Environmental, Health and Safety Services

Select Agent and Toxin Program

Introduction
Responsibilities
Requirements
Definitions
Resources

Introduction

Regulatory Drivers

Department of Health and Human Services (HHS): Centers for Disease Control and Prevention (CDC)

"The Antiterrorism and Effective Death Penalty Act of 1996” required the Secretary of Health and Human Services to regulate the transfer of select biological agents and toxins that pose a severe threat to public health and safety. As a result, the CDC implemented its rule, 42 Code of Federal Regulations (CFR) 72.6: Additional Requirements for Facilities Transferring or Receiving Select Agents. The final rule became effective April 15, 1997.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188, signed into law June 12, 2002 expanded the requirements of 42 CFR 72 to include possession and use under the new interim regulation 42 CFR Part 73: Possession, Use, and Transfer of Select Agents and Toxins. This interim regulation superseded 42 CFR 72.6 and became effective February 7, 2003. The final rule was published March 18, 2005 and became effective April 18, 2005.

United States Department of Agriculture (USDA): Animal and Plant Health Inspection Service (APHIS)

The Public Health and Security and Bioterrorism Preparedness and Response Act of 2002 also included provisions for the regulation of certain biological agents and toxins that pose a severe threat to animal or plant health, or to animal or plant products by the Department of Agriculture through the Animal and Plant Health Inspection Service (APHIS). This regulation, 7 CFR Part 331 (for plants) and 9 CFR Part 121 (for animal and animal products), mirrors the CDC regulation in requirements.

Purpose

The intent of the CDC and APHIS regulations is to protect public health and safety, animal and plant health and safety, and animal and plant products by:

  • providing a mechanism for determining where select agents and toxins are located;
  • ensuring that their transfer, storage, and use can be tracked;
  • screening of personnel with access to select agents or toxins; and
  • requiring entities in possession of select agents and toxins to develop and implement effective biosafety, security, and incident response plans and procedures.

The Virginia Tech Select Agent and Toxin Program has been developed to:

  • specify university policies, procedures, and requirements to ensure compliance with the CDC and APHIS regulations; and
  • aid principal investigators, researchers, and supervisors in achieving compliance.

Scope

This program applies to:

  • Specific biological agents and toxins listed by the HHS and the USDA
  • Activities involving these agents/toxins
    • possession and use at Virginia Tech’s main campus in Blacksburg, Virginia
    • transfers made within the United States between Virginia Tech’s main campus and other approved facilities
    • importation from other countries (exportation is regulated by the Department of Commerce)
  • Individuals (e.g., faculty, staff, students, visitors) requiring access to a select agent or toxin or an area where select agents and toxins are present
  • Facilities where select agents and toxins are used and stored

Responsibilities

Laboratory Personnel

Laboratory personnel under the direct supervision of a Principal Investigator, Researcher, or Lab Supervisor have the responsibility to:

  • be familiar with the requirements of this program;
  • know the specific hazards of the select agent and toxins utilized in their work and how to access additional information on these agents;
  • immediately inform the Virginia Tech Police of any suspicious activity or persons, theft, or emergency related to select agent use areas;
  • immediately inform the lab supervisor, principal investigator, or University Biosafety Officer of any:
    • loss or compromise of their keys, passwords, or combinations to areas where select agents and/or toxins are used or stored;
    • suspicious use of select agents or toxins;
    • loss or release of a select agent or toxin; and
    • suspected alteration or compromise to inventory records.
  • provide required information for inventory access and acquisition, room entry/exit, and transfers of select agents;
  • ensure that unauthorized individuals are either escorted or denied entry into select agent areas; and
  • comply with responsibilities for Laboratory Employees listed in Virginia Tech’s Biosafety for Researchers which includes:
    • wearing and properly maintaining any personal protective equipment necessary to perform each assigned task;
    • properly using engineering controls and safety equipment;
    • following good personal and laboratory hygiene practices;
    • participating in all required training;
    • reading, understanding, and signing off on laboratory-specific procedures and training;
    • informing the lab supervisor if any deficiencies are noted in the laboratory facility, equipment, and procedures;
    • ensuring all waste is properly packaged and promptly disposed of;
    • reporting, to the lab supervisor, any accident that results in injury or exposure to a hazardous substance; and
    • knowing all emergency procedures and what is expected of them during an emergency.

Principal Investigators, Researchers, Supervisors

Principal Investigators, Researchers, and Supervisors shall assume responsibility for the daily operations of a laboratory or group of laboratories. Principal Investigators/Researchers/Supervisors shall:

  • read this document and be familiar with its requirements;
  • determine whether or not labs under their direction must comply with this program;
  • register their select agents and toxins with the University Biosafety Officer;
  • complete a risk assessment for each select agent or toxin;
  • annually review safety, security, and incident response procedures;
  • ensure that:
    • transfers comply with regulatory requirements;
    • safety, security, and incident response plans are developed and implemented;
    • the University Biosafety Officer is immediately notified in the event of a loss, theft, or release;
    • all required records are completed and maintained indefinitely;
    • only approved individuals are allowed access to select agents and toxins;
    • individuals are trained on the requirements of this program, as well as university and lab-specific security, safety, and incident response procedures;
    • annual mock drills or tabletop exercises and information-sharing sessions are conducted with local emergency responders; and
    • experiments involving the transfer of a drug resistance trait or the formation of a lethal toxin are not conducted unless approved by the University Biosafety Officer and CDC and/or APHIS.
  • comply with responsibilities for Principal Investigators, Researchers, and Supervisors listed in Virginia Tech’s Biosafety for Researchers which includes:
    • ensuring all laboratory work is conducted in accordance with this program and all applicable federal, state, and local regulations/guidelines regarding laboratory safety;
    • selecting the appropriate control practices for handling hazardous substances;
    • preparing procedures for response to accidents/incidents involving hazardous substances;
    • preparing lab-specific policies and procedures;
    • ensuring that laboratory employees are properly trained on the hazards and how to handle hazardous substances in the laboratory;
    • ensuring that engineering controls and safety equipment are properly maintained;
    • working with the University Biosafety Officer to correct any laboratory deficiencies;
    • ensuring all abandoned hazardous material is promptly disposed of;
    • conducting regular self-audits; and
    • completing all necessary accident and incident reports.

Deans/Directors/Department Heads

Deans, Directors, and Department Heads shall assume overall responsibility for ensuring their respective college/department/center/facility complies with the requirements of this program. Deans/Directors/Department Heads shall:

  • be aware of the requirements of this program;
  • ensure that Principal Investigators, Researchers, and Supervisors are aware of the requirements of this program;
  • mandate laboratory participation; and
  • ensure all facilities and activities under their supervision comply with all applicable federal, state, and local regulations/guidelines regarding health and safety.

Responsible Official (RO)

This function shall be the responsibility of EHSS through its University Biosafety Officer. The University Biosafety Officer shall:

  • act as liaison between Virginia Tech and regulatory agencies regarding the possession, use, and transfer of select agents and toxins;
  • maintain Virginia Tech’s registration with the CDC and/or APHIS;
  • conduct regular inspections (at least annually) of laboratories using select agents and toxins;
  • review and approve risk assessments completed for each select agent and toxin;
  • annually review safety, security, and incident response procedures;
  • in collaboration with the Principal Investigator, Researcher, or Supervisor, ensure that:
    • transfers comply with regulatory requirements;
    • safety, security, and incident response plans are developed and implemented;
    • the CDC and/or APHIS is immediately notified in the event of a loss, theft, or release of a select agent or toxin;
    • all records are completed and maintained for at least three years;
    • only approved individuals are allowed access to select agents and toxins;
    • individuals are trained on the requirements of this program, as well as university and lab-specific security, safety, and incident response procedures;
    • annual mock drills or tabletop exercises and information-sharing sessions are conducted;
    • the identification of a select agent or toxin as a result of diagnosis, verification or proficiency testing is reported to the CDC and/or APHIS; and
    • experiments involving the transfer of a drug resistance trait or the formation of a lethal toxin are not conducted unless approved by the CDC and/or APHIS.
  • comply with responsibilities for the University Biosafety Officer listed in Virginia Tech’s Biosafety for Researchers which includes:
    • assisting laboratory personnel in identifying hazardous operations, establishing safe work practices, and selecting protective equipment and other exposure controls;
    • maintaining the written Biosafety for Researchers and Select Agent and Toxin Program to include minimum requirements for lab activities and facilities;
    • developing and/or providing training programs in conjunction with principal investigators, researchers, and supervisors;
    • coordinating exposure monitoring and respiratory protection, as needed, with EHSS’ Occupational Health and Industrial Hygiene service group;
    • consulting with laboratory personnel on evaluation and correction of safety and security deficiencies;
    • investigating and reporting to principal investigators, researchers, and lab supervisors any significant problems with equipment, facilities, and/or safe work practices/procedures; and
    • remaining knowledgeable of regulatory and legal requirements associated with biological agents.

Alternate Responsible Officials (AROs)

This function shall be the responsibility of EHSS. The responsibilities of the AROs are the same as the RO. The ARO may act on behalf of the RO in his/her absence.

University Safety Committees

Virginia Tech supports a number of safety oversight committees comprised of researchers, university officials, and EHSS representatives. A regulatory body requires the majority of committees, but a couple have been established based upon identified needs of the research community.

  • Biotechnology Oversight Committee (BOC)

    The BOC is charged with:

    • reviewing recombinant DNA/RNA research proposals conducted at, or sponsored by, Virginia Tech for compliance with the National Institutes of Health (NIH) Guidelines;
    • approving those research projects that conform with the NIH Guidelines;
    • periodically reviewing recombinant DNA research for continued compliance; and
    • adopting emergency plans covering accidental spills and personnel contamination.

  • Institutional Animal Care and Use Committee (IACUC)

    The IACUC is responsible for:

    • reviewing proposed uses of animals in research, testing, or education;
    • evaluating programs and animal activity areas; and
    • inspecting facilities used to house animals.

  • Radiation Safety Committee (RSC)

    The RSC is charged with:

    • reviewing and approving research projects utilizing radiation or radioactive materials;
    • establishing institutional policies on radiation safety; and
    • monitoring existing programs.

  • Institutional Review Board (IRB)

    The IRB is responsible for:

    • reviewing and approving research projects utilizing human subjects (including nonviable fetuses, fetal material, and the placenta); and
    • monitoring research using human subjects.
Page Last updated: January 2009

Contact Information

Charlotte Waggoner, University Biosafety Officer

Chris Wakley, Associate Biosafety Officer

Anna Kroner, Associate Biosafety Officer