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

AFS 2012:17Mikrobiologiska arbetsmiljörisker– smitta, toxinpåverkan, överkänslighetArbetsmiljöverkets föreskrifter om ändring i Arbetsmiljöverketsföreskrifter (AFS 2005:1) om mikrobiologiskaarbetsmiljörisker – smitta, toxinpåverkan, överkänslighet

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.

1. Risk classes and risk assessment

2. Safety precautions

3. Notification/permission

4. Genetically modifiedmicroorganisms (GMM)

Content

Biological agents /influencing factors

a) Microorganisms, i.e., microbiological units capable of proliferation or transfer of genetic material

b) Cellcultures of multicellular organismsc) Virus and prions,d) Human parasitese) Components or substances produced

by agents in a) to d) in connection with these agents.

Definitions in AV provisins:

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, Campylobacter-species

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 00Telefax 031-13 50 60e-post: goteborg@av.se

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 measuresFour 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.)AlcoholVirkon (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.

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.

Information and instructions

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 ill-health.

o Implementing measures to avoid that the same thing will happen again.

Contained use of genetically modified microorganisms (GMM)

AFS 2011:2Contained 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.

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 riskNotification to AV.

R-activity Medium or high riskPermission 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.

GMM

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.