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BMBL Section IV
Vertebrate Animal Biosafety Level Criteria
If experimental animals are used, institutional management must
provide facilities, staff, and established practices that reasonably ensure appropriate
levels of environmental quality, safety, and care. Laboratory animal facilities are simply
a special type of laboratory. As a general principle, the biosafety level (facilities,
practices, and operational requirements) recommended for working with infectious agents in
vivo and in vitro are comparable.
However, it is well to remember that the animal room can present some unique problems. In
the microbiological laboratory, hazardous conditions are caused by personnel or by the
equipment being used. In the animal room, the activities of the animals themselves can
present new hazards. Animals may generate aerosols, they may bite and scratch, and they
may be infected with a zoonotic disease.
These recommendations presuppose that laboratory animal facilities,
operational practices, and quality of animal care meet applicable standards and
regulations (e.g., Guide for the Care and Use of Laboratory Animals(1)
and Laboratory Animal Welfare Regulations(2))
and that appropriate species have been selected for animal experiments. In addition, the
organization should have an occupational health and safety plan. The recent publication of
the Institute of Medicine, Occupational Health and Safety in the Care of Research
Animals,(3) is most helpful in this regard.
Ideally, facilities for laboratory animals used in studies of
infectious or noninfectious disease should be physically separate from other activities
such as animal production and quarantine, clinical laboratories, and especially from
facilities providing patient care. Traffic flow that will minimize the risk of cross
contamination should be considered in the plans. A "clean/dirty hall" layout may
be useful to minimize this risk.
The recommendations detailed below describe four combinations of
practices, safety equipment, and facilities for experiments with animals infected with
agents that cause, or may cause, human infection. These four combinations, designated
Animal Biosafety Levels (ABSL) 1-4, provide increasing levels of protection to personnel
and to the environment, and are recommended as minimal standards for activities involving
infected laboratory animals. The four ABSLs describe animal facilities and practices
applicable to work with animals infected with agents assigned to Biosafety Levels 1-4,
respectively.
Investigators inexperienced in conducting these types of experiments
should seek help in designing their experiments from individuals who are experienced in
this special work.
Facility standards and practices for invertebrate vectors and hosts
are not specifically addressed in the standards for commonly used laboratory animals. Laboratory
Safety for Arboviruses and Certain Other Viruses of Vertebrates,(4)
prepared by the Subcommittee on Arbovirus Laboratory Safety (SALS) of the American
Committee on Arthropod-Borne Viruses, serves as a useful reference in the design and
operation of facilities using arthropods.
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Animal Biosafety Level 1 (ABSL-1) is suitable for work
involving well characterized agents that are not known to cause disease in healthy adult
humans, and that are of minimal potential hazard to laboratory personnel and the
environment. A. Standard Practices
1. The animal facility director establishes policies, procedures,
and protocols for emergency situations. Each project is subject to pre-approval by the
Institutional Animal Care and Use Committee (IACUC) and the Institutional Biohazard
Committee (IBC). Any special practices are approved at this time.
2. Only those persons required for program or support purposes are
authorized to enter the facility. Before entering, persons are advised of the potential
biohazards and are instructed on the appropriate safeguards.
3. An appropriate medical surveillance program is in place.
4. A safety manual is prepared or adopted. Personnel are advised of
special hazards, and are required to read and follow instructions on practices and
procedures.
5. Eating, drinking, smoking, handling contact lenses, applying
cosmetics, and storing food for human use should only be done in designated areas and are
not permitted in animal or procedure rooms.
6. All procedures are carefully performed to minimize the creation
of aerosols or splatters.
7. Work surfaces are decontaminated after use or after any spill of
viable materials.
8. All wastes from the animal room (including animal tissues,
carcasses, and contaminated bedding) are transported from the animal room in leak-proof,
covered containers for appropriate disposal in compliance with applicable institutional or
local requirements. Incineration is recommended.
9. Policies for the safe handling of sharps are instituted.
10. Personnel wash their hands after handling cultures and animals,
after removing gloves, and before leaving the animal facility.
11. A biohazard sign must be posted on the entrance to the animal
room whenever infectious agents are present. The hazard warning sign identifies the
infectious agent(s) in use, lists the name and telephone number of the responsible
person(s), and indicates the special requirements for entering the animal room (e.g., the
need for immunizations and respirators).
12. An insect and rodent control program is in effect (see Appendix
G).
B. Special Practices: None.
C. Safety Equipment (Primary Barriers):
1. The wearing of laboratory coats, gowns, and/or uniforms in the
facility is recommended. Laboratory coats remain in the animal room. Gowns and uniforms
are not worn outside the facility.
2. Persons having contact with non-human primates should assess
their risk of mucous membrane exposure and wear appropriate eye and face protection.(5)
D. Facilities (Secondary Barriers)
1. The animal facility is separated from areas that are open to
unrestricted personnel traffic within the building.
2. External facility doors are self-closing and self-locking. Doors
to animal rooms open inward, are self-closing, and are kept closed when experimental
animals are present. Cubicle room inner doors may open outward or be horizontal or
vertical sliding.
3. The animal facility is designed, constructed, and maintained to
facilitate cleaning and housekeeping. The interior surfaces (walls, floors, and ceilings)
are water resistant.
4. Internal facility appurtenances, such as light fixtures, air
ducts, and utility pipes, are arranged to minimize horizontal surface areas.
5. Windows are not recommended. Any windows must be resistant to
breakage. Where possible, windows should be sealed. If the animal facility has windows
that open, they are fitted with fly screens.
6. If floor drains are provided, the traps are always filled with
water and/or an appropriate disinfectant.
7. Ventilation should be provided in accordance with the Guide
for Care and Use of Laboratory Animals, latest edition.(6) No recirculation of exhaust air should occur. It is
recommended that animal rooms maintain negative pressure compared to adjoining hallways.
8. The facility has a hand washing sink.
9. Cages are washed manually or in a cage washer. The mechanical
cage washer should have a final rinse temperature of at least 180F.
10. Illumination is adequate for all activities, avoiding
reflections and glare that could impede vision. |
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Animal Biosafety Level 2 involves practices for work
with those agents associated with human disease. It addresses hazards from ingestion as
well as from percutaneous and mucous membrane exposure. ABSL-2 builds upon the practices,
procedures, containment equipment, and facility requirements of ABSL-1.
A. Standard Practices
1. Aside from the standard policies, procedures, and protocols for
emergency situations established by the facility director, appropriate special policies
and procedures should be developed as needed and approved by the Institutional Animal Care
and Use Committee (IACUC) and the Institutional Biohazard Committee (IBC).
2. Access to the animal room is limited to the fewest number of
individuals possible. Personnel who must enter the room for program or service purposes
when work is in progress are advised of the potential hazard.
3. An appropriate medical surveillance program is in place. All
personnel receive appropriate immunizations or tests for the agents handled or potentially
present (e.g., hepatitis B vaccine, TB skin testing). When appropriate, a serum
surveillance system should be implemented.(7)
4. A biosafety manual is prepared or adopted. Personnel are advised
of special hazards, and are required to read and follow instructions on practices and
procedures.
5. Eating, drinking, smoking, handling contact lenses, applying
cosmetics, and storing food for human use should only be done in designated areas and are
not permitted in animal or procedure rooms.
6. All procedures are carefully performed to minimize the creation
of aerosols or splatters.
7. Equipment and work surfaces in the room are routinely
decontaminated with an effective disinfectant after work with the infectious agent, and
especially after overt spills, splashes, or other contamination by infectious materials.
8. All infectious samples are collected, labeled, transported, and
processed in a manner that contains and prevents transmission of the agent(s). All wastes
from the animal room (including animal tissues, carcasses, contaminated bedding, unused
feed, sharps, and other refuse) are transported from the animal room in leak-proof,
covered containers for appropriate disposal in compliance with applicable institutional or
local requirements. The outer surface of the containers is disinfected prior to moving the
material. Autoclaving of the contents prior to incineration is recommended.
9. Policies for the safe handling of sharps are instituted:
a. Needles and syringes or other sharp instruments are restricted
for use in the animal facility only when there is no alternative, such as for parenteral
injection, blood collection, or aspiration of fluids from laboratory animals and diaphragm
bottles.
b. Syringes that re-sheathe the needle, needle-less systems, and
other safe devices should be used when appropriate.
c. Plasticware should be substituted for glassware whenever
possible.
10. Personnel wash their hands after handling cultures and animals,
after removing gloves, and before leaving the animal facility.
11. A biohazard sign must be posted on the entrance to the animal
room whenever infectious agents are present. The hazard warning sign identifies the
infectious agent(s) in use, lists the name and telephone number of the responsible
person(s), and indicates the special requirements (e.g., the need for immunizations and
respirators) for entering the animal room.
12. An insect and rodent control program is in effect (see Appendix
G).
B. Special Practices
1. Animal care laboratory and support personnel receive appropriate
training on the potential hazards associated with the work involved, the necessary
precautions to prevent exposures, and the exposure evaluation procedures. Personnel
receive annual updates, or additional training as necessary for procedural or policy
changes. Records of all training provided are maintained. In general, persons who may be
at increased risk of acquiring infection, or for whom infection might be unusually
hazardous, are not allowed in the animal facility unless special procedures can eliminate
the extra risk.
2. Only animals used for the experiment(s) are allowed in the room.
3. All equipment must be appropriately decontaminated prior to
removal from the room.
4. Spills and accidents which result in overt exposures to
infectious materials must be immediately reported to the facility director. Medical
evaluation, surveillance, and treatment are provided as appropriate and written records
are maintained.
C. Safety Equipment (Primary Barriers)
1. Gowns, uniforms, or laboratory coats are worn while in the animal
room. The laboratory coat is removed and left in the animal room. Gowns, uniforms, and
laboratory coats are removed before leaving the animal facility. Gloves are worn when
handling infected animals and when skin contact with infectious materials is unavoidable.
2. Personal protective equipment is used based on risk assessment
determinations (see Section V ). Appropriate face/eye and respiratory protection is worn
by all personnel entering animal rooms that house nonhuman primates.(8)
3. Biological safety cabinets, other physical containment devices,
and/or personal protective equipment (e.g., respirators, face shields) are used whenever
conducting procedures with a high potential for creating aerosols. These include necropsy
of infected animals, harvesting of tissues or fluids from infected animals or eggs, or
intranasal inoculation of animals.
4. When needed, animals are housed in primary biosafety containment
equipment appropriate for the animal species. Filter top cages are always handled in
properly designed and operating animal biocontainment cabinets recommended for rodents.
D. Facilities (Secondary Barriers)
1. The animal facility is separated from areas that are open to
unrestricted personnel traffic within the building.
2. Access to the facility is limited by secure locked doors.
External doors are self-closing and self-locking. Doors to animal rooms open inward, are
self-closing, and are kept closed when experimental animals are present. Cubicle room
inner doors may open outward or be horizontal or vertical sliding.
3. The animal facility is designed, constructed, and maintained to
facilitate cleaning and housekeeping. The interior surfaces (walls, floors, and ceilings)
are water resistant.
4. Internal facility appurtenances, such as light fixtures, air
ducts, and utility pipes, are arranged to minimize horizontal surface areas.
5. Any windows must be resistant to breakage. Where possible,
windows should be sealed. If the animal facility has windows that open, they are fitted
with fly screens.
6. If floor drains are provided, the traps are always filled with an
appropriate disinfectant.
7. Exhaust air is discharged to the outside without being
recirculated to other rooms. Ventilation should be provided in accordance with criteria
from Guide for Care and Use of Laboratory Animals, latest edition. The direction
of airflow in the animal facility is inward; animal rooms should maintain negative
pressure compared to adjoining hallways.
8. Cages are washed manually or in an appropriate cage washer. The
mechanical cage washer should have a final rinse temperature of at least 180F.
9. An autoclave is available in the animal facility to decontaminate
infectious waste.
10. A hand washing sink is in the animal room where infected animals
are housed, as well as elsewhere in the facility.
11. Illumination is adequate for all activities, avoiding
reflections and glare that could impede vision. |
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Animal Biosafety Level 3 involves practices suitable
for work with animals infected with indigenous or exotic agents that present the potential
of aerosol transmission and of causing serious or potentially lethal disease. ABSL-3
builds upon the standard practices, procedures, containment equipment, and facility
requirements of ABSL-2.
A. Standard Practices
1. Aside from the standard policies, procedures, and protocols for
emergency situations established by the facility director, appropriate special policies
and procedures should be developed as needed and approved by the Institutional Animal Care
and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC).
2. The laboratory or animal facility director limits access to the
animal room to the fewest number of individuals possible. Personnel who must enter the
room for program or service purposes when work is in progress are advised of the potential
hazard.
3. An appropriate medical surveillance program is in place. All
personnel receive appropriate immunizations or tests for the agents handled or potentially
present (e.g., hepatitis B vaccine, TB skin testing). When appropriate, a serum
surveillance system should be implemented.(9) In general,
persons who may be at increased risk of acquiring infection, or for whom infection might
have serious consequences, are not allowed in the animal facility unless special
procedures can eliminate the extra risk. Assessment should be made by the occupational
health physician.
4. A biosafety manual is prepared or adopted. Personnel are advised
of special hazards, and are required to read and follow instructions on practices and
procedures.
5. Eating, drinking, smoking, handling contact lenses, applying
cosmetics, and storing food for human use should be done only in designated areas and are
not permitted in animal or procedure rooms.
6. All procedures are carefully performed to minimize the creation
of aerosols or splatters.
7. Equipment and work surfaces in the room are routinely
decontaminated with an effective disinfectant after work with the infectious agent, and
especially after overt spills, splashes, or other contamination by infectious materials.
8. All wastes from the animal room (including animal tissues,
carcasses, contaminated bedding, unused feed, sharps, and other refuse animal tissues) are
transported from the animal room in leak-proof, covered containers for appropriate
disposal in compliance with applicable institutional or local requirements. Incineration
is recommended. The outer surface of the containers is disinfected prior to moving the
material (see Special Practices #3 below).
9. Policies for the safe handling of sharps are instituted.
a. Needles and syringes or other sharp instruments are restricted in
the animal facility for use only when there is no alternative, such as for parenteral
injection, blood collection, or aspiration of fluids from laboratory animals and diaphragm
bottles.
b. Syringes that re-sheathe the needle, needle-less systems, and
other safe devices should be used when appropriate.
c. Plasticware should be substituted for glassware whenever
possible.
10. Personnel wash their hands after handling cultures and animals,
after removing gloves, and before leaving the animal facility.
11. A biohazard sign must be posted on the entrance to the animal
room whenever infectious agents are present. The hazard warning sign identifies the
infectious agent(s) in use, lists the name and telephone number of the responsible
person(s), and indicates the special requirements for entering the animal room (e.g., the
need for immunizations and respirators).
12. All infectious samples are collected, labeled, transported, and
processed in a manner that contains and prevents transmission of the agent(s).
13. Laboratory and support personnel receive appropriate training on
the potential hazards associated with the work involved, the necessary precautions to
prevent exposures, and the exposure evaluation procedures. As necessary, personnel receive
updates and/or additional training on procedural or policy changes. Records of all
training provided are maintained.
14. An insect and rodent control program is in effect.
B. Special Practices
1. Cages are autoclaved or thoroughly decontaminated before bedding
is removed and before they are cleaned and washed. Equipment must be decontaminated
according to any local, state, or federal regulations before being packaged for transport
or removal from the facility for repair or maintenance.
2. A spill procedure is developed and posted. Only personnel
properly trained and equipped to work with infectious materials are to clean up spills.
Spills and accidents that result in overt exposures to infectious materials must be
immediately reported to the facility director. Medical evaluation, surveillance, and
treatment are provided as appropriate and written records are maintained.
3. All wastes from the animal room must be autoclaved prior to
incineration or other appropriate terminal treatment.
4. Materials not related to the experiment (e.g., plants, animals)
are not permitted in the animal room.
C. Safety Equipment (Primary Barriers)
1. Uniforms or scrub suits are worn by personnel entering the animal
room. Wrap-around or solid-front gowns should be worn over this clothing. Front-button
laboratory coats are unsuitable. The gown must be removed and left in the animal room.
Before leaving the animal facility, scrub suits and uniforms are removed and appropriately
contained and decontaminated prior to laundering or disposal.
2. Personal protective equipment used is based on risk assessment
determinations.
a. Personal protective equipment is used for all activities
involving manipulations of infectious material or infected animals.
b. Personnel wear gloves when handling infected animals. Gloves are
removed aseptically and autoclaved with other animal room wastes before disposal.
c. Appropriate face/eye and respiratory protection (e.g.,
respirators and face shields) is worn by all personnel entering animal rooms.
d. Boots, shoe covers, or other protective footwear, and
disinfectant foot baths are available and used where indicated.
3. The risk of infectious aerosols from infected animals or their
bedding also can be reduced if animals are housed in containment caging systems, such as
open cages placed in inward flow ventilated enclosures (e.g., laminar flow cabinets),
solid wall and bottom cages covered with filter bonnets, or other equivalent primary
containment systems.
4. Biological safety cabinets and other physical containment devices
are used whenever conducting procedures with a potential for creating aerosols. These
include necropsy of infected animals, harvesting of tissues or fluids from infected
animals or eggs, or intranasal inoculation of animals. At BSL-3, all work should be done
in a primary barrier; otherwise respirators should be worn by personnel in the room.
D. Facilities (Secondary Barriers)
1. The animal facility is separated from areas that are open to
unrestricted personnel traffic within the building.
2. Access to the facility is limited by a self-closing and
self-locking door. This exterior entry door may be controlled by a key lock, card key, or
proximity reader. Entry into the animal room is via a double-door entry which includes a
change room and shower(s). An additional double-door access (air-lock) or double-doored
autoclave may be provided for movement of supplies and wastes into and out of the
facility, respectively. Doors to animal rooms open inward and are self-closing. Doors to
cubicles inside an animal room may open outward or slide horizontally or vertically.
3. The animal facility is designed, constructed, and maintained to
facilitate cleaning and housekeeping. The interior surfaces (walls, floors, and ceilings)
are water resistant. Penetrations in floors, walls and ceiling surfaces are sealed and
openings around ducts and the spaces between doors and frames are capable of being sealed
to facilitate decontamination.
4. A hands-free or automatically operated hand washing sink is
provided in each animal room near the exit door. The sink trap is filled with an
appropriate disinfectant after each use.
5. Internal facility appurtenances, such as light fixtures, air
ducts, and utility pipes, are arranged to minimize horizontal surface areas.
6. Windows are not recommended. Any windows must be resistant
to breakage and should be sealed.
7. If floor drains are provided, they are always filled with an
appropriate disinfectant.
8. Ventilation should be provided in accordance with criteria from
the Guide for Care and Use of Laboratory Animals, latest edition. A ducted
exhaust air ventilation system is provided. This system creates directional airflow which
draws air into the laboratory from "clean" areas and toward
"contaminated" areas. The exhaust air is not recirculated to any other area of
the building. Filtration and other treatments of the exhaust air may not be required, but
should be considered based on site requirements, and specific agent manipulations and use
conditions. The exhaust must be dispersed away from occupied areas and air intakes, or the
exhaust must be HEPA-filtered. Personnel must verify that the direction of the airflow
(into the animal areas) is proper. It is recommended that a visual monitoring device that
indicates and confirms directional inward airflow be provided at the animal room entry.
Consideration should be given to installing an HVAC control system to prevent sustained
positive pressurization of the animal spaces. Audible alarms should be considered to
notify personnel of HVAC system failure.
9. HEPA-filtered exhaust air from a Class II biological safety
cabinet can be recirculated into the animal room if the cabinet is tested and certified at
least annually. When exhaust air from Class II safety cabinets is to be discharged to the
outside through the building exhaust air system, the cabinets must be connected in a
manner that avoids any interference with the air balance of the cabinets or the building
exhaust system (e.g., an air gap between the cabinet exhaust and the exhaust duct). When
Class III biological safety cabinets are used, they should be directly connected to the
exhaust system. If the Class III cabinets are connected to the supply system, it is done
in a manner that prevents positive pressurization of the cabinets (see Appendix A).
10. Cages are washed in a cage washer. The mechanical cage washer
has a final rinse temperature of at least 180F.
11. An autoclave is available which is convenient to the animal
rooms where the biohazard is contained. The autoclave is utilized to decontaminate
infectious waste before moving it to other areas of the facility.
12. If vacuum service (i.e., central or local) is provided, each
service connection should be fitted with liquid disinfectant traps and an in-line HEPA
filter, placed as near as practicable to each use point or service cock. Filters are
installed to permit in-place decontamination and replacement.
13. Illumination is adequate for all activities, avoiding
reflections and glare that could impede vision.
14. The completed Biosafety Level 3 facility design and operational
procedures must be documented. The facility must be tested for verification that the
design and operational parameters have been met prior to operation. Facilities should be
re-verified at least annually against these procedures as modified by operational
experience.
15. Additional environmental protection (e.g., personnel showers,
HEPA filtration of exhaust air, containment of other piped services, and the provision of
effluent decontamination) should be considered if recommended by the agent summary
statement, as determined by risk assessment of the site conditions, or other applicable
federal, state, or local regulations.
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Animal
Biosafety Level 4 (ABSL-4)
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Animal Biosafety Level 4 involves practices suitable
for addressing dangerous or exotic agents that pose high risk of life threatening disease,
aerosol transmission, or related agents with unknown risk of transmission. ABSL-4 builds
upon the standard practices, procedures, containment equipment, and facility requirements
of ABSL-3. Procedures must be developed locally to address specific operations of the
Class III cabinet line or the suit laboratory.
A. Standard Practices
1. Aside from the standard policies, procedures, and protocols for
emergency situations established by the facility director, appropriate special policies
and procedures should be developed as needed and approved by the Institutional Animal Care
and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC).
2. The laboratory or animal facility director limits access to the
animal room to the fewest individuals possible. Personnel who must enter the room for
program or service purposes when work is in progress are advised of the potential hazard.
3. A medical surveillance program must be instituted for all persons
entering an ABSL-4 facility. This program must include appropriate immunizations, serum
collection, and availability of post-exposure counseling and potential prophylaxis.(10) In general, persons who may be at increased risk of
acquiring infection, or for whom infection might have serious consequences, are not
allowed in the animal facility unless special procedures can eliminate the extra risk.
Assessment should be made by the occupational health physician.
4. A site-specific biosafety manual is prepared or adopted.
Personnel are advised of special hazards, and are required to read and to follow
instructions on practices and procedures.
5. Eating, drinking, smoking, handling contact lenses, applying
cosmetics, and storing food for human use should be done only in designated areas and are
not permitted in animal or procedure rooms.
6. All procedures are carefully performed to minimize the creation
of aerosols or splatters.
7. Equipment and work surfaces in the room are routinely
decontaminated with an appropriate disinfectant after work with the infectious agent, and
especially after overt spills, splashes, or other contamination by infectious materials.
8. A spill procedure is developed and posted. Only personnel
properly trained and equipped to work with infectious materials are to clean up spills.
Spills and accidents that result in overt exposures to infectious materials must be
immediately reported to the facility director. Medical evaluation, surveillance, and
treatment are provided as appropriate and written records are maintained.
9. All wastes (including animal tissues, carcasses, and contaminated
bedding), other materials for disposal, and clothing to be laundered, are sterilized in a
double-door autoclave located in the secondary barrier wall of the facility (see B-4
below). Disposable wastes are incinerated.
10. Policies for the safe handling of sharps are instituted.
a. Needles and syringes or other sharp instruments are restricted in
the animal facility for use only when there is no alternative, such as for parenteral
injection, blood collection, or aspiration of fluids from laboratory animals and diaphragm
bottles.
b. Syringes that re-sheathe the needle, needle-less systems, and
other safe devices should be used when appropriate.
c. Plasticware should be substituted for glassware whenever possible
11. A biohazard sign must be posted on the entrance to the animal
room whenever infectious agents are present. The hazard warning sign identifies the
infectious agent(s) in use, lists the name and telephone number of the responsible
person(s), and indicates the special requirements for entering the animal room (e.g., the
need for immunizations and respirators).
12. Laboratory personnel receive appropriate training on the
potential hazards associated with the work involved, the necessary precautions to prevent
exposures, and the exposure evaluation procedures. Personnel receive annual updates, or
additional training as necessary for procedural or policy changes. Records are maintained
on all training provided.
13. Cages are autoclaved or thoroughly decontaminated before bedding
is removed and before they are cleaned and washed. Equipment and work surfaces are
routinely decontaminated with an appropriate disinfectant after work with infectious
materials, and especially after spills, splashes, or other contamination by infectious
materials. Equipment must be decontaminated according to any local, state, or federal
regulations before removal from the facility for repair or maintenance.
14. Personnel assigned to work with infected animals should work in
pairs. Based on the risk assessment (see Section V), use of squeeze cages, working only
with anesthetized animals, or other appropriate procedures to reduce possible worker
exposure must be instituted.
15. Materials not related to the experiment (e.g., plants, animals)
are not permitted in the facility.
B. Special Practices
1. Additional measures are effected to control access (e.g., 24-hour
guard and check in/out system). Personnel enter and leave the facility only through the
clothing change and shower rooms. Personnel shower each time they leave the facility.
Personnel should not enter or leave the facility through the air locks, except in an
emergency.
2. In a Class III cabinet operation, personal clothing is removed in
the outer clothing change room and kept there. Complete laboratory clothing, including
undergarments, pants and shirts or jump suits, shoes, and gloves, is provided and used by
personnel entering the facility. When exiting, personnel remove laboratory clothing in the
inner change room before entering the shower area. Soiled clothing is sterilized in an
autoclave.
3. In an ABSL-4 suit operation, a complete clothing change is
required. A personal shower is required following removal of the decontaminated suit.
Soiled lab clothing is autoclaved before laundering.
4. Supplies and materials are introduced into the facility via a
double-door autoclave or fumigation chamber. After the outer door is secure, personnel
inside the facility open the inner door to retrieve the materials. The doors of the
autoclave and fumigation chamber are interlocked in a manner that prevents opening of the
outer door unless the autoclave has been operated through a
"sterilization cycle" or the fumigation chamber has been decontaminated.
5. A system is established for the reporting of accidents,
incidents, exposures, and employee absenteeism, and for the medical surveillance of
potential laboratory-associated illnesses. An essential adjunct to such a
reporting/surveillance system is the availability of a facility for the quarantine,
isolation, and medical care of persons with potential or known laboratory-associated
illnesses.
6. The serum samples collected are analyzed at intervals. The
results are communicated to the participants.
C. Safety Equipment (Primary Barriers)
1. Laboratory animals infected with Biosafety Level 4 agents must be
housed within a Class III biological safety cabinet in a BSL-4 Cabinet Laboratory. In a
BSL-4 Suit Laboratory, all personnel are required to wear one-piece positive pressure
suits ventilated with a life support system. Infected animals should be housed in a
partial containment system (such as open cages placed in ventilated enclosures, solid wall
and bottom cages covered with filter bonnets and opened in laminar flow hoods, or other
equivalent primary containment systems).
2. The use of disposable material that does not require cleaning,
including animal caging, should be considered. Disposable materials must be autoclaved on
exit from the facility and then incinerated.
D. Facilities (Secondary Barriers)
BSL-4 animal areas may be included as an integral part of BSL-4
Cabinet Laboratories or Suit Laboratories as described in Section III of this document.
The facility requirements described in the BSL-4 Laboratory section should be utilized in
conjunction with the caging described in the equipment section above. |
1. Guide for the Care and Use of Laboratory
Animals, National Academy Press, Washington, DC, 1996
2. U.S. Department of Agriculture. Laboratory
Animal Welfare Regulations - 9 CFR, Subchapter A, Parts 1, 2, and 3.
3. Occupational Health and Safety in the Care of
Research Animals. National Academy Press, Washington, D.C., 1996.
4. Subcommittee on Arbovirus Laboratory Safety
for Arboviruses and Certain Other Viruses of Vertebrates. 1980. Am J Trop Med Hyg 29(6):1359-1381.
5. Centers for Disease Control and Prevention.
1998. Fatal Cercopithecine herpesvirus 1 (B Virus) Infection Following a Mucocutaneous
Exposure and Interim Recommendations for Worker Protection. MMWR 47(49);
1073-6,1083
6. Guide for the Care and Use of Laboratory
Animals (1)
7. Occupational Health and Safety in the Care of
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