WPC N@B0'ډɑ+F2S̤u֔_yUaUU=;BO@Wǖ H/2INRZsƋ6Ȓl={[jt>6wN %A 0:GNj^ w4  m"U9>9U@wHP LaserJet 4 Plus,,,,,,0(9 Z6Times New Roman RegularX($USUS.,questions to address.wpd  '  0 .   L1cSg(:i+003|xU\  `&Times New Roman(O Z(Times New Roman !USUS.,  _ Xd#XXX-XXd#_SolicitationNumber:EPA/ORD/NHEERL/ETD/04001#Xd#X-_#-XXd##--@#--  Title:ExploringBodyBurdensofPolybrominatedDephenylethers(PBDEs)and#Xd#X-#-XXd##--!#--  ProjectOfficer:JanetDilibertoThisisanamendmenttoSolicitationNumber:EPA/ORD/NHEERL/ETD/04001#--#--#Xd#X-#-XXd#.    #Xd#X-#vXXd##Xd#Xve# 1)#Xd#XXXd##Question: Hasthe$200,000anticipatedforthefirstyearbeenconfirmed? v   XbXXXd# Answer:#Xd#XX Xb4#Ԁ Ofthisamountofmoney,only$105,000isconfirmedforthefirstyear.Thefunding R  forthesecondandthirdyearsisdependentupontheavailabilityoffunds.Thishasbeenstatedonpage2under AnticipatedFunding . B   2)Question: Isthereaparticulartypeofapplicantthatismorecompetitiveoverothers?  Z  XbXXXd# Answer:#Xd#XX Xb #Ԁ Thisisanopencompetition,asstatedonpage2under EligibleApplicants . 6  3)Question: Whatawardamountshavebeenofferedinpreviousyearsofcompetition,ifthe  amountshavediffered? XbXXXd# Answer:#Xd#XX XbQ#Ԁ Toourknowledge,thisisanewprojectandtherearenopreviousawardamountsthat  havebeenoffered. 4) Question: Istherealistofpriorawardrecipients? R  XbXXXd# Answer:#Xd#XX Xb|#Ԁ Thisisthefirsttimethisprojecthasbeensolicited. . ~  5)Question: DoyouadviseapplicantscontactyouorMargaretMannbeforesubmitting  #Z  applications? XbXXXd# Answer:#Xd#XX Xb #Ԁ ItisnotnecessarytocontactMargaretMannorJanetDilibertobeforesubmitting %"!# applications. XbXXXd# 6)#Xd#XX Xbc #ԀQuestion:  XbXXXd#Questionsconcerningthecohortofwomentobestudied: )$' Astheproposaliswritten,thewomentobestudiedhavealreadybeencharacterizedre:PBDElevels;and,thiswouldlimitthenumberofapplicantsasthecohortwouldthusbealreadyestablished#Xd#XX Xb # XbXXXd#.Isthisso?Dowewanttheapplicanttohaveanalreadycharacterizedpopulation ~,'* whichwillbeusedforfurtherresearch?#Xd#XX Xb # XbXXXd#ԀIfnot,thenisittheintentionoftheproposalthatthe n-(+ applicantcouldgathersamplesandthencharacterizethem? -), Ї Answer:#XDXX XD#Ԁ  XDXXXDAnalreadycharacterizedpopulationisneededforfurtherresearchasstatedinthe  _RFIP_.Anapplicantcouldgathersamplesandthencharacterizethemforlevelsof_PBDE_Ԁusing  thecriteriaof#XDXX XD#firsttimemothersintheirsecondtoeighthweekoflactation XDXXXD,buttheapplicant  mustprovidehis/herfundingfromanalternatesourcetoconductthiswork. x  7)#XDXX XD7#Questions:  XDXXXDLongitudinalstudycomponent(page7):3relatedquestions. <   A. Bythetimetheprojectstarts,manywomenintheexistingcohortwithmeasuredlevelsmay , | havestoppedbreastfeedingor,iftheycontinuedbreastfeeding,alreadysignificantlyreduced  l theirbodyburdens.Wouldn'titmakemoresensetorecruitnewadditionalparticipantsforthe  X  longitudinalstudy?  D   Answer toQuestion7A#XDXX XD# XDXXXD:#XDXX XDT#Ԁ  XDXXXDIfatthestartofthestudytherearenowomenintheexistingcohort   withmeasuredlevelsbreastfeeding,thenitwillbenecessarytorecruitnewadditional   participantsforthelongitudinal(offloadingof_PBDEs_Ԁvialactation#XDXX XD# XDXXXD)partoftheproject.#XDXX XD#Ԁ XDXXXD    B. WehavethelargestongoingstudyofbreastmilkfromtheUSAforbrominatedflame l retardants.Wehaveover60analysescompleteatthistime.Your_RFIP_Ԁrequiresthewomento \ stillbenursingsoserialmilk_PBDE_Ԁandother_BFR_Ԁcanbeobtainedtodeterminedecreaseifany H overtime.SincethetypicalmotherintheUSAdoesnotnursebeyond3monthsthispresentsa 4 majorproblem.Canwerecruitnewpersonswhoplantonurselongerandthusqualifyforyour  p study?#XDXX XDh# XDXXXD  \  Answer toQuestion7B#XDXX XD_# XDXXXD:#XDXX XD#Ԁ 󀀀 XDXXXDIfitisnecessarytorecruitnewadditionalparticipantforthestudy 4 onoffloadingof_PBDEs_Ԁvialactation,thenitmaybepossibletorecruitnewparticipantswho $ plantonurselonger.  Ѐ C.#XDXX XD"#  XDXXXDSincewehaveevidenceofaslowdecreaseinmilkandorblood_PCDD_/_Fs_,_PCBs_Ԁinmother  withnursing,withgradualincreaseafternursingendswithintakeofnewcompoundsindiets t  woulditnotprovidemorescientificdataofinterestbyfindingmotherswhoplannedtonursefor `! longperiodsoftime,farinexcessofthefewmonthstypicalofUSmothers,andfollowtheir L"  milkandbloodlevelstohavepartitioninginformationallowingextrapolationbetweenbloodand 8#! milkandalsoadeterminationofdecreaseinlevelsoverlongtimeperiodsratherthanselecting $$t" mothersalreadysampledwhoarenotlikelytonurseverymuchlonger?#XDXX XD# XDXXXD %` #  AnswertoQuestion7C:#XDXX XD# 󀀀Focusofthe_RFIP_Ԁisonbreastmilk,urine,andhousedust,andnot &8"% blood.Alongtermstudyasaddressedinquestion7Cwouldbeveryinformative,butthe '(#& fundinginthisproposalislimited.Ifapplicantscanshowthattheycanperformbloodstudiesas ($' wellasbreastmilk,urine,andhousedustasproposedwithintheapprovedbudget,theycan )%( includeitintheirproposalortheycanprovidetheirownfundingforbloodstudies. XDXXXD *%)  8) #XDXX XD!# Questions:  XDXXXDLocationoflaboratory(page14):3relatedquestions. `-(,  A. Doescriteria2meanthatthelaboratoryanalyzingthe_PBDEs_Ԁmustbelocatedinornearthe  areawheretheparticipantsreside?Ifso,why?Someofthebestlaboratoriesintheworld  (particularlyfor_deca_Ԅ_PBDE_)areinEurope.#XDXX XD/"#Ԁ   B. Whatscientificjustificationcantherebeforwantingthelaboratoryanalyzingbrominated d flameretardantstobegeographicallyneartheresearchsubjects? T   XDXXXD C. OurteamhaspublishedtheonlyarticleonbrominatedflameretardantsinUSnursing , | mothersmilkinapeerreviewedpublication.Asisourcustom,wesendthefrozenspecimensto  l thebestlaboratorywithgoodturnaroundtimeandgoodprice.Kindlyletusknowwhythisisnot  X  allowedunderthetermsofthe_RFIP_?#XDXX XD%#  D   XDXXXD AnswertoQuestions8A,B,andC:#XDXX XD'#Ԁ Intheapplicantsproposal,theapplicantcanaddressthis   issueoflocationoflaboratoryanddocumentwhythisisnotimportantandwhyanother   laboratoryinadifferentareathatcanperformedtheworkasspecifiedinthesolicitationneedsto   beconsidered.    XDXXXD#XDXX XD(# XDXXXD 9)#XDXX XD)#Question:  XDXXXDCanwedoastudyonpartitioningbetweenmilkandbloodfromthesamemothers X todeterminethepartitioningratio?Andthenusebloodmeasurementsafternursingisoverto H estimatedecreaseinbodyburdenfromnursing? 4 #XDXX XDu)# XDXXXDԀ  p  Answer:#XDXX XD*# Thefocusofthis_RFIP_Ԁisonbreastmilk,urine,andhousedust.Thepartitioning  \ betweenmilkandbloodandthedeterminationofpartitionratiosisnotpartoftheproposed L study.  XDXXXD 8 #XDXX XD;,# XDXXXD 10)#XDXX XD,#Question:  XDXXXDCanwomennotnursingforthefirsttimebeincludedinthestudy?Ifnot,whatis  therationaleforthisdecision?  #XDXX XD,# XDXXXDԀ  #XDXX XD-# XDXXXD Answer:#XDXX XD".#Ԁ Usingonlywomennursingforthefirsttimeisimportantbecause_multipara_Ԁwomen t  mayinitiallyhadhighlevelsof_PBDEs_Ԁintheirbreastmilkfromprevious_nursings_Ԁwhichare d! nowmuchlower. XDXXXD P"   11) #XDXX XD/# Question:  XDXXXDSincealmostno_BFR_Ԁcanbeexpectedinurineatmeasurablelevels,canthispart %d # beconsideredaseparatepartofthestudywithbloodandormilkaswellasurinecollectedfrom &T!$ asubsetofasmallnumberofmotherstosatisfytheconditionsofyour_RFIP_? &@"% #XDXX XD-0# XDXXXDԀ ',#&  Answer:#XDXX XD1#Ԁ Wedontknowifthisistrueaboutnomeasurablelevelsof_BFR_Ԁintheurine.The ($' levelsinurinemayvaryfromwomantowoman.Measurementof_PBDEs_Ԁinurineisnecessaryto )%( understandwhether_PBDE_Ԁlevelsinurinecorrelatewithbodyburdensasmeasuredinbreast *%) milk. XDXXXD +&*  h-(, #XDXX XD3# XDXXXD 12) #XDXX XDl4# Question:  XDXXXDSincemilkfromwomeninallregionsstudiedtodateintheUSAhasbeen  consistentlyshowntohavemuchhigherlevelsof_PBDEs_Ԁthanfromotherlocationsworldwide  cananygeographicallocationintheUSAqualifyforthestudy?  #XDXX XD4# XDXXXDԀ x #XDXX XDL6# XDXXXD Answer:#XDXX XD6#Ԁ Asstatedintheproposal , acohortofwomenlivinginageographicalareawherehigh d levelsof_PBDEs_Ԁhavebeendocumentedandpreviouslyreportedcanqualifyforthestudy.  XDXXXD T   #XDXX XD7# XDXXXD 13) #XDXX XD;8# Question:  XDXXXDSincemarketbasketsurveysfindthehighestlevelsof_PBDEs_ԀintheworldinUS  h food,couldfood_BFR_Ԁanalysesandestimatedintakebeincludedinthestudy?Ifsowoulditnot  X  beadvisabletocontinueanongoingstudytomaximizetheN?Ourstudy,theonlyUSstudyina  D  peerreviewedjournalpublishedtodate,nowhasanalysesof48USfoodsamplesandis 0  continuingwithmoneyforanalysestheonlylimitation.Woulditbescientificallyadvisableto   continueandaddtothismarketbasketsurveytomakeitmorerepresentativeoftheUSfood   intakeof_BFR_Ԁsincefoodisalmostcertainlythemajorrouteofexposure?   #XDXX XD8# XDXXXDԀ   #XDXX XD4<# XDXXXD Answer:#XDXX XD<#Ԁ Thisstudydoesrequireviadietaryandlifestylesurveysinformationondietary | practicesinthecohort.Marketbasketsurveysarenotthefocusoftheproposal.However,ifthe l applicantwantstofindanalternatesourcetofundastudysuchasthis,thenthatwouldcertainly X addimportantdatatoamarketbasketsurvey. XDXXXD D #XDXX XDa># XDXXXD 14)#XDXX XD>#Question:  XDXXXDWhiledustisofinterestandwehaveinpressavacuumsampleandcomputer X wipesample_PBDE_Ԁarticleshowingtherearelevelsof_PBDEs_Ԁinthesesubstances,thelevelsand H patternsindustseemsuchthatitisnotprobablethatthereisasubstantialcontributionfromthese 4 tohumansandhencehumanmilk.Isitnotawasteofvaluableresourcestodomorethanasmall   numberofsuchanalyses,especiallysincethecostofanalysesisabout$500each?#XDXX XD?# XDXXXD   #XDXX XDA# XDXXXD Answer:#XDXX XDB#Ԁ The_RFIP_Ԁcallsforanalysesofhousedustandurineinwomenwithhighandlow  levelsof_PBDEs_Ԁinbreastmilk.Testinghousedustofwomenwhosebreastmilkhasalready  beencharacterizedfor_PBDEs_Ԁisimportantinassessingthepossibleroutesofexposureto_PBDEs_ p  andwhetherlevelsindustcorrelatewithbodyburdens.Intheapplicantsproposal,theapplicant \! canaddressanddocumentthecostofanalysesandtheuseofanappropriatenumberofsamples H"  tofulfilltheobjectivesofthe_RFIP_. XDXXXD 4#! #XDXX XDNE#  XDXXXD#XDXX XDE# XDXXXD 15)#XDXX XDE#Question:  XDXXXDWoulditnotbeasusefulormoresotomonitorfecesinadditiontourinewere %H!$ anymonitoringtobedoneinadditiontomilkandorblood?#XDXX XDGF# &8"%  XDXXXD Answer:#XDXX XD>G# 󀀀Thecollectionandanalysisoffecesisnotpartofthisproposal.Thefocusofthis ($' _RFIP_Ԁisonbreastmilk,urine,andhousedust.Obviously,ifadditionalfundingispossible,then )%( food,feces,andindooraircharacterizationswouldbeuseful.  *%)