Title
University of North Carolina at Chapel Hill Standard on Animal Procedural Space Exception (APSE)
Introduction
Purpose
The standards and procedures described in this document provide guidance to all researchers and animal handlers for the establishment and maintenance of an Animal Procedural Space Exception (APSE).
Scope
This Standard applies to all personnel engaged in the care of animals maintained within an APSE. A PI must seek IACUC approval for an APSE if they must maintain animals long-term in a PI-managed space (i.e., long-term animal housing outside of a Division of Comparative Medicine [DCM] housing facility).
The University of North Carolina at Chapel Hill ("UNC-Chapel Hill" or "University") Institutional Animal Care and Use Committee (IACUC) expects that anyone involved in animal work at the University will comply with this Standard. Requests for exceptions to this Standard must be reviewed and approved by the IACUC. PIs anticipating the need for an Animal Procedural Space Exception (APSE) should contact the Office of Animal Care and Use (OACU).
Standard
Federal regulations state that the authority and oversight of these facilities lies with the institution through the IACUC.
The IACUC will consider, on a case-by-case basis, an APSE for an investigator-maintained space in which animals will be temporarily maintained and tested for greater than 12 hours for USDA-regulated species (24 hours for non-USDA regulated species) but less than or equal to 72 hours. During this testing phase, required facility maintenance and animal care are provided by the investigator.
Approval of an Animal Care Application (ACAP) which includes a request for an APSE in Section 8 and approval of an APSE physical space are two separate requirements. Approval of an APSE in the protocol does not imply or guarantee IACUC approval of the proposed space. The justification included in ACAP must be based on experimental needs (not convenience) and/or the inability of the DCM to provide the necessary procedural space and must be reviewed at a convened meeting of the IACUC.
In addition, IACUC approval of a proposed APSE will be granted only if the space meets IACUC, Environment, Health and Safety (EHS), and Division of Comparative Medicine (DCM) standards.
NO ANIMALS ARE ALLOWED TO BE HOUSED FOR A PERIOD LONGER THAN 12 (USDA covered species) or 24 (non-USDA covered species) HOURS IN THE ANIMAL PROCEDURAL SPACE FACILITY UNTIL RECEIPT OF WRITTEN IACUC APPROVAL OF THE EXCEPTION.
Prior to occupancy, the following are required steps for approval of an APSE Facility at UNC-Chapel Hill:
- PI consultation with DCM about whether there is appropriate space in DCM facilities, and if not, identify suitable space outside DCM facilities to use as an APSE.
- Contact OACU to start the process of preparing written justification describing need for the APSE. The written justification will be reviewed at a fully convened IACUC meeting and will be approved if the justification is appropriate, if the housing cannot be achieved in a DCM facility and if the request is not based on convenience.
- Approval of APSE request in Section 8.0 (Exception Request) of the protocol reviewed at a convened IACUC meeting.
- Initial inspection of proposed APSE facility by IACUC, OACU, DCM, and EHS representatives.
- Collection of temperature and humidity data (high/low) over a five-day period, except in spaces used only for prolonged non-survival surgery, or when animals will be continuously housed in climate-controlled equipment (e.g., Biocabinets, incubator). For APSEs consisting only of an incubator, the PI should provide IACUC/OACU with manufacturer specifications.
- Final inspection by IACUC, OACU, EHS, and DCM of required modifications to improve space.
- Written approval from the IACUC.
- Two keys (or key code) provided by PI to OACU. One will be provided to DCM.
Approval of an Animal Procedural Space Exception:
The approval process requires that the investigator initially submit a request with justification to the IACUC through ACAP (by completing section 8.0), followed by a written justification provided to the OACU to present at the next fully convened IACUC meeting. Justification for a proposed APSE cannot be based on convenience. Rather, it must be based on factors such as the inability to house animals in a DCM facility, the inability of DCM to provide the desired space, care, or for scientific reasons.
If the IACUC approves the APSE justification, the investigator may begin coordinating an initial inspection of the proposed site. IACUC, OACU, DCM, and EHS representatives must be included in the initial inspection. These representatives will help identify any potential problematic issues such as cluttered space, improper storage of equipment, re-circulating or inadequate air exchange, and the inability to control temperature, humidity, and light cycles. The investigator’s written documentation indicating correction of previously identified issues will prompt IACUC, OACU, DCM and EHS representatives to re-inspect the proposed site.
Prior to using the space to house animals, the PI requesting the APSE must receive both of the following:
- Written notification from the IACUC indicating approval of the justification for a PI-maintained APSE;
- Approval of Section 8.0 in ACAP describing the APSE; and
- Written notification from the IACUC indicating approval of the space.
Post Approval Maintenance of an APSE:
It is the PI’s responsibility to ensure that all federal and institutional requirements are implemented consistently. This includes the care and use of all animals, seven days a week including weekends and holidays, and also Emergency/Adverse Weather situations. (See pages 4-5 regarding contacting DCM in emergencies).
The PI is responsible for compliance with EHS policies for the space including complying with the University’s Chemical Hygiene Plan, submitting a laboratory safety plan, and following policies outlined in the University's Laboratory Safety Manual. In addition, the PI must check and maintain safety controls within the space (e.g., chemical fume hoods, biological safety cabinets, safety eye washes, and safety showers).
The PI is responsible for ensuring that all personnel exposed to animals are enrolled in the University Employee Occupational Health Clinic (UEOHC) Program through completion of the Animal Handler Form. This form should be updated annually.
The PI must ensure that all personnel involved in animal handling are properly trained. Veterinary and IACUC Compliance oversight will be the same as for animals housed in a DCM facility.
Semi-annual IACUC inspections of each APSE are required. At UNC-Chapel Hill, APSE physical inspections are conducted semiannually. Failure of the PI to meet all required expectations may result in the loss and decommissioning of the APSE.
Animal Procedural Space Exception Standard Operating Procedure (SOP)
The PI should design an Animal Procedural Space SOP based on the topics listed below. The Animal Procedural Space SOP must address each topic in a detailed manner and must be approved by DCM Veterinarians, EHS, and the IACUC, and must be maintained in an accessible location in the Animal Procedural Space Facility (as described in "Required Documentation" below).
Standardization of Procedures:
The Guide states “While the animal use protocol is aimed at describing the overall procedures, SOPs should be developed to standardize the completion of animal care procedures.”
- Physical Plant: Where possible, the facility should meet the species-specific recommendations for animal housing units set forth in the current version of the Guide for the Care and Use of Laboratory Animals. However, the APSE facility may be in rooms not originally designed for animal occupancy and unable to meet all recommendations of the Guide. Since the APSE facility is a temporary experimental area, not a designated animal housing facility, deviations from the Guide may be approved by the IACUC so long as the animal is maintained in conditions (i.e., ventilation, temperature control, etc.) suitable to the health and well-being of its species and to the health of human occupants.Accessibility/Security: The PI is responsible for ensuring that the APSE facility is always locked when unoccupied by research personnel. Discrete signs should be posted instructing housekeeping to not enter the space when animals are present, and discontinued when animals are not present The APSE must be accessible to IACUC and DCM representatives at all times. The PI must provide a minimum of two (2) keys or the entry codes to facilitate IACUC and DCM access to the facility. Biosecurity: Personal protective equipment (PPE) must be made available at all times and will be provided by the investigator’s lab. A plan to prevent and resolve animal escape is required. For instance, a door sweep should be installed to prevent animals from crawling under the door space. An agreement must be made with the DCM facility supervisor on handling and return of caging materials borrowed from a DCM facility. If the PI wishes to return any animals to the DCM animal facilities, the PI must first arrange with DCM.
- Disaster Plan: The PI is responsible for ensuring that a disaster plan is in place in the event of an emergency which endangers the health and welfare of the animals maintained in the APSE facility. The plan must indicate Mandatory Employees to ensure continuity of animal care during University Conditions 2 & 3, when all non-mandatory operations are suspended and non-mandatory employees are not allowed to report to work. All student workers are considered non-mandatory and should be encouraged to leave the area. Please see the University's Adverse Weather and Emergency Event Policy for more details. (Described in the UNC-Chapel Hill Adverse Weather and Emergency Events Policy and Pandemic and Communicable Disease Emergency Policy).
The names and contact information for two mandatory employees, as well as a detailed description of a plan and backup plan for animal care during emergencies must be included. It is expected that labs provide care to animals in their satellite facilities during these conditions above. Additionally, the lab needs to have a plan with DCM, such that there is advance coordination and training of DCM personnel in the rare case that DCM needs to provide husbandry in an emergency. (Include DCM contact information to be used in case of emergency, and describe training provided to DCM). In the case of imminent adverse weather in which only mandatory employees are allowed on campus, PIs should refrain from starting any studies. DCM will not provide study-related care during emergencies and will terminate the study in such cases.
- Contact Information: Current 24-hour contact information should be posted on the door of the APSE facility so that the PI/LAC/researchers can be contacted in the event of an emergency.
- Animal Identification: All animals must be identified by a current IACUC approved protocol (e.g., with DCM RFID cage cards or another approved, acceptable method), and the date the animal was brought to the APSE facility.
- Required Documentation: In each APSE Facility, the PI must maintain daily husbandry documentation which includes the date, initials/signature of caretaker, and a description of all completed tasks (e.g., daily observation, feed, water, cage change, temperature, humidity, etc.). These log sheets must always be available in the facility for audit purposes. The PI must maintain the current approved animal protocol, and the APSE SOP in the APSE facility. These documents should be reviewed annually by personnel handling animals and updated as necessary. It is acceptable to maintain IACUC Protocol number, APSE SOP documents within a notebook in the room, which is accessible to inspectors.
- Signage: All required safety signage (EHS), IACUC signage, husbandry documentation, and after-hours emergency contact information must be present in the facility. The UNC-Chapel Hill notice "Reporting Adverse Events, Animal Welfare Concerns or Animal Protocol Noncompliance" and contact information for animal health (veterinary) concerns must be visibly posted within the APSE. The PI is responsible for posting and maintaining an accurate emergency contact information sheet in the APSE Facility. The posting must include the PI, Laboratory Animal Coordinator and/or APSE manager. Current 24-hour contact information should be posted on the door within the APSE Facility so that the PI/LAC/researchers can be contacted in the event of an emergency.
- Training: It is the PI’s responsibility to ensure that everyone working in the approved APSE space when animals are present is adequately trained in all animal-handling aspects. Training includes knowledge of the requirements for the Animal Biological Safety Level (ABSL) of that facility.Occupational Health: The PI is responsible for complying with all UNC-Chapel Hill occupational health requirements stipulated by the University Employee Occupational Health Clinic (UEOHC). This includes ensuring that all persons who are exposed to animals being held in the APSE facility are enrolled with the UEOHC. The Research Profile and Animal Handler Form can be found on the Research website. Additionally, appropriate personal protective equipment (PPE) is required.Hazards: The PI is responsible for complying with EHS requirements and all other applicable local, state and federal rules and regulations regarding physical, radiological, biological and chemical hazards. The PI is responsible for notifying all personnel (including IACUC) of any hazards present, using the required cage cards and/or signs, and assuring that all personnel are aware of potential hazards, and properly trained to avoid any hazard present.
- Sanitation: The PI is responsible for documenting compliance with species-specific sanitation requirements as per DCM SOPs. Please request information from the specific SOP for the species being used. The space must be easily cleaned and sanitized with approved supplies. Cages must be clean when brought to the APSE facility and promptly returned after use. An extensive cleaning routine should be outlined by the PI and may be performed when animals are not present.
- Husbandry Materials: All caging and materials such as food, water, bedding, enrichment device(s), cage cards and cleaning materials necessary for proper husbandry and care must be approved (and described within this SOP) and provided by the PI. Storage should be limited to items necessary for housing the animals and all cardboard must be removed. Stored materials must be kept in sealed vermin proof containers. The milling date or date of expiration must be clearly indicated on animal feed.
Exceptions:
Any modifications to the APSE and its SOP must be presented in writing to, and be approved, by the IACUC. Exceptions and modifications must be clearly outlined in Section 8.0 of the ACAP as well as in the individual APSE SOP. Additionally, requests for exceptions to this Standard must be reviewed and approved by the IACUC.
Related Requirements
External Regulations and Consequences
University Policies, Standards, and Procedures
Contact Information
Policy Contact
- Name: Michael Chi
- Title: Associate Director, Office of Animal Care and Use
- Email: mchi@unc.edu
Subject: Animal Health
- Contact: DCM Vet Services
- Telephone: 919-962-5535
Subject: Office of Animal Care and Use
Subject: EHS Concerns
Important Dates
- Effective Date and title of Approver: 10/2009; UNC IACUC
- Revision and Review Dates, Change notes, title of Reviewer or Approver: Revised 08/2012; Revised 08/2012; Revised 04/2016; Revised 11/2018, Placed on University Standard Template; UNC IACUC; Revised 11/2024
Approved by: UNC IACUC