The URL can be used to link to this page

Home My WebLink AboutDEQ-CFW_00013611From: 8ehLBetsy[Behi8etsyv@epa.gov Sent: 7/7/201710:34:24PW To: Risen, Amy ][/o=ExchangeLabs/ou=ExchangeAdministrative Group (FYD|BOHFI]3PDLT)/cn=Kecipients/cn=f7ZO96b57eeQ47cOaI3f73dZ05edfe86-ajrisen];AudraHenry [ateI@cdcgmv]; Wheeler, John [Wheeler.John@epa.gov]; Mitchell, Ken [Mitchell.Ken@epa.gov]; Strong, Jamie [StronXJamie@epa.gov];Henry, Ta|a[Henry.Ta|a@epa.gov];8ehrsing,Tracy [behrsinX.tracy@epa.gov];Benson, Amy [8enson.Amy@epa.gov];Aubee,Catherine [Aubeelatherine@epa.gov];Kemker,Carol [KemkerIaro|@epa.gov];A||enbach,Becky [AUenbach.Becky@pepa.Xov];Doa,Maria [Doa.K8aria@epa.gov];Mort, Sandra L[/o=ExchangeLabs/ou=[xchangeAdministrative Group (FY08OHF23SPDLT)/cn=Redpient$cn=1cl1a1bcef744d6a9bc3fca47f74Odf7'dmnrtl]; SheheeK8ina [/n=ExchanDeLabs/nu=ExchangeAdministrative Group (FY08OHF23SPDLT)/cn=Redpient$cn=e72b9b373955417O9f2a93d971ca3]91'mwshehep];Dittman,[|izabeth [/n=ExchanDeLabs/nu=ExchangeAdministrative Group (FY08OHF23SPDLT)/cn=Redpient$cn=6ce67eac872242O389d9d84Z3e74adal-pdittman];Ho|t,Kennpdy [/n=ExchanDeLabs/nu=ExchanDeAdministrative Group (FY08OHF23SPDLT)/cn=Redpient$cn=d7e0f51aa27b4f b897]bdGa067l1O77-kho|tl];Lang|eKRick [/n=ExchanDeLabs/nu=ExchangeAdministrative Group (FYD|BOHF23SPDO)/cn=Recipient$cn=Da98ffo6Ie26427O879Z2ca]cG15G8O2-r|ang|ey];8rovmr,Connie [/o=ExchungeLabs/ou=ExchangeAdministrative Group (FYD|BOHF23SPDO)/cn=Recipient$cn=7ee8db84d95G4]1c9a1f7D1f5597buG2-cubrovver];Cu|pepper,Linda [/o=ExchungeLabs/ou=ExchangeAdministrative Group (FYD|BOHF23SPDO)/cn=Recipient$cn=73d475cbue324a29687e1711dc9u79c5'|mcu|pepper];Holloway, Tracey 5 [/o=ExchungeLabs/ou=ExchangeAdministrative Group (FYD|BOHF23SPDO)/cn=Recipient$cn=]473a494c10u46298u414f94G4cubc5b-tshoUoway];Donohue`]oyce [Don ohueJoyce@epa.gov] CC: Tina Forrester [txf5@cdc.gov]; Susan Moore [sym8@cdc.gov]; Selene Chou [cjc3@cdc.gov]; Trent LeCoultre [t117@cdc.gov];idz7@Pcdc.Xov Subject: RE: 6enXRisk Assessment Knowledge Gaps From: Risen, Amy J [naiho:Amny.Riuen@dhhsoc8ov Sent: Friday, July O7,JO176:17PK4 To: AudraHenry <ate1@cdc.gov>;Wheeler, John <VVhee|erJohn@epa.gov>; Mitchell, Ken <K8kche|iKen0Depa.Bov>; Beh|,Betsy <BehiBetsy@epa.guv>; Strong, Jamie «Strun8Jamie@epa.8ov>;Henry, Ta|a<HenryJa|a@epa.8uv>; 8ehrsin8,Tracy xbehrsing.tracy@epa.8ov>;Benson, Amy <Benson.Amy@epa.8ov>;Aubee,Catherine <AubeeIatherine@epa.8ov>;Kemker,Carol <KemkerIaro|@epa.8ov>; A||enbach,Becky <A||enbach.8ecky@epa.8o«~; Doa,Maria <Doa.Maria @epa.gov>; Mort, Sandra L«uandy.mort@nodenr.guv>; Shehee, Mina <mina.shehee@dhhs.nc.gov>; Elizabeth Dittman <Beth. Dittman @dhhs. nc.gov>; Holt, Kennedy <Kennedy.Ho|t@dhhsoc.8ov>;Langley, Rick <rick.|an8|ey@dhhs.nc.8ov>;cunniebrovver@ncdenr.8ov; Culpepper, Linda <|indazu|pepper0Dncdenr.8ov>;Holloway, Tracey S <Tracey.HoUow/ay@ncdenr.8ov>;Donohue, Joyce <DonohueJoyce@epa.Bov> Cc: Tina Forrester «txfS@cdc8ov>;Susan Moore <sym8@cdc.8ov>; Selene Chou «cjc3@cdc8ov»;Trent LeCou|tre ^t||7@cdc.8ov>;idz70Dcdc.gov Subject: RE: GenXRisk Assessment Knowledge Gaps Thank you to everyone for providing feedback on our risk assessment for GenX. I'm providing a summary below, which includes points ofcontact to hz||oxv up with. Questions 1'4m/ere posed by DHH8 before the call as main talking points. Text in blue is a summary ofthe comments. N[ DHHS makes every attempt to follow the approach used by the EPA when doing risk assessments. Therefore, we have underlined blue text as take home messages that DHHS will be applying tothe GenX risk assessment for NC residents using drinking water originally referenced in Sun et al 2016. DHHS intends to respond to the public with a new drinking water level and health guidance early in the week of July 101h. We are hopeful that you will be able to provide feedback on cancer and fish consumption ASAP; please see number 5 below for details. | am also interested in data we discussed on interspedes kinetics differences. OEQ-CFVV_00013611 1) Animal toxicity studies and the point of departure (POD): Sufficient data was available to lower the POD NOAEL to 0.1 mg/kg/day (subchronic toxicity test OECD 407 with mice). An uncertainty factor of 10 will be applied for subchronic to chronic extrapolation a, We have consensus that the POD of 0.1 m k /da will also be us the EPA Risk Assessment Division (.R&P.)..fprjsk assessment of GenX. b, Joyce Donohue, Tracy Behrs|n8&AmyBenson requested that toxicological effects andendpoint descriptions be, strengthened so we can be rnone specific about the effects associated with NOAELs and PODstbat are.,. referenced during the ;bkassessment. c It was noted that PODs on the ECHA dossier are selected and reported by chernical rnanufacturer rather than the [[HA. J) Routes of exposure and the relative source contribution (RSQ People may be exposed to GenXdhrough routes other than drinking water. The typical value used for RSC in risk assessment of organic chemicals is 0.2, and this iuthe value used bythe EPA for their evaluation ufPFOAand PFOSdrinking water health advisories. �A��Lu—est a, EPA BAD has not evaluated RSC for drinking water exposures to GenX because drinking water was not previously thought tobearoute ofexposure tothis chemicai b, EPA OST4C14 did use 20% RSC for PFOA and PFOS due to obiquitow.-, presence in the environmentand uncertainty about amountsofthese chemicals reaching people through the different exposure routes, o, EPA OSTRAP-uses 100% RS[vxhen looking at exposures to the infant age group. & DHHS intends to use 20% RSC based on the EPA decision tree for deriving water � uality criteria (EPA - new EPA RAGS supplement (OSWER Directive 9200,1-1201_ 3) Risk assessment method and interspecies uncertainty factor: The default value for interspeciesvahabi|ityof1D is likely to underestimate the toxicity of GenX to humans. We present the EPA method used to extrapolate a human equivalent dose (HED) for PFOA and PFOS in this document. Interspecies uncertainty modeling for PFOA and PFOS yielded a calculated factor of 140 to 71OX for kinetics differences and an additional 3X was allocated for other variability across species. The total uncertainty accounted for across species by EPA for PFOA and PFOS was calculated byDHHSand the maximum was 2,1OOX. X. m.QHHS understands that EPA R D-curre t! intends to us ..a.UF for their risk assessment for b. EPA� While human PFOS & PFOA clearance rates are slower in humans than test anirrals, interspecies kinetics variability isnot expected tnoccur at the. sanoemagnitude for GeoX,Tbe»uppo;ting infonnadoo comes from a comparison of the clearance rates for branched vs linear PFOAs, in which branched isorners Fire cleared faster., GenX is branched and so would be predicted to clear faster, i QHHSrequests references oncomparison ufbranched vslinear PFOAs renal transfer proteins used, and any additional inforn:ation helpful in reviewing the prediction of the interypecies variability expected for GenX, Follow up discussions will go through.lc)yce Dcmohue., Catherine Aubree^and Jaime Strong aspoints ofcontact, c. Additional UEswere discussed, including, the uu6chronicbuchronic extrapolation. EPA RADdoes riot use aUF�S part of its typical procedure, DHHS explained our goal to be protective of public health over aUfetimeofexposure. EPA explained that EPA IRIS procedure does focus more on lifetime OEQ-CFVV_00013612 6. Questions were raised regarding EPA's current review of the Gen% consent order and associated risk assessment; now that a release to a water source is known,, will the riskassessrnent include a public drinking water level? 4) Drinking water concentration guidance for other PFECAs: The Sun et al 2016 publication identified not only GenX, but also other perUuoroa|ky| ether carboxylic acids (PFE[As) present in the Cape Fear River and local drinking water in 2013 and 2014. Quantification of the concentrations of other PFECAs was not possible due to the lack of analytical chemistry standards, however some PFECAs may have been present at concentrations 15 times higher than 6enX. Presumed high concentrations are prompting questions about drinking water safety, however notoxicity data isavailable for these PFECAs. a. Maria Doa and Catherine, Aubree will review the PFECAs chemical structures to see if general advice can be given on how much we can read across health conce.rns frorn PFOA and PFOS. It: isnot within the scope of their work on GenX to review PFECAs at this time and it is understood that guidance along these lines may be|imited. Amy RiyennviUprovide the suppiementaidocumentfor Sun eta|toclarify the PF[CAs|nquestion, 5` Additional questions raised incall a, FishConsumphon� i. DHHS� The public is asking about safety offish consurr.ption. Can the EPA rnake any ;e000nmen dations? [PA�TheEPA does not expect GenXtubioaccumu|ate,Thereissome data onconcentrations |n fish frorn documents that are confidential,. as well as some non-confidentia-1 da-ta� 1- The. DHHSspoke with Tala Henry after the call for clarification, She explained that the BCF reported by Hoke et @12016 is low enough as to not typically warrant additional fish ccmsurnptions studies, EPA will follow up Monday vM:h a staternent with the appropriate caveats, for the unknowns of ernerging chemicals and limited data, b. Cancer Risk Assessment: L DHHS�ThepubUcdmnooenoedaboutthedskofoaooerfnonoGenX.VVehaveUmiteddata,but can the EPA suggest oway 10convey the risk ofcancer? ii EPA�Joyce Donohue will review the raw data fron) OECD 4S3 to deterrnine if the notes on the rate ofoccurrence for liver necrosis are sufficient to calculate a risk, Amy Risen will provide the raw data, which had beem provided by Chernours. Amy also has raw data for 0ECD 407 GenX testing for rats & mice, ifneeded byanyone inthe group, From: Risen, Amy J Sent: Wednesday, July OS 20177:38PK4 Tb:'AudnaHenn/ ; 'John Wheeler' ;'mitcheU.ken@epa.gov' '8ehibetsy0Depa�ov � 'SLnnngjamie0Depagov ;'Henry.ta|a0�epa.8ov' ;'Behnin8.tracy@epa.gov' '8enson.amy@epa.8ov )Aubee.oathehne@epa.guv ' 'Kemker�caro|��epa��m/ �'AJ|enbachbecky��epa.8ov' ''Doa Maria' 'K4oML Sandra '�hehee ' ' ' ' ' Mina Dittman, Elizabeth ; Holt, Kennedy OEQ-CFVV_00013613 Langley, Brovve�[onnie Cc: 7inaFornester' ''�usanK400re' 'Selene '7rentLeCou|tne' ' ' ' ; 'Rachel Worley' Subject: GenX Risk Assessment Knowledge Gaps NC DHHS has been discussing GenX with both EPA and ATSDR and we really appreciate the help you've been giving us. We'll be holding a conference call tomorrow to talk about the progress we've made on our GenX risk assessment, and talk about knowledge gaps. We'll be asking for rapid feedback within the next week to help inform our risk communications with the public. I've attached a document for you to review with requests for feedback bolded in purple. Thanks so much and talk to you all tomorrow! Amy Risen, PhD Environmental Toxicologist Division Public Health, Occupational and Environmental Epidemiology North Carolina Department ofHealth and Human Services (919)787'5911 office (919)870~4807 fax /\mv.Riomn(Mdbho,nc.00v nnnh��f�m��wtw, OEQ-CFVV_00013614