Select Agents

1.0 Policy

It is the policy of California State University, Fullerton that all laboratories and campus facilities that will use, transfer, possess, or receive select agents must comply with Possession, Use, and Transfer of Select Agents and Toxins, 42 Code of Federal Regulations Part 73. http://www.cdc.gov/od/sap/42_cfr_73_final_rule.pdf

2.0 Scope

This policy applies to University faculty and staff, students and visitors who receive, possess, use, transfer or acquire Select Agent(s) while participating in any university and non-university sponsored activity on all university facilities.

3.0 Definitions

3.1

"Select Agent" as defined by the CDC and APHIS, means biological agents or toxins deemed a threat to the public, animal or plant health, or to animal or plant products.

3.2

"Biological agent" means any microorganism (including, but not limited to bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring bioengineered or synthesized component of any such microorganism or infectious substance, capable of causing death, disease or other biological malfunction in a human, an animal, a plant or another living organism; deterioration of food, water, equipment, supplies or material of any kind; or deleterious alteration of the environment.

3.3

"Toxin" means the toxic material or product of plants, animals, microorganisms (including, but not limited to bacteria, viruses, fungi, ricksettsiae or protozoa) or infectious substances, or recombinant or synthesized molecule, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such a substance.

3.4

"Access" means having the permission or ability to obtain or make use of Select Agents. Only authorized persons are permitted access to Select Agents. Access to a Select Agents can be limited by either security containers or authorized personnel. For non-laboratory functions including routine cleaning, maintenance and repairs, non-approved individuals will be allowed access to areas where Select Agents are accessible only if they are escorted and monitored by authorized personnel.

3.5

"Authorized person" is an individual who has been approved for access to Select Agents through the successful completion of an FBI security risk assessment as described in 42CFR73.8.

3.6

"Responsible Official" (RO) means the individual designated by the entity to act on its behalf. This individual must have the authority and control to ensure compliance with the regulations. For purposes of this policy, the RO is the Associate Vice President for Administration.

3.7

"Assistant Responsible Official" (ARO) assists the RO in the implementation of the Select Agents Program. For purposes of this policy, the ARO is the Radiation/Biosafety Officer.

3.8

"Restricted Persons" are prohibited from having access to Select Agents. A restricted person is any individual who:

has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
is under indictment for a crime punishable by imprisonment for a term exceeding 1 year
is a fugitive from justice;
is an unlawful user of any controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802));
is an alien illegally or unlawfully in the United States;
has been adjudicated as a mental defective or has been committed to any mental institution;
is an alien (other than an alien lawfully admitted for permanent residence) who is a national of Cuba, Iran, Iraq, Libya, North Korea, Sudan or Syria, or any other country to which the Secretary of State, pursuant to applicable law, has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or
has been discharged from the Armed Services of the United States under dishonorable conditions.

4.0 Implementation

The President approved this policy on XX, 2004, and authorized its immediate university-wide application and distribution. The Associate Vice President for Administration is responsible for assuring the effective distribution of this Policy and its annual review. Questions concerning this Policy and its implementation should be directed to sfisher@fullerton.edu.

5.0 Accountability

5.1 Responsible Official (RO)

The Responsible Official (RO) is responsible for ensuring that research involving the possession, use, transfer, or receipt of select agents is conducted in accordance with 42 Code of Federal Regulations Part 73, also known as the "Select Agent Rule." The Associate Vice President for Administration will serve as the RO for the Campus. Responsibilities include:

Administration of the Select Agent Program and coordination with CDC regarding the Select Agent Registration process.
Maintaining an inventory of the principal investigators that are using Select Agents.
Notifying the CDC if a Select Agent is depleted or destroyed.
Verifying that the requestor is an employee has a current registration, and has an appropriate laboratory or campus facility for the research proposed.

5.2 Alternate Responsible Facility Official (ARO)

The Alternate Responsible Facility Official (ARO) is the Radiation/Biosafety Officer in the Environmental Health and Instructional Safety office. The ARO's duties include, but are not limited to:

Maintain an inventory of select agents. Review and update annually.
Review research proposals and laboratory protocols involving the possession and use of select agents.
Provide select agent specific training to procurement officials and principal investigators, as necessary.
Verify that a select agent has been depleted or destroyed.
Document all select agent activity including inventory, purchases, exchanges, use and disposal. Maintain records in a secure location.

5.3 Principal Investigator

The Principal Investigator (PI) is responsible for compliance with all of the policies, practices, and procedures set forth by this 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. The PI may not receive agents until they are registered with this program and have received approval from the RO, EHIS and the Federal Health and Human Services Secretary. The PI requesting the use of Select Agents must notify the RO prior to the start of any research or classroom activity involving select agents. All new faculty will be surveyed for their potential use of select agents.

6.0 Program

Registration

All principal investigators must register with the Centers for Disease Control prior to the receipt, use, or transfer of select agents that are on the list in the attached Appendix. PI's must comply with all of the requirements established by the Centers for Disease Control as outlined in 42 CFR 73. Contact the ARO (278-7233) prior to planning any work with select agents.

Authorization/Approval

Any person wishing to begin a research project, teaching activity, or other work involving select agents must receive authorization by the RO and ARO before the work begins. EHIS will coordinate all 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 RO and ARO.
http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4ai.htm
Any modification of containment will be based upon a risk assessment.
http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4s5.htm

Training

All personnel that purchase or approve the purchase of select agents must have training on the procedures necessary for the purchase of select agents. Principal investigators that possess, use, transfer, or receive 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, (6) purchasing, transfer, shipping, and receiving protocols.

Security

All laboratories and campus facilities that purchase, possess, use, transfer, or receive 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 that purchase, possess, use, transfer, or receive select agents must be inspected quarterly by the ARO to ensure that all requirements are being met. If a facility is found to be in non-compliance, the CDC Select Agent Certificate of Registration 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 and (2) must have a visual indication of airflow to ensure 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 EHIS and/or ARO.

Administrative Controls

All principal investigators that purchase possess, use, transfer, or receive select agents must develop operating procedures to ensure safe work practices are being consistently used. EHIS and/or ARO will assist PI's in the development of these procedures. PI's must review the procedures annually, or as necessary, to reflect changes. 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 approved by EHIS and appropriate protection for the select agent used.

When a Select Agent is Depleted or Destroyed

The RO or ARO 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 RO 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, the CDC must be notified in writing by the RO to have the PI removed from the registration. The CDC will send a letter to confirm the change.

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 RO/ARO prior to shipment of Select Agents. 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 ARO at 714-278-7233.

Receipt of Select Agents or Biological Toxins

All select agents and biological toxins must be addressed to and received by the Environmental Health and Instructional Safety Office prior to delivery to the laboratories. Packages will be picked up by EHIS personnel and processed in an appropriate facility on campus. This is to ensure proper shipment, notification, and tracking of select agents. The PI receiving select agents must notify the RO/ARO prior to the shipment of select agents.

Appendix

Select Agents - HHS Select Agent Program

Viruses

Crimean-Congo hemorrhagic fever virus
Ebola viruses
Lassa fever virus
Marburg virus
South American Hemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
Tick-borne encephalitis complex viruses
Variola major virus (Smallpox virus)
Viruses causing Hantavirus pulmonary syndrome
Yellow fever virus

Bacteria

Yesinia pestis

Rickettsiae

Rickettsia prowazekii
Rickettsia rickettsii

Toxins

Abrin
Conotoxins
Diacetoxyscirpenol
Ricin
Saxitoxin
Tetrodotoxin