Biosafety Program
Management
EMD Lecture #3
Biosafety Program
• Institutional oversight & acceptance
– President, CEO, CFO
• Institutional Biosafety Committee (IBC)
– peer review, adopt/establish policies
• Biosafety Office
– inform, administer program, assist
• Faculty, staff, students & visitors
– merge biosafety into work
Related Compliance Entities
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IRB
IACUC
ICC
Grants & Contracts
Police, Security
Other
Regulations/Responsibilities
• 1970 OSH Act
– 5(a)(1) General Duty Clause
• Related OSHA Standards
– PPE, BBP, EtO, Labels, HAZWOPER, etc.
• NIH Guidelines (rDNA)
– Applicability, scope
• Transport
– DOT, IATA, USDA, CDC/PHS, DoC, other
Regulations/Responsibilities
• Agencies
– FDA, EPA, NIH OHRP, State, City
• Guidelines
– CDC/NIH BMBL, CDC TB, APIC, WHO, NSF
49, etc.
• Training
– BBP, TB, Shipping, Biosafety, Lab Safety, PPE,
Infection Control, special hazards
Information to Employees
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Hazard awareness
Risk (toxicity/disease), signs/symptoms
Exposure limits/infectious dose
Employer’s responsibilities
Protective measures (controls)
Medical surveillance/monitoring
Emergency response procedures
Biosafety Program
Management
I GO WHERE
I’M TOWED TO!
Biosafety Program
Management
• IBC as DMV
– speed limits, rules/regulations
– registrations/renewals, fines
• Program is tow truck and pace car
– safely deliver to desired location
• BSO as State Police
– inform, assist, control, emergency response
Biosafety Program
Management
• Employees
– luxury, economy, SUV’s, dragsters, stalled, etc.
• AAA
– Administrative support
– Active (pro-active biosafety program =
awareness)
– Accountability for compliance at all levels
Biosafety Program
Management
• Adopt/mandate required policies
• Apply OSHA General Duty Clause
elsewhere
• Establish policies where needed
Rationale
• Control hazards
– Anticipate
– Identify
– Evaluate
• Prevent lab-acquired infections
– Interaction
– Proactive
– Assumption of responsibility
Prevention
• Interaction
– Registration/reauthorization
– Initial and periodic training & inspections
– Sanctions
• Evaluation
– Risk assessment/risk management
– Incidents/near misses
Risk Assessment &
Risk Management
Prior Planning
Prevents Poor Performance
Risk Assessment &
Risk Management
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Pathogen
Procedures
Personnel
Place
Protective Equipment
Ineffective Program Management
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Morbidity/mortality
Perceived lack of institutional control
Regulatory visit/action
Legal action (civil/criminal penalties)
Bad press
Low morale
Biosafety Program
Management
• “I go where I’m towed to!”
– “Tell ‘em where you’re going to tow them”
– “Tow ‘em where you want them”
– “Tell ‘em why you’ve towed them there”
Identification of
Biological Agents
Identification of Agents
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Department
PI/Lab Director
Type of Lab
Lab Supervisor
Building(s)/room(s)
Phone/fax/email/campus address
Identification of Agents
• rDNA
– exempt/non-exempt, IBC, NIH-OBA
registration
• Human material
– OSHA regulated, other
• Plants
– low risk, plant pests, pathogens, USDA APHIS
requirements
Identification of Agents
• Human Pathogens
– Risk group
– local, state, federal registrations
• Animals
– natural infections
– work with biohazards
– work with animal pathogens
Identification of Agents
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Human subjects
Healthcare/clinical locations
Toxins of biological origin
Shipping/transport of regulated agents
Other?
Identification of Equipment
• Autoclaves
• Biosafety cabinets, clean benches, glove
boxes
• Eyewashes, showers
• Centrifuge containment
Identification of Handlers
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Name, employee ID Number
Campus address/contact information
Identify work experience
Observe work practices if necessary
Refresher training as needed
Biosafety Database
Management
Occupationally exposed workers
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Bloodborne Pathogen training (initial/annual)
Biosafety Training (initial/periodic)
HBV Vaccination program (other immunizations)
TB Training, PPD Test
Shipping/Transport Training (biennial)
BSL3 Training/certification of researchers
Select Agent registration/training/review
Equipment & Facilities
• Autoclave (location, testing)
• Clean air device (location, certification)
• biosafety cabinets, ventilated enclosures
– repairs, moves
• BSL3 facilities
– commissioning
– annual air balancing
– HEPA filter testing
Research Registration
• Comprehensive Biohazard Registration
Form (all biological materials used)
• rDNA protocols (new, updates, new
personnel)
• Human pathogens (biennial)
• Select Agent transfers (inventory, tracking)
• Inspections (semi-annual, annual)
– BSL1, BSL2, BSL3, Animal, Select Agents
Institutional Documentation
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IBC minutes (subcommittee deliberations)
Approval letters
Safety Manuals (periodic updates)
Incidents
– Non-compliance reports
– Accidents, exposure investigations and
recommendations
– Serious adverse events (human subjects)
Biosafety
Manual
Biosafety Manual
• Introduction/Contact Info/Overview
• Responsibilities
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Chairperson
Principal Investigator/Manager
Researcher/Employee
Safety Office
IBC
Biosafety Manual
• Requirements
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Annual registration
Human etiologic agents/select agents
rDNA
Regulated human material
Biohazards in animals/USDA Regulated agents
Clean air device program
Training
Biosafety Manual
• Medical Surveillance/Employee Health
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Screening
Immunization
Medical restrictions
Serum storage
Incident reporting/evaluation/follow-up
Counseling
Records
Biosafety Manual
• Risk Assessment/Risk Management
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Biosafety levels
Routes of transmission
Signs/labels
Work practices
Personal protective equipment
Protective equipment/engineering controls
Biosafety Manual
• Decontamination
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Disinfectants
Sterilization methods
Medical waste program
Treatment of mixed wastes
Biosafety Manual
• Spill/Emergency Response
– Spill kits/training/preparation
– BSL1, BSL2, BSL3 spill response
– Mixed spills
Biosafety Manual
• Shipping/Transport
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Clinical, diagnostic specimens
Etiologic agents, toxins of biological origin
Packaging
Shipping declaration forms
Import/export requirements
Biosafety Training
Biosafety Training
• Lab safety
– chemical, biological, fire, security, incident
response
• Biosafety
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human/animal pathogens
RG2/BSL2
rDNA
proficiency/competency
Biosafety Training
• Bloodborne Pathogens
– Initial @ time of hire
• specific components of standard
• targeted to audience
– Annual retraining
– Sharps Safety Devices
• Evaluation & training
Biosafety Training
• BSL3 Training
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work practices, PPE, controls
biosafety cabinet
facility operations
spill/incident response
formal evaluation of proficiency
inspection of proposed SOP
Biosafety Training
• Shipping/Transport of Infectious Substances
– IATA (initial and every 2 years)
– DOT (initial and every 3 years)
• labs working with etiologic & other regulated agents
• provide info to those handling clinical specimens
– Shipper/transporter/receiver
• general awareness
• function specific
Biosafety Training
• Tuberculosis
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At time of hire, screening
Infection control
Proposed annual training requirement
Respiratory protection
Healthcare and beyond!
Biosafety Training
• Effective Use of the Biosafety Cabinet
– recommended
– part of Biosafety training
– can require based on audit results
Institutional Biosafety
Committee
Role of the IBC
• Established by highest administrator
• Oversight for potentially hazardous work
• Set policy for safe conduct of biohazard
research
• Oversee rDNA projects; ensure compliance
• Responsibilities not restricted to rDNA
IBC Membership (NIH rDNA)
• varied disciplines (rDNA, microbiology, lab
safety, engineering, lab technical staff,
legal, community)
• > 5 members (2 from community)
• plant pathogen/containment expertise
• animal containment expertise
• biosafety officer if BL3/BL4 or large scale
IBC Membership
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consult with other scientists as needed
annual report to NIH/OBA
suggest opening meetings to public
minutes available to public upon request
Suggested IBC Subcommittees
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Human Gene Transfer Clinical Trials
Xenotransplantation
Medical Surveillance
Biosafety Level 3
• All report back/through IBC
IBC Function
• review rDNA research
• assess physical/biological containment level
• assess:
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facilities
procedures
practices
training/expertise of personnel
IBC Function
• Infectious agents, toxins, other biohazards
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review PI written risk assessment
perform risk assessment/assign RG or BSL
train personnel, verify proficiency, retrain
inspect proposed work practices/area
periodically monitor
• Design/commissioning containment labs
– annual verification
IBC Function
• periodically review rDNA research
• adopt emergency response plans
• report significant accidents/illnesses to state
local public health agencies & NIH/OBA
• report significant problems/violations of
guidelines to NIH/OBA
IBC Function
• communicate results of review to PI
• don’t authorize initiation of work not
covered by guidelines w/out NIH review
• ensure compliance with surveillance data
reporting for human gene transfer projects
IBC Function
• Sanctions
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establish framework in advance
develop with related institutional entities
acquire administrative backing
perform case by case review
work with & prevent repeat
document, file, and report to required bodies
Communication with Related
Committees/Groups
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NIH OBA, OHRP
FDA CBER
CDC, USDA
IACUC
IRB
Grants & Contracts
Occupational
Health Program
Goals of Health Program
• prevention of occupational illness and
injury
• early recognition of health alterations due to
exposure
• prompt treatment and management of
occupational illness/injury
Occupational Health Program
• identify employees at risk
– medical history compared to hazards of position
• pre-placement medical evaluation
– baseline health information
– pre-existing conditions
• determine need for medical surveillance
• schedule update of work/health history
Occupational Health Program
• understand the risks faced by employees
• inform of hazards and methods of protection
• educate on warning signals of illness
(prompt visit to health clinic)
• clear procedure for reporting incidents and
exposures
Medical Evaluation
• BL3, BL4, non-human primate handlers,
respirator users
• pre-assignment/periodic evaluations
– immunization status
– base-line tests (TB, biochemical analysis,
serology)
– high risk medical conditions (GI disorders,
pregnancy, immunosuppressive drugs, etc)
Immunizations
• effective vaccine
• condition of employment?
• evidence of antibody response before
starting work
• booster or revaccination as necessary
Serum Storage
• potential to monitor serological changes
resulting from employee’s exposure
• sample at time of hire, annually, after overt
exposure, at termination
• test at time of collection if agent produces
known serological response
• confidential
• informed consent (may decline)
Report of seroconversion
• examine worker
• investigate procedures
• revise procedures to eliminate exposure
Accidents & Illnesses
• prompt reporting
• immediate medical assistance
– serum samples, stool specimens, nasal and skin
washings
• investigate serious, unusual or extended
illnesses
Employee Health Records
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confidential
exposure reports
serious illnesses
maintain for duration of employment plus
30 years