New requirements for toxins and human pathogens

NEWREQUIREMENTSFORTOXINSANDHUMANPATHOGENS
JASONMOSCOVICI*
LEGERROBICRICHARD,
L.L.P.
L
AWYERS,PATENTANDTRADE-MARKSAGENTS

Anewlawofinteresttothosepracticinginthelifesciencesfieldplacestheonuson
anyonehandlingcertaincategoriesofbiologicalmaterialstotake“allreasonable
measurestoprotecttheheathandsafetyofthepublicwhenconductingactivities
involvinghumanpathogensandtoxins”.
Whatusedtobethepremiseforaclichépopcornscience-fictionmoviehasnow
becomearealglobalconcernasrecentexposuretomediatisedeventssurrounding
thehazardsposedbytheexploitationofpathogenicmaterial,asrawmaterialsfor
researchandcommercialuse,hassensitisedgoverningbodieswiththeneedto
enhancedomesticsurveillanceofsuchbiologicalmatterundertheumbrellaof
“biosafety”.TheGovernmentofCanadahasprepareditsownstrategyinresponse
tothisissueandonJune23rd,2009gaveRoyalAssenttothelonganticipated
HumanPathogensandToxinsAct(the“Act”)inaneffortto“promotesafetyand
securitywithrespecttohumanpathogensandtoxins”andallactivitiesassociated
withthemandthereforehelpcontrolandregulateanydisease-producingagentor
othersubstancesthatareharmfultothebody.
WhiletheoldrulesregardingimportationstillapplyundertheHumanPathogens
ImportationRegulations,theActclassifieshumanpathogensandtoxinsintoseveral
Schedulesdependingontheirriskgroupsandimposesregistrationrequirementsto
anyonehandlingsuchmaterialsthroughtheissuanceofalicensefromthePublic
HealthAgencyofCanada.Naturally,theobligationsandrestrictionsattachedtosaid
scheduledmaterialsvarydependingontheevaluatedrisksassociatedwiththem.

Fromatransitionalperspective,theActistocomeintoforceinthreemainphases.

Phase1(currentlyineffectasofJune23rd,2009)statesthatanypersonknowingly
handlingscheduledpathogensortoxinsnowhasadutyofcarewithregardstothe
publicandmustadvisetheMinister,withinninetydays,ofallriskgroupsintheir
possessionaswellastheirlocation.Apersonnewlyacquiringsuchmaterialshas
thirtydaystoregisterthesameinformation.Apersonwiththeappropriatesafety
trainingmustbenamedasaprimarycontactandallinformationprovidedistobe
updatedannually.Anycommunicationoffalseormisleadinginformationis

©CIPS,2009.
*WithLEGERROBICRICHARD,LLPamultidisciplinaryfirmofLawyers,andPatentandTrade-mark
Agents.PublishedintheFall2009Newsletterofthefirm(Vol.13,No.3).Publication068.113E.

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prohibited,aswellastheactofintentionallyreleasinghumanpathogensortoxins
causingrisktothehealthandsafetyofthepublic,whichusuallyshouldgowithout
saying.
Phase2willcomeintoeffectonlyafterextensiveconsultationwithaffected
stakeholdersinordertodeveloptheproperregulatoryframework.Inessence,the
consultationsaretocovertheproceduresforobtainingalicensetohandlehuman
pathogensandtoxinsfromacertainriskgroup,aswellasthenecessarysecurity
screenings,inventorydetailsandcontenttobeprovidedduringtheregistration
process.Consultationswillalsoaddressanyadditionalrulesregardingtransfers,
imports,exports,aswellasthespecificqualificationsandpowersofthe“biological
safetyofficers”,whoareindividualsnamedbyeachapplicanthavingcertain
obligationsthataretobedefinedbyregulation.
Phase3willbringintoforcetheprovisionsoftheActassociatedwithspecific
prohibitions,penaltiesandotherrequirements,includingthecriteriaforfacility
access,securityclearancesaswellastheobligationtoreportanyinadvertent
releaseorexposure.
MuchisstillunknownaboutthescopeandtheimpactthattheActwillhave,since
manyofitsprovisionshaveeithernotcomeintoforceorrelyonasofyetunreleased
regulationstogovernmanyaspectsofitsadministration.Stakeholdersare
recommendedtostartdevelopinginternalactionplansinordertocomplywiththe
newActandareencouragedtoparticipateinanyconsultationsessionsheldbythe
PublicHealthAgencyofCanada,asthecasemaybe.Moreinformationisavailable
attheURLhttp://www.phac-aspc.gc.ca/ols-bsl/pathogen/register-eng..php.

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