HSE & Dutyholders working together to manage biological safety

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? HSE‘s 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

9. Agree Initial Interventions • Timetable of interventions • Benchmark inspections - site or topic based: • Safety management within Dept. X • Working @ 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

12. 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 H&S • 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

16. 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”

28. 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

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