University of California, Riverside
Select Agent Policy and Procedures
(Adopted by the UCR Institutional Biosafety Committee
July 18, 2002)
REFERENCES
Centers for Disease Control and Prevention-National Institutes of Health “Biosafety in Microbiological and Biomedical Laboratories”
Centers for Disease Control and Prevention-“Additional Requirements
for Transferring and Receiving Select Agents”
International Air Transport Association - IATA Dangerous Goods Program
(http://www.iata.org/cargo/dg/iata.htm)
POLICY
It is the policy of the University of California, Riverside that all laboratories and campus facilities possessing, intending to use, transfer or receive select agents must comply with The Antiterrorism and Effective Death Penalty Act of 1996, 42 CFR 72, which is also known as the Select Agent Rule.
http://www.cdc.gov/od/ohs/lrsat/42cfr72.htm
PROCEDURES
Registration
All laboratories and campus facilities will be required to register with the Centers for Disease Control and Prevention (CDC-LRSAT) Laboratory Registration Select Agent Transfer Program Office prior to possessing, or intending to use, transfer or receive select agents that are not currently exempt. Laboratories must comply with all of the requirements established by the Centers for Disease Control and Prevention. The registration form should include a review of the ventilation, security for the lab, and a floor plan with the lab equipment listed. Registration forms can be downloaded from:
http://www.cdc.gov/od/ohs/lrsat/downloads.htm
Authorization
Any person wishing to begin or significantly change a research project, teaching activity, or other work involving a select agent must receive authorization by the Institutional Biosafety Committee beforethe work begins. The Environment, Health and Safety Office coordinates requests for authorization of select agent work.
Practices and Procedures
Practices and procedures for safe use of select agents will be based upon the conditions set forth in Reference A, CDC-NIH “Biosafety in Microbiological and Biomedical Laboratories” (Sections III through VII and Appendix I) but may be modified by the Institutional Biosafety Committee. http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ai.htm
Any modification of containment will be based upon a risk assessment (See Section V in Reference A).
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s5.htm
Training
All personnel possessing, using, transferring, or receiving select agents must have training regarding (1) the symptoms of exposure, (2) a post-exposure management protocol, (3) spill cleanup and decontamination, (4) proper use of engineering, administrative and work practice controls, and (5) personal protective equipment, and security requirements for select agent possession and use.
Security
All laboratories and campus facilities possessing, using, transferring, or receiving select agents must comply with all of the security requirements established by the Centers for Disease Control and Prevention for the inventory and containment of select agents. CDC minimum recommendations are listed in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) Appendix F.
http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4af.htm
Laboratory Inspections
Laboratories and campus facilities possessing, using, transferring or receiving select agents must be inspected routinely by UCR Environmental Health and Safety to ensure that all requirements are being met. If a facility is found to be in non-compliance, the Select Agent Registration with Centers for Disease Control and Prevention may be revoked.
Engineering Controls
Engineering controls, such as fume hoods and biological safety cabinets, must be used as the primary containment method to limit personnel exposure to select agents. Engineering controls must be: (1) inspected in order to ensure efficient removal of hazards, (2) must have a visual indication of airflow, and (3) have alarms to indicate that airflow has fallen below acceptable standards. Notification of laboratory personnel must be made prior to any maintenance that will impact the capture velocity of ventilation systems. Local exhaust ventilation systems including laboratory-type chemical fume hoods and biosafety cabinets must be certified upon installation, after maintenance and annually thereafter. Hood inspection is performed by UCR Environmental Health and Safety.
Administrative Controls
Written standard operating procedures should be developed for all laboratories possessing, using, transferring, or receiving select agents to ensure safe work practices are being consistently used. Standard operating procedures must be reviewed by UCR Environmental Health and Safety annually or as necessary to reflect changes to procedures. Standard Laboratory Practices for Guidelines for Work with Toxins of Biological Origin are addressed in the BMBL Appendix I. http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ai.htm
Personal protective equipment
Personal protective equipment appropriate to the select agent or biological toxin must be used to protect personnel from exposure. Personal protective equipment must be provided to the employee free of charge and must be appropriate protection from the select agent used.
When a Select Agent is Depleted or Destroyed
The Responsible Facility Official must verify the depletion or destruction of the select agent. It is good practice to have at least 2 people witness and document the destruction of the select agent. The RFO must maintain the records of destruction for a minimum of 5 years following the depletion or the destruction of the select agent. If the PI no longer has select agents, they CDC must be notified to have the PI removed from the registration. RFO writes a letter to CDC stating that the PI is no longer using select agents. The CDC LR/SAT will send a letter to confirm the change.
RESPONSIBILITY
Responsible Facility Official (RFO)
The Responsible Facility Official (RFO) is responsible for ensuring that research involving the possession, use, transfer, or receipt of select agents is conducted in accordance with The Antiterrorism and Effective Death Penalty Act of 1996 also known as the “Select Agent Rule.”
The Director of UCR Environmental Health and Safety will serve as the RFO for the Campus. (909-787-6324, Environmental Health and Safety Building.) The RFO is an ex officio member of the Institutional Biosafety Committee (IBC) and reports directly to the IBC.
To fulfill this responsibility, the RFO shall:
Ensure oversight of the Select Agent transfer process.
Administer the Select Agent Program and coordinate with CDC regarding the Select Agent Registration process.
Review and sign EA-101 Forms for Select Agent transfers.
Forward completed EA-101’s to CDC within 36 hours.
Notify CDC-LRSAT Program if there is a suspicion that the Select Agent may not be used for the intended purpose.
Maintain an inventory of the facilities that are using Select Agents.
Notifies the CDC if a Select Agent is depleted or destroyed.
Verify that the requestor is an employee, has a current registration, and has an appropriate laboratory or campus facility for the BL level of research proposed.
Principal Investigator
The Principal Investigator (PI) is responsible for compliance with all of the policies, practices, and procedures set forth by the CDC-LRSAT Program. This responsibility extends to all aspects of the select agent program including authorization of laboratory personnel, proposing safety practices and equipment, controlling access, security, and transferring or receiving select agents.
Although the PI may choose to delegate aspects of the select agent program the laboratory to other laboratory personnel, this does not absolve the PI of the ultimate responsibility. The PI remains accountable for all of the activities in his/her laboratory.
Documentation of training and compliance with the appropriate select agent practices and procedures is essential. The PI may not transfer or receive select agents until they are registered with the CDC-LRSAT Program and have received approval from CDC and Environmental Health and Safety. The PI requiring shipment of Select Agents must notify the RFO prior to shipment of select agents. Please contact the RFO at 787-5528 for signature on the EA-101 Shipping Form. PI responsibilities include:
· Notify the RFO of current inventory.
· Notify the RFO of intent to transfer or receive Select Agents.
· Complete EA-101 and forward to the RFO for signature.
· Notify the RFO when the Select Agent is shipped and received.
· Notify the RFO when the Select Agent is depleted or destroyed.
· Notify the RFO of any requests for Select Agents (Intra-facility or external)
· Forward a copy of the completed EA-101 to the RFO after transfer of select agents.
· Notify the RFO of any problems encountered during the Select Agent transfer process.
Institutional Biosafety Committee
The Institutional Biosafety Committee (IBC) is advisory to the Chancellor on all matters regarding the safe use of biohazardous materials, recombinant DNA, and infectious agents. It is the IBC’s responsibility to establish, monitor, and enforce policies and procedures that meet or exceed applicable regulations. Any use of Select Agents must be reviewed and approved by the IBC prior to the initiation of experiments involving Select Agents.
Alternate Responsible Facility Official
The Alternate Responsible Facility Official (ARFO) is a member of the Environmental Health and Safety staff and advises the Institutional Biosafety Committee on select agent issues. The ARFO’s duties include, but are not limited to:
- Verification that the laboratory meets the requirements for working with the requested select agents.
- Review of specific laboratory protocols involving the possession, and use of select agents.
- Provided select agent specific training, as necessary.
- Verification that a select agent has been depleted or destroyed.
Shipper’s Responsibilities
Shipping of Select Agents or Biological Toxins
All select agents and biological toxins must be shipped in accordance with the International Air Transport Association (IATA) requirements as an “Etiologic Agent with a Dangerous Goods Manifest” and must meet other applicable regulatory requirements and Select Agent specific hazard information. The PI requiring shipment or receipt of Select Agents must notify the RFO prior to shipment of Select Agents. Please contact the RFO, 787-5528 for signature on the EA-101 Shipping Form.
Receipt of Select Agents or Biological Toxins\
All select agents and biological toxins must be shipped to the Environmental Health and Safety Office prior to delivery to the laboratories. This is to ensure proper shipment, notification, and tracking of select agents. The PI requiring shipment of select agents must notify the RFO prior to shipment of select agents. Please contact the RFO at 787-5528 for signature on the EA-101 Shipping Form.
Shipper responsibilities include:
· Shipper is required to notify CDC of any transportation incident involving a select agent at the CDC Emergency Phone Number (1-800-232-0124), 24 hours a day, 7 days a week.
· Packages containing select agents are required to be packaged as “Infectious Substances,” and labeled with “Infectious Substance and Etiologic Agent” Label.
· Packaging requirements for select agents require that the shipper’s name and phone number appear on the outer package, in order to be used in emergencies.
· The phone number must be answered 24 hours a day by the shipper in case of emergency.
· Importers of select agents are also subject to CDC’s regulation 42 CFR Part 71.54, (“Importation of Etiologic Agents and Vectors”), and are responsible for obtaining an import permit from the CDC prior to importing Select Agents.
· For questions regarding shipping or permitting issues please contact the RFO at 787-5528.
APPENDIX
Select Agents – HHS Select Agent Program
Updated August 26, 2002
Viruses
1. Crimean-Congo haemorrhagic fever virus
2. Ebola viruses
3. Lassa fever virus
4. Marburg virus
5. .South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
6. Tick-borne encephalitis complex viruses
7. Variola major virus (Smallpox virus)
8. Viruses causing hantavirus pulmonary syndrome
9. Yellow fever virus
Bacteria
1. Yersinia pestis
Rickettsiae
1. Rickettsia prowazekii
2. Rickettsia rickettsii
Toxins
1. Abrin
2. Conotoxins
3. Diacetoxyscirpenol
4. Ricin
5. Saxitoxin
6. Tetrodotoxin
Bacteria
1. Bacillus anthracis
2. Brucella abortus
3. Brucella melitensis
4. Brucella suis
5. Burkholderia (Pseudomonas) mallei
6. Burkholderia (Pseudomonas) pseudomallei
7. Clostridium botulinum
8. Francisella tularensis
Fungi
1. Coccidioides immitis
Rickettsiae
1. Coxiella burnetii
Viruses
1. Eastern Equine Encephalitis virus
2. Equine Morbillivirus (Hendra virus) NIPAH virus
3. Rift Valley fever virus
4. Venezuelan Equine Encephalitis virus
Toxins
1. Aflatoxins
2. Botulinum toxins
3. Clostridium perfringens epsilon toxin
4. Shigatoxin
5. Staphylococcal enterotoxins
6. T-2 toxin
USDA High Consequence of Livestock Pathogens and Toxins
1. African horse sickness virus
2. African swine fever
3. Akabane virus
4. Avian influenza (highly pathogenic)
5. Blue tongue virus (exotic)
6. Bovine spongiform encepalopathy agent
7. Camel pox virus
8. Classical swine fever
9. Cowdria ruminantium (heartwater)
10. Foot and mouth disease virus
11. Goat pox virus
12. Japanese encephalitis virus
13. Lumpy skin disease virus
14. Malignant catarrhal fever
15. Menangle virus
16. Mycoplasma capricolum/M.F 38/M.M ycoides capri (contagious caprine pleuropneumonia agent)
17. Mycoplasma mycoides mycoides (contagious bovine pleuropneumonia agent)
18. Newcastle disease virus (exotic)
19. Peste des petits ruminants
20. Rinderpest virus
21. Sheep pox
22. Swine vesicular disease virus
23. Vesicular stomatitis virus