Basic

Laborator
y Safety
Objectives: Upon completion of the
lecture, accompanying video,
required readings and clinical
rotations, the student will be able to:

1) List and describe the appropriate

safety procedures practiced in the
clinical laboratory that pertain to
general laboratory safety and
awareness: a) personal safety
b) eye safety
c) handling of biologically
hazardous material
d) handling of needles and
sharps

2) Discuss the significance of

OSHA to the regulation of safe
practices within the clinical
laboratory.

3) Define the term ‘Universal

Precautions’ and state its
 importance in the handling of accidents and,
potential biohazardous materials. because it involves
the human element,
is one of the most
4) Discuss appropriate safety difficult to cope
procedures practiced in the clinical with. The purpose
laboratory when handling all of this discussion is
chemicals, flammables, ether and to help the student
compressed gases. understand proper
laboratory safety, to
5) Discuss the information provided by increase his
awareness of the
and the appropriate use of the possible risks or
Material Safety Data Sheet hazards involved
(MSDS). with laboratory
work and to realize
6) Discuss appropriate safety the laboratory is
precautions practiced in the clinical generally a safe
place to work if
laboratory when handling
safety guidelines are
radioactive materials. properly followed.

7) Discuss appropriate procedures I. Standard Operating Procedures

practiced in the clinical laboratory
for fire, electrical, and severe A. General Personal Safety
weather safety.
1. Eating, drinking,
smoking, applying
cosmetics or lip balm,
READING: and handling contact
lenses are prohibited
Linne & Ringsrud, Clinical Laboratory in areas where
Science – The Basics and Routine specimens are
Techniques, 4th ed., 1999, C. V. handled.
Mosby, pp 23-42.
2. Food and drink are not
17
stored in refrigerators,
SAFETY IN freezers, cabinets, or
THE on
shelves,
LABORATOR countertops,
Y or bench tops
where blood
Purpose: Faulty technique is one of or other
the chief causes of potentially
 infectious infectious
materials are materials.
stored or in other
areas of possible Gloves should be worn for
contamination. handling
blood and
3. Long hair, ties, scarves body fluid
and earrings should be specimens,
secured. touching the
mucous
4. Keep pens and pencils membranes or
OUT OF YOUR non-intact
MOUTH!! skin of
patients,
5. Appropriate Personal touching
Protective Equipment items or
(PPE) will be used where surfaces
indicated: soiled with
blood or body
Lab coats or disposable fluid, and for
aprons should be performing
worn in the lab venipunctures
to protect you and other
and your vascular
clothing from access
contamination. procedures.
Lab coats should Cuts and
not be worn abrasions
outside the should be
laboratory. kept
bandaged in
Lab footwear should consist addition to
of normal closed wearing
shoes to protect gloves when
all areas of the handling
foot from biohazardous
possible materials.
puncture from
sharp objects Protective eyewear and/or
and/or broken masks may
glass and from need to be
contamination worn when
from corrosive contact with
reagents and/or hazardous
aerosols,
 caustic b. After
chemicals and/or remo
reagents is ving
anticipated. glove
s.
6. NEVER MOUTH c. Befor
PIPETTE!! Mechanical e
pipetting devices must be eatin
used for pipetting all g,
liquids. drinki
ng,
7. Frequent hand washing is smok
an important safety ing,
precaution, which should apply
be practiced after contact ing
with patients and cosm
laboratory specimens. etics,
chang
Proper hand washing ing
techniques conta
include soap, ct
running water lense
and 10-15 s or
seconds of using
friction or lavat
scrubbing action. ory
Hands should be facilit
dried and the ies.
paper towel used d. Befor
to turn the e all
faucets off. other
activi
Hands are washed: ties
whic
a. After h
completi entail
on of hand
work conta
and ct
before with
leaving muco
the us
laborato mem
ry. brane
s or
 breaks a. Whe
in the n
skin. wor
e. Immedia king
tely with
after certa
accident in
al skin caus
contact tic
with reag
blood or ents
other and/
potential or
ly solv
infectiou ents,
s or
material
s. conc
f. Between entra
patient ted
contact acid
and s
before and
invasive base
procedur s.
es. b. Whe
n
8. Laboratory work surfaces perf
must be disinfected daily ormi
and after a spill of blood ng
or body fluid with a 1:10 proc
dilution of Clorox in edur
water. es
that
B. Eye Safety are
likel
1. KNOW WHERE THE NEAREST y to
EYE WASH STATION IS gene
LOCATED AND rate
HOW TO OPERATE
droplets/aerosols of blood or other body
IT.
fluid.
c. Whe
2. Eye goggles should be worn:
n
wor
 king
with a. Wea
reagent r
s under prot
pressur ectiv
e. e
d. When closi
workin ng
g in (lab
close coat,
proximi glov
ty to es.
ultra- If
violet you
radiatio have
n a
(light). cut/a
brasi
3. Wearing contact lenses in the laboratory on,
is discouraged and requires extra also
precaution if worn. Gases and vapors can wear
be concentrated under the lenses and a
cause permanent eye damage. band
Furthermore, in the event of a chemical -aid.
splash into an eye, it is often nearly b. Avoi
impossible to remove the contact lens to d
irrigate the eye because of involuntary spill
spasm of the eyelid. Persons who must age
wear contact lenses should inform their and
supervisor to determine which procedures aero
would require wearing no-vent goggles. sol
C. Safe Handling of Biologically form
Hazardous Material ation
.
1. YOU SHOULD HANDLE ALL c. Han
PATIENT SAMPLES AS ds
POTENTIALLY BIOHAZARDOUS shou
MATERIAL. This means ld be
UNIVERSAL was
PRECAUTIONS hed
should be imm
followed at all ediat
times!! ely
and
2. When working in the laboratory: thor
 oughly rem
if oved
contam .
inated e. You
with shou
blood ld
or other was
body h
fluids. your
d. Gloves hand
should s
be after
remove com
d pleti
before ng
handlin labo
g a rator
telepho y
ne, activ
comput ities
er and
keyboa befo
rd, etc., re
and leavi
must ng
NOT the
be area.
worn All
outside prot
the ectiv
immedi e
ate cloth
work ing
area. shou
Hands ld be
should rem
always oved
be prior
washed to
immedi leavi
ately ng
after the
gloves lab.
are f. All
bioh
 azardou
s o
materia f
l
should t
be h
discard e
ed in a
biohaza d
rd bag
a
to be
y
autocla
.
ved.
g. All
counter 2) I
and f
table
tops y
should o
be u
disinfec
ted s
with a h
proper o
disinfec u
ting l
solutio d
n:
1) A s
t p
i
l
t
l
h
e a

b p
e a
g t
i i
n e
n n
i t
n
g s
a
 m b. Was
p h
l your
e hand
. s
whe
3 neve
) r
you
chan
A ge
t glov
es.
t c. Disp
h ose
e of
cont
e amin
n ated
d need
le,
o syrin
f ge
and
t test
h tube
e s in
a
d prop
a er
y bioh
. azar
dous
rece
3. When performing venipuncture: ptacl
e.
a. Wear d. Whe
clean n
gloves draw
for ing
each bloo
patient d
you from
a
draw.
patie
 nt in an the
isolatio room.
n room. 2) Label
all
1) A tubes
ll draw
m n
a from
t this
e patien
ri t with
a isolati
l on
t sticke
rs.
a
k
4. Proper handling of SHARPS:
e
n
a. Conta
i
minat
n
ed
t needl
o es
t and
h other
i sharp
s s are
r never
o broke
o n,
m bent,
recap
m ped
u or re-
s sheat
t hed
r by
e hand.
b. Used
m
needl
a
es are
i
not
n remo
i ved
n from
 disposab Flammable
le
syringes (Red);
. Instability
c. Needles (Yellow);
and
sharps Health (Blue)
are and Special
disposed Notice
of in
impervi (White)
ous
containe NFPA
rs Chemical
located
near the Hazard Sign
point of
use. A. Toxic and Corrosive Materials
(acids and alkali):
II. Chemical and Gas Safety

To provide a safe working

environment, all personnel
should be aware of potentially
hazardous materials and the
proper way of handling this
material. Avoid unnecessary
exposure to chemicals.
Occupational Safety and Toxic or Poison Hazard
Health Administration Corrosive Hazard
(OSHA) requires any
necessary information in the 1. To avoid
form of MATERIAL dangerous
SAFETY DATA SHEETS splatter,
(MSDS) concerning the ALWAYS
handling of hazardous ADD ACID
materials to be available to all TO
laboratory personnel, so that WATER!
they may achieve and 2. Toxic
maintain safe working materials
conditions. should be
labeled with
special tape
when used in
compounded
 reagents and
stored in B. Carcinogens
separate
containers. 1. All
These materials laborato
should be ry
handled chemica
carefully and ls
kept in the hood identifie
during d as
preparation. carcinog
3. Acids and alkali ens
should be must be
carried by labeled
means of CARCI
special NOGE
protective N.
carriers when 2. When
transported. working
4. Acid and alkali with
spills should be these
covered and substanc
neutralized by es,
using the protecti
material from ve
the ‘spill clothing
bucket’. All and
material, spill gloves
and compound, should
should be swept be
up and placed worn.
in a plastic
bucket for
proper disposal. C. Flammable Compounds
5. In case of 1. All
spillage, wash flammable
all exposed reagents
human tissue should be
(including eyes) kept in the
generously with flammable
water and notify storage
your supervisor facilities
for proper (closet or
reporting of the refrigerator)
incident.
 at all times 1. These
when not in use. compounds
2. Any solutions tend to react
compounded with oxygen
from these to form
reagents should explosive
be labeled as peroxides.
flammable. When ether
3. Flammable containers
substances are opened
should be they are to be
handled in areas dated and all
free of ignition material
sources. remaining
4. Flammable after six (6)
substances months must
should never be be disposed
heated using an of
open flame. immediately.
5. Ventilation is 2. Disposal of
one of the most ether
effective ways compounds
to prevent is through
accumulation of the
explosive levels Hazardous
of flammable Materials
vapors. An Office.
exhaust hood 3. Ether
should be used compounds
whenever will be
appreciable stored in an
quantities of explosion-
flammables are proof
handled. refrigerator.
6. Flammable (boiling
compounds point of ether
should be is
placed in proper approximatel
receptacle for y room
disposal. temperature)

D. Ether Precautions (flammable E. Compressed Gases

compound)
1. The storage
of all
 compressed B. Radioactive material should
gases shall be in be labeled as radioactive
containers and stored in a proper
designed, container so as to prevent
constructed, spillage or leakage.
tested and C. These materials must be
maintained in handled carefully.
accordance with Remember: the amount of
the U.S. radiation exposure
Department of decreases with distance.
Transportation D. Radioactive spills should be
Specifications absorbed with absorbent
and toweling. The area should
Regulations. be cleaned with soap and
2. In the water and then
laboratory, gas decontaminated with a
containers are product such as
to be limited to ‘count-off’. The
the number of area of the spill is
containers in then monitored for
use at any time. any residual
Low pressure radioactivity. If the
(LP) gases shall area is not
also be limited decontaminated, the
to the smallest above regimen is
size container. repeated and re-
3. Containers shall monitored.
be securely E. In the case of a radioactive
strapped, spill in a high traffic area,
chained or the area will be ‘roped off’
secured in a until proper
cylinder stand decontamination has been
so they cannot achieved.
fall. F. In the case of a major
4. Oxidizing gases radioactive spill, all
should be personnel in the area must
separated from be notified. The appropriate
flammable safety officer must be
gasses. notified and all attempts to
keep contamination at a
III. Radiation Safety minimum must
be used.
A. No eating, drinking, smoking
permitted! IV. Fire Safety
 A. KNOW
WHERE
ALL FIRE
EXITS,
FIRE

For
electrical
fires: BLUE
CIRCLE
WITH THE

LETTER
‘C’ uses non-
conducting
EXTINGUISHERS AND extinguishing
FIRE ALARMS ARE LOCATED! agents
(carbon
B. KNOW HOW TO dioxide or a
PROPERLY OPERATE dry
APPROPRIATE FIRE chemical).
ALARMS AND FIRE
SAFETY EQUIPMENT! Multipurpose:
Recommended for all
Portable fire types of fire. Most
extinguishers are common
classified by their ability extinguisher found in
to handle specific most clinical
classes of fires: laboratories.

For burning C. Know the proper

combustible procedure for
materials (wood, notifying
paper, clothing, colleagues and
trash). GREEN proper personnel
TRIANGLE of a fire.
WITH
THE LETTER ‘A’ RACE
an all-purpose dry chemical. 1. Rescue those
in danger
For burning liquids: 2. Alarm
RED SQUARE WITH a. Activ
THE LETTER ‘B’, ate
uses foam, a dry chemical the
or carbon dioxide. fire
 pull completely insulated against
station shock. If the victim is
Notify unconscious, call 911 (at
switchboard UTMB) to report the
operator of the incident and request
location, your assistance.
name and the
type of fire, if VI. Severe Weather Safety
known A. When the tornado-warning
3. Contain the fire message is heard on the
by closing all hospital public address
doors and system, all personnel should
windows move to a safe area. Safe
4. Extinguish the areas are considered to be:
fire, if possible. 1. below ground level if
Do not re-enter possible
a room that has 2. inside, interior halls in an
already been east/west corridor, away
closed. from windows
Evacuate 3. inside, interior windowless
V. Electrical Safety rooms
A. The use of extension cords is B. Stair towers should be used
prohibited. for evacuation
B. All equipment must be C. Elevators should be used
properly grounded. only in emergency
C. Never operate electrical D. No one will leave the
equipment with fluid spillage building until the ‘all clear’
in the immediate are or with is announced
wet hands.
D. Never use plugs with exposed VII. General Procedures and
or frayed wires. Equipment
E. If there are sparks or smoke or A. Cracked or chipped
any unusual evens occur, shut glassware should not be
down the instrument and notify used.
the manager or safety officer. B. Centrifuges should not be
Electrical equipment that is not used without the covers
working properly should not completely closed.
be used. C. When removing tops from
F. If a person is shocked by evacuated test tubes, care
electricity, shut off the current must be taken to
or break contact with the live prevent
wire immediately. Do not aerosol
touch the victim while he is in formation.
contact with the source of
current unless you are
 VIII. In Case of Accidents A.
Accidental Needle Stick 1.
Bleed wound.
2. Wash
wound
thoroug
hly with
soap.
3. Notify
the
supervis
or of the
incident
and BACKGROUND
report to Within three weeks of the destruction of the
Student World Trade Center towers on September 11,
Health 2001, the United States experienced a second
with an assault in the form of anthrax spores delivered
incident through the U.S. mail. The event initiated
report widespread changes in the scientific enterprise
form. of the United States, in its federally-based
4. May funding priorities and in the regulatory and
need to oversight mechanisms that strive to keep
get laboratories and communities safe.
blood
tested “The events of September 11, 2001, and the
for anthrax attacks in October of that year
hepatitis reshaped and changed, forever, the way we
. manage and conduct work in biological and
clinical laboratories.”1
B. If you should wound
yourself in the laboratory: Biosafety and biosecurity have dominated the
1. Any type of accident should be policy discourse and the two have been
brought to the attention of the inexorably intertwined. Biosafety and
Teaching Supervisor of the biosecurity are defined by the World Health
area. Organization (WHO):2 Biosafety comprises
“the containment principles, technologies and
IX. Summary……….USE COMMON practices that are implemented to prevent
SENSE!!!
1 U.S. National Institutes of Health and the Centers for Disease
Control and Prevention, 2007. Biosafety in Microbiological and
Biomedical
Laboratories, 5th ed. L.C. Chosewood and D. E. Wilson, eds.
Washington D.C. U.S. Government Printing Office; online version
http://www.cdc.gov/ od/ohs/biosfty/bmbl5/bmbl5toc.htm.
2 (WHO. Biorisk management: Laboratory biosecurity guidance.
World Health Organization [online] http://
www.who.int/csr/resources/publications/ biosafety/
WHO_CDS_EPR_2006_6.pdf (2006).
unintentional exposure to pathogens and toxins changes in the meetings in 1964-1965: the
or their accidental release”; biosecurity is NIH and CDC
defined as “the protection, control and joined for the first
accountability for valuable biological materials time, along with a
(including information) in laboratories in order number of other
to prevent their unauthorized access, loss, theft, relevant federal
misuse, diversion or intentional release.” The agencies. All
two terms are related but often used classified
interchangeably and, as noted by Casedevall and information was
Relman, differ significantly by the “crucial removed
criterion of intent.”3 The U.S. research and accompanied by a
regulatory communities are engaged in a long- concerted effort to
term, evolving struggle to reconcile these terms declassify safety
and establish acceptable oversight mechanisms studies and release
that satisfy both biosafety and biosecurity them for public
concerns. Here, we offer a short history of knowledge and
oversight and regulation of dangerous biological advantage. By
research in the United States and the ongoing 1966, the
debate over how such oversight should be attendees included
carried out. universities,
BRIEF HISTORY OF private
laboratories,
BIOSAFETY hospitals, and
Innovation and development of biosafety in the industry.
United States is reflected accurately in the Gradually, federal
history and pre-history of the American regulations began
Biological Safety Association (ABSA). The first to appear. In 1973,
unofficial meeting was held on April 18, 1955 at the impact of new
Camp Detrick OSHA regulations
(now Fort Detrick) and involved members of the was analyzed and
military representing debated at the
Camp Detrick, Pine Bluff Arsenal, Arkansas ASBA meeting;
(PBA), and Dugway Proving Grounds, Utah interestingly, there
(DPG). In those days, the offensive BW was a range of
program of the United States was in full swing: responses to the
the opening keynote address was “The Role of new regulations:
Safety in the Biological Warfare Effort.”
“Some view it as
Beginning in 1957, the yearly meetings began to
the most important social legislation since
include non-classified sessions to broaden the
social security, or Our Savior Has Arrived;
reach of the Association; representatives of the
whereas others term it the most un-
USDA were regular attendees through this
constitutional freedominterfering repressive
“transition period.” 4 There were striking
3 Casadevall, A and Relman, D.A. Microbial threat lists: obstacles in the
quest for biosecurity? 2010. Nat Rev Microbiol Feb;8(2):149-54
4 Manuel S. Barbeito and Richard H. Kruse, 1997, “A History of the
American Biological Safety Association Part I: The First Ten Biological Safety Conferences 1955-1965.” JABSA, 2(3): 7-19.
legislation since prohibition,”5 according to
Manuel Barbeito and Richard Kruse’s historical
analysis.

5 Richard H. Kruse and Manuel S. Barbeito, 1997, “A History of the

American Biological Safety Association Part II: Safety Conferences 1966-
1977.” JABSA 2(4): 10-25.
 In 1974, the United States Postal Service and Department of Transportation introduced regulations for
shipping of etiologic agents (microorganisms and toxins that cause disease in humans). New safety
programs and trainings
were introduced. The
designation of 4 levels of
biosafety originated in
the mid-1970s,6 and the
safety requirements for
research with
recombinant DNA were
hotly debated. A survey
of the ABSA meetings in
the 1980s reveals
increased focus on
individual agents or
groups of agents and
coordination of
international safety
issues.7 ABSA now
represents biosafety
professionals in 20
countries, and reflects the
organic nature of the
topic: biosafety is a fast-
moving field with
constant research into
and reevaluation of its

Biological Agents in
tenets as threat
perception change and

the Laboratory -
technologies advance.

The Regulatory Issues CURRENT U.S.

REGULATIONS FOR
— BY NANCY CONNELL BIOSAFETY AND

BIOCONTAINMENT
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 8 required
institutions to notify HHS and/or the USDA of possession of select agents or high-consequence
pathogens and instituted increased oversight mechanisms for use of and access to the agents.
6 There are four basic biosafety levels as determined by CDC and NIH which describe the microbiological techniques, lab practices, safety
equipment and lab facilities necessary to protect workers and the environment.
7 Richard H. Kruse and Manuel S. Barbeito, 1997, “A History of the American Biological Safety Association Part III: Safety Conferences 1978-
1987.” JABSA 3(1): 11-25.
8 2002 ACT
Currently, multiple federal, state, local and institutional agencies are involved in oversight of
dangerous pathogens and toxins, and the overlap of these oversight systems can be thought to ensure a
positive outcome. The primary agencies involved are the Department of Labor (DOL), Occupational
Safety and
Health Administration (OSHA), Health and
Human Services (HHS) Centers for Disease Control and Prevention (CDC), and the U.S. Department
of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS).

The relevant regulations and Personal Protective There are a number of basic
guidelines are found in four Equipment Standards10 (3) aspects to working with Select
places, listed below. Note that CDC permit regulations for Agents that are codified under
the collection includes one work with high- 42 CFR part 73: the Select
coded law, one set of consequence pathogens Agent list, laboratory
standards, one set of (4) NIH and CDC registration, laboratory
regulations and a set of guidelines, entitled security, personnel oversight,
guidelines, not federally Biosafety in notifications of loss or theft,
mandated. Microbiological and restricted experiments, incident
of 2011, the Public Health example, in a 2010
Safety and Bioterrorism Perspectives piece in Nature
Preparedness and Response Reviews Microbiology by
Act of 2002 specified that Casadevall and Relman, the
HHS establish a list of authors question the utility of
biological agents and toxins the SATL and highlight the
that following paradox: if an agent
“have the potential to pose a lacks countermeasures, it is
severe threat to public health more likely to be included on
and safety.” A list of the SATL; yet the increased
approximately 80 bacteria, regulatory burden placed on
viruses, fungi and toxins was research with the agent might
established by HHS and in turn prevent the discovery
USDA. A combination of and development of effective
considerations is used to countermeasures.13 Similarly,
determine an agent’s inclusion while a mechanism is available
on the Select Agent and Toxin to request the removal of an
List agent from the SATL, the
(SATL): past or potential use regulatory burden associated
as biological weapon, with the experimental evidence
countermeasures available, required to support such an
infectivity, contagiousness, etc. application may hinder
Although the exact criteria are initiation of the request.15
not part of the public domain,
the public comment sections of
the Code are a source of rich
discussion of these matters.11

The status of the current SATL

has been challenged in a
number of venues since 2002,
including scientific
publications and U.S.
government advisory bodies
such as the NSABB.12 For

11 42 CFR Part 73. Possession, Use, and

Transfer of Select Agents and Toxins; Biennial
Review; Proposed Rule Federal Register / Vol.
76 , No. 191 / Monday, October 3, 2011/
Proposed Rules
12 NSABB (National Science Advisory Board
for Biosecurity). 2007. Proposed Framework
for the Oversight of Dual Use Life Sciences
Research: Strategies for
Minimizing the Potential Misuse of Research 13 Casadevall, A and Relman,
Information. Available at D.A. Microbial threat lists:
<http://oba.od.nih.gov/biosecurity/pdf/Framew obstacles in the quest for
ork%20for%20transmittal biosecurity? 2010. Nat Rev
%200807_Sept07.pdf> Microbiol Feb;8(2):149-54 15 Ibid.
 and posted by the programs, and
CDC for public comment until requirements.
December 2, 2011.15 For example,
If an agent lacks several
LABORATO
countermeasures, it is more likely In December
to be included on the Select Agent guidelines w
released, add
and Toxin List, yet the increased management a
entitled “Laboratory Security
regulatory burden placed on and Emergency Response
Guidance for
research with the agent might in Laboratories working with
Select
turn prevent the discovery and Agents.”21 These guidelines
were built upon the 1999
development of countermeasures. guidelines (“BMBL”) released
More recently, a Federal Experts viruses, fungi and toxins are by the NIH and CDC.22 The
Security targeted for removal from the following topics were
Advisory Panel (FESAP) released its list, while two viruses are slated addressed: risk and threat
Recommendations Concerning for addition.16 Further, the assessment, facility security
the Select Agent Program proposed changes designate plans, physical security, data
(finalized June 2011) in response eleven agents (“Tier 1 agents”) and electronic technology
to Executive Order 13546.14 for increased oversight. The 15 42 CFR Part 73. Possession, Use, and
select agents and toxins in this Transfer of Select Agents and Toxins; Biennial
In the report, the following issues subset are considered the greatest Review; Proposed Rule Federal Register / Vol.
76 , No. 191 / Monday, October 3, 2011/
were addressed: risks of deliberate misuse with Proposed Rules
the “most significant potential for 16 Ibid.
1. the designation of Tier 1 Biological
Select Agents and Toxins (BSAT); mass casualties or devastating 17 Ibid.
18 Proposed Tier 1 agents: Ebola, Francisella
2. reduction in the number of BSAT on effects to the economy, critical tularensis, Marburg virus, Variola major,
the Select Agent List;
infrastructure or public Variola minor, Yersinia pestis, botulinum
3. the establishment of appropriate neurotoxins, toxin producing strains of
practices to ensure reliability of personnel confidence.” The proposed Clostridium botulinum, Bacillus anthracis,
with access to Tier 1 BSAT at registered regulations contain options for Burkholderia mallei, Burkholderia
facilities;
4. the establishment of appropriate “graded protection” for these pseudomallei.
19 Richmond JY, Nesby-O'Dell SL. 2002.
practices for physical and cyber security Tier 1 agents and toxins to permit Laboratory security and emergency response
for facilities that possess Tier 1 BSAT; “tailored risk management guidance for laboratories working with select
and agents. Centers for Disease Control and
5.other emerging policy issues relevant to practices based upon relevant Prevention. MMWR Recomm Rep. Dec
the security of BSAT. contextual factors.”17 Entities 6;51(RR-19):1-6
with Tier 1 Agents18192021 will be 20 U.S. Department of Health and Human
A set of proposed changes to Services/CDC and National Institutes of Health.
subject to additional Biosafety in microbiological and biomedical
every section of the Select Agent requirements in personnel laboratories [BMBL]. Richmond JY, McKinney
Rule was under consideration reliability, occupational health RW, eds. 4th ed. Washington, DC: US
Department of Health and Human Services,
1999.
14 Federal Experts Security Advisory Panel Recommendations Concerning the Select Agent 21 42 CFR Part 73. Possession, Use, and
Program. Nov 2, 2010, revised Dec 2, 2010 and Jan 10, 2011. Transfer of Select Agents and Toxins; Biennial
http://www.phe.gov/Preparedness/legal/boards/fesap/Documents/fesap-recommendations- Review; Proposed Rule Federal Register / Vol.
101102.pdf. Accessed Oct 30, 2011. 76 , No. 191 /
systems, security policies for personnel, policies regarding
accessing the laboratory and animal areas, specimen
accountability, receipt of agents into the laboratory, transfer or
shipping of select agents from the laboratory, emergency
response plans and reporting of incidents, unintentional injuries,
and security breaches. The complexity involved in launching a
select agent reseach program is clear from this list of
requirements, and highlights the enormous commitment of
infrastucture and support personnel demanded of sponsoring
institutions.

INVENTORY:
ACCOUNTING vs.
ACCOUNTABILITY
The current requirement for record keeping is found in 42 CFR
part 73.17: “Accurate, current inventory for each select agent
(including viral genetic elements, recombinant nucleic acids, and
recombinant organisms) held in long-term storage (placement in
a system designed to ensure viability for future use, such as in a
freezer or lyophilized materials). Specific instructions are
provided to ensure that adequate information (date, time,
location and personnel involved) is available describing the
agent, its use and purpose of use, its source, any transfers out,
storage site, removal from or return to storage (and for what
purpose). The
frequency of inventory review is remains a contested issue within involves an FBI background
not mandated by the Select the research community. check for disqualifying
Agent Rule, but is tailored to Indeed, the American Society behaviors and activites, relying
each program in consultation for Microbiology has submitted on a wide range of databases. 24
with the CDC. several eloquent arguments Clearance, once obtained, lasts
during public comment periods, for five years. The terms in the
The proposed changes to the and Victoria Sutten of the Texas 2002
Select Agent Rule do not Tech School of Law’s Center Bioterrorism Response Act that
include any modification of for Biodefense, Law and Public related to the identification of
existing requirements, despite Policy argued that “the restricted persons are the
the fact that many commenters regulatory agency attempted to following, modeled on the
have pointed out that use a regulatory model that fit Bureau of Alcohol, Tobacco,
“requirement to account for neither the target nor the Firearms, and Explosives (ATF)
individual vials of each outcome.”24 However, the CDC when enforcing the Gun Control
pathogen is inappropriate for remains steadfast in its Act of 1968:permanent
replicating biological agents” commitment to requiring certain residence, mental institution,
and “that this is a costly and kinds of quantification methods and unlawful user of any
burdensome responsibility for in maintaining current, accurate controlled
laboratories and their staff and inventory, stating “we are not substance.”25
that this requirement should be proposing any changes to the
abolished except for Tier 1 select agent regulations based The proposed changes to the
agents.”23 The National on these comments.” 22 Select Agent Rule further
Academies’ Report entitled clarify these terms, including,
“Responsible Research with for example, how to interpret
Biological Select Agents and PERSONNEL foreign criminal convictions and
Toxins,” released in 2009, extending the conviction terms
argues that while accurate RELIABILITY to include misdemeanors
accounting and inventory Personnel reliability remains a accompanied by imprisonment.
maintenance is essential for critical aspect of the U.S. Select In the proposed rules,
both safety and security, the Agent oversight program, institutional responsibility for
current especially in view of the FBI’s personnel will be further
“requirements for counting the conclusion that the bacterial increased by requiring (1) self
number of vials or other strain used in the anthrax and peer reporting of incidents
unreliable measures of the mailings likely originated in a or conditions that could affect a
quantity of biological select government research person’s ability to safely access/
agents are counter-productive, laboratory.23 The current work with SA/ toxins; (2)
and lead to a false sense of screening process for employees procedures that ensure that
security.” The report suggests to work with select agents those accessing Tier 1 agents
that the focus of inventory are trustworthy and behaving in
22 See 42 CFR Part 73. Possession, Use, and
should be on controlling access Transfer of Select Agents and Toxins; Biennial
a manner that upholds public
while maintaining accurate Review; Proposed Rule Federal Register / Vol. health and safety, security and
records of the identity of all 76 , No.
191 / Monday, October 3, 2011/ Proposed Rules, 24 A “restricted person” is identified as an
agents and toxins, who uses p. 61213, paragraph 6. individual under section 817 of the USA
them and for what purpose. 23 FBI (Federal Bureau of Investigation). 2008. PATRIOT Act (18 U.S.C. 175b).
Science Briefing on the Anthrax Investigation: 25 42 CFR Part 73. Possession, Use, and
Opening Statement by Dr. Vahid Majidi. Transfer of Select Agents and Toxins; Biennial
The exact nature of inventory Available at Review; Proposed Rule Federal Register / Vol.
requirements going forward <http://www.fbi.gov/page2/august08/anthraxscie 76 , No. 191 / Monday, October 3, 2011/
nce_081808.html>. Proposed Rules.
PUBLIC INTEREST REPORT FALL 2011

the integrity of the scientific monitoring. the d engagement of interacti

enterprise; and (3) “ongoing Program should worker under discussion on
between
suitability assessments” of encourage and to within and between M.
personnel with access, including support In 2009, finish the stakeholders in tubercul
shorter times between FBI the directors of all quickly, oversight of the osis and
clearance (i.e. at three year of the BSL4 the and by Select Agent the
rather than at five year implementation of exposing research and macroph
age. She
intervals). It can be argued that programs and the regulatory is the
during a five or even three year laboratories in the observer communities. director
period, an individual might United States met The Program, a federal of the
experience significant personal to practices aimed NAS Biological Select Biosafety
changes, including those that at fostering a report Agents and Toxins Level
Three
might render him or her a culture of discuss provides Advisory Facility
security risk.26 these and other the final Committee should of
Various people options.30 The word in be established.”32 UMDNJ'
approaches have be trust and unnecess Such a committee s Center
been explored to present responsibility,” arily to would provide a for the
Taken together, during including the mechanism to Study of
Emergin
these proposed all consensus view containm increase g and
changes ensure Select was that video ent this communication Re-
that laboratory active monitoring brief among all the Emergin
workers do not monito “training in analysis stakeholders: g
underscore the ring scientific ethics of some funding and Pathoge
ns.
role of “laboratory and and dual-use of the regulatory agencies
engage in manag provided a regulator and research
malfeasance while ement, marginal increase y communities,
simul- culture” in Agent in safety and environ including,
the safe execution work research to foster ment. importantly,
of Select (“the community Again, institutional
taneously two- security over the the issue management, safety
guaranteeing person two-person rule. of the and response
safety and Agent rule”) The responsibility two- personnel.
Research. Indeed, and and raise issues
the National laborat awareness of involved Dr. Nancy Connell is
experimental ory latter may in Select the Vice-Chair for
standards. There leaders decrease Agent Research in the
Department of
are two hip compliance with research: Medicine at the
Academies’ 2009 and the both available “to University of
report on Select institutional person Medicine and
Responsible Agent support and safety rule and Dentistry of New
approaches in use: the and security video Jersey (UMDNJ),
New Jersey Medical
one is to require second requirement by monitori School. A Harvard
that Research is the placing ng University Ph.D. in
states that in order use of resources.”31 remains Microbiology, Dr.
“to support two video undue pressure on provide Connell's major
continue research focus is the
26 Ibid.
 30
LeDuc JW, Anderson K, Bloom ME, Carrion R Jr, Feldmann H, Fitch JP, et al. Potential impact of a 2-person security
rule on BioSafety Level 4 laboratory workers [online report]. Emerg Infect Dis [serial on the Internet]. 2009 Jul [date cited].
Available from http://wwwnc.cdc.gov/eid/article/ 15/7/08-1523.htm (http://wwwnc.cdc.gov/eid/article/15/7/08-1523.htm)
31
NRC 2009. Responsible Research with Biological Select Agents and Toxins. Washington, D.C.: The National
Academies Press. 32 Ibid.

Letters to the Edit0r Listen

FAS wants to hear
from you.
The PIR welcomes Letters to the
and
Editor. Letters should not exceed 300
words and may be edited for length
and clarity.
Learn
FAS Public Interest Report
DeSales Street, NW
6th Floor
Washington, DC 20036
PHONE: (202) 546-3300
FAX: (202) 675-1010
EMAIL: [email protected]

Podcasts
FAS records “Conversations with Experts” on a wide range of
topics.

Download
the interviews: www.FAS.org/ podcasts/
index.html
18