Chapter 400: Animal Research

400.010 Occupational Health and Safety Program for Laboratory Animal Care and Use Personnel

kuscheld — Thu, 27 May 2010 16:43:00 +0000

400.010 Occupational Health and Safety Program for Laboratory Animal Care and Use Personnel kuscheld Thu, 05/27/2010 - 16:43

Executive Guideline No. 21, 11-11-83; Revised 7-6-16.

Purpose - This Executive Guideline is intended to provide general direction for the development and maintenance of an Occupational Health and Safety Program (OHSP) tailored to the needs of persons whose employment involves contact with laboratory animals and/or animal tissue. Because of this contact, these individuals are considered to experience a greater risk of encountering certain health hazards than is the case with the general population. Health hazards of concern include development of allergies, physical injury, exposure to cleaning and disinfecting chemicals, and rarely, zoonotic diseases. The goal of the OHSP is to maintain a safe and healthy workplace.
Scope
1. The OHSP is applicable to all University employees whose work involves contact with laboratory animals and/or animal tissues, defined as follows:
  1. "Contact" is any contact with animals, animal waste and unfixed animal tissues and fluids.
  2. "Laboratory animal" means any University owned animal that is produced for or used in research, testing or teaching.
2. The OHSP described herein is basic in that it applies to a baseline level of risk experienced by personnel using or caring for laboratory animals and/or animal tissue as part of their assigned job duties. This program is not sufficiently broad in scope or sufficiently detailed to address situations in which specific hazardous agents are used that are known to present specific risks above the routine. In these cases, specific procedures are indicated to protect personnel, monitor exposure and/or facilitate diagnosis and treatment in the event of exposure.
Responsibilities
1. It is the responsibility of each campus Institutional Animal Care and Use Committee (IACUC) to review the adequacy of their OHSP semiannually.
2. Funding of the OHSP shall continue to be the responsibility of the individual campus. Direct animal care funds such as “per diem” charges are not appropriate for funding of this program.
3. Individuals (Principal Investigators, facility directors/managers or supervisors) responsible for hiring or supervising full-time, part-time, or student personnel who have contact with laboratory animals, animal waste or unfixed animal tissues or fluids are responsible for seeing that such persons hired or supervised are included in the appropriate OHSP.
4. Each OHSP shall include the following:
  1. Mandatory training of personnel–regarding occupational hazards associated with the care and use of laboratory animals, including information related to animal-related hazards such as allergies, bites and scratches, zoonotic disease, physical hazards such as sharps handling and the use of hazardous agents.
  2. Risk Assessment–for each individual, to mitigate risks associated with each individual's personal medical status; this will include an assessment of the specific hazards to the individual of the animals and materials used; the exposure intensity, duration and frequency, the susceptibility of the individual to harm, and the individual's history of occupational illness and injury in the specific workplace. The Risk Assessment will also include identification of the necessary immunizations and personal protective equipment for each individual.
  3. Monitoring–on-going monitoring of hazards should occur, including periodic inspections and on-going assessments of risks to determine appropriate strategies to minimize or manage the risks.
  4. Reporting–all incidents/accidents, including "near misses," must be reported to the employee's supervisor.
  5. Operational and day-to-day responsibility for safety in the work place resides with the laboratory or facility supervisor (e.g., principal investigator, facility director or a staff veterinarian) and depends on safe work practices by all employees.
Control and Prevention Strategies
1. Each OHSP should identify potential hazards in the work environment and conduct an assessment of the associated risks, so as to reduce and manage such risks at minimal acceptable levels.
2. Personal protective measures should be made available to individuals including but not limited to:
  1. Protective Clothing:
    1. Depending on the level of risks, suitable attire and personal protective equipment should be provided by the University for use in animal facilities and laboratories in which animals are used. Soiled attire should be disposed of, laundered or decontaminated by each facility. Outer garments worn in animal areas should not be worn outside of the animal facilities unless covered. Work clothing must be changed with sufficient frequency to avoid prolonged exposure of personnel to contaminants that have soiled the clothing and to ensure that clothing does not spread contamination within the work place.
    2. Exam gloves should be worn while handling animals.
    3. Eye protection is mandatory when handling concentrated acids, caustics, detergents, disinfectants, and other irritant chemicals.
    4. When known hazards exist which are beyond those routinely found in the laboratory animal quarters or laboratories, special personal protective equipment appropriate to the nature of the hazard should be used. Examples of such equipment include but are not limited to hearing protection, arm protectors, face masks, goggles and respiratory protection.
  2. Personnel Hygiene:
    1. Standards of personnel hygiene must be high to protect both personnel and laboratory animals.
    2. Hand washing and/or Disinfection - frequent hand washing/ disinfection is necessary. In particular, hand washing/ disinfection should occur at the start of the workday, when changing gloves, upon leaving work for breaks, meals or rest rooms, and when returning to work.
    3. Eating, drinking, use of tobacco products, application of cosmetics, and handling or applying contact lenses are prohibited in laboratory animal quarters and other areas where laboratory animals or hazardous agents are used.
  3. Medical Surveillance:
    1. The purposes of medical surveillance are to identify persons who may be at higher than normal risk for exposure related illness or injury, and to monitor for changes in the health of the worker which may be due to exposure to animals or hazardous agents.
    2. The animal facility director/manager/supervisor or principal investigator will provide the occupational health medical professional with a description of the employee's duties which includes the animal species contacted and the toxic, biologic, and radiologic agents to which the employee may be exposed.
    3. The employee should provide the occupational health medical professional with a confidential health history so that an accurate risk assessment can be made and further action can be recommended.
    4. Following the risk assessment, the employee and his/her supervisor must be provided a written report from the occupational health medical professional stating what actions are required to maintain a safe work environment for the employee.
  4. Immunizations
    1. An appropriate immunization schedule should be adopted by each OHSP. Pre-exposure immunization should be offered to employees at risk of infection or exposure to specific agents, such as rabies, tetanus or hepatitis B. Current, applicable vaccine information statements must be provided whenever a vaccine is administered. Each employee's immunization history should be evaluated for completeness and currency at the time of employment and re-evaluated when the employee is assigned job responsibilities with a new hazard. Employees may decline a recommended vaccine but must sign a waiver; employees will not be permitted to decline a recommended vaccine if the employee's failure to get such vaccine places other personnel or laboratory animals at a material risk of harm.
  5. Report of Injuries:
    1. The University requires that all accidents or incidents (including near misses), including but not limited to bites, scratches, allergic reactions or other injuries, shall be reported to the employee's supervisor immediately (even if the employee does not feel medical treatment will be required at the time).
    2. Each campus shall develop its own procedure for handling accidents or incidents; however, at a minimum, each procedure must include a written record documenting the nature of the accident/ incident including date and location, the identification of all persons involved or who witnessed the accident/ incident, including contact information, and the nature of any injuries sustained as a result of the accident/ incident.
    3. The procedure for the handling of accidents shall include an assessment of the need for medical attention.

400.020 Care and Use of Vertebrate Animals as Subjects in Research and Teaching

kuscheld — Thu, 27 May 2010 16:45:02 +0000

400.020 Care and Use of Vertebrate Animals as Subjects in Research and Teaching kuscheld Thu, 05/27/2010 - 16:45

Executive Guideline No. 22, 2-15-84; Revised 5-20-87.

Purpose -- The policy of the ��ϲʹ�� is to foster the humane care and use of vertebrate animals in research and teaching and to adhere to applicable laws, principles, standards, guidelines and policies affecting such care and use.
This policy and the principles below apply in all situations and activities of the University where vertebrate animals are used in research, instruction or other activities regardless of the source(s) of support. It shall apply equally whether the supporting funds are from outside or from within the University, whether separately budgeted or unbudgeted.

Responsibility for implementing and administering this policy shall rest wit the Chancellor of each campus (the Vice President for Academic Affairs in the case of UM research programs). In accordance with federal policy and regulations, the Chancellor has responsibility for appointing the Institutional Animal Care and Use Committee. The composition of this committee shall conform to Federal Guidelines.

The committee will:
1. Review, at least once every six months, the institution's program for humane care and use of animals, using the Guide for the Care and Use of Laboratory Animals and the Animal Welfare Act Regulations and Standards as a basis for evaluation.
2. Inspect, at least once every six months, the institution's animal facilities (including satellite facilities).
3. Prepare reports of the IACUC evaluation set forth in the PHS policy and submit the reports to the Chancellor. A more complete list of IACUC regulations and responsibilities is in the PHS policy and 9CRF Parts 1 and 2, Animal Welfare Proposed Rules.
  As part of the campus's program for animal care and use, the Chancellor will provide training or instruction to scientists, animal technicians, and other personnel involved in animal care, treatment, or use in both the practice of animal care and in research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress.
  
  The Chancellor will ensure that records of the semiannual reports and recommendations are maintained for at least three years and that, at least once every twelve months, the Institutional Animal Care and Use Committee (IACUC) will report through the Chancellor to Office for Protection from Research Risks (OPRR) on its activities, especially with regard to any changes in the status of the institution's Assurance and other information as required by OPRR.
Principles for the Care and Use of Animals
1. The Personnel
  1. Experiments involving live, vertebrate animals and the procurement of tissues from living animals for research must be performed by , or under the immediate supervision of, a qualified biological, behavioral or medical scientist.
  2. The housing care and feeding of all experimental animals must be supervised by a properly qualified veterinarian or other scientists competent in such matters.
2. The Research
  1. The research should be expected to yield results beneficial to society and not be random or unnecessary in nature.
  2. The experiment should be based on knowledge of the disease or problem under study and so designed that the anticipated results will justify its performance.
  3. Statistical analysis, mathematical models or in vitro biological systems should be used when appropriate to complement animal experiments and reduce numbers of animals used.
  4. The experiment should be conducted so as to avoid all unnecessary suffering and injury to animals.
  5. The scientist in charge of the experiment must be prepared to terminate it whenever he or she believes that its continuation may result in unnecessary injury or suffering to animals.
  6. If the experiment or procedure is likely to cause greater discomfort than that attending anesthetization, the animals must first be rendered incapable of perceiving pain and be maintained in that condition until the experiment or procedure is ended. The only exception to these guidelines should be in those cases where anesthetization would defeat the purpose of the procedures. Such procedures must be carefully supervised by the principal investigator or other qualified senior scientists.
  7. Post-experiment care of animals must be such as to minimize discomfort and the consequences of any disability resulting from the experiment in accordance with acceptable practices in veterinary medicine.
  8. If it is necessary to kill an experimental animal, the animal must be killed in a humane manner; i.e., in such a way as to ensure immediate death in accordance with procedures approved by an institutional committee. No animal shall be discarded until after it is dead.
  9. Occupational health procedures outlined in the Personnel Health and Medical Surveillance Program for Animal Care Personnel (See Executive Guideline No. 21) must be followed to minimize the risk of disease transmission between animals and humans.
  10. Safety procedures shall be such as to minimize the risk of exposure of personnel or the unintended risk of animals to hazardous agents.
3. The Facilities -- Standards for the construction and use of housing, service and surgical facilities should meet those described in the current edition of the publication, Guide for the Care and Use of Laboratory Animals, DHHS, (NIH_ 85-23, or as otherwise required by the U.S. Department of Agriculture regulations established under the terms of the Laboratory Animal Welfare Act (P.L. 89-544) 1966; P.L. 91-579, as amended, 1970; P.L. 94-270; as amended, 1976; P.L. 99-198, as amended 1985), and other laws and regulations as duly promulgated.
4. Transportation -- Transportation of animals must be in accord with applicable standards and regulations, especially those intended to reduce discomfort, stress to the animals, or spread of disease.
5. References
  1. Committee on Care and Use of Laboratory Animals: Guide for the Care and Use of Laboratory Animals. DHHS (NIH) 85-23, Institute of Laboratory Animal Resources, NRC, revised, 1985.
  2. Code of Federal Regulations, Title 9-Animals and Animal Products, Subchapter A-Animal Welfare, January 1985.
  3. Recommendations for Governance and Management of Institutional Animal Resources. Association of American Medical Colleges; Association of American Universities, October 1985.
  4. Rules for Animal Welfare. Federal Register, Vol. 52, No. 61, p. 10292 et seq.
  5. Public Health Service Policy on Humane Care and Use of Laboratory Animals, OPRR, Revised September 1986.