|


Johns Hopkins University (JHU) Policy and Standards for Research Animal Housing in Satellite Facilities
This document sets forth JHU policy regarding satellite animal
housing facilities, outlines the salient features of such housing
that must be addressed, and summarizes the activities needed
to ensure that the entire animal housing and care program meet
JHUstandards.
“Satellite facility” is defined as any area outside
of JHU’s centrally-managed housing facilities where animals
are maintained for more than 24 hours (12 hrs for species covered
by the Animal Welfare Act Regulations).[1]
In brief, the elements critical to our success include a laboratory
point (or points) of contact (POC) with direct or delegated responsibility
for the satellite facility; physical plant and environmental
considerations; appropriate choices of caging, husbandry procedures,
and sanitation procedures for equipment used with animals; management
of caging and supplies; arrangements for daily animal care; and
veterinary care.
I. POLICY
JHU is committed to a uniform standard of excellence in all
aspects of its animal care and use program. The entire
program is based on the recommendations of the Guide for
the Care and Use of Laboratory Animals (Guide). At
JHU, Research Animal Resources (RAR) is responsible for the animal
housing and veterinary care programs.
The operating standard at JHU is to maintain animals within
its centralized animal housing facility program managed by RAR. The
scientific needs of some research programs or particular phases
of some projects may not be able to be accommodated within central
facilities, however. In those cases, satellite housing
is needed. The JHU Animal Care and Use Committee (ACUC)
must review and approve the scientific rationale for short- or
long-term satellite housing in the context of the applicable
research protocol. The Guide indicates that convenience
alone is not sufficient justification to maintain animals in
satellite housing.
The policy of the JHU ACUC is to provide the RAR Director of
Laboratory Animal Management copies of protocol and amendment
applications involving satellite housing to enable RAR (1) to
determine whether the activity can be accommodated within central
facilities and (2) to provide consultation on the written plan
for care in satellite housing that has been submitted to the
ACUC. For first-time satellite housing location requests,
ACUC evaluation of the request also requires a consultative inspection
of the location by the Director or a designee.
Regardless of the length of time an animal is housed in an ACUC-approved
satellite facility, the principal investigator (PI) on the ACUC-approved
protocol is responsible for seeing that its housing and care
are consistent with JHU Policy. To facilitate this, RAR
is responsible for maintaining contact with the satellite facility
to assure appropriate support, guidance, and oversight of the
care of animals housed there.
By their very nature, physical plant, housing, and procedures
in satellite facilities will deviate in some manner from those
in central facilities. Adherence to the general principles
of the Guide and to an overarching focus on animal welfare
consistent with the needs of the research procedures approved
by the ACUC is a basic tenet of this policy. The Guide itself
sets forth an emphasis on a “performance approach,” as
preferable to an “engineering approach.” That
is, “Performance standards define an outcome in detail
and provide criteria for assessing that outcome, but do not limit
the methods by which to achieve that outcome.” (Guide,
1996, p. 3) Given the wide range of research at JHU, it
is possible that this document does not adequately address potential
variations on housing and procedures that will arise. We
anticipate that such variations will be discussed with RAR as
they arise and incorporated in the laboratory standard operating
procedures as appropriate.
This document has been written to be very general, but applies
primarily to satellite housing of mammals and birds. A
supplementary policy applies to fish and aquatic species.
II. STANDARDS
A. The Laboratory Point of Contact (POC)
Accountability for the care of animals housed in satellite facilities
is established formally in the satellite housing application
through a laboratory POC. This person may be either the
PI or another qualified person with delegated responsibility
to ensure that the care given to laboratory animals in the
satellite facility will be consistent with this policy. When
delegated by the PI to a JHU staff member, POC responsibility
should be listed as a major element on the individual’s
job description and annual performance evaluation. In
some laboratories, depending on the continuity of animals in
satellite housing, it is desirable to appoint a secondary POC
as well.
The POC may operate by directing and overseeing others in the
laboratory who are performing hands-on care, may perform laboratory-based
care as a primary function, or may provide RAR technical personnel
with specialty guidance to enable them to care for animals with
unique experimental requirements in the satellite facility. The
POCs are required to be familiar with and to follow the provisions
of this policy and other institutional standards (e.g., RAR policies
and ACUC-approved policies and guidelines) in support of the
institution’s mission to provide high quality care to all
laboratory animals, regardless of housing location.
Laboratories are encouraged to create a simple task list for
animal care, to have a posted list of the trained personnel who
will provide back-up care in the absence of the primary care-giver(s),
and to clearly establish the mechanism for arranging coverage
by back-up personnel. Regardless of the approach to providing
care, the POC is seen as responsible for assuring that all animals
housed in the satellite receive adequate care every day.
Each satellite facility must have a copy of the Guide readily
available, and the POC should be familiar with its contents. The Guide may
be obtained free of charge from the ACUC office. Training
and orientation sessions on satellite housing are arranged periodically
by the ACUC office and/or RAR for POCs and others who are interested
in this topic. In addition, RAR personnel make regular,
usually weekly, visits to each satellite facility, which provides
the opportunity for addressing emerging issues relevant to each
location.
B. Daily Checklist
Most of the critical elements of a basic program of laboratory-based
care are included in a “Daily Animal Room Checklist” used
in central facilities, which is available from RAR. This
checklist provides a means for recording basic required elements
of animal maintenance (i.e., temperature and humidity in the
housing location as well as annotation that all animals were
visually inspected seven days a week). It may also incorporate
other actions performed in support of the animals in that location,
as applicable. This sheet, as well as the animal census sheet,
must be submitted at the end of each month by the method requested
by RAR.
C. Physical Plant and Environmental Conditions
in Satellite Housing Areas
General Principles: According to the Guide (Chapter
4, Physical Plant),animal housing facilities
should be constructed with smooth, durable, impervious surfaces
to aid in maintaining a high level of sanitation and to permit
effective pest and infection control efforts. The room interior
should have sealed penetrations (for pest control), ceiling mounted
and sealed light fixtures, and minimal cabinetry or shelf work. The
room heating, ventilation and air conditioning system should
provide 10 or more air changes of 100% fresh, non-recirculated
air in a temperature range suited for the species involved, and
between 30-70% relative humidity. Whenever possible, animal housing
areas should be isolated from other areas containing personnel
who do not need to have animal contact, and the differential
airflow between the housing area and other personnel areas should
be negative pressure to reduce personnel exposures. All JHU personnel
should be afforded the opportunity to work with minimal exposure
to animal allergens. In housing areas where wet sanitation
of walls and floors is conducted on a routine basis, water resistant
(i.e., with ground-fault interruption control) electrical outlets
and switches should be installed. Animals should be provided
with a regular diurnal light cycle of appropriate duration for
the species and experimental requirements.
Some satellite housing facilities at JHU were constructed to
be consistent with the above. Others are in laboratories,
constructed for other purposes, but which may be acceptable if
the basic principles of the Guide and performance standards
are kept in mind. Thus those arranging satellite housing
in a laboratory should direct their efforts to create an acceptable
environment by implementing the following:
1) Place animals in a dedicated, secure area (e.g., lab bay
or portion thereof) out of direct sunlight and, as much as possible,
away from other areas in the laboratory that do not involve laboratory
animals. The door(s) to the room should be locked when responsible
personnel are not present.
2) The physical plant in the area should be in good repair. Surfaces
should be constructed of materials that can be easily sanitized
to the standards required by the research. Remove or seal
unsealed wood (e.g., shelves), unnecessary wall attachments,
and replace damaged ceiling tiles. The floor, coving, and walls
should be free of defects that allow vermin harborage and impede
sanitation.
3) Use a light timer and/or have a laboratory process to ensure
that animals have a regular daily light cycle (unless an exception
has been granted by the ACUC for scientific reasons). If
the room has windows that provide natural light, a timer is not
required; but the room light must be turned off reliably rather
than left on overnight.
4) Where temperature or humidity fall out of the Guide range
for more than three consecutive days (or sooner if preferred),
facilities management should be contacted to make adjustments. In
some areas, humidity is difficult to maintain at greater than
30% in the winter in Baltimore, even by use of an appropriately
placed room humidifier. If this is the case, consult with
RAR and/or a veterinarian for appropriate methods to sample humidity
at the cage level (for rodents) and/or to document whether the
low humidity has an impact on the health of the animal.
D. General Housekeeping Provisions for Satellite
Housing Areas
1) The housing area must be maintained in a clean and orderly
condition.
2) The placement of standard rodent housing cages should permit
easy visualization of the animals contained within unless otherwise
precluded by the requirements of the experimental protocol.
3) The priority should be on arranging the housing area to facilitate
sanitation and pest control. Considerations include:
a) Remove laboratory apparatus, equipment, furniture, books,
papers and supplies that are not needed for ongoing experimental
or husbandry. Fabric-covered chairs should be moved out
of the area.
b) Where practical, movable racks or carts should be used
to hold animal cages in the laboratory. The racks or carts
ideally will be capable of withstanding sanitation in a mechanical
cage washer. If wall mounted shelves or bench tops are
used for cage placement, these surfaces should be sanitized
when cages are changed.
c) Corrugated cardboard boxes should be moved away from the
animal housing area, because the glue in them supports vermin
propagation.
d) The floors of the housing area should be swept as needed,
and mopped at least weekly.
4) Potentially harmful chemicals should not be stored near animal
cages, or in biosafety cabinets or fume hoods when animals are
present. All risks that a chemical spill would injure or
contaminate animals should be eliminated.
5) Bench space used for animal manipulations should be wiped
down with a disinfectant/soap solution after each use. Other
surfaces in the housing area (e.g., walls) should be sanitized
on a quarterly basis.
E. Husbandry/Caging Requirements for Rodents:
Type, Sanitation Schedule, Movement to and from Laboratory
1) Rodents housed in laboratories must be housed in microbarrier
(closed top) caging with a cage lid that is appropriate to the
circumstances. These cages aid in infection control, allergen
and odor control, and in some cases may improve intra-cage
humidity under low room humidity conditions. Whenever
appropriate and practical, given the needs of the research, animals/cages
in the laboratory should be handled with the infection control
techniques (exterior disinfection, manipulation in a biosafety
cabinet or cage change station) that are practiced in central
RAR facilities.
a.
Satellite areas that hold mouse populations in excess of 35
cages in rooms that were not designed for animal housing will
be provided with an individually ventilated caging (IVC) rack
by RAR if available and if it can be accommodated in the space
available. Such a rack helps address issues related to animal
health, animal allergens, and cage-changing frequency that
may be problematic in satellite facilities. Other containment devices, such as semi-rigid
or flexible film isolators, may also be considered for mice or
rats in areas with lower cage counts if satellite housing is
in a mixed function area. Cage changing in the IVC system
should be adequate at the two-week interval used in central
facilities.
b.
Laboratories housing few rodent cages will be provided with
static microbarrier cages. The tops of these cages are perforated
to permit air exchange and dispersion of intra-cage moisture. Static
microbarrier cages require sanitation weekly for mice, and
twice weekly for rats, although longer intervals may be appropriate
where rodents are singly housed.
c.
If specialized caging used for experimental purposes does not
provide an effective cage level barrier between the animal and
the laboratory environment, a method of secondary containment
is desirable if the housing is in a multiple use area. Specialized
cages of this type should be designed to permit the detachment
of sensitive components and constructed from materials that permit
the cage to be washed in a mechanical cage washer on a weekly
or bi-weekly basis. If mechanical washing cannot be done, the
method of cage sanitation, including agent(s) used, is to be
described in a written standard operating procedure (SOP; see
below).
2) The acquisition of clean cages must be coordinated through
RAR. Arrangements may be made by the POC to have RAR personnel
transport cages to the laboratory.
3) Reassemble dirty cages that contain bedding in the closed
position to prevent spillage and access by pests. Transport
of cages in the closed-box position is preferred because the
piston action of cage stacking has been associated with the airborne
spread of pathogens. This may not be practical
if large numbers of cages must be moved to the cage wash facilities.
If dirty cages are stacked without lids to aid transportation,
they must be bagged or covered to prevent the spread of waste,
allergens and airborne pathogens during transit. Dirty
cages must be taken to the RAR cage wash centers no later than
the morning after cage changing. To aid the institutional vermin
and infection control efforts, dirty cages with bedding should
never sit in the laboratory un-bagged. Empty water bottles in
the lab prior to transport to RAR.
4) To ensure that food remains fresh and uncontaminated and
does not attract vermin, it must be stored in a container that
is kept tightly closed. The container must have the type
and production date (mill date), which are found on the feed
bag. Feed must be used before the expiration date, which
is 180 days beyond the mill date in most cases. A common
method of storing feed in a laboratory is to use a microbarrier
sanitized or sterilized rodent cage. A container used for
feed storage should be sanitized or replaced with a clean one
each time it is emptied.
F. Standards for Sanitation and Specific Practices
for Laboratory-Based Animal Care and Use Activities
Equipment used for research animal caging, restraint, transport,
or experimentation should be designed and constructed to allow
efficient cleaning or sterilization as necessary for effective
infection control measures. A sound, comprehensive sanitation
program for laboratory-based animal care and use activities involves
the following components:
- All equipment used in animal housing or to support animal
care or in vivo experimental activities must be sanitized at
appropriate intervals as specified below. Pertinent equipment
may include, but is not limited to, specialized lab housing
systems, exposure chambers, restraint chairs, transport boxes,
behavioral testing equipment (e.g., mazes, swim tanks), surgery
support equipment (e.g., rodent surgery boards), and bell jars
used for anesthesia with recovery. Apparatus that is only used
in non-survival applications should be cleaned immediately
after use, but documentation of effective sanitation is not
required.
- Equipment that can withstand treatment in the RAR
cage washers should be scheduled for routine sanitation. Equipment
that cannot withstand cage washing should be sanitized by appropriate
methods devised in the laboratory, which will need to be verified
as efficacious by RAR, as described below.
- Mechanisms (e.g.,
schedules, equipment identification codes) should be established
so that a record can be kept of equipment that needs to be
sanitized and of the dates on which it is sanitized.
- Laboratories should give high priority to the replacement
of equipment that may not be easily sanitized if improved versions
that are easy to sanitize are available. If a wooden
item is used, it should be sealed with a washable and impervious
paint, polyurethane, or varnish that will allow disinfection.
- In general, the minimum interval for the sanitation of equipment
that has direct contact with animals used during in vivo studies
is two weeks assuming the animals are all of a similar microbiological background. In
some cases, more frequent sanitation may be required. The following
list summarizes the usual sanitation recommendations for common
items other than caging:
- Large animal food containers on or within
cage: Physically
clean daily; sanitize every two weeks.
- Large animal water containers: Sanitize
every two weeks.
- Mouse caging: Change static microbarrier
cages weekly; change IVC caging every other week.
- Rat caging: Change
static microbarrier cages twice weekly.
- Rodent water bottles: Provide
fresh bottles weekly. Obtain
reverse osmosis treated water from central facilities if needed
for the experiments being conducted.
- Animal transport devices: Clean
between animals; sanitize every two weeks, or between animals
if warranted by disease conditions.
- Animal restraint chairs/devices – clean
between animals, sanitize every two weeks or between animals
if warranted by disease conditions
- Experimental animal exposure chambers: If the animals
are contained in a cage within a chamber then every two weeks.
If the animals have direct contact with the chamber, it should
be cleaned between individuals and sanitized every other week.
- Behavioral test apparatus: Clean between animals or cohorts
as dictated by scientific requirements; sanitize every two
weeks.
- Equipment used to support animal survival surgery and post
operative care: Physically clean between animals or
surgical cohorts (on a given day); sanitize every two weeks
during periods of active use and keep area uncluttered.
- Additional
items can be discussed during meetings with RAR.
- Sanitation
of items should be recorded on the “Daily
Animal Room Checklist” or on a comparably maintained
sanitation record that can be submitted to RAR.
- Equipment that
can be sanitized (or sterilized) in a cage washer is automatically
afforded the benefit of existing quality assurance measures
(i.e., temperature-time monitoring, microbiological monitoring). As
noted in the Guide, hand sanitation
is less reliable than cage washing, and the process used must
be shown to be efficacious. For caging and equipment
that must be sanitized by hand, laboratories should have written
SOPs that describe the sanitation process, specify the chemical
agents used, and indicate the contact times necessary for disinfection
as applicable. RAR will provide guidance on what information
should be included in the SOPs and information on the laboratory
disinfectants it has available for equipment, and will assist
in the selection of suitable agents. Periodic assessment
of the efficacy of the sanitation process will be conducted
by RAR to determine whether alteration of the sanitation procedure
or practices is needed.
III. Veterinary Care and Participation in the
RAR Rodent Sentinel Surveillance Programs for Animals Housed
in Satellite Areas.
The program of veterinary care at JHU is housed in RAR, under
the Director of Laboratory Animal Medicine. The responsibility
for veterinary care rests exclusively with the RAR veterinary
staff. The only exceptions to this policy are those specific
elements of clinical care that are associated with the maintenance
of an experimental animal that have been defined and explicitly
stated in the ACUC-approved animal care and use protocol. In
particular, use of antibiotics that are not included in an approved
protocol must be under the direction of a clinical veterinarian.
The RAR rodent disease surveillance program will be applied
to animals housed in the satellite areas as deemed appropriate
by the director of this program. Participation in this program
will help RAR promptly identify areas of disease that pose a
risk for rodent populations in central facilities. Laboratories
that house only small populations of animals for relatively short
periods episodically may have the requirement for participation
waived. Participation will involve either the placement of sentinel
animals for the detection of infections or infestations, or the
submission of tissues and blood samples from experimental animals
residing in the facility at appropriate times.
IV. What Assistance will be provided by RAR to
Satellite Facilities?
To assure that standards and practices for laboratory animals
housed in satellite areas conform to this policy, RAR provides
the following assistance:
1) An RAR technician will visit each satellite facility on a
regular schedule (usually weekly) to review the provision of
care in conformance with this and provide consultation; frequency
of visits may increase or decrease as conditions warrant.
2) The RAR technician will review animal health and coordinate
submission of samples for disease surveillance activities.
3) The RAR technician will supply caging and water bottles,
as well as racks and carts to hold rodent caging wherever possible;
and will coordinate equipment and supply exchange between the
laboratory and central RAR facilities.
4) RAR will perform pre- and post-sanitization quality assurance
testing on laboratory equipment on a regular schedule (usually
twice a year).
5) RAR will coordinate pest control measures, and recommend
physical plant repairs and improvements to be made by the laboratory. Recommendations
for commonly needed physical plant improvements will be forwarded
to the appropriate dean’s office.
6) RAR technicians will be available at the laboratory’s
request, excluding weekends, to provide in-laboratory animal
care services. Satellite facilities must assure coverage
of the animals seven days per week.
7) RAR will continue to look for new opportunities and approaches
to accommodate specialized housing and research needs in central
facilities.
1. References
for the definitions and criteria in this document include
the Public Health Service Policy on the Humane Care and
Use of Laboratory Animals, the National Research Council’s
1996 Guide to the Care and Use of Laboratory Animals, and/orthe
U.S. Animal Welfare Act Regulations (enforced by the U.S.
Department of Agriculture, USDA). Species
covered by the Animal Welfare Act (i.e., “USDA species”)
include all mammals and wild-caught birds. Rats, mice,
and birds that were bred for use in research are specifically
excluded from coverage by the Act.
|