ÿWPCù  ì"qŸoénë퇺dÍ€¸=.Éí¯Ù “´&¬øµ-+g|Kgšl•²Àd~1Fõ·QU²É+-9ô½u+€Ë5*ƒßú–½ ª.¿Ç"‚~ŽÜÙå¾è`uåe,¯_Ô÷Æ(ÀÚåJ¥=»I>ÍðÞÂí&ê³%s:ác¨šT:»Lwþ§oÍ+…=J“‚8‘è…ØíR~Ó—Dý†‹0¨/BÛª¿ÌüP<›¶ð ¥l;W”?íu,£ªÇ= ¹ÁZ)ùëè7*7ù¾WŒÚ–ò›?ʱœ¼°¡>:_Br -¢t{kHL[ü.= —~WÜ}-ŽØ}QÒТl°Í%X¾MT`„¢p¥÷WÝÇÍ}–JLˆœS<ý%…î拏(Œ’ó2¸|×»”úKѯÄOósÈæwûJ7ï×Èô9cQÎÈE7Œ+Ö8dÃÝ—´òò9ZPÂwËkËöÀû¬9~#ô_hf6iÝó&BÛÿE682CvÞñ;_`é´Ö`•Lv_©eÉ ¯M:GwÖÍ„â%K:ÌϙΠ­Òõ˜új®­㸿 üÔÓ ~òôþBgPáUÂm×ÑÙ %_©ƒûVþ%#ÁU NÇ % 0:U BU 1‡— 72 1‡P 1u× 72L^ ~wŠ4Ž¢± m³ 0UÊ 1‡' 72® Nà 1‡â 72i 1‡› 72" BT T T T T T T T T T 0c– ˜HP LaserJet 4100 PCL 6ÈÈÈÈÈÈÈÈ0(ÈhH  Z‹6Times New Roman RegularX(üœ$¡¡ÔUSUS.,Ôô\  `*Times New RomanTT(ehCEKQW]cioAutoList41.1.1.1.1.1.1.1.1.(UhCEKQW]cioAutoList31.1.1.1.1.1.1.1.3#37=CIQYag­­1.a.i.(1)(a)(i)1)a) i)§†Å.s šnA-ê:i¢Ø+003|x.ÿU‹ÿÀÀÀ(-2†æ$§§Ý ƒüœ!ÝÔUSUS.,ÔÝ  Ý (uhCEKQW]cioAutoList51.1.1.1.1.1.1.1.1.(…hCEKQW]cioAutoList61.1.1.1.1.1.1.1.1.(•hCEKQW]cioAutoList71.1.1.1.1.1.1.1.1. 8Ñ8€#pXXdìXXdì8Ñ(;3£$´´Ô2#ÔÚ  Ú0Ú  Ú.Ô3  Ôà0  àÝ ƒüœ!ÝÔUSUS.,ÔÝ  ÝÔ_ÔÑ€0ÍÑÓÓà  àà ` àà ¸ àà  àà h àà À àà  àà p àà È àBilling€Code:€3510„33„PÐ ° ÐÌDEPARTMENT€OF€COMMERCEÐ `° ÐÌBureau€of€Industry€and€SecurityÐ  ` ÐÌ15€CFR€Parts€742,€745,€and€774Ð À  ÐÌ[Docket€No.€€030523133„3133„01]Ð pÀ ÐÌRIN€€€€€0694„AC70Ð  p ÐÌImplementation€of€the€Understandings€Reached€at€the€June€2002€Australia€Group€(AG)€PlenaryÐ Ð  ÐMeeting€and€the€AG€Intersessional€Decision€on€Cross€Flow€Filtration€Equipment€ð!ð€Chemical€andÐ ¨ø ÐBiological€Weapons€Controls€in€the€Export€Administration€RegulationsÐ €Ð ÐÌAGENCY:€€Bureau€of€Industry€and€Security,€CommerceÐ 0"€  Ðà  à€€€Ð $X" ÐACTION:€€Final€rule.Ð à%0!$ ÐÌSUMMARY:€€The€Bureau€of€Industry€and€Security€(BIS)€is€publishing€this€final€rule€to€describeÐ )à$( Ðthe€understandings€reached€at€the€June€2002€plenary€meeting€of€the€Australia€Group€(AG)€and€toÐ h+¸&* Ðamend€the€Export€Administration€Regulations€(EAR),€as€needed,€to€implement€these€AGÐ @-(, ÐÑ0ÍÑâ âÑ8€8ðXXdìdÈ8Ñâ âÑ  Ñunderstandings.€€This€final€rule€amends€the€licensing€policy€provisions€in€the€EAR€that€apply€toÐ d Ðexports€and€reexports€of€items€on€the€AG€control€list€by€clarifying€several€factors€that€are€amongÐ <Ø Ðthose€used€to€evaluate€license€applications€for€these€AG„listed€items€and€by€identifying€additionalÐ  ° Ðfactors€not€previously€listed€in€the€EAR.€€In€addition,€this€rule€clarifies€the€circumstances€underÐ ì ˆ Ðwhich€BIS€would€deny€license€applications€to€export€or€reexport€these€AG„listed€items.€€All€ofÐ Ä ` Ðthese€changes€are€intended€to€ensure€that€the€EAR€provisions€that€apply€to€AG„listed€items€areÐ œ8  Ðconsistent€with€the€ð ðGuidelines€for€Transfers€of€Sensitive€Chemical€or€Biological€Items,ðð€whichÐ t  Ðwere€adopted€at€the€June€2002€AG€plenary€meeting.Ð Lè  ÐÌThis€rule€also€implements€understandings€reached€at€the€June€2002€plenary€meeting€concerningÐ ü˜ ÐAG€controls€on€fermenters€and€toxins.€€The€control€threshold€for€AG„listed€fermenters€describedÐ Ôp Ðon€the€Commerce€Control€List€(CCL)€is€lowered€from€a€capacity€of€100€liters€or€greater€to€aÐ ¬H Ðcapacity€of€20€liters€or€greater.€€In€addition,€this€rule€adds€eight€new€toxins€to€the€list€of€AG„listedÐ „  Ðhuman€and€zoonotic€pathogens€and€toxins€described€on€the€CCL.Ð \ø ÐÌIn€addition€to€the€AG€plenary€meeting€changes€described€above,€this€rule€implements€an€AGÐ  "¨ Ðintersessional€decision€concerning€cross€(tangential)€flow€filtration€equipment.Ð ä#€  ÐÌThe€rule€makes€corrections€in€four€CCL€entries€that€contain€AG„listed€items.€€One€entry,Ð ”'0!$ Ðcontaining€AG„listed€genetic€elements€and€genetically€modified€organisms,€is€amended€to€correctÐ l)#& Ðerrors€in€the€use€of€the€terms€ð ðorganismðð€and€ð ðmicroorganism.ðð€€Another€entry,€containing€AG„Ð D+à$( Ðlisted€chemical€manufacturing€facilities€and€equipment,€is€amended€to€clarify€the€scope€of€thatÐ -¸&* Ðentryððs€controls€on€certain€valves€containing€nickel€and€nickel€alloys€and€on€agitators€for€use€inÐ d Ðreaction€vessels€or€reactors.€€Two€other€CCL€entries€are€amended€to€clarify€the€licenseÐ <Ø Ðrequirements€that€apply€to€technology€for€the€ð ðdevelopmentðð€or€ð ðproductionðð€of€AG„listed€valvesÐ  ° Ðcontaining€nickel€and€nickel€alloys.€€In€addition,€the€rule€amends€the€AG„based€licensingÐ ì ˆ Ðprovisions€in€the€EAR€to€identify€certain€CCL€entries€that€were€inadvertently€omitted€when€BISÐ Ä ` Ðamended€these€provisions€on€previous€occasions.Ð œ8  ÐÌFinally,€this€rule€updates€the€list€of€countries€that€are€currently€States€Parties€to€the€ChemicalÐ Lè  ÐWeapons€Convention€(CWC)€by€adding€six€countries€that€recently€became€States€Parties:€Ð $À ÐAndorra,€Guatemala,€Palau,€Saint€Vincent€and€the€Grenadines,€Samoa,€and€Thailand.Ð ü˜ ÐÌDATES:€This€rule€is€effective€(òòINSERT€DATE€OF€PUBLICATIONóó).Ð ¬H ÐÌADDRESSES:€Written€comments€should€be€sent€to€Willard€Fisher,€Regulatory€Policy€Division,Ð \ø ÐOffice€of€Exporter€Services,€Bureau€of€Industry€and€Security,€Room€2705,€14òòthóó€Street€andÐ 4 Ð ÐPennsylvania€Avenue,€N.W.,€Washington,€D.C.€€20230.Ð  "¨ ÐÌFOR€FURTHER€INFORMATION€CONTACT:€Douglas€Brown,€Office€of€Chemical€andÐ ¼%X" ÐBiological€Controls€and€Treaty€Compliance,€Bureau€of€Industry€and€Security,€Telephone:€Ð ”'0!$ Ð(202)€482„7900.Ð l)#& ÐÌSUPPLEMENTARY€INFORMATION:Ð -¸&* ЇBackgroundÐ d ÐÌòòA.€Revisions€to€the€EAR€Based€on€the€June€2002€Plenary€Meeting€of€the€Australia€GroupóóÐ  ° ÐÌThe€Bureau€of€Industry€and€Security€(BIS)€is€amending€the€Export€Administration€RegulationsÐ Ä ` Ð(EAR)€to€implement€understandings€reached€at€the€annual€plenary€meeting€of€the€AustraliaÐ œ8  ÐGroup€(AG)€that€was€held€in€Paris€on€June€3„6,€2002.€€The€Australia€Group€is€a€multilateralÐ t  Ðforum,€consisting€of€33€participating€countries,€that€maintains€export€controls€on€a€list€ofÐ Lè  Ðchemicals,€biological€agents,€and€related€equipment€and€technology€that€could€be€used€in€aÐ $À Ðchemical€or€biological€weaponsò ò€ó óprogram.€€The€AG€periodically€reviews€items€on€its€control€listÐ ü˜ Ðto€enhance€the€effectiveness€of€participating€governmentsðð€national€controls€and€to€achieveÐ Üx Ðgreater€harmonization€among€these€controls.Ð ´P ÐÌThis€rule€implements€two€understandings€reached€at€the€June€2002€plenary€meeting€concerningÐ d ÐAG€controls€on€fermenters€and€toxins.€€The€control€threshold€for€AG„listed€fermenters,€describedÐ < Ø Ðin€ECCN€2B352.b€on€the€Commerce€Control€List€(CCL),€is€lowered€from€a€capacity€(i.e.,Ð "° Ðvolume)€of€100€liters€or€greater€to€a€capacity€of€20€liters€or€greater.€€In€addition,€this€rule€adds€theÐ ì#ˆ  Ðfollowing€eight€toxins€to€the€list€of€AG„listed€toxins€described€in€ECCN€1C351.d€on€the€CCL:€Ð Ä%`" Ð(1)€abrin,€(2)€cholera€toxin,€(3)€diacetoxyscirpenol€toxin,€(4)€T„2€toxin,€(5)€HT„2€toxin,€(6)Ð œ'8!$ Ðmodeccin€toxin,€(7)€volkensin€toxin,€and€(8)€viscum€album€lectin€1€(viscumin).€€These€AG„listedÐ t)#& Ðtoxins,€along€with€all€other€items€controlled€by€ECCN€1C351,€require€a€license€for€export€orÐ L+è$( Ðreexport€to€all€destinations,€worldwide.Ð $-À&* ЇThis€rule€makes€conforming€changes€to€the€List€of€Items€Controlled€in€ECCN€1C991€by€revisingÐ d ÐECCN€1C991.d€to€include€medical€products€containing€any€of€the€eight€toxins€that€were€added€toÐ <Ø ÐECCN€1C351.d€by€this€rule.€€In€addition,€this€rule€revises€the€Related€Definitions€paragraph€inÐ  ° Ðthe€List€of€Items€Controlled€by€ECCN€1C991€by€adding€the€AG€definition€of€ð ðvaccine,ðð€whichÐ ì ˆ Ðwas€adopted€at€the€June€2002€AG€plenary€meeting.€€For€the€purpose€of€ECCN€1C991,€ð ðvaccineððÐ Ä ` Ðis€defined€as€a€medicinal€(or€veterinary)€product€in€a€pharmaceutical€formulation,€approved€byÐ œ8  Ðthe€U.S.€Food€and€Drug€Administration€or€the€U.S.€Department€of€Agriculture€to€be€marketed€asÐ t  Ða€medical€(or€veterinary)€product€or€for€use€in€clinical€trials,€that€is€intended€to€stimulate€aÐ Lè  Ðprotective€immunological€response€in€humans€or€animals€in€order€to€prevent€disease€in€those€toÐ $À Ðwhom€or€to€which€it€is€administered.€€ECCN€1C991.a€is€revised€to€conform€with€the€AGÐ ü˜ Ðdefinition€of€ð ðvaccineðð€by€clarifying€the€control€language€to€indicate€that€1C991.a€controlsÐ Ôp Ðvaccines€against€items€controlled€by€ECCN€1C351,€1C352,€1C353,€or€1C354.€Ð ¬H ÐÌThis€final€rule€also€amends€the€EAR€to€ensure€that€the€licensing€policy€provisions€in€the€EARÐ \ø Ðthat€apply€to€AG„listed€items€are€consistent€with€the€ð ðGuidelines€for€Transfers€of€SensitiveÐ 4 Ð ÐChemical€or€Biological€Items,ðð€which€were€adopted€by€the€AG€at€the€June€2002€plenary€meeting.€Ð  "¨ ÐSpecifically,€this€rule€amends€Section€742.2(b)(2)€of€the€EAR€by€clarifying€several€factors€thatÐ ä#€  Ðare€among€those€used€to€evaluate€license€applications€to€export€or€reexport€these€AG„listed€itemsÐ ¼%X" Ðand€by€identifying€additional€factors€not€previously€listed€in€the€EAR.€€The€additional€licensingÐ ”'0!$ Ðfactors€that€are€now€identified€in€the€EAR€include:€€(1)€the€reliability€of€the€parties€to€theÐ l)#& Ðtransaction€(including€previous€licensing€history,€information€on€any€clandestine€or€illegalÐ D+à$( Ðprocurement€activities,€and€the€end„userððs€ability€to€securely€handle€and€store€the€items€to€beÐ -¸&* Ðexported);€(2)€relevant€information€about€proliferation€and€terrorism€activities€(including€thoseÐ d Ðinvolving€any€parties€to€the€transaction);€(3)€the€risk€of€diversion€of€the€items;€and€(4)€theÐ <Ø Ðapplicability€of€other€multilateral€export€control€or€nonproliferation€agreements€(e.g.,€theÐ  ° ÐChemical€Weapons€Convention€and€the€Biological€and€Toxin€Weapons€Convention)€to€theÐ ì ˆ Ðtransaction.Ð Ä ` ÐÌIn€addition,€this€rule€clarifies€the€circumstances€under€which€BIS€would€deny€license€applicationsÐ t  Ðto€export€or€reexport€AG„listed€chemical€and€biological€items.€€Specifically,€this€rule€amendsÐ Lè  ÐSection€742.2(b)(1)€of€the€EAR€to€show€that€where€an€export€is€intended€to€be€used€in€a€chemicalÐ $À Ðweapons€or€biological€weapons€program,€or€for€chemical€or€biological€weapons€terrorismÐ ü˜ Ðpurposes,€it€is€deemed€to€make€a€material€contribution€to€the€design,€development€production,Ð Ôp Ðstockpiling,€or€use€of€chemical€or€biological€weapons.€€Note€that€certain€AG„listed€chemicalsÐ ¬H Ðalso€are€controlled€for€Chemical€Weapons€Convention€(CW)€reasons€and,€therefore,€are€subjectÐ „  Ðto€the€licensing€requirements€and€policies€described€in€Section€742.18€of€the€EAR,€as€well€asÐ \ø Ðthose€in€Section€742.2€of€the€EAR.Ð 4 Ð ÐÌòòB.€Additional€Understandings€Reached€at€the€June€2002€Plenary€Meeting€of€the€Australia€GroupÐ ä#€  Ðthat€Conform€with€Existing€Provisions€in€the€EARóóÐ ¼%X" ÐÌCertain€understandings€reached€at€the€June€2002€plenary€meeting€of€the€Australia€Group€(AG)€doÐ l)#& Ðnot€require€any€regulatory€action€by€the€BIS,€because€they€are€adequately€addressed€by€existingÐ D+à$( Ðprovisions€in€the€EAR.€€These€understandings€are€important€because€they€represent€a€significantÐ -¸&* Ðstep€by€AG€participating€countries€to€further€harmonize€controls€on€AG„listed€items€and€relatedÐ d Ðtechnology.Ð <Ø ÐÌParticipating€countries€in€the€AG€reached€an€understanding,€at€the€June€2002€plenary€meeting,€toÐ ì ˆ Ðcontrol€transfers€of€technology€for€the€ð ðdevelopmentðð€or€ð ðproductionðð€of€AG„listed€dual„useÐ Ä ` Ðbiological€equipment.€€Since€this€technology€currently€is€controlled€by€the€EAR€under€ECCNsÐ œ8  Ð2E001€and€2E002,€this€rule€makes€no€changes€in€existing€EAR€controls€on€such€technology.Ð t  ÐÌThe€AG€participating€countries€also€agreed,€for€the€first€time,€to€establish€AG€controls€on€theÐ $À Ðintangible€transfer€of€information€and€knowledge€that€could€be€used€for€chemical€or€biologicalÐ ü˜ Ðweapons€purposes.€€The€transfer€of€such€information€and€knowledge€currently€is€defined€in€theÐ Ôp ÐEAR€as€ð ðtechnical€assistance,ðð€which€may€take€such€forms€as€instruction,€skills,€training,Ð ¬H Ðworking€knowledge,€and€consulting€services€and€may€involve€the€transfer€of€ð ðtechnical€dataððÐ „  Ð(ð ðtechnical€assistanceðð€is€described€in€the€note€that€follows€the€definition€of€ð ðtechnologyðð€inÐ \ø ÐSection€772.1€of€the€EAR).€€Since€the€EAR€currently€define€ð ðtechnologyðð€(e.g.,€technology€forÐ 4 Ð ÐAG„listed€items)€to€include€ð ðtechnical€dataðð€or€ð ðtechnical€assistance,ðð€this€rule€makes€no€changesÐ  "¨ Ðin€existing€EAR€controls€that€apply€to€the€provision€of€€ð ðtechnical€assistance.ððÐ ä#€  ÐÌFinally,€the€AG€participating€countries€agreed€to€expand€the€license€requirement€for€exports€ofÐ ”'0!$ ÐAG„listed€biological€agents€to€apply€to€all€destinations,€with€an€exception€for€intra„EuropeanÐ l)#& ÐUnion€(EU)€trade.€€In€accordance€with€Section€742.2(a)(1)€of€the€EAR,€these€AG„listedÐ D+à$( Ðbiological€agents€currently€are€controlled€under€ECCNs€1C351,€1C352,€1C353,€and€1C354€onÐ -¸&* Ðthe€CCL€and€require€a€license,€for€CB€(chemical/biological)€reasons,€to€all€of€the€destinationsÐ d Ðindicated€under€CB€Column€1€in€the€Commerce€Country€Chart€(Supplement€No.€1€to€Part€738€ofÐ <Ø Ðthe€EAR),€i.e.,€all€destinations,€worldwide.€€Since€the€EAR€currently€have€a€worldwide€licensingÐ  ° Ðrequirement€for€these€biological€agents,€this€rule€makes€no€changes€in€the€existing€EAR€licensingÐ ì ˆ Ðprovisions€for€these€agents.€€In€addition,€please€note€that€the€EAR€continue€to€require€a€licenseÐ Ä ` Ðfor€reexports€of€U.S.„origin€AG„listed€biological€agents€to€all€destinations,€including€reexportsÐ œ8  Ðamong€EU€member€countries.Ð t  ÐÌòòC.€Revisions€to€the€EAR€Based€on€an€Intersessional€Decision€by€the€Australia€Group.óóÐ $À ÐÌBIS€is€amending€the€EAR€to€implement€an€intersessional€decision€by€the€AG€that€was€made€priorÐ Ôp Ðto€the€June€2002€plenary€meeting.€€Specifically,€this€rule€revises€AG€controls€on€crossÐ ¬H Ð(tangential)€flow€filtration€equipment€by€amending€ECCN€2B352.d€to€lower€the€control€thresholdÐ „  Ðfor€such€equipment€from€a€total€filtration€area€equal€to€or€greater€than€5€square€meters€(5€mòò2óó)€to€aÐ \ø Ðtotal€filtration€area€equal€to€or€greater€than€1€square€meter€(1€mòò2óó).€€In€addition,€this€rule€revisesÐ 4 Ð Ð2B352.d€to€indicate€that€the€ECCN€controls€not€only€cross€(tangential)€flow€filtration€equipmentÐ  "¨ Ðcapable€of€in„situ€sterilization,€but€also€such€equipment€capable€of€being€disinfected€in„situ.€€AÐ ä#€  Ðtechnical€note€is€added€to€2B352.d€to€define€the€terms€ð ðsterilizedðð€and€ð ðdisinfectedðð€and€toÐ ¼%X" Ðdemonstrate€how€the€processes€of€€ð ðdisinfectionðð€and€ð ðsterilizationðð€are€distinct€from€the€processÐ ”'0!$ Ðof€ð ðsanitization.ðð€€This€rule€also€adds€a€nota€bene€(i.e.,€N.B.)€to€2B352.d€that€excludes€reverseÐ l)#& Ðosmosis€equipment,€as€specified€by€the€manufacturer,€from€control€under€this€ECCN.Ð D+à$( ÐÐ -¸&* ÐIn€addition,€this€rule€amends€2B352.d€to€control€cross€(tangential)€flow€filtration€componentsÐ d Ðthat:€€(1)€have€a€filtration€area€equal€to€or€greater€than€0.2€square€meters€(0.2€mòò2óó)€for€eachÐ <Ø Ðcomponent€and€(2)€are€designed€for€use€with€the€cross€(tangential)€flow€filtration€equipmentÐ  ° Ðdescribed€in€2B352.d.Ð ì ˆ ÐÌòòD.€Corrections€to€ECCN€1C353€(Genetic€Elements€and€Genetically€Modified€Organisms)€andÐ œ8  ÐECCN€2B350€(Chemical€Manufacturing€Facilities€and€Equipment).óóÐ t  ÐÌThis€rule€amends€the€heading€and€the€List€of€Items€Controlled€in€ECCN€1C353€to€correct€errorsÐ $À Ðin€the€use€of€the€terms€ð ðorganismðð€and€ð ðmicroorganism.ðð€€The€revisions€to€this€ECCN€that€wereÐ ü˜ Ðmade€in€a€final€rule€published€by€BIS€on€May€31,€2002€(67€FR€37977)€€incorrectly€used€the€termÐ Ôp Ðð ðorganismsðð€in€1C353.a.1€and€.b.1€when€referring€to€ð ðmicroorganismsðð€controlled€by€1C351.a.€toÐ ¬H Ð.c.€€In€addition,€that€rule€did€not€revise€the€heading€of€the€ECCN€to€include€the€term€geneticallyÐ „  Ðmodified€ð ðorganisms.ðð€€This€rule€corrects€these€errors.Ð \ø ÐÌIn€addition,€this€rule€amends€the€heading€in€ECCN€2B350€to€indicate€that€this€entry€does€notÐ  "¨ Ðcontrol€valves€described€in€ECCN€2A292.€€BIS€published€a€rule,€on€August€29,€2002€(67€FRÐ ä#€  Ð55594),€that€revised€the€heading€of€ECCN€2B350€to€exclude€valves€controlled€by€ECCN€2A226;Ð ¼%X" Ðhowever,€an€exclusion€for€valves€controlled€by€ECCN€2A292€was€unintentionally€omitted.€€ThisÐ ”'0!$ Ðrule€corrects€that€omission.€€Valves€controlled€by€ECCN€2A226€or€ECCN€2A292,€which€alsoÐ l)#& Ðmeet€or€exceed€the€technical€parameters€described€in€ECCN€2B350.g,€continue€to€be€subject€toÐ D+à$( ÐCB€controls€(as€well€as€NP€and€AT€controls)€even€though€they€are€not€controlled€under€Ð -¸&* ÐECCN€2B350.Ð d ÐÌThis€rule€also€amends€the€List€of€Items€Controlled€in€ECCN€2B350€to€clarify€that€2B350.bÐ  ° Ðcontrols€only€those€agitators€that€are€for€use€in€reaction€vessels€or€reactors€described€in€2B350.a.Ð ì ˆ ÐÌòòE.€Corrections€to€ðð742.2€(Proliferation€of€chemical€and€biological€weapons)€and€ECCNs€2E001Ð œ8  Ðand€2E002.óóÐ t  ÐÌThis€rule€revises€ðð742.2(a)(3)€of€the€EAR,€which€identifies€ECCNs€containing€items€that€requireÐ $À Ða€license€to€Country€Group€D:3€destinations€for€CB€reasons,€to€include€a€reference€to€medicalÐ ü˜ Ðproducts€controlled€by€ECCN€1C991.d.€€A€reference€to€these€medical€products€was€inadvertentlyÐ Ôp Ðomitted€in€previous€rulemakings.€€ECCN€1C991.d€controls€medical€products€containingÐ ¬H Ðbiological€toxins€controlled€by€ECCN€1C351.d.2€through€.d.19,€except€biological€toxinsÐ „  Ðcontrolled€for€CW€reasons€under€1C351.d.5€or€.d.6.Ð \ø ÐÌThis€rule€also€revises€ðð742.2(a)(3)€of€the€EAR€and€ECCNs€2E001€and€2E002€to€clarify€theÐ  "¨ Ðcontrol€status€of€technology€for€valves€described€in€ECCN€2A226€or€2A292€that€also€possess€theÐ ä#€  Ðcharacteristics€of€valves€described€in€ECCN€2B350.g.€€The€control€status€of€the€valves,Ð ¼%X" Ðthemselves,€was€first€clarified€in€a€final€rule€published€by€BIS€on€August€29,€2002€(67€FR€55594)Ð ”'0!$ Ðand€is€further€clarified€in€this€rule€(see€the€changes€to€the€heading€of€ECCN€2B350,€as€describedÐ l)#& Ðin€Part€D,€Background,€in€the€Supplementary€Information€section€of€this€rule).€€òòFirstóó,€this€ruleÐ D+à$( Ðrevises€ðð742.2(a)(3)€to€clarify€that€ð ðdevelopmentðð€and€ð ðproductionðð€technology€for€valvesÐ -¸&* Ðcontrolled€by€ECCN€2A226€or€2A292€for€CB€reasons€(i.e.,€valves€in€2A226€or€2A292€that€alsoÐ d Ðpossess€the€characteristics€of€valves€described€in€ECCN€2B350.g)€is€controlled€under€ECCNsÐ <Ø Ð2E001€(ð ðdevelopmentðð€technology)€and€2E002€(ð ðproductionðð€technology)€and€requires€a€licenseÐ  ° Ðto€Country€Group€D:3€destinations€for€CB€reasons€ð!ð€note€that€this€technology€also€requires€aÐ ì ˆ Ðlicense€to€certain€destinations€for€NP€and€AT€reasons.€€òòSecondóó,€this€rule€revises€ðð742.2(a)(3)€toÐ Ä ` Ðindicate€that€ð ðuseðð€technology€for€valves€controlled€by€ECCN€2A226€or€2A292€for€CB€reasons€isÐ œ8  Ðcontrolled€under€ECCNs€2E201€and€2E290,€respectively,€and€requires€a€license€to€CountryÐ t  ÐGroup€D:3€destinations€for€CB€reasons€ð!ð€note€that€this€technology€also€requires€a€license€toÐ Lè  Ðcertain€destinations€for€NP€and€AT€reasons.€€òòThirdóó,€this€rule€revises€the€License€RequirementsÐ $À Ðsections€of€ECCNs€2E001€and€2E002€on€the€CCL€to€indicate€that€CB€controls€apply€toÐ ü˜ Ðtechnology€in€these€ECCNs€for€the€ð ðdevelopmentðð€or€ð ðproduction,ðð€respectively,€of€valvesÐ Ôp Ðcontrolled€for€CB€reasons€under€ECCN€2A226€or€2A292.Ð ¬H ÐÌòòF.€Clarifications€to€ECCNs€1C351€and€1C991.óóÐ \ø ÐÌThis€rule€revises€the€heading€of€ECCN€1C351€to€clarify€that€this€entry€controls€certain€zoonoticÐ  "¨ Ðpathogens€and€toxins€that€are€the€causative€organisms€for€a€number€of€zoonoses€(i.e.,€diseases€ofÐ ä#€  Ðanimals€that€may€be€transmitted€to€humans€under€natural€conditions).€€In€addition,€this€ruleÐ ¼%X" Ðrevises€ECCN€1C991.d€to€clarify€that€it€does€not€control€medical€products€containing€botulinumÐ ”'0!$ Ðtoxins€described€in€ECCN€1C351.d.1.€€Medical€products€containing€1C351.d.1€toxins€areÐ l)#& Ðcontrolled€by€1C991.c€for€anti„terrorism€(AT)€reasons€only,€while€the€medical€products€inÐ D+à$( Ð1C991.d€are€controlled€for€both€CB€and€AT€reasons.Ð -¸&* ЇòòG.€Changes€to€the€EAR€Based€on€the€Addition€of€New€States€Parties€to€the€Chemical€WeaponsÐ d ÐConvention€(CWC).óóÐ <Ø ÐÌThis€rule€revises€Supplement€No.€2€to€Part€745€of€the€EAR€(titled€ð ðStates€Parties€to€theÐ ì ˆ ÐConvention€on€the€Prohibition€of€the€Development,€Production,€Stockpiling,€and€Use€ofÐ Ä ` ÐChemical€Weapons€and€on€Their€Destructionðð)€by€adding€the€names€of€six€countries€that€haveÐ œ8  Ðrecently€become€States€Parties€to€the€CWC€(i.e.,€Andorra,€Guatemala,€Palau,€Saint€Vincent€andÐ t  Ðthe€Grenadines,€Samoa,€and€Thailand).Ð Lè  ÐÌÔ‡X8ðXXXÔò òSavings€Clauseó óÐ ü˜ ÐÌShipments€of€items€removed€from€license€exception€eligibility€or€NLR€authorization€as€a€resultÐ ¬H Ðof€this€regulatory€action€that€were€on€dock€for€loading,€on€lighter,€laden€aboard€an€exportingÐ „  Ðcarrier,€or€en€route€aboard€a€carrier€to€a€port€of€export,€on€(òòINSERT€DATE€OF€PUBLICATIONóó),Ð \ø Ðpursuant€to€actual€orders€for€export€to€a€foreign€destination,€may€proceed€to€that€destinationÐ 4 Ð Ðunder€the€previous€license€exception€eligibility€or€NLR€authorization€provisions€so€long€as€theyÐ  "¨ Ðhave€been€exported€from€the€United€States€before€òò(INSERT€DATE€30€DAYS€AFTER€DATE€OFÐ ä#€  ÐPUBLICATIONóó).€€Any€such€items€not€actually€exported€before€midnight,€on€òò(INSERT€DATE€30Ð ¼%X" ÐDAYS€AFTER€DATE€OF€PUBLICATIONóó),€require€a€license€in€accordance€with€this€regulation.Ð ”'0!$ ÐÔ#†X8ðXXX8ðVX#ÔÌÌÐ -¸&* ÐRulemaking€RequirementsÐ d ÐÌà  à1.à ` àThis€rule€has€been€determined€to€be€not€significant€for€purposes€of€ExecutiveÐ  ° ÐOrder€12866.Ð ì ˆ ÐÌà  à2.à ` àNotwithstanding€any€other€provision€of€law,€no€person€is€required€to€respond€to,Ð œ8  Ðnor€shall€any€person€be€subject€to€a€penalty€for€failure€to€comply€with,€a€collection€of€informationÐ t  Ðsubject€to€the€requirements€of€the€Paperwork€Reduction€Act,€unless€that€collection€of€informationÐ Lè  Ðdisplays€a€currently€valid€OMB€Control€Number.€€This€rule€contains€collections€of€information€Ð $À Ðsubject€to€the€requirements€of€the€Paperwork€Reduction€Act€of€1980€(44€U.S.C.€3501€òòet€seq.óó).€Ð ü˜ ÐThese€collections€have€been€approved€by€the€Office€of€Management€and€Budget€under€ControlÐ Ôp ÐNumbers€0694„0088€and€0694„0117.Ð ¬H ÐÌà  à3.à ` àThis€rule€does€not€contain€policies€with€Federalism€implications€as€that€term€isÐ \ø Ðdefined€in€Executive€Order€13132.Ð 4 Ð ÐÌà  à4.à ` àThe€provisions€of€the€Administrative€Procedure€Act€(5€U.S.C.€553)€requiringÐ ä#€  Ðnotice€of€proposed€rulemaking,€the€opportunity€for€public€participation,€and€a€delay€in€effectiveÐ ¼%X" Ðdate,€are€inapplicable€because€this€regulation€involves€a€military€and€foreign€affairs€function€ofÐ ”'0!$ Ðthe€United€States€(Sec.€5€U.S.C.€553(a)(1)).€€Further,€no€other€law€requires€that€a€notice€ofÐ l)#& Ðproposed€rulemaking€and€an€opportunity€for€public€comment€be€given€for€this€final€rule.€Ð D+à$( ÐBecause€a€notice€of€proposed€rulemaking€and€an€opportunity€for€public€comment€are€not€requiredÐ -¸&* Ðto€be€given€for€this€rule€under€5€U.S.C.€553€or€by€any€other€law,€the€analytical€requirements€ofÐ d Ðthe€Regulatory€Flexibility€Act€(5€U.S.C.€601€òòet€seqóó.)€are€not€applicable.Ð <Ø ÐÌà  àTherefore,€this€regulation€is€issued€in€final€form.€€Although€there€is€no€formal€commentÐ ì ˆ Ðperiod,€public€comments€on€this€regulation€are€welcome€on€a€continuing€basis.€€CommentsÐ Ä ` Ðshould€be€submitted€to€Willard€Fisher,€Regulatory€Policy€Division,€Bureau€of€Industry€andÐ œ8  ÐSecurity,€U.S.€Department€of€Commerce,€Room€2705,€14th€Street€and€Pennsylvania€Avenue,€Ð t  ÐN.W.,€Washington,€DC€20230.Ð Lè  ÐÌList€of€SubjectsÐ ü˜ ÐÌ15€CFR€Part€742Ð ¬H Ðà  àExports,€Foreign€trade.Ð „  ÐÌ15€Ô_ÔCFRÔ_Ô€Part€745Ð 4 Ð Ðà  àAdministrative€practice€and€procedure,€Chemicals,€Exports,€Foreign€trade,€Reporting€andÐ  "¨ Ðrecordkeeping€requirements.Ð ä#€  ÐÌ15€Ô_ÔCFRÔ_Ô€Part€774Ð ”'0!$ Ðà  àExports,€Foreign€trade,€Reporting€and€Ô_ÔrecordkeepingÔ_Ô€requirements.Ð l)#& ÐÌÐ -¸&* Ðà  àAccordingly,€Parts€742,€745,€and€774€of€the€Export€Administration€Regulations€(15€CFRÐ d ÐParts€730„799)€are€amended€as€follows:Ð <Ø ÐÌò òPART€742€„€[AMENDED]ó óÐ ì ˆ ÐÌà  à1.à ` àThe€authority€citation€for€15€CFR€Part€742€continues€to€read€as€follows:Ð œ8  ÐÌà  àAuthority:€€50€U.S.C.€app.€2401€òòet€seqóó.;€50€U.S.C.€1701€òòet€seqóó.;€18€U.S.C.€2510€òòet€seqóó.;Ð Lè  Ð22€U.S.C.€3201€òòet€seqóó.;€42€U.S.C.€2139a;€Sec.€901„911,€Pub.€L.€106„387;€Sec.€221,€Pub.€L.€107„Ð $À Ð56;€E.O.€12058,€43€FR€20947,€3€CFR,€1978€Comp.,€p.€179;€E.O.€12851,€58€FR€33181,€3€CFR,Ð ü˜ Ð1993€Comp.,€p.€608;€E.O.€12938,€59€FR€59099,€3€CFR,€1994€Comp.,€p.€950;€E.O.€13026,€61€FRÐ Ôp Ð58767,€3€CFR,€1996€Comp.,€p.€228;€E.O.€13222,€66€FR€44025,€3€CFR,€2001€Comp.,€p.€783;Ð ¬H ÐNotice€of€November€9,€2001,€66€FR€56965,€3€CFR,€2001€Comp.,€p.€917;€Notice€of€August€14,Ð „  Ð2002,€67€FR€53721,€August€16,€2002.Ð \ø ÐÌÌà  à2.à ` àSection€742.2€is€amended€by€revising€paragraphs€(a)(3)€and€(b)€to€read€as€follows:Ð ä#€  ÐÌò òðð742.2€€Proliferation€of€chemical€and€biological€weapons.ó óÐ ”'0!$ ÐÌ(a)€*€€€€€*€€€€€*Ð D+à$( ÐÐ -¸&* Ðà  à(3)€If€CB€Column€3€of€the€Country€Chart€(Supplement€No.€1€to€part€738€of€the€EAR)€isÐ d Ðindicated€in€the€appropriate€ECCN,€a€license€is€required€to€Country€Group€D:3€(see€SupplementÐ <Ø ÐNo.€1€to€part€740€of€the€EAR)€for€the€following:Ð  ° Ðà  àà ` à(i)€Equipment€and€materials€identified€in€ECCN€2B350€or€2B351€on€the€CCL,€andÐ ì ˆ Ðvalves€controlled€by€ECCN€2A226€or€ECCN€2A292€having€the€characteristics€of€those€describedÐ Ä ` Ðin€2B350.g,€which€can€be€used€in€the€production€of€chemical€weapons€precursors€or€chemicalÐ œ8  Ðwarfare€agents;Ð t  Ðà  àà ` à(ii)€Equipment€and€materials€identified€in€ECCN€2B352,€which€can€be€used€in€theÐ Lè  Ðproduction€of€biological€agents;Ð $À Ðà  àà ` à(iii)€Medical€products€identified€in€ECCN€1C991.d;Ð ü˜ Ðà  àà ` à(iv)€Technology€identified€in€ECCN€2E001,€2E002,€or€2E301€for:Ð Ôp Ðà0  àà ` àà ¸ à(A)€The€development,€production,€or€use€of€items€controlled€by€ECCNÐ ¬H Ð2B350,€2B351,€or€2B352;€orЄ (#(# Ðà0  àà ` àà ¸ à(B)€The€development€or€production€of€valves€controlled€by€ECCN€2A226Ð \ø Ðor€2A292€having€the€characteristics€of€those€described€in€ECCN€2B350.g;€andÐ4 Ð(#(# Ðà  àà ` à(v)€Technology€identified€in€ECCN€2E201€or€2E290€for€the€use€of€valvesÐ  "¨ Ðcontrolled€by€ECCN€2A226€or€2A292€having€the€characteristics€of€those€described€in€2B350.g.Ð ä#€  ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ ”'0!$ ÐÌ(b)€òòLicensing€policyóó.€€(1)€License€applications€for€the€items€described€in€paragraph€(a)€of€thisÐ D+à$( Ðsection€will€be€considered€on€a€case„by„case€basis€to€determine€whether€the€export€or€reexportÐ -¸&* Ðwould€make€a€material€contribution€to€the€design,€development,€production,€stockpiling€or€use€ofÐ d Ðchemical€of€biological€weapons.€€When€an€export€or€reexport€is€deemed€to€make€such€a€materialÐ <Ø Ðcontribution,€the€license€will€be€denied.€€When€an€export€or€reexport€is€intended€to€be€used€in€aÐ  ° Ðchemical€weapons€or€biological€weapons€program,€or€for€chemical€or€biological€weaponsÐ ì ˆ Ðterrorism€purposes,€it€is€deemed€to€make€a€material€contribution.€€The€factors€listed€in€paragraphÐ Ä ` Ð(b)(2)€of€this€section€are€among€those€that€will€be€considered€to€determine€what€action€should€beÐ œ8  Ðtaken€on€license€applications€for€these€items.Ð t  ÐÌà  àà ` à(2)€€The€following€factors€are€among€those€that€will€be€considered€to€determineÐ $À Ðwhat€action€should€be€taken€on€license€applications€for€the€items€described€in€paragraph€(a)€ofÐ ü˜ Ðthis€section:Ð Ôp ÐÌà  àà ` à(i)€€The€specific€nature€of€the€end-use,€including€the€appropriateness€of€the€statedÐ „  Ðend„use;Ð \ø ÐÌà  àà ` à(ii)€€The€significance€of€the€export€and€reexport€in€terms€of€its€potentialÐ  "¨ Ðcontribution€to€the€design,€development,€production,€stockpiling,€or€use€of€chemical€or€biologicalÐ ä#€  Ðweapons;Ð ¼%X" ÐÌà  àà ` à(iii)€€The€nonproliferation€credentials€of€the€importing€country,€including€theÐ l)#& Ðimporting€countryððs€chemical€and€biological€capabilities€and€objectives;Ð D+à$( ÐÐ -¸&* Ðà  àà ` à(iv)€The€risk€that€the€items€will€be€diverted€for€use€in€a€chemical€weapons€orÐ d Ðbiological€weapons€program,€or€for€chemical€weapons€or€biological€weapons€terrorism€purposes;Ð <Ø ÐÌà  àà ` à(v)€The€reliability€of€the€parties€to€the€transaction,€including€whether:Ð ì ˆ Ðà0  àà ` àà ¸ à(A)€An€export€or€reexport€license€application€involving€any€such€partiesÐ Ä ` Ðhas€previously€been€denied;Ðœ8 (#(# Ðà0  àà ` àà ¸ à(B)€Any€such€parties€have€been€engaged€in€clandestine€or€illegalÐ t  Ðprocurement€activities;ÐLè (#(# Ðà0  àà ` àà ¸ à(C)€The€end„user€is€capable€of€securely€handling€and€storing€the€items€toÐ $À Ðbe€exported€or€reexported;Ðü˜(#(# ÐÌà  àà ` à(vi)€Relevant€information€about€proliferation€and€terrorism€activities,€includingÐ ¬H Ðactivities€involving€the€design,€development,€production,€stockpiling,€or€use€of€chemical€orÐ „  Ðbiological€weapons€by€any€parties€to€the€transaction;Ð \ø ÐÌà  àà ` à(vii)€€The€types€of€assurances€or€guarantees€against€the€design,€development,Ð  "¨ Ðproduction,€stockpiling,€or€use€of€chemical€or€biological€weapons€that€are€given€in€a€particularÐ ä#€  Ðcase,€including€any€relevant€assurances€provided€by€the€importing€country€or€the€end„user;Ð ¼%X" ÐÌà  àà ` à(viii)€The€applicability€of€other€multilateral€export€control€or€nonproliferationÐ l)#& Ðagreements€(e.g.,€the€Chemical€Weapons€Convention€and€the€Biological€and€Toxin€WeaponsÐ D+à$( ÐConvention)€to€the€transaction;€andÐ -¸&* Їà  àà ` à(ix)€€The€existence€of€a€pre-existing€contract.Ð d ÐÌ(3)€€BIS€will€review€license€applications€in€accordance€with€the€licensing€policy€described€inÐ  ° Ðparagraph€(b)(1)€of€this€section€for€items€not€described€in€paragraph€(a)€of€this€section€that:Ð ì ˆ ÐÌà  à(i)€€Require€a€license€for€reasons€other€than€short€supply;€òòandóóÐ œ8  ÐÌà  à(ii)€€Could€be€destined€for€the€design,€development,€production,€stockpiling,€or€use€ofÐ Lè  Ðchemical€or€biological€weapons,€or€for€a€facility€engaged€in€such€activities.Ð $À ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ Ôp ÐÌò òPART€745€„€[AMENDED]ó óÐ „  ÐÌà  à4.à ` àThe€authority€citation€for€15€CFR€Part€745€continues€to€read€as€follows:Ð 4 Ð ÐÌà  àAuthority:€€50€U.S.C.€1701€òòet€seqóó.;€E.O.€12938,€59€FR€59099,€3€CFR,€1994€Comp.,€Ð ä#€  Ðp.€950;€Notice€of€November€9,€2000,€65€FR€68063,€3€CFR,€2000€Comp.,€p.€408.Ð ¼%X" ÐÌÌà  à5.à ` àSupplement€No.€2€to€Part€745€is€amended€by€revising€the€undesignated€center€Ð D+à$( Ðheading€ð ðList€of€States€Parties€as€of€May€1,€2002"€to€read€ð ðList€of€States€Parties€as€of€April€1,Ð -¸&* Ð2003"€and€by€adding,€in€alphabetical€order,€the€countries€ð ðAndorraðð,€ð ðGuatemalaðð,€ð ðPalauðð,Ð d Ðð ðSaint€Vincent€and€the€Grenadinesðð,€ð ðSamoaðð€and€ð ðThailandðð.Ð <Ø ÐÌò òPART€774€„€[AMENDED]ó óÐ ì ˆ ÐÌà  à6.à ` àThe€authority€citation€for€15€CFR€Part€774€continues€to€read€as€follows:Ð œ8  ÐÌà  àAuthority:€€50€U.S.C.€app.€2401€òòet€seqóó.;€50€U.S.C.€1701€òòet€seqóó.;€10€U.S.C.€7420;€Ð Lè  Ð10€U.S.C.€7430(e);€18€U.S.C.€2510€òòet€seqóó.;€22€U.S.C.€287c;€22€U.S.C.€3201€òòet€seqóó.;€22€U.S.C.Ð $À Ð6004;€30€U.S.C.€185(s),€185(u);€42€U.S.C.€2139a;€42€U.S.C.€6212;€43€U.S.C.€1354;€46€U.S.C.Ð ü˜ Ðapp.€466c;€50€U.S.C.€app.€5;€Sec.€901„911,€Pub.€L.€106„387;€Sec.€221,€Pub.€L.€107„56;€Ð Ôp ÐE.O.€13026,€61€FR€58767,€3€CFR,€1996€Comp.,€p.€228;€E.O.€13222,€66€FR€44025,€3€CFR,€2001Ð ¬H ÐComp.,€p.€783;€Notice€of€August€14,€2002,€67€FR€53721,€August€16,€2002.Ð „  ÐÌà  à7.à ` àIn€Supplement€No.€1€to€Part€774€(the€Commerce€Control€List),€Category€1€„„Ð 4 Ð ÐMaterials,€Chemicals,€ð ðMicroorganismsðð&€ð ðToxins,ðð€ECCN€1C351€is€amended€by€revising€theÐ  "¨ Ðheading€of€the€ECCN€and€the€List€of€Items€Controlled€to€read€as€follows:Ð ä#€  ÐÌò ò1C351€€Human€and€zoonotic€pathogens€and€ð ðtoxinsðð,€as€follows€(see€List€of€ItemsÐ ”'0!$ ÐControlled).ó óÐ l)#& ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ -¸&* Їò òList€of€Items€Controlledó óÐ d ÐÌà  àòòUnitóó:€€ValueÐ  ° Ðà0  àòòRelated€Controlsóó:€€Certain€forms€of€ricin€and€saxitoxin€in€1C351.d.5.€and€d.6€are€CWCÐ ì ˆ ÐSchedule€1€chemicals€(see€ðð742.18€of€the€EAR).€The€U.S.€Government€must€provideÐ Ä ` Ðadvance€notification€and€annual€reports€to€the€OPCW€of€all€exports€of€Schedule€1Ð œ8  Ðchemicals.€€See€ðð745.1€of€the€EAR€for€notification€procedures.€€See€22€CFR€part€121,Ð t  ÐCategory€XIV€and€ðð121.7€for€additional€CWC€Schedule€1€chemicals€controlled€by€theÐ Lè  ÐDepartment€of€State.€€All€vaccines€and€"immunotoxins"€are€excluded€from€the€scope€ofÐ $À Ðthis€entry.€€Certain€medical€products€and€diagnostic€and€food€testing€kits€that€containÐ ü˜ Ðbiological€toxins€controlled€under€paragraph€(d)€of€this€entry,€with€the€exception€of€toxinsÐ Ôp Ðcontrolled€for€CW€reasons€under€d.5€and€d.6,€are€excluded€from€the€scope€of€this€entry.€Ð ¬H ÐVaccines,€ð ðimmunotoxinsðð,€certain€medical€products,€and€diagnostic€and€food€testing€kitsÐ „  Ðexcluded€from€the€scope€of€this€entry€are€controlled€under€ECCN€1C991.€€For€theÐ \ø Ðpurposes€of€this€entry,€only€saxitoxin€is€controlled€under€paragraph€d.6;€other€members€ofÐ 4 Ð Ðthe€paralytic€shellfish€poison€family€(e.g.€neosaxitoxin)€are€classified€as€EAR99.€Ð "¨(#(# Ðà0  àòòRelated€Definitionsóó:€€1.€For€the€purposes€of€this€entry€"immunotoxin"€is€defined€as€anÐ ä#€  Ðantibody„toxin€conjugate€intended€to€destroy€specific€target€cells€(e.g.,€tumor€cells)€thatÐ ¼%X" Ðbear€antigens€homologous€to€the€antibody.€€2.€For€the€purposes€of€this€entry€"subunit"€isÐ ”'0!$ Ðdefined€as€a€portion€of€the€"toxin".Ðl)#&(#(# Ðà  àòòItemsóó:€Ð D+à$( ÐÐ -¸&* Ða.€Viruses,€as€follows:Ð d ÐÌà  àa.1.€€Chikungunya€virus;Ð  ° ÐÌà  àa.2.€€Congo-Crimean€haemorrhagic€fever€virus;Ð Ä ` ÐÌà  àa.3.€€Dengue€fever€virus;Ð t  ÐÌà  àa.4.€€Eastern€equine€encephalitis€virus;Ð $À ÐÌà  àa.5.€€Ebola€virus;Ð Ôp ÐÌà  àa.6.€€Hantaan€virus;Ð „  ÐÌà  àa.7.€€Japanese€encephalitis€virus;Ð 4 Ð ÐÌà  àa.8.€€Junin€virus;Ð ä#€  ÐÌà  àa.9.€€Lassa€fever€virusÐ ”'0!$ ÐÌà  àa.10.€€Lymphocytic€choriomeningitis€virus;Ð D+à$( ÐÐ -¸&* Ðà  àa.11.€€Machupo€virus;Ð d ÐÌà  àa.12.€€Marburg€virus;Ð  ° ÐÌà  àa.13.€€Monkey€pox€virus;Ð Ä ` ÐÌà  àa.14.€€Rift€Valley€fever€virus;Ð t  ÐÌà  àa.15.€€Tick-borne€encephalitis€virus€(Russian€Spring-Summer€encephalitis€virus);Ð $À ÐÌà  àa.16.€€Variola€virus;Ð Ôp ÐÌà  àa.17.€€Venezuelan€equine€encephalitis€virus;Ð „  ÐÌà  àa.18.€€Western€equine€encephalitis€virus;Ð 4 Ð ÐÌà  àa.19.€€White€pox;€òòoróóÐ ä#€  ÐÌà  àa.20.€€Yellow€fever€virus.Ð ”'0!$ ÐÌb.€€Rickettsiae,€as€follows:Ð D+à$( ÐÐ -¸&* Ðà  àb.1.€€Bartonella€quintana€(Rochalimea€quintana,€Rickettsia€quintana);Ð d ÐÌà  àb.2.€€Coxiella€burnetii;Ð  ° ÐÌà  àb.3.€€Rickettsia€prowasecki;òò€oróóÐ Ä ` ÐÌà  àb.4.€€Rickettsia€rickettsii.Ð t  ÐÌc.€€Bacteria,€as€follows:Ð $À ÐÌà  àc.1.€€Bacillus€anthracis;Ð Ôp Ðà  àÌà  àc.2.€€Brucella€abortus;Ð „  ÐÌà  àc.3.€€Brucella€melitensis;Ð 4 Ð ÐÌà  àc.4.€€Brucella€suis;Ð ä#€  ÐÌà  àc.5.€€Burkholderia€mallei€(Pseudomonas€mallei);Ð ”'0!$ ÐÌà  àc.6.€€Burkholderia€pseudomallei€(Pseudomonas€pseudomallei);Ð D+à$( ÐÐ -¸&* Ðà  àc.7.€€Chlamydia€psittaci;Ð d ÐÌà  àc.8.€€Clostridium€botulinum;Ð  ° ÐÌà  àc.9.€€Francisella€tularensis;Ð Ä ` ÐÌà  àc.10.€€Salmonella€typhi;Ð t  ÐÌà  àc.11.€€Shigella€dysenteriae;Ð $À ÐÌà  àc.12.€€Vibrio€cholerae;€òòoróóÐ Ôp ÐÌà  àc.13.€€Yersinia€pestis.Ð „  ÐÌd.€€"Toxins",€as€follows,€and€"subunits"€thereof:Ð 4 Ð ÐÌà  àd.1.€€Botulinum€toxins;Ð ä#€  ÐÌà  àd.2.€€Clostridium€perfringens€toxins;Ð ”'0!$ ÐÌà  àd.3.€€Conotoxin;Ð D+à$( ÐÐ -¸&* Ðà  àd.4.€€Microcystin€(Cyanginosin);Ð d ÐÌà  àd.5.€€Ricin;Ð  ° ÐÌà  àd.6.€€Saxitoxin;Ð Ä ` ÐÌà  àd.7.€€Shiga€toxin;Ð t  ÐÌà  àd.8.€€Staphylococcus€aureus€toxins;Ð $À ÐÌà  àd.9.€€Tetrodotoxin;Ð Ôp Ðà  àÌà  àd.10.€€Verotoxin;Ð „  ÐÌà  àd.11.€€Aflatoxins;Ð 4 Ð ÐÌà  àd.12.€€Abrin;Ð ä#€  ÐÌà  àd.13.€€Cholera€toxin;Ð ”'0!$ ÐÌà  àd.14.€€Diacetoxyscirpenol€toxin;Ð D+à$( ÐÐ -¸&* Ðà  àd.15.€€T„2€toxin;Ð d ÐÌà  àd.16.€€HT„2€toxin;Ð  ° ÐÌà  àd.17.€€Modeccin€toxin;Ð Ä ` ÐÌà  àd.18.€€Volkensin€toxin;€òòoróóÐ t  ÐÌà  àd.19.€€Viscum€Album€Lectin€1€(Viscumin).Ð $À ÐÌà  à8.à ` àIn€Supplement€No.€1€to€Part€774€(the€Commerce€Control€List),€Category€1€„„Ð Ôp ÐMaterials,€Chemicals,€ð ðMicroorganismsðð€&€ð ðToxins,ðð€ECCN€1C353€is€amended€by€revising€theÐ ¬H ÐECCN€heading€and€the€List€of€Items€Controlled€to€read€as€follows:Ð „  ÐÌò ò1C353€€Genetic€elements€and€genetically€modified€organisms,€as€follows€(see€List€of€ItemsÐ 4 Ð ÐControlled).ó óÐ  "¨ ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ ¼%X" ÐÌò òList€of€Items€Controlledó óÐ l)#& ÐÌà  àòòUnitóó:€$€valueÐ -¸&* Ðà0  àòòRelated€Controlsóó:€€Vaccines€that€contain€genetic€elements€or€genetically€modifiedÐ d Ðorganisms€identified€in€this€entry€are€controlled€by€ECCN€1C991.Ð<Ø(#(# Ðà0  àòòRelated€Definitionsóó:€€N/AÐ °(#(# Ðà  àòòItemsóó:Ð ì ˆ ÐÌa.€€Genetic€elements,€as€follows:Ð œ8  Ðà  àa.1.€€Genetic€elements€that€contain€nucleic€acid€sequences€associated€with€theÐ t  Ðpathogenicity€of€microorganisms€controlled€by€1C351.a.€to€.c,€1C352,€or€1C354;Ð Lè  Ðà  àa.2.€€Genetic€elements€that€contain€nucleic€acid€sequences€coding€for€any€of€the€ð ðtoxinsððÐ $À Ðcontrolled€by€1C351.d€or€ð ðsubunits€of€toxinsðð€thereof.Ð ü˜ ÐÌà  àò òTechnical€Noteó ó:€€Genetic€elements€include,€inter€alia,€chromosomes,€genomes,€plasmids,Ð ¬H Ðtransposons,€and€vectors,€whether€genetically€modified€or€unmodified.Ð Œ( ÐÌb.€€Genetically€modified€organisms,€as€follows:Ð < Ø Ðà  àb.1.€€Genetically€modified€organisms€that€contain€nucleic€acid€sequences€associated€withÐ "° Ðthe€pathogenicity€of€microorganisms€controlled€by€1C351.a.€to€.c,€1C352,€or€1C354;Ð ì#ˆ  ÐÌà  àb.2.€€Genetically€modified€organisms€that€contain€nucleic€acid€sequences€coding€for€anyÐ œ'8!$ Ðof€the€ð ðtoxinsðð€controlled€by€1C351.d€or€ð ðsubunits€of€toxinsðð€thereof.Ð t)#& ÐÌÐ $-À&* Ðà  à9.à ` àIn€Supplement€No.€1€to€Part€774€(the€Commerce€Control€List),€Category€1€ð!ðÐ d ÐMaterials,€Chemicals,€ð ðMicroorganismsðð€&€ð ðToxins,ðð€ECCN€1C991€is€amended€by€revising€theÐ <Ø ÐList€of€Items€Controlled€to€read€as€follows:Ð  ° ÐÌò ò1C991€€Vaccines,€immunotoxins,€medical€products,€diagnostic€and€food€testing€kits,€asÐ Ä ` Ðfollows€(see€List€of€Items€Controlled).ó óÐ œ8  ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ Lè  ÐÌò òList€of€Items€Controlledó óÐ ü˜ ÐÌà  àòòUnitóó:€$€valueÐ ¬H Ðà0  àòòRelated€Controlsóó:€€Medical€products€containing€ricin€or€saxitoxin,€as€follows,€areÐ „  Ðcontrolled€for€CW€reasons€under€ECCN€1C351:Ð\ø(#(# Ðà0  àà ` à(1)€Ricinus€Communis€AgglutininòòIIóó€(RCAòòIIóó),€also€known€as€ricin€D,€or€RicinusÐ 4 Ð ÐCommunis€LectinòòIIIóó€(RCLòòIIIóó);Ð "¨(#(# Ðà0  àà ` à(2)€Ricinus€Communis€LectinòòIVóó€(RCLòòIVóó),€also€known€as€ricin€E;€orÐä#€ (#(# Ðà0  àà ` à(3)€Saxitoxin€identified€by€C.A.S.€#35523„89„8.м%X"(#(# Ðà0  àòòRelated€Definitionsóó:€€For€the€purpose€of€this€entry,€ð ðòòimmunotoxinóóðð€is€defined€as€anÐ ”'0!$ Ðantibody„toxin€conjugate€intended€to€destroy€specific€target€cells€(e.g.,€tumor€cells)€thatÐ l)#& Ðbear€antigens€homologous€to€the€antibody.€€For€the€purpose€of€this€entry,€ð ðòòmedicalÐ D+à$( Ðproductsóóðð€are:€€(1)€pharmaceutical€formulations€designed€for€human€administration€in€theÐ -¸&* Ðtreatment€of€medical€conditions,€(2)€prepackaged€for€distribution€as€medical€products,Ð d Ðand€(3)€approved€by€the€U.S.€Food€and€Drug€Administration€to€be€marketed€as€medicalÐ <Ø Ðproducts.€€For€the€purpose€of€this€entry,€ð ðòòdiagnostic€and€food€testing€kitsóóðð€are€specificallyÐ  ° Ðdeveloped,€packaged€and€marketed€for€diagnostic€or€public€health€purposes.€€BiologicalÐ ì ˆ Ðtoxins€in€any€other€configuration,€including€bulk€shipments,€or€for€any€other€end„uses€areÐ Ä ` Ðcontrolled€by€ECCN€1C351.€€For€the€purpose€of€this€entry,€ð ðòòvaccineóóðð€is€defined€as€aÐ œ8  Ðmedicinal€(or€veterinary)€product€in€a€pharmaceutical€formulation,€approved€by€the€U.S.Ð t  ÐFood€and€Drug€Administration€or€the€U.S.€Department€of€Agriculture€to€be€marketed€as€aÐ Lè  Ðmedical€(or€veterinary)€product€or€for€use€in€clinical€trials,€that€is€intended€to€stimulate€aÐ $À Ðprotective€immunological€response€in€humans€or€animals€in€order€to€prevent€disease€inÐ ü˜ Ðthose€to€whom€or€to€which€it€is€administered.ÐÔp(#(# Ðà  àòòItemsóó:Ð ¬H ÐÌa.€€Vaccines€against€items€controlled€by€ECCN€1C351,€1C352,€1C353,€or€1C354;Ð \ø ÐÌb.€€Immunotoxins€containing€items€controlled€by€1C351.d;Ð  "¨ ÐÌc.€€Medical€products€containing€botulinum€toxins€controlled€by€ECCN€1C351.d.1;Ð ¼%X" ÐÌd.€€Medical€products€containing€items€controlled€by€ECCN€1C351.d,€except€botulinum€toxinsÐ l)#& Ðcontrolled€by€ECCN€1C351.d.1€and€items€controlled€for€CW€reasons€under€1C351.d.5€or€.d.6;Ð D+à$( ÐòòandóóÐ -¸&* Їe.€€Diagnostic€and€food€testing€kits€containing€items€controlled€by€ECCN€1C351.d,€except€itemsÐ d Ðcontrolled€for€CW€reasons€under€ECCN€1C351.d.5€or€.d.6.Ð <Ø ÐÌà  à10.à ` àIn€Supplement€No.€1€to€Part€774€(the€Commerce€Control€List),€Category€2€„„Ð ì ˆ ÐMaterials€Processing,€ECCN€2B350€is€amended€by€revising€the€ECCN€heading€and€the€List€ofÐ Ä ` ÐItems€Controlled€to€read€as€follows:Ð œ8  ÐÌò ò2B350€€Chemical€manufacturing€facilities€and€equipment,€except€valves€controlled€byÐ Lè  Ð2A226€or€2A292,€as€follows€(see€List€of€Items€Controlled).ó óÐ $À ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ Ôp ÐÌò òÔ‡X8ðXXX8ðÔList€of€Items€Controlledó óÐ „  Ðà  àòòUnitóó:€Equipment€in€numberÐ \ø Ðà0  àòòRelated€Controlsóó:€The€controls€in€this€entry€do€not€apply€to€equipment€that€is:€a.)Ð 4 Ð Ðspecially€designed€for€use€in€civil€applications€(e.g.,€food€processing,€pulp€and€paperÐ  "¨ Ðprocessing,€or€water€purification);€AND€b.)€inappropriate,€by€the€nature€of€its€design,€forÐ ä#€  Ðuse€in€storing,€processing,€producing€or€conducting€and€controlling€the€flow€of€chemicalÐ ¼%X" Ðweapons€precursors€controlled€by€1C350.Д'0!$(#(# Ðà0  àòòRelated€Definitionsóó:€€For€purposes€of€this€entry€the€term€"chemical€warfare€agents"€areÐ l)#& Ðthose€agents€subject€to€the€export€licensing€authority€of€the€U.S.€Department€of€State,Ð D+à$( ÐOffice€of€Defense€Trade€Controls.€€(See€22€CFR€part€121)Ð-¸&*(#(# Ðà  àòòItemsóó:Ð d ÐÌa.€€Reaction€vessels€or€reactors,€with€or€without€agitators,€with€total€internal€(geometric)€volumeÐ  ° Ðgreater€than€0.1€mòò3óó€(100€liters)€and€less€than€20€mòò3óó€(20,000€liters),€where€all€surfaces€that€come€inÐ ì ˆ Ðdirect€contact€with€the€chemical(s)€being€processed€or€contained€are€made€from€any€of€theÐ Ä ` Ðfollowing€materials:Ð œ8  Ðà  àa.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð t  Ðà  àa.2.€€Fluoropolymers;Ð Lè  Ðà  àa.3.€€Glass€(including€vitrified€or€enameled€coating€or€glass€lining);Ð $À Ðà  àa.4.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ð ü˜ Ðà  àa.5.€€Tantalum€or€tantalum€alloys;Ð Ôp Ðà  àa.6.€€Titanium€or€titanium€alloys;€òòoróóÐ ¬H Ðà  àa.7.€€Zirconium€or€zirconium€alloys.Ð „  ÐÌb.€€Agitators€for€use€in€reaction€vessels€or€reactors€described€in€2B350.a,€and€impellers,€blades€orÐ 4 Ð Ðshafts€designed€for€such€agitators,€where€all€surfaces€that€come€in€direct€contact€with€theÐ  "¨ Ðchemical(s)€being€processed€or€contained€are€made€from€any€of€the€following€materials:Ð ä#€  Ðà  àb.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð ¼%X" Ðà  àb.2.€€Fluoropolymers;Ð ”'0!$ Ðà  àb.3.€€Glass€(including€vitrified€or€enameled€coatings€or€glass€lining);Ð l)#& Ðà  àb.4.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ð D+à$( Ðà  àb.5.€€Tantalum€or€tantalum€alloys;Ð -¸&* Ðà  àb.6.€€Titanium€or€titanium€alloys;€òòoróó€Ð d Ðà  àb.7.€€Zirconium€or€zirconium€alloys.Ð <Ø ÐÌc.€€Storage€tanks,€containers€or€receivers€with€a€total€internal€(geometric)€volume€greater€than€0.1Ð ì ˆ Ðmòò3óó€(100€liters)€where€all€surfaces€that€come€in€direct€contact€with€the€chemical(s)€beingÐ Ä ` Ðprocessed€or€contained€are€made€from€any€of€the€following€materials:Ð œ8  ÐÌà  àc.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð Lè  Ðà  àc.2.€€Fluoropolymers;Ð $À Ðà  àc.3.€€Glass€(including€vitrified€or€enameled€coatings€or€glass€lining);Ð ü˜ Ðà  àc.4.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ð Ôp Ðà  àc.5.€€Tantalum€or€tantalum€alloys;Ð ¬H Ðà  àc.6.€€Titanium€or€titanium€alloys;€òòoróóÐ „  Ðà  àc.7.€€Zirconium€or€zirconium€alloys.Ð \ø ÐÌd.€€Heat€exchangers€or€condensers€with€a€heat€transfer€surface€area€of€less€than€20€mòò2óó,€but€greaterÐ  "¨ Ðthan€0.15€mòò2óó,€and€tubes,€plates,€coils€or€blocks€(cores)€designed€for€such€heat€exchangers€orÐ ä#€  Ðcondensers,€where€all€surfaces€that€come€in€direct€contact€with€the€chemical(s)€being€processedÐ ¼%X" Ðare€made€from€any€of€the€following€materials:Ð ”'0!$ Ðà  àd.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð l)#& Ðà  àd.2.€€Fluoropolymers;Ð D+à$( Ðà  àd.3.€€Glass€(including€vitrified€or€enameled€coatings€or€glass€lining);Ð -¸&* Ðà  àd.4.€€Graphite€or€carbon„graphite;Ð d Ðà  àd.5.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ð <Ø Ðà  àd.6.€€Silicon€carbide;Ð  ° Ðà  àd.7.€€Tantalum€or€tantalum€alloys;Ð ì ˆ Ðà  àd.8.€€Titanium€or€titanium€alloys;Ð Ä ` Ðà  àd.9.€€Titanium€carbide;€€òòoróóÐ œ8  Ðà  àd.10.€€Zirconium€or€zirconium€alloys.Ð t  ÐÌe.€€Distillation€or€absorption€columns€of€internal€diameter€greater€than€0.1€m,€and€liquidÐ $À Ðdistributors,€vapor€distributors€or€liquid€collectors€designed€for€such€distillation€or€absorptionÐ ü˜ Ðcolumns,€where€all€surfaces€that€come€in€direct€contact€with€the€chemical(s)€being€processed€areÐ Ôp Ðmade€from€any€of€the€following€materials:Ð ¬H Ðà  àe.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð „  Ðà  àe.2.€€Fluoropolymers;Ð \ø Ðà  àe.3.€€Glass€(including€vitrified€or€enameled€coatings€or€glass€lining);Ð 4 Ð Ðà  àe.4.€€Graphite€or€carbon„graphite;Ð  "¨ Ðà  àe.5.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ð ä#€  Ðà  àe.6.€€Tantalum€or€tantalum€alloys;Ð ¼%X" Ðà  àe.7.€€Titanium€or€titanium€alloys;€òòoróóÐ ”'0!$ Ðà  àe.8.€€Zirconium€or€zirconium€alloys.Ð l)#& ÐÌÐ -¸&* Ðf.€€Remotely€operated€filling€equipment€in€which€all€surfaces€that€come€in€direct€contact€with€theÐ d Ðchemical(s)€being€processed€are€made€from€any€of€the€following€materials:Ð <Ø Ðà  àf.1.€€Alloys€with€more€than€25%€nickels€and€20%€chromium€by€weight;€òòoróóÐ  ° Ðà  àf.2.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight.Ð ì ˆ ÐÌg.€€Valves€with€nominal€sizes€greater€than€1.0€cm€(ðCð€in.),€and€casings€(valve€bodies)€orÐ œ8  Ðpreformed€casing€liners€designed€for€such€valves,€Ô#†X8ðXXX8ð|¿#ÔÔ‡X8ðXXX8ðÔin€which€all€surfaces€that€come€in€directÐ t  Ðcontact€with€the€chemical(s)€being€processed€or€contained€are€made€from€any€of€the€followingÐ Lè  Ðmaterials:Ð $À Ðà  àg.1.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ô#†X8ðXXX8ðbÙ#ÔÔ‡X8ðXXX8ðÔÐ ü˜ Ðà  àg.2.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ô#†X8ðXXX8ð¹Ú#ÔÔ‡X8ðXXX8ðÔÐ Ôp Ðà  àg.3.€€Fluoropolymers;Ô#†X8ðXXX8ð^Û#ÔÔ‡X8ðXXX8ðÔÐ ¬H Ðà  àg.4.€€Glass€or€glass€lined€(including€vitrified€or€enameled€coatings);Ô#†X8ðXXX8ðÖÛ#ÔÔ‡X8ðXXX8ðÔÐ „  Ðà  àg.5.€€Tantalum€or€tantalum€alloys;Ð \ø Ðà  àg.6.€€Titanium€or€titanium€alloys;€òòoróó€Ð 4 Ð Ðà  àg.7.€€Zirconium€or€zirconium€alloys.Ð  "¨ ÐÌh.€€Multi„walled€piping€incorporating€a€leak€detection€port,€in€which€all€surfaces€that€come€inÐ ¼%X" Ðdirect€contact€with€the€chemical(s)€being€processed€or€contained€are€made€from€any€of€theÐ ”'0!$ Ðfollowing€materials:Ð l)#& Ðà  àh.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð D+à$( Ðà  àh.2.€€Fluoropolymers;Ð -¸&* Ðà  àh.3.€€Glass€(including€vitrified€or€enameled€coatings€or€glass€lining);Ð d Ðà  àh.4.€€Graphite€or€carbon„graphite;Ð <Ø Ðà  àh.5.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ð  ° Ðà  àh.6.€€Tantalum€or€tantalum€alloys;Ð ì ˆ Ðà  àh.7.€€Titanium€or€titanium€alloys;€òòoróóÐ Ä ` Ðà  àh.8.€€Zirconium€or€zirconium€alloys.Ð œ8  ÐÌi.€€Multiple„seal,€canned€drive,€magnetic€drive,€bellows€or€diaphragm€pumps,€with€manufacturer'sÐ Lè  Ðspecified€maximum€flow„rate€greater€than€0.6€mòò3óó/hour,€or€vacuum€pumps€with€manufacturer'sÐ $À Ðspecified€maximum€flow„rate€greater€than€5€mòò3óó/hour€(under€standard€temperature€(273€K€(0òòoóó€C))Ð ü˜ Ðand€pressure€(101.3€kPa)€conditions),€and€casings€(pump€bodies),€preformed€casing€liners,Ð Ôp Ðimpellers,€rotors€or€jet€pump€nozzles€designed€for€such€pumps,€in€which€all€surfaces€that€comeÐ ¬H Ðinto€direct€contact€with€the€chemical(s)€being€processed€are€made€from€any€of€the€of€theÐ „  Ðfollowing€materials:Ð \ø Ðà  ài.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð 4 Ð Ðà  ài.2.€€Ceramics;Ð  "¨ Ðà  ài.3.€€Ferrosilicon;Ð ä#€  Ðà  ài.4.€€Fluoropolymers;Ð ¼%X" Ðà  ài.5.€€Glass€(including€vitrified€or€enameled€coatings€or€glass€lining);Ð ”'0!$ Ðà  ài.6.€€Graphite€or€carbon„graphite;Ð l)#& Ðà  ài.7.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight;Ð D+à$( Ðà  ài.8.€€Tantalum€or€tantalum€alloys;Ð -¸&* Ðà  ài.9.€€Titanium€or€titanium€alloys,€òòoróó€Ð d Ðà  ài.10.€Zirconium€or€zirconium€alloys.Ð <Ø ÐÌj.€€Incinerators€designed€to€destroy€chemical€warfare€agents,€chemical€weapons€precursorsÐ ì ˆ Ðcontrolled€by€1C350,€or€chemical€munitions€having€specially€designed€waste€supply€systems,Ð Ä ` Ðspecial€handling€facilities€and€an€average€combustion€chamber€temperature€greater€than€1000òòo€óóCÐ œ8  Ðin€which€all€surfaces€in€the€waste€supply€system€that€come€into€direct€contact€with€the€wasteÐ t  Ðproducts€are€made€from€or€lined€with€any€of€the€following€materials:Ð Lè  Ðà  àj.1.€€Alloys€with€more€than€25%€nickel€and€20%€chromium€by€weight;Ð $À Ðà  àj.2.€€Ceramics;€òòoróóÐ ü˜ Ðà  àj.3.€€Nickel€or€alloys€with€more€than€40%€nickel€by€weight.Ð Ôp ÐÌà  àò òTechnical€Note:ó ó€€Carbon„graphite€is€a€composition€consisting€primarily€of€graphite€andÐ „  Ðamorphous€carbon,€in€which€the€graphite€is€8€percent€or€more€by€weight€of€the€composition.Ð d ÐÔ#†X8ðXXX8ðÜ#ÔÌà  à11.à ` àIn€Supplement€No.€1€to€Part€774€(the€Commerce€Control€List),€Category€2€„„Ð "° ÐMaterials€Processing,€ECCN€2B352€is€amended€by€revising€the€List€of€Items€Controlled€to€readÐ ì#ˆ  Ðas€follows:Ð Ä%`" ÐÌÌÌÐ $-À&* Ðò ò2B352€€Equipment€capable€of€use€in€handling€biological€materials,€as€follows€(see€List€ofÐ d ÐItems€Controlled).€ó óÐ <Ø ÐÌÓ  Ó*€€€€€*€€€€€*€€€€€*€€€€€*Ð ì ˆ ÐÔ& ° ÔÓ  Óò òList€of€Items€Controlledó óÐ Ä ` ÐÔ'°Ä åìÔà  àòòUnitóó:€Equipment€in€numberÐ œ8  Ðà  àòòRelated€Controlsóó:€N/AÐ t  Ðà0  àòòRelated€Definitionsóó:€For€purposes€of€this€entry,€isolators€include€flexible€isolators,€dryÐ Lè  Ðboxes,€anaerobic€chambers€and€glove€boxes.Ð$À(#(# Ðà  àòòItemsóó:Ð ü˜ ÐÌa.€€Complete€containment€facilities€at€P3€or€P4€containment€level.Ð ¬H ÐÌà  àò òTechnical€Noteó ó:€€P3€or€P4€(BL3,€BL4,€L3,€L4)€containment€levels€are€as€specified€in€theÐ \ø ÐWHO€Laboratory€Biosafety€Manual€(Geneva,€1983).Ð < Ø ÐÌb.€€Fermenters€capable€of€cultivation€of€pathogenic€microorganisms,€viruses,€or€for€toxinÐ ì#ˆ  Ðproduction,€without€the€propagation€of€aerosols,€having€a€capacity€equal€to€or€greater€than€Ð Ä%`" Ð20€liters.Ð œ'8!$ ÐÌà  àò òTechnical€Noteó ó:€€Fermenters€include€bioreactors,€chemostats,€and€continuous-flowÐ L+è$( Ðsystems.Ð ,-È&* Їc.€€Centrifugal€separators€capable€of€the€continuous€separation€of€pathogenic€microorganisms,Ð d Ðwithout€the€propagation€of€aerosols,€and€having€all€of€the€following€characteristics:Ð <Ø Ðà  àc.1.€€One€or€more€sealing€joints€within€the€steam€containment€area;Ð  ° Ðà  àc.2.€€A€flow€rate€greater€than€100€liters€per€hour;Ð ì ˆ Ðà  àc.3.€€Components€of€polished€stainless€steel€or€titanium;€òòandóóÐ Ä ` Ðà  àc.4.€€Capable€of€in„situ€steam€sterilization€in€a€closed€state.Ð œ8  ÐÌà  àò òTechnical€Noteó ó:€€Centrifugal€separators€include€decanters.Ð Lè  ÐÌd.€€Cross€(tangential)€flow€filtration€equipment€and€accessories,€as€follows:Ð   Ðà  àd.1.€€Cross€(tangential)€flow€filtration€equipment€capable€of€separation€of€pathogenicÐ Üx Ðmicroorganisms,€viruses,€toxins€or€cell€cultures,€without€the€propagation€of€aerosols,€having€allÐ ´P Ðof€the€following€characteristics:Ð Œ( Ðà  àà ` àd.1.a.€€A€total€filtration€area€equal€to€or€greater€than€1€square€meter€(1€mòò2óó);€andÐ d Ðà  àà ` àd.1.b.€€Capable€of€being€sterilized€or€disinfected€in„situ.Ð < Ø ÐÌà  àò òN.B.:ó ó€€2B352.d.1€does€not€control€reverse€osmosis€equipment,€as€specified€by€theÐ ì#ˆ  Ðmanufacturer.Ð Ì%h" ÐÌà  àd.2.€€Cross€(tangential)€flow€filtration€components€(e.g.,€modules,€elements,€cassettes,Ð |)#& Ðcartridges,€units€or€plates)€with€filtration€area€equal€to€or€greater€than€0.2€square€meters€(0.2€mòò2óó)Ð T+ð$( Ðfor€each€component€and€designed€for€use€in€cross€(tangential)€flow€filtration€equipmentÐ ,-È&* Ðcontrolled€by€2B352.d.1.Ð d ÐÌà  àò òTechnical€Note:ó ó€€In€this€ECCN,€ð ðsterilizedðð€denotes€the€elimination€of€all€viableÐ  ° Ðmicrobes€from€the€equipment€through€the€use€of€either€physical€(e.g.,€steam)€or€chemical€agents.€Ð ô  Ðð ðDisinfectedðð€denotes€the€destruction€of€potential€microbial€infectivity€in€the€equipment€throughÐ Ì h Ðthe€use€of€chemical€agents€with€a€germicidal€effect.€€ð ðDisinfectionðð€and€ð ðsterilizationðð€areÐ ¤@  Ðdistinct€from€ð ðsanitizationðð,€the€latter€referring€to€cleaning€procedures€designed€to€lower€theÐ |  Ðmicrobial€content€of€equipment€without€necessarily€achieving€elimination€of€all€microbialÐ Tð  Ðinfectivity€or€viability.Ð ,È ÐÌe.€€Steam€sterilizable€freeze-drying€equipment€with€a€condenser€capacity€of€10€kgs€of€ice€orÐ Üx Ðgreater€in€24€hours,€but€less€than€1,000€kgs€of€ice€in€24€hours.Ð ´P ÐÌf.€€Protective€and€containment€equipment,€as€follows:Ð d Ðà  àf.1.€€Protective€full€or€half€suits,€or€hoods€dependant€upon€a€tethered€external€air€supplyÐ < Ø Ðand€operating€under€positive€pressure;Ð "° ÐÌà  àò òTechnical€Noteó ó:€This€entry€does€not€control€suits€designed€to€be€worn€with€self„Ð Ä%`" Ðcontained€breathing€apparatus.Ð ¤'@!$ ÐÌà  àf.2.€€Class€III€biological€safety€cabinets€or€isolators€with€similar€performance€standards,Ð T+ð$( Ðe.g.,€flexible€isolators,€dry€boxes,€anaerobic€chambers,€glove€boxes€or€laminar€flow€hoods€(closedÐ ,-È&* Ðwith€vertical€flow).Ð d ÐÌg.€€Chambers€designed€for€aerosol€challenge€testing€with€microorganisms,€viruses,€or€toxins€andÐ  ° Ðhaving€a€capacity€of€1€mòò3óó€or€greater.Ð ì ˆ ÐÌà  à12.à ` àIn€Supplement€No.€1€to€Part€774€(the€Commerce€Control€List),€Category€2€„„Ð œ8  ÐMaterials€Processing,€ECCN€2E001€is€amended€by€revising€the€License€Requirements€section€toÐ t  Ðread€as€follows:Ð Lè  ÐÌò ò2E001€€ð ðTechnology€according€to€the€General€Technology€Note€for€the€ð ðdevelopmentðð€ofÐ ü˜ Ðequipment€or€ð ðsoftwareðð€controlled€by€2A€(except€2A991,€2A993,€or€2A994),€2B€(exceptÐ Ôp Ð2B991,€2B993,€2B996€2B997€or€2B998),€or€2D€(except€2D991,€2D992,€or€2D994).ó óÐ ¬H ÐÌò òLicense€Requirementsó óÐ \ø ÐÌÔ‡X8ðXXX8ðÔà  àòòReason€for€Controlóó:€€NS,€MT,€NP,€CB,€ATÐ  "¨ ÐÌòòControl(s)óóà0 ` àà0¸ ` (#` (#àà0¸ (#¸ (#àà0h(#(#àòòCountry€Chartóóм%X"h(#h(# ÐÌNS€applies€to€ð ðtechnologyððà0  àà0h(#(#àNS€Column€1Ðl)#&h(#h(# Ðfor€items€controlled€byÐ D+à$( Ð2A001,€2B001€to€2B009,Ð -¸&* Ð2D001€or€2D002Ð d ÐÌMT€applies€to€ð ðtechnologyððà  àà h àMT€Column€1Ð  ° Ðfor€items€controlled€byÐ ì ˆ Ð2B004,€2B009,€2B018,Ð Ä ` Ð2B104,€2B105,€2B109,Ð œ8  Ð2B116,€2B117,€2D001€orÐ t  Ð2D101€for€MT€reasonsÐ Lè  ÐÌNP€applies€to€ð ðtechnologyððà0  àà0h(#(#àNP€Column€1Ðü˜h(#h(# Ðfor€items€controlled€byÐ Ôp Ð2A225,€2A226,€2B001,€Ð ¬H Ð2B004,€2B006,€2B007,Ð „  Ð2B009,€2B104,€2B109,Ð \ø Ð2B116,€2B201,€2B204,Ð 4 Ð Ð2B206,€2B207,€2B209,Ð  "¨ Ð2B225€to€2B232,€2D001,Ð ä#€  Ð2D002,€2D101,€2D201€orÐ ¼%X" Ð2D202€for€NP€reasonsÐ ”'0!$ ÐÌNP€applies€to€ð ðtechnologyððà0  àà0h(#(#àNP€Column€2ÐD+à$(h(#h(# Ðfor€items€controlled€by€Ð -¸&* Ð2A290€to€2A293,€2B290,€orÐ d Ð2D290€for€NP€reasonsÐ <Ø ÐÌCB€applies€to€ð ðtechnologyððà0  àà0h(#(#àCB€Column€3Ðì ˆh(#h(# Ðfor€equipment€controlledÐ Ä ` Ðby€2B350€to€2B352€and€for€Ð œ8  Ðvalves€controlled€by€2A226€orÐ t  Ð2A292€having€the€characteristicsÐ Lè  Ðof€those€controlled€by€2B350.gÐ $À ÐÌAT€applies€to€entire€entryà0  àà0h(#(#àAT€Column€1ÐÔph(#h(# ÐÌà  àò òLicense€Requirement€Notes:ó ó€€See€ðð743.1€of€the€EAR€for€reporting€requirements€forÐ „  Ðexports€under€License€Exceptions.Ð d ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ "° ÐÌà  à13.à ` àIn€Supplement€No.€1€to€Part€774€(the€Commerce€Control€List),€Category€2€ð!ðÐ Ä%`" ÐMaterials€Processing,€ECCN€2E002€is€amended€by€revising€the€License€Requirements€section€toÐ œ'8!$ Ðread€as€follows:Ð t)#& ÐÌÐ $-À&* Ðò ò2E002€€ð ðTechnologyðð€according€to€the€General€Technology€Note€for€the€ð ðproductionðð€ofÐ d Ðequipment€controlled€by€2A,€(except€2A991,€2A993,€or€2A994)€or€2B€(except€2B991,€2B993,Ð <Ø Ð2B996,€2B997,€or€2B998).ó óÐ  ° ÐÌò òLicense€Requirementsó óÐ Ä ` ÐÌà  àòòReason€for€Controlóó:€€NS,€MT,€NP,€CB,€ATÐ t  ÐÌòòControl(s)óóà0 ` àà0¸ ` (#` (#àà0¸ (#¸ (#àà0h(#(#àòòCountry€ChartóóÐ$Àh(#h(# ÐÌNS€applies€to€ð ðtechnologyððà0  àà0h(#(#àNS€Column€1ÐÔph(#h(# Ðfor€equipment€controlled€byÐ ¬H Ð2A001,€2B001€to€2B009Ð „  ÐÌMT€applies€to€ð ðtechnologyððà0  àà0h(#(#àMT€Column€1Ð4 Ðh(#h(# Ðfor€equipment€controlled€byÐ  "¨ Ð2B004,€2B009,€2B018,Ð ä#€  Ð2B104,€2B105,€2B109,Ð ¼%X" Ð2B116€or€2B117€forÐ ”'0!$ ÐMT€reasonsÐ l)#& ÐÌÐ -¸&* ÐNP€applies€to€ð ðtechnologyððà0  àà0h(#(#àNP€Column€1Ðdh(#h(# Ðfor€equipment€controlled€byÐ <Ø Ð2A225,€2A226,€2B001,€Ð  ° Ð2B004,€2B006,€2B007,Ð ì ˆ Ð2B009,€2B104,€2B109,Ð Ä ` Ð2B116,€2B201,€2B204,Ð œ8  Ð2B206,€2B207,€2B209,Ð t  Ð2B225€to€2B232€forÐ Lè  ÐNP€reasonsÐ $À ÐÌNP€applies€to€ð ðtechnologyððà0  àà0h(#(#àNP€Column€2ÐÔph(#h(# Ðfor€equipment€controlled€by€Ð ¬H Ð2A290€to€2A293,€2B290Ð „  Ðfor€NP€reasonsÐ \ø ÐÌCB€applies€to€ð ðtechnologyððà0  àà0h(#(#àCB€Column€3Ð "¨h(#h(# Ðfor€equipment€controlledÐ ä#€  Ðby€2B350€to€2B352€and€for€Ð ¼%X" Ðvalves€controlled€by€2A226€orÐ ”'0!$ Ð2A292€having€the€characteristicsÐ l)#& Ðof€those€controlled€by€2B350.gÔ#†X8ðXXX8ð”#ÔÔ‡X8ðXXX8ðÔÐ D+à$( ÐÐ -¸&* ÐAT€applies€to€entire€entryà0  àà0h(#(#àAT€Column€1Ðdh(#h(# ÐÌà  àò òLicense€Requirement€Notes:ó ó€€See€ðð743.1€of€the€EAR€for€reporting€requirements€forÐ  ° Ðexports€under€License€Exceptions.Ð ô  ÐÌà@þþìà*€€€€€*€€€€€*€€€€€*€€€€€*ˆÐ ¤@  ÐÔ#†X8ðXXX8ð‚#ÔÌDATED:Ð Tð  ÐÌÌJames€J.€JochumÐ Üx ÐAssistant€SecretaryÐ ´P Ðfor€Export€AdministrationÐ Œ( ÐÓNÓ