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Biological agents: Managing the risks. Steve Copping HM Specialist Inspector Health and Safety Executive. Managing safely?. HSE Biological Agents Unit What we do Changes in HSE Future working relationships. Update Guidance and advice RIDDOR Hot topics Transport Waste. Aims.

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biological agents managing the risks

Biological agents:Managing the risks

Steve Copping

HM Specialist Inspector

Health and Safety Executive


Biological Agents Unit

What we do

Changes in HSE

Future working relationships


Guidance and advice


Hot topics



biological agents unit
Biological Agents Unit
  • Has primary inspection/enforcement responsibilities for all work with higher hazard pathogens and genetically modified organisms
what we do
What we do
  • Inspect work places
  • Investigate accidents and cases of ill health
  • Enforce good standards
  • Publish guidance and advice
  • Provide an information service
    • Tel:08701 545500
    • Fax:02920 859260
  • Conduct and sponsor research

The Carriage of Dangerous Goods

(Amendment) Regulations

Reporting of Injuries, Diseases and

Dangerous Occurrences Regulations

Control of Substances

Hazardous to Health










and training

Management of Health

And Safety at Work


Genetically Modified

Organisms (Contained

Use) Regulations



Working with biological agents

changes in hse
Changes in HSE
  • 2004 Strategy has four key messages
    • Sensible health and safety is a cornerstone of a civilised society
    • Sensible health and safety is about managing risks, not eliminating them
    • The people best placed to make workplaces safer are the staff and managers who work in them.They do this best by working together; and
    • HSE is committed to being a good partner – working with others to improve health and safety
what this means for the biological agents unit
What this means for the Biological agents unit

Key partner in managing

the risks





(old ‘GM’)

Knowledge Centre



Management Team






(Old ‘DP’)

future working relationships
Future working relationships
  • Continue to inspect
  • Continue to investigate accidents
  • Continue to provide advice and support
  • Continue to enforce where appropriate
  • Continue to run training events/roadshows
  • Use of designated inspectors
  • Intervention plans
designated inspectors
Designated inspectors
  • Allocated to larger centres
  • Maintains overview of all BA issues throughout centre
  • More interaction with senior management and employees
  • Coordinated inspections
  • Oversees BA intervention plan
intervention plans
Intervention plans
  • Developed in consultation with you
  • Prioritisation of topics based on risk
  • Identifying key risk control measures
  • Benchmark inspections- agree where improvements needed
  • Subsequent verification at inspection
  • Improved transparency- both know what is expected

Safety Management



Planning & Implementation

Measuring & Reviewing Performance

safety management
“the people best placed to make workplaces safer are the staff and managers who work in them. They do this best by working together”

Should promote positive safety culture - shared perception of the importance of risk-based safety management

There is nothing that we do as HSE inspectors that you cannot do yourselves

Safety Management
  • Guidance and advice
    • Managing the risks
      • Sealability
      • Fumigation
    • CL4
    • Funeral guidance
    • Spa Pools
management of spa pools controlling the risks of infection
Management of Spa Pools:Controlling the risks of infection
  • Health and Safety Executive (HSE) and Health Protection Agency (HPA)
  • Raise awareness of the microbiological risks and to give advice on some of the control measures that can be used to manage these risks effectively
cl3 sealability fumigation
CL3: sealability & fumigation

SEM M. tuberculosis

Mtb isolated on Löwenstein-Jensen medium

  • COSHH requires that at CL3 the workplace is sealable to permit disinfection
  • Web based guidance
    • Testing for sealability
    • What you can do
testing for sealability
Testing for sealability
  • Smoke pencils
  • Room negative pressure
  • Look for leakage sites from inside the laboratory
  • Easy to use and simple to visualise
  • Readily available and inexpensive
  • Requires knowledgeable tester
testing for sealability1
Testing for sealability
  • Smoke generator to fill the room with smoke
  • Laboratory under neutral pressure
  • Look for smoke outside the laboratory
  • Advantage when detecting leaks into large areas in which smoke builds up over time e.g roof voids, cavity walls
  • Aided by use of a dust lamp
what you should do
What you should do
  • Smoke test when commissioning laboratory
  • Smoke test following any major structural changes to the fabric of the room
  • Check for sealability following routine maintenance
  • Carry out visual inspections as part of an internal auditing programme
why is this so important
Why is this so important?
  • Accidental breakage or spillage outside of a microbiological safety cabinet
    • Breach of containment with potential for release of infectious agent
    • Nothing to prevent escape of toxic fumigant gas
fumigation operations
Fumigation operations
  • Formaldehyde
  • Hydrogen peroxide
  • Fundamental review
  • Discussion document
  • HSC Advisory Committees
  • Paper to HSC
  • Final decision on the way forward
Regulation 3 & 4

Schedule 1 para 8 & 10

Schedule 2 para 7

Incident contact centre (ICC)


Tel: 0845 300 9923

Fax: 0845 300 9924

Open 0830 and 1700 Monday to Friday

hot topics
Hot topics
  • Transport
  • Waste
  • Significant changes in transport regulations for dangerous goods
  • Regulations governing air and postal transfers changed in January 2005
  • Regulations governing road and rail transfers changed in July 2005
the law
The Law
  • The law means that laboratories need to work with all involved in the transfer chain so as to be confident about the safety and security of samples and packages they send and receive.
  • Laboratories have a duty of care to their own staff, to the patient and the public
  • Familiar with new transport Regs for Category A/B
    • Staff trained
  • New procedures for Cat A transfers
  • Adapt existing transfer procedures to deal with transfers of Cat B material
  • Ensure management overview of the whole transfer process
  • Carry out a security review of the transfer process
    • Transfer security plan
  • On clinical/security and safety grounds improve
    • Tracking and alerting
    • Emergency planning
    • Auditing
    • Documentation
further information
Further information
  • Biological Agents: managing the risks Appendix 1.2
  • DH guidance from Inspector of Microbiology
  • DfT “transport of infectious substances”
    • Http://
  • “Guidance on regulations for the transport of infectioussubstances.” WHO
  • Changes
  • Key points
  • Guidance on best practice
    • Unified approach
  • Further information
key changes
Key changes
  • The definition and classification of infectious waste in accordance with hazardous waste regulations
    • Clinical waste classification system using groups A-E no longer used
  • Changes in carriage regulation bought about by the amended transport regs
  • A revised colour coded best practice waste segregation and packaging system
  • The use of European Waste Catalogue (EWC) codes
legislative requirements
Legislative requirements
  • Waste legislation
    • Licences and permits
    • Duty of care
  • Carriage legislation
  • Health and safety legislation
    • HSWA
    • MHSWR
    • COSHH
  • Assess the risks to employees and others
  • Make arrangements for reviewing the assessment
  • Adequately control the risks
  • Provide suitable and sufficient information, instruction and training
  • Provide health surveillance and immunisation where appropriate
  • Suitable and sufficient risk assessment
  • New expectant mothers / young people
  • Effective planning, organisation, control
  • Monitoring and review of any precautions
  • Health surveillance where appropriate
  • Access to competent H&S advice
  • Information for employees
  • Co-operate with other employers
unified definition
Unified definition
  • Clinical waste
  • Hazardous waste (H9)
  • Infectious substance class 6.2
  • If an item of healthcare waste is considered to pose a risk of infection it should be considered clinical waste, it should be classified as hazardous waste and should be transported as an infectious substance
unified approach
Unified Approach
  • Highly infectious waste
    • Known or suspected to be contaminated with Cat A pathogens
    • Should be treated on-site prior to removal to a disposal facility
    • In exceptional circumstances, e.g. autoclave malfunction, waste should be packaged and transferred to an incinerator ASAP
unified approach1
Unified approach
  • Yellow stream infectious waste
    • Disposal by incineration
    • Unautoclaved waste from clinical laboratories
    • Known or suspected to contain Cat B pathogens
unified approach2
Unified approach
  • Orange stream
    • Treated to render safe prior to final disposal
    • Known or suspected Cat B pathogens
    • May contain autoclaved Cat A waste
further information1
Further information
  • DOH (7th July 2005)
    • “The classification of waste as hazardous infectious waste is unlikely to alter the existing treatment/disposal route and further guidance should be sought from your waste contractor(s).”
  • Safe management of healthcare waste
    • Revised and updated HSAC guidance
    • DoH website consultation
      • Closing date 7th February 2006
contact details
Contact details
  • Tel: 0151 951 3964