Standard on Animal Procedural Space Exception (APSE)

Title

University of North Carolina at Chapel Hill Standard on Animal Procedural Space Exception (APSE)

Introduction

Purpose

The standards and procedures described below provide guidance to all researchers and animal handlers for the responsibility of the Principal Investigator (PI) to ensure that all institutional regulations are implemented within the PI maintained areas.

Scope

This Standard applies to all personnel engaged in the care and testing of animals in a PI-maintained space for durations greater than allowed without an exception.

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

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 and 24 hours for non-USDA regulated species.

During this testing phase, required facility maintenance and animal care are provided by the investigator. Federal regulations state that the authority and oversight of these facilities lies with the institution through the IACUC.

Approval of an Animal Care Application (ACAP) and approval of an APSE are two separate requirements. Approval of an APSE will only occur where there is appropriate justification and provided the requested procedural space meets IACUC, Environment, Health and Safety (EHS), and Division of Comparative Medicine (DCM) standards. Justification 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.

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:

1. Written justification describing need for the APSE (requires approval at a fully convened IACUC meeting).
2. Approval of APSE request in Section 8.0 (Exception Request) of the protocol.
3. Initial inspection of proposed APSE facility by IACUC, DCM, and EHS representatives.
4. Collection of temperature and humidity data (high/low) over a five-day period, except in spaces used only for prolonged non-survival surgery, incubator housing, or continuous testing in which animals are maintained in climate-controlled equipment (e.g., Biocabinets). For APSEs consisting only of an incubator, the PI should provide IACUC/OACU with manufacturer specifications.
5. Final inspection of required modifications to improve space.
6. Written approval from the IACUC.

The PI should design an individual Animal Procedural Space SOP based on the topics listed below. The Animal Procedural Space SOP must be approved by DCM/EHS, and must be maintained in an accessible location in the Animal Procedural Space Facility (as described in "Required Documentation" below).

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 are allowed 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.

Security: The PI is responsible for ensuring that the APSE facility is locked at all times when unoccupied by research personnel. Discrete signs should be posted instructing housekeeping to not enter the space when animals are present.

Biosecurity: 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.

Animal Identification: All animals must be identified by a current IACUC approved protocol (e.g., with DCM RFID cage cards or an approved, acceptable method), and the date the animal was brought to the APSE facility.

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.

Sanitation: The PI is responsible for complying with species-specific sanitation requirements as per DCM SOPs. 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.

Required Documentation: Current IACUC ACAP ID #s, APSE SOP and all EHS-required safety signage must be present in the space. It is acceptable to maintain ACAP and SOP documents within a notebook in the room, which is accessible to inspectors. The UNC-Chapel Hill notice "Reporting Animal Welfare Concerns or Animal Protocol Noncompliance" and contact information for animal health (veterinary) concerns must be visibly posted within the APSE facility.

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.

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 should indicate how animals will be housed and will require care in the event that the University is operating under conditions when only ‘Mandatory’ employees are allowed access to campus. (Described in the UNC-Chapel Hill Adverse Weather and Emergency Events Policy and Pandemic and Communicable Disease Emergency Policy). Advance coordination and training with DCM personnel is required to ensure emergency backup husbandry. (Include DCM contact information to be used in the case of emergency, and describe training provided to DCM.) Alternately, indicate the key employees who are considered ‘Mandatory’ personnel (list employees’ names with Mandatory status).

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.

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

• U.S. National Institutes of Health. Guide for the Care and Use of Laboratory Animals, 8th edition.

University Policies, Standards, and Procedures

• For more detailed guidance, please refer to the University Policy on the Care and Use of Vertebrate Animals for Research, Training and Teaching Purposes.
• Adverse Weather and Emergency Events Policy
• Pandemic and Communicable Disease Emergency Policy
• Emergency Management Policy
• Reporting Animal Welfare Concerns or Animal Protocol Noncompliance

Contact Information

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

Approved by: UNC IACUC