Download Risk class 1 - Medarbetarportalen

How shall we work with microorganisms?
AFS 2005:01
”Provisions from the Swedisk Work Environment Authority” (AV)
http://www.av.se/lagochratt/afs/
Ingrid Bölin Dep. Microbiology and Immunology, GU
The provisions from 2005 were revised 2012 and
now include regulations for work with blood and
other body fluids.
The revised version will come into force May 1
2013.
AFS 2012:17
Mikrobiologiska arbetsmiljörisker
– smitta, toxinpåverkan, överkänslighet
Arbetsmiljöverkets föreskrifter om ändring i Arbetsmiljöverkets
föreskrifter (AFS 2005:1) om mikrobiologiska
arbetsmiljörisker – smitta, toxinpåverkan, överkänslighet
Content
1. Risk classes and
risk assessment
2. Safety precautions
3. Notification/permission
4. Genetically modified
microorganisms
(GMM)
Definitions in AV provisins:
Biological agents /influencing factors
a) Microorganisms, i.e., microbiological
units capable of proliferation or transfer
of genetic material
b) Cellcultures of multicellular organisms
c) Virus and prions,
d) Human parasites
e) Components or substances produced
by agents in a) to d) in connection with
these agents.
Risk class 1
• Risk class 1 comprises normally non-pathogenic
biological agents and non-pathogenic strains of
pathogenic species or viruses.
• Included in risk class 1 are also nonpathogenic
biological agents that can cause disease in other
ways, like allergic reactions or toxic reactions.
Example of riskclass 1: non-pathogenic
Escherichia coli
Risk class 2
• Biological agents that may cause diseases which can be
cured or prevented or normally are self-limited without
serious sequelae.
• Viruses that have been isolated from humans and do not
belong to a higher risk class.
• Included are also biological agents suspected to cause
cancer in humans, but with a low risk after exposure, e.g.
many other concurrent factors are needed.
Example: Streptococcus pyogenes, Campylobacterspecies
Risk class 3
• Included in risk class 3 are infectious agents with a risk
of serious consequences after exposure, i.e.,causing
serious illness with limited possibilities for cure or
prevention or being highly contagious.
• Biological agents which may cause cancer and where
the probability of cancer development is high after
exposure.
Exempel: Mycobacterium tuberculosis
Risk class 4
• Risk class 4 contains biological agents with a very high
risk of serious disease after exposure. It may be a
combination of a serious or deadly disease, with no cure
or prevention, and the risk of epidemic transmission of a
highly contagious agent.
Exempel: Ebolavirus
• If a biologicala agent may cause cancer in humans
without any concurrent factors involved it is also
classified as 4.
Swedish Institute for
Communicable Disease Control
(Smittskyddsinstitutet,SMI)
harbours the only P4 laboratory for
work with risk class 4
microorganisms in the Nordic
countries.
=safety level 4.
Work with risk class 3
microorganisms also requires
special containment laboratories.
Permission from AV is needed for
work with both the highest risk
classes.
Notification and permission
28 §
The first time an employer intends to use an infectious agent AV should
be notified no later than 30 days before the work will start. Major
changes that will affect the risks should be reported within a month
after they have been implemented.
Arbetsmiljöverket, Distriktet i Göteborg (Västra Götalands och Hallands län)
Rosenlundsgatan 8, Box 2555,
403 17 Göteborg.
Tel 031-743 72 00
Telefax 031-13 50 60
e-post: [email protected]
29 §
The following activities are only allowed after permission from AV.
1. Work with risk class 2 agents in culture volumes exceeding 500.
2. Work with, or storage of risk class 3 or 4 biological agents.
Risk assessment and documentation
• The role of the employer is to assess the risks for
diseases and accidents in the workplace.
• Risk assessments should be done to identify
microbiological risks and necessary preventive
measures.
• Adequate competences for risk assessement shall be
available.
• Written documentation is needed.
• Risk assessments have to be renewed at regular
intervals.
Factors that may influence the risk
assessment
 The properties of the infectious agent: infective dose,
airborne transmission, availability of antimicrobial
drugs or vaccines and possible toxic or allergic risks.
 Procedures with high risk: creation of aerosols or risk
of spill.
 The design of the working environment.
 Staff knowledge and training .
Protective measures
Four different levels of protective measures are described
in the provisions. The risk assessment and risk class of the
agent decides which level that should be applied.
Good microbiological practice should be employed :
Cleanliness and order.
Hand wash and/or disinfection after finishing work.
No jewells on hands or hair or shawls hanging
loose.
No eating, drinking or working in a way that may
contaminate the mouth.
Avoid spill, splashes and creation of aerosols.
Avoid using sharp items.
Use closed containers for contaminated glassware,
etc.
Use protective clothing (lab coat).
Protection level 2
Appropriate warning signs should be displayed at
entrences or at work places where biological agents are.
The design of the signs should be ”biological hazard” with
information of risk class or protective level and additional
necessary information.
The biological agents should be
stored in a safe way.
Protective clothing should be worn when working with risk
class 2 agents. Protective clothes and other personal
protective equipment must be removed when leaving the
restricted area.
Protection level 2, cont.
Premises, furnishing and equipment.
The premises should be demarcated.
This means that the rooms should be physically separated from
other activities with walls and doors.
Access to the premises should be restricted (locked doors, acess
cards for qualified personnel).
Washbasins with hand desinfectant. The taps should be possible to
use without hands.
Benches and floors should be resistant to disinfectants.
The roooms should be rodent and insect proof.
Protection level 2, cont.
Autoclave should be available.
Autoclave must be in the vicinity of the work place, normally located
in the same building.
Procedures that may cause
aerosol formation should be
done in a microbiological
safety hood equipped with
HEPA-filter. The function of
the hood should be checked
regularily.
Protection level 2, cont.
Decontamination
Decontamination should be done to an extent that prevents
biological agents to cause disease and as soon as possible with
suitable methods .
The methods used should be designed as to avoid
microbiological air pollution or other health hazards.
Examples of methods:
Autoclaving (should be used before washing-up of glassware.)
Alcohol
Virkon (for viruses)
Iodine or chlorine compounds
Protective level 2, cont.
Waste disposal
Contaminated waste should be handled and transferred to other
companies or organisations according to routines made in advance
to avoid health risks.
Necessary information about the waste, the risks associated with
handling and the appropriate preventive measures should be given
to the personnel receiving the waste.
Containers should be leak proof and durable to avoid spread of the
content.The content should also be clearly marked on the
containers.
Microbiological waste may in some case be sent for burning in
special boxes for risk waste without previous autoclaving.
Information and instructions
14 §
The employer should ensure that the employee responsible for work with
biological agents and all employees that may be exposed to
microbiological risks have appropriate education and sufficient knowledge
of the infectious agents used in the working place.
All personnel involve in work with these agents should be given
information on the risks and how to avoid them.
15 §
The employer have to ensure that the employees are given written safety
instructions and that the information has been understood and that the
instructions are followed.
If an accident happens…..
The employer is required to have routines for:
o Reporting and documenting unwanted events and
ill-health.
o Taking measures to limit the consequences of
unwanted events.
o Cooperating with people involved in order to
investigate the cause of unwanted events or illhealth.
o Implementing measures to avoid that the same
thing will happen again.
Contained use of genetically modified
microorganisms (GMM)
AFS 2011:2
Contained use: when organisms are genetically modified
or grown, stored, transported, destroid or if such modifed
organisms are handled in other ways and special
cointainments measures are used to prevent them from
contact with the general public.
GMM: a microorganism which has been genetically
changed in a way that does not occur in nature.
GMM
The provisions on GMM are based on the provisions for
microbiological working environment risks, but have a
broader scope.
In addition to risks regarding human health these
provisions also includes:
Risks for diseases in animals and plants.
Risks as a consequence of spread of GMM to the
environment.
Risks as a result of transfer of genetic material to
other organsisms.
Gene technology is also regulated by other laws
(Miljöbalken).
GMM
Work with GMM is classified according to the required
containment level
F-activity
Work with GMM with neglectable or no risk for humans or
the environment.
L-Activity
Low risk
Notification to AV.
R-activity
Medium or high risk
Permission required from AV!
GMM
Risk assessment
What kind of genetic material has been inserted?
What are the properties of the receiving organism?
Will the new construct change these properties?
What are the risks if the GMM is released into the
environment?
Special demands for use of GMM in plants.
Referenser och användbara sidor
• WHO Biorisk management: Laboratory
biosecurity guidance (2006)
• WHO Laboratory biosafety manual (2004)
• CWA Laboratory biorisk management standard
(2008)
• EU-direktiv 2000/54/EC (2000)
• www.gmo.nu
Biotechnology legislation in Sweden with links to
different authorities.