IACUC Hazard Risk Assessment

IACUC Policy: 005-06, Effective Date: 10/2002, Last Revision: 11/19/2021

Overview/Purpose

It is the IACUC’s responsibility to ensure that the university maintains an occupational health and safety program as an essential part of the overall program of animal care and use. All IACUC protocols and amendments are reviewed by an Environmental Health and Safety (EHS) staff member for the use of hazardous agents as part of this program.

Definitions

• Animal Hazard Safety Protocol (AHSP): The AHSP form provides information relating to appropriate containment levels necessary for the safety of both researchers and animal care staff due to excretion/shedding of hazardous materials from animals. The AHSP form will outline specific requirements for disposition of carcasses, contaminated waste, bedding, and cage processing as well as required engineering controls and personal protective equipment. The hazards that are currently covered are biological agents (Risk Group 2 and above), chemical agents (GHS Group 1A and 1B carcinogens, reproductive toxins, germ cell mutagens and Group 1 and 2 highly acute toxins), radioactive isotopes, and investigational agents (agents lacking safety information). To be covered the agent must also be shed or excreted from the animal or require special handling for cages, cage accessories or waste.
• Online Risk Assessment Tool (ORAT): online form prepared by an individual in order that a risk assessment is completed. The risk assessment is to identify, evaluate, manage and reduce potential health risks associated with an individual’s exposure to animals and hazardous agents.

Requirements

• Hazard Risk Assessment: EHS reviews all protocol/amendment submissions prior to approval to identify hazardous agents that will require an AHSP. EHS staff will then prepare a draft AHSP, forward it to the Principal Investigator and University Laboratory Animal Resources (ULAR) for review. A final document will be provided to ORRP staff to upload into the applicable eProtocol.
• Ancillary Safety Plans: EHS also determines the need for additional approvals such as an Institutional Biosafety Protocol or a Radiation Safety Permit. These plans are reviewed by the Institutional Biosafety Committee (IBC) or Radiation Safety (RS), respectively. Both IBC and RS approvals must be obtained prior to IACUC approval. The IBC determines the animal biosafety level, when applicable, and communicates that information to the investigator.
• Active Use of Hazardous Agents: Investigators are responsible for posting the AHSP in any area where animals are housed or used. When animals are no longer present, investigators must remove the AHSP. All instructions on the AHSP form are to be followed by both researchers and animal care employees.
  • Notification of Hazardous Agent Use: In areas with core animal care staff, investigators must provide notification at least 3 working days prior to use of a hazard in the animal facility. For animals housed in the centralized ULAR facilities, the biohazard notification is done through the e-Protocol system.
• Occupational Risk Assessment: Individuals with occupational exposure to animals, hazardous agents (e.g., infectious agents / biohazards, hazardous and toxic substances / chemicals, or radioactive materials) should identify this exposure using the online risk assessment tool (ORAT). All personnel should update their risk assessment on at least an annual basis and any time there are changes to personal health status, exposure to hazardous agents, or types of animals. Personnel involved in research will be reminded on an annual basis to review their risk assessment. The IACUC will verify that all individuals listed on an IACUC protocol are up to date with their enrollment in the program.

Applicable Regulations

• Animal Welfare Act (AWA, Public Law 89-544, 7 U.S.C.)
• Animal Welfare Act Regulations (AWAR, 9 CFR, Chapter 1, Subchapter A)
• Health Research Extension Act of 1985 and Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
• National Research Council Guide for the Care and Use of Laboratory Animals, Eighth Edition. National Academy of Sciences, 2011
• The Federation of Animal Science Societies Guide for the Care and Use of Agricultural Animals in Research and Teaching

Additional Information/Guidance

• Institutional Biosafety Committee 
• Environmental Health and Safety
• Institutional Biosafety Manual
• Occupational Health Program 
• Radiation Safety Standards