University of South Carolina
Select Agent
Compliance
SAFETY, BIOCONTAINMENT, SECURITY, TRAINING, AND EMERGENCY RESPONSE
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A. ACKNOWLEDGEMENTS ......................................................................................................... 1
B. INTRODUCTION ........................................................................................................................ 1
C. RESPONSIBLE OFFICIAL........................................................................................................ 2
D. RECORDS..................................................................................................................................... 2
E. GENERAL REQUIREMENTS ................................................................................................... 2
F. AFFECTED INDIVIDUALS ........................................................................................................ 2
G. RESTRICTED SPACE(S)............................................................................................................ 3
H. GENERAL SAFETY.................................................................................................................... 3
I. PURCHASING, REQUESTING, RECEIVING OR SHIPPING SELECT AGENTS.............. 3
1. PURCHASES AND/OR REQUESTS OF SELECT AGENTS .................................................................... 3
2. RECEIPT OF SELECT AGENTS ......................................................................................................... 3
3. SHIPPING SELECT AGENTS ............................................................................................................. 4
J. DISPOSAL OF SELECT AGENTS ............................................................................................. 4
1. DISPOSAL OF WORKING CULTURES ............................................................................................... 4
2. DISPOSAL OF STOCK CULTURES .................................................................................................... 4
3. DISPOSAL OF TOXINS...................................................................................................................... 5
K. PHYSICAL SECURITY .............................................................................................................. 5
1. ACCESS TO RESTRICTED SPACES ................................................................................................... 5
2. SIGNS AND LABELING ..................................................................................................................... 5
L. PERSONNEL SECURITY........................................................................................................... 6
M. CYBER SECURITY.................................................................................................................... 6
N. INVENTORY CONTROL PROCEDURES............................................................................... 7
O. SECURITY BREACH ................................................................................................................. 8
P. VIOLATIONS/ NON-CONFORMANCES ................................................................................. 8
Q. NON-BIOLOGICAL INCIDENTS............................................................................................. 8
1. WORKPLACE VIOLENCE................................................................................................................. 8
2. CYBER SECURITY BREACH ............................................................................................................. 8
R. INCIDENT RESPONSE .............................................................................................................. 9
1. FIRE ................................................................................................................................................. 9
2. HAZMAT OPERATIONS ................................................................................................................... 9
3. BOMB THREATS............................................................................................................................... 9
4. SEVERE WEATHER ........................................................................................................................ 10
5. POWER OUTAGES .......................................................................................................................... 10
6. OTHER NATURAL DISASTERS OR EMERGENCIES ........................................................................ 10
S. CONTAINMENT BREACH ...................................................................................................... 10
1. BIOLOGICAL AGENT SPILL ...........................................................................................................11
2. DECONTAMINATION AGENTS ........................................................................................................11
3. ALCOHOL ........................................................................................................................................11
4. CHLORINE .......................................................................................................................................11
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5. IODOPHOR .......................................................................................................................................11
6. SPILL INSIDE A BIOLOGICAL SAFETY CABINET (BSC)............................................................... 12
7. SURFACE DECONTAMINATION ..................................................................................................... 12
8. GAS DECONTAMINATION ............................................................................................................. 12
T. TRAINING .................................................................................................................................. 12
APPENDIX A - SELECT AGENTS............................................................................................... 14
HHS SELECT AGENTS ...................................................................................................................... 14
USDA-HHS OVERLAP AGENTS ....................................................................................................... 14
USDA HIGH CONSEQUENCE LIVESTOCK PATHOGENS AND TOXINS ............................................ 15
APHIS PLANT PATHOGENS .............................................................................................................. 16
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A. Acknowledgements
This manual was modified from Clemson’s Select agents Manual written by W. Robin
Newberry.
B. Introduction
In 1996, the U.S. Congress passed “The Anti-terrorism and Effective Death Penalty Act”
requiring institutions transferring or receiving certain micro-organisms or toxins (which they
referred to as select agents) to register with the CDC. After the anthrax incidents in the fall
of 2001, Congress passed more restrictive laws governing the possession and use of
select agents: the USA Patriot Act of 2002 and the Bioterrorism Preparedness and
Response Act of 2002.
These Acts required the Centers for Disease Control (CDC) and the Animal and Plant
Health Inspection Service (APHIS) to develop and implement regulations governing the
possession and use of select agents. They also require that an institution possessing
select agents to appoint a responsible official, and to implement safety, security, and
emergency response plans for select agent use. For the University of South Carolina the
duly authorized Responsible Official is Tom A. Syfert, Environmental Health and Safety
Director for the University.
This document was based in part on the CDC publication “Laboratory Security and
Emergency Response Guidance for Laboratories Working with select agents”, 42 CFR
Part 73 (the CDC regulations), 7 CFR Part 331 and 9 CFR Part 121 (the APHIS
regulations).
Additional sources included the American Public Health Association publication “Control of
Communicable Diseases, 17th Edition”, the American Industrial Hygiene Association
publication “Biohazards Reference Manual, 2nd Edition”, and on the National Research
Council publication “Biosafety in the Laboratory: Prudent Practices for the Handling and
Disposal of Infectious Materials”. Employees desiring more information than is presented
here should refer to these references, or consult an Environmental Health and Safety
(EHS) staff member.
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C. Responsible Official
The duly appointed and authorized Responsible Official (RO) for the University of South
Carolina is Tom A. Syfert, Environmental Health and Safety. He has appointed Patty Gillies
Hamilton as an Alternate Responsible Official (ARO’s). She, as an ARO, will undergo the
same security clearance procedures as the RO. Duties assigned to the Responsible
Official may be carried out by a duly authorized ARO with the RO’s permission. Portions of
this plan stating, “the RO will” or words to that effect also indicate that an ARO may
perform the task at the RO’s discretion.
D. Records
All records pertaining to select agents will be maintained for at least three years. Access
records will be audited monthly by the RO or Alternate RO. Any discrepancies will be
investigated.
E. General Requirements
Both the CDC and APHIS regulations require that only properly registered institutions and
individuals may have access to select agents. The CDC regulation reads in part:
"An entity or individual may not possess or use in the United States,
receive from outside the United States, or transfer within the United
States, a select agent or toxin unless such activities are conducted for a
lawful purpose and in accordance with the provisions of this part. "
All possession of select agents – be they micro-organisms or toxins – are required to
conform to these regulations. This plan is their implementation at the University of South
Carolina, and adherence to it is mandatory.
See Appendix A for the list of select agents. Note that both the CDC and APHIS are
required to review and revise this list every six months; be alert for updates to the list.
F. Affected individuals
The regulations restrict access to select agents to those specifically authorized. “Having
access” includes anyone who enters a laboratory space or other room where select agents
are in use or are stored, as well as those using and/or possessing select agents. This
includes housekeeping and maintenance personnel, although non-authorized personnel
may be allowed entry into a restricted space if they are escorted at all times by an
individual with the appropriate approvals. All escorted personnel must sign in and out and
a written log retained in the laboratories.
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G. Restricted Space(s)
Any room or laboratory containing a select agent or agents is a restricted space for the
purposes of the regulations and this plan.
H. General Safety
All work with select agents will proceed as detailed for acutely hazardous materials in the
Chemical Hygiene Plan (Toxins) or procedures as detailed in the Biosafety Manual
(organisms/viruses).
All work with select agents requires a protocol approval from the USC Biosafety
Committee.
I. Purchasing, requesting, receiving or shipping
Select agents
No one other than the RO may order, request, receive, or ship select agents.
Anyone other than the RO who purchases, requests, receives or ships a select agent
will be detained by University Police and referred to the Federal Bureau of
Investigation (FBI) for further action.
1. Purchases and/or requests of Select agents
All purchases or requests for select agents must be made by the responsible official (RO).
The RO will not order or request select agents for an Investigator until and unless the
safety, security, training, and emergency response provisions of this Plan are implemented
in the investigator’s laboratory(ies). The RO may require laboratory specific plans
(Standard Operating Procedures, Chemical safety or biological safety plans, etc.) at his
discretion.
Requests for purchase of select agents must be made in writing (no email) to:
Tom A. Syfert
Environmental Health and Safety Director
306 Benson School
All select agents will be shipped to:
Tom A. Syfert
Environmental Health and Safety Director
306 Benson School
Columbia, SC 29208
The RO will log all orders, receipts, and dispersals of select agents.
2. Receipt of Select agents
All select agents will be delivered directly to the RO at the above address.
The RO will hand deliver the select agents to the requesting Principle Investigator (PI) only.
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The agents will be in the unopened shipping package and taken by the RO to the restricted
space approved for select agents. The package containing the select agent may not be
opened outside of a restricted space. Only the PI who ordered the material may open the
select agent package. He/she will be asked to verify that the contents are in order, and
sign for the package in the RO’s logbook. The RO will stay with the select agent until it is
secured to his satisfaction.
In the event that a select agent cannot be immediately delivered, it will be secured by the
RO in a safe that meets or exceeds the specifications listed below under “Minimum secure
storage requirements”. If refrigeration is required, the select agent(s) will be stored in either
a secure refrigerator, or a safe meets the specifications outlined under “Minimum secure
storage requirements” inside the refrigerator.
3. Shipping Select agents
When a PI wishes to ship a select agent, he must first contact the RO with the name and
affiliation of the individual to whom the select agent is being shipped. Once the RO has
confirmed that the individual and institution receiving the select agent has
CDC/APHIS/DOJ clearance to possess select agents, the RO will complete APHIS Form
2041 requesting approval to transfer the select agent, and submit it to the appropriate
agency (CDC or APHIS). Upon receipt of the appropriate approvals, the PI may then
proceed as follows:
a) Prepare the package as directed by the shipping company, BUT DO NOT SEAL
THE PACKAGE (note that the U.S. DOT has minimum training requirements for
individuals shipping any hazardous material.
b) Contact the RO, who will verify the contents and other pertinent information, and
observe the package being sealed.
c) The RO will take possession of the agent. The transfer from the PI to the RO will be
noted in the PI’s inventory logbook. The transfer shall also be noted, witnessed,
and countersigned in the RO’s Inventory logbook.
d) The RO will contact the shipping company and arrange shipment.
e) The RO will turn the package over to the shipping company’s agent, along with
copies of the appropriate shipping papers.
f)
The RO will make a copy of the shipping papers for the PI’s use.
g) The RO will file the shipping papers in a secure manner.
J. Disposal of Select agents
1. Disposal of working cultures
Working cultures may be either autoclaved or chemically inactivated. Disposal shall be
noted in the inventory logbook (as detailed in the Inventories section), witnessed, and
countersigned.
2. Disposal of Stock Cultures
PI’s desiring to cease all activities with a select agent and destroy their stock cultures
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should contact the RO. The RO will witness the disposal of the stock culture and all
working cultures of an agent. Disposal shall be noted in the inventory logbook (as detailed
in the Inventories section), and countersigned by the RO. The RO will store the Inventory
logbook.
The RO will make the appropriate amendments to the University’s CDC/APHIS
registration.
3. Disposal of Toxins
Toxin destruction methods will be determined on a case-by-case basis, but will generally
involve chemical inactivation. PI’s wishing to dispose of select agents that are toxins
should contact the RO. The RO will witness the disposal of the toxin and all working
solutions. Disposal shall be noted in the inventory logbook (as detailed in the Inventories
section), and countersigned by the RO. The RO will store the Inventory logbook.
K. Physical Security
No select agent may be taken out of its assigned restricted space, except when being
shipped off site or received on site. All laboratories using select agents will have a specific
written security plan for the laboratory that includes a risk analysis. This plan must be
submitted to the RO. The RO will review the plan during the annual laboratory audit. Any
security breach must be reported immediately to the Responsible Official for USC.
1. Access to restricted spaces
Laboratories or rooms housing select agents must be locked at all times. Each lab must be
secured with a lock with audit trail capabilities. Individual combinations to these spaces will
be distributed to the investigator and those individuals specifically cleared to access the
lab. All restricted spaces will have a sign on all entrances stating “Authorized Personnel
Only”.
Any unauthorized individual discovered with a combination or key to a restricted
space will be detained by University Police and referred to the Federal Bureau of
Investigation (FBI) for further action.
If the RO does not have a combination or the key, the investigator is required to allow the
RO access to the restricted space when requested.
Each authorized user of select agents will have his or her own combination, which he or
she will set themselves. They are not to share this combination with anyone.
The entry systems will be set to record the combinations used, date, and time every time
the lab door is opened. The RO will download the audit record from the system at least
annually.
2. Signs and labeling
In addition to otherwise required signage (e.g., Biohazard signs), all restricted spaces will
have a sign on the door clearly stating “Authorized Personnel Only”, and the PPE required
to enter the lab. Please note that the minimum required PPE for entry into any biological
Safety Level 2 science lab at the University of South Carolina is lab coat and closed toed
shoes. No sandals, shorts, or short skirts are permitted.
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Within the lab space, labeling will conform to the OSHA Laboratory Standard and the
University’s Chemical Hygiene Plan and/or the Biological Safety Plan. Freezers,
incubators, refrigerators, etc. containing select agents WILL NOT BE MARKED OR
LABELED in any fashion, which indicates they contain select agents, but will be labeled
with a biohazard label.
L. Personnel Security
All individuals will submit the appropriate information to the RO for submission to the U. S.
Department of Justice to obtain the appropriate clearance for working with a select agent
or agents. Under law, the following people are prohibited from access to select agents:
(A) Individuals who are under indictment for a crime punishable by imprisonment
for a term exceeding one year;
(B) Individuals who have been convicted in any court of a crime punishable by
imprisonment for a term exceeding one year;
(C) Individuals who are fugitives from justice;
(D) Individuals who are unlawful users of any controlled substance (as defined in
section 102 of the Controlled Substances Act (21 U.S.C. 802));
(E) Individuals who are aliens illegally or unlawfully in the United States;
(F) Individuals who have been adjudicated as a mental defective or have been
committed to any mental institution;
(G) Individuals who are aliens (other than an alien lawfully admitted for permanent
residence) who are nationals of a country as to which the Secretary of State,
pursuant to section 6(j) of the Export Administration Act of 1979 (50 U.S.C. App.
2405(j)), section 620A of chapter 1 of part M of the Foreign Assistance Act of
1961 (22 U.S.C. 2371), or section 40(d) of chapter 3 of the Arms Export Control
Act (22 U.S.C. 2780(d)), has made a determination (that remains in effect) that
such country has repeatedly provided support for acts of international terrorism;
or
(H) Individuals who have been discharged from the Armed Services of the United
States under dishonorable conditions.
Only individuals who are cleared by the U. S. department of Justice and who have written
approval from the RO may have unescorted access to select agents.
M. Cyber security
No maps/floor plans/etc. of any restricted space will be made available to the general
public, either through the web, on disk, or other means, without the express written
permission of the RO.
No spreadsheets or other digital copies containing restricted select agent information (lock
combinations, personnel records, etc.) kept on an unsecured server. Any spreadsheets or
other digital copies containing restricted select agent information (lock combinations,
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personnel records, etc.) MAY NOT be stored on any un-secured network drives. This
information may be stored on non-removable media (i.e. hard drives) or secured network
drives. Such information may be stored on laptop computer, provided the laptop computer
is treated as if it were removable media, i.e., securely stored when not in use.
No electronic communications (email, electronic messaging, etc.) containing combinations,
personnel data, select agent details, maps, storage locations, orders, receipts, etc. are
permitted. However, the RO may permit encrypted electronic communications on a caseby-case basis.
N. Inventory Control Procedures
All repository stock cultures are tracked via an inventory log (EHS-F-04) and Select Agent
Use Log (SAF-F-02). Every time a stock vial is used, it is noted on the inventory sheet,
subtracted out and the user signs and dates the form. Working/experimental stock
inventory is also maintained via an inventory log. Inventory logs are reconciled on a yearly
basis.
The minimum education required for access to select agents is a high school education, or
equivalent, unless the PI and RO grant special permission. Each person with access to
the select agent must receive security training from EH& S and safety training from the
principle investigator of the laboratory where the research is conducted.
All select agent related packages are inspected upon arrival. Any packages that appear to
be leaking, damaged, or suspicious in any way are reported to the RO before being
opened. The RO and PI determine how and whether such a package should be opened
on a case-by-case basis.
Freezers used for repositories and other equipment (incubators and shakers) used for
working stock storage are locked at all times, with the brief exception of removal of a stock
for use in the laboratory. These areas have controlled access including either electronic
control alone or in combination with a sign-in log and locked room doors. Following any
staff changes, the electronic lock will be reprogrammed to remove the staff ability to
access the select agent area. The out going staff must return any keys to the area. If all
keys are not obtained, the locks shall be changed.
Upon termination of the use of a select agent, the agent may be destroyed by autoclaving
or transferred to another registered facility. This will be carried out in accordance with 42
CFR 73. All activities will be documented appropriately and records will be maintained by
the RO.
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O. Security breach
Unescorted unauthorized individuals caught in, or attempting to gain entrance to, a
restricted room will be detained by University Police and referred to the Federal Bureau of
Investigation (FBI) for further action. Any security breach must be reported to the
Responsible Official immediately.
P. Violations/ Non-conformances
At least biannually unannounced inspections of the facilities using or storing select agents
will be conducted by the RO or the ARO. Any serious non-conformances must be
immediately corrected. If non-conformances are not immediately corrected the RO will
revoke approval for use select agents. The work with the agents will be immediately
stopped and access to the agent will be restricted.
At least once per year, the RO or his duly authorized and cleared designee will compare
the written inventory to the actual inventory, and the audit trail of the door lock to the
entries in the logbook. Discrepancies will have to be explained in writing to the RO.
Failure to maintain accurate inventories may result in loss of approval to possess and/or
use select agents. Falsification of inventory records will result in immediate revocation of
approval to possess and/or use select agents. The RO will make the decision as to
whether or not the individual will have their authorization to work with or access select
agents re-instated.
PI’s who have their approval revoked will have all select agents confiscated by the RO.
Other authorized individuals having their approvals revoked will no longer be allowed
access to the restricted space.
Q. Non-biological incidents
1. Workplace violence
Authorized individuals engaged in violent behavior in the workplace will have their approval
to work with select agents suspended by the RO pending an investigation. The RO will
make the decision as to whether or not the individual will have their authorization to work
with or access select agents re-instated.
2. Cyber security breach
Authorized individuals who fail to maintain cyber security or accurate inventories of
removable media will have their approval to work with select agents suspended by the RO
pending an investigation. Failure may result in loss of approval to possess and/or use
select agents. Falsification of inventory records will result in immediate revocation of
approval to possess and/or use select agents. The RO will make the decision as to
whether or not the individual will have their authorization to work with or access select
agents re-instated.
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R. Incident Response
Most emergencies in restricted spaces will be small in scope (less than 4 liters spilled, etc.)
and will fall under the emergency procedures in either the Biological Safety Manual or the
Chemical Hygiene Plan. In the event of a large emergency (spills greater than 4 liters, fire,
bomb threat, weather emergencies) the University of South Carolina’s Emergency
Management Plan takes precedence.
1. Fire
In the event of a fire, all select agents will be secured ONLY IF IT CAN BE DONE
SAFELY. Individuals in an affected restricted space should evacuate in an orderly manner,
closing the door to the restricted space behind them. They should assemble in a predetermined gathering place for evaluation by medical personnel.
Fire personnel will proceed without waiting for the RO. The RO will debrief the response
personnel immediately after the incident; the RO and users will conduct a physical
inventory of the select agents if possible.
2. HazMat Operations
In the event of a HazMat incident sufficiently large to necessitate requesting fire
departments assistance (greater than 4 liters), all select agents will be secured ONLY IF IT
CAN BE DONE SAFELY. Individuals in an affected restricted space should evacuate in
an orderly manner, closing the door to the restricted space behind them. They should
assemble in a pre-determined gathering place for evaluation by medical personnel.
The University police responders should assist in the evacuation, secure the area against
unauthorized entrance, and notify the RO.
The incident commander, in consultation with the RO, will decide on the appropriate steps
to take to control the incident. Response personnel not authorized to have select agent
access should not enter a restricted space without escort.
If, in the opinion of the incident commander the event is of sufficient danger to require an
immediate response, response personnel are authorized to proceed without waiting for the
RO. Under these circumstances, the RO will debrief the response personnel immediately
after the incident, and conduct a physical inventory of the select agents if possible.
3. Bomb threats
In the event of a bomb threat, all select agents must be secured prior to evacuation.
Individuals in an affected restricted space should evacuate in an orderly manner, closing
the door to the restricted space behind them. They should assemble in a pre-determined
gathering place for further instructions.
The University police responders should assist in the evacuation, secure the area against
unauthorized entrance, and notify the RO.
The incident commander, in consultation with the RO, will decide on the appropriate steps
to take to control the incident. Response personnel not authorized to have select agent
access should not enter a restricted space without escort.
If, in the opinion of the incident commander, the event is of sufficient danger to require an
immediate response, response personnel are authorized to proceed without waiting for the
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RO. Under these circumstances, the RO will debrief the response personnel immediately
after the incident. The RO and users will conduct a physical inventory of the select agents
if possible.
4. Severe weather
In the event of severe weather requiring evacuation, all select agents must be secured
prior to evacuation. Individuals in an affected restricted space should evacuate in an
orderly manner, closing the door to the restricted space behind them. They should
assemble in a pre-determined gathering place for further instructions.
The University responders should assist in the evacuation, secure the area against
unauthorized entrance if possible, and notify the RO.
After the threat has passed, the RO will survey the restricted space for external damage
immediately after the incident; the RO and users will conduct a physical inventory of the
select agents if damage is detected.
5. Power outages
In the event of a power outage, any work with select agents in a chemical fume hood,
biological safety cabinet, or other ventilation assisted activity will be halted, and the sash
closed if possible. If the users choose to evacuate the restricted space, all select agents –
excluding those in chemical fume hoods or biological safety cabinets where removal would
present a personnel hazard – must be secured. If the users decide to evacuate, upon
restoration of power and return to the space they must verify the select agent inventory of
any materials left unsecured (i.e., those left in Chemical Fume Hoods or Biological Safety
Cabinets).
6. Other natural disasters or emergencies
In the event of some other disaster or emergency requiring evacuation, all select agents
must be secured prior to evacuation. Individuals in an affected restricted space should
evacuate in an orderly manner, closing the door to the restricted space behind them. They
should assemble in a pre-determined gathering place for further instructions.
The University police responders should assist in the evacuation, secures the area against
unauthorized entrance if possible, and notifies the RO.
After the threat has passed, the RO will survey the restricted space for external damage
immediately after the incident; the RO and users will conduct a physical inventory of the
select agents if damage is detected.
S. Containment breach
All restricted areas will have spill response equipment appropriate for the select agents
they use.
Upon any spill of a select agent or solutions containing a select agent, immediately notify
the RO at:
RO Cell Phone Number
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EHS Main Number
803-777-5269
1. Biological Agent Spill
The following guide is to be followed in the event of a small, contained spill of biological
materials or until assistance from the RO is obtained:
a. If the substance is dry or nonvolatile, shut off hoods, close windows and doors, and
vacate rooms. Label door with appropriate warning. Allow the aerosol to settle for at
least 60 minutes before reentering room. Label door with appropriate warning.
b. If the substance is volatile, leave on ventilation and vacate room, closing door.
Label door with appropriate warning.
c. Notify the appropriate PI.
d. Assemble materials necessary for decontamination and don appropriate protective
clothing, i.e., disposable lab coat, impermeable gloves. Note that surgical latex
gloves are permeable to alcohol and that a respirator may be required. If you feel
unsure of your ability to respond appropriately to the spill, or if you are not
approved by EHS for a respirator, do not attempt clean up until the RO arrives.
e. For a liquid biological spill: pour the appropriate decontaminating solution (see
“Decontamination agents” below) on the spill, working from the perimeter inward.
2. Decontamination agents
Note that the PI’s decontamination procedures must be spelled out in their protocol.
3. Alcohol
Isopropyl and ethyl alcohols in 70-90% concentrations may be germicidal against lipidcontaining agents but are not effective against spores and infectious DNA. Note that 100%
ethanol is not a good disinfectant.
4. Chlorine
A very active disinfectant, chlorine is cidal against a wide variety of gram-negative and
gram-positive bacteria, bacterial spores and most viruses. Disinfect media with a 10%
solution of chlorine bleach (5.25% hypochlorite or 52,500 ppm) for 15 to 30 minutes. Note
that solutions deteriorate with age and are rapidly neutralized by organic matter. Its
effectiveness may be enhanced by the addition of 0.1% solution of an ionic detergent. If
used directly on a stainless steel surface, rinse thoroughly with water to prevent tarnishing
and decomposition. Do not autoclave chlorine solutions.
5. Iodophor
Characteristics of chlorine and iodine are similar. Iodophors are effective against grampositive and gram-negative organisms, mycobacteria, and some viruses, and are most
effective in acid solutions. Organic matter reduces effectiveness, but iodophors are less
affected than hypochlorites. Do not autoclave since iodophors vaporize at 120°F.
Iodophors are stable in storage if kept cool and tightly covered.
Contact EHS for information on emergency procedures, training, and environmental
monitoring.
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6. Spill inside a Biological Safety Cabinet (BSC)
Small spills within a biological safety cabinet can be handled immediately by placing the
contaminated absorbent paper toweling into a biohazard bag. Any splatter onto items
within the cabinet, or the cabinet interior, should be immediately wiped with a towel
dampened with decontaminating solution. Gloves should be changed after the work
surface is decontaminated and before placing clean absorbent toweling in the cabinet.
Hands should be washed whenever gloves are changed or removed.
Spills large enough to result in liquids flowing through the front or rear grilles of a biological
safety cabinet require more extensive decontamination. All items within the cabinet should
be surface decontaminated and removed. After ensuring that the drain valve is closed,
decontaminating solution can be poured onto the work surface and through the grille(s)
into the drain pan.
Twenty to thirty minutes is generally considered an appropriate contact time for
decontamination, but this varies with the disinfectant and the microbiological agent.
Manufacturer’s directions should be followed. The spilled fluid and disinfectant solution on
the work surface should be absorbed with paper towels and discarded into a biohazard
bag. The drain pan should be emptied into a collection vessel containing disinfectant. A
flexible tube should be attached to the drain valve and be of sufficient length to allow the
open end to be submerged in the disinfectant within the collection vessel (this procedure
serves to minimize aerosol generation). The drain pan should be flushed with water and
the drain tube removed.
7. Surface Decontamination
All containers and equipment should be surface decontaminated when work with a select
agent is completed. At the end of the workday, the final surface decontamination of the
work area should include a wipe-down of the work surface.
8. Gas Decontamination
BSCs that have been used for work involving infectious materials and/or select agents
must be decontaminated before HEPA filters are changed or internal repair work is done.
Before a BSC is relocated, a risk assessment that considers the agents manipulated within
the BSC, must be done to determine the need for decontamination. The most common
decontamination method uses formaldehyde gas.
T. Training
The RO or designee will train all users authorized to access select agents on the
regulations and this manual prior to their being allowed to work with select agents. The
training class will be cover select agent security, biosafety protocols of using select agents,
and risks associated with the select agent used in the laboratory.
Drills and exercises will be conducted to train select agent user and to test and evaluate
the effectiveness of the Biosecurity plan, the Biosafety plan and the Emergency and
Incident plan. Each plan will be reviewed after the drills and updated if necessary.
Any new user will be trained by the RO or designee before working with select agents.
The PI is responsible for informing the RO of any personnel changes.
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Once per year, the RO or designee will hold a training session for all select agent users
and other interested individuals. Annual refresher training is required. Any individual
missing the annual training session will have to contact the RO to make other
arrangements.
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Appendix A - Select agents
HHS Select agents
Crimean-congo haemorrhagic fever virus
Ebola viruses
Lassa fever virus
Marburg virus
Rickettsia prowazekii
Rickettsia rickettsii
South american haemorrhagic fever viruses
Tick-borne encephalitis complex viruses
Variola major virus (smallpox virus)
Viruses causing hantavirus pulmonary syndrome
Yellow fever virus
Yersinia pestis
Abrin
Conotoxins
Diacetoxyscirpenol
Ricin
Saxitoxin
Tetrodotoxin
USDA-HHS Overlap Agents
Bacillus anthracis
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia (pseudomonas) mallei
Burkholderia (pseudomonas) pseudomallei
Clostridium botulinum
Coccidioides immitis
Coxiella burnetii
Eastern equine encephalitis virus
Equine morbillivirus (hendra virus)
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Francisella tularensis
Rift valley fever virus
Venezuelan equine encephalitis virus
Botulinum toxins
Clostridium perfringens epsilon toxin
Shigatoxin
Staphylococcal enterotoxin
T-2 toxin
USDA High Consequence Livestock Pathogens and Toxins
African horse sickness virus
African swine fever virus
Akabane virus
Avian influenza virus (highly pathogenic)
Blue tongue virus (exotic)
Bovine spongiform encephalopathy agent
Camel pox virus
Classical swine fever virus
Cowdria ruminantium (heartwater)
Foot and mouth disease virus
Goat pox virus
Japanese encephalitis virus
Lumpy skin disease virus
Malignant catarrhal fever virus
Menangle virus
Mycoplasma capricolum/m.f 38/m.mycoides capri (contagious caprine pleuropneumonia
agent)
Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia agent)
Newcastle disease virus (exotic)
Nipah virus
Peste des petits ruminants virus
Rinderpest virus
Sheep pox virus
Swine vesicular disease virus
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Vesicular stomatitis virus
APHIS plant pathogens
Ralstonia solanacearum race 3 biovar 2
Synchytrium endobioticum
Xanthamonas oryzae pv. Oryzicola
Phakopsora pachyrhizi
Peronosclerospora phillippinensis
Schlerophthora rayssiae var zeae
Liberobacter africanus
Liberobacter asiaticus
Xylella fastidiosas (citrus variegated chlorosis strain)
Plum pox potyvirus
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