ÿWPC† ¤âXP‡7as)=®Ê„ì…ƒâß–h¨Å=÷ÑJ&H<ÐB´‰@ðNhórèþ?ų†2Ç;ežnZ½Õà*§úkyÆU9èJÝaém–ðs8•l.ËÉß[:•âŠbø>„=º}Yk –ØRïàqü“›´ó¡ ˆÄSò09í~&Q†ýçɲÛÞ =kžuoŒRÁ‚£Á¹i¦.¶Ÿú+mø@±ný5×2d*N ×9V×iس§‹˜ýŠF¨±I’k¦þsïf9kÔ ðKû-O‚©"€Wƒ89!ƒØ<•Ôu"Û&½#v£,æÍÕ¶˜úAˆç¢å™7ÞMá8É­Zñ7¤¼»¢ú¶Jã§~X@[0£A}øÿ\bÐ߸ž-ÿýª¹5’UñêIÄø „k!Ž¿žR -©‹7u‹4Es´š‹ÖÄÚJ6-ÊÕ„$4^Ç-?ìAyáÑÑ VY8¹ŸI•@pr»"®}±ÐØ!Q›• ¥ôµ$(NªúgÍ2*t§ß/cÃÝw"‡Œd ç“gB1«¨`ˆúpþœè7‘ϼò¿•6}UN»»»»»»»»» B U.&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&ÆT 0Æ› 0‡aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa 0(èè 0v˜HP LaserJet 4SiWINSPOOL,,^^,,0 (ÖÃ9 Z ‹6Times New Roman RegularX($¡¡ Ù{ÚEÛÜEÝÞßàáâHÖ‹Î( 33|xâ'ô\ `V& ÿÿ8Document[8]Document Styleà0..àà8` ..` àÌ(3¯$©©Ý ƒ!ÝÝ  Ý  CFR RIN xxxxtoxinx ECCNSeevaratnamrulemakingSubchapterzoonosesimmunotoxinsimmunotoxinChikungunyahaemorrhagicEbolaHantaan$choriomeningitisMachupoMarburgRickettsiaeBartonellaquintanaRochalimeaCoxiellaburnetiiprowaseckirickettsiianthracisBrucellaabortusmelitensis suisBurkholderiamalleipseudomalleipsittaciFrancisellatularensistyphidysenteriaecholeraeYersiniapestisperfringensConotoxinMicrocystincyanginosinSaxitoxinTetrodotoxinVerotoxinAflatoxinsEC O.J. IVPI haemagglutininAujeszkyLyssaPesteenterovirusTeschenstomatitismycoidesalbilineanspvA,B,C,D,Ecitrumelo ColletotrichumcoffeanumvirulanskahawaeCochliobolus((3/Q$««Ý ƒ!ÝÝ  ÝÔ d ÔH€X&‰' e37=CIQYag³³1.a.i.(1)(a)(i)1)a)# e37=CIQYag­­1.a.i.(1)(a)(i)1)a)ÿU‹ÿÀÀÀDraft 29 FEB: Med Prod ver CBC 000229a.wpd  '  (A) Corrected "medial" to "medical" on pg 6. (B) Short technical note on TGMS from Mark Brown . (c) Corrections from Toni.(ÈhH  Z6Times New Roman Regular d $Verdana1, 2, 3,Level 1Level 2Level 3Level 4Level 5B?my21, 2, 3,Numbersà  àÚƒRÚ2Ú  Ú.Û€RÛa, b, c,Level 1Level 2Level 3Level 4Level 5V1êa2a, b, c,Lowercase LettersÚƒVÚÚ  Ú.Û€VÛà0 à($(-!2Vf$¤¤Ý ƒ!ÝÝ  ÝÓÓ€€€€€òòÚ  Ú0Ú  ÚóóÝ ƒ!ÝÝ  ÝÓC€  e' CÓÑ7€­‰XXdðXXdð7ÑÓ °°šX°œXÓÓÓà  à›à ` àà ¸ àà  àà h àà À àà  àà p àà È àBilling€Code:€3510„33„PÐ ° Ðà  àà ` àà ¸ àà  àà h àà À àà  àà p àÌÌDEPARTMENT€OF€COMMERCEÌÌBureau€of€Export€AdministrationÌÌ15€CFR€Parts€742€and€774ÌÌ[Docket€No.€œ000920265„0265„01]›ÌÌRIN:€0694„AC13ÌÌRevisions€and€Clarifications€to€the€Commerce€Control€œList;›€Chemical€and€Biological€WeaponsÏControls;€Australia€GroupÌÌAGENCY:€Bureau€of€Export€Administration,€Commerce.ÌÌACTION:€Final€rule.ÌÌSUMMARY:ÌÐ ,`'* ÐThis€final€rule€amends€the€Commerce€Control€List€(CCL)€of€the€Export€AdministrationÏRegulations€to€implement€an€October€1999€Australia€Group€agreement€to€clarify€the€scope€ofÏcontrols€on€saxitoxin,€toxic€gas€monitoring€systems,€and€cross„flow€filtration€equipment,€as€wellÏas€clarifying€the€application€of€the€rule€for€mixtures€containing€Australia€Group€(AG)€chemicalsÏthat€are€also€identified€as€Schedule€1€chemicals€under€the€Chemical€Weapons€Convention.€€TheÏfinal€rule€also€amends€the€CCL€to€authorize,€without€a€license,€exports€of€certain€medicalÏproducts€containing€botulinum€toxin,€and€certain€diagnostic€and€food€testing€kits€that€containÏAG„controlled€toxins.€€Finally,€this€final€rule€amends€the€CCL€to€add€titanium€carbide€andÏsilicon€carbide€to€the€list€of€construction€materials€for€heat€exchangers.€€Restrictions€onÏchemicals€and€toxins€that€are€also€controlled€for€CW€(Chemical€Weapons€Convention)€purposesÏcontinue€to€apply.€€This€rule€will€result€in€an€overall€decreased€licensing€burden€on€U.S.€industry.ÌÌEFFECTIVE€DATE:€This€rule€is€effective:€œñáñOctober€3,€2000€ñáññâñ(ñâñòòñâñDATE›€OF›€PUBLICATIONñâñóóñâñ).ñâñ›Ð 0€ ÐÌFOR€FURTHER€INFORMATION€CONTACT:€James€Seevaratnam,€Director,€Chemical€andÏBiological€Controls€Division,€Bureau€of€Export€Administration,€(202)€501„7900.ÌÌÌSUPPLEMENTARY€INFORMATIONÌÌBackgroundÌÐ ,`'* ÐOn€October€7,€1999,€the€Bureau€of€Export€Administration€(BXA)€published€a€final€ruleÏamending€the€Export€Administration€Regulations€(EAR)€to€implement€the€October€1998ÏAustralia€Group€agreement€to€amend€controls€on€toxic€gas€monitoring€systems€and€to€amend€theÏCCL€to€authorize,€without€a€license,€exports€of€medical€products€containing€controlled€biologicalÏtoxins€that€are€developed,€packaged€and€sold€for€medical€treatment.€ÌÌThe€Australia€Group€(AG),€a€multilateral€forum€that€coordinates€export€controls€to€curtail€theÏproliferation€of€chemical€and€biological€weapons,€held€its€annual€consultations€in€Paris,€OctoberÏ4„8,€1999.€€The€30€AG€œparticipating›€countries€agreed€to€maintain€export€controls€on€a€list€ofÏchemicals,€biological€agents,€relevant€equipment€and€technology€that€could€be€used€in€theÏproduction€of€chemical€or€biological€weapons.€€The€AG€reviews€items€on€its€control€listÏperiodically€to€enhance€the€effectiveness€and€achieve€greater€harmonization€of€€participatingÏgovernmentsðð€national€controls.ÌÌAt€the€October€1999€Australia€Group€consultations,€participants€agreed€to€further€revise€theÏcontrol€list€entry€for€toxic€gas€monitoring€systems€to€clarify€the€scope€of€controls.€€To€implementÏthis€agreement,€this€final€rule€amends€the€Commerce€Control€List€(CCL)€of€the€ExportÏAdministration€Regulations€(EAR)€by€revising€Export€Control€Classification€Number€(ECCN)Ï2B351.€€Specifically,€this€rule€clarifies€that€the€control€of€toxic€gas€monitoring€systems€underÏECCN€2B351€applies€only€to€such€systems€that€operate€on€line€without€any€requirement€forÏhuman€intervention.€€The€AG€agreed€that€the€intent€of€this€control€is€to€control€systems€capableÏof€detecting€toxic€gases€in€environments€such€as€a€chemical€plant€rather€than€batch„modeÐ ,`'* Ðoperation€equipment€that€is€normally€used€in€a€laboratory.€€While€not€changing€the€scope€of€theÏcontrol€in€any€way,€this€rule€also€clarifies€the€description€of€cross„flow€filtration€equipment€inÏECCN€2B352€by€describing€it€as€cross€(tangential)€flow€filtration€equipment.€€In€an€expansion€ofÏcontrols,€the€Australia€Group€€agreed€to€add€titanium€carbide€and€silicon€carbide€to€the€list€ofÏmaterials€describing€heat€exchangers€subject€to€control€in€ECCN€2B350.€ÌÌThe€Department€of€Commerce€also€maintains€controls€on€exports€of€biological€agents€that€couldÏbe€used€in€the€production€of€biological€weapons.€€These€materials€require€a€license€under€ECCNÏ1C351€for€export€and€reexport€for€CB€(chemical€and€biological€weapons)€reasons€to€allÏdestinations,€except€Canada.€€These€controls€are€implemented€in€accordance€with€the€exportÏcontrol€provisions€of€the€Australia€Group.€€Note€that€two€biological€agents,€ricin€and€saxitoxin,Ïclassified€as€ECCN€1C351.d.5€and€.d.6,€respectively,€are€Schedule€1€chemicals€under€theÏChemical€Weapons€Convention€and€are€also€controlled€for€CW€reasons€to€all€destinations,Ïincluding€Canada.€€ÌÌAs€agreed€by€the€AG,€medical€products€that€contain€the€AG„controlled€botulinum€toxin€that€areÏpharmaceutical€formulations€designed€for€human€administration€in€the€treatment€of€medicalÏconditions€have€broad€medical€applications€while€posing€no€significant€proliferation€concerns.€ÏSuch€products€are€controlled€under€ECCN€1C991€and€may€be€exported€and€reexported€without€aÏlicense€to€all€destinations€and€entities,€except€terrorist€supporting€countries€(Cuba,€Iran,€Iraq,ÏLibya,€North€Korea,€Sudan,€Syria)€and€Serbia,€and€except€as€provided€in€Parts€736€and€744€of€theÏEAR.€€This€further€liberalization€of€licensing€requirements€for€the€botulinum€toxin€does€notÐ ,`'* Ðapply€if€the€botulinum€toxin€is€to€be€exported€in€any€other€configuration,€including€bulkÏshipments,€or€for€any€other€end„uses,€in€which€case€it€is€still€controlled€under€ECCN€1C351.€œÌÌIn›€addition,€this€final€rule€further€amends€ECCN€1C991€to€clarify€the€criteria€for€defining€an€item€Ïcontaining€botulinum€toxin€as€a€medical€product€when€approved€by€the€Food€and€DrugÏAdministration€(FDA)€for€distribution€in€interstate€commerce€as€a€medical€product.€€Specifically,Ïthe€medical€product€must€be:€1)€pharmaceutical€formulations€designed€for€human€administrationÏin€the€treatment€of€medical€conditions;€2)€prepackaged€for€distribution€as€medical€products;€and,Ï3)€approved€by€the€Food€and€Drug€Administration€to€be€marketed€as€medical€products.ÌÌFurther,€this€rule€removes€controls€on€certain€diagnostic€and€food€testing€kits€that€contain€toxinsÏcontrolled€by€the€AG.€€Specifically,€this€final€rule€amends€ECCN€1C991€to€include€diagnosticÏand€food€testing€kits€containing€AG„controlled€toxins€controlled€under€ECCN€1C351.€€SuchÏtesting€kits€may€be€exported€and€reexported€without€a€license€to€all€destinations€and€entities,Ïexcept€to€terrorist€supporting€countries€and€Serbia,€and€except€as€provided€in€Parts€736€and€744Ïof€the€EAR,€when€the€kits€are€specifically€developed,€packaged,€and€marketed€for€diagnostic€orÏpublic€œhealth›€purposes.€€Diagnostic€and€food€testing€kits€containing€CW„controlled€toxinsÏcontinue€to€be€controlled€under€ECCN€1C351€to€all€destinations,€including€Canada.€ÌÌThis€rule€clarifies€that€the€scope€of€AG„controls€on€saxitoxin€under€1C351.d.6€applies€only€toÏsaxitoxin€and€not€the€entire€family€of€paralytic€shellfish€poisons€œ(e.g.,›€neosaxitoxin)€which,€otherÏthan€saxitoxin,€are€classified€under€EAR99.€€This€rule€also€clarifies€the€forms€of€saxitoxin€andÐ ,`'* Ðricin€that€are€controlled€for€CW€reasons€under€ECCN€1C351.ÌÌFinally,€the€AG€agreed€to€the€development€of€a€rounding€rule€for€mixtures€that€contain€trace€andÏunintended€quantities€of€AG„controlled€chemicals€that€are€also€on€CWC€Schedule€1€listed€inÏECCN€1C350.€€The€United€States€is€providing€a€ð ðround€to€zeroðð€rule€for€Schedule€1€chemicalsÏsimilar€to€that€agreed€by€the€AG.€€This€rule,€currently€set€forth€in€section€712.1€of€the€ChemicalÏWeapons€Convention€Regulations,€is€now€added€to€the€note€under€1C350€on€mixtures.€€TheÏlicensing€requirements€do€not€apply€to€mixtures€containing€less€than€0.5%€aggregate€quantities€ofÏSchedule€1€chemicals€as€unavoidable€by„products€or€impurities,€and€the€Schedule€1€chemicalsÏare€not€intentionally€produced€or€added.ÌÌExporters€are€reminded€that€although€license€requirements€have€been€removed€for€shipments€ofÏthe€medical€products€and€test€kits€for€CB€reasons€as€described€above,€these€items€continue€toÏrequire€a€license€under€1C991€for€export€or€reexport€to€terrorist€supporting€and€embargoedÏdestinations€and€entitiesò ò.ó ó€€Exporters€may€also€need€to€consult€with€the€Department€of€theÐ ð@ ÐTreasuryððs€Office€of€Foreign€Assets€Control,€which€administers€economic€sanctions€againstÏcertain€countries€and€entities,€including€the€Taliban€controlled€areas€of€Afghanistan.ÌÌAlthough€the€EAA€expired€on€August€20,€1994,€the€President€invoked€the€InternationalÏEmergency€Economic€Powers€Act€and€continued€in€effect€the€Export€Administration€RegulationsÏand,€to€the€extent€permitted€by€law,€the€provisions€of€the€EAA€in€Executive€Order€12924€ofÏAugust€19,€1994,€as€extended€by€the€President's€notices€of€August€15,€1995€(60€FR€42767),Ð ,`'* ÐAugust€14,€1996€(61€FR€42527),€August€13,€1997€(62€FR€43629),€August€13,€1998€(63€FRÏ44121),€August€10,€1999€(64€FR€44101)€and€AugustÔ‡X­‰XXXÔ€8,€2000€(65€FR€48347).€Ô#†X­‰XXX­‰à$#ÔÔ_ÔÔ_ÔÔ_ Ôà x àà Ð àÐ à Ðà  àà ` àà ¸ àÌRulemaking€RequirementsÌÔ‡ X­‰XXX­‰ÔÌà  à1.€€This€final€rule€has€been€determined€to€be€not€significant€for€purposes€of€E.O.€12866.ÌÌà  à2.€€Ô#†X­‰XX X­‰Ô%#ÔNotwithstanding€any€other€provision€of€law,€no€person€is€required€to€respond€to,€norÐ Ð  Ðshall€any€person€be€subject€to€a€penalty€for€failure€to€comply€with€a€collection€of€information,Ïsubject€to€the€requirements€of€the€Paperwork€Reduction€Act,€unless€that€collection€of€informationÏdisplays€a€currently€valid€Office€of€Management€and€Budget€Control€Number.Ô‡ X­‰XXX­‰Ô€This€rule€involvesÐ pÀ Ða€collection€of€information€subject€to€the€Paperwork€Reduction€Act€of€1980€(44€U.S.C.€3501€òòetÐ P  Ðseq.óó).€€This€collection€has€been€approved€by€the€Office€of€Management€and€Budget€under€controlÐ 0€ Ðnumbers€€0694„0088,€Ô#†X­‰XX X­‰(#Ôð ðMulti„Purpose€Application,ðð€which€carries€a€burden€hour€estimate€of€45Ð ` Ðminutes€for€a€manual€submission€and€40€minutes€for€an€electronic€submission.ÌÔ‡ X­‰XXX­‰ÔÌà  àœ3.€€Ô#†X­‰XX X­‰*#ÔÔ‡ X­‰XXX­‰ÔThis›€rule€does€not€contain€policies€with€Federalism€implications€sufficient€to€warrantÐ °"  Ðpreparation€of€a€Federalism€assessment€under€E.O.€13132.Ô#†X­‰XX X­‰p*#ÔÔ‡ X­‰XXX­‰ÔÐ $à" ÐÔ#†X­‰XX X­‰V+#ÔÌà  à4.€The€provisions€of€the€Administrative€Procedure€Act€(5€U.S.C.€553)€requiring€notice€ofÏproposed€rulemaking,€the€opportunity€for€public€participation,€and€a€delay€in€effective€date,€areÏinapplicable€because€this€regulation€involves€a€military€and€foreign€affairs€function€of€the€UnitedÐ ,`'* ÐStates€(5€U.S.C.€553(a)(1)).€€Further,€no€other€law€requires€that€a€notice€of€proposed€rulemakingÏand€an€opportunity€for€public€comment€be€given€for€this€final€rule.€€Because€a€notice€of€proposedÏrulemaking€and€an€opportunity€for€public€comment€are€not€required€to€be€given€for€this€ruleÏunder€the€Administrative€Procedure€Act€or€by€any€other€law,€the€analytical€requirementsÌof€the€Regulatory€Flexibility€Act€(5€U.S.C.€601€et€seq.)€are€not€applicable.€€Therefore,€thisÏregulation€is€issued€in€final€form.€€Although€there€is€no€formal€comment€period,€public€commentsÏon€this€regulation€are€welcome€on€a€continuing€basis.€€Comments€should€be€submitted€to€KirstenÏMortimer,€Office€of€Exporter€Services,€Bureau€of€Export€Administration,€Department€ofÏCommerce,€P.O.€Box€273,€Washington,€D.C.€20044.ÌÌList€of€Subjects€in€15€CFR€Parts€742€and€774ÌÌà  àExports,€foreign€trade.ÌÌAccordingly,€15€CFR€Chapter€7,€Subchapter€C,€is€amended€to€read€as€follows:ÌÌà  àÔ2 eÔÚ  Ú1Ú  Ú.Ô3  Ô€€The€authority€citation€for€15€CFR€part€742€is€revised€to€read€as€follows:ÌÌà  àòòAuthorityóó:€50€U.S.C.€app.€2401€òòet€seqóó.;€50€U.S.C.€1701€òòet€seqóó.;€18€U.S.C.€2510€òòet€seqóó.;€22Ð p&À!$ ÐU.S.C.€3201€òòet€seqóó.;€42€U.S.C.€2139a;€E.O.€12058,€43€FR€20947,€3€Ô_ÔCFRÔ_Ô,€1978€Comp.,€p.€179;Ð P( #& ÐE.O.€12851,€58€FR€33181,€3€Ô_ÔCFRÔ_Ô,€1993€Comp.,€p.€608;€E.O.€12924,€59€FR€43437,€3€Ô_ÔCFRÔ_Ô,€1994ÏComp.,€p.€917;€E.O.€12938,€59€FR€59099,€3€Ô_ÔCFRÔ_Ô,€1994€Comp.,€p.€950;€E.O.€13026,€61€FRÐ ,`'* Ð58767,€3€Ô_ÔCFRÔ_Ô,€1996€Comp.,€p.€228;€Notice€of€November€12,€1998,€63€FR€63589,Ô‡ô