Docket Number EPA-HQ-OPP-2008-0519 www.regulations.gov

SOAP SALTS Interim Registration

Review Decision Case Number

4083 July

2015 Approved

by: **~~ p~~** 

)4' Richard

P. Keigwin,

Jr. Director Pesticide Re-evaluation

Division Date: **---~~~**

**a_o._f_~_**

**S** ___

_TableofContentsI.'INTRODUCTION.........................................................................................................3A.PublicParticipationandComments.........................................................................4II.USEANDUSAGE..;.....................................................................................................5III.SCIENTIFICASSESSMENTS.....................................................................................5A.HumanHealth..........................................................................................................51.RiskConclusions...............................................................................................52.HumanIncidents................................................................................................63.Tolerances..........................................................................................................6B.Ecological................................................................................................................61.RiskConclusions...............................................................................................7C.EndangeredSpeciesAssessment.............................................................................8D.EndocrineDisruptorScreeningProgram.................................................................9IV.INTERIMREGISTRATIONREVIEWDECISION.....................................................9V.NEXTSTEPSANDTIMELINE...................................................................................92I. INTRODUCTION This document

is the Environmental

Protection

Agency's

(EPA

or the Agency)

Interim Registration

Review Decision

for soap

salts

(case

4083,

PC 031801,079021,

079009)

and

is being issued pursuant

to

40 CFR sections

155.56

and 155.58.

A registration

review decision

is the Agency's determination

whether

a pesticide

meets,

or does

not meet,

the standard

for registration

in the Federal Insecticide,

Fungicide,

and Rodenticide

Act (FIFRA).

The Agency may issue,

when

it determines

it

to

be appropriate,

an Interim Registration

Review Decision before completing

a registration

review.

Among

other things,

the

· Interim Registration

Review Decision

may:

1) require

new

risk mitigation

measures;

2) impose

interim

risk mitigation measures;

3) identify

data

or information

required

to complete

the review;

and

4) include schedules

for submitting

the required

data, conducting

the new

risk assessment

and completing the registration

review.

For further information

on soap

salts, additional documents

can

be found in EPA's

public

docket (EPA-HQ-OPP-2008-0519)

at www.regulations.gov. FIFRA,

as amended

by

the Food Quality Protection

Act (FQPA)

of 1996, mandated

the continuous

review

of existing pesticides.

All pesticides **distribute~**

or sold

in the United

States generally

must

be registered

by

the EPA based

on scientific

data showing

that they

will

not cause unreasonable

risks

to human

health

or

to the environment

when

used

as directed

on product labeling.

The registration

review program

is intended

to make

sure

that,

as the ability

to assess and reduce

risk evolves

and

as policies

and practices

change,

all registered

pesticides

continue

to meet

the statutory

standard

of

no unreasonable

adverse

effects. Changes

in science,

public policy,

and pesticide

use practices

will occur

over

time. Through

the registration

review

· program,

the Agency periodically

re-evaluates

pesticides

to make

sure

that

as these changes occur, products

in the marketplace

can continue

to

be used safely. Information

on this program

is provided

as www.epa.gov/oru>srrdllregistration

review/. In 2006,

the Agency implemented

the registration

review program

pursuant

to FIFRA section

3(g)

and

will review

each registered

pesticide

every

15 years

to determine

whether

it continues

to meet

the FIFRA standard

for registration. Products containing

soap

salts

are registered

for

use

as

ac

. ¢cides, algaecides,

herbicides, and insecticides

on food

and non-

food crops

in various

settings,

ehiefly residential

and agricultural.

Products containing ammonium

and sodium

soap

salts

are also registered

for

use

as animal repellants.

The Reregistration

Eligibility

Decision document

(RED)

for soap

salts

was completed

in 1992. Pursuant

to

40 CFR section

155.50,

EPA formally

initiated registration

review

for soap salts

(case 4083).

The following

highlights

significant

events

that have occurred

during

the registration

review

of soap

salts

and

can

be found

in EPA's

public docket, EPA-HQ-OPP-2008- 0519, accessed

at www.regulations.gov: • September

15,2008- Publication

of Soap

Salts Prelimin{;lry

Work

Plan (PWP)

for

a 60- day public comment

period.

The Preliminary

Work

Plan (PWP)

was accompanied

by the scoping document

and problem formulation.

While

the public comment

period

was underway,

the Agency

revised

the

list

of data needs

to more accurately

represent

the registered

uses

and chemical properties

of the three

soap

salts

and revised

the Preliminary

3ProblemFormulationfor.theRegistrationReviewofSoapSaltsdocumenttoreflectthesechanges.•March5,2009-TheAgencypublishedtheRevisedPreliminaryProblemFormulationfortheRegistrationofSoapSalts,datedFebruary23,2009.•March5,2009-FinalWorkPlan(FWP)forsoapsaltswasissued--onecommentwasreceivedduringthe60-daycommentperiodforthesoapsaltsPWP.Whilethiscommentdidnotaffecttheproposeddatarequirements,riskassessments,ortimeline,theFWPdidpresentareducedlistofdataneedsfromthePWPbasedontheconclusionsoftherevisedproblemformulation.•February25,2010-GenericDataCall-InNotice(GDCI)forsoapsaltsissued.•March20,2013-TheAgencypublishedtheEnvironmentalandEcologicalRiskAssessmentfortheRegistrationReviewofSoapSaltsdatedMarch5,2013andtheSoapSalts.PreliminaryRiskAssessmenttoSupportRegistrationReviewdatedAugust29,2012fora60-daypublic·commentperiod.Twosetsofcommentswerereceived.ThesecommentswereaddressedintheSoapSaltsProposedInterimRegistrationReviewDecision,datedMarch11,2015andbytheRevisedEnvironmentalandEcologicalRiskAssessmentfortheRegistrationReviewofSoapSalts,datedMarch3,2015.Thecommentsenabledrefmementstotheecologicalriskassessment.•May8-9,2013-TheAgencyheldfocusmeetingswiththesoapsaltsregistrants.•March26,2015-TheAgencypublishedtheSoapSaltsProposedInterimRegistrationReviewDecision,datedMarch11,2015,indocketnumberEPA-HQ-OPP-2008-0519,fora60-daypublicperiod.Onecommentwasreceivedwhichisdiscussedbelow.Inadditiontothisdocument,theAgencypublishedthefollowingrevisedriskassessment,updatedtoincorporateadditionalinformationprovidedbysoapsaltsregistrants:oRevisedEnvironmentalandEcologicalRiskAssessmentfortheRegistrationReviewofSoapSalts,datedMarch3,2015•September2015-TheAgencyisnowpublishingtheSoapSaltsInterimRegistrationReviewDecision.A.PublicCommentsCommentsReceivedfromtheCenterforBiologicalDiversity(EPA-HQ-OPP-2008-0519)Comment:TheCenterforBiologicalDiversity's(CBD)commentsfocusontheEPA'sdutytoconsultwiththeU.S.FishandWildlifeServiceandtheNationalMarineFisheriesService(theServices)ontheregistrationreviewofsoapsaltsinaccordancewiththeEndangeredSpeciesAct(ESA).TheCBDcommentsmentionvariousaspectsoftheriskassessmentprocess,includinguseofthebestavailabledatato·developendangeredspeciesriskassessments,andevaluationofeffectsonendangeredandthreatenedspecies(listed)andtheirdesignatedcriticalhabitat.CBD4alsoexpressesconcernregardingtherigoroftheAgency'spreliminarydeterminationsregardingtheeffectsofsoapsaltsonlistedspeciesandtheirdesignatedcriticalhabitatforthesoapsaltsregistrationreview.Response:TheAgencyhasreviewedthecommentsfromCBDontheSoapSaltsProposedInterimDecisionandplanstoaddressmanyoftheconcernsraisedbyCBDaspartoftheimplementationplanforassessingtheriskstolistedspeciesbasedontherecommendationsoftheApril2013NationalAcademyofSciences(NAS)report.Theagencyiscurrentlyworkingwithitsfederalcounterpartsandotherstakeholderstoimplementaninterimapproachforassessingpotentialrisktolistedspeciesandtheirdesignatedcriticalhabitats.Oncethescientificmethodsnecessarytocompleteriskassessmentsforlistedspeiesandtheirdesignatedcriticalhabitatsarefinalized,theAgencywillcompleteitsendangeredspeciesassessmentforsoapsaltsandissueafinaldecisionforregistrationreview.SeeSectionIII.(C.)foradescriptionoftheAgency'splantoaddressriskstoendangeredspeciesandcriticalhabitat.II.USEANDUSAGETheactiveingredientscomprisingthesoapsaltscaseareammonimum,potassium,andsodiumsaltsoffattyacids.Productscontainingthesesaltsareregisteredforuseasacaricides,algaecides,herbicides,insecticidesonfoodandnon-foodcropsinvarioussettings,chieflyresidentialandagricultural.Soapsaltsareregisteredforuseonawiderangeoffoodandnonfoodcropsaswellasornamentalplants,shrubs,lawns,walks,driveways,dogs,andcats.Productscontainingammoniumandsodiumsoapsaltsarealsoregisteredforuseasanimalrepellants.Soapsaltsproductsareformulatedasaerosolsprays,solids,ready-to-useliquids,andliquidconcentrations.Potassiumsaltsoffattyacidsdisrupttheexoskeletonininsects,causinginsectstodie.Theyalsokillplantsbydisruptingthephotosyntheticprocess.Ammoniumandsodiumsaltsoffattyacidsactasrepellants,affectingtheolfactorynervesofdeerandrabbits,thusrepellingtheanimalsawayfromthetargetareaIII.SCIENTIFICASSESSMENTSA.HumanHealthAsummaryoftheAgency'shumanhealthriskassessmentispresentedbelow.TheAgencyusedthemostupdatedAgencysciencepoliciesandriskassessmentmethodologiestoprepareaqualitativeriskassessmentinsupportoftheregistrationreviewofsoapsalts.Foradetaileddiscussionofthehumanhealthassessmentforsoapsalts,seeSoapSalts.PreliminaryRiskAssessmenttoSupportRegistrationReview,datedAugust29,2012availableinthepublicdocketEPA-HQ-OPP-2008-0519,whichcanbeaccessedathttp://www.regulations.gov/.1.RiskConclusionsTheAgencyconductedaqualitativehumanhealthriskassessmentforthesoapsaltstoevaluatepotentialoccupational,residential,dietary,andaggregateriskfromthesoapsalts'5pesticidaluses.Availabledatashowthatthesoapsaltshaveverylowtoxicity.TheAgencyhasdeterminedthattherearenohumanhealthriskconcernsfromthecurrentpesticidalusesofsoapsalts.2.HumanIncidentsTheAgencyconductedareviewofthehumanincidentsattributedtosoapsaltsin2013.Sevenincidentswererecordedduringtheperiodanalyzed,January1,2007,toSeptember4,2012.Basedonthelowfrequencyandseverityofincidentcasesreportedforsoapsalts,theredoesnotappeartobeaconcernatthistimethatwouldwarrantfurtherinvestigation.TheAgencywillcontinuetomonitortheincidentinformationandifaconcernistriggered,additionalanalysiswillbeconducted.3.TolerancesPotassiumandammoniumsaltsarecurrentlyexemptfromtherequirementofatolerance.Anexemptionforsodiumsaltsisnotneeded,astherearenouseson/nearfoodcrops.B.EcologicalAsummaryoftheAgency'secologicalriskassessmentispresentedbelow.TheAgencyusedthemostupdatedAgencysciencepoliciesandriskassessmentmethodologiestoprepareaquantitativeriskassessmentinsupportoftheregistrationreviewofsoapsalts.Foradetaileddiscussionoftheecologicalassessmentforsoapsalts,seeRevisedEnvironmentalandEcologicalRiskAssessmentfortheRegistrationReviewofSoapSaltsdatedMarch3,2015availableinthepublicdocketEPA-HQ-OPP-2008-0519,whichcanbeaccessedathttp://www.regulations.gov/.Wheninitiallyscopingtheregistrationreviewforsoapsalts,EPAdidnotidentifytheneedforanyadditionalstudiestoevaluatepotentialeffectsonpollinators.However,sincetheissuanceoftheJune2014GuidanceforAssessingPesticideRiskstoBeesf11,EPAhasbeguntorequirethesedatawhereapplicable.EPAiscurrentlydeterminingwhetheradditionalpollinatordataareneededforactiveingredientsinregistrationreviewwhosedocketsopenedpriortoJune2014.ForthoseactiveingredientswhereEPAdeterminesthatadditionalpollinatorexposureandeffectsdataarenecessarytohelpmakeafinalregistrationreviewdecision,EPAintendstoissueaDCItoobtainthesedata.Inthenearfuture,EPAwillprovidefurtherinformationandguidanceonthiseffort.ThepollinatorstudiesthatcouldberequiredareincludedinTable1below.TheAgencywillrequiredataitbelievesarenecessarytohelpinformthepollinatorriskassessment.[IJhttp://www2.epa.gov/sites/production/files/2014-06/documents/pollinatorriskassessmentguidance061914.pdf6Tbl1Pae·1Pll'otenttaomatorDRataeqmrementsGuideline#Study850.3020*1Acutecontacttoxicitystudywithadulthoneybees850.3030*1Honeybeetoxicityofresiduesonfoliage850.3040**FieldtestingforpollinatorsNon-Guideline*Honeybeeadultacuteoraltoxicity(OECD213)Non-Guideline*Honeybeelarvaeacuteoraltoxicity(OECD237)Non-Guideline*HoneybeeadultchronicoraltoxicityNon-Guideline*HoneybeelarvaechronicoraltoxicityNon-Residuesinpollenandnectar/fieldresidueanalysisGuideline**Non-Semi-fieldtestingforpollinators(tunnelorcolonyfeedingGuideline**(OECD75)studies)*TierI(Laboratory-basedstudies)**Tier2and3(Semi-fieldandfullfieldcolony-levelstudies)Theneedforahighertiertestforpollinatorswillbedeterminedbaseduponlower-tieredtestsand/orotherlinesofdataandtheneedforarefinedpollinatorriskassessment.1.Acceptabledatahavealreadybeensubmittedforsoapsaltsorarewaivedbasedonavailableinformation.TheAgencyalsocompletedascreening-levelendangeredandthreatened(listed)speciesassessmentforsoapsaltsandidentifiedpotentialriskstoseveraltaxa:freshwaterinvertebrates,estuarine/marineinvertebrates,andterrestrialplants.InordertomeettherequirementsofFIFRAandtheESA,thisassessmentfollowsEPAguidanceonconductingecologicalriskassessmentsandtheOfficeofPesticideProgram'sOverviewDocument,whichcontainsguidanceforassessingpesticideriskstonon-targetandlistedspecies(USEPA,2004).However,asdescribedbelow,theAgencyiscurrentlyworkingwithitsFederalcounterpartsandotherstakeholderstoimplementaninterimapproachforassessingpotentialrisktolistedspeciesandtheirdesignatedcriticalhabitats.Oncethescientificmethodsnecessarytocompleteriskassessmentsforlistedspeciesandtheirdesignatedcriticalhabitatsarefinalized,theAgencywillcompleteitsendangeredspeciesassessmentforsoapsalts.1.RiskConclusionsTerrestrialAssessmentThescreening-levelriskassessmentidentifiedthepotentialforminorrisktoterrestrialplantsfromtheuseofpotassiumandammoniumsalts.However,theAgencybelievesthereislittleactualrisktonon-targetplantsexposedtosoapsaltsduetotherapid degradationofsoapsaltsinsurfacewaterrunoff,whichisnotaccountedforintheriskassessmentmodel,andtheinherentinsolubilityandlowtoxicityofsoapsalts.Additionally,tobeeffective,soapsaltsgenerallymustbeappliedtothoroughlywetthetargetpest(insectorplant)sincetheyhaveaphysical,nottoxic,modeofaction.Thislimitstheeffectofsoapsaltstospecieswithinthe7immediateareaofapplication.Therefore,theAgencyhasnoriskconcernsfromtheterrestrialassessmentfornon-listedspecies.AquaticAssessmentThescreening-levelriskassessmentonaquaticorganismsexposedtobothpotassiumandammoniumsaltsfoundthepotentialforrisktofreshwaterandestuarine/marineinvertebrates.However,theAgencybelievesthereisnodirecteffecttoaquaticorganisms,becausefattyacidssuchassoapsaltsarenotsufficientlysolubleinambientwatertobetoxictoaquaticorganisms.Therefore,theAgencyhasnoriskconcernsfromtheaquaticassessmentfornon-listedspecies.C.EndangeredSpeciesAssessmentConsistentwithEPA'sresponsibilityundertheEndangeredSpeciesAct(ESA),theAgencywillevaluateriskstofederallylistedthreatenedandendangered(listed)speciesfromregisteredusesofpesticidesinaccordancewiththeJointInterimApproachesdevelopedtoimplementtherecommendationsoftheApril2013NationalAcademyofSciences(NAS)report,AssessingRiskstoEndangeredandThreatenedSpecies.fromPesticides.TheNASreportllloutlinesrecommendationsonspecificscientificandtechnicalissuesrelatedtothedevelopmentofpesticideriskassessments thatEPAandtheServicesmustconductinconnectionwiththeirobligationsundertheESAandFIFRA.EPAwilladdressconcernsspecifictosoapsaltsinconnectionwiththedevelopmentofitsfinalregistrationreviewdecisionforsoapsalts.InNovember2013,EPA,theU.S.FishandWildlifeService,NationalMarineFisheriesServices(theServices),andtheU.S.DepartmentofAgriculturereleasedawhitepapercontainingasummaryoftheirjointInterimApproachesforassessingriskstolistedspeciesfrompesticides.TheseInterimApproachesweredevelopedjointlybytheagenciesinresponsetotheNASrecommendations,andreflectacommonapproachtoriskassessmentsharedbytheagenciesasawayofaddressingscientificdifferencesbetweentheEPAandtheServices.DetailsofthejointInterimApproachesarecontainedintheNovember1,2013whitepaper,InterimApproachesforNational-LevelPesticideEndangeredSpeciesActAssessmentsBasedontheRecommendationsoftheNationalAcademyofSciencesApri/2013Report.fllGiventhattheagenciesarecontinuingtodevelopandworktowardimplementationoftheInterimApproachestoassessthepotentialrisksofpesticidestolistedspeciesandtheirdesignatedcriticalhabitat,theecologicalriskassessmentsupportingthisInterimRegistrationReviewDecisionforsoapsaltsdoesnotcontainacompleteESAanalysis,includingeffectsdeterminationsforspecificlistedspeciesordesignatedcriticalhabitat.WhiletheagenciescontinuetodevelopacommonmethodforESAanalysis,therevisedriskassessmentfortheregistrationreviewofsoapsaltsdescribesthelevelofESAanalysiscompletedforthisparticularregistrationreviewcase.ThisassessmentwillallowEPAtofocusitsfutureevaluationsonthetypesofspecieswherethepotentialforeffectsexists,oncethescientificmethodsbeingdevelopedbytheagencieshavebeenfullyvetted.Oncetheagencieshavefullydevelopedandimplementedthescientificmethodsnecessarytocompleteriskassessmentsforlistedspeciesand[IIhttp://www.nap.edu/catalog.php?recordid=18344[21http://www.epa.gov/espp/2013/nas.html8their designated

critical habitats,

these methods

will

be applied

to subsequent

analyses

of soap salts

as part

of completing

this registration

review. D. Endocrine

Disruptor

Screening

Program EPA

has developed

the Endocrine

Disruptor

Screening

Program

(EDSP)

to determine whether

certain substances

(including

pesticide

active

and other ingredients)

may

have

an effect in humans

or wildlife

similar

to

an effect produced

by

a "naturally

occurring

estrogen,

or other such endocrine

effects

as the Administrator

may designate."

Under FFDCA

section

408(p

), the Agency

must screen

all pesticide chemicals.

Between

October

2009

and November

2010,

EPA issued

test orders/data

call-ins

for

the first group

of

67 chemicals

and published

a second

list

of chemicals

proposed

for order issuance

in the future.

Soap

salts

are

not among

the group

of

58 pesticide

active ingredients

on the initial

list

nor

are they proposed

on

the second

list

of chemicals

to

be screened

under

the EDSP. Accordingly,

as part

of registration

review,

EPA

will issue future

EDSP orders/data

call-ins

for registration

review chemicals,

including

soap

salts. For further information

on the status

of the EDSP,

the policies

and procedures,

the

list

of

67 chemicals,

future chemical

lists proposed

for screening,

the

test guidelines

and

the Tier

1 screening

battery,

please

visit

our website: http://www.epa.gov/endo/. In this interim decision,

EPA

is making

no human

health

or environmental

safety findings associated

with

the EDSP screening

of soap

salts. Before completing

this Registration

Review, the Agency

will make

an EDSP FFDCA

section

408(p) determination. IV. INTERIM REGISTRATION

REVIEW DECISION In accordance

with

40 CFR Sections

155

. 56 and 155.58

, the Agency

is issuing

this Interim Registration

Review Decision document

for soap

salts. Except

for

the EDSP,

ESA,

and pollinator components

of this case,

EPA

has made

the following

Interim Registration

Review Decision determination

for soap

salts:

1)

no additional

data

are required

at this time;

and

2)

no changes

to the affected registrations

or their labeling

are needed

at this time. In this interim registration

review decision

, EPA

is making

no human

health

or environmental

safety findings associated

with

the EDSP screening

of soap

salts,

nor

is

it making a complete endangered

species

finding

or

a complete assessment

of effects

to pollinators.

The Agency's

final registration

review decision

for soap

salts

will depend

upon

the results

of

an ESA Section

7 consultation

with

the Services,

an EDSP FFDCA

section

408(p) determination,

and

an assessment

of the non-target

exposure

to bees. V. NEXT

STEPS

AND TIMELINE Interim Registration

Review Decision A final decision

on

the soap

salts registration

review

case

will occur

after

ESA

and EDSP FFDCA

section

408(p) determinations

have

been

made

, as well

as completion

of

an assessment of the non-target

exposure

to bees.

9