ethoproplabels, it is unclear what risk was identified for these 3ESUs/DPSs (of the 28 evaluated) and where additionalmitigation for ethoprop may be warranted15 July 201012Co-occurrence (land use and adverse effects)5%High (21), Medium (5), Low (3)EndangeredDPSSteelhead-Southern California2.3%Not EvaluatedEndangeredESUCoho-Central California Coast25%High-entire areaEndangeredESUChinook-Sacramento River WinterRun% Ag Areain ESU/DPSWatershed ConservationValueListingAreaDesignationSpeciesNo maps or details on the co-occurrence analysis wereprovided for evaluationNMFS stated where there is significant overlap of landuse and salmon habitat there is a higher risk forlikelihood of adverse effectsFor the 3 ethoprop jeopardy decisions percent ag areawas low and therefore the decision criterion is unclearReminder - ethoprop has no urban uses15 July 201013Co-occurrence (land use and adverse effects)What is the criteria fordetermining overlap?Is there a specific % agland value?How did the 2.5 kmdistance from habitatfactor into thisdetermination?How did you make thedetermination for the"likelihood of adverseeffects”?NMFS used a classification of likelihood of adverseeffects overlapping with co-occurrence with land use15 July 201014Co-occurrence (land use and adverse effects)Similar questions as last slide15 July 201015Ethoprop ToxicitySpeciesLC50 (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 DataConservative attribute of studiesAll concentrations were maintainedfor the entire exposure periodJuvenile salmonids were used(sensitive life stage)Food is withheld during entireexposure periodToxicity values are significantlyhigher than relevant monitoring datafor ethopropWhen multiple toxicity values are available for the samespecies it is appropriate to use a geometric mean of thesevalues15 July 201016Ethoprop ToxicityAChE values for the 12 Ops were discussed in theopinion and were subsequently used in thepopulation modeling, both citing a NOAA 2009document. This study is not available for review ofmethodology or results and therefore seemsinappropriate for regulatory useFor the risk characterization phase - exposuredurations for EECs should be consistent withthose from the toxicity studies15 July 201017Mixtures - ToxicityThe BiOp raises strong concerns on potential synergisticeffects amongst pesticides particularly OPsWe strongly disagree based on the following:It draws heavily on a single recent paper (Laetz et al., 2009)in whichAuthors state significant synergistic effects at highconcentrations beyond those detected in the environmentSynergistic effects at lower concentrations much less significant–Baldwin at the 2009 SETAC meeting presented results showing nosynergy at lower concentrations – this paper is not discussedNeeds better dose response characterizationMixtures do occur but generally at low concentrationsfor shortdurations. The environmentally relevant concentrations are belowthe concentrations where the above stated paper found synergy.Majority of the literature indicates that additivity is by far themost common interaction of pesticides15 July 201018Population and Organismal ModelingModel for Reduced Growth of SalmonStatus of peer review of model unknown, thereforeappropriateness of use of model in questionThese models need to be peer-reviewed before beingused in a regulatory processHas a sensitivity analysis on the model for the inputparameters and assumptions been conducted?Given the current available methods, it is unclearwhy the models must rely on point estimates15 July 201019Population and Organismal ModelingDifficult to assess how inputs and assumptions weredetermined. For example:What is the justification for assuming density independence?Are exposure concentrations assumed to be the same acrosswatershed’s and habitats for all ESUs/DPSs? Are theyassumed to be stable? How werethey chosen? Why were novalues in the range of the monitoring data chosen?What is the justification that100% of the females reproduceand/or 100% of subyearlings are exposed to an event?How did the models account for opportunistic feeding behaviorof salmon?Did the models examine the spatial and temporal aspects ofsalmon life histories and habitats? Why or why not?15 July 201020Population and Organismal Modeling – clarificationsneededDoes this meanconcentrations in waterwould need to be 558 ppb tosignificantly effectpopulation growth rate?How was this informationused in the jeopardydecisions?15 July 201021Population-Level AnalysisPlease explain how these were determined based on dataavailable for ethoprop15 July 201022Maximum Concentration Limits for RPA Element 3NMFS provided the above table for maximum concentrations insalmonid habitat based on population model resultsPlease explain the derivation ofthese values and where they can befound in the biological opinion15 July 201023Exposure and Environmental Fate TopicsMonitoringIncorporationPersistence in SoilSoil Field Capacity RestrictionDimensions of Floodplain HabitatMonitoring Requirement15 July 201024MonitoringNMFS emphasis on the peak values frommonitoring data is unwarranted andmischaracterizes the exposureMonitoring values should always be placed inperspective and should be used probabilisticallyEthoprop residues in samples in all three database sources cited by NMFS are all below NMFSmaximum level of 20 ppb for salmon habitatNAWQA: 5.75 ppbWashington: 0.27 ppbCalifornia: 1.1 ppb15 July 201025NAWQA Ethoprop Data in CA, ID, OR, and WA4803Total41-5.75330.1 -≤1 ppb1530.01 -≤0.1117≤0.01 ppb4494Not detectedNo. of SamplesConcentration Range (ppb)15 July 201026NAWQA Ethoprop Data in CA, ID, OR, and WA0.6899.9th0.07699th0.0398th0.01695thEthoprop Concentration(ppb)PercentileGiven the low Koc of ethoprop, NMFS’s concernover the NAWQA program’s use of filteredsamples is not relevant for ethoprop.15 July 201027Ethoprop Analyses in Washington Data Base1666Total85Residues not detected above the specifieddetection limit of 0.012-0.25 ppb1556Residues not detected4Residues estimated: 0.0019-0.064 ppb18Residues detected: 0.013-0.070 ppb3Residues detected: 0.14-0.27 ppbNo. of SamplesCategory and Concentration Range(ppb)15 July 201028MonitoringNMFS emphasis on detection in NC golf course incidentseems inappropriate:Turf uses are no longer on the labelClimate conditions are differentTurf applications were not incorporated while incorporation isrequired for all current usesTherefore NMFS is not correct in its categorization of thisevent as “associated with application methods comparableto current registered uses.”The water analysis associated with the incident is notrelevant for a salmonid analysis in the Pacific NorthwestReferences to this value should be eliminated or explicitlystated that it is not relevant15 July 201029IncorporationThe label requires all ethoprop applications to beincorporated into the soilBy the application equipmentImmediately after application mechanically or byirrigation.Reduction of runoff due to incorporationMechanical tillage: 25-80 percentShanking into the soil or placing in the seed furrow:10-100 percent15 July 201030IncorporationThe relatively low concentrations of ethoprop in surfacewater demonstrates that this incorporation is effective inminimizing concentrations in surface waterIt is unclear how NMFS considered the incorporation, aswell as the existing required buffers, into the biologicalopinion and decisions on jeopardyThis should be explicitly statedListing of input parameters for exposure assessments isrequired and needs to be addedFormulation type, e-fate parameters, buffers, incorporation,droplet size, etc.15 July 201031Cumulative Exposure AssessmentNMFS modeled 3 scenarios (potatoes, citrus andcherries) for various OP’s with the assumption thatthe different crops were grown on the same landresulting in a cumulative exposure in the samewater bodyAssumption is not valid, these crops would not begrown on same land at the same timeInput parameters were not provided for GENEECmodel to allow verification of the results15 July 201032Persistence in SoilNMFS’s statement that ethoprop is persistent insoil is not supported by field studies6 trials in the U.S. including one in California andtwo in Washington3 trials in the NetherlandsAll studies showed degradation rates of 0.3-1.4months15 July 201033Persistence in SoilThe degradation of ethoprop tends to increasewith increasing time and depth into the soilPotential explanationsMicrobial adaptation to ethopropIncreased availability due to the general decreaseinorganic matter with increasing depth15 July 201034Soil Field Capacity RestrictionThe restriction on applications when soilmoisture is at field capacity isunnecessaryRunoff occurs in response to rainfallThis restriction in combination with restriction with the rainfallevents should be an “and” statement, not an “or” statementThis restriction has the potentialof increasing residues in runoffThis restriction may reducethe time between application andrainfall producing runoffFor example: The situation might be that a heavy rain occursleaving the soil at field capacity for another week (the growerhaving to delay his application), then the grower makes andapplication and then in three days itrains causing runoff. If thegrower had been able to make hisapplication immediately after thefirst rainfall, there would have been an extra week for degradationand increased binding to the soil before the runoff event.From an enforceability standpoint: isit clear what is meant by “when astorm eventlikely to produce runoff from the treated areaisforecasted by NOAA/NWS, to occurwithin 48 h following application”What is likely? Will the NWS make such forecasts?15 July 201035Floodplain Habitat Water Body DimensionsNMFS has specified the dimensions of floodplainhabitat to be 1-2 m wide and 0.1 m deepThis will require the development of a flowingwater scenario for assessing potentialconcentrations in the floodplain habitat15 July 201036Floodplain Habitat Water Body DimensionsExample:1 inch runoffsquare 160 acre field2 m wide and 0.1 m deep running along one side ofthe field and draining the entire fieldThe runoff is 100 times the volume of the streamTherefore, a scenario with a static water body ofthese dimensions would not be appropriate15 July 201037Monitoring RequirementThe monitoring program should notbe atheoretical exercise to:validate spray drift modelsindicate that residues can be present in certaintypes of surface water bodies, when salmonids arenot presentInstead the monitoring should focus onconcentrations in water bodies in which salmonare present during the actual times of sampling15 July 201038Monitoring RequirementThe monitoring available to date indicate that themitigations being requested are much more restrictive thanrequired to protect salmonidsBayer CropScience requests that EPA:draw on the considerable experience available within theregistrant community in designing such studiesbetter utilize existing monitoring data, as well as consider thespatial and temporal intersection of pesticides and specificspecies in the design of the studyuse the opportunity to design the study such that anyrequired mitigations can be refined15 July 201039ConclusionsAn extension for reviewing the document should bepursuedAs registrants/applicants we need to have a validated,predictable, risk assessment and consultation processGreater clarity is needed in some of the methods used andin how jeopardy decisions were reachedMore detailed assessment accounting for the temporal andspatial components of the salmon life history and usepatterns can be conductedExposure assessments need to be current and specific tothe compound under evaluationMonitoring data shows that existing ethoprop mitigationsmeasures are effective andno additional measures toprotect salmon are needed