1. Basics of Biosafety Working Safely with Biological Materials Central Michigan University College of Science and Technology

2. Principles and practices employed to protect laboratory personnel and the environment from exposure or infection while working with living organisms, biological materials, or agents.  Included are any materials that may be potentially infectious.  Includes recombinant DNA research What is Biosafety?

3. The “agent” is the what creates risk Risks to the worker or environment are often unknown Determining “acceptable risk”? Agents and Risks

4. There is always risk!  The risk must be identified  The risk is evaluated  The risk must be measured  Plan to minimize the risk Assessing Risk

5. Assessment is conducted by a Biosafety Professional in partnership with and based on information provided by the Principal Investigator The assessment is presented to the Institutional Biosafety Committee (IBC) for approval Who Determines Acceptable Risk?

6. Understand the biology of the agent Susceptibility and transmission within the host Hazards associated with equipment and procedures Goal:  Provide the highest practical protection and the lowest practical exposure Identifying Risk

7. Worst case scenario -What might happen? Likelihood of an event Seriousness of the incident Actions needed to resolve the problems Evaluating Risk Acceptability

8. Since there is no such thing as “no risk” “Safe” means risk has been judged acceptable Judging risk is a subjective- humans make decisions Measuring risk is objective- use available guidelines, data, and documentation Keep records of how determinations were made due to subjective nature of the process What is Acceptable Risk?

9. Agents Assigned Risk Groups RG-1 Unlikely to cause disease in humans or animals  low individual or community risk RG-2 May cause disease but typically not serious  individual risk, low community risk, treatable RG-3 May cause serious disease, usually treatable  High individual but low community risk, serious respiratory agents RG-4 Serious or fatal, often not treatable,  Easy transmission, high individual and community risk WHO-World Health Organization

10. Different than the Risk Groups!!  Risk groups used in risk assessment  BSL are used in risk management BSL are ways to control the agent  facilities, safety equipment, practices, PPE, etc. Once risk is assessed then the appropriate BSL is determined Biosafety Levels (BSL)

11. Well characterized, non-pathogenic organisms or agents Open bench- no containment Use good laboratory practices, waste disposal, and aseptic techniques Example: E. coli K-12 strains BioSafety Level 1

12. Agents of moderate hazard to personnel or environment Basic lab, but restricted access, containment during certain processes (i.e. aerosols, large volumes, etc.) Autoclave and Biological Safety Cabinet desired Use good laboratory practices, waste disposal, and aseptic techniques Example: most non-respiratory, non lethal, agents BioSafety Level 2

13. Agents of high hazard to personnel or environment Respiratory exotic or indigenous agents which are easily transmissible causing serious or lethal disease All work is contained, engineering controls and controlled environments we currently do not have the facilities to handle. Example: Mycobacterium tuberculosis, SARS, etc. BioSafety Level 3

14. FORGET ABOUT IT!!! Hemorrhagic fever, deadly viruses, etc. Total containment, airtight labs, “submarine” doors, air pumps, water treatment, HEPA filtration, etc. Positive pressure “moonsuits” BioSafety Level 4

15. Bacterial: 76% from clinical labs 8% from research labs Exposure: 60% acquired from inhalation Other exposures include: digestion, sharps, splashes, direct and indirect contact Laboratory Acquired Infections (LAI)

16. Viral 16% from clinical labs 70% from research labs  32% from animal related activities Laboratory Acquired Infections (LAI)

17. Biohazardous/Medical Waste Waste that is potentially infectious to humans, animals or plants. It includes:  Medical Waste according to MMWRA  Regulated Waste by MIOSHA  Regulated Waste by CDC/NIH

18. Michigan Medical Waste Regulatory Act (MMWRA) Defines “medical waste” Requirements for waste handling and disposal Requires generators to register with DEQ and implement a Medical Waste Management Plan

19. Michigan Medical Waste Regulatory Act (MMWRA) Defines “medical waste” Requirements for waste handling and disposal Requires generators to register with DEQ and implement a Medical Waste Management Plan

20. Biohazardous Waste Management Plan Must outline how generating facility complies with the MMWRA: Types of wastes generated Storage and disposal of wastes Contingency plans Training

21. Biohazardous Waste Categories Cultures and stocks of infectious agents and associated biologicals  laboratory waste  biological production waste  discarded live and attenuated vaccines  culture dishes and related materials  contaminated PPE

22. Biohazardous Waste Categories Liquid human and animal waste  liquid or semi-liquid blood and blood products and body fluids  contaminated items that would release blood or items that are caked with blood or other potentially infectious materials; NOT including urine or materials stained with blood or body fluids  infectious animal waste (research)

23. Biohazardous Waste Categories Pathological waste  tissues  body parts other than teeth  products of conception  fluids removed by trauma or during surgery or autopsy/necropsy or other medical procedure and not chemically fixed.

24. …And More Biohazardous Waste Categories Animal and plant pathogen waste Recombinant DNA waste Sharps

25. Biowaste vs. Trash 3 basic questions to differentiate: 1. Is it contaminated with viable biological material? 2. Can blood or other regulated body or biological fluids be released? 3. Is it a sharps hazard?

26. #1 Is it contaminated with viable biological material? Examples: Contaminated lab waste Personal protective equipment used for handling potentially infectious materials (including handling infected animals or their products) Wastes from infectious disease research (carcasses, body fluids…)

27. #2 Can blood or other (regulated) body fluids or viable biological materials be released? Some Examples… Tubes of blood Vacuum flasks containing body fluids or cell line waste

28. Managing Liquid Biohazardous Waste Storage: Label and secure bulk vessels if not disposed of immediately Treatment: Chemical disinfection OR Autoclave Disposal: THEN Flush to sewer Use proper PPE!

29. 10% bleach solution  good for general disinfection  High organics use 20%  Needs to be made weekly  Test contact time Ethanol  Use 70% solution (most effective)  Longer contact time and flammable *Should research and know effectiveness and contact time for the best disinfectant against your agent! Disinfection

30. WRAPPERS/NON- ABSORBENT MATERIALS CONTAMINATED WITH BLOOD

31. BANDAGES/OTHER ABSORBENTS SATURATED OR CRUSTED WITH BLOOD

32. STAINED?…. or SATURATED?

33. Managing Non-Sharp Biohazardous Waste labeled container lined with a biohazardous waste bag equipped with a lid.

34. Managing Non-Sharp Biohazardous Waste Securely tie bags for transport to treatment/collection site. When moving wastes, use secondary containment; avoid using public halls and elevators.

35. “Breakable” Non-sharps Biowaste Store in labeled containers that are puncture-resistant, closable and will capture leakage, BUT…. …Do NOT use SHARPS containers!

36. Effective Waste Autoclaving Leave bag open during autoclaving or loosely closed Add water to bag prior to autoclaving if primarily dry materials Steam must contact materials Place bag in autoclavable tray with sides

37. Treated Waste Bag Disposal Allow waste bag to cool Use fume hood to reduce odors Securely tie bag shut Place bag in a non- transparent black bag for regular disposal Remember: NO ORANGE BAGS IN DUMPSTER!

38. #3 Is it a sharps hazard? Examples: –needles –syringes –scalpels –all biologically contaminated objects that can easily penetrate skin (Pasteur pipettes, razor blades, etc.) Place sharps in approved sharps container for disposal!

39. …Syringes in research settings should be disposed of as a sharp to avoid public relations concerns!

40. Sharps Containers Containers must be leak-proof, puncture-resistant, closable & labeled with the biohazard symbol. Proper sharps containers must be used for both clinic and field work.

41. Proper Use of Sharps Containers Place tops on containers before use on lab bench Don’t forget to date the container when first put into use Remember: sharps containers are a one-way disposal system

42. Proper Use of Sharps Containers Use sharps containers for sharps ONLY! No solid biohazardous waste (i.e. gauze, un-broken pipettes, gloves) No mercury thermometers

43. What’s wrong with this picture?

44. Sharps Container Disposal Containers must be permanently closed and disposed of through the animal facility manager:  Within 90 days of first use  When ¾ full Disposal methods:  Landfill  Incineration  We use waste hauler

45. Safety Notes on Sharps Use Do not re-cap sharps Keep sharps container in close proximity to point of use (i.e. limit handling) for easy disposal Do not leave needles in pockets of coveralls or smocks

46. Carcasses and Body Parts Human tissues  Unfixed tissues are medical waste  Make waste unrecognizable! Animal tissues, carcasses  When generated in infectious disease or recombinant DNA research, these are medical waste These items must be stored in biolabeled, leakproof containers for incineration. Waste service- see Audrey Brown

47. Managing All That Other Waste… Drain bottles of non-hazardous materials before disposal in trash <3% of volume is considered empty Higher volumes must not be thrown in the trash

48. Managing All That Other Waste… Do NOT discard medications in the trash. Return to source for disposal or seek assistance from your campus waste group. See Jaime Stock!

49. Any Questions? Thank You for your attention! Thanks to Carol Stevens at CMU & Robin Mecklem at MSU for their assistance with this presentation