Environmental Health & Safety Manual (EHS)

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Effective: 7/8/2003

Revised: 7/1/2007

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EHS 112: Biosafety and the Possession, Use, and Transfer of Select Agents and Toxins

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Purpose

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To ensure that biohazard and recombinant DNA activities at ASU are conducted safely and in accordance with applicable statutes, rules, regulations, standards, and university policy

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Background

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ASU has instituted and maintains a biosafety program for the possession, use, transfer and storage of biohazards and recombinant DNA and for laboratory employees who may be exposed to biohazards during the performance of their duties. The biosafety program is designed to promote and achieve regulatory compliance and provides a means for laboratory employees to be better informed about and protected from biohazards.

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Sources

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7 Code of Federal Regulations § 331
9 Code of Federal Regulations § 121
42 Code of Federal Regulations §§ 73, 1003
US Patriot Act, 18 United States Code § 175b
Bioterrorism Preparedness and Response Act of 2002, HR3448, Public Act 107-188
Centers for Disease Control & Prevention/National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories. 4th Ed. May, 1999
Department of Health and Human Services. National Institutes of Health. Guidelines for Research Involving Recombinant DNA Molecules. May 7, 1986
Arizona State University Biosafety Manual

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Applicability

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ASU academic, research, and other operations involved in the possession, use, transfer, or storage of biohazards and/or recombinant DNA. This applies to activities involving:

  1. CDC/USDA select agents and toxins
  2. recombinant DNA, including experiments that are specifically exempt under the NIH Guidelines
  3. bacterial, fungal, parasitic, or other potentially infectious agents
  4. live viruses
  5. biohazard exposure to research animals
  6. human blood and tissue

    and

  7. infectious waste.

The list of select agents and toxins in the select agent regulations is available at http://www.cdc.gov/od/sap/docs/salist.pdf.

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Policy

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Responsibilities of the Department of Environmental Health & Safety

Biosafety Officer

The university Biosafety Officer (BSO) is responsible for the following:

  1. develops and maintains the university’s biosafety program, including select agents and toxins
  2. reviews and approves registration for research proposals involving biohazards and recombinant DNA in coordination with the Institutional Biosafety Committee (IBC) and Office for Research and Sponsored Projects Administration (ORSPA)
  3. consults with researchers on issues of biosafety and the safe use of biohazards in the laboratory
  4. develops protocols and procedures for biosafety
  5. advises researchers on proper waste disposal methods
  6. provides oversight of the Arizona State University Exposure Control Plan for Bloodborne Pathogens; Needlesticks and Other Sharps Injuries
  7. conducts required initial and annual training for laboratory personnel with potential biohazard exposures in their workplace
  8. conducts annual laboratory biosafety audits to determine compliance status

    and

  9. promotes regulatory compliance and a safe laboratory work environment.
The BSO is the director of Environmental Health & Safety or designee and serves as the university’s Alternate Responsible Official (ARO) for the select agents and toxins program.

Responsibilities of Departments and Units

Departments and units must identify laboratory employees who use and/or may be exposed to biohazards and ensure that these employees are provided the protections required when working with biohazards.

Deans, Directors, and Chairs

Deans, directors, and chairs of colleges, departments, and other units have the primary responsibility for the biosafety of people, animals, and the environment within their jurisdiction. They receive from the IBC the material for registration of biological research; ensure that registration forms are completed by each principal investigator conducting applicable research; and submit completed registration forms to the IBC.

Principal Investigators

Principal Investigators (PI) in charge of biohazard or recombinant DNA activities are responsible for ensuring the health and safety of those working with those materials. The PI completes and submits registration forms for all research proposals involving the use of biohazards, including select agents and toxins and recombinant DNA, and develops specific biosafety standard operating procedures for each biohazard and select agent and toxin used in the laboratory.

The PI must ensure the following:

  1. that proper training and instruction are provided for laboratory personnel in safe practices and protocols, including, at a minimum, training in aseptic techniques and biology of the organism(s) being used
  2. that laboratory personnel receive any necessary medical surveillance
  3. that biosafety cabinets are certified as needed
  4. that personal protective equipment is provided and used

    and

  5. that laboratory personnel are in compliance with applicable statutes, rules, regulations, standards, and university policy.

Responsibilities of Employees

Laboratory employees who use biohazards or recombinant DNA during the performance of their duties have the following responsibilities:

  1. participate in appropriate training and instruction
  2. become familiar with biohazards, select agents and toxins, and recombinant DNA being used in the laboratory and the potential risks associated with exposure
  3. follow all laboratory practices and protocols and comply with all applicable statutes, rules, regulations, standards, and university policy
  4. participate in medical surveillance as required

    and

  5. report all thefts, security incidents, accidents, spills, or contamination incidents to the laboratory supervisor.

Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) analyzes university operations and facilities involving, or proposed to be involved in, biohazard and recombinant DNA activities. The IBC is appointed by and responsible to the vice president for Research and Economic Affairs and recommends actions necessary to maintain and/or improve biosafety.

Tasks of the IBC include the following:

  1. initiate the registration of biohazard and recombinant DNA research by providing department chairs with the registration materials
  2. review and approve research proposals involving recombinant DNA and biohazards and approve those that comply with NIH and CDC guidelines and university policy
  3. review and approve research proposals involving the use of select agents and toxins
  4. adopt policies supporting the safe use of biohazards and the elimination or reduction of exposure to biohazards

    and

  5. address biosafety issues related to experimentally infected laboratory animals.

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ProceduresD

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


Responsibility
Action
Principal investigator or researcher
  1. Contact the chair of the Institutional Biosafety Committee (IBC) to initiate a review of the project.
    Note: 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
  2. Become familiar with the Arizona State University Biosafety Manual and, if applicable, complete the Recombinant DNA and Artificial Gene Transfer Form or the Infectious Agent Use Form. Submit 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 EHS@asu.edu.
Institutional Biosafety Committee
  1. Distribute 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. Review the completed form(s) to determine whether the project meets federal and university standards.
  3. Approve or disapprove the project.

If the project is not approved:

  1. Return the form(s) unsigned to the principal investigator or researcher, with comments for discussion.

If the project is approved:

  1. Sign the form(s) and forward 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).
Institutional Animal Care and Use Committee (IACUC)
  1. Review the completed form if the use of animals is involved.
  2. Approve or disapprove the project.

If the project is not approved:

  1. Return the form(s) unsigned to the principal investigator or researcher, with comments for discussion and resolution.

If the project is approved:

  1. Sign the form(s) and forward it to the BSO and ORSPA.
Office for Research and Sponsored Projects Administration
  1. Review the form(s) to determine whether the project meets federal and university standards.
  2. Approve or disapprove the project.

If the project is not approved:

  1. Return the form(s) unsigned to the principal investigator or researcher, with comments for discussion and resolution.

If the project is approved:

  1. Sign the form(s) and forward it to the IBC coordinator.
Biosafety Officer
  1. Review the form(s) to determine whether the project meets federal and university standards.
  2. Approve or disapprove the project.

If the project is not approved:

  1. Return the form(s) unsigned to the principal investigator or researcher, with comments for discussion and resolution.

If the project is approved:

  1. Sign the form(s) and forward it to the IBC coordinator.
IBC Chair
  1. Send a copy of the approved form(s) to the principal investigator or researcher and retain 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:


Responsibility
Action
Executive vice president for Administration and Finance and the vice president for Research and Economic Affairs
  1. Appoint the university’s select agent Responsible Official (RO) and Alternate Responsible Official (ARO) in accordance with select agent regulations.
RO
  1. Establish 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.
Principal investigator (PI)
  1. Complete the Select Agent and Toxin Pre-Registration Form and submit to the RO for permission.
    Note: ASU must register select agents and toxins with CDC and/or 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).
BSO
  1. Obtain 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.

RO
  1. Inspect annually 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 EHS@asu.edu.

PI and BSO
  1. 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. proper use of engineering, administrative, and work practice controls

      and

    5. personal protective equipment, and security requirements for select agent possession and use.
PI
  1. Notify the RO when a select agent is destroyed or depleted.
RO
  1. Notify the CDC of intent to destroy the select agent at least five working days prior to the planned destruction (CDC Form 1318).
  1. Maintain a record of the destruction for three years.
  1. If the PI no longer has select agents, notify the CDC to have the PI removed from the registration.
  1. Consult 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 Arizona State University 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 EHS@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.

endtable

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Cross-References

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For more information, see:

  1. EHS 101, “Bloodborne Pathogens and Needlestick Prevention”
  2. EHS 103, “Hazard Communication Program”
  3. EHS 105, “Personal Protective Equipment”
  4. EHS 108, “Environmental Health and Safety Training”
  5. EHS 205, “Storage of Hazardous Chemicals”

    and

  6. EHS 403, “Chemical Release Emergency Response.”

See also the Police Department Policies and Procedures ManualPDP 104–01, “Laboratory Emergencies.”


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