Facilities animal care

Requirements in the areas of facilities, animal care, and personnel were the most often met, while the fewest requirements were met in the areas of the quality assurance unit, mixing and storage of the test substances, and record retention. 

All procedures performed in this study conform to the "Guide to the Care and Use of Laboratory Animals published by the National Institutes of Health, Bethesda, Maryland. All research facilities are accredited by the American Association for Accreditation of Laboratory Animal Care. 

Proper facilities and care for test animals is not only a matter of regulatory compliance (and a legal requirement), but also essential for a scientifically sound and valid study. Husbandry requires clean cages of sufficient size and continuous availability of clean water and food (unless the protocol requires some restriction on their availability). Environmental conditions (temperature, humidity, and light-dark cycle) must be kept within specified limits. All of these must, in turn, be detailed in the protocols of studies. The limits for these conditions are set forth in relevant NIH and USDA publications. 

Animal studies require the approval of a local institutional animal care and use committee and have to be performed in special animal facilities. Often, the... 

Animal care facilities 160.43 Test system care facilities... 

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

Food and Drug Administration investigators found generally acceptable performance in the archival and record retention areas as well as in the area of the physical facilities associated with animal care and laboratory operations. The lack of findings in these areas is encouraging, since it may be... 

Good animal care is critical at all times because toxicity has been shown to vary with diet, disease, and environmental factors. Animals should be quarantined for some time before being admitted to the test area, their diet should be optimum for the test species, and the facility should be kept clean at all times. Regular inspection by a veterinarian is essential, and any animals showing unusual symptoms not related to the treatment (e.g., in controls or in low dose but not high dose animals) should be removed from the test and autopsied. 

Chapter 17. Burger, G. T., and L. C. Miller Animal care and facilities. 

Current Animal care facilities Proposed Test System care facilities Section 160.45... 

Subpart C Facilities General Animal care Animal supply Laboratory operation areas Specimen and data storage facilities Administrative and personnel facilities... 

Facilities (1) general (2) animal care facilities (3) animal supply facilities ... 

Stringent control of environment conditions and proper animal care techniques are mandatory for meaningful results. As part of such control, access to animal facilities should be monitored to prevent excessive traffic and other disturbances. Factors such as housing conditions, intercurrent disease, drug therapy, impurities in diet, air, water, and bedding can significantly influence the outcome of experiments. 

In addition, the American Association for Laboratory Animal Science (AALAS) provides guidelines for animal care and use, operates a certification program for animal technicians, and develops educational materials. The AALAS also serves as a scientific forum for laboratory medicine and care. The American Association for the Accreditation of Laboratory Animal Care (AAALAC) offers a peer review laboratory accreditation program for research facilities. In addition, the FDA and the EPA have Good Laboratory Practice (GLP) regulations. 

A number of immunological techniques have been used in comparative studies.8,9 The most important of these is microcomplement fixation (MC F), a quantitative technique that has played a key role in many classic studies of molecular evolution and molecular systematics. By selecting proteins with different rates of evolution, a broad range of divergences can be examined. The cost of the technique is moderate, but biochemical expertise is required and the labor involved is substantial. Protein must be purified from some or all taxa for antibody production, and, for those taxa, a sizable tissue or serum sample is needed. Antibody production itself is usually done in rabbits, so an animal care facility must be available. Like isozyme electrophoresis, the large body of immunological distance data already available ensures the continued value of this technique for certain investigations. 

Is the system used to control or monitor the environment in a production area, finished goods or raw material warehouse, or a research animal care facility ... 

In institutions that are equipped with animal care facilities, polyclonal sera or ascites can be produced in house. Information on the generation of antibodies in animals can be found in several excellent references (16-19). Alternatively, a number of service companies exist that can provide the investigator with sera and ascites, as well as help in the design of injection and harvesting protocols. Immune serum contains approx 10 mg/mL of immunoglobulins, 0.1-1 mg/mL of which comprise the anti-... 

Note the words as needed and proper. The facility s veterinarian in charge should be consulted as to when generally accepted standards for laboratory animal care require the separation, isolation, or specialized housing of animals. It is generally accepted that all newly received animals should undergo a quarantine and acclimation period. 

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