rg1andrg2localriskassessmenttemplate.doc

7/27/2019 RG1andRG2LocalRiskAssessmentTemplate.doc

1/12

Local Biohazard Risk Assessment

Requirements, Instructions and Template

For Risk Group 1, 2, and 2+ aterial

Local Risk Assessment Requirements!

It is a requirement of the Public Health Agency of Canada (PHAC) and the Canadian FoodInspection Agency (CFIA) that each laboratory performs a detailed local risk assessment(LRA)

to determine the biohaard containment le!el required for both facilities and operational

practices to mitigate the ris"s associated #ith the biohaardous agents in use$

%he local ris" assessment of all #or" #ith biohaardous material (Ris" &roup ' and and )* isto be documented as part of a +ueen,s -ni!ersity .iohaard Permit Application$

A local risk assessment "ill!

identify the Ris" &roup of the microorganism* (or tissue that might contain this

microorganism)

describe the potential haard associated #ith the microorganism* including symptoms of

disease if it is pathogenic (#hich it is important for all lab members to "no# so that they

#ill be a#are of any potential lab acquired infection so that it can be diagnosed and

treated appropriately$ Although disease is unli"ely #ith R&' microorganisms* if #or"ing#ith an R&' agent that is other than a cloning strain of bacteria* determine if it has been

pathogenic in immune/compromised indi!iduals$)

indicate #hether the material #ill be used only in vitro* or also in vivo

o #hat is being done #ith the material and #here0 consider procedure,s potential for

generating aerosols that might contain and spread infectious agents

o indicate #hether or not sharps #ill be used and the precautions associated #iththem

o in vivouse of infectious materials increases the ris" of e1posure* so the facilities

and operational practices for in vivo#or" must be described separately from that

for in vitro#or"

describe the o!erall ris" mitigation strategy and details of this strategy including2

o physical containment and engineering controls (i$e$ lab design) %his can be

indicated simply by stating the #hich of your containment le!el ' or

laboratories (or shared facilities) #ill be used for the different types of #or"*

because the .iohaard Committee inspects all laboratories$

o operational requirements

containment equipment and supplies equipment might include e$g$ .iological 3afety Cabinet* centrifuge

cups #ith aerosol resistant lids containing o/rings

supplies might include e$g$ closed* scre#/capped tubes

appropriate personal protecti!e equipment (PP4)

decontamination and disposal methods


2/12

medical sur!eillance (e$g$ immuniation* titre chec"s* first aid and medical

response to accidental e1posure)

training needs (this #ill be supplied as a separate statement in theapplication)

At +ueen,s the Principal In!estigator,s local ris" assessment is to be documented and appendedto the .iohaard Permit Application along #ith any applicable ris" assessments from reputable

sources (e$g$ PHAC P353) and lab specific procedures637Ps$

In general* more detail is required for material and acti!ities that pose a greater ris"$

%he local ris" assessment and associated documents are re!ie#ed and appro!ed by the

.iohaard Committee$

After appro!al* these documents become an integral part of the training of lab personnel$

Follo#ing appro!al of a .iohaard Application or a .iohaard Amendment that changes

the type or ris" group of material used in the lab (re!ie#ed by the .iohaard Committee)*each member of the biohaard lab team is required to2

o read the appro!ed .iohaard application6amendment and associated documents

that are posted on the %RA+6Romeo site

o ha!e any questions that they might ha!e ans#ered by their P$I$ and6or the

.iosafety 7fficer

o submit the .iohaard %eam 8ember Attestation form through the %RA+6Romeo

system* to indicate that they understand and #ill abide by the requirements for#or"ing safely #ith the biohaardous material$

All ne" personnelmust read the #ersion o$ this local risk assessmentthat has been

appro!ed by the .iohaard Committee as part of the lab specific training before they areadded to the list of authoried indi!iduals on your .iohaard Permit$

Instructions re%ardin% the use o$ the Template!

Examples or partial templates of local risk assessments are provided below to assist researchers

in developing a local risk assessment for their laboratories.

It is not required that this format be used and the examples are not exhaustive .

The requirements for your Local Biohaard !isk "ssessment are outlined above# and in

the $ueen%s Environmental &ealth and 'afety '()* Biosafety*+, which is available on

the web site www.safety.queensu.ca. The material that is regulated as a biohaard through the $ueen%s Biohaard -ommittee

is described in '()*Biosafety*+ http/00www.safety.queensu.ca0pol.htm1biopol.

"lthough some of the information required for the local biohaard risk assessment is contained

in the biohaard permit application form# and in your biohaard inventory and risk group table#the local risk assessment is very helpful for the Biohaard -ommittee and for your personnel

because the narrative form clarifies what is being done and demonstrates that the researchers
http://www.safety.queensu.ca/http://www.safety.queensu.ca/http://www.safety.queensu.ca/pol.htm#biopolhttp://www.safety.queensu.ca/http://www.safety.queensu.ca/pol.htm#biopol


3/12

have thought about the safety haards and how to mitigate the risks. In some cases the

procedures being used affect the risk and this is much clearer in the local risk assessment than

from looking at the form.

%he current !ersion of the Canadian .iosafety 3tandards and &uidelines (9':)* is a!ailable on/

line at http266###$phac/aspc$gc$ca6lab/bio6inde1/eng$phpHard copies are no longer a!ailabledue to a limited print run$

Italicized text is a comment, example, alternative or a question.

Abbreviations:

PHAC Public Health Agency of Canada

CFIA Canadian Food Inspection Agency

A%CC American %ype Culture CollectionPHAC P353 Public Health Agency of Canada Pathogen 3afety 5ata 3heet

In the Template below, please remove my italicized comments and remove or alter any other

text that does not apply to your lab.

If a $ueen%s Biosafety '() has been written for the biohaard# equipment# or procedure thatyou will be using then it should be mentioned in your local risk assessment# indicating that you

and your personnel are aware of the contents of the '() and will follow it

http/00www.safety.queensu.ca0pol.htm. "lso# where appropriate# indicate deviations from the

'() 2and briefly 3ustify the change4 or indicate where practices will be followed that arerecommended but not required in the '(). )lease do not attach $ueen%s E&5' '()s.
http://www.phac-aspc.gc.ca/lab-bio/index-eng.phphttp://www.safety.queensu.ca/pol.htmhttp://www.phac-aspc.gc.ca/lab-bio/index-eng.phphttp://www.safety.queensu.ca/pol.htm


4/12

P.I. name Biohazard &ontainment Le#el 1 and 2 Local Risk Assessment

General 'ro%ram (#er#ie"!

'tart with one or two sentences or a short paragraph describing the research pro3ect goals and

general approach.

Biohazardous aterial!

Then describe# first in general terms# what types of biohaardous material are used and thecommon techniques# and then more specifically with paragraphs for each type of biohaard e$g$

%he pro;ect in!ol!es the use of multiple standard laboratory techniques for the manipulation of

mammalian* insect* bacterial and yeast cell cultures and the proteins* R


5/12

9escribe any in vivo work that includes intentional infection with bacteria.

3ome of the yeast cells contain recombinant 5>>> protein(s)$

It is acceptable to ma"e the follo#ing note here and on your in!entory2 .acteria (or yeast)

containing recombinant 5


6/12

?1 tissues or cells from species are used for >> analysis$ %hose from species are from

purpose/bred specific pathogen free animals and from tissues that should not contain large

numbers of bacteria$ %hey are therefore not considered biohaardous but are treated #ith goodgeneral lab practices (so this doesn>t actually have to be reported to the Biohaard -ommittee#

but sometimes it is helpful to clarify in the context of an application4....... "r are from the

intestines and therefore contain large numbers of risk group 8 bacteria and so the tissues0cellsare treated using level 8 biohaard procedures and containment 2describe important lab safety

practices briefly if not described elsewhere in this risk assessment4 *'or are from species

that are collected from the #ild or are not specific pathogen free$ %his species could contain thefollo#ing oonoses that are classified as ris" group pathogens for humans* so the follo#ing

precautions are ta"en *'or are from humans$

All fresh human blood and tissue samples#ill be treated as ris" group because they mightcontain unidentified human pathogens$ All personnel #ill read and follo# +ueen,s 37P/

.iosafety/9 on Human %issue* .lood or 7ther .odily Fluid$

The actual risk 2haard times probability4# the amount of care in containment# and the responseto an accident will vary depending on the source of the human material# the volume handled#

and the techniques used.

9escribe the population that the samples are from and what the associated risks might be eg. Is

the population a generally healthy population< Is it screened for &I?# &ep B# &ep -# etc. and

are samples from positive individuals excluded< "re the patients all positive for &I? 2orpositive for some other human pathogen4# and if so then indicate the precautions that will be

taken....consider whether aerosol resistant centrifuge cups should be used and opened only in a

biological safety cabinet 2or if appropriate state that no centrifuging will be done4.

?olume handled at one time is important because risk increases with large volumes.

-onsider the risk of what will be done with the blood or tissue. :ill the blood or tissue be

maniputlated in the lab in ways that could generate aerosols< 9escribe these techniques and

the precautions that will be taken to reduce or contain aerosols 2e.g. proper pipetting technique#pipetting down the side of the tube with no forceful expulsion# to reduce aerosol generation=

capped tubes and rotors to contain aerosols during centrifugation= aerosols allo#ed to settle for

'9 minutes before tubes opened after centrifugation if #or"ing outside of a .3C4.

It is preferable to do level 6 work inside a B'- to contain aerosols and this is recommended.

&owever if this is not feasible then indicate why and what work is done outside of the B'- using

cells or their extracts or serum.

If using a B'- consider whether or not the cells0serum0etc. have been treated in a way that

would inactivate any level 6 pathogens that are# or might be# present before removal from theB'- for further work with the material eg. detergent extraction# formalin fixation# etc. If not so

treated then what is done to minimie aerosol generation and contamination of the laboratory

rg1andrg2localriskassessmenttemplate.doc

Documents