UNITED

STATES ENVIRONMENTAL

PROTECTION

AGENCY WASHINGTON,

D.C

. 20460

OFFICE

OF CHEMICAL

SAFETY AND POLLUTION PREVENTION MEMORANDUM DATE: SUBJECT: TO: FROM:

August

21, 2014 Antimicrobial

Division's

Response

to Public Comments

on the Registration Review Preliminary

Work

Plan

for Thiabendazole

(PC Code 060101) Registration

Review

Docket Docket Number: EPA-HQ-OPP-2014-0175 www.regulations.gov

**£~** Thao Pham, Chemical

Review Manager

**~ ~**  James Parker,

Acting

Team Leader

-;;:/£- ..,/;c,t--- Regulatory Management

Branc

I Antimicrobials

Division Najm Shamim,

PhD, Chemist

**~~**

,_.,......., **~** Timothy Leighton,

Senior **Hum~eal)h**

**ientist**

\ .-.-- William Erickson,

Biologist

?h/f-.___

..

,

.

, Patricia Jennings,

Senior

Enviro

**ental Eng~·** 

eer **~ ~~**  Srinivas

Gowda, **Microbiologist~~~-v**

.... **~** Nathan

Mottl, Biologist

**AI~**

vwvr1

!"' Jenny

Tao, Toxicologist

**~** Risk Assessment

and Science

Support

Branch Antimicrobials

Division THROUGH: Lance Wormell,

Chief Regulatory Managemen

Branch

II Antimicrobials

Division On March

28, 2014

EPA opened

a 60-day

public comment

period

on the preliminary

work

plan (PWP)

for

the registration

review

of thiabendazole.

The comment

period

ended

on May

27, 20.14. During

the public comment

period

the agency received

two comments

for

the antimicrobial

uses

of tlll.abendazole.

The comments

received

did result

in

a modification

to the anticipated

data needs

in the Thiabendazole

PWP.

1Thepurposeofthismemorandumistoaddressthesecomments.TheAntimicrobialsDivision(AD)generallyusesanoutlineformattoaddressthecomments(withnameofsubmitter,commentandADresponse,inthatorder).Commentsaresummarizedbelow.1.LuanneJeram,LanxessCorporationComment:TestsubstanceforIndoorresiduestudy(875.2300):Submitterinquiredwhichsurfaces/surfaceresidueswillbecoveredbythestudyreferenced.ADResponse:Theindoorresiduedata(875.2300)isanORE(occupationalandresidentialexposure)study,asindicatedbythetableonpage7ofthePWP.Howeverthespecificusesthatrequirethisdata(e.g.,carpets)werenotfootnotedinthetable.Thetableonpage12ofthePWPindicatesthatthestudyforindoorresidueisbasedonthecarpetuse.Onpage10,thefirstbulletindicatesthattheusesforcarpetsmustbeclarifiedastowhethertheuseistotreatcarpetbackingonly.Ifthatisthecase,thennodataarerequired.However,iftheplushofthecarpetistreatedthenaresiduestudyisneeded.Note:Ifnorisksofconcernaredeterminedat100%residuetransfer,adatawaiverrequestwouldbegranted.2.LuanneJeram,LanxessCorporationComment:TestprotocolforSpecialStudy,Non-guideline(Leachingfromtreatedtextiles):Submitterinquiredifthespecialstudywouldbeamigration_orleachingtypetestandifdatadevelopedfromaEuropeanlaboratorytestmethod(EN16105)wouldbeacceptabletosatisfytherequirement.Inaddition,thesubmitteraskedifanyothertestmethodsandprotocolsarerecommendedbytheagency.ADResponse:Theleachingfrom treatedtextiles(i.e.,clothing)iscapturedonpage7asa"specialstudy,non-guideline".Theagencyusedthisclassificationuntilrecently,butnowclassifiesthetextileleachingstudiesas875.2300.FortheFinalWorkPlantheagencyplanstochangethetextilestudyto875.2300andalsolistthetwostudiesinthetable(i.e.,carpetplushandclothing).Theagencyrecommendsthatthedatasubmitterprovideaprotocolforreviewpriortoconductingastudy.Theagencyisavailabletodiscussprotocolsasneeded.Belowaretotwoexamplesofleachingprotocolsthatareavailableonline.http://pubs.acs.org/doi/abs/10.10211es4015844http://publicationslist.org/data/nowack/ref-126/Lorenz%20%282012%29.pdf2