Changes to Legislation

1. Alan Esland – Compliance ManagerMobile – 07931 747363e-mail – alan.esland@whiteroseenvironmental.comPresentation on Clinical WasteFocus on Infectious Waste.

2. Changes to Legislation • Hazardous Waste Regulations 2005 • List of Wastes Regulations 2005 • Carriage of Dangerous Goods and ADR Regulations • Pollution Prevention and Control Regulations 2000 • Genetically Modified Organisms ( contained use ) Regulations 2000 • The Animal By-Products Regulations 2005 Guidance • HTM 07-01 : Safe Management of Healthcare Waste • WM2 : Interpretation of the definition and classification of hazardous waste ( which can be downloaded from the Agency’s website )

3. Definition of Clinical Waste Controlled Waste Regulations 1992 (a)…any waste which consists wholly or partly of human or animal tissue, blood or other bodily fluids, excretions, drugs or other pharmaceutical products, swabs or dressings, syringes, needles or other sharp instruments, being waste which unless rendered safe may prove hazardous to any person coming into contact with it. And (b) Any other waste arising from medical, nursing, dental, veterinary, pharmaceutical or similar practice, investigation, treatment, care, teaching or research, or the collection of blood for transfusion, being waste which may cause infection to any person coming into contact with it.

4. Old Classification of Clinical Waste Health Services Advisory Committee Group A. Human/animal tissue, blood, dressings swabs etc Group B. Sharps Group C. Microbiological cultures, pathology waste Group D. Drugs or other pharmaceutical products Group E. Sanpro waste, incontinence pads, nappies, stoma bags etc.

5. New Classification of Clinical Waste ( human ) European Waste Catalogue ( EWC Codes ) 180101 – Sharps ( except180103 ) 180102 – Body parts and organs including blood bags and preserves 180103* - Wastes whose collection and disposal is subject to special requirements in order to prevent infection. 180104 – non-infectious waste 180106 – Chemicals containing dangerous substances 180107 – Chemicals other than those mentioned in 180106 180108* - Cytotoxic and cytostatic medicines 180109 – Medicines other than those mentioned in 180108 180110* – Amalgam waste from dental care ( Similarly, 180201 to 180208 for animal healthcare wastes )

6. Definitions of Infectious • Special Waste Definition : Waste containing an ACDP hazard group 4 pathogen ( Lassa fever, Ebola etc ) HWR 2005 Definition : (i) Waste arising from a patient known or suspected to contain a disease caused by a micro-organism or its toxin, where the causal micro-organism or its toxin is present in the waste. (ii) Waste that may cause infection to any person, or other living organism, coming into contact with it. Transport Definition : Category A. An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease to humans or animals. ( UN 2814 for humans, UN 2900 for animals ) ) Category B. An infectious substance that does not meet the criteria for inclusion in Category A. ( UN 3291 N.O.S. used ).

7. Disposal Methods for Clinical waste • 1. High temperature incineration • 2. Pyrolysis and Gasification • 3. Alternative Technologies • a) Autoclaves • b) Hot oil augers • c) Microwaves • d) Chemical disinfection • e) Novel methods • Advantages of Incineration • Accepts all waste types; medicinal residues destroyed; all pathogens and toxins destroyed; proven technology; waste heat recovery • Advantages of AT plants • Cheaper to build and operate, few process emissions, better perception

8. The Aims and Effects of HTM 07-01 • Aims • To improve identification and segregation of clinical wastes. b) To re-classify infectious waste c) To re-classify medicinal wastes d) To introduce use of EWC codes e) To provide guidance on “ best practice “. f) To propose colour-coding system g) Introduction of waste audit systems Effects i) Huge increase in amount of infectious waste ii) Terms cytotoxic and cytostatic now used for medicines rather than POM iii) NHS still coming to terms with segregation/training/audit issues

9. HTM 07-01. Assessment of Infectious Properties Step 1. Is the waste a culture or enrichment, or pathogen or its toxin ? All cultures, enrichments or diagnostic samples ( discarded ) known or suspected to contain viable microbial pathogens or their toxins render the waste H9 infectious. This element of the waste is clinical waste and hazardous waste. The EWC codes 180103* or 180202* should be assigned. Where a toxin is present, the assessment should also consider both the concentration and the chemical properties of the toxin to determine whether the waste also possesses hazardous chemical properties, for example H5 Harmful or H6 Toxic

10. Continuation-Step 2 Step 2. Does the waste arise from a patient who is known or suspected to have a disease/infection caused by a micro-organism or its toxin ? The term “ known or suspected “ relates to diagnosis and treatment rather than laboratory identification. Thus where a patient presents with symptoms that may have several causes, one of which is an infectious agent, an infection is suspected. Once a diagnosis has been made, or a laboratory result obtained, this may become “ known “. Both are considered to represent H9 Infectious. The assessment of waste does not require the identification of a pathogen; the fact that the symptoms may be caused by a pathogen is sufficient. The assessment does not consider the severity of disease or transmission potential at this stage. All pathogens of man or other living organisms are captured.

11. Continuation- Step 3 Step 3. May the waste cause infection to any person, or other living organism, coming into contact with it ? Essentially, is there any other reason why the waste may cause an infection and therefore be considered a clinical waste ? The waste producer may, through item-specific risk assessment, identify reasons other than those outlined above, why the waste may be infectious. Key indications of this would be the producer identifying that the waste is a clinical waste and should be subject to a process that is intended to reduce the number of micro-organisms. Such waste should be assigned the hazardous property H9 Infectious.

12. Continuation- Step 4a Step 4a. Is the waste a sharp ? The main disposal and segregation consideration for sharps waste is medicinal contamination. This guidance does not therefore recommend the item-specific assessment and segregation of sharps waste on the grounds of infectivity. Sharps waste produced as a result of the proposed segregation will contain a mixture of infectious and non-infectious waste. Such waste is therefore likely to contain an element with the hazardous property H9 Infectious. Appropriate EWC codes are 180103*, 180202*, or 200199 ( if it arises from non-healthcare activities – e.g. Drug litter, tattooists )

13. Continuation- Step 4b Step 4b. Is the waste an anatomical waste ? This guidance does not recommend the item-specific assessment and segregation of anatomical waste. Anatomical waste produced as a result of the proposed segregation is therefore likely to contain a mixture of infectious and non-infectious waste, and possess the hazardous property H9 Infectious.

14. Colour coding and Disposal Options Waste typeColourDisposal Domestic Black bag Landfill Offensive/hygiene Tiger bag Deep landfill Mixed infectious Yellow bag Incineration Segregated infectious Orange bag Inc. or AT Cytotoxic/cytostatic Purple striped Incineration Non-cyto medicines Yellow Incineration Dental amalgam White Recovery Cyto sharps Purple lidded Incineration Not-discharged sharps Yellow Incineration Fully discharged sharps Orange lidded Inc. or AT(?)

15. Stericycle Systems • Biotrack system i) Part-completed HWCN and CWTN ii) Colour-coded bin labels 2. Consignment note system for radioactive wastes 3. Consignment note systems for GMO wastes 4. Consignment note system for Animal By-Products 5. Waste producer audits i) Self audit forms ii) Technical audits 6. Waste Advisory Managers 7. Account Managers 8. Customer Service Team 9. Environmental/Compliance Team

16. White Rose Environmental Contains unique barcode number which Identifies client and site ID and waste type Tamperproof and waterproof tag applied to every bin Contains further information including ADR and UN numbering Colour coded with EWC code to ensure segregation and correct treatment A Biotrack Label

17. Research and Laboratory Facilities Brief Description of the sector activities This sector guide covers research and laboratory facilities that undertake work with infectious substances ( that is, those known or reasonably expected to contain pathogens or genetically modified micro-organisms ( GMMs )). While this guidance focuses on waste generated in healthcare premises, it is also pertinent and applicable to healthcare waste from other occupational settings. For the most part, the research and laboratory facilities most likely to generate infectious waste include : • Research laboratories ( for example universities )

18. Continuation • Teaching laboratories ( for example medical schools ) • Clinical laboratories ( for example clinical microbiology departments ) • Forensic laboratories ( for example pathology and post-mortem ) • Veterinary laboratories ( for example diagnostic and research institutes ) • Environmental laboratories ( for example food and water testing )

19. Continuation Work in these facilities falls into two main types : • Where the work involves the intentional propagation or concentration of pathogens or GMMs ( for example, work with infected cell cultures, infected animals, or large-scale propagation of pathogens ). b) Where the work involves materials ( for example clinical specimens ) that may contain pathogens ( for example diagnostic work such as pathology, microbiology, haematology or serology ) and may involve limited culture stage ( for example preliminary isolation of bacteria ).

20. Final Slide ANY QUESTIONS ?