Policy for the Use of Select Agents & Toxins at Stony Brook University

Policy Category	Issuing Authority	Responsibility	Publication Date	Next Review Date
Environmental Health & Safety	Enterprise Risk Management	Environmental Health & Safety	7/27/2026	7/27/2029

Policy Statement & Background:

This policy establishes the requirements for all Principal Investigators (PIs) and their laboratories possessing and using Select Agents and Toxins at Stony Brook University as defined by the Centers for Disease Control and Prevention (CDC) and USDA Animal and Plant Health Inspection Service (APHIS).

Scope

All personnel possessing and using Select Agents and Toxins in all Stony Brook University laboratories and facilities.

Policy:

Principal Investigators (PIs) may not possess, use or transfer Select Agents & Toxins appearing on the CDC/APHIS list of regulated Select Agents & Toxins without obtaining approval from their department chair or dean, the Institutional Biosafety Committee (IBC), and Responsible Official/Alternate Responsible Official (RO/ARO) with the Department of Environmental Health and Safety (EH&S). PIs that are granted approval to possess and/or use Select Agents & Toxins must adhere to regulations set forth in 42 CFR Part 72 & 73, 7 CFR Part 331 and 9 CFR Part 121. PIs possessing and/or using Select Toxins in de minimis quantities must notify the RO or ARO and EH&S with information specifying the Select Toxin that will be possessed and/or used and indicate the maximum quantity of the toxin that will be possessed and/or used. Risk Group 4 agents are not permitted on the SBU campus and Biosafety Level 4 facilities are not available.

Procedures

Select Agent and Toxin Registration

PIs considering work with Select Agents and Toxins must first contact the RO/ARO in the Department of Environmental Health and Safety to discuss their proposed research and agents to be used to determine if they fall under the CDC/APHIS regulations. PIs who fall under the regulations will work in collaboration with the RO/ARO to complete the application packet and information for submission to the CDC and/or APHIS.

Exemptions / Exclusions

Certain Select Agents and Toxins that do not meet regulatory criteria are exempt from registration with the CDC and/or APHIS. The list of exemptions can be found on the Federal Select Agent Program website (https://www.selectagents.gov/). An excluded select agent strain or modified toxin will be subject to regulations if there is a reintroduction of factors associated with virulence, toxic activity, or other manipulations that modify the attenuation such that virulence or toxic activity is restored or enhanced.

Certain toxins may not require regulation if they are possessed or used under limits specified by the CDC and/or APHIS (https://www.selectagents.gov/PermissibleToxinAmounts.html). At no time may a PI exceed these limits indicated in the table. Should a PI exceed the permissible toxin limits for any reason they must immediately notify the RO/ARO with EH&S and indicate information specifying the select toxin that will be possessed and/or used and indicate the maximum quantity of the toxin that will be possessed and/or used.

Personnel Suitability Risk Assessment (SRA)

Prior to possessing or working with Select Agents and Toxins all individuals must undergo a security risk assessment (SRA). This process is arranged and coordinated through the RO/ARO with EH&S. It includes background checks by the FBI, the SBU Police Department and Human Resources. Applicants must undergo fingerprinting and complete a FD-961 form and EH&S Access to Select Agents & Toxins form.

Security

CDC and APHIS regulations require that stored Select Agents & Toxins must be secured in a locked container, incubator or freezer at all times. Laboratories that store or use Select Agents & Toxins must maintain security requirements as established in the Security Plan.

Although PIs maintaining Select Toxins in de minimus quantities are not subject to the same security requirements as registered Select Agents and Toxins, they are still expected to secure such materials in a manner that allows them to be accounted for and will prevent them from being lost or stolen.

Visitors requiring entrance to facilities where Select Agents and Toxins are stored and/or used must be escorted at all times by an individual that has been cleared to work and enter such facilities.

Training

Select Agent and Toxin training (initial and annual) is provided by the RO/ARO and EH&S and is required for cleared individuals who are allowed access to Select Agents and Toxins. The training will cover biosafety containment and biosecurity procedures.

Visitors must be informed of the safety & security requirements and procedures prior to being escorted into facilities containing Select Agents and Toxins. Visitors must also acknowledge in writing that they understand and will comply with these requirements.

Transfer and Receipt of Select Agents and Toxins

Transfers of Select Agents and Toxins from another institution may not occur without prior authorization of the RO at the facilities of the transferor and recipient. PIs seeking to transfer or receive Select Agents and Toxins must request that the RO complete an APHIS/CDC Form 2 as required by the CDC.

Transfer of Select Agents and Toxins within Stony Brook University must be approved by the RO before the transfer occurs.

Destruction and Disposal

Destruction and disposal of Select Agents and Toxins must be done in accordance with federal law and procedures. PIs must contact the RO/ARO for further instructions.

Clinical and Diagnostic Laboratories

Directors and laboratory managers of clinical or diagnostic laboratories that identify Select Agents and Toxins from diagnostic or verification testing activities must immediately notify the RO/ARO. The RO/ARO will then complete APHIS/CDC Form 4 as required by the CDC.

Occupational Medicine Program

All individuals that work within BSL-3/ABSL-3 laboratories cleared for working with Tier 1 Select Agents and Toxins are required to be enrolled in the Occupational Medicine Program (OMP).

Individuals enrolled in the OMP will be required to receive from Stony Brook Preventative Medicine Clinical Services: A general health assessment; health history assessment and clearance for work with infectious agents at BSL-3; medical clearance for use of N95 and PAPR respiratory protection; fit testing and training by EH&S; a reassessment upon changes in health status that may affect their immune status or other health risks.

It is important that individuals report any illnesses that may be work related or occupational exposure to infectious agents to the Laboratory Safety and Security Officer (LSSO) or Director of Laboratories in a timely manner. In the event that an individual experience symptoms similar to those caused by Select Agents and Toxins they should seek medical attention. In the event that a healthcare provider determines that the symptoms may be related to a possible occupational exposure, the individual, must notify the LSSO or Director of Laboratories immediately.

Prior to entry and training in BSL-3/ABSL-3 operations, the LSSO or BSO will provide each individual with a wallet card which contains information on the agents used within the laboratory for their reference and information for healthcare providers.

Responsibilities

Principal Investigators

Must receive approval for the possession and/or use of Select Agents & Toxins from their department chair or dean, the IBC and RO/ARO (EH&S).
Ensure that lab personnel are properly trained and proficient in the techniques to be used and are aware of the potential hazards associated with the safe handling of the select agent or toxin to be used.
Ensure that lab personnel are enrolled in the Occupational Medicine Program and provide clearance documentation for respirator fit testing to the RO/ARO/BSO.
Ensure that suitable containment, PPE, biosafety and security precautions/protocols are in place or planned to mitigate potential hazards.
Ensure that he/she will report immediately to the RO/ARO and EH&S all accidents (spills, needle-sticks, exposures, injuries, etc.) which result in overt or potential exposure to select agents and toxins as required by federal, state, local and University regulations.
Ensure that he/she will report immediately to the RO/ARO and EH&S all security incidents/concerns (missing inventory, personnel displaying unusual behaviors, etc.) which result in overt or potential exposure to select agent and toxins as required by federal, state, local and University regulations.

Laboratory Workers

Ensure that they have completed required training and are proficient in the techniques to be used and are aware of the potential hazards associated with the safe handling of the select agent or toxin to be used.
Ensure that he/she will report immediately to the RO/ARO and EH&S all accidents (spills, needle-sticks, exposures, injuries, etc.) which result in overt or potential exposure to select agents and toxins as required by federal, state, local and University regulations.
Ensure that he/she will report immediately to the RO/ARO and EH&S all security incidents/concerns (missing inventory, personnel displaying unusual behaviors, etc.) which result in overt or potential exposure to select agent and toxins as required by federal, state, local and University regulations.

Office of Research Compliance (ORC)

The ORC is responsible for receiving the requests for work with Select Agents and Toxins, distribution to the Biosafety Officer (BSO) and the IBC, and ensuring that the committee acts upon the requests in a timely manner. The ORC is responsible for forwarding all approved requests to the University’s designated RO/ARO as registered per 42 CFR Part 72 & 73, 7 CFR Part 331 and 9 CFR Part 121.

Department Chairpersons / Deans

Department Chairpersons or Deans are responsible for review of all applications for approval of Select Agents and Toxins and must sign off on these requests prior to review by the IBC.

University Biosafety Officer (BSO)

The BSO is responsible for the initial review of requests for the use of Select Agents and Toxins and requesting any additional information that he/she feels will be required by the IBC to review, approve or reject a Select Agent and Toxin use request.

Responsible Official (RO) / Alternate Responsible Official (ARO)

The RO/ARO is responsible for pursuing registration of PIs’ lab personnel and laboratory space with the necessary federal agencies as per federal laws for possession, use and transfer of select agents and toxins for all laboratories that are approved by the IBC for work with Select Agents and Toxins.

Institutional Biosafety Committee (IBC)

The IBC is responsible for the review and approval of research that contains adequate safeguards to protect the health and safety of the laboratory personnel, students, staff, and visitors of Stony Brook University and the community and to interpret guidelines and/or regulations of the U.S. department of Health and Human Services, the National Institutes of Health, and other applicable federal, state and local authorities.

Laboratory Safety and Security Officer (LSSO)

The LSSO is the primary liaison between the laboratory and the RO/ARO in matters relating to security, access and safety and their implementation at the laboratory level. The LSSO is familiar with the workings and personnel requiring access to laboratories containing Select Agents and Toxins.

Definitions:

Biological Agent: Any microorganism (including but not limited to bacteria, viruses, fungi 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 other living organism; deterioration of food, water, equipment, supplies, or material of any kind; or deleterious alteration of the environment.

Select Agent and/or Toxin: Unless specified, all biological agents or toxins listed by the CDC/APHIS and regulated by 42 CFR Part 72 & 73, 7 CFR Part 331 and 9 CFR Part 121 that have been deemed to pose a threat to the public, animal or plant health, or to animal or plant products.

Toxin: An antigenic poison or venom of plant or animal origin, especially one produced by or derived from microorganisms and causing disease or death when present in low concentrations.

Contact:

Additional information about this policy is available here:

Environmental Health and Safety

Christopher Kuhlow, Biological Safety Officer (BSO), Alternate Responsible Official (ARO)

110 Suffolk Hall

Stony Brook, NY 11794

(631) 632-6410

https://www.stonybrook.edu/ehs/