Rose-Hulman Institute of Technology Laboratory Animal Care and Use Policies and Procedures

Transcription

1 Rose-Hulman Institute of Technology Laboratory Animal Care and Use Policies and Procedures Approved: November 16, 2005

2 I. Purpose This document describes policies and procedures for Laboratory Animal Care and Use at Rose-Hulman Institute of Technology. 1 These policies and procedures have been developed to ensure the humane treatment and welfare of laboratory animals used in research and teaching, and to ensure compliance with federal, state and local laws. The policies and procedures outlined in this document apply to all activities (research, research training, teaching, experimentation, and biological testing) involving the use of live vertebrate animals on Rose- Hulman s campus. Rose-Hulman s Animal Care and Use program is based on the Animal Welfare Act, and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (rev. 1986) both of which are incorporated herein and attached as appendices A and B respectively. II. Governmental Animal Care and Use Regulations In 1966 Congress passed the Animal Welfare Act (PL ) and the United States Department of Agriculture (USDA) was named the responsible agency. In 1973, the Public Health Service (PHS) published the first Public Health Service Policy on Humane Care and Use of Laboratory Animals. In 1979, PHS Policy required each animal-using recipient of funds to have a PHS Assurance and a committee (IACUC) to maintain oversight of its animal care program. In 1985 the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training was promulgated. In 1985, Congress passed the Health Research Extension Act (P.L ) and amendments to the Animal Welfare Act. In 1986, the PHS Policy was revised. The Office of Laboratory Animal Welfare has oversight responsibility for the PHS policy. Between 1989 and 1991, the USDA promulgated additional amendments to the Animal Welfare Act. In 1996 the 7th edition of the Guide for the Care and Use of Laboratory Animals (The Guide), was revised by the Institute of Laboratory Animal Research and published by the National Research Council. III. Institute Animal Care and Use Committee (IACUC) A. Authority The IACUC derives its authority from the law. It is mandated by the Health Research Extension Act of 1985 and the Animal Welfare Act. The law requires the CEO of an organization to appoint the IACUC. The President at Rose-Hulman will appoint IACUC members. The IACUC will report to a designated Institute Official (IO), also appointed by the President. B. Committee Composition The PHS and USDA policy mandates the first five (5) committee members with an additional requirement that not more than three (3) of these five (5) members may come from the same administrative unit of the Institute. The Rose-Hulman IACUC will consist of the following 9 members (8 voting): 1 Italicized text refers to a regulation or policy to which the reader may refer if desired. Approved: November 16, /28 -

3 1. One Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine who has direct or delegated program authority and responsibility for activities involving animals at the Institute. 2. One practicing scientist from Rose-Hulman experienced in research involving animals 3. One member from Rose-Hulman whose primary concerns are in a non-scientific area 4. One public member, not affiliated in any way with the Institute and not an immediate family member of a person affiliated with the Institute, to represent general community interests in proper care and use of animals who neither works with laboratory animals, nor has responsibility for administering an animal care and use program 5. Chair of the IACUC committee. The Chair of the IACUC serves at the request of the Institute Official. 6. One Rose-Hulman scientist with statistical or analytical experience (From Math, Chemistry, Chemical Engineering, or Physics) 7. One Rose-Hulman scientist with biology background 8. The Institute Environmental Health and Safety Coordinator 9. One secretary appointed by the chair (non-voting member) C. Term of Appointment and Changes in Appointment The Term of appointment for IACUC voting members will be for a period of up to 3 years. Terms will be staggered such that approximately 2/3 of the committee will be retained from year to year. Any proposed changes to the composition of the committee will be submitted to the Chair and Institute Official. The Institute Official will inform the President of the proposed change and the President will take appropriate action, notifying the Chair, Institute Official, and committee members affected. The composition of the committee will not deviate from Section B. above. D. Responsibilities of the IACUC The IACUC is responsible for overseeing and evaluating all aspects of animal care and use at Rose-Hulman, and to ensure activities are in compliance with the Animal Welfare Act and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. The responsibilities outlined below will be carried out in accordance with these regulations: Approved: November 16, /28 -

4 1. Review, at least once every six months, the Rose-Hulman program for the humane care and use of animals. Prepare and submit the evaluation report to Institute Official. 2. Inspect, at least once every six months, all Rose-Hulman animal facilities including satellite facilities, satellite holding facilities (a facility outside of a core facility or centrally designated area in which animals are housed for more than 12 hours), and areas in which surgical manipulations are performed. Deficiencies, where found, will be classified as significant or minor and a plan and timeline for correction will be documented. A significant deficiency is one that is, or may be, a threat to the health and safety of the animals. Prepare and submit the facility inspection report to the Institute Official. 3. Provide a copy of the IACUC evaluation reports for items 1. & 2. above to Office of Laboratory Animal Welfare (OLAW) upon request. Committee will report to USDA, in writing, all significant deficiencies remaining uncorrected beyond the scheduled correction date within 15 business days of the original correction date. The IACUC will submit this report through the Institute Official, to the Animal and Plant Health Inspection Service (APHIS) and to any federal agency funding the activity as described in the Institutional Animal Care and Use Committee Guidebook. 4. Review all concerns involving the care and use of animals at Rose-Hulman Institute of Technology 5. Make recommendations to the Institute Official regarding any aspect of the animal program, facilities or personnel training. 6. Review, approve, or require modifications to, protocols for live vertebrate animal care and use activities. A complete review of all activity (protocols) is required at least once every three years for PHS and annually for USDA. 7. Review, approve, or require modifications to, protocols that propose significant changes regarding the use of animals in ongoing activities. 8. Be authorized to suspend an activity involving animals in accordance with specifications in IV.C.6 of PHS Policy (i.e., an activity that is not being conducted in accordance with applicable provision of the Animal Welfare Act, the Guide, the Institute s Assurance, or PHS Policy.) This action may be taken only after review of the matter at a convened meeting of a quorum of the IACUC and a vote for suspension by the majority of the quorum present. The Institute Official, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW. Approved: November 16, /28 -

5 9. Submit an annual report to OLAW through the Institute Official if Rose-Hulman holds a PHS Assurance. This report details changes in the animal care and use program, IACUC membership, dates of semiannual review and reports submitted to the Institute Official. 10. Submit annual report (on or before December 1 each year) to APHIS, AC Regional Director for Indiana. Form 7023 will be prepared by the IACUC and signed by the IO. This report includes assurances to the USDA that animal care and use are at professionally accepted standards, that alternatives to painful procedures have been considered and that Animal Welfare Regulations have been followed. E. Training for the IACUC 1. Each new IACUC member will receive a copy of Rose-Hulman Institute of Technology Laboratory Animal Care and Use Policy, and the Institutional Animal Care and Use Committee Guidebook for review and reference. 2. Rose-Hulman subscribes to the Veterans Administration web site, designed to help institutions meet requirements for research training mandates. Each IACUC member will review course materials for Essentials for IACUC Members and subsequently pass the course exam. Rose-Hulman s Environmental Health and Safety Officer is the administrator of this web site and will have access to training records for the Institute. F. IACUC Proceedings 1. Meetings A meeting of the IACUC will occur once per month during the academic year and as needed during the months of June through August. The IACUC Chair will provide the Rose-Hulman community with the meeting schedule in September of each year. The Chair of the IACUC may also call special meetings as required. Questions regarding the meeting schedule should be addressed to the IACUC Chair. The IACUC Chair will develop the meeting agenda and preside over the meetings. Protocols to be reviewed will be distributed to IACUC members no later than 10 working days in advance of the monthly meeting. 2. Quorum In order to conduct official business throughout a convened meeting of the IACUC, a quorum of voting members must always be present. Quorum is defined as a majority (>50%) of the voting members. If the number of committee members present falls below the quorum for any reason, official business must be tabled until a quorum can be reconvened. Approved: November 16, /28 -

6 3. Minutes a) The Secretary for the Committee will document the proceedings of the IACUC meetings which will serve as the official record. These minutes will be in sufficient detail to show attendance at the meetings; actions taken by the IACUC; the vote on these actions, including the vote count (for, against, and abstaining); the basis for requiring change in or disapproving a protocol; and a summary of deliberations leading to a decision. 4. Conflict of Interest a) No IACUC member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest, except to provide information requested by the IACUC. Possible examples of conflict of interest include cases where: (1) a member is personally involved in the activity (2) a member has a personal bias that may interfere with impartial judgment (3) a member s access to funding or intellectual information may provide an unfair competitive advantage (4) a member is involved in a competing research program Approved: November 16, /28 -

7 b) If the investigator submitting a protocol believes that an IACUC member has a potential conflict, the investigator may request that the member be excluded from the review process by submitting a written request to the IACUC Chair. c) When an IACUC member believes he/she has a conflict of interest, the voting member will notify the Chair in writing and recuse him/herself from voting and/or review as appropriate. G. Recordkeeping d) The IACUC Chair will determine how to resolve the disclosed conflict. In some situations, the member will be recused from voting only; in others it may be more appropriate to exclude the member from the review, discussion, and vote. 1. IACUC meeting minutes will be retained for a period of 6 years. Meeting minutes will include a record of attendance, activities of the committee, and Committee deliberations. 2. Protocols and proposed significant changes to protocols will be retained for a period of 3 years beyond the end date of the animal activity. All protocols submitted to the IACUC, whether approved or used, will be retained. The official protocol records will be kept in the IACUC Chair s Office. 3. Semiannual IACUC reports of the Animal Care and Use Program at Rose- Hulman and the Institute facility inspection report will be kept on file in the IACUC Chair s Office. 4. Animal health records will be kept in the animal facility for a minimum of 3 years. The Animal Care Facility Manager will ensure these records include the appropriate data and are in compliance with the Guide and Animal Welfare Regulations. Records will be accessible to PHS, APHIS and funding agencies for inspection or copying, and the IACUC during the semi-annual inspection. 5. The PHS Assurance document will be kept on file in the IACUC Chair s Office. 6. Annual reports to PHS (submitted to OLAW) and the USDA (submitted to APHIS) will be kept on file in the IACUC Chair s Office. 7. A copy of USDA registration will be maintained in the IACUC Chair s Office. 8. Suspensions and noncompliance require notification of PHS and/or USDA as appropriate. The IACUC will be responsible for reporting these situations in accordance with the procedures outlined in the Institutional Animal Care and Use Committee Guidebook. Approved: November 16, /28 -

8 IV. Program and Facility Review The PHS Policy and Animal Welfare Regulations (AWRs) stipulate that the IACUC must review the program for humane care and use of animals at least once every six months, using the Guide as the basis for evaluation. A. Program Review The IACUC is responsible for evaluating the Rose-Hulman Institute of Technology Animal Care and Use Program and for providing the Institute Official with a formal report of that evaluation. The IACUC will evaluate the following aspects of the Rose- Hulman Animal Care and Use Program during the semi-annual evaluation: 1. IACUC membership 2. functions and procedures (including protocol review) 3. facility inspection process 4. provisions for reviewing and investigating concerns regarding animal care and use 5. recordkeeping practices 6. methods employed to meet reporting requirements 7. occupational health and safety program 8. veterinary medical care program 9. personnel qualifications and training B. Facility Review Rose-Hulman, through its IACUC, is responsible for all animal-related activities regardless of where animals are maintained or the duration of the housing. The IACUC must have reasonable access to these areas for the purpose of verifying that activities involving animals are being conducted in accordance with the protocol approved by the IACUC. All animal housing facilities will be inspected in the semiannual review and are subject to random inspection. Animal housing facilities include containment areas such as satellite facilities and study areas where animals are housed for more than 12 hours, areas in which surgical manipulations are performed, and holding facilities. 1. Staffing and Scheduling Inspection a) Facility Inspection Team- While the entire IACUC is responsible for the review, the IACUC Chair, Veterinarian, and at least one other IACUC member will constitute the Facility Inspection Team. By law, any IACUC member who wishes to participate on the Team may do so. Approved: November 16, /28 -

9 b) The IACUC Chair will notify the Facility Manager of the date and time of an inspection. The Facility Manager is expected to be present at inspections to answer questions posed by the IACUC. 2. The IACUC will evaluate the following categories during the semi-annual review: a) Location b) Construction c) Room/Cage d) Cage/Run e) Sheltered or Outdoor Housing f) Behavioral Management g) Food and Water h) Bedding i) Sanitation j) Environmental Health and Safety k) Pest Control l) Emergency, Weekend, & Holiday Animal Care m) Animal Identification and Records n) Nomenclature o) Personnel p) Specialized Space C. Documentation and Reporting 1. The IACUC will prepare a written report of the semiannual program review and facility inspection and submit it to the Institute Official. While a designated inspection team may perform the facility review, the report must be reviewed and signed by a majority of the IACUC members. The report must describe the institution s adherence to the Animal Welfare Regulations, the PHS Policy, and the Guide, and identify specifically any deviations from these documents. The report will also indicate whether or not any minority views were filed. Minority views must be included in the final document. The report must be kept on file for Approved: November 16, /28 -

10 a minimum of 3 years. 2. Deficiencies identified in these reviews will be designated by the IACUC as minor or significant. A significant deficiency is defined as a situation that is, or may be, a threat to animal health or safety. The IACUC, in consultation with individuals to be involved in corrective action, will develop a reasonable and specific plan and schedule with dates for correction. Through the IO, the IACUC will promptly report to OLAW any significant or continuing noncompliance with the PHS Policy or any significant deviation from the provisions of the Guide. 3. IACUC will report to USDA, in writing, all significant deficiencies remaining uncorrected beyond the scheduled correction date within 15 business days of the original correction date. IACUC will submit this report through the Institute Official, to the Animal and Plant Health Inspection Service (APHIS) and to any federal agency funding the activity. V. Animal Environment, Housing and Management The Animal Care Facility Manager, appointed by Rose-Hulman, will be responsible for ensuring the animal environment, housing, and management is in accordance with the Guide. The Guide provides recommendations that are written in general terms and require the application of sound professional judgment (i.e., current best practices). Variances from Guide recommendations in animal care and husbandry will be evaluated by the Facility Manager to determine whether there is clear scientific justification or rationale for an alternative approach to accomplish a Guide standard. The Animal Care Facility Manager will be responsible for keeping the IACUC and the Veterinarian informed of any variances from the Guide standards. These variances are subject to approval by the IACUC. A. General Considerations for Housing and Management of Animal Facilities The Guide states: Proper housing and management of animal facilities are essential to animal well-being, to the quality of research data and teaching or testing programs in which animals are used, and to the health and safety of personnel. A good management program provides the environment, housing, and care that permit animals to grow, mature, reproduce, and maintain good health; provides for their well-being; and minimizes variations that can affect research results. BEFORE purchasing and housing animals in the Rose-Hulman Animal Care Facility, Principal Investigators must consider the following and consult with the Animal Care Facility Manager. 1. Animals must be housed in a manner that facilitates the expression of speciestypical behavior and minimizes stress-induced behaviors. For social species, housing systems should be designed to accommodate pair or group housing of animals. 2. Adequate animal husbandry practices and health maintenance are facilitated by well-constructed and maintained caging or housing systems. Cages should: Approved: November 16, /28 -

11 B. Animal Environment a) allow for conspecific (within species) social interaction within or between enclosures, adequate ventilation, and observation of animals with minimal disturbance b) provide a safe and secure environment that permits the normal physiologic and behavioral needs of the animals to be expressed c) enable ready access to food and water receptacles and be constructed of materials that balance the needs of the animal with sanitation d) be constructed with materials that resist corrosion and withstand chipping, cracking or rusting; Unsealed wood may be acceptable for use as perches or other climbing structures, resting areas, or in the construction of perimeter fences, runs and pens, but wooden items need to be replaced periodically because of wear, damage, and to achieve adequate sanitization. e) meet size requirements/recommendations provided in the AWRs and the Guide; Cage complexities, vertical height of the cage, and the cage design can influence how an animal uses the cage space provided. The cage must provide sufficient space so that, at a minimum, the animal can turn around and express normal postural adjustments. The animal must have sufficient clean and unobstructed space to move and rest in. Use of wire bottom cages is discouraged for rodents, especially on longterm studies or in larger and older animals, as it may cause foot injury. Use of wire bottom cages should be scientifically justified and approved by the IACUC. 1. Temperature, humidity, air pressure differential and air exchange rate, illumination level, and noise levels all may affect animal well-being and research results. a) The range of daily temperature fluctuations should be kept to a minimum to avoid large demands on the animals metabolic and behavioral processes. Relative humidity should also be controlled. In general, an air exchange rate of 10 to 15 changes per hour is considered an acceptable standard. b) Light intensity, duration of exposure, wavelength of light, light history of the animal, pigmentation of the animal and other factors should be considered when establishing an illumination level in the animal room. c) Because sound exposure can have variable effects on animals, noise should be minimized in animal areas. Approved: November 16, /28 -

12 d) Environments should be designed to accommodate animals that make noise, rather than resorting to methods of reducing the noise made by animals. e) Reliable methods for monitoring environmental control systems should be in place, including an after-hours monitoring and response program. Back-up heating, ventilation, air conditioning, and lighting systems are highly desirable. C. Animal Identification All research animals must be adequately and appropriately identified and records pertaining to individuals or groups of animals will be maintained by the Facility Manager. A wide range of acceptable identification methods can be employed, including: 1. cage cards 2. subcutaneous transponders 3. ear notches and tags 4. collars 5. colored stains 6. individual animal tattoos D. Animal Records 1. Records may consist of a cage card or may involve detailed individual animal information, depending principally on the species and research requirements. Cage cards should include: a) source of the animal b) strain or stock c) names and locations of responsible investigators d) pertinent dates (especially date animals received and surgery performed) e) protocol number E. Animal Diet and Nutrition 1. All animals should receive food that is: palatable, free from contamination, and of sufficient quantity and nutritive value to maintain their good health. Specific diets should be selected based on the needs of each species, with special consideration of the requirements for Vitamin C by guinea pigs and some species of nonhuman primates. Animals should be fed at least once a day except under Approved: November 16, /28 -

13 conditions of hibernation, veterinary treatment, pre-procedural fasts, or other justified circumstances. In some species and in some circumstances, varying the diet by providing treats can improve animal health and well-being. However, caution should be exercised that animals do not forsake eating their nutritionally balanced diet for treats. To help ensure that fresh, uncontaminated food is provided: a) bags should be stored off the floor, b) the milling date should be known (the date or a code is usually stamped on each bag) c) the oldest stock should be used first d) care must be taken to ensure animal food is discarded on expiration or shelf life expiration date 2. Food Storage -small quantities of food may be kept in animal rooms if stored in tightly covered, leak- and vermin-proof containers. Containers should not be moved from room to room. 3. Food Receptacles- Food should be provided in receptacles that are accessible to all animals in a cage or pen and placed so as to minimize contamination. More than one receptacle may be necessary for some socially housed animals. Food receptacles should be easily cleaned and sanitized, and those functions should be performed on a schedule that meets Guide and AWR requirements. With limited exceptions, (e.g., neonatal animals or animals with limited mobility) food should not be placed on the bottom of the cage. Although some species may prefer this presentation, it results in waste and contamination of the food. F. Watering Potable drinking water should be available continuously or provided as often as necessary for the health and well-being of the animal, considering the animal s species, age, condition, and any research requirements. Water may be provided in receptacles (e.g., bowls, bottles or via automatic watering systems). Whatever method is used, care should be taken to ensure that water does not become contaminated and is actually available. G. Bedding Bedding may be used in the housing of a variety of commonly used laboratory animals. Bedding material should be absorbent and free of any substances that might harm the animals or alter research data. Cedar and untreated softwood products can affect an animal s metabolism (e.g., liver enzymes), which may in turn affect immunologic or other physiologic parameters, and can increase the incidence of cancer. Bedding should be stored off the floor. Animals may be placed directly on bedding material, a common practice with many rodent species, or bedding may be placed under a slat-bottom cage. Bedding should be used in sufficient amounts and changed as often as necessary to keep the animals clean and dry and the animal room relatively odor free. Care should be taken Approved: November 16, /28 -

14 to keep bedding from contacting water tubes as this may lead to leakage of water into the cage. The frequency of bedding change depends on several factors, including the number of animals, species, type of caging, and type of bedding. VI. Facility Maintenance The Animal Facility Manager will oversee the animal care facility at Rose-Hulman and in that capacity will ensure the following facility maintenance standards are met. Animal facility workers (PIs, technicians, students) will address questions regarding operating procedure to the Animal Facility Manager. A. Cleaning and Sanitation Cleanliness and sanitation are essential to the operation of an animal facility. The Guide and Animal Welfare Regulations set forth recommended frequencies and methods for cleaning and sanitation of facilities, equipment and accessories. In general, the frequency and methods should ensure that animals are maintained in a clean, dry environment, free from exposure to harmful contamination and excessive animal odors. Cleaning agents that mask animal odors should not be used as a substitute for good sanitation practices. Cleaning equipment such as mops and buckets should not be moved from room to room due to the potential for cross-contamination. The most efficient and effective method of cleaning and sanitizing cages and accessories (e.g., feeders, water bottles, sipper tubes) is the use of a mechanical washing machine that provides rinse water temperature of at least 82.2 C (180 F) for a time adequate to achieve sanitization. Alternatively, portable high pressure spray washing and disinfection may be used. Least efficient and effective is hand washing and disinfection of such equipment. In general, enclosures and accessories (e.g., cage tops) should be sanitized at least every two weeks. Solid bottom cages, water bottles and sipper tubes should usually be sanitized weekly. The supply lines of automatic watering systems should be flushed and disinfected on a regular basis. B. Waste Disposal C. A research animal facility generates a significant amount of waste that must be removed and disposed of on a regular, frequent basis. All soiled animal bedding and carcasses from the research facility are considered medical waste. Waste containers with leakproof, tight fitting lids, and a biohazard sign are located in the animal facility. Animal facility workers must conform to the guidelines set forth in Rose-Hulman s Hazardous Waste Management Program. Contact the Environmental Health and Safety Office for medical waste disposal and questions regarding proper disposal. D. Pest Control The research animal facility is an active place, with frequent movement of personnel, animals, equipment, containers, and food and bedding, creating ideal conditions for the introduction of pests, including arthropods, birds and wild rodents. Pest control programs are complicated by the potential for harm to animals and personnel, as well as interference with research data by many commonly used pesticides. Approved: November 16, /28 -

15 A regularly scheduled, documented, pest control and monitoring program is coordinated through the Animal Facility Manager and managed by the Facilities Department. E. Emergency, Weekend and Holiday Care Laboratory animals must be observed by qualified personnel every day, including weekends and holidays to ensure their health and well-being, as well as to promote sound research practices. Skilled assistance, including veterinary care, must be readily available at all times. Names and telephone or pager numbers of those assigned these responsibilities should be prominently displayed in the facility. The Emergency Response and Disaster Preparedness Program is part of the Office of Public Safety. This program contains all relevant information relating to emergency situations on the Rose- Hulman campus. This program can be obtained from the Director of the Office of Public Safety at F. Behavior Management for Laboratory Animals There are varying requirements for attention to the behavioral management of laboratory animals, depending on the species of animal and the reference document. The Animal Facility Manager in conjunction with the Principal Investigator will be responsible for ensuring that all steps necessary are taken to promote the psychological well-being of the animals. There must be a documented environment enhancement plan for all non-human primates. The Guide provides recommendations for: 1. increasing the complexity of the structural environment 2. addressing the social environment of animals 3. promoting the expression of species-typical activity in a cohesive behavioral management program for all vertebrate species VII. Role of the Veterinarian A. Overview Rose-Hulman contracts with a local Veterinarian to provide veterinary care for animals used for research, teaching and demonstration purposes. The veterinarian is considered the resident expert on proper care and handling of laboratory animals and, as such, will educate and advise the IACUC and Animal Care Facility Manager as required. B. Responsibilities of the Veterinarian 1. Provide for the health and welfare of animals 2. Ensure the program and care provided to animals complies with standard veterinary practice Approved: November 16, /28 -

16 3. Consult with Animal Care Facility Manager and Principal Investigator regarding the introduction of new animals into the facility, providing advice on stabilization periods, isolation, and quarantine 4. Oversee preventive medicine programs such as: immunization against infectious pathogens, surveillance of colonies for specific infectious microbial agents, disease prophylaxis utilizing pharmaceutical agents, separate housing of animals according to species, source or different background microbial floras 5. Monitor animal health, providing adequate diagnostic support through clinical assessments, laboratory diagnosis and necropsy when required, and treating animals when illness or injury necessitates veterinary medical care 6. Delegate responsibility for care to trained technical staff using a documented process, but must always be available to provide rapid diagnosis and treatment 7. Provide guidance in selection and utilization of suitable anesthetic and analgesic agents and methods of euthanasia; appropriate selection of species for research projects; and proper performance of surgical procedures and adequate preoperative, surgical, and post-operative care 8. The veterinarian should discuss with investigators the design and implementation of protocols and may provide written guidelines dealing with these and other issues. (See New Protocol Submission section IX.C.2) VIII. Environmental Health and Safety (EHS) A. Overview Human environmental health and safety programs and animal colony health and use, as they relate to animal work, are regulated by federal, state, and/or local laws. Rose- Hulman Institute of Technology is committed to providing a safe and healthy work environment. To facilitate this objective, Rose-Hulman has established an Environmental Health and Safety Management Program, which addresses all relevant EHS issues involving animal care and use. The health and safety of animal and humans is the responsibility of all parties involved and depends on effective communication. B. Scope All animal facility personnel (e.g. animal caretakers, technicians, students, volunteers, investigators, veterinarians, facilities maintenance and custodial staff, and security) must adhere to established Rose-Hulman environmental health and safety programs. C. Responsibility and Commitment 1. The environmental health and safety of individuals working in animal care and use programs is the responsibility of Rose-Hulman and requires a commitment that begins with senior officials and department heads of the Institute. Approved: November 16, /28 -

17 2. Principal Investigators, the Animal Facility Manager, and other Supervisors must promote a higher level of safety awareness through positive leadership and reinforcement. In order for Rose-Hulman to maintain a safe, healthful environment for animals, caretakers, and researchers, these individuals must not permit safety to be sacrificed for any reason. 3. The Institute s Environmental Health and Safety Coordinator is charged with oversight of the Rose-Hulman Environmental Health and Safety Management Program. Questions regarding the environmental health and safety program related to animal care and use or other EHS issues should be addressed to this individual. D. Guidelines for EHS standards for Animal Care and Use Program Standards for Rose-Hulman Institute of Technology are modeled after guidelines set forth on pages of the Institute of Laboratory Animal Resources Guide for the Care and Use of Laboratory Animals (1996). Copies of this guide may be obtained from the Office of Environmental Health and Safety or may by viewed on-line at: 1. Personal Hygiene - Laboratory Safety Procedures All laboratory environmental health and safety compliance is prescribed in the Institute s Laboratory Safety and Chemical Hygiene Program. 2. Vaccinations and Exposure Control All vaccination requirements and exposure control issues are prescribed in the Institute s Exposure Control Program. 3. Female Caretakers a) Serological samples shall be taken on all women handling high-risk species (i.e. cats) prior to beginning work to avoid confusion about the significance of various positive antibody tests in case of subsequent pregnancy. b) Female caretakers, especially those of child-bearing age, without immunity to toxoplasmosis (cat scratch fever), should not be exposed to possible toxoplasmosis infection from infected species or contact with cats. c) Working with hazardous agents, in particular exposure to the possible inhalation of toxic chemicals, in the first trimester of pregnancy is discouraged. d) Personal Protective Equipment shall be worn at all times with additional precautions outlined by the principal investigator or supervisor prior to the start of the project. Approved: November 16, /28 -

18 4. Personal Protective Equipment Please refer to on Rose-Hulman s Personal Protective Equipment Program. A copy of this standard may be obtained from the Office of Environmental Health and Safety (OEHS). 5. Infectious Diseases Infectious diseases also pose a significant risk depending on the species and health status of animals involved and the level of exposure to them by animal care personnel. Infectious diseases to which animal care personnel may be exposed include: 6. Zoonoses a) viral infections, such as contagious ecthyma, the hepatitides, and Cercopithecine herpes virus 1 (Herpes B); b) rickettisal diseases, such as Q fever and cat scratch fever; c) bacterial diseases, such as tuberculosis, salmonellosis, and shigellosis; 1. protozoal diseases, such as toxoplasmosis, giardiasis, and cryptosporidiosis; and fungal diseases, such as dermatomycosis Zoonoses are diseases that can be transmitted from animals to humans and may be acquired through various routes. In many cases the animals show little, if any, sign of illness. Animal contact includes contact with animal products, the animal itself or a byproduct of the animal. Careful monitoring and quarantine of any animals with potential viral or bacterial infections or parasitic infestations are crucial components of any animal care and use program. It is important to immunize animal care personnel against tetanus. Routine tuberculosis testing is essential and measles vaccination may also be appropriate for workers exposed to nonhuman primates. a) Individuals whose work involves exposure to or handling of animals and animal tissues, body fluids and cell cultures should be aware of the possibility of illnesses that may be transmitted by contact with animals. b) The routes of infection include ingestion, inhalation, penetration of broken or unbroken skin, wound penetration, and contact with the mucous membranes of the eyes, nose and mouth via the following: (1) animal bites and scratches (2) contact with animal tissues and cultures, body fluids and excreta Approved: November 16, /28 -

19 (3) inanimate objects that are contaminated by the animal or animal contact (4) exposure to aerosols produced as a result of activities such as cleansing of cages c) All known human exposure to a zoonotic disease is considered an accident and must be reported by the employee to the principal investigator or their supervisor for appropriate medical treatment and investigation. An Employee and Supervisor Incident/Accident Report must be filed. d) If a zoonotic disease is suspected in an animal, the principal investigator or supervisor, and the IACUC Chairman shall be notified immediately for appropriate action. No Incident/Accident Report must be filed. e) All personnel are advised to contact the principal investigator or immediate supervisor for additional guidance and detailed information on specific zoonoses. Special attention shall be given to appropriate animal handling procedures, personal hygiene and protective equipment. E. Animal Care after Human Accident 1. An animal may require special procedures to identify the risk of human exposure to diseases. All samples, animals or equipment involved in a human injury shall be preserved and have special identification to aid in further testing and/or procedures. 2. The principal investigator or supervisor and the IACUC Chairman should be notified immediately for appropriate care of the animal, investigation of the incident and corrective action. 3. If the animal is used for teaching or research, medical information and care required shall be relayed to all participants specific to the animal type and use. F. Incident/Accident Investigation and Reporting 4. All work related incidents, work related injuries/illnesses and work related near misses, or those incidents/accidents that appear to have no apparent adverse effect, shall be reported immediately by the employee to their immediate supervisor or the Principal Investigator. a) The Principal Investigator must ensure that the appropriate department s Site Coordinator files an Incident/Accident Report with the Office of Risk Management. Approved: November 16, /28 -

20 b) If the Principal Investigator, immediate supervisor or other department or administrative personnel are unavailable, the employee should call the Rose-Hulman Public Safety Office ( ) to report incidents involving work related injury and/or property damage. Please refer to the Risk Management Office for procedures, detailed instructions and review of the appropriate claim forms. IX. Personnel Training and Documentation A. Animal Research Training Program All staff working directly with laboratory animals or in the animal care facility must be qualified to do so in order to ensure the humane treatment of animals. The PHS Policy and Animal Welfare Regulations (AWRs) mandate that personnel be trained and demonstrate competency in proper animal care and use procedures. Competencies required of animal care personnel vary according to their job responsibilities. Therefore, Rose-Hulman Institute of Technology has developed an Animal Research Training Program (ARTP) consisting of training modules tailored to the needs of animal care personnel. Individuals must complete the ARTP modules described below PRIOR to working with laboratory animals: 1. Core Module. This training module is required of all animal care personnel (PI, all animal facility workers, students, and technicians) a) Animal welfare laws, regulations, policies, guidelines b) The Rose-Hulman Animal Care and Use Policy and protocol form c) The role of the IACUC d) The basic needs of each species of animal (housing, food, water, bedding, social interaction) e) Behavior and appearance of healthy animals f) Cage card information and animal health record maintenance g) Proper handling and care for the various species of animals used by the facility h) Proper pre-procedural and post-procedural care of animals i) Recognition of pain and distress (including notification of PI, Vet or Facility Manager) j) How to report perceived deficiencies in animal care and use k) Environmental health and safety issues including: Approved: November 16, /28 -

21 (1) personal hygiene (2) prophylactic vaccinations (3) use of personal protective equipment (4) potential hazards - to include chemical and microbiologic safety and handling of waste (5) physical hazards - work related illness or injury (6) zoonoses (7) animal care after human accident (8) susceptibility of personnel - to include pregnant women, women of child-bearing age, and decreased immunocompetence (9) incident/accident reporting and medical treatment 2. Experimental Design and Protocol Preparation Module This module is for personnel involved directly with experimental design, protocol preparation and performance of animal research procedures (PI, research personnel, students assisting with experiments) and will include: a) The concepts of Replacement (using non-animal models), Reduction (use fewest number of animals possible), and Refinement (elimination or reduction of unnecessary pain and distress in animals) b) Minimizing and alleviating pain and distress: Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility c) Euthanasia and humane endpoints d) Aseptic technique, pre-procedural and post-procedural care e) Surgical techniques and proper pre- and post-operative care f) Utilization of services and resources (e.g. Animal Welfare Information Center, National Agricultural Library) available to provide information: (1) On appropriate methods of animal care and use (2) On alternatives to the use of live animals in research (3) That could prevent unintended and unnecessary duplication of research involving animals Approved: November 16, /28 -

22 (4) Regarding the intent and requirements of the [Animal Welfare] Act. g) Completing the Rose-Hulman Protocol Form 3. Species Specific Techniques Module This module is for personnel involved directly with experimental design, protocol preparation and performance of animal research procedures (PI, research personnel, students assisting with experiments) and will be prepared for each species of animal on campus. Topics will include: a) selection and procurement of animals b) husbandry and care c) handling and restraint d) identification and records e) animal health f) safety and health considerations g) specific techniques B. Frequency of Training 1. Animal care and facility personnel must complete the Core Module biannually. 2. Appropriate personnel must complete the Experimental Design and Protocol Preparation Module biannually. 3. Appropriate personnel must complete Species Specific Techniques either biannually and each time a new species is introduced into the facility. C. Personnel Training Records and Documentation 1. A training record will be maintained in the Environmental Health and Safety Office for each employee working either directly or peripherally with animals. The Environmental Health and Safety Coordinator will notify employees and their supervisor when re-certification is required. 2. It is the responsibility of the Facility Manager, Principal Investigators, and other Supervisors to notify the Environmental Health and Safety Coordinator when new personnel are hired or existing personnel or students are assigned to work with animals. Approved: November 16, /28 -

23 3. Proper training in humane animal care and use is an important component of the Environmental Health and Safety Management Program at Rose-Hulman. Its success is dependent on each employee s active participation and cooperation in every aspect of the program. X. Protocol Submission, Review, and Notification A. New Protocol Submission 1. All animal care and use procedures at Rose-Hulman Institute of Technology are to be documented on a Rose-Hulman Protocol Form (Attachment A) for review by the IACUC. The Principal Investigator is responsible for the submission of the written procedures. He or she may also be asked by the IACUC Chair to attend the IACUC review proceedings. 2. The law requires that an Attending Veterinarian (AV) be consulted by the PI when planning procedures in order to provide guidance in matters of animal medicine/technology and information necessary to complete immobilization, anesthesia, analgesia, tranquilization, euthanasia, proper performance of surgical procedures and adequate pre-operative, surgical, and post-operative care in accordance with current established veterinary medical and nursing procedures. The PI is to consult with the Attending Veterinarian prior to completing the form. 3. The PI is responsible for obtaining approval and signature from the Attending Veterinarian, Environmental Health and Safety Coordinator, Animal Care Facility Manager, and his/her Department Head prior to submitting a protocol form to the IACUC for review. Signature of each of these individuals is required on the protocol form before it is considered complete. Electronic signatures will be accepted. B. Protocol Review 1. Scope All activities involving the use of live vertebrate animals on Rose-Hulman s campus must be approved by the Institutional Animal Care and Use Committee (IACUC) before such procedures commence. 2. Review Criteria Principal Investigators and the IACUC share an equal responsibility to ensure animal experiment plans and procedures adhere to the following U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training (which encompass both the PHS Policy and the Animal Welfare Regulations): a) Principle I: The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C et. seq.) and other applicable Federal laws, guidelines, and policies.* Approved: November 16, /28 -

24 b) Principle II: Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society. c) Principle III. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. d) Principle IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals. e) Principle V. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on un-anesthetized animals paralyzed by chemical agents. f) Principle VI. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure. g) Principle VII. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated. h) Principle VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals. i) Principle IX. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration. *For guidance throughout these Principles, the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences. Approved: November 16, /28 -