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Possession, Use and Transfer of Select Agents and Toxins
    Department of Health and Human Services
    42 CFR Part 73
    Office of inspector General
    2 CFR Part 1003

    In December of 2002 the Select Agent Regulation, 42 CFR 73.0, Interim Final Rule was published. All facilities possessing select agents or wishing to ship or receive select agents must be registered with the federal government. All researchers working with or storing select agents must be included on the University’s Certificate of Registration with the CDC and must follow all applicable federal regulations and University policies. Prior approval and training is required to use, store, ship, or receive a select agent.

    Select agents are viruses, bacteria, rickettsiae, fungi, and toxins that, according to HHS, have the potential to cause substantial harm to public health. 

    High Consequence Livestock Pathogens and Toxins are agents that are considered by USDA to have the potential to pose a severe threat to animal or plant health, or to animal or plant products. “Overlap Agents” are agents and toxins that appear on the HHS and USDA lists. For registration of select agents with EH&S; biosafety@columbia.edu

    Requirements

    • Entities possessing select agents must appoint a Responsible Official (RO). An Alternate Responsible Official (ARO) may also be appointed.
    • Entities possessing select agents must register with either the CDC or USDA, depending on the select agents possessed.
    • Individuals with a legitimate need to work with select agents must undergo a security risk assessment.
    • Only approved individuals may have access to select agents.
    • Non-approved individuals must be escorted by an approved person at all times while in the laboratory.
    • The facility must develop and implement a Security Plan.
    • Security systems and procedures must be designed according to a site-specific risk assessment and must provide graded protection in accordance with the threat posed by the select agent.
    • Select agents may only be transferred to registered entities.
    • Either the CDC or USDA must approve all transfers of select agents prior to the transfer.

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    Training

    • The RO must provide training in biosafety, containment, and security procedures to individuals with access to select agents.
    • The RO must provide annual refresher training.
    • Visitors must be informed of the security requirements and procedures.

    Reporting

    • Suspected loss or theft of select agents must be reported to the US Department of Agriculture immediately upon discovery.
    • Changes in circumstances must be reported by the RO to the agency that issued the certificate of registration.

    Inspections

    • Prior to issuing a certificate of registration, USDA or CDC may inspect and evaluate a facility.
    • The RO may inspect the facility at least annually.

    Recordkeeping

    The RO must keep records including:

    • The Biosafety and Security Plan;
    • Current list of individuals with access to select agents;
    • Training records for individuals with access to select agents;
    • Accurate and current inventory records;
    • Permits and transfer documents (USDA 2041);
    • Security records (e.g., transactions from automated access control systems, testing and maintenance of security systems, visitor logs);
    • Biosafety, containment, and security incident reports;

    All records must be kept for 3 years.

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    Written Program

    A Biosafety and Security Plan must be prepared for each entity possessing select agents or toxins. The University has prepared a Biosafety and Security Plan for its laboratories possessing select agents and toxins.

    Select agent materials currently regulated under the new laws include:

    • Live biological agents and toxins (see EH&S website)
    • Nucleic acids that encode infectious and/or replication competent forms of the listed viruses
    • Nucleic acids that encode for the functional form of any of the listed toxins
    • Genetically modified select agents and toxins 

    The following categories of select agent materials are excluded under the new laws. However, please consult the Environmental Health and Radiation Safety office before proceeding with any work.

    • Agents or toxins present in their naturally occurring environment (not intentionally introduced)
    • Nonviable agents or fixed tissues
    • Certain vaccine strains
    • Attenuated strains or forms of agents or toxins (must apply for an exclusion)
    • Toxins below the aggregate limits (see EH&S website)

    SELECT AGENTS RELATED LINKS

    http://www.cdc.gov/od/sap/
    http://www.aphis.usda.gov/vs/ncie/bta.html
    http://www.nih.gov/od/ors/ds/pubs/appendxa.html
    http://www.aphis.usda.gov/vs/cvb/selectagent.htm