Basics of Biosafety

Working Safely with Biological Materials

Central Michigan University
College of Science and Technology

What is Biosafety?


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

Agents and Risks



The agent is the what creates risk Risks to the worker or environment are often unknown Determining acceptable risk?

Assessing Risk
 There

is always risk!

The risk must be identified The risk is evaluated The risk must be measured Plan to minimize the risk

Who Determines Acceptable Risk?

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


Identifying Risk
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

Evaluating Risk Acceptability

   

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

What is Acceptable Risk?

    

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

WHO-World Health Organization

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

Biosafety Levels (BSL)



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 Level 1


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 2


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 3
 

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 4
  

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

Laboratory Acquired Infections (LAI)

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)

Viral
16% from clinical labs  70% from research labs


32% from animal related activities

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

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


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

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

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

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)

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.

And More Biohazardous Waste Categories

Animal and plant pathogen waste  Recombinant DNA waste  Sharps


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?

#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)

#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

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!

Disinfection


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!

WRAPPERS/NONABSORBENT MATERIALS CONTAMINATED WITH BLOOD

BANDAGES/OTHER ABSORBENTS SATURATED OR CRUSTED WITH BLOOD

STAINED?. or SATURATED?

Managing Non-Sharp Biohazardous Waste

labeled container lined with a biohazardous waste bag equipped with a lid.

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.

Breakable Non-sharps Biowaste

Store in labeled containers that are puncture-resistant, closable and will capture leakage, BUT.

Do NOT use SHARPS containers!

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

 

Treated Waste Bag Disposal

   

Allow waste bag to cool Use fume hood to reduce odors Securely tie bag shut Place bag in a nontransparent black bag for regular disposal Remember: NO ORANGE BAGS IN DUMPSTER!

#3
Examples:

Is it a sharps hazard?

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!

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

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.

Proper Use of Sharps Containers

  

Place tops on containers before use on lab bench Dont forget to date the container when first put into use Remember: sharps containers are a one-way disposal system

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

Whats wrong with this picture?

Sharps Container Disposal



Containers must be permanently closed and disposed of through the animal facility manager: Within 90 days of first use When full

Disposal methods: Landfill Incineration We use waste hauler

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

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

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


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!

Any Questions?

Thank You for your attention!

Thanks to Carol Stevens at CMU & Robin Mecklem at MSU for their assistance with this presentation