Revision to Safe Disposal of Clinical Waste

2. Revision to Safe Disposal of Clinical Waste Wendy Rayner, Enviros Consulting Ltd.

3. In summary…… • Why re-write the guidance ? • Steering Group – changes in UK Regulation & guidance • Hazardous waste • Classification of infectious Waste • Classification of medicinal wastes best practice colour coding • Classification of sharps waste • Guide to Waste Management Licences & Exemptions • Consultation process

4. Changes in waste management regulation, notably Landfill Waste Regulations 2002, & Hazardous Waste Regulation 2005 • Changes in carriage regulations, notably amendments to CDGTPE 2004 Regulations (ADR 2005) • Changes in waste segregation – the need to segregate and identify waste destined for different disposal routes. Why re-write the guidance ?

5. Project Management NHS Estates Steering Group Classification & Segregation Transport Treatment & Disposal Working Groups

6. Who influenced the guidance …… • Steering Group included representatives from: • NHS NI • NHS Scotland • NHS Wales • NHS England • PASA • SEPA • EHS • EA • DEFRA • Total 14 • Working Group included representatives from: • SMDSA • FTA • NHS Trusts • NPAG • PIRA • DoT • WAMITAB • Total 28

7. Devolved Regulation of Hazardous Waste Scotland The Special Waste Amendment (Scotland) Regulations 2004. (1st July 2004) England The Hazardous Waste (England and Wales) Regulations 2005. (16th July 2005) Wales The Hazardous Waste (Wales) Regulations 2005 (16th July 2005) Northern Ireland The Hazardous Waste (Northern Ireland) Regulations 2005 (16th July 2005)

8. Hazardous Properties • H1 Explosive H8 Corrosive • H2 Oxidising H9 Infectious • H3A Highly Flammable H10 Toxic for Reproduction • H3B Flammable H11 Mutagenic • H4 Irritant H12 Substances that release toxic gases • H5 Harmful H13 Substances capable of yielding substances listed above • H6 Toxic H14 Ecotoxic • H7 Carcinogenic

9. What is HazardousWaste ? • Regardless of regulatory regime- • guidance on the interpretation and classification of hazardous waste available • in one document: WM2 • Available to download from: • http://www.environment-agency.gov.uk

10. WM2 is Based on the EWC • 20 Chapters relating to ‘industry sectors’ • For example: • Chapter 1 Wastes Resulting from Exploration, Mining, Quarrying, and Physical and Chemical Treatment of Minerals • Chapter 2 Wastes from Agriculture, Horticulture, Aquaculture, Forestry, Hunting and Fishing, Food Preparation and Processing. • Chapter 20Municipal Wastes (Household waste and similar commercial, industrial and institutional wastes) including separately collected fractions. • (Chapter 16 Wastes not Otherwise Specified on the List)

11. EWC is Colour Coded • The EWC is colour coded to aid the identification of hazardous waste. • Non-hazardous entries are shown in BLACK text. • ‘Absolute’ entries are shown inREDtext. • ‘Mirror’ (or threshold entries) are shown inBLUEtext.

12. ‘New’ Classification of Infectious • Not ‘new’ – originates from Hazardous Waste Directive • In WM2 – Joint Agencies Hazardous Waste guidance • Infectious: • “Substances containing viable micro-organisms or their toxins which are known or • reliably believed to cause disease in man or other living organisms”. • WM2 – provides additional guidance

13. Appendix C9 WM2 YES Does the waste arise from (or is contaminated with) material from a human / animal clinically assessed to have a disease caused by a micro-organism or its toxin ? Is the waste listed in chapter 18 (Healthcare Waste) of the EWC? NO YES Is the waste a culture, or enrichment of a micro-organism or toxin known or reliably believed to cause disease in man or other living animal. OR A sample for an animal or animal known or clinically assessed to have a disease caused by a micro-organism or its toxin. Does the waste contain the viable causal pathogen or toxin ? YES YES NO NO Special Requirements DO NOT Apply NOT Hazardous by H9 Special Requirements Apply Hazardous by H9 EWC Codes: 18 01 03 / 18 02 02

14. Unified Classification - New Guidance • 'Unified’ approach linking waste and carriage (transport) definitions • Take into account Hazardous Waste and transport changes. • ‘Practical’ interpretation of WM2 • What is infectious : *It should be noted that waste contaminated with the fluids (liquid or dried) listed in column 2 may be considered infectious if they contain visible blood or there has been a clinical assessment that an infection pathway exists from the waste

15. Better segregation 18 01 03* 18 01 04 20 03 01

16. Classification of Medicinal Wastes • ‘Old’ Special Waste Regulations – reference to POM’s • EWC does not have a category for POM’s

17. Defining cyto toxic & cyto static waste • Term cyto toxic – defined and understood (BNF Chapter8) • Proposed UK definition for cyto static • Proposed definition based on ‘tried & tested’ approach in USA, based on hazardous properties of pharmaceutical product: • Reliance on pharmacists to identify these products – safety data sheets ? • Opportunity for increased segregation

18. Classification of sharps From Healthcare: 18 01 01 Sharps 18 01 03* Waste whose collection & disposal is subject to special requirements in order to prevent infection(infectious) 18 01 08* Cytotoxic & cytostatic medicines (Hazardous drugs)

19. Classification of sharps From Non-Healthcare Sources: • Sharps from the application of tattoos; • Sharps from cosmetic or body piercing; • Sharps from substance abuse (where not arising from healthcare) 20 01 99 Sharps waste for treatment • Waste needs to be labelled and packaged appropriately – still clinical waste & still requires appropriate treatment/disposal. • No need to register as a hazardous waste producer.

20. Best Practice Colour Coding

21. DRAFT – NOT FINAL

22. Waste Management Licences What is a waste management licence ? A conditional authorisation with the objective of ensuring that the storage, treatment or disposal of waste does not cause pollution of the environment, harm to human health or serious detriment to local amenities. When do you need one ? A waste management licence is required for all activities which involve the storage, treatment or disposal of waste. A licence is not generally required to store waste on the site of production however, there are limits to the quantities that may be stored without a licence. Are there any exemptions ? Yes - Exemptions from waste management licensing are mainly for small-scale waste storage and waste recovery operations and are subject to certain limitations.

23. Common Exemptions (WML Regs1994) • Storage of returned medicines to dispensing pharmacy by householder. • Storage of waste on site of production (limitations apply). • Preparatory treatment of certain wastes (shredding / bailing, etc). In addition the EA has identified certain ‘low risk’ activities where they: “do not believe it is in the public interest to expect the operators to obtain a licence”.

24. Low Risk Activities - Exemptions • Treatment by laboratory autocalve of containment level 1-3 microbiological laboratory waste on the premise it is produced • Storage of waste medicines and denaturing of controlled drugs at a pharmacy returned by householders and by individuals • Secure storage of sharps at a pharmacy returned by householders and by individuals. • Secure storage of sharps as a result of operational work by local authorities, public bodies, emergency services, utility and transport companies pending disposal. • In general exemptions should be registered with the EA

25. Consultation • Due October 2005 • Department of Health Estates web site. • 6 week consultation period. • Final guidance due to be published Spring 2006 • Incorporated in regional guidance throughout the UK.

26. Wendy RaynerTel: 07800 624364 wendy.rayner@enviros.com