Environmental Health and Safety

SDSU Biosafety Manual

San Diego State University
BIOHAZARD CONTROL PROGRAM

Part VII:
SELECT AGENTS AND TOXINS

A. PURPOSE

B. RESPONSIBILITIES

C. REQUIREMENTS

D. THE PROGRAM

E. SECURITY

F. DEFINITIONS

A. PURPOSE

This chapter describes the requirements for the safe and secure transportation, storage and possession of listed select agents and toxins. The requirements are found in the following Public Law and Federal Regulations:

• Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (US Patriot Act) of 2001 (Public Law 107-56, October 26, 2001)
  
  
• Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188, June 12, 2002)
  
  
• Agricultural Bioterrorism Protection Act of 2002
  
  
• Interstate Shipment of Etiologic Agents (42 CFR Part 72)
  
  
• Possession, Use and Transfer of Select Agents and Toxins (42 CFR Part 73)
  
  
• Possession of Biological Agents and Toxins (7 CFR Part 331)
  
  
• Organisms and Vectors (9 CFR Part 121-122)
  
  

B. RESPONSIBILITIES

San Diego State University (SDSU) is responsible for providing notification to the U.S. Department of Health and Human Services (DHHS) Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) for the possession, disposal and transfer of any listed select agent or toxin as specified in the above mentioned federal regulations.

President, provost,vice presidents, deans and department chairs are responsible for assuring compliance by SDSU faculty, staff, students, PIs, animal handlers, and other personnel with the Select Agent and Toxin Inventory and Registration Program and assuring that funding is available to provide security and safety to facilities and during transport where select agents are possessed or handled.

Responsible Official (RO) is responsible for:

• Overseeing the facility inventory for select agents and toxins and consulting with others (e.g., PIs) as necessary to obtain information required for registration or exemption and exclusion declarations.
  
  
• Reviewing and signing the registration form and sending the form to CDC and/or APHIS.
  
  
• Declaring exemption or exclusion, if applicable to CDC and/or APHIS.
  
  
• Being point of contact if the CDC has questions concerning the application or other matters relating to the Select Agents or Toxins.
  
  
• Promptly notifying the CDC or APHIS and the appropriate (local, state or federal) law enforcement agency in the event of a loss or theft of a listed select agent or toxin.
  
  

Principal Investigators (PIs) and any person handling, possessing or transferring listed select agents and toxins are responsible for:

• Annually providing an accurate inventory of all listed select agents or toxins upon request.
  
  
• Assuring that select agents and toxins are securely contained in locked locations such as a locked freezer within a locked laboratory with limited access to authorized personnel only.
  
  
• Ensuring that proper training is provided (skills are learned not provided) to personnel assigned to possess, handle, transfer or dispose of select agents and toxins.
  
  
• Notifying the RO and EHS prior to the procurement, arrival or disposal of any listed select agents.
  
  
• Coordinating with deans, Facilities Planning Management, SDSU Foundation and EHS to ensure that the proper laboratory or animal facilities and equipment exist to safely contain, dispose and secure listed select agents and prevent access.
  
  

Center for Human Resources and the Department of Public Safety are responsible for obtaining and maintaining information on “restricted persons” as they pertain to access to select agents.

Department of Environmental Health and Safety (EHS) is responsible for:

• Developing campus procedures in collaboration with the Department of Public Safety, Center for Human Resources, PIs and others for compliance with the “Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”
  
  
• Providing consultation to the PI, IBC and others regarding BSL classifications, prudent practices, safety and security, procurement and training.
  
  
• Receiving and documenting the receipt of all select agents procured by the facility.
  
  

C. REQUIREMENTS

This section addresses the individual requirements for transfer, possession and storage of select agents and toxins at the facility level. Additional requirements may apply to specific operations, personnel and locations.

D. THE PROGRAM

E. SECURITY

Security requirements for select agents and toxins are based in part on Appendix F of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (4th Ed., 1999) entitled Laboratory Security and Emergency Response for Microbiological and Biomedical Laboratories. The physical security of the agents and toxins depends on preventing unauthorized access to the facility and unauthorized removal of these agents. These precautions are in addition to safe work practices, containment equipment, and administrative and engineering controls that prevent a biological release or exposure to workers or the environment.

F. DEFINITIONS

Altered USDA or FDA Approved Vaccine Strains: Vaccine strains that have been modified from their original licensed, approved or registered forms.

Exotic Disease: Disease that is not native to the U.S. animal or plant population. The term “exotic” is used to indicate that either the disease or the strain of a particular disease is from another country. Therefore, these agents pose a threat to U.S. animal or plant populations.

Overlap agents and toxins: Biological agents or toxins that are listed pursuant to the CDC and APHIS.

Recombinant Organism, Nucleic Acid or Genetic Elements from Agents include any of the following:

• Non-viable agents.
  
  
• Full-length nucleic acid from any of the viruses on the list. For Variola major virus (Smallpox), any segment that exceeds 100 nucleotides in length.
  
  
• Natural or synthetic nucleic acids from bacteria, fungi or viruses on the list that encode for either a functional toxin or virulence factor sufficient to cause disease, or natural or synthetic nucleic acid that encodes for a functional toxin of any of the toxins listed, if 1) expressed in vivo; 2) in an expression vector or host chromosome; or 3) in a carrier plasmid.
  
  

Responsible Official (RO): Either a safety officer or a senior management official of the facility or both, who is authorized to complete and submit the Select Agent and Toxin Registration Form. The RO should not be an individual who actually possesses, uses, stores or transfers select agents or toxins.

Restricted Person: An individual who:

• Has been indicted for or convicted of any felony or crime punishable by imprisonment exceeding one year.
  
  
• Is a fugitive from justice.
  
  
• Is an unlawful user of any controlled substance.
  
  
• Is an alien illegally or unlawfully in the U.S.
  
  
• Has been adjudicated as a “mental defective” or has been committed to a mental institution.
  
  
• Has knowing involvement with an organization that engages in domestic or international terrorism.
  
  
• Has received a dishonorable discharge from a U.S. Armed Service.
  
  
• Is an alien (other than lawfully admitted for permanent residence) who is a national of a country that supports acts of international terrorism. (The seven countries currently on the list are Cuba, Iran, Iraq, Libya, North Korea, Sudan and Syria).
  
  

Viable: Capable of replication on its own, in a cell culture or an appropriate host.