Syracuse University is currently restricted by the Federal Government from possessing Select Agents in non-exempt quantities. Before a Syracuse University Laboratory can receive a Select Agent, the facility must submit an application to the CDC for approval and meet all requirements listed in 42 CFR Part 73. The initial application process is time consuming and may require a 12-24 month delay in research until approval is granted. The requirements of 42 CFR Part 73 are listed below.
Contents
6.1 Select Agent Review Process
For Select Agent use, a biosafety review will be achieved with the participation of the Biosafety Officer, the PI, and the IBC. The review process shall be completed before obtaining any Select Agent on campus. As part of the review process the following shall be achieved:
- The appropriate Biosafety Level required for use, handling and storage shall be determined.
- An application to use the agent (requiring biosafety level 2, 3, 4) shall be submitted.
- Facility requirements shall be met for the appropriate biosafety level required.
- Committee review and approval shall be obtained.
Review, analysis and evaluation will cover the following:
- standard microbiological practices,
- special practices required by the nature of the specific hazard,
- containment equipment, and
- laboratory facilities.
A procedure analysis will be completed to assist with identification of potential hazards. The procedure analysis will also further identify required containment practices, and will specify personal protection requirements, decontamination and disposal procedures. The PI will be responsible for completing the procedure analysis.
The completed procedure analysis will be kept on file at the Environmental Health and Safety Services Office and the Biosafety Officer will monitor the lab periodically to determine if biosafety procedures and equipment are being maintained. The PI and laboratory staff will keep the Biosafety Report on file and available to use for training new staff, for reference, and for self-checks on procedures, equipment, and personal protection requirements. This report will also serve to document standard operating procedures for the laboratory since practices and procedures are detailed in the report. Similar Standard Operating Procedures are required by the OSHA Laboratory Standard 29 CFR 1910.1450.
6.2 Training for Select Agent Use
All staff, faculty and students who will be handling or have access to Select Agents on campus must be trained on the proper handling and storage of Select Agents. Training will include the following specific topics:
- Biosafety levels defined and reviewed,
- Storage and security requirements,
- Inventory control method,
- CDC guidelines for shipping the agent both on and off-campus,
- Specific hazards of the Select Agent or toxin,
- Universal precautions, personal hygiene, and lab-acquired infections,
- Laboratory design and ventilation,
- Toxicology of overexposure,
- Identification and use of required PPE,
- Procedures for visitors,
- Spill or leak procedures,
- First Aid or antidote use procedures in case of accidental exposure,
- Incident reporting requirements,
- Biohazardous sharps / waste disposal procedures,
- Disinfection, autoclave, and/or inactivation procedures,
- Medical surveillance / immunization requirement,
- Biological Safety Cabinet inspection, use, and care.
6.3 Select Agent Security Measures
Laboratories using Select Agents must comply with the facility’s Security Plan. Security issues during normal day-to-day activities shall be addressed by the principal investigator. The PI shall have complete knowledge of the facilities security plan, which at minimum, require the following:
- Allow un-escorted access only to individuals who have been approved (for work with Select Agents) and who are performing a specifically authorized function during hours required to perform the defined job.
- Allow individuals not approved (for work with Select Agents) to conduct routine cleaning, maintenance, repairs, and other non-laboratory functions only when escorted and continually monitored by individuals approved (for work with Select Agents).
- Select Agent storage areas must be locked when they are not in the direct view of the staff.
- Require the inspection of all packages upon entry and exit from the area.
- Require that each individual approved (for work with Select Agents) does not share with any other person, their unique means (e.g., key cards or password) of accessing the area or Select Agents or toxins.
- Require that each individual approved (for work with Select Agents) report any loss or compromise of their keys, passwords, combinations, etc., and report any sign that inventory and use records have been altered or otherwise compromised.
Refer to Section 6.3.4 f for further information on approved and restricted personnel.
6.3.1 Select Agent Inventory Control
The PI shall establish a system to maintain a current inventory of containers, plates, tubes, etc. that contains viable agents or quantities of controlled toxins. The inventory shall be updated when a significant volume or concentration of a given select agent changes during the course of the research. The inventory list shall be maintained and available for inspection by authorized representatives of the CDC and/or members of the SU Biosafety Committee. Records will include the following:
- A current inventory and an annual physical inventory each June 30th,
- Records of disposal and destruction, use and access, and
- A record of Select Agents lost or stolen, with notification to the IBC, the Biosafety Officer, and the CDC concerning lost or stolen items.
6.3.2 Notification for Theft, Loss, or Release
Thefts or losses of Select Agents must be reported immediately to the Biosafety officer. When reporting a theft or a loss, the following information must be provided:
- The name of the Select Agent or toxin and any identifying information,
- An estimate of the quantity lost or stolen,
- An estimate of the time during which the theft or loss occurred, and
- The location from which the theft or loss occurred.
6.3.3 Select Agent Storage
Select Agents shall be kept in locked storage areas. Keys to these areas shall be maintained only by staff and researchers approved by the PI. Environmental Health and Safety Services shall be informed as to the location of each Select Agent.
6.3.4 Restricted Access
Access to the Select Agent shall be limited to a list of approved staff and students. Access shall be defined as having the physical ability to handle containers that hold the microorganism or toxin under control. Lab personnel shall have met security clearance requirements as set forth in the regulations and/or program requirements.
6.3.5 Restricted Persons
The University will not permit an individual access to a Select Agent or toxin, unless the individual is approved by the HHS Secretary or the USDA Secretary, based on a security risk assessment conducted by the Attorney General. The HHS Secretary will deny or revoke access to select agents to any individual who:
- Is under indictment for a crime punishable by imprisonment for a term exceeding one year,
- Has been convicted in any court of a crime punishable by imprisonment for a term exceeding one year,
- Is a fugitive from justice,
- Is an unlawful user of any controlled substance,
- 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 permitted for permanent residence) who is a national of a country as to which the Secretary of State has made a determination (that remain effective) that such country has repeatedly provided support for act of international terrorism,
- Has been discharged from the Armed Services of the United States under dishonorable conditions.
Individuals who have not received approval, training, and relevant immunizations shall be prevented from gaining access to the select agents by locked doors, alarm systems, posted access requirements, etc. Unapproved individuals must be escorted and monitored by authorized personnel when entering select agent areas.
6.4 Facility Requirements
Facility requirements shall meet the biosafety level requirements established for the Select Agent in use. Facility requirements shall also provide for adequate security, storage, and communications. If laboratory facility design features are not adequate to meet the appropriate biosafety level, then research using the Select Agent shall not proceed until upgrades are performed, cabinets certified, etc. and all facility requirements are met.
6.5 Possession of Exempt Quantities of Select Agent Toxins
Federal regulations allow each PI to possess a specified amount of Select Agent Toxin without triggering CDC registration and other Federal requirements. However, Syracuse University has established requirements for possession of exempt quantities of Select Agents Toxins. These requirements ensure the following:
- Safe laboratory handling, use, and storage procedures,
- Effective tracking and security of the regulated toxins, and
- Co-compliance with federal regulations.
6.5.1 Exempt Quantities of CDC Select Agent Toxins
Below is the list of SA Toxins and the Federal allowable maximum exempt quantities (per PI). Allowable possession quantities at Syracuse University will ultimately be determined by the IBC, based on a review of the PI’s Possession and Use Application. A completed Possession and Use Application must be submitted to the IBC for review and approval, prior to any individual taking possession of a Select Agent Toxin at Syracuse University.
Toxin Maximum allowable per PI for exemption:
- Abrin 100 mg
- Botulinum neurotoxins 0.5 mg
- Clostridium perfringens epsilon toxin 100 mg
- Conotoxins 100 mg
- Diacetoxyscirpenol 1000 mg
- Ricin 100 mg
- Saxitoxin 100 mg
- Shigatoxin and Shiga-like ribosome inactivating proteins 100 mg
- Staphylococcal enterotoxins 5 mg
- Tetrodotoxin 100 mg
- T-2 toxin 1000 mg
It is important to ensure that the total amount of toxin per PI in a laboratory is maintained below these limits at all times for exemption from Federal registration and the attendant restrictive requirements. Due to the severe penalties associated with non-compliance with the SA rules, it is imperative that each laboratory using and storing toxins maintains current inventory information for these substances. Failure to register a Select Agent is now a criminal offense, punishable by up to five years in prison and/or $500,000 in fines. (Public Health Security & Preparedness Response Act of 2002, s. 231(c)).
6.5.2 Requirements for Possession of Exempt Quantities of Select Agent Toxins
All laboratories using exempt quantities of Select Agent Toxins will be assessed by the Biosafety Officer for compliance with the requirements of this Program. An assessment will be conducted using a Select Agent Toxin Safety Assessment form. The assessment form will be used to assess the adequacy of the laboratory equipment, work practices, and administrative controls used for experiments that require the use of Select Agent Toxins. Based on the assessment, the Biosafety Officer will make recommendations in regards to the practices used in the laboratory. Before exempt quantities of Select Agents may be acquired, the Principal Investigator must meet the following requirements and have approval from the Biosafety Committee.
Application for Possession and Use
The PI must submit an application for the Possession of a Select Agent in Exempt Quantities by completing the appropriate form to the Biosafety Committee. A formal approval letter must be issued by the Committee before any Select Agent Toxin is allowed at Syracuse University.
Standard Operating Procedures (SOP)
The PI must prepare and submit a written SOP for each research processes that involves Select Agents Toxins to the Biosafety Committee for approval. The SOP must comply with Section 3.3 of this Program.
Personnel Training
The PI must provide an initial lab-specific safety training to staff on each process involving a Select Agent. Training must be documented and all records must be documented for a minimum of 5 years. Training topics should include:
- Toxin-associated hazards
- Engineering controls used to minimize exposure (i.e., fume hood use)
- Personal protective equipment to be used when handling toxin (PPE)
- Safe handling and storage proper decontamination and disposal
- Administrative requirements (record-keeping, inventory, security)
Personal Protective Equipment (PPE)
Appropriate personal protection is to be provided (i.e., gloves, safety goggles, lab coat or disposable lab coat). Principal Investigators must select PPE that will adequately protect against the specific hazards associated with the Select Agent. NOTE: If respirators are necessary, contact EHSS at 315-443-9131 for necessary respirator use approval and compliance documentation.
Engineering Controls
All manipulations of Select Agents Toxins must take place in a properly functioning fume hood. Signs stating the health hazards and contact person will be posted on the fume hood when experiments using Select Agent Toxins are conducted. All fume hood surfaces must be wiped with a disinfectant that is specific to the Select Agent Toxin after each use, and or, prior to reuse for any other purpose.
Disposal
Prior to disposal, all biological toxins must be inactivated. The PI must choose an inactivation process that is effective for each specific toxin (i.e. appropriate chemical or steam heat). Inactivated biological toxins may be disposed of via laboratory sink drains, provided the pH range is between 5.5-11.0. All inactivated toxins outside this range must be managed as hazardous waste per SU Hazardous Waste Management procedures.
Storage/Security
Select Agents shall be kept in locked storage areas. Keys to these areas shall be maintained only by staff and researchers approved by the PI. EHSS shall be informed as to the location of each select agent. Items must be:
- Stored with compatible materials within secondary containment; and
- Provided one layer of physical security (i.e., toxin secured within a locked freezer, or secured within a permanently fixed lockbox).
List of PI-Approved Users
A documented list must be maintained of PI-approved toxin users (including those having access to toxin materials). The lab must keep track of who uses the stock (and who has access to the freezer). Before becoming an approved user, the PI must ensure that each person has received training regarding the hazards associated with the toxins and the standard operating procedures used in the lab.
Inventory Maintenance
The PI shall establish a system to maintain a current inventory of containers, plates, tubes, etc., that contain viable agents or quantities of controlled toxins. The inventory shall be updated each time a volume or concentration of a given Select Agent Toxin changes during the course of the research. The inventory list shall be maintained and available for inspection by authorized representatives of the CDC and/or members of the IBC. For any questions regarding Select Agent Toxin possession at Syracuse University, contact the Biosafety Officer at 315-443-2447.