Environmental Health & Safety Manual (EHS)

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EHS 112 Table

Research Involving Recombinant DNA, Infectious Agents (other than Select Agents and Toxins) or Other Biosafety Matters

The principal investigator (PI) or researcher contacts the chair of the Institutional Biosafety Committee (IBC) to initiate a review of the project.

Each researcher is primarily responsible for ensuring safety in activities involving recombinant DNA or gene-splicing techniques, infectious microorganisms, infectious waste, or hazardous and toxic chemicals.

The PI becomes familiar with the Arizona State University Biosafety Manual and, if applicable, completes the Recombinant DNA and Artificial Gene Transfer Form or the Infectious Agent Use Form. The PI submits the form(s) to the IBC coordinator.

Note: General questions and information regarding the Arizona State University Biosafety Manual can be obtained by calling Environmental Health & Safety at 480/965–1823 or by contacting them at risk@asu.edu.

The Institutional Biosafety Committee does the following:

  1. distributes the Arizona State University Biosafety Manual and registration forms to anyone requesting them and those who may work with recombinant DNA, infectious agents, or other biosafety concerns
    Note: The IBC advises the Vice President for Research and Economic Affairs regarding these activities and certifies compliance with the National Institutes of Health guidelines for all projects involving recombinant DNA molecules and/or gene-splicing techniques.
  2. reviews the completed form(s) to determine whether the project meets federal and university standards
  3. approves or disapproves the project
  4. returns the form(s) unsigned to the principal investigator or researcher, with comments for discussion, if the project is not approved
  5. signs the form(s) and forwards it to the Biosafety Officer (BSO), Institutional Animal Care and Use Committee (IACUC) (if necessary), and the Office for Research and Sponsored Projects Administration (ORSPA) if the project is approved.

The Institutional Animal Care and Use Committee (IACUC):

  1. reviews the completed form if the use of animals is involved
  2. approves or disapproves the project
  3. returns the form(s) unsigned to the principal investigator or researcher, with comments for discussion and resolution, if the project is not approved
  4. signs the form(s) and forwards it to the BSO and ORSPA if the project is approved.

The Office for Research and Sponsored Projects Administration:

  1. reviews the form(s) to determine whether the project meets federal and university standards
  2. approves or disapproves the project
  3. returns the form(s) unsigned to the principal investigator or researcher, with comments for discussion and resolution, if the project is not approved
  4. signs the form(s) and forwards it to the IBC coordinator if the project is approved.

The Biosafety Officer:

  1. reviews the form(s) to determine whether the project meets federal and university standards
  2. approves or disapproves the project
  3. if the project is not approved, returns the form(s) unsigned to the principal investigator or researcher, with comments for discussion and resolution
  4. if the project is approved, signs the form(s) and forwards it to the IBC coordinator.

The IBC chair sends a copy of the approved form(s) to the principal investigator or researcher and retains the original for administrative records.

Note: These forms must be completed annually.

Research Involving Select Agents and Toxins

In addition to the above described procedures, select agents are subject to the additional following requirements:

The executive vice president for Administration and Finance and the vice president for Research and Economic Affairs appoint the university’s select agent Responsible Official (RO) and Alternate Responsible Official (ARO) in accordance with select agent regulations.

The RO establishes policies, procedures, protocols, and forms involving the possession, use, and transfer of select agents at ASU facilities in accordance with the Centers for Disease Control and Prevention (CDC) and the United States Department of Agriculture (USDA) select agent regulations and other applicable local, state, and federal statutes, rules, regulations, standards, and university policy.

Note: Such policies, procedures, protocols, and forms shall provide for registration, security clearance, restrictions on access, safety, emergency plans, biocontainment, security plans, and such other measures deemed necessary or prudent to carry out the requirements for select agents.

The principal investigator (PI) completes the Select Agent and Toxin Pre-Registration Form and submits it to the RO for permission.

Note: ASU must register select agents and toxins with the CDC and/or the USDA. Each agent must be registered individually if any PI working in an ASU facility possesses, uses, or transfers select agents. No such individuals shall possess, use, or transfer select agents without prior written approval of the ASU Institutional Biosafety Committee (IBC).

The Biosafety Officer (BSO) obtains security clearance from the Department of Justice for individuals with access to select agents.

Note: Individuals with access to select agents who do not have security clearance must be accompanied and monitored at all times by a person who has received a security clearance.

The USA Patriot Act (paragraph 175b) prohibits “Restricted Persons” from working with select agents. Persons restricted from working with select agents can be found on the following website: http://www.epic.org/privacy/terrorism/hr3162.html.

The RO annually inspects laboratories and campus facilities possessing, using, transferring, or receiving select agents to ensure that all requirements are being met.

Note: If a facility is found to be non-compliant the select agent registration with CDC may be revoked. Practices and procedures for safe use of select agents will be based on the conditions set forth in CDC-NIH “Biosafety in Microbiological and Biomedical Laboratories.”

The ASU Specific Biosafety Emergency response plan is contained in the Biosafety Manual. General questions and information regarding the Arizona State University Biosafety Manual can be obtained by calling Environmental Health & Safety at 480/965–1823 or by contacting them at risk@asu.edu.

The PI and BSO conduct training for all personnel possessing, using, transferring, or receiving select agents regarding:

  1. the symptoms of exposure
  2. a post-exposure management protocol
  3. spill cleanup and decontamination
  4. the proper use of engineering, administrative, and work practice controls

    and

  5. personal protective equipment, and security requirements for select agent possession and use.

The PI notifies the RO when a select agent is destroyed or depleted.

The RO:

  1. notifies the CDC of intent to destroy the select agent at least five working days prior to the planned destruction (CDC Form 1318)
  2. maintains a record of the destruction for three years
  3. notifies the CDC to have the PI removed from the registration, if the PI no longer has select agents
  4. consults with the ASU Police Department in carrying out a safety and emergency response plan related to the possession, use, and transfer of select agents.
    Note: All laboratories and campus facilities possessing, using, transferring, or receiving select agents must comply with all of the security requirements established by the Centers for Disease Control and Prevention for the inventory and containment of select agents. CDC minimum recommendations are listed in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) Appendix F, http://www.cdc.gov/od/ohs/biosfty/bmbl4/b4af.htm.

    The ASU Specific Biosafety Emergency response plan is contained in the Biosafety Manual. General questions and information regarding the Arizona State University Biosafety Manual can be obtained by calling Environmental Health & Safety at 480/965–1823 or by contacting them at risk@asu.edu.

    Compliance

    1. The RO is responsible for enforcing this policy.
    2. The RO shall consult with the IBC, the Biosafety Officer, the Police Department, ASU General Counsel, Information Technology, and others in responding to technical issues and implementation of this policy.
    3. A person aggrieved by a decision of ORSPA or BSO may appeal that decision to the executive vice president for Administration and Finance within 10 working days of ORSPA’s or BSO’s decision. The decision of the executive vice president shall be final.

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