HSE

1
HSE Dutyholders working together to manage
biological safety

• Dr John Pride
• Specialist Inspector
• Biological Agents Unit

2
Intervention plans

• Why introduce intervention plans?
• What will an intervention plan mean for you?
• What are the key stages?
• How have they evolved since conception?

3
Changes in Government and HSE

• Key Drivers
• Government initiatives on Better Regulation
• Hampton Report 2005
• Better Regulation Executive - May 2007
• New HSE strategy for workplace health and safety
• A strategy for workplace health and safety in
  Great Britain to 2010 and beyond

4
Why introduce intervention plans?

• HSEs strategy has 4 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
• HSE is committed to being a good partner working
  with others to improve health and safety

5
Intervention Plan Ethos

• Engagement to maintain high standards
• Tailored - time period is centre specific
• Evolving
• Applies to all centres
• Success - high level of confidence in biosafety
  management systems
• Rewards reduced inspections, degree of self
  regulation, what else?

6
Intervention plan

• Proactive techniques to influence safety
  standards
• Inspections / Audits
• Training courses / Presentations
• Notification reviews
• Consultation
• Tailored
• Evolving

7
Launch

• Discussions between designated inspector BSO
• Meetings with senior managers
• Ultimately looking to get buy in
• Need input as to what YOU want from the programme

8
Compile BA profile

• Agree what activities undertaken where
• Agree how will refer/break down
• Decide where risks/needs greatest

BSOs fundamental to this step
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Agree Initial Interventions

• Timetable of interventions
• Benchmark inspections - site or topic based
• Safety management within Dept. X
• Working _at_ CL3 across organisation

BSOs local safety reps key - factor in your
aims objectives
10
Deliver Initial Interventions

• May need to undertake several visits in order to
  address different topics
• Local feedback

Feedback into wider plan
11
Monitor Review

• Initial interventions inform next series
• Identify areas of good practice
• Identify areas for improvement
• Next round of interventions
• Targeted
• Alternatives to inspection? e.g. increased
  support for internal audits, training courses etc.

Ongoing dialogue
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Fine Tuning the System

• BAU Designated Inspectors (DI)
• Primary point of contact
• Overview of all BA issues - GM COSHH
• Interaction with wider range of staff, including
  senior managers
• Consistency, resources and expertise/interest
  within BAU
• Sites not exclusive to DI other Inspectors
  may/will visit
• Inspectors to feedback and liaise with DI to
  ensure actions in line with Intervention Plan

13
Summary

• Intervention programmes likely to be cornerstone
  of on-site contact
• Underpinned by sensible HS
• Requires ongoing dialogue feedback

14
Techniques for laboratory decontamination
15
New Guidance

• Fumigation operations in microbiological
  containment laboratories guidance on the
  available technologies and their application
• Automated hydrogen peroxide systems
• Formaldehyde

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Hydrogen Peroxide
17
Alternative Systems

• Dry (VHP)
• Concentration of VHP is maintained below the
  condensation point
• Four phases
• Dehumidification
• Conditioning
• Sterilisation
• Aeration

• Wet
• Layer of hydrogen peroxide micro-condensation on
  all exposed surfaces
• Three phases
• Pre-conditioning
• Gassing
• Aeration

18
HP Efficacy Validation

• Broad spectrum, rapid antimicrobial activity
• Efficacy affect by presence of organic and
  inorganic materials (e.g. proteins, lipids)
• Presence of blood
• Cell wall - Mycobacterium species
• Catalase producers?
• Validation considerations
• Type, scope and source of contamination
• Reflect worst case conditions i.e. most resistant
  organism on the most resistant material

19
HP Efficacy Validation

• Wet and Dry Systems being evaluated at HSL
• Disinfection within a complete room setting
• Efficacy testing will move onto M. tuberculosis
  in near future
• Outcome of testing will be disseminated in due
  course

20
Formaldehyde

• Advantages
• Claimed broad spectrum efficacy
• Inexpensive and easy to handle
• Effective against M. tuberculosis
• Disadvantages
• Slow acting, poor penetration
• Health effects Toxic, carcinogenic
• Paraformaldehyde deposition

21
Reclassification

• International Agency for Research on Cancer
  (IARC)
• Overall, the working group concluded that the
  results of the study of industrial workers in
  the USA, supported by the largely positive
  findings from other studies, provided sufficient
  epidemiological evidence that formaldehyde causes
  nasopharyngeal cancer in humans.

22
Reclassification as Carcinogen?

• French proposal for classification as Carc.
  Cat.1 R49 (July 2005)
• Discussed, Nov 05 Oct 06 EU Technical
  Committee, Classification and Labelling meeting -
  Nothing finalised
• Not tabled for Sept 07 Meeting
• Now under European Chemicals Agency remit.

23
Formaldehyde the Future?

• BPD concerns products placed on the market as
  disinfectants
• Does not affect general chemicals
• Therefore if formaldehyde is not marketed as
  disinfectant
• If end user decides to use as a biocide?
• Out of scope of the regulations
• However - REACH could apply
• Research Evaluation Assessment of Chemicals

24
REACH

• New EU Regulatory Framework for Chemicals
• All substances supplied above one tonne per year
• New authorisation for substances of high concern
• Improve the protection of human health and the
  environment
• Maintain competitiveness and enhance innovative
  capability of EU chemical industry
• Came into force 1st June 2007

25
REACH BPD

• Substances registered under biocides/ pesticides
  will not require REACH registration
• Authorisation and restriction may still apply
• EU Technical Committee, Classification and
  Labelling change may have implications on how
  REACH could regulate formaldehyde

26
Recent Developments BPD

• Formaldehyde application for approval has been
  withdrawn
• All Biocide uses, including decontamination, will
  potentially become banned

27
BPD

• Active substances and preparations containing
  one or more active substances, put up in the form
  in which they are supplied to the user, intended
  to destroy, deter, render harmless, prevent the
  action of, or otherwise exert a controlling
  effect on any harmful organism by chemical or
  biological means

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Recent Developments BPD

• Formaldehyde application for approval has been
  withdrawn
• All Biocide uses, including decontamination, will
  potentially become banned
• All biocidal uses of formaldehyde will be banned
• Fourth (final) list deadline 01.11.2008

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Contact Us
Biological Agents Unit 1.2 Redgrave Court Merton
Road, Bootle, Merseyside, L20 7HS