Standard on Satellite Animal Facilities

Title

University of North Carolina at Chapel Hill Standard on Satellite Animal Facilities

Introduction

Purpose

The standards and procedures described in this document provide guidance to all researchers and animal handlers for the establishment and maintenance of a Satellite Animal Facility.

Scope of Applicability

All personnel engaged in the care of animals maintained within a Satellite Animal Facility.

The UNC-CH 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.

Standard

Federal regulations state that the authority and oversight of Satellite Animal Facilities lies with the institution through the Institutional Animal Care and Use Committee (IACUC).

Approval of an Animal Care Application (ACAP) and approval of a Satellite Animal Facility are two separate issues. Approval of an application with a Satellite Animal Facility request does not imply or guarantee automatic IACUC approval of the proposed Satellite Animal Facility. Satellite Animal Facilities are approved in rare instances where there is appropriate justification. In addition, IACUC approval of a proposed satellite facility will be granted only if the environment, housing, care and oversight meet the standards of the Guide for the Care and Use of Laboratory Animals (Guide), federal law, and current institutional policies. The process of Satellite Animal Facility approval is dependent on several factors and the process can take a considerable amount of time.

The required steps for development of a Satellite Animal Facility at UNC-Chapel Hill are as follows:

  1. Before beginning the process of the Satellite Animal Facility, consult with Division of Comparative Medicine (DCM) about whether there is appropriate space in DCM facilities, and- if there is not appropriate space in DCM facilities- identify suitable space outside DCM facilities to use as a satellite.
  2. Written justification for a Satellite Animal Facility reviewed and approved at a fully convened IACUC meeting (including completion of section 3.3 in the protocol application).
  3. Written IACUC, DCM, and Environment Health and Safety (EHS) approval of the following:
    1. Space assignment including collection and review of temperature and humidity data (high/low) over a 5 day period prior to facility approval. DCM may have temperature/humidity devices available for loan to investigators.
    2. Satellite Animal Facility Standard Operating Procedures (SOP) (included in this document).
    3. Satellite Disaster Plan with satellite specifics described in section F. – Available here on the IACUC website.
  4. Final Inspection and approval by -- IACUC, DCM, EHS
  5. Two (2) keys provided by PI (Principal Investigator) to OACU (Office of Animal Care and Use)
  6. Occupancy

Approval of a Satellite:

The approval process requires that the investigator initially submit a request with justification to the IACUC through ACAP (by completing section 3.3). Justification for a proposed satellite facility 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 scientific reasons.

If the IACUC approves the satellite facility justification, then the investigator can begin coordinating an initial inspection of the proposed site. IACUC, 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, DCM and EHS representatives to re-inspect the proposed site.

Prior to using the space to house animals, the PI requesting the Satellite Animal Facility must receive both 1) written notification from the IACUC indicating approval of the space and 2) approval of the ACAP which contains the completed Section 3.3 describing the Satellite space.

Post Approval Maintenance of a Satellite:

It is the responsibility of the PI to ensure that all federal and institutional requirements are implemented consistently. This covers the care and use of all animals, seven days a week including weekends and holidays, and also including Emergency/Adverse Weather situations. (see pg 6 -Procedures included in the Satellite SOP, item C. iv. re contacting DCM in emergencies).

The PI is responsible for ensuring compliance with EHS policies for the space including complying with the University’s Chemical Hygiene Plan (submittal of a laboratory safety plan and following policies outlined in Laboratory Safety Manual). In addition, the PI must check and maintain safety controls within the space (i.e. chemical fume hoods, biological safety cabinets, safety eye washes, safety showers).

The PI is responsible for enrolling all personnel exposed to the animals (including non-animal handlers) in the University Employee Occupational Health Clinic Program (by completion of the Animal Handler Form). The PI must ensure that all personnel involved in animal handling are properly trained in animal care and use. Veterinary and IACUC Compliance oversight will continue as if the animals were in a DCM facility.

Semi-annual IACUC inspections are federally mandated of each Satellite Animal Facility; however, at UNC, Satellite facility inspections are conducted on a quarterly basis. Failure of the PI to meet all required expectations will result in the loss of privilege and decommissioning of the Satellite Animal Facility.

Satellite Animal SOP

The PI must use this SOP form to design the proposed space. The individual Satellite Animal Facility SOP must address each topic in a detailed manner, must be approved by DCM Veterinarians, EHS, and the IACUC. The PI must maintain a final approved copy in the Satellite Animal Facility. Laboratory staff responsible for provision of care within the Satellite Animal Facility must review the SOP annually.

Standardization of Procedures:

The Guide for the Care and Use of Laboratory Animals, 8th edition, indicates, “While the animal use protocol is aimed at describing the overall procedures, SOPs should be developed to standardize the completion of animal care procedures.”

  1. Physical Plant: The facility must meet the minimum standards as set forth by the Guide for the Care and Use of Laboratory Animals. The PI is responsible for meeting or exceeding these standards at all times. The space must be clearly designated as an area reserved for animal holding only.
  2. Experiment: Should any experiments or procedures need to be performed in the designated space, an exception must be submitted for full committee review and approval.
  3. Biosecurity: Animal entry or departure from the Satellite Animal Facility must be in accordance with IACUC and DCM standard policies. If the PI wishes to return any animals to the DCM animal facilities, the PI must first make arrangements with DCM.
  4. Documentation: In each satellite facility, the Investigator must maintain daily husbandry documentation which includes the date, signature of caretaker, and a description of all completed tasks (daily observation, feed, water, cage change, etc.). These log sheets must be available in the facility at all times for audit purposes (announced or unannounced). The PI must maintain the current approved animal protocol, the Satellite Animal Facility SOP, and the Satellite Disaster Plan in the satellite and should be reviewed annually by personnel handling animals.
  5. Signage: All required safety signage (EHS), IACUC signage, husbandry documentation, and after-hours emergency contact information must be present in the facility. All animals must be identified by the current IACUC approved protocol number (i.e. with DCM animal identification cage cards or individual acceptable method), along with any physical markings/identifications. The PI is responsible for posting and maintaining an accurate emergency contact information sheet in the Satellite Animal Facility. The posting must include the Principal Investigator, Laboratory Animal Coordinator and/or satellite manager. DCM Veterinary Contact information must also be posted for animal health related issues. The PI or his/her designee must be contactable at all times to respond to emergencies.
  6. Accessibility/Security: The Satellite Animal Facility must be accessible to IACUC and DCM representatives at all times. The Satellite Animal Facility PI must provide a minimum of two (2) keys or the entry codes to facilitate IACUC and DCM access to the facility. Additionally, the PI is responsible for maintaining and ensuring that the Satellite Animal Facility animal holding area is secured at all times. An Essential Personnel must be indicated – to ensure continuity of animal care during University Condition 2 & 3, when all non-mandatory operations are suspended and non-essential employees are not to report to work. All student workers are considered non-essential and should be encouraged to leave the area. If an Essential Personnel cannot be designated, DCM must be contacted and alternate care arrangements made, prior to the approval of this SOP. Please see the University Adverse Weather and Emergency Event Policy for more details.
  7. Training: It is the responsibility of the PI to ensure that the PI, Laboratory Animal Coordinator (LAC), Office of Animal Care and Use (OACU) personnel, or DCM adequately trains everyone providing care for animals in the Satellite Animal Facility.
  8. 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 need to be approved by DCM veterinarians (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.

Procedures to Be Included in the Satellite Animal Facility SOP:

Provide details for each of the following items. Include the frequency of each procedure and the level/position (not individual name for security purposes) responsible for the completion of each procedure. PIs should contact a DCM Veterinarian for consultation in development of the SOP.

1. Care of Animals: Animal handling (consult with DCM veterinarians and/or EHS)

  1. Personal protective equipment (PPE)
    1. Indicate what PPE is necessary when handling the animals.
  2. Zoonotic agents associated with this species
    1. What are they?
    2. Describe how animals are to be handled (captured & restrained)
    3. Are there any other risks such as bite wounds, etc. associated with this species?
    4. What are the clinical signs that might indicate that someone working with these animals has contracted a zoonotic disease?
    5. What precautions should be taken to protect staff?
  3. Are there tools such as nets used for their capture or restraint?
    1. Are these tools dedicated to a particular animal or set of animals? (If so, indicate sanitization schedule in chart below)
    2. What should be done if animal escapes?
    3. If animal makes contact with the floor, should it be returned to the original primary enclosure or are there additional steps for cleaning/isolating this animal?
    4. Health checks: All animals must be checked daily, including weekends and holidays.
    5. What is the procedure for checking animals?
    6. 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 facility. Indicate how animals will be cared for in the event that the University is operating under conditions when only ‘Mandatory’ employees are allowed access to campus. (Described in the UNC 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.) Please indicate the name of the Essential Personnel: ________ or DCM plan here ___________.
    7. What clinical or behavioral signs denote an animal may be sick or otherwise compromised?
    8. What steps are taken with this animal and to whom does the investigator report the health case (supervisor, DCM veterinary services)?
  4. Feed/watering of animals
    1. What type of food (brand/source) is used?
    2. How is this food stored?
    3. How is expiration date determined?
    4. How often and how much is given of both feed and water (if applicable)
    5. Describe water treatment and water quality assessment
    6. What is done with excess food in the enclosure?
  5. Primary enclosures (tank or cage): Note: An agreement must be made with the DCM facility supervisor on handling cages borrowed from a DCM facility.
    1. Describe enclosure
    2. Indicate the number of animals (minimum and maximum) per enclosure
    3. Will animals outgrow their enclosure, and at what point will they be transferred to larger housing?
    4. Are animals provided enrichment? If not, what is justification?
  6. Procurement of animals
    1. How are animals transported to housing location (shipped, hand-delivered, etc.)?
    2. Are health checks conducted upon arrival; who conducts the health check?
  7. Quarantine procedures
    1. Is a separate tank/enclosure provided to quarantine new arrivals and/or sick animals?
    2. Where is the location of quarantine enclosure?
    3. Are special arrangements made to change workflow when dealing with sick or new animals so as not to introduce disease to the rest of the colony?
    4. Is the health of newly arrived animals monitored? If so, by whom (researcher, veterinarian)
    5. Is animal quality discussed with the vendor?

2. Sanitation: The PI is responsible for complying with species-specific sanitation requirement as per DCM’s SOPs. The housing area must be easily cleaned and sanitized. (Complete all aspects of charts below):

Sanitation
Microenvironment (primary enclosures) Washing/Sanitizing Method (mechanical wash, hand wash, high pressure sprayers, etc.) Washing/Sanitizing Frequency Tools and detergents used Temperature of water to be used
Cage Lids        
Filter        
Cage Rack and Shelves        
Aquatic, Amphibian, and Reptile Tanks and Enclosures        
Feeders        
Watering Devices        
Exercise Devices and Manipulanda used in Environmental Enrichment Programs, etc.        
Transport Cages        
Sanitation
Macro-environment: rooms, floors, wash areas Washing/Sanitizing Frequency Detergents/agents used Environmental monitoring (with DCM) Yes/No
Animal Room Floors      
Animal Room Walls      
Animal Room Ducts/Pipes      
Animal Room Fixtures      
Support Area* Floors      
Support Area Walls      
Support Area Ceilings      
Support Area Ducts/Pipes      
Support Area Fixtures      
Implement* Mops      
Implement* Mop Buckets      
Implement* Aquaria Nets      
Implement* Other      
Other:      
*Support Areas include: (e.g. surgery, procedure rooms, etc.)
*Implements: Note whether or not shared

3. Primary Enclosures and Animal Space Provisions-

Please complete the table below considering performance criteria and guiding documents (e.g. Guide, Ag Guide, ETS 123 and/or other applicable standards) used by the IACUC/OB to establish adequacy of space provided for all research animals including; traditional laboratory species, agricultural animals, aquatic species and wildlife when reviewing biomedical, field and agricultural research studies.

Adequacy of Space
Species Dimensions of Enclosure (cage, pen, tank*, corral, paddock, etc.) Maximum Number Animals/Enclosure Guiding document used to determine the Institution’s space standards (Guide, AG Guide, ETS 123, Other) Enclosure Composition & Description**
         
         
         
         
*For aquatic species, provide tank volume.
**Include descriptors such as open-topped, static microisolator, individually-ventilated cage systems (IVCS).

Exceptions

Requests for exceptions to this Standard must be reviewed and approved by the IACUC.

Definitions

  • IACUC: Institutional Animal Care and Use Committee
  • DCM: Division of Comparative Medicine
  • University Standard: The minimum acceptable limits or rules used to achieve Policy implementation, enforceable by the IACUC.
  • Satellite Animal Facilities: A non-DCM animal facility in which animals are housed on a long-term basis and are cared for by the PI’s laboratory personnel
  • PI: Principal Investigator
  • OACU: Office of Animal Care and Use
  • SOP: Standard Operating Procedure
  • UEOHC: University Employee Occupational Health Clinic
  • LAC: Laboratory Animal Coordinator
  • EHS: Environment Health and Safety

Related Requirements

University Policies, Standards, and Procedures

Contact Information

 

Policy Contact
Subject Contact Telephone E-Mail
Veterinary Services DCM    
IACUC Protocol and Training Office of Animal Care and Use 919-966-5569 iacuc@med.unc.edu
Laboratory Safety Environment, Health and Safety 919-962-5507  

 

Important Dates

 

  • Effective Date and title of Approver: January 2009; UNC IACUC
  • Revision and Review Dates, Change notes, title of Reviewer or Approver: Revised 04/2015; UNC IACUC; Revised 04/2016; Revised 11/2018, Placed on new Standard template, updated contact information and added hyperlinks; Revised 01/2019, Added information regarding Condition 2 & Condition 3 Essential Employees;UNC IACUC.

 

Approved by: UNC IACUC

 

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Details

Article ID: 132211
Created
Thu 4/8/21 9:26 PM
Modified
Thu 6/17/21 4:28 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
10/21/2020 12:00 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Vice Chancellor for Research
Last Review
Date on which the most recent document review was completed.
10/21/2020 12:00 AM
Last Revised
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10/21/2020 12:00 AM
Origination
Date on which the original version of this document was first made official.
09/16/2019 12:00 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-Institutional Animal Care & Use Committee