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Introduction

The Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA), Animal Plant Health Inspection Service (APHIS) have identified specific biological agents and toxins that are considered to be a severe threat to public health and safety as bioterrorism agents. These materials are referred to as select agents and toxins by the CDC and high consequence livestock pathogens and toxins, and listed plant pathogens, by APHIS. Transfer, possession, use, and disposal of all of these agents and toxins are strictly regulated. Tier 1 select agents and toxins is a subset that represents the greatest risk of deliberate misuse with significant potential for mass casualties or severe effects to the economy, infrastructure, or public confidence. There are additional regulations that apply to Tier 1 select agents and toxins. Because the list of select agents may be revised, it is recommended that the most current list of select agents and toxins be checked before acquiring pathogenic agents and biological toxins by accessing the web site (click on “Select Agents & Toxins” to find the current list).

The regulations associated with select agents and toxins are very complex and strict, and there are significant monetary fines and criminal penalties associated with non-compliance. The information in this Chapter is a summary of the select agent regulations; it is not a complete description of the regulatory requirements associated with select agents and toxins. Investigators must review and understand the select agent regulations and their responsibilities prior to acquiring or working with any select agent or toxin (see above link to regulatory information).

Responsible Official

Select agent regulations require that a Responsible Official (RO) be designated for each institution that possesses and uses select agents or toxins. The ÍƼöÐÓ°ÉÔ­´´ Laboratory Safety Manager, Cheston Carpenter, is the RO for University. Additionally, an alternate Responsible Official has been designated to act in the RO’s absence. The RO has institutional responsibility for the biosafety, security, and regulatory compliance of select agents, and as such, must be contacted prior to obtaining any select agents.

Authorization to Possess and Use Select Agents

Prior to obtaining any select agent or toxin, a MOUA (see Chapter 2) covering the proposed work must be submitted to, and approved by, the University Institutional Biosafety Committee.

PIs who want to acquire, possess, or use any select agent or toxin must be registered and approved with the appropriate agency (CDC or USDA) prior to obtaining the agent(s) or toxins(s). Both the institution (University) and individual personnel must be approved by the appropriate agency. Investigators who want to possess and use select agents or toxins must contact the RO (Cheston Carpenter) for assistance with the registration application process. Approval by the CDC or USDA will take a few months (plan a minimum of three months) and will require a site inspection by Select Agent Program inspectors. PIs should plan research projects accordingly.

The select agent regulations contain very strict requirements regarding biosafety, training, incident response, security and accountability, as well as other requirements. Investigators wanting to acquire select agents or toxins should review the applicable select agent regulations thoroughly before initiating the registration application process.

Exemptions and Exclusions

Diagnostic labs that do not maintain select agents or toxins are largely excluded from the select agent regulations; however, there are notification and possession time limits and other requirements that do apply. Additionally, the CDC and APHIS can grant exclusions for temporary public health emergency situations, and other special circumstances. Consequently, any laboratory that conducts diagnostic or verification testing for any select agent or toxin must self-identify and contact the University RO as soon as possible. Identification of any select agent or toxin in a specimen or isolate must be reported to the RO as soon as possible.

Several specific select agent microbial strains and toxin forms have been determined to not present a severe threat to public health and safety, and are therefore excluded from the CDC/APHIS select agent regulations. The list of excluded biological agents and toxins is dynamic and the most current list is available on the web site. Only the specific strains and toxins listed are excluded. Altered strains or toxin forms derived (even directly) from excluded agents and toxins are not themselves excluded unless specifically approved by the CDC or APHIS. Toxins are also excluded based on threshold quantities. Laboratories maintaining exempt quantities of select agent toxins must keep an accurate inventory of toxin amounts to verify that total quantities are below the threshold, and must keep toxins stored in locked containers (e.g., freezer).

Safety Plan

Each select agent laboratory must develop and implement a written safety plan that addresses the biological and chemical safety issues associated with the specific select agents and toxins maintained by the laboratory. In particular, the plan must address the hazards associated with the select agents and toxins, methods to be used to prevent exposures, including use of laboratory ventilation (biological safety cabinets and lab hoods) and personal protective equipment, disinfection and decontamination methods, waste handling and disposal procedures, and the proper response to spills, personal contamination, and other incidents.

Biosafety plans for select agents and toxins must meet the agent-specific and biosafety level criteria listed in the most current version of the BMBL. Use of recombinant or synthetic nucleic acid molecules that are considered to be a select agent must meet the applicable criteria listed in the most current version of the NIH guidelines. Chemical safety plans for select toxins must meet the criteria listed in the OSHA Standard .

Security Requirements

All persons who will have access to any select agent or toxin must be approved by the Department of Justice. Approval requires that each individual successfully pass a background security check (conducted by the FBI in accordance with the USA PATRIOT Act) and submit fingerprints to the FBI, with approval by the Select Agent Program and the RO. Additionally, access to Tier 1 select agents and toxins requires successful screening through the University Select Agent Personnel Suitability Assessment Program and approval by the RO. Contact the RO for more information on obtaining approval for access to select agents and toxins.

Anyone who has not been approved for access to select agents and toxins must be denied access unless they are escorted by an approved person (including Tier 1 select agent and toxin approval as applicable). Everyone who enters a laboratory where select agents are stored or present must have security approval or be accompanied by an approved person. This includes visiting scientists (University or off campus), maintenance workers, custodians, and vendors. Persons without a security approval cannot have direct (hands on) access to select agents and toxins, even if under direct escort of an approved person.

Each laboratory that possesses or uses select agent or toxins must have a written security plan. This plan must be based on a site-specific security risk assessment and must addresses the following topics:

• Physical security
• Cyber security
• Inventory of select agents
• Select agent transfers
• Training
• Reporting of unauthorized persons and missing materials
• Provisions for cleaning, maintenance, and repairs

Laboratories that possess Tier 1 select agents and toxins require additional security measures over and above those required for other select agents and toxins.

Any theft or loss of select agents must be immediately reported to the RO and the University Police at (775) 334-COPS. The RO will make the required notification to the Select Agent Program.

Incident Response

Each laboratory that possesses or uses select agents or toxins must develop a written incident response plan that is laboratory specific and based on a site-specific risk assessment. This plan must be coordinated with the department, building, and university incident response plans. The plan must address the hazards of the select agents, planning and coordination with emergency responders, building evacuation, site security and control, decontamination and emergency medical treatment, and other incident response issues.

Training

All persons approved for access to select agents and toxins must receive documented training covering safety of select agents and toxins and their safe handling, use, and disposal; security requirements and procedures; inventory and accounting procedures; and emergency response procedures. Personnel who require access to Tier 1 select agents and toxins must receive additional training on Tier 1 select agents and toxins, including the Personnel Suitability Assessment Program. Training is required before beginning work with select agents and annually thereafter.

Transfers

Select agents and toxins can only be transferred between entities that are currently approved by the CDC or USDA to possess and use the specific select agents and toxins to be transferred. All transfers of select agents and toxins require prior approval of the Select Agent Program. Both the sender and recipient must complete a transfer form (APHIS/CDC Form 2), and the recipient submits the completed form to the Select Agent Program. The Form 2 requires the signature of the RO from both the sender and recipient facilities. Contact the University RO, Cheston Carpenter, at 775-784-4342 or chestonc@unr.edu prior to any transfer of select agents.

Inventory and Disposal of Select Agents

An accurate record of all select agents and toxins, from receipt to destruction or disposal, must be maintained. The inventory must include specific information on individual containers and vials, as well as a record of each use and disposal. The select agent and toxin inventory must be verified at least monthly to account for all quantities and containers of select agents and toxins. Any discrepancies between the inventory record and the actual inventory must be reported as soon as possible to the University RO.

Records

The select agent regulations require that several records be maintained, including the following:

• Detailed inventory of each select agent and associated containers
• Access to select agents and toxins
• Access to areas where select agents and toxins are used or stored
• Safety, security, and incident response plans
• Training records
• Transfer documents (From 2) and other APHIS/CDC select agent/toxin forms
• Safety and security incident reports

Each individual laboratory that possesses or uses select agents or toxins is responsible for maintaining these records. EH&S will keep records of any training that it conducts, including select agent training presented by the RO. Laboratories must maintain records of training conducted by laboratory personnel or any other applicable training. EH&S will maintain APHIS/CDC forms; however, laboratories must also maintain copies of these forms. The recordkeeping requirements are complex, and therefore the select agent regulations should be reviewed for a complete description of the recordkeeping requirements.

Chapter 15: Animal Care and Use in University Research, Testing, and Education Programs