Biosafety & IBC Overview
Tim Muller, MS, CBSP
University Biosafety Officer
Biosafety and Risk Groups
• Biosafety is the development and implementation of
administrative policies, work practices, facility design, and
safety equipment to prevent transmission of biologic agents
to workers, other persons, and the environment.
• The World Health Organization (WHO) has recommended an
agent risk group classification for laboratory use that
describes four general risk groups based on these principal
characteristics and the route of transmission of the natural
disease.
• The NIH Guidelines for Research involving Recombinant DNA
Molecules established a comparable classification and
assigned human etiological agents into four risk groups on the
basis of hazard.
Risk Groups and Biosafety Levels
• A risk assessment will determine the degree of
correlation between an agent’s risk group
classification and biosafety level.
• Biosafety Levels (BSL) consist of combinations of
laboratory practices and techniques, safety
equipment, and laboratory facilities.
– The CDC publication “Biosafety in
Microbiological and Biomedical Laboratories
(BMBL)” has ranked four different biosafety
levels based on risk, with BSL-1 being the
lowest and BSL-4 being the highest.
CLASSIFICATION OF INFECTIOUS MICROORGANISMS
BY RISK GROUP
RISK GROUP
CLASSIFICATION
NIH GUIDELINES FOR
RESEARCH
INVOLVING
RECOMBINANT DNA
WORLD HEALTH ORGANIZATION
LABORATORY BIOSAFETY MANUAL
Risk Group 1
Agents that are not
associated with
disease in healthy adult
humans.
(No or low individual and community risk) A
microorganism that is unlikely to cause human
or animal disease.
Risk Group 2
Agents that are
associated with human
disease which is rarely
serious and for
which preventive or
therapeutic
interventions are often
available.
(Moderate individual risk; low community risk)
A pathogen that can cause human or animal
disease but is unlikely to be a serious hazard to
laboratory workers, the community, livestock
or the environment. Laboratory exposures may
cause serious infection, but effective
treatment and preventive measures are
available and the risk of spread of infection is
limited.
CLASSIFICATION OF INFECTIOUS MICROORGANISMS
BY RISK GROUP
RISK GROUP
CLASSIFICATION
NIH GUIDELINES FOR
RESEARCH
INVOLVING RECOMBINANT
DNA
WORLD HEALTH ORGANIZATION
LABORATORY BIOSAFETY MANUAL
Risk Group 3
Agents that are associated
with serious or lethal human
disease for which preventive
or therapeutic interventions
may be available (high
individual risk but low
community risk).
(High individual risk; low community risk)
A pathogen that usually causes serious
human or animal disease but does not
ordinarily spread from one infected
individual to another. Effective treatment
and preventive measures are available.
Risk Group 4
Agents that are likely to cause
serious or lethal human
disease for which
preventive or therapeutic
interventions are not usually
available (high individual risk
and high community risk).
(High individual and community risk)
A pathogen that usually causes serious
human or animal disease and that can be
readily transmitted from one individual
to another, directly or indirectly. Effective
treatment and preventive measures are
not usually available.
Laboratory Postings
• Labs are posted with appropriate
BSL signage for PI disclosed
biological agents.
• Posting for BSL-1 and BSL-2 labs
include the following:
– Medical Surveillance Cues (2)
– Basic Biosafety Training (2)
– Standard Microbiological
Practices (1 & 2)
– Facility Requirements (1 & 2)
– Waste Disposal (1 & 2)
– PI Contact Info (1 , 2 & 3)
– Biological Materials in lab (W/S)
Routes of Disease Transmission
Contact
• Mucous membrane (mouth,
nose, etc.)
• Eyes
• Skin abrasions/cuts
• Parenteral (needlesticks)
• Fomites - contaminated
environmental surfaces
Ingestion
• Contaminated food or drink
Aerosol
• Inhalation in lungs
• Intranasal
Standard Microbiological Practices
• Restrictive access to lab
•
•
Authorized personnel only
• Principal Investigator / Supervisor :
• Controls lab access
• Ensures compliance with institutional policies and
procedures
• Ensures personnel have been advised of hazards and
received appropriate safety training
Theft prevention /Biosecurity
• Hand washing
•
•
•
•
Soap and water for 15 seconds
After removing gloves
After working with hazardous materials
Before leaving the lab
• No eating, drinking or food storage in lab
•
•
Use break rooms
Common areas
• No mouth pipetting
•
Use mechanical pipetting devices
Standard Microbiological Practices
• Personal Protective Equipment (PPE)
to be used for laboratory procedures
– Lab coats
• Remove before leaving lab area
• Don’t launder at home
– Autoclave (decontaminate) before
sending to a commercial laundry service
– Eye and face protection (goggles,
mask, face shield or other splatter guard)
• When working outside the Biological
Safety Cabinet (BSC)
• Decontaminate before reuse
– Use an appropriate disinfectant
–
No shorts or open-toed shoes
Standard Microbiological Practices
• Personal Protective Equipment (PPE)
• Gloves
• Selection based on a risk assessment
– Chemical compatibility
• Wear two pairs of gloves when appropriate
• Latex alternative available
• Replace as needed, when compromised or visibly
contaminated
• Wash hand after removal
• Don’t wash or reuse disposable gloves
• Remove before leaving the lab
– Respirators
•
•
•
•
Risk Assessment – BHC (272-5993)
Proper selection (particulate, chemical or both)
Medically cleared to wear – EOHS (272-8043)
Respirator fit testing / training – SRS (277- 9006)
Standard Microbiological Practices
• Handle sharps safely (needles / syringes,
scalpel blades, glass pipettes, slides, etc.)
• Avoid manipulating needles after use
• No Bending
• No Shearing
• No Breaking
• No Recapping
• Place used needles, syringes, glass pipettes and
other contaminated sharps in sharps containers
consistent with 29 CFR 1910.1030
(OSHA Bloodborne Pathogens Standard)
• Closable
• Puncture resistant
• Leak proof on sides and bottom
• Red / fluorescent orange container or
orange-red BioHaz label
Standard Microbiological Practices
• Handle sharps safely
• Use mechanical method to handle
broken glassware (place
contaminated sharps in sharps
container)
• Brush and dustpan
• Tongs
• Forceps
• Use plasticware instead of glassware
to reduce chances of sharps injuries
or accidental inoculations
• Pipettes
• Serological
• Pasteur
• Misc. lab containers
Standard Microbiological Practices
• Perform procedures to minimize
splashes or aerosols
– Pipette carefully
– Transfer biological solutions with caution
• Decontaminate work surfaces with an
appropriate disinfectant
– After completing work
– After spills (potentially infectious materials)
– Splashes (potentially infectious materials)
• Decontaminate all cultures, stocks and
potentially infectious materials before
disposal
– Appropriate disinfectant / adequate contact time
• Bleach (final volume adjusted to 10%) for 30
minutes. Use copious amounts of water after
discharge into the drain/sewer to reduce corrosion
Standard Microbiological Practices
• Biomedical waste disposal (infectious or
potentially infectious materials)
– Use red bags consistent with 29 CFR
1910.1030 (OSHA Bloodborne Pathogens Standard)
– Acceptable waste (Biomedical Waste Contractor
policy)
• Gloves
• PPE
• Lab supplies / Plastic items (without sharp edges)
• Sealed / closed sharps containers
(no uncontained sharps in red bags)
Institutional Biosafety Committee (IBC)
• The IBC is a safety committee that reviews research
with recombinant or synthetic nucleic acid molecules
and Risk Group 2 and higher biological agents.
• The IBC has expertise in the following area:
–
–
–
–
–
–
–
–
rDNA / nucleic acid technology
Microbiology
Biological and animal containment
Biosafety / general safety
Public health
Epidemiology
Veterinary medicine
Occupational medicine
Institutional Biosafety Committee (IBC)
• The IBC meets quarterly (Feb, May, Aug and Nov) to
review & approve submitted research protocols.
– Protocol submission deadline is three weeks prior to the
scheduled IBC meeting.
• Research protocols and procedures requiring IBC
review must be approved by the IBC before initiation.
• The Biohazard Compliance (BHC) Office
administratively manages the IBC for UNM. The BHC
website contains information on the IBC, biosafety
related topics and contact information.
http://hsc.unm.edu/som/biohazard/
Online Biosafety Training
Course
BIO-H 107
Title
BIO-H 111
The Safe Transport of Division 6.2 Infectious Substances,
Biological Specimens, Dry Ice & Related Materials
ABSL-2 Working Safely with Laboratory Animals (ABSA video)
BIO-H 112
ABSL-3 Working Safely with Laboratory Animals (ABSA video)
BIO-H 117
Effective Use of Class II Biological Safety Cabinets
BIO-H 118
The Bad Laboratorian
BIO-H 119
Safe Use of Chemical Fume Hoods
Bio-H 122
Biosafety Training for BSL-1 & BSL-2 Laboratories
Bio-H 400
BSL-3 Concepts
BioHazard Compliance
• Webpage
– http://hsc.unm.edu/som/biohazard/
• Personnel
– Biosafety Officer, Tim Muller
• Reginald Heber Fitz Hall / RHFH.B83
• 272-5993
• tmuller@salud.unm.edu
– Biosafety Specialist, Monica Moya Balasch
• Reginald Heber Fitz Hall / RHFH.B83
• 272-8001
• mmoya55@salud.unm.edu
Export Control
Tim Muller, MS, CBSP
Foreign Nationals
Permanent Residents
Dual Citizenship
Export Control
• Export control laws (“ECL”) are U.S. federal
laws and regulations that regulate the export
of strategically important products, services
and technologies to foreign persons.
• Foreign person(s)
– Any foreign government
– Any foreign corporation or organization that is not
incorporated or organized to do business in the U.S.
– Any individual who is not a U.S. citizen or lawful
permanent resident of the U.S. (green card holder)
Export Control
• Federal Agencies
– State Department: International Traffic in Arms Regulations (ITAR)
• Military technologies
– Commerce Department: Export Administration Regulations (EAR)
• Dual use technologies with civilian or military applications
(e.g., biologicals, chemicals, satellites, software, computers)
• EAR’s list of controlled technologies is called the Commerce
Control List (CCL)
– Bureau of Industry and Security (BIS) website
– Treasury Department: Office of Foreign Assets Control (OFAC)
• Prohibits certain transactions with countries subject to boycotts,
trade sanctions and embargoes (e.g., Balkans, Burma, Cuba, Iran,
Iraq, Libya, North Korea, Sudan, Syria, and Zimbabwe)
Export Control
• Deemed Export
• EAR 734.2(b)(2)(ii) - Any release of technology or
source code subject to the EAR to a foreign national.
Such release is deemed to be an export to the home
country or countries of the foreign national.
• This deemed export rule does not apply to persons
lawfully admitted for permanent residence in the
United States and does not apply to persons who are
protected individuals under the Immigration and
Naturalization Act (8 U.S.C. 1324b(a)(3)).
Export Control
• EAR Technology Defined - Specific information necessary
for the development, production and use of a product.
• Development - is related to all stages prior to serial production,
such as: design, design research, design analyses, design
concepts, assembly and testing of prototypes, pilot production
schemes, design data, process of transforming design data into
a product, configuration design, integration design, layouts.
• Production - all production stages, such as: product
engineering, manufacture, integration, assembly (mounting),
inspection, testing, quality assurance.
• Use - Operation, installation (including on-site installation),
maintenance (checking), repair, overhaul and refurbishing.
Export Control
• Use of controlled technology (EAR) by a
foreign national does not required a license,
unless all 6 components of the use definition
are met.
– Operation
– Installation
– Maintenance
– Repair
– Overhaul
– Refurbishing
Export Control
• 2B352 Equipment capable of use in handling
biological materials
– Complete containment facilities (BSL-3 and BSL-4)
– Fermenters with a capacity of 20L….
– Spray drying equipment
– Class III biological safety cabinets
– Chambers designed for aerosol challenge testing
with microorganisms, viruses, or toxins and having
the capacity of 1 m3 or greater.
Export Control
• EAR Deemed Export Requirements
• Foreign Nationals
– EAR NLR (if not performing all components of
Development or Production or Use of controlled
technology listed the CCL)
– Other exemptions available for academic institutions
• Permanent Resident
– EAR NLR
• Dual Citizenship (US and X)
– EAR NLR
Export Control
• Foreign Nationals
– Disclosed to HSC Export Control
• Export Control Exclusion Screening Form(s)
– Sponsored Projects Office(SPO) / Preaward
– I-129 Form (Petition for a Nonimmigrant Worker)
• Attestations for Export Control Compliance
• H-1B, L-1 or O-1A beneficiaries
Export Control
• Webpage
– HSCexport@salud.unm.edu
– Tim Muller
• Reginald Heber Fitz Hall / RHFH.B83
• 272-5993
• tmuller@salud.unm.edu