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CPCSEA GUIDELINES FOR LABORATORY ANIMAL FACILITY
Committee for the Purpose of Control and Supervision on Experiments on Animals
No.13/1, 3rd Seward Road, Valmiki Nagar, Thiruvanmiyur, Chennai-600 041.
Good Laboratory Practices (GLP) for animal facilities is intended to assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioral research and testing of products. GOAL The goal of these Guidelines is to promote the humane care of animals used in biomedical and behavioral research and testing with the basic objective of providing specifications that will enhance animal wellbeing, quality in the pursuit of advancement of biological knowledge that is relevant to humans and animals. VETERINARY CARE Adequate veterinary care must be provided and is the responsibility of a veterinarian or a person who has training or experience in laboratory animal sciences and medicine.
ANIMAL PROCUREMENT All animals must be acquired lawfully as per the CPCSEA guidelines. A health surveillance program for screening incoming animals should be carried out to assess animal quality. Methods of transportation should also be taken into account (Annexure – 4). Each consignment of animals should be inspected for compliance with procurement specifications, and the animals should be quarantined and stabilized according to procedures appropriate for the species and circumstances. QUARANTINE, STABILIZATION AND SEPARATION
Quarantine is the separation of newly received animals from those already in the facility until the health and possibly the microbial status of the newly received animals have been determined. An effective quarantine minimizes the chance for introduction of pathogens Daily observation of animals can be accomplished by into an established colony. A minimum duration of someone other than a veterinarian; however, a quarantine for small lab animals is one week and larger mechanism of direct and frequent communication animals is 6 weeks (cat, dog and monkey) should be adopted so that timely and accurate information on problems in animal health, behaviour, Effective quarantine procedures should be used for and well-being is conveyed to the attending non-human primates to help limit exposure of humans to zoonotic infections. veterinarian. Regardless of the duration of quarantine, newly The veterinarian can also contribute to the received animals should be given a period for establishment of appropriate policies and procedures physiologic, psychologic and nutritional stabilization for ancillary aspects of veterinary care, such as before their use. The length of time stabilization will reviewing protocols and proposals, animal husbandry depend on the type and duration of animal and animal welfare; monitoring occupational health transportation, the species involved and the intended hazards containment, and zoonosis control programs; use of the animals. and supervising animal nutrition and sanitation. Institutional requirements will determine the need for Physical separation of animals by species is full-time or part-time or consultative veterinary services. recommended to prevent interspecies disease
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Animals that show signs of a contagious disease should be isolated from healthy animals in the colony. showers.g. footwears etc. masks. DURATIONS OF EXPERIMENTS No animal should be used for experimentation for more than 3 years unless adequate justification is provided. distress. the group should be kept intact and isolated during the process of diagnosis. . As a rule. DIAGNOSIS. In some instances. A separate area or room should be made available for these purposes. and isolators shall be suitable alternatives. change of uniforms. ANIMAL CARE AND TECHNICAL PERSONNEL Animal care programs require technical and husbandry support. MULTIPLE SURGICAL PROCEDURES ON SINGLE ANIMAL Multiple surgical procedures on a single animal for any testing or experiment are not to be practiced unless specified in a protocol only approved by the IAEC. coveralls and shoe covers. Clothing suitable for use in the animal facility should be supplied and laundered by the institution. such as during postoperative recovery or when animals are ill or have a physical deficit. for example. Since the use of animals in such studies requires special consideration. and control. This committee shall also examine the proposal on animal experiments involving hazardous agents in addition to its existing functions (Annexure – 8). however. Such separation is usually accomplished by housing different species in separate rooms. head covers. injury. it shall be acceptable to house different species in the same room. Personnel should not be permitted to eat. research institutes and in many pharmaceutical industries for safety issues. drink. Outer garments worn in the animal rooms should not be worn outside the animal facility. ANIMAL EXPERIMENTATION INVOLVING HAZARDOUS AGENTS Institutions should have policies governing experimentation with hazardous agents. or other deviations from normal health condition in animals should be reported promptly to ensure appropriate and timely delivery of veterinary medical care. this should occur daily. but more-frequent observations might be warranted.258 SPECIAL ARTICLE transmission and to eliminate anxiety and possible physiological and behavioral changes due to interspecies conflict. if two species have a similar pathogen status and are behaviorally compatible. coats. cubicles. the procedures and the facilities to be used must be reviewed by both the Institutional Biosafety Committee and Institutional Animal Ethics Committee (IAEC). Facilities and supplies for meeting this obligation should be provided e. Personnel should change clothing as often as is necessary to maintain personal hygiene. SURVEILLANCE. treatment. laminar-flow units. cages that have filtered air or separate ventilation. Washing and showering facilities appropriate to the program should be available. TREATMENT AND CONTROL OF DISEASE All animals should be observed for signs of illness. In some circumstances. Unexpected deaths and signs of illness. however. A commercial laundering service is acceptable in many situations.g. smoke or apply cosmetics in animal rooms. it is acceptable to use disposable wear such as gloves. Institutional Biosafety Committee whose members are knowledgeable about hazardous agents are in place in most of the higher level education. Institutions should employ people trained in laboratory animal science or provide for both formal and on-the-job training to ensure effective implementation of the program (Annexure – 7). Mycobacterium tuberculosis in non-human primates). It is imperative that appropriate methods be in place for disease surveillance and diagnosis (Annexure 1 and 2). If an entire room of animals is known or believed to be exposed to an infectious agent (e. institutional facilities should be used to decontaminate clothing exposed to potentially hazardous microbial agents or toxic substances. PERSONAL HYGIENE It is essential that the animal care staff maintain a high standard of personal cleanliness. Diagnostic clinical laboratory may be made available. or abnormal behavior by animal house staff.
such as the tether system or the pole and collar system. PHYSICAL PLANT The physical condition and design of animal facility determine. Provision should be made for observation of the animal at appropriate intervals. Veterinary care should be provided if lesions or illness associated with restraint are observed. and most laboratories.g. for different species are given in (Annexure – 3). The recommended space requirements for animal rooms. sharp fluctuations in temperature. sound and ventilation should be avoided. and a variety of other clinical and experimental manipulations can be accomplished manually or with devices be suitable in size and design for the animal being held and operated properly to minimize stress and avoid injury to the animal. In facilities that are small. properly maintained facility is an important element in good animal care. The presence of lesions. washing. Less restrictive systems. insects and birds. physical relationship to the rest of the institution. FUNCTIONAL AREAS The size and nature of a facility will determine whether areas for separate service functions are possible or necessary. light. office and staff. corridors. cages and environment of animal rooms are the major factors. including the chairing of non-human primates. The environment of animal room (macroenvironment) and animal cage (microenvironment) are factors on which the production and experimental efficiency of the animal depends. or floors. machine rooms. Prolonged restraint of any animal. but separated from them by barriers such as entry locks. The building. conference rooms. and isolate animals and Ø provide for animal housing. Animals to be placed in restraint devices should be given training to adapt to the equipment. . floor. illness. should be used when compatible with research objectives. Ø In planning an animal facility the space should be well divided for various activities. the efficiency and economy of their operation. humidity. and geographic location. maintain few animals or maintain animals under special conditions ( . collection of samples. noise. to a great extent. animals to be housed. Sufficient animal area is required to: Ø ensure separation of species or isolation of individual projects when necessary Ø receive. quarantine. wild rodents. The animal rooms should occupy about 50-60% of the total constructed area and the remaining area should be utilized for services such as stores. The period of restraint should be the minimum required to accomplish the research objectives. It is important that they shall be housed in an isolated building located as far away from human habitations as possible and not exposed to dust. Careful planning should make it possible to place animal housing areas adjacent to or near laboratories. A well-planned. The following are important guidelines for the use of restraint equipments: Restraint devices cannot be used simply as a convenience in handling or managing animals. quarantine and corridors. should be avoided unless essential to research objectives. PHYSICAL RELATIONSHIP FACILITIES TO LABORATORIES OF ANIMAL Ø Laboratory animals are very sensitive to their living conditions. which affect the quality of animals. Since animals are very sensitive to environmental changes. The design and size of an animal facility depend on the scope of institutional research activities.CPCSEA GUIDELINES 259 PHYSICAL RESTRAINT Brief physical restraint of animals for examination. smoke. or severe behavioral change should be dealt with by the temporary or permanent removal of the animal from restraint. wing.. e facilities exclusively used for housing germfree colonies or animals in runs and pens) some functional areas listed below could be unnecessary or included Good animal husbandry and human comfort and health protection require separation of animal facilities from personnel areas such as offices. or room. Ø This separation can be accomplished by having the animal quarters in a separate building.
intensive care. if hazardous biological. To prevent high humidity. fire-resistant. Ø Specialized laboratories Ø Individual areas contiguous with or near animal housing areas for such activities as surgery. lockers and toilets for personnel Ø An area for washing and sterilization of equipment and supplies. However. A continuous moisture-proof membrane might be needed. unsealed utility penetrations. moisture proof. physical. and stored items without becoming gouged. equipment. (g) Drains Floor drains are not essential in all rooms used exclusively for housing rodents. with minimum number of joints. Surface materials should be capable of withstanding scrubbing with detergents and disinfectants and the impact of water under high pressure. moisture-proof. or imperfect junctions with doors. Ø An autoclave for equipment Ø Food and bedding and separate areas Ø For holding soiled and unclean equipment Ø An area for repairing cages and equipment Ø An area to store wastes prior to incineration or removal PHYSICAL FACILITIES (a) Building materials should be selected to facilitate efficient and hygienic operation of animal facilities. (f) Floors Floors should be smooth. Rodent barriers can be provided in the doors of the small animal facilities. (c) Utilities such as water lines. (e) Exterior windows Windows are not recommended for small animal facilities. drain pipes and electrical connections should preferably be accessible through service panels or shafts in corridors outside the animal rooms. In primate rooms. where power failures are frequent and backup power is not available. (b) Corridor(s) should be wide enough to facilitate the movement of personnel as well as equipments and should be kept clean. Floor in such rooms can be maintained satisfactorily by wet vacuuming or mopping with appropriate disinfectants or cleaning compounds. adverse effects of detergents and disinfectants. floors and corners. treatment. . If sills are installed at the entrance to a room. They should fit properly within their frames and provided with an observation window. necropsy. or chemical agents are to be used Ø Receiving and storage areas for food. radiography. Durable. preparation of special diets. skid-proof. sinks. drainage must be adequate to allow rapid removal of water and drying of surfaces. or pitted. (h) Walls and ceilings Walls should be free of cracks. (d) Animal room doors Doors should be rust. solvents. and diagnostic laboratory procedures containment facilities or Ø Equipment. the floors should be sloped and drain taps kept filled with water or corrosion free mesh. windows can be provided. experimental manipulation.260 SPECIAL ARTICLE in a multipurpose area. Door closures may also be provided. They should be capable of supporting racks. Where floor drains are used. bedding Ø Pharmaceuticals and biologics and supplies Ø Space for administration. ceilings. supervision and direction of the facility Ø Showers. they may be necessary to provide alternate source of light and ventilation. nonabsorbent. vermin and dust proof. resistant to wear. Professional judgement must be exercised when developing a practical system for animal care. they should be designed to allow for convenient passage of equipment. acid. cracked. seamless materials are most desirable for interior surfaces including vermin and pest resistance.
ANIMAL HUSBANDRY (a) Caging or housing system The caging or housing system is one of the most important elements in the physical and social environment of research animals. bedding. is essential for storage of dead animals and animal tissue waste. The relative humidity should be controllable within the range of 30% to 70% throughout the year. cages and materials not in use. It should be designed carefully to facilitate animal well being. Ø provide adequate ventilation Ø meet the biological needs of the animals. Fluorescent lights are efficient and available in a variety of acceptable fixtures. permit freedom of movement and normal postural adjustments. which includes the temperature ranges usually recommended for common laboratory animals.4 to 84. (c) Power and lighting The electrical system should be safe and provide appropriate lighting and a sufficient number of power outlets. and an area for intensive care and supportive treatment of animals. and air-conditioning systems should be designed so that operation can be continued with a standby system. and minimize experimental variables. consideration should be given to the ventilation of the animals’ primary enclosures.. Concrete walls are more effective than metal or plaster walls in containing noise because their density reduces sound transmission. Temperature and humidity control prevents variations due to changing climatic conditions or differences in the number and kind of room occupants. ENVIRONMENT (a) Temperature and humidity control Air conditioning is an effective means of regulating these environmental parameters for laboratory animals. (Annexure – 3) Ø provide a comfortable environment Ø provide an escape proof enclosure that confines animal safety Ø provide easy acces to food and water. Ideally. For larger animals a comfortable zone (18 to 37°C) should be maintained during extreme summer by appropriate methods for cooling. The housing system should: Ø provide space that is adequate. (j) Facilities for sanitizing equipment and supplies An area for sanitizing cages and ancillary equipment is essential with adequate water supply (k) Experimental area All experimental procedures in small animals should be carried out in a separate area away from the place where animals are housed. (b) Ventilation In renovating existing or in building new animal facilities. (d) Noise control The facility should be provided with noise free environment. defecation and reproduction .CPCSEA GUIDELINES 261 (i) Storage areas Separate storage areas should be designed for feed. Noise control is an important consideration in designing an animal facility.g. meet research requirements. maintenance of body temperature. e. urination.2øF). capability should be provided to allow variations within the range of approximately 18 to 29°C (64. For larger animal functional areas for aseptic surgery should include a separate surgical support area. separated from other cold storage. It is suggested that a lighting system be installed that provides adequate illumination while people are working in the animal rooms and a lowered intensity of light for the animals. and have a resting place appropriate to the species. Refrigerated storage. Emergency power should be available in the event of power failure. Heating. a preparation area. The animal facility and human occupancy areas should be ventilated separately. ventilating. the operating room or rooms. A time-controlled lighting system should be used to ensure a regular diurnal lighting cycle wherever required.
Shelter should be accessible to all animals. and social rank. and corners in which dirt or water can accumulate. Particular attention must be given to eliminate sharp edges and broken wires. should be provided. initial familiarity among animals. ropes. In selecting a suitable social environment. isolation of sick dogs. Ground-level surfaces of outdoor housing facilities can be covered with absorbent bedding. runs. They should be constructed of sturdy. In grouping animals. sand. or other out-of-cage space provide more opportunity for exercise. Feeding and watering devices should be easily accessible for filling.g. dens. To simplify servicing and sanitation. (c) Social environment The social environment includes all interactions among individuals of a group or among those able to communicate. Houses. Pens. have sufficient ventilation. keeping cage floors in good condition. consistent with species requirements Ø facilitate research while maintaining good health of the animals. and behavior.. non-human primates. promote physical comfort. gravel. Polypropylene. grass. Cages are often used for short-term (up to 3 months) housing of dogs and may be necessary for postsurgical care. especially when the animals are held for long periods. or other large enclosures. Group composition should be held as stable as possible. cages should have smooth. impervious surfaces that neither attract nor retain dirt and a minimum number of ledges. and their use is encouraged when holding dogs for long periods. Monkeys should be housed in cages made of steel or painted mild steel and for other animals such as sheep. group housing should be considered for communal animals. by using contoured or drained surface. (b) Sheltered or outdoor housing When animals are maintained in outdoor runs. The design should allow inspection of cage occupants without disturbing them. as in case of monkeys by way of an indoor portion of a run. there must be protection from extremes in temperature or other harsh whether conditions and adequate protective and escape mechanism for submissive animals. and age. changing. Population density can affect reproduction. and metabolic studies. runs and pens must be kept in good condition to prevent injuries to animals. particularly for canine. bars. cleaning and servicing. and other highly social mammals. pens.262 SPECIAL ARTICLE Ø keep the animals dry and clean. ACTIVITY Provision should be made for animals with specialized locomotor pattern to express these patterns. metabolism. Non-human primates should have a run for free ranging activities. When appropriate. Cages. boxes. shelves. polycarbonate and stainless steel cages should be used to house small lab animals. The effects of social environment on caged animals vary with the species and experience of the animals. Buildup of animal waste and stagnant water should be avoided for example. it is important to take into account population density and ability to disperse. horses. durable materials and designed to minimize cross-infection between adjoining units. because mixing of groups or introducing new members can alter behavioral and physiological functions. and facilitate sanitation and servicing. . attention should be given to whether the animals are naturally territorial or communal and whether they will be housed singly or in groups. and be designed to prevent build up of waste materials and excessive moisture. For e. and other furnishings should be constructed in a manner and made of materials that allow cleaning or replacement in accordance with generally accepted husbandry practices when the furnishings are soiled or wornout. immune responses. angles. sex. or similar material that can be removed or replaced when needed to ensure appropriate sanitation. the details can be seen in Annexure – 3. and perches are appropriate for branching jon-human primates. Other surfaces should be able to withstand the elements and be easily maintained. perches.
uncontaminated drinking water. It is better to replace water bottles than to refill them. Nesting materials for newly delivered pups wherever can be provided (e. Diet should be free from heavy metals ( e. nickel. Periodic monitoring of microbial contamination in water is necessary. The frequency is a matter of professional judgement of the animal care personnel in consultation with the investigation depending on the number of animals and size of cages. non-deleterious to cage-washers. and insects hasten the deterioration of food. nonnutritious and non-palatable. fruits. Food hoppers should not be transferred from room to room unless cleaned and sanitized. insecticides. antibiotics.g. unlikely to be chewed or mouthed. Bedding should be used in amounts sufficient to keep animals dry between cage changes without coming into contact with watering tubes. while avoiding contamination by urine and feces. potable. The desirable criteria for rodent contact bedding is ammonia binding. Watering devices. care should be taken that each bottle is replaced on the cage which it was removed. uncontaminated. and of a type not readily eaten by animals. hormones. if bottles are refilled. readily available. fruits. easily stored. Meats. open food should be stored in vermin – proof condition to minimize contamination and to avoid potential spread of disease agents. The animal feed should contain moisture. Food should be available in a mounts sufficient to ensure normal growth in immature animals and maintenance of normal body weight. deleterious products not formed as a result of sterilization. BEDDING Bedding should be absorbent. and nutritionally adequate food daily unless the experimental protocol requires otherwise. and vegetables are fed. non-injurious and non-hazardous to personnel. reproduction. minerals crude fat and carbohydrate for providing appropriate nutrition. such as drinking tubes and automatic waterers if used should be examined routinely to ensure their proper operation. nonmalodorous. non-contaminated. Areas in which diets are processed or stored should be kept clean and enclosed to prevent entry of insects or other animals. cadmium. Feeders should allow easy access to food. WATER Ordinarily animals should have continuous access to fresh. and other perishable items should be refrigerated if required to be stored. Food should contain adequate nutrition. fumigants. non-toxic. nestable. according to their particular requirements. freedom from chemical and microbial contaminants. oxygen. Bedding should be removed and replaced with fresh materials as often as necessary to keep the animals clean and dry. and lactation in adults. non-desiccating to the animal. remains chemically stable during use. paper. Sometimes it is necessary to train animals to use automatic watering devices. because these are potential sources of biological and chemical contamination and can also lead to variation in the amount of nutrients consumed. naturally occurring toxins and other contaminants..CPCSEA GUIDELINES 263 FOOD Animals should be fed palatable. Laboratory animal diets should not be manufactured or stored in facilities used for farm feeds or any products containing additives such as rodenticides. light. manifests batch uniformity. however. arsenic. crude fibre. bio-availability of nutrients should be at par with the nutritional requirement of the animal. sterillizable. mercury). disposable by incineration. tissue paper and cotton). or other potential toxicants. lead. Precautions should be taken if perishable items such as meats. including formulation and preparation. Exposure to extremes in relative humidity. essential vitamins. optimizes normal animal behaviour.g. crude protein. Unused. unsanitary conditions. However it is ideal to change the bedding twice a week. vegetables. free of toxic chemicals or other substances that could injure animals or personnel. .
The most preferred method of waste disposal is incineration. such as dogs. A decision to alter the frequency of cage – bedding changes or cage – washing should be based on such factors as the concentration of ammonia.g. stoppers. should not be transported between animal rooms. food and bedding is not considered essential if care is taken to use clean materials from reliable sources. debris . and other areas should be cleaned with appropriate detergents and disinfectants as often as necessary to keep them free of dirt. or microbiologic monitoring. or physical agents are used. Wire – bottom rodent cages for all other animals should be washed at least every 2 weeks. Incinerators should be in compliance with all central. All waste should be collected and disposed of in a safe and sanitary manner. a system of equipment monitoring might be appropriate. and hazardous wastes should be lined with leak-proof. the appearance of the cage. is essential when pathogenic organisms are present. ASSESSING THE EFFECTIVENESS OF SANITATION Monitoring of sanitation practices should be appropriate to the process and materials being cleaned. sipper tubes. chemical. particularly that of ammonia. such as guinea pigs and hamsters. Animal rooms. Cages should be sanitized before animals are placed in them. and local regulations. and harmful contamination. Such products are not a substitute for good sanitation. hyperchlorite) to destroy pathogenic organisms. it can include visual inspection of the materials. Routine sterilization of cages. state. carcasses. pails. racks at least monthly. and accessory equipments. the condition of the bedding and the number and size of animals housed in the cage. Rabbits and some rodents. WASTE DISPOSAL Wastes should be removed regularly and frequently. the waste storage area should be separated . A twocompartment sink or tub is adequate for this purpose. such as feeders and watering devices. should be washed and sanitized frequently to keep them clean and contamination free. and brooms. disposable liners. equipments should be rinsed free of chemicals prior to use. It is good practice to have extra cages available at all times so that a systematic cage-washing schedule can be maintained. cats. Where hazardous biological. For larger animals. this should be done at least twice a day. soiled litter material should be removed twice daily. Animal cages. and provision should be made for dipping or soaking the water bottles in detergents and disinfectant solutions.2oC (180oF) or higher for a period long enough to ensure the destruction of vegetative pathogenic organisms. Some means for sterilizing equipments and supplies. such as an autoclave or gas sterilizer. Disinfection can also be accomplished with appropriate chemicals. Ordinarily this can be achieved by washing solid bottom rodent cages and accessories once or twice a week and cages. Cages can be disinfected by rinsing at a temperature of 82. Cleaning utensils. Animals should be kept dry during such procedures. Where animal waste is removed by hosting or flushing. racks. If wastes must be stored before removal. monitoring of water temperatures. produce urine with high concentration of proteins and minerals. if bottles are washed by hand. Minerals and organic compounds in the urine from these animals often adhere to cage surfaces and necessitate treatment with acid solutions before washing. storage spaces. Deodorizers or chemical agents other than germicidal should not be used to mask animal odors.264 SPECIAL ARTICLE SANITATION AND CLEANLINESS Sanitation is essential in an animal facility. Water bottles. and other watering equipment should be washed and then sanitized by rinsing with water of at least 82. Waste cans containing animal tissues. such as mops. powered rotating brushes at the washing sink are useful. should not be used as the sole means of assessing the effectiveness of the sanitation program. The intensity of animal odors.2o C (180 o F) or appropriate chemicals agents (e. corridors. and non-human primates. Periodic microbiologic monitoring is useful to determine the efficacy of disinfection or sterilization procedures.
The animal house . or telephone numbers in animals facilities or by placing them in the security department or telephone center. particularly the staff working in animal rooms or involved in transportation. and other vermin. That can be enhanced by prominently posting emergency procedures. WEEKEND AND HOLIDAY CARE Animals should be cared for by qualified personnel every day. It is also important a regular medical check-up is arranged for the workers to ensure that they have not picked up any zoonotic infection and also that they are not acting as a source of transmission of infection to the animals. breeding. or other appropriate means before they are removed from an animal facility for disposal. Hazardous wastes should be rendered safe by sterilization. Facilities should be provided for change over with lockers. Cold storage might be necessary to prevent decomposition of biological wastes. institutional security personnel and fire or police officials should be able to reach people responsible for the animals.. A SOP should contain the following items: Ø Name of the Author Ø Title of the SOP Ø Date of preparation Ø Reference of previous SOP on the same subject and date (Issue no and Date) Ø Location and distribution of SOPs with sign of each recipient Ø Objectives Ø Detailed information of the instruments used in relation with animals with methodology (Model no. cockroaches. toilets and bathrooms to maintain personal hygiene.CPCSEA GUIDELINES 265 from other storage facilities and free of flies. Serial no. RECORD KEEPING The animal house should maintain the following records: Ø Animal house plans. A disaster plan that takes into account both personnel and animals should be prepared as part of the overall safety plan for the animal facility. gloves and gumboots and other footwear) while working in animal rooms. including weekends and holidays. In the event of an emergency. purchase and sales records Ø Minutes of institute Animals Ethics Committee Meetings Ø Records of experiments conducted with the number of animals used (copy of Form D) Ø Death Record Ø Clinical record of sick animals Ø Training record of staff involved in animal activities Ø Water analysis report STANDARD OPERATING PROCEDURES (SOPs) / GUIDELINES The Institute shall maintain SOPs describing procedures / methods adapted with regard to animal husbandry. rodents. names. which includes typical floor plan. is a critical component in the management of an animal facility. wash basin. Ø Animal house staff record-both technical and non -technical Ø Health record of staff/ animals Ø All standard operating procedures (SOPs) relevant to the animals Ø Breeding. The staff must be provided with all required protective clothing (masks. animal house microbial analysis and experimentation records. aprons. all fixtures etc. control. contamination. stock. to safeguards their well-being including emergency veterinary care. PEST CONTROL Programs designed to prevent. or eliminate the presence of or infestations by pests are essential in an animal environment. maintenance. and Date of commissioning) Ø The name of the manufacturer of the reagents and the methodology of the analysis pertaining to animals Ø Normal value of all parameters Ø Hazard identification and risk assessment PERSONNEL AND TRAINING The selection of animal facility staff. EMERGENCY.
It must also be ensured that the anaesthesia is given for the full duration of experiment and at no stage the animal is conscious to perceive pain during the experiment. Initial in-house training of staff at all levels is essential. disinfection and sterilization. analgesics and anaesthetics should be used to control pain or distress under experiment. The mode of transport of animals depends on the distance. They should also be made familiar with the activities of normal healthy and sick animals so that they are able to spot the sick animal during their daily routine check up of cages (Annexure – 7). convulsions. the mode of transport. respiratory and thermo-regulatory mechanism in addition to central nervous system. Anaesthetic agents generally affect cardiovascular. TRANSPORT OF LABORATORY ANIMALS The transport of animals from one place to another is very important and must be undertaken with care. protection from transit infections. In the event of a decision to sacrifice an animal on termination of an experiment or otherwise. Side effects such as excessive salivation. The transport containers (cages or crates) should be of appropriate size and only a permissible number of animals should be accommodated in each container to avoid overcrowding and infighting (Annexure – 4) ANAESTHESIA AND EUTHANASIA The scientists should ensure that the procedures. General anaesthetics are also used in the form of intravenous or intramuscular injections such as barbiturates. injuries and stress. Local or general anaesthesia may be used. The main considerations for transport of animals are. drink. Species characteristics and variation must be kept in mind while using an anaesthetic. Animals can be transported by road. food and water during transit. nerve blocks and for epidural and spinal anaesthesia. excitement and disorientation should be suitably prevented and controlled. If at any stage during the experiment the investigator feels that he has to abandon the experiment or he has inflicted irrepairable injury. cleaning of cages and importance of hygiene. the animal should be sacrificed. The animal should remain under veterinary care till it completely recovers from anaesthesia and postoperative stress. This should be carried out under expert supervision for regional infiltration of surgical site. Anaesthesia Unless contrary to the achievement of the results of study. The food and water should be provided in suitable containers or in suitable form so as to ensure that they get adequate food and more particularly water during transit. Atropine is the most commonly used anticholinergic agent. free movement and protection from possible injuries. which block parasympathetic stimulation of cardio-pulmonary system and reduce salivary secretion. sedatives. Before using actual anaesthetics the animal is prepared for anaesthesia by overnight fasting and using pre-anaesthetics. rail or air taking into consideration of above factors. Neuromuscular blocking agents must not be used without adequate general anaesthesia (Annexure – 5). The . In any case the transport stress should be avoided and the containers should be of an appropriate size so as to enable these animals to have a comfortable. The data about large animals. A number of general anaesthetic agents are used in the form of inhalants. the containers. seasonal and climatic conditions and the species of animals. A few weeks must be spent on the training of the newly recruited staff. particularly against tetanus and other zoonotic diseases. Euthanasia Euthanasia is resorted to events where an animal is required to be sacrificed on termination of an experiment or otherwise for ethical reasons.266 SPECIAL ARTICLE in-charge should ensure that persons working in animal house do not eat. the animal density in cages. which are considered painful. smoke in animal room and have all required vaccination. which have been euthanised. should be maintained. are conducted under appropriate anaesthesia as recommended for each species of animals. depending on the type of surgical procedure. teaching them the animal handling techniques. Local anaesthetics are used to block the nerve supply to a limited area and are used only for minor and rapid procedures. an approved method of euthanasia should be adopted (Annexure – 6) and the investigator must ensure that the animal is clinically dead before it is sent for disposal.
g. e. . and generally from abroad with approval from appropriate authorities. TRANSGENIC ANIMALS Transgenic animals are those animals. Transgenic animals are used to study the biological functions of specific genes. the breeding stock must be procured from CPCSEA registered breeders or suppliers ensuring that genetic makeup and health status of animal is known. The transgenic and knockout animals carry additional genes or lack genes compared to the wild population. The method should in all cases meet the following requirements: (a) Death. at institutional level and finally at the national level. The health status should indicate their origin. feeding. The transgenic and knockout animals should be maintained in clean room environment or in animal isolators. These can be either developed in the laboratory or produced for R&D purpose from registered scientific/academic institutions or commercial firms. In case of an inbred strain. LABORATORY ANIMAL ETHICS All scientists working with laboratory animals must have a deep ethical consideration for the animals they are dealing with. sanitation and routine management practices for such animals are similar to those for the other animals of the species as given in guidelines. vaccines and for biological screening. pain or distress with minimum time lag phase. To avoid the spread of the genes in wild population care should be taken to ensure that these are not inadvertently released in the wild to prevent cross breeding with other animals. (b) Minimum physiological and psychological disturbances. From the ethical point of view it is important that such considerations are taken care at the individual level. special care has to be taken with transgenic/gene knockout animals where the animals can become susceptible to diseases where special conditions of maintenance are required due to the altered metabolic activities.CPCSEA GUIDELINES 267 procedure should be carried out quickly and painlessly in an atmosphere free from fear or anxiety. the species of animal to be killed (Annexure – 6). A record of disposal and the manner of disposal should be kept as a matter of routine. the characters of the strain with their gene distribution and the number of inbred generation must be known for further propagation. These animals can be bred to establish transgenic animal strains. into whose germ line foreign gene(s) have been engineered. BREEDING AND GENETICS For initiating a colony. MAINTENANCE Housing. to produce therapeutic products. lighting. However. to develop animal models for diseases of humans or animals. dogs and cats before an euthanasia procedure. specific pathogen free or transgenic gnotobiotic or knockout stock. conventional. Tranquilizers have to be administered to larger species such as monkeys. (d) Location should be separate from animal rooms and free from environmental contaminants. whereas knockout animals are those whose specific gene(s) have been disrupted leading to loss of function. ventilation. without causing anxiety. DISPOSAL The transgenic and knockout animals should be first euthanized and then disposed off as prescribed elsewhere in the guidelines. (c) Compatibility with the purpose of study and minimum emotional effect on the operator. The choice of a method will depend on the nature of study. For accepting an euthanasia method as humane it should have an initial depressive action on the central nervous system for immediate insensitivity to pain.
6 2.91-0.9 0.5-7.1-2.268 SPECIAL ARTICLE Annexure – 1 Haematological data of commonly used laboratory animals.6-6.25-0.7-4.0 (mmol/l) Cholesterol (mg/dl) 26-82 40-130 25-135 20-43 35-53 2-4 4-7 (mmol/l) Monkey 4.0 <180 Dog 6-7.5 35-75 20-55 2-12 1-4 rare 300-700 * Neutrophils often resemble eosinophils due to granules (NOTE.8-16. .5 3-4 2.5-8.1-2 (nmol/l) 108-263 (mmol/l) The range of normal values may vary in a laboratory using specific species. strain or substrain of these animals. Any major deviation on higher or lower side may be considered as a condition and not a disease per se) Annexure – 2 Biochemical data of commonly used laboratory animals.5 0.5-2. strain or sub strain of these animals.8 1.1-0.8 81-108 3.1-3.pig Rabbit Cat Dog (Beagle) 5.7 5-88 8-92 0-14 0-11 0-6 109-597 RBC(x10v /mm³) PCV(%) Hb (g/dl) WBC(X10³/mm³) Neutrophils(%) Lymphocytes(%) Eosinophils(%) Monocytes(%) Basophils(%) Platelets(X10³/mm³) 7-12.2-0.5-8.8 46-178 8-40 0.5 39-49 10.3 2. Any major deviation on higher or side may be considered as a condition and not a disease per se).2-5.5 2.6-4.0 <5.6-7.5-26.8-4.5-7 37-48 11-15 7-18 28-44 39-72 1-5 3-12 0-3 250-850 4-7 36-48 10-15.5-7.6 62-175 12-28 0.5 0-3 0-1 200-500 4.8-1.5 500-1300 6-10 36-55 10-16 3-11 10-42 50-95 0-4.2 2.74 <4.2 60-150 12-25 0.5 9-11 20-75* 30-85 0-4 1-4 2-7 250-656 5-10 30-15 8-15 5.7 54-99 3.8-3 50-135 15-21 0.5 2.6-2.0 2.5-3.1 2.9 1.96 26-48 8.pig 4.56-6.4-3.3-0.5 2.9 0.2-16.3 160-410 7-10 36-18 11-18 6-17 9-34 65-85 0-6 0-5 0-1.1-3.6 0.7-4.9-9.2-0.7-2.25-0.4-7.8 Cat 6-7.55 0.8 0.6 6-15 10-40 55-95 0-4 0.2 2.8 Hamster 4.5-4.5 37-55 12-18 6-17 60-70 12-30 2-10 3-10 rare 200-900 Monkey (Rhesus) 3.8-5.5-4.5-7.5 2.6 60-125 9-31.The range of normal values may vary in a laboratory using specific species.99 G.6 1.5-19.2 1. Mouse Rat Hamster G.5 0.8 (nmol/I) 0.2 Rabbit 5.5 <120 (nmol/I) Bilirubin (mg/dl) 0.3-1 Rat 5.5 0-0. Mouse Protein (g/dl) Albumin (g/dl) Globulin (g/dl) Glucose (mg/dl) Urea nitrogen Creatinine (mg/dl) 3.8 75-150 17-23.
135 0. Thus.40 14 14 14 14 14 Cage size. the number of animals which can be housed in a particular cage (of different sizes) can be calculated on the basis of a) floor area of the cage.0 4. the number of animal which can be housed in a particular cage (of different sizes) can be calculated on the basis of (a) floor area of the cage. specially length and breadth may vary.0 258.0 upto 500 2 >451.0 upto 400 3 387. 1 male and 2 females) along with the pups from delivery up to weaning stage are permitted.5 3. based on floor area recommended per animal according to their weight (size) and size of the cage Recommended floor area per animal (cm²) Weight of animal (grams) Example: Cage size 32.0 >=451.4 Cage height (cm²) Recommended floor Area per animal (cm²) Weight of animals (g) 12 Example I: Cage size 24 x 14 cm i.7 109.0 4.e.6 <100 148. floor area of 682 cm² maximum number of animals Note: 109. * Annexure – 3C Example for calculating the number of rats to be kept per cage. b) recommended floor area per animal and c) weight of animal.5 83. However.0 5.e.8 103. However the minimum floor area and cage height recommended for group housing has to be taken into consideration. In case of breeding pairs.6 148. floor area of 336 cm² maximum number of animals Example II: Cage size 32.5 0. (b) recommended floor area per animal and (c) weight of animal. specially length and breadth may vary. the minimum floor area and cage height recommended for group housing has to be taken into consideration.0 >=651.meter) (inches) Rabbits <2000 Upto 4000 Upto 5400 >5400 Mother with kids 1.0 upto 300 4 258.5 >500 6 1 Cage size.6 77.45 0.36 0.5 387.5 x 21 cm i. Thus.3 upto 200 5 187.7 51.CPCSEA GUIDELINES Annexure – 3A Minimum floor area recommended for laboratory animals (based on their weight/size and behavioral activity) Animal Weight In grams Mice <10 upto15 upto25 >25 <100 upto200 upto300 upto400 upto500 >500 Floor area/Animal (cm²) 38. based on floor area recommended for animal according to their weight (size) and size of the cage <10 upto15 upto25 >25 Rats 8 7 4 3* 14 Hamsters/Gerbils/ >60 Mastomys/ Cotton rats upto 80 upto100 >100 Guinea pigs <350 >350 12 17 14 9 7 18 Floor area Height (Sq.4 96. .5 64.27 0.6 77.e floor area of 682 cm² maximum number of animals Note: 38.4 96. three adults (i.0 387.7 51.5 x 21 cm i.e.3 187.ft) (Sq.7 Annexure – 3B 269 Example for calculating the number of mice to be kept per cage.2 122.
0 4.5 Up to 3. Thus. b) recommended floor area pre animal and c) weight of animal. If the experimental protocol demands caging for more than 6 months. dogs and birds Animals Weight. All primate facilities should have one or more runs as big as possible with minimum floor space of 150 sq.00 2. 90 cm as mentioned in INSA guidelines. based on floor area recommended per animal according to their weight (size) and size of the cage Recommended 64.ft and height not less than 2 meters for free ranging activities.3 6. specially length and breadth may vary.0 0.00 Height inches 24 24 - Cats Dogs <4 <4 <15 Up to 30 >30 <0.270 SPECIAL ARTICLE Annexure – 3E Minimum floor area and height recommended for monkeys (rhesus and bonnet) based on their weight (size) and behavioral activity (for langurs.e floor area of 682 cm² maximum number of animals Note: <60 83. However the minimum floor area and cage height recommended for group housing has to be taken into consideration.0 Pigeons Chicken . 6000-9000 cm² is recommended. Note: a) The height of the cage should be sufficient for the animals to stand erect with their feet on the floor.0 10 8 6 5 Upto 12-15 Upto 15-25 Cage size.0 >4.50 1.8 0.0 12. b) The floor area for langurs upto 6 kg weight.5 Up to 1. 5000 cm² and above 6 kg.5 upto80 upto100 >100 Upto 1 Upto 3 Upto 10-12 1.25 0. animals should be provided with double the floor space mentioned above. The height of the cage in either case remains the same.e. whereas the minimum height of the cage for langurs has to be 90 cm as mentioned in INSA guidelines.2 122.0 8.8 103.5 x 21 cm i.0 8.5 floor area per animal (cm²) Weight of animal (g) Example: Cage size 32. c) d) Annexure – 3F Recommended space for cats. ft² b 3.0 >24.25 Up to 0. i. the recommended space is in the foot note) Weight (in kg) ft² Floor area cm² 1440 2700 3870 5400 7200 50 72 72 72 90 Height (cm) Annexure – 3D Example for calculating the number of Hamster/ Gerbils/ Mastomys/Cotton rats to be kept per cage. the number of animal which can be housed in a particular cage (of different sizes) can be calculated on the basis of a) floor area of the cage.00 >3. kga Floor area/animal.0 >3.6 3.
0 >52. .09 Larger animals might require more space.0 48.0 72.0 24.0 9. bTo convert square feet to square meters multiply by 0.0 15.0 60.0 36.0 8 10 2 –5 >5 Horses/ponies 1–4 >4/pen <200 >200 ªTo convert kilograms to pounds multiply by 2.0 15.0 105.0 8 2-5 >5 Swine 12.0 60.0 36.0 80.CPCSEA GUIDELINES Annexure – 3G Recommended space for commonly used farm animals Animals/enclosure Weight (kgª) Floor Area/Animal ft² b Height (ft) 271 Sheep and goats <25 Up to 50 >50 <25 Up to 50 >50 <25 Up to 50 >50 Up to 25 Up to 50 Up to 100 Up to 200 >200 <25 Up to 50 Up to 100 Up to 200 >200 <25 Up to 50 Up to 100 Up to 200 >200 <75 Up to 200 Up to 350 Up to 500 Up to 650 >650 <75 Up to 200 Up to 350 Up to 500 Up to 650 >650 <75 Up to 200 Up to 350 Up to 500 Up to 650 >650 10.0 124.0 7.0 40.0 >108.5 17.2.0 8.5 12.0 10.3 15.0 48.0 8 2-5 >5 Cattle 1 8 24.0 20.0 >144.0 >120.0 >72.0 144.0 20.5 11.0 40.0 20.0 93.0 72.0 6.0 96.0 18.0 >60.0 54.0 72.0 >48.0 6.0 18.
i/v 25 i/v 1. s/c = subcutaneous . rail and air. pig Rabbit Cat Dog Monkey Maximum No. Mouse Rat Hamster G. i/p = intraperitoneal. Synthetic material Metal Cardboard. i/m = intramuscular.0 i/v Rabbit 22-24 30 i/v 40 i/p Cat 30 i/m 25 i/v Dog 30 i/m 20-30 i/v Monkey 15-40 35 i/v - Atropine: Dose 0. pig 22-24 30 i/v 40 i/p 20 i/v 55 i/p 1.272 SPECIAL ARTICLE Annexure – 4 Requirements for transport of laboratory animals by road.0 i/p. i/v = intravenous.02 – 0.50 i/p 25 i/v 1. Drugs (mg/kg) Ketamine HCl Pentobarbitone sodium " " Thiopentone sodium " Urethane " " Mouse 22-24 i/m 35 i/v 50 i/p 25 i/v 50 i/p Rat 22-24 i/m 25 i/v 50 i/p 20 i/v 40 i/p 0.05 mg/kg for all species by s/c or i/m or i/v routes used to reduce salivary and bronchial secretions and protect heart from vagal inhibition. of Animals per cage 25 25 25 12 2 1 or 2 1 or 2 1 Material used in transport box Metal Cardboard. given prior to anaesthesia.5 i/p 20 i/v 1.75 i/p Hamster 35 i/v 20 i/v 40 i/p G. Synthetic material Metal Metal Bamboo / wood / metal Space per Animal (cm2) Minimum height of box (cm) 20-25 80-100 80-100 160-180 1000-1200 1400-1500 3000 2000-4000 12 14 12 15 30 40 50 48 Annexure. Synthetic material Metal Cardboard.5 Commonly used anaesthetic drugs for laboratory animals.25 i/v 1. Synthetic material Metal Cardboard.00 i/v 25 i/v60 i/p 1. Synthetic material Metal Cardboard.
6 Euthanasia of laboratory animals. Handling of animals – precautions while handling animals – common injuries and ailments in animals – liters – weaning – maintenance – record keeping. air (aenar). handling of detergents and other cleaning substances – zoonoses – need of safety handling – antidotes for specific poisons if handling poisonous animals like venomous snakes – first aid.CPCSEA GUIDELINES Annexure . Animals rooms – animals chambers/cages – sizes of animal chambers general dimensions for monkey and rat cages stocking density – need for light (LD cycles). IP) A(IV. mask. pig Rabbit Cat Dog Monkey 273 A(IV. IP) A(IV) IV A A A A A A A A A A A A A A A A A A A A A A A A A NR NR A A NR NR A A NR A A A NR A NR A NR A NR NR NR A NR NR NR A NR NR NR NR NR NR NR NR NR NR Mouse Rat Hamster G. .Definition of plants and animals – types of animals – animals without back bones (invertebrates) and those with back bones (chordates/vertebrates) – animals that live in water (aquatic). gloves. Emergency situations: escaping animals – use of fire extinguishers – emergency lamps – sirens. IP) A(IV) IV A(IV) IV A(IV) IV A(IM/IP) A(IM/IP) A(IM/IP) A(IM/IP) A(IM/IV) A(IM/IV) A(IM/IV) A(IM/IV) Sodium pentothol [overdose (route)] IP Methods Not Acceptable for any species of animals a) Physical methods: (i) Decompression (ii) Stunning b) Inhalation of gases (i) Nitrogen Flushing (ii) Argon Flushing c) Drug administration (i) Curariform drugs (v) Strychnine (ii) Nicotine sulphate (vi) Paraquat (iii) Magnesium sulphate (vii) Dichlorvos (iv) Potassium chloride (vii) Air Embolism Annexure – 7 Certificate course for laboratory attendant (Basic education: 8th standard) IP = intraperitoneal IV = Intravenous IM = Intramuscular Introduction . animal runs. (A – Methods Acceptable for species of animals indicated NR – Not Recommended) Species a) Physical methods Electrocution NR Exsanguination A Decapitation (for analysis of stress) A Cervical dislocation b) Inhalation of gases Carbon monoxide Carbon dioxide Carbon dioxide plus chloroform/halothane c) Drug administration Barbiturate overdose (route) Chloral hydrate overdose (route) Ketamine overdose (route) A(IP) NR A(IP) NR IP A(IP) NR IP A(IP) NR IP A(IV. land (terrestrial) – wild animals and domesticated animals – poisonous and non-poisonous animals – laboratory bred and non-laboratory bred animals – diurnal and nocturnal animals (suitable and relevant Indian examples to be given). Personal hygiene – need to use apron. IP) A(IV. air water and feed – cleaning animal chambers. aquana and animal rooms – frequency of feeding – frequency of cleaning.
Registration of Biosafety Committee membership composition with RCGM and submission of report. Adopting emergency plans. ii. Join "IndPharm" IJP uses "IndPharm" to broadcast announcements. It will provide half yearly reports on the ongoing projects to RCGM regarding the observance of the safety guidelines on accidents. annually for scientific workers involved in such projects. Follow up medical check ups including pathological test should be done periodically. III. VI. The biosafety functions and activity include the following: I. Instituting health monitoring program for laboratory personnel Complete medical check up of personnel working in projects involving work with potentially dangerous microorganism should be done prior to starting such projects. Any research project which is likely to have biohazard potential (as envisaged by the guidelines) during the execution stage or which involve the production of either micro-organisms or biologically active molecules that might cause biohazard should be notified to ISBC. Head of the institution or his nominee 3 or more scientists engaged in DNA work or molecular biology with an outside expert in the relevant discipline. Provision of suitable safe storage facility of donor. The other institutions will be asked to take similar action.274 SPECIAL ARTICLE Annexure – 8 Institutional Biosafety Committee (IBSC) Institutional Biosafety Committee (IBSC) is to be constituted in all centers engaged in genetic engineering research and production activities. Tailoring biosafety program to the level of risk assessment IV. Training of personnel on biosafety V. Want to join? Please e-mail : adithan@vsnl. So far biosafety committee have been already set up in 124 institutions. risks and on deviations if any. The committee will constitute the following. A computerized Central Registry for collation of periodic reports on approved projects will be setup with RCGM to monitor compliance on safeguards as stipulated in the guidelines. Review and clearance of project proposals falling under restricted category that meets the requirements under the guidelines.com . II. ISBC will allow genetic engineering activity on classified organisms only at places where such work should be performed as per guidelines. risks and on deviations if any. IBSC would make efforts to issue clearance certificates quickly on receiving the research proposals from investigators. i.) iv. recipients and other materials involved in experimental work should be made and may be subjected to inspection on accountability. A member with medical qualification-Biosafety officer (in case of work with pathogenic agents/large scale used. One member nominated by DBT The Institutional Biosafety Committee shall be the point for interaction within institution for implementation of the guidelines. iii. vectors. Their medical record should be accessible to the RCGM. ISBC will provide half yearly reports on the ongoing projects to RCGM regarding the observance of the safety guidelines on accidents.
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