Biosafety Program Management
Refresher Course
Malcolm Barth, Ph.D.
Marian Downing, RBP, CBSP, SM(NRCM)
Ryan Burnette, Ph.D., Director
www.AllianceBiosciences.com

What does a BSO have to know?
◦ No correct answer – “It depends”
◦ ABSA’s definition of a Biosafety Officer is outlined in the NRCM
(National Registry of Certified Microbiologists) task list for
Biological Safety
◦ Some of these tasks may not apply to your institution, e.g.,
 BSC certification (but you need to know the basics)
 How to pack and ship infectious materials (you may have a trained
shipping group)
 Select Agent regulations
www.AllianceBiosciences.com

Develops, implements, maintains
and monitors biosafety programs,
policies and procedures
◦ Goal is to reduce/eliminate
exposure to biological hazards




Provides recommendations for
use/storage/disposal of
infectious waste in accordance
with applicable laws
Manages/performs laboratory
inspections
Develops and delivers biosafety
training
May supervise and develop staff




Reviews/advises on research
protocols for rDNA, humansourced materials, Select
Agents/Toxins
Sits on various committees: IBC,
IACUC, IRB, Occupational Health,
etc.
Responds/investigates spills and
accidental exposures
Finds time for personal
professional development!
www.AllianceBiosciences.com

A BSO is required if:
◦ There is rDNA ongoing at an institution, and
◦ There is large scale (>10 Liters) of recombinant work, or
◦ There is BSL-3 work with rDNA materials



Select Agent regulations do not specify a “BSO”, but
leave the door open for a PI to potentially fulfill all the
registration requirements.
Some institutions – the BSO does very little beyond
reviewing IBC research proposals and lab inspections.
Other institutions – the bulk of the IBC operational
issues are handled by a Research Compliance Group.
www.AllianceBiosciences.com
www.AllianceBiosciences.com

Management commitment to safety, which may be classified
as including:
◦
◦
◦
◦
◦
◦
◦

Prioritization of safety over production (or research, in this case)
Maintaining a high profile for safety in meetings
Personal attendance of managers at safety meetings and in walk-abouts
Face-to-face meetings with employees that feature safety as a topic
Job descriptions that include safety contracts
Communication about safety issues (both formal and informal)
Regular communication between management, supervisors and the workforce
Involvement of employees, including:
◦ Empowerment
◦ Delegation of responsibility for safety
◦ Encouraging commitment to the organization.
www.AllianceBiosciences.com

Encourage PI commitment to safety (new PI interviews?)
 Setting a good example (e.g., wearing PPE)
 Setting aside a few minutes in lab meetings to discuss safety
issues or staff concerns about safety




Promote reporting of incidents (non-punitive)
Upper management support (written commitment to safety
for the School, signed by the Dean, and posted)
Reward good safety practices (certificates for good lab audits
or reporting unsafe practices)
Self-audits of lab areas by staff (with PI involvement)
www.AllianceBiosciences.com



Must occur for rDNA, frequency
is determined by IBC (should be
in writing)
SA – committed to quarterly?
Recommend all labs inspected at
least annually
◦ Safety technicians can be trained
to do lab audits, supervised by the
BSO
 Checklists – can use ones provided
by CDC on SA website, or make your
own. Need to document audits,
notification of deficiencies,
corrective action.
◦ Labs can do self-audits
(documented) to increase
frequency of inspections and
buy in to “safety culture”
 Provide checklists
◦ Fire dept. weekly inspections
 Could be used to cover many of
the labs that need inspection
◦ Scheduled vs. drop-in?
◦ Start audit program with sister
campuses
◦ Summer worker? Could be
trained to do audits
◦ Team audits with radiation,
fire, etc. (safety in numbers)
www.AllianceBiosciences.com

Follow up:
◦
◦
◦
◦
◦
◦
◦



Near misses
Spills
Releases
Any report of loss or release to a govt. agency
Lab associated infection
Noted deficiencies after previous inspection
Fire department observations while doing rounds
New PI (after orientation and lab setup)
New agent in use
Change-over of lab
www.AllianceBiosciences.com



Should be non-confrontational but thorough
Should be documented (spreadsheets/databases
available for this)
Provide solutions for most common deficiencies at the
time of the audit
◦
◦
◦
◦
Carry vacuum setup diagram for lab vacuum
List of appropriate disinfectants
Extra signage for doors
Handout on proper sharps disposal
www.AllianceBiosciences.com

Repeat offenders, or labs that do not correct
deficiencies
◦ Attempt to correct any IDLH situations before you
leave
◦ Arrange meeting with PI, EHS Manager, if necessary
◦ IBC policy on this issue would help
 Some institutions give additional time to correct
deficiencies, then escalate it to the Dept. Chair, and if
necessary, to the Dean
 Must be published for PIs to read in advance (Safety
Bulletin?)
 Need upper administration buy in
www.AllianceBiosciences.com

Eating/drinking in the lab
◦ Definitely a no-no and hard to defend
◦ An easy catch for regulators
◦ Includes drinks on desks in the lab,
unless there is a wall with a door
◦ PIs have to enforce
◦ Carry a copy of a LAI that was
contracted via ingestion – hand out to
violators?

Drinking water dispenser in the lab
www.AllianceBiosciences.com

PPE Issues
◦ A tough nut to crack in most academic institutions, but not impossible
 Carry pairs of safety glasses on inspections and hand out if they
cannot produce them?
 Information on how to order safety glasses
 Remind them that eyes cannot be replaced
 Compliance is possible. Industry is able to get 99% compliance, but only
after working on the “safety culture” and enforcing use of PPE by putting a
letter in the file of offenders, followed by probation for repeat offenders
◦ Even at BSL-1, safety glasses should be worn for any manipulation
involving chemicals or organisms
 Eye infection from a yeast culture in the lab
 Do not want common lab chemicals in eyes (bleach, 7X, SDS, etc.)
www.AllianceBiosciences.com

BSC issues
◦ Moldy collection flasks
 Carry copy of flask setup and disinfectant
suggestions
 Remind them that good science (i.e., tissue
culture) depends on scrupulous cleaning.
 Collection flasks should be plastic or have
tape or netting on them, and if they are
under the BSC, they should be in a plastic
pan (secondary containment).
www.AllianceBiosciences.com

Sharps (such as Pasteur pipets) in
regular trash
◦ Carry a handout on proper sharps disposal
◦ Provide a small poster to be posted in the labs (with pictures) that
summarizes disposal of broken glass, sharps, glass tubes, etc.

Expired BSC certifications
◦ Hands on training should include teaching staff to check Magnahelic
gauge and last certification date before working inside BSC
◦ Different way to handle annual certification – many institutions do not
leave this up to the PIs. They have a program that tracks the dates (in
Maintenance or EHS) and prompts for annual testing.
www.AllianceBiosciences.com

Young children in the labs
◦ Definitely not in the “business” area of the
lab. May be acceptable if they are in an
office with a door. Concerns are chemical
as well as biological. There should be a
written policy about where children can
go.

Cloth chairs
◦ BMBL – even at BSL-1, chairs must be
impermeable and able to be disinfected
 Quick fix – cover with a heavy duty plastic
bag or duct tape until chair can be replaced
www.AllianceBiosciences.com
◦ Dirty BSCs
 Training course should discuss routine lab cleaning and
include monthly wipe down of BSC, including under
work surface (if removable)
 Many problems avoided by cleaning/disinfecting BSC
thoroughly (walls, glass, work surface) before and after
work. Use a “Swiffer” duster.
 All equipment going into the BSC is wiped down with
alcohol or disinfectant.
 All items coming out of the BSC after work is done are
decontaminated with an appropriate disinfectant.
 Chemicals and other items should not be stored in the
BSC
www.AllianceBiosciences.com

Lab equipment and surfaces
◦ Monthly decontamination of water baths
and incubators
 Discard old cultures
 After any spill, for sure
 Follow manufacturers instructions, or use
disinfectant followed by alcohol or sterile
water
◦ Daily wipedown of bench tops
◦ Who cleans the floors?
 Use appropriate detergent disinfectant, such as
Vesphene
www.AllianceBiosciences.com

Training of lab staff
◦ Ask to see their SOPs for lab tasks or equipment operation
◦ Ask to see the documentation that the SOPs were read

Is there a copy of the research proposal(s) available in the
lab, and have the employees doing the research signed off
that they have read it?
◦ Various agencies conduct interviews to determine if
PI and/or staff are informed. This is an easy catch for a
regulator.

The staff should be able to describe the spill procedure,
who to notify, where to go to report an exposure, etc.
◦ Ask informal questions during your visits to test their
understanding
◦ Post emergency procedures in lab (spills, exposures, etc.)
www.AllianceBiosciences.com


Should have a biohazard symbol and the word “Biohazard”
List contact information for lab, including a night contact
◦ Can Security contact PI at home if they have a name to call?

Should list Biosafety Level, infectious agents in use (BSL-2 and
above), human-sourced products, etc.
◦ Unless security is a concern, SA may not have to be listed, but
since building is secured, this should not be a big issue

List any special entry requirements or concerns, e.g.,
◦ Need a respirator when work is ongoing
◦ Vaccinations needed to enter
◦ Agent may put pregnant or immune suppressed person at
increased risk
◦ Anyone entering should have Occupational Health approval
www.AllianceBiosciences.com

Disinfection
◦ List of appropriate disinfectants included in Biosafety Manual
 Should be based off of EPA Approved lists, and targeted for type
of organism as well as application
 It is illegal to use/prepare disinfectants in opposition to label
claims
 E.g., using on porous surfaces when claims are for hard surfaces or not
using on precleaned surfaces
 Alcohol is not an appropriate disinfectant for most infectious
agents
 OSHA will cite you for using alcohol with human sourced materials
 Alcohol is appropriate for controlling environmental contamination on
clean surfaces
 Wiping down materials going into a BSC, etc.
www.AllianceBiosciences.com

For BBP and most infectious
agents, use:
◦ List B (tuberculocides)
◦ List A Sterilants
◦ List D, List E (eff vs. TB, HBV)

Commonly used:
◦ 2 -10% bleach (@5.25% NaOCl)
◦ Cavicide, Citrex, Amphyl, Dispatch
◦ “Lysol” has many different
formulations – make sure you are
using one that is tuberculocidal

Disinfection website:
http://www.epa.gov/oppad001/chemregindex.htm

Floors: Vesphene, LpH
Hand sanitizers do not
belong next to the sink!
www.AllianceBiosciences.com


Should provide copies of slides so those that may
not understand immediately can have a reference
Exercises and ice-breakers to keep people focused
◦ Gameshow Pro game – load your own questions, force
audience participation
◦ Crossword puzzle, fill in the blank, break into groups and
discuss an issue, case studies, etc.

Lab Associated Infection case study
◦ Have trainees point out all of the mistakes that
were made
◦ Use to reinforce timely reporting, knowing signs and
symptoms, use of PPE, etc.
www.AllianceBiosciences.com



AAALAC demanded animal handler training
sessions for
all infectious agents in the facility
Training of animal handlers (in a group) is a good
way to get to know them so they feel comfortable
telling you about their concerns
Game format works well (Gameshow Pro or
manual game of Jeopardy or Tic-Tac-Toe)
◦ Hand out candy as prizes (they will remember you)
www.AllianceBiosciences.com

Handouts written in layman’s terms
(esp. for infectious agents – modify
Canadian MSDS to focus on mode
of transmission, signs and
symptoms, incubation period)
◦ Give them your phone # and e-mail address
on the handouts


Keep it fun and interesting
Document all session attendance
www.AllianceBiosciences.com

4 hour classroom for all
BSL2, 8 hour classroom for
all BSL3, including all new
MDs, PIs, grad students,
etc.
◦ Minimum 6 hours hands-on
EHS training for all BSL3
◦ BSL2 hands-on offered -mandatory for SA work


BSL3 workers –
◦ Mandatory verbal test with RO
covering all emergency
procedures, spills, exposure
reporting, BMBL, agent specific
info, etc.

Voluntary serum banking,
medical surveillance,
mental fitness check
12 page test for BSL3, 4
page test for BSL2
www.AllianceBiosciences.com

Even experienced PIs, MDs, etc. may have
marginal technique
◦ Some non-nationals may not have had much
lab experience, or may not have used
appropriate equipment

Making training mandatory for everyone
(BSL-3) gives a baseline of institutional
expectations and eliminates feeling of
being singled out
◦ People will know what they are supposed to be
doing, even if they may choose not to do it
www.AllianceBiosciences.com

Focus on use of BSC
◦ Cleaning and decontamination of BSC, placement of
equipment, hand movements, decon of equipment, entering
and leaving BSC, spills in the cabinet


Table-top exercises for centrifuge spills and leaks, spills
in the lab, demonstration of BSC airflow with smoke
stick or machine
Use of PPE, training on PAPR (if appropriate) and
wearing PAPR while working in the BSC during the
training
www.AllianceBiosciences.com


Trainee given new safety glasses
to keep, appropriate PPE
Simple lab experiment (serial
dilution) given to trainee, who
does it with their normal
technique, observed by the
biosafety trainer (~2 hours)
◦ Usually use diluted fluorescein as
“virus” for procedure


Lapses in technique discussed with
trainee
Black light can be used to point out
aerosols, drips, etc.



Next, trainee comes back another
day and performs a similar
experiment, attempting to
correct procedure based on
trainer comments
Trainee returns at least one more
time to work, ideally with good
technique.
Trainee may have to come back
for additional sessions until they
have mastered use of the BSC,
able to answer questions about
spills, cleanup, use of centrifuges,
etc.
www.AllianceBiosciences.com
www.AllianceBiosciences.com

73.9 Responsible
Official
◦ Have authority and
responsibility to act on
behalf of the institution
◦ Ensure compliance
◦ Document annual
inspections and correct
deficiencies
◦ May designate alternate

73.10 Restricting Access
and SRAs
◦ Access
 Possession or the ability to
gain possession
 Do you have access defined
in your document?
 No access with approved
SRA
 Can request expedited
approval
 Can appeal denial
 Valid for a max. of 5 years
www.AllianceBiosciences.com

73.11 Security

◦ Develop and implement a
written security plan

 Site specific risk assessment
 Provide graded protection in
accordance with the risk








Physical security
Inventory control
Information systems control
Access control
Routine cleaning, maintenance,
repairs
Removing unauthorized or
suspicious persons
Badge, key and card control
Reporting
Training
Drilled and reviewed annually
www.AllianceBiosciences.com



Only individuals with
approved SRA have
unescorted access
Unapproved individuals
are continuously
escorted by an
approved individual
Separate SA from the
public areas





Storage containers are
secured
Inspect all suspicious
packages
Establish a protocol for
intra-entity transfers
Prohibit sharing pins,
keycards, passwords
Plan for how/who will
receive packages of SA
www.AllianceBiosciences.com

The RO will be
immediately notified:
◦ Loss or compromise of
keys, passwords,
combination
◦ Suspicious
persons/activities
◦ Loss or theft of SA
◦ Release of SA
◦ Inventory record
alteration or discrepancy
www.AllianceBiosciences.com


Written Biosafety Plan
Describe the biosafety
and containment
procedures sufficient to
contain the SA or toxin
◦ Physical structure
◦ Operational and
procedural safeguards

Consider
◦ BMBL
◦ OHSA 29 CFR parts 1910.
1200 (HazCom) and
1910.1450 (Occ Exp to
Hazardous Chemicals)
◦ NIH Guidelines for rDNA

Annual drills/exercises
to test plan
◦ Revise as necessary
www.AllianceBiosciences.com

Need approval from
CDC or USDA for
◦ Transfer of a drug
resistance
◦ Biosynthesis of select
toxins with
LD50<100ng/kg body
weight
www.AllianceBiosciences.com

Written Incident Response
Plan
◦ Coordinated with any entitywide plans
◦ Kept in the workplace and
available to employees for
review
◦ Drills/exercises held annually

Entity’s response
procedures for:
◦ Theft, loss, release
◦ Inventory discrepancies
◦ Security breaches (including
information systems
◦ Severe weather and natural
disasters
◦ Workplace violence
◦ Bomb threats
◦ Suspicious packages
◦ Emergencies (fire, gas leak,
explosion, power outage)
www.AllianceBiosciences.com

The response procedures
must account for:
◦ Hazards associated with the SA
or toxin
◦ Appropriate actions to contain
the SA/toxin

Name and contact info for
key individuals
◦ Backup for people on vacation,
ill






Personnel roles, lines of
authority and
communication
Emergency medical
treatment and First Aid
PPE and emergency
equipment
Site security and control
Procedures for emergency
evacuation
Decontamination
procedures
www.AllianceBiosciences.com


Provide training prior to
access
Training address:
◦ Particular needs of the
individual
◦ The work they will do
◦ The risks posed by the SA


Annual refresher training
Training records maintained
www.AllianceBiosciences.com

CDC or APHIS must
authorize all transfers
◦ Form 2

Transfer only to registered
entities/individuals
◦ The sender is either registered
for the SA/toxin, is exempt, or
is outside the US and meets all
import requirements
◦ The recipient must be
registered for the SA or toxin
www.AllianceBiosciences.com

Accurate, current inventory
for each SA held in long
term storage
◦ Guidance on CDC website for
definition of “long term
storage”


List of approved individuals
Record of all entries into SA
areas

Accurate, current records
associated with
◦ RO, Security, Biosafety,
Incident Response, Training
sections



Written explanation of any
discrepancies
Ensure that all records and
databases are accurate,
have controlled access, and
authenticity may be verified
Maintain for 3 years
www.AllianceBiosciences.com

When?
◦ Without prior notification
◦ Prior to issuing a certificate of registration
www.AllianceBiosciences.com

Immediately notify CDC or APHIS for:
◦ Theft or loss of SA or toxin
◦ Release of an agent causing occupational exposure or outside
the primary barriers of the biocontainment area
 Some people regard this as a spill outside the BSC, if this is the
primary biocontainment area
 Notifications that are overly cautious are preferred to no
notifications. They would rather know about anything you are
unsure about.
www.AllianceBiosciences.com

73.20 Administrative
Review
◦ Person or entity my
appeal a denial,
revocation, suspension,
limitation or revocation in
writing if submitted
within 30 days


73.21 Civil Money
Penalties
The Inspector General
(DHHS only) is the
delegated authority to
conduct investigations
and to impose civil
money penalties
against any individual
or entity for violations
www.AllianceBiosciences.com

Updates on the CDC
Select Agent home
page
◦ http://www.selectagents.
gov/index.html


Biosafety Listserve
notices of changes and
proposals
Bill to move Select
Agent process under
Homeland Security
www.AllianceBiosciences.com

Info from Texas Society for Biomedical
Research meeting
◦ Southwest Foundation (San Antonio)
 Deficiencies in training and inventory system
 Implemented a computerized bar-coding system
for identifying all vials of SA
 Implemented a computer based training and
tracking system
Research at SW Foundation
www.AllianceBiosciences.com




Present outline of course training topics
Define record keeping requirements ensuring
compliance
Refresher training annually
“Means used to verify that the employee
understood the training”
◦ Quiz with passing grade and retraining on missed
questions


GAP notification for training due/missed
Provide “Proficiency Statement” and/or Training
Certificate for completed training modules
www.AllianceBiosciences.com

Inventory discrepancies -common citation
◦ Provide form to researchers
(examples on internet)
◦ BSO or staff should do spot
checks of inventory
(Quarterly?)
www.AllianceBiosciences.com

ABSA involvement and meeting attendance
◦
◦
◦
◦

Keep up with current issues
Make contacts that last a lifetime
Find a mentor for new projects
Attend courses to broaden knowledge and
fulfill continuing education requirements
Local affiliate (MABSA)
◦ CM credits for meetings/seminars

RBP
◦ Will be required to recertify every 5 years with 40 points,
similar to CBSPs
www.AllianceBiosciences.com




Sign up for MMWR (Morbidity and
Mortality Weekly Reports) from CDC.
Free, interesting and sent via e-mail
(http://www.cdc.gov/mmwr/)
Read ABSA Journal for notices,
research into biosafety issues
List Serve – don’t need to read
everything, but often there are
timely notices of legislation, news
items, etc.
NIH outreach sessions
◦ Keep up with NIH proposed
regulations, interpretations of the
guidelines
www.AllianceBiosciences.com
Ryan Burnette, Ph.D.
Director
9011 Arboretum Parkway, Suite 310
Richmond, VA 23236
866-654-6674
www.AllianceBiosciences.com
info@AllianceBiosciences.com
www.AllianceBiosciences.com
www.AllianceBiosciences.com