UPPS 02.02.05 - Animal Care and Use Policy

POLICY STATEMENT

Texas State is committed to maintaining the highest possible standards for the care and use of animals.

1. BACKGROUND INFORMATION

   1. Texas State University recognizes the importance of the use of animals in its education and research programs. The use of animals is vital both for understanding basic biological, agricultural, and ecosystem processes, as well as in developing diagnostic, therapeutic, and preventive approaches for human and animal diseases. It is Texas State’s policy to provide all animals used in education and research with humane care and treatment.

   2. Texas State endorses as its own, United States Government’s Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. Texas State, including its researchers, faculty, students, and staff, accepts responsibility for determining that research and education involving the use of animals fulfill the principles outlined in the aforementioned document.

   3. The purpose of this policy is to establish and standardize procedures and regulations concerning the procurement, maintenance, handling, and disposal of all live animals for education and research purposes by Texas State.

   4. Specifically, adherence to the policy set forth in this document will ensure that Texas State is in compliance with regulations established by the federal government under the Animal Welfare Act (AWA) and with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS policy), whether or not federal funding is involved.

   5. The U.S. Department of Agriculture (USDA) administers AWA (7 U.S.C. Sections 2131-2156) and its implementing regulations, published in 9 C.F.R., Title 9, Subchapter A, Parts 1-4. The AWA regulates the transportation, purchase, sale, housing, care, handling, and treatment of animals used in research, for exhibition, and sold as pets. The AWA specifically includes dogs, cats, nonhuman primates, guinea pigs, hamsters, rabbits, wild animal species, and any other warm-blooded animals that the Secretary of Agriculture determines are being used or intended for use for research, testing, experimentation, exhibition purposes, or as pets. Beginning June, 1990, farm animals used in biomedical research are subject to inspection under the AWA.

      USDA’s Regulatory Enforcement and Animal Care Branch of the Animal and Plant Health Inspection Service (APHIS) administers the AWA. Research facilities are subject to unannounced inspections by USDA personnel and are required to furnish annual reports that include, in addition to other information and assurances, the common names and numbers of animals used, listed by procedures involving:

      1. no pain or distress;

      2. pain or distress for which appropriate anesthetic, analgesic, or tranquilizing drugs were used; and

      3. pain or distress for which the use of appropriate drugs would adversely affect the procedures, results, or interpretation of the research.

   6. PHS policy incorporates the changes in the Public Health Service Act mandated by the Health Research Extension Act of 1985, Public Law 99-158, as amended in 2002. PHS policy requires that each institution receiving PHS funds for research involving animals submit detailed information regarding the institution’s program for the care and use of animals (including all vertebrate animals) to the Office of Laboratory Animal Welfare (OLAW). At least every five years, the university must resubmit this information in the form of an Animal Welfare Assurance. The university must report significant changes in existing assurance status or problems encountered in implementing this policy to the OLAW immediately. PHS policy requires institutions to use "The Guide for the Care and Use of Laboratory Animals" (the Guide) as a basis for developing an institutional program for activities involving laboratory animals. In 1962, the National Academy of Sciences Institute for Laboratory Animal Resources (ILAR) developed the Guide under contract with the National Institute of Health (NIH). Its purpose is to assist scientific institutions in using and caring for laboratory animals in ways judged to be professionally appropriate. NIH policy dictates that grantees and contractors using live vertebrate animals in projects or activities supported by NIH use the recommendations in this publication for guidance.

   7. The institutional official (see Section 02.10) shall maintain awareness of people or organizations that may illegally interfere with legitimate institution activities involving the care and use of animals. This official should be informed of such activities elsewhere and be prepared to act in the event of such an occurrence at Texas State.

   8. The policy set forth in this document will be changed as required by future changes in federal law.

2. DEFINITIONS

   1. Ag Guide – Guide for the Care and Use of Agricultural Animals in Research and Teaching, Fourth Edition, 2020, or succeeding revised editions, developed by the Federation of Animal Science Societies.

   2. American Veterinary Medical Association Guidelines (AVMA) – AVMA Guidelines for the Euthanasia of Animals, 2020 Edition, or succeeding revised editions, is the prime reference for methods of euthanasia of animals. The methods of euthanasia developed by the AVMA Panel on Euthanasia are considered acceptable by both PHS policy and the AWA.

   3. Animal – any live, vertebrate animal used or intended for use in education, research, research training, experimentation, biological testing, exhibition, or for related purposes. Control of feral animals, nuisance species, exotics, or other uses outside of the uses listed within this policy do not require Institutional Animal Care and Use Committee (IACUC) approval, but may require permitting by other agencies, as appropriate to the taxa.

   4. Animal Facility – any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. A satellite facility is a containment outside a core facility or centrally-designated or managed area that houses animals for more than 24 hours. This includes all buildings, structures, farms, fish tanks, and other facilities owned or used by Texas State, such as federal and state fish hatcheries.

   5. Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) – provides voluntary peer review and awards accreditation of laboratory animal care facilities and programs that meet its rigid standards. Representatives of this organization make periodic visits and inspections to assure the institution meets the standards. The NIH, in its current policies, accepts AAALAC accreditation as the best means of demonstrating conformance with NIH requirements for animal care and use.

   6. Assurance – the Animal Welfare Assurance, an agreement negotiated by OLAW formalizing Texas State’s commitment to compliance with PHS policy, the Guide, and the AWA.

   7. EHSREM – Texas State’s Environmental, Health, Safety, Risk and Emergency Management program.

   8. Good Laboratory Practice Act (GLP) – pertains to nonclinical laboratory studies done in support of applications or marketing permits for products regulated by the Food and Drug Administration (FDA). The GLP regulations, as they apply to the use of animals, address such issues as construction and maintenance of facilities, quarantine and isolation, disease and diagnosis and treatment, animal identification, caging and routine care, sanitation, and documentation requirements.

   9. Institution – Texas State University.

   10. Institutional Official – an individual who signs, and has the authority to sign, Texas State’s Assurance, making a commitment on behalf of Texas State that the requirements of PHS and USDA policy are met. The institutional official is the Chief Operating Officer of the Division of Research.

   11. Livestock Conservation Institute (LCI) – national organization that focuses research, outreach, marketing and promotion, and genetic rescues to help ensure the future of rare breed agriculture.

   12. Office of Laboratory Animal Welfare (OLAW) – a component of the PHS that provides guidance and interpretation of the PHS policy and monitors compliance of assured institutions and PHS funding components.

   13. Principal Investigator (PI) – the researcher, faculty, or staff member with primary responsibility for the education, research, research training, experimentation, biological testing, exhibition, or other activity in which vertebrate animals will be used.

   14. Public Health Service (PHS) – includes the Alcohol, Drug Abuse, and Mental Health Administration; The Centers for Disease Control and Prevention; the FDA; the Health Resources and Services Administration; the NIH; and the Office of the Assistant Secretary for Health, Department of Health and Human Services.

   15. Quorum – a majority of the total number of voting members of the IACUC.

   16. Texas State’s Institutional Animal Care and Use Committee (IACUC) – The IACUC is not a law enforcement agency.

   17. The Guide – The Guide for the Care and Use of Laboratory Animals, 2020, Eighth Edition, or succeeding revised editions.

   18. U.S. Department of Agriculture (USDA) – administers the AWA and its implementing regulations.

   19. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training – developed by the Interagency Research Animal Committee (IRAC). These principles are consistent with the guidelines Texas State has adopted for laboratory animal care.

3. INSTITUTIONAL RESPONSIBILITIES AND AUTHORITY

   1. Recognition of the Authority of OLAW

      1. Texas State recognizes that OLAW has the authority to:

         1. restrict or withdraw approval of Assurances; request and negotiate, approve or disapprove, and, as necessary;

         2. distribute to executive secretaries of initial review and technical evaluation groups and to PHS awarding units, lists of institutions that have an approved Assurance;

         3. advise awarding units and awardee institutions concerning the implementation of animal care policy;

         4. evaluate allegations of non-compliance with PHS policy;

         5. review and approve or disapprove waivers to PHS policy; and

         6. conduct site visits to Texas State.

   2. Institutional Program for Animal Care and Use

      1. The Assurance shall fully describe Texas State’s program for the care and use of vertebrate animals. The PHS requires institutions to use the Guide as a basis for developing and implementing an institutional program for activities involving animals. The program description will include the following:

         1. a list of every branch and major component of Texas State, as well as of any other institution included under the Assurance;

         2. the lines of authority and responsibility for administering the program and ensuring compliance with institutional policy;

         3. the qualifications, authority, and responsibility of the veterinarian who will participate in the program and the percent of time each will contribute to the program;

         4. the membership list of the IACUC, established in accordance with the requirements set forth in this policy;

         5. the procedures that the IACUC will follow to fulfill the requirements set forth in this policy;

         6. the health program for personnel who work in laboratory animal facilities or have frequent contact with animals;

         7. a synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment, or use;

         8. the gross square footage of each animal facility (including satellite facilities), the species housed therein, and the average daily inventory, by species, of animals in each facility; and

         9. any other pertinent information requested by OLAW.

      2. The institution will implement policies that will enable it to maintain its Assurance in the event that PHS funding is applied for or ongoing. The institutional official will type the Assurance on Texas State letterhead, sign it, and submit it to the PHS for OLAW evaluation.

      3. All Assurances submitted to the PHS will be evaluated by OLAW to determine the adequacy of Texas State’s proposed program for the care and use of animals.

      4. An Assurance is approved for a specified period, no longer than five years, after which time Texas State must submit a new Assurance to OLAW. On the basis of this evaluation, OLAW may approve or disapprove the Assurance or negotiate an Assurance with Texas State. OLAW may limit the period during which any approved Assurance shall remain effective.

   3. Reporting Requirements During Times of PHS Funding

      1. At least once every 12 months, the IACUC, through the institutional official, shall report in writing to OLAW:

         1. any change in Texas State’s program or facilities that would place Texas State in a different category (see Section 03.07) than specified in its Assurance;

         2. any change in the description of Texas State’s program for animal care and use;

         3. any changes in the IACUC membership; and

         4. notice of the dates that the IACUC conducted its semi-annual evaluations of Texas State’s program and facilities and submitted the evaluations to the institutional official.

      2. At least once every 12 months, the IACUC, if it has no changes to report, shall submit a letter, through the institutional official, to OLAW stating that there are no changes and informing OLAW of the dates of the required IACUC evaluations and submissions to the institutional official.

      3. The IACUC, through the institutional official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

         1. serious or continuing non-compliance with this policy;

         2. any serious deviation from the provisions of the appropriate guide;

         3. any suspension of an activity by the IACUC; and

         4. reports filed, including any minority views filed by members of the IACUC.

   4. Record Keeping Requirements

      1. The institutional official of Texas State shall maintain:

         1. an Assurance that OLAW has either approved or deemed provisionally acceptable;

         2. minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations;

         3. records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld; and

         4. records of semi-annual IACUC reports and recommendations (including minority views) and records of accrediting body determinations.

      2. The institution will maintain all records for at least three years. Records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the IACUC will be maintained for the duration of the activity and for an additional three years after completion of the activity.

      3. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

   5. Procedure for Appointment of the Institutional Official and the IACUC

      1. Appointment of the Institutional Official

         1. The president of Texas State will designate the vice president for Research and Sponsored Programs as the institutional official with the authority to sign Assurances and other documents related to the institutional program for animal care and use.

      2. Appointment and Responsibilities of the IACUC Chair

         1. The institutional official will appoint the IACUC chair from existing Texas State faculty. The chair must have a Ph.D., D.V.M., or M.D. degree in a scientific discipline and have experience in animal research and with federal regulations concerning animal research.

         2. The IACUC chair will implement policy, as described in Section 04.

         3. The IACUC chair will report to the institutional official and will serve in this capacity for a renewable three-year term.

      3. Compensation for the IACUC Chair

         1. Compensation for the duties of the IACUC chair shall consist of appropriate release time for the faculty person usually equivalent to the teaching of one course during the fall or spring semesters, or during one summer session, or salary compensation equivalent to that of one summer session.

      4. Appointment of the IACUC

         1. Upon the recommendation of the IACUC chair, the institutional official will appoint the members of the IACUC committee.

         2. The members of the committee will serve for a renewable three-year term.

   6. Institutional Status

      1. Texas State will assure that its program and facilities are in one of the following categories:

         1. Category 1 – accredited by the AAALAC. The institution will evaluate all of its programs and facilities (including satellite facilities) for activities involving animals under guidelines applicable for AAALAC accreditation or another accrediting body recognized by PHS. The IACUC will evaluate all of the institution’s programs and facilities (including satellite facilities) for activities involving animals and will re-evaluate these same programs at least once every six months, in accordance with Section 04.06 d. and reports prepared in accordance with Section 04.06 e.; or

         2. Category 2 – evaluated by the institution. The IACUC will evaluate all of the institution’s programs and facilities (including satellite facilities) and will re-evaluate them at least once every six months, in accordance with Section 04.06 d. and prepare reports in accordance with Section 04.06 e.

   7. Institutional Program Standards

      1. The Guide provides standards to assist institutions in caring for and using animals in ways judged to be scientifically, technically, and humanely appropriate.

      2. Recommendations in the Guide are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with both high-quality research and humane animal care and use.

         1. Space Requirements – Generally, animals shall receive adequate space for normal movement, changing position (e.g., standing, lying down, turning around, and other physical activities), and body maintenance (grooming, etc.) with respect to their size, age, condition, and expected confinement duration. Subject to justification and committee review, the institution may approve modifications for specific experiments, such as metabolism studies involving a limited number of animals. The institution will ensure working pens, fencing, and other retention or holding facilities are free of harmful objects or protrusions to avoid unnecessary pain, harm, or fear to the animal.

         2. Transportation – The institution will ensure loading equipment and transport vehicles are built and maintained to prevent animal and personnel injuries, and protect animals against extreme heat or cold conditions as the LCI guidelines (trucking guide and poultry handling) recommend, considering intensity, trip length, and weather conditions.

         3. Outdoor Maintenance and Protection – Animals should be maintained under conditions compatible with general comfort, health, and well-being. To help protect animals from weather extremes, the institution will provide appropriate shelter and shade and a thermoneutrality comfort range to a reasonable extent. Outdoor protection considerations may include breed background or adaptation, accessible natural protection, and other factors.

         4. Nutrition – Minimal animal nutritional requirements are provided as outlined in the National Academy of Sciences publications of nutrient requirements for domestic animals. As part of research objectives, the institution may justify significant deviations from published requirements. In extreme cases (such as prolonged withholding of essential nutrients), a full justification and review will be required.

         5. Sanitation – The institution will keep animal facilities clean and will remove animal excrement on a reasonable periodic basis. It will not force animals to lie in their own excrement or that of other animals. When areas become excessively wet and boggy (to the degree that it jeopardizes health or significantly inhibits normal movement) due to precipitation or feces or urine accumulation, the institution will remove the animals. In instances where animals are not in direct contact with excrement (pits or litter-drop systems), some excrement accumulation is acceptable. The accumulation of harmful odors and gases (such as ammonia) should be minimized.

         6. Animal Identification – During research studies, the institution will identify each animal individually and retain its identity, using ear tags, neck chains, and other methods. When branding is merited or essential for identification, freeze branding is recommended.

         7. Maintenance and Treatment – Animal care procedures shall meet or exceed those in commercial practices with major consideration given to humane and sanitary care in handling and treating animals, including castration, dehorning, and other cultural practices.

         8. Standard Agricultural Practices – Long-term animal welfare may necessitate certain commercial husbandry procedures that may cause temporary discomfort or pain. The AWA accepts these practices as standard procedures provided they are:

            1. warranted in agricultural production;

            2. performed by or under the supervision of capable personnel; and

            3. performed with precautions to reduce pain, stress, and infection.

         9. Protocols – The PI or instructor must design animal experiments or activities that comply with the Guide practices for the reasonable care and use of agricultural animals.

         10. Surgery – The institution will conduct surgical, metabolic, and other physiological and biological studies with appropriate facilities, adequate equipment, with veterinary consultation, and under the direction and supervision of qualified personnel for animal sanitation and protection, including both operative and post-operative recovery.

         11. Posted Information and Emergency Procedures – The institution will display a list of names and points of contact (i.e., responsible animal caretaker or ranch manager, key researchers, emergency or weekend telephone numbers, and feeding and inspection schedules) near the entrance to each livestock facility, building, or pasture. It will provide instructions regarding which personnel to notify in the event of an emergency (i.e., escaped animals, power failure, fire, injured, or sick animals) and reporting procedures regarding animal welfare concerns. The institution expects employees to conduct themselves according to the IACUC Code of Ethics that will be posted near the entrance to each livestock center or unit.

         12. Concerns Regarding Animal Welfare – Anyone with concerns about animal care and use should report their concern to the IACUC chair, or representative (24 hours a day), who will investigate the concern immediately. The IACUC chair, or representative, will take corrective action if a legitimate concern exists. If an animal is found in pain due to injury or other cause, the attending veterinarian or backup veterinarian will be notified. Care will be provided in accordance with veterinary recommendations. The IACUC will review such cases and issue a report to the appropriate department chair.

         13. Agricultural Animals for Market – The Freeman Center engages in teaching, research, and selected outreach activities, some of which involve animals raised and housed for the purpose of market production. Care of these livestock will meet all above guidelines, and inspections will be done alongside IACUC protocol animals. As market production is not an IACUC activity, per se, the Freeman Center will use the best management practices (BMPs) for the annual activities, with inspections and any necessary modifications done by the IACUC in the absence of a specific IACUC protocol for these market livestock activities.

4. INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) RESPONSIBILITIES AND AUTHORITY

   1. The institutional official shall recommend IACUC appointments, as described in Section 03.05.

   2. The committee shall consist of no fewer than six members, and shall include at least:

      1. one doctor of veterinary medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving laboratory animals at Texas State; or one doctor of veterinary medicine experienced in disease prevention and animal health procedures associated with farm animals;

      2. a member to serve as committee chair. The IACUC Chair has the responsibility for overseeing the coordination and implementation of effective, efficient systems for protocol review and program review by the IACUC in compliance with PHS policy and the AWA.

      3. a practicing scientist experienced in animal research;

      4. one member whose primary concerns are in a non-scientific area (e.g., ethicist, lawyer, or member of the clergy); and

      5. one individual who is not affiliated with Texas State in any way other than as a member of the IACUC and is not a member of the immediate family of a person who is affiliated with Texas State.

      An individual who meets the requirements of more than one of the categories may fulfill more than one requirement; however, no committee will consist of fewer than six members.

   3. As an agent of Texas State, the IACUC shall, with respect to teaching and research activities involving animals:

      1. review concerns involving the care and use of animals at Texas State;

      2. make recommendations to the institutional official regarding any aspect of Texas State’s animal program, facilities, or personnel training;

      3. review and approve, require modifications in (to secure approval), or withhold approval of those components of activities related to the care and use of animals as specified in this document;

      4. review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and

      5. have authorization to suspend any activity involving animals in accordance with specifications set forth in this document.

   4. Meetings of the IACUC

      1. The IACUC will hold meetings semi-annually, and as required, to approve proposals or review programs already in progress.

      2. During full committee review members are provided with access to all protocols prior to the meeting.

      3. The IACUC chair will convene these meetings.

   5. Review of Educational and Research Projects

      1. In order to approve proposed projects or proposed significant changes in ongoing projects, the IACUC shall review those components related to animal care and use, and determine whether the proposed projects agree with this document.

      2. In making this determination, the IACUC shall confirm that the PI will conduct the project in accordance with the AWA insofar as it applies to the project, and that the project complies with the Guide unless the PI presents acceptable justification for a departure.

      3. Further, the IACUC shall determine that the project meets the following requirements:

         1. procedures with animals will avoid or minimize discomfort, distress, and pain to the animals;

         2. procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the absence of sedative, analgesia, or anesthesia is justified for scientific reasons in writing by the PI;

         3. animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure;

         4. the living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and non-medical care of the animals will 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;

         5. medical care for animals will be available and provided as necessary by a qualified veterinarian;

         6. personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures; and

         7. methods of euthanasia used will be consistent with the recommendations of the AVMA, unless a deviation is justified for scientific reasons in writing by the PI.

      4. Prior to the review, each IACUC member will receive a list of protocols to review. All IACUC members will have access to written protocols of projects that involve the care and use of animals, and any IACUC member may request full committee reviews of those research projects.

      5. If full committee review is not requested, at least one member of the IACUC, designated by the chair and qualified to conduct the review, shall review those research projects and have the authority to approve, require modifications in (to secure approval), or request full committee review of those research projects.

      6. If full committee review is requested, the IACUC may grant approval of those research projects only after review at a convened meeting of a quorum of the IACUC and with the approval vote of a majority of the quorum present.

      7. No member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest (i.e., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.

      8. The IACUC may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an activity or vote with the IACUC.

      9. The IACUC shall notify PIs in writing or electronically of its decision to approve or withhold approval of those activities related to the care and use of animals or of modifications required to secure IACUC approval. If the IACUC decides to withhold approval of an activity, it shall include in its written notification, a statement of the reasons for its decision and give the PI an opportunity to respond in person or in writing.

      10. The IACUC shall conduct continuing review of activities covered by the protocol at appropriate intervals as determined by the IACUC, but not less than once each year. The IACUC will conduct a de novo review of the protocol every three years.

          1. The PI is responsible for:

             1. ensuring all study personnel remain compliant with animal research training requirements;

             2. ensuring the continuing review submission is received in time for the IACUC review prior to the study’s expiration date; and

             3. providing enough time and accurate information to the IACUC for the determination of whether the criteria for approval of research continues to be met. IACUC staff and members will carry out these procedures.

      11. The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the AWA, the Guide, the Ag Guide, Texas State’s Assurance, or this policy.

      12. The IACUC may suspend an activity only after review of the matter at a convened meeting of a quorum of the IACUC and with the suspension vote of a majority of the quorum present.

      13. The chair of the IACUC may intervene in the event of existing threats to animal welfare, departure from protocol, or other extraordinary circumstances to immediately rectify the situation prior to the quorum meeting of the IACUC for review.

      14. If the IACUC suspends an activity involving animals, the institutional official, in consultation with the IACUC, shall review the reasons for suspension, take appropriate corrective action, and report such action with a full explanation to OLAW.

      15. Protocol applications and proposals that have been approved by the IACUC may be subject to further appropriate review and approval by officials of Texas State. However, those officials may not approve an activity involving the care and use of animals if that protocol has not been approved by the IACUC.

   6. Inspection and Review

      1. At least every six months, the IACUC and the IACUC chair, or delegate, will inspect all Texas State animal housing facilities. The IACUC will use the Guide to determine compliance with Texas State policy, with written notice of non-compliance given to the responsible PI and the institutional official.

      2. Every six months, the IACUC and the IACUC chair, or delegate, will inspect all animal-handling facilities, including surgeries, restraining devices, and any structure or device used for the temporary restraint or manipulation of animals.

      3. The IACUC and the IACUC chair, or delegate, will use the Guide to determine compliance with Texas State policy, with written notice of non-compliance given to the responsible PI and the institutional official.

      4. Every six months, Texas State’s program for humane care and use of animals will be reviewed and evaluated at least once, using the Guide as a basis for evaluation.

      5. The PHS policy, Section IV.B.3., requires the IACUC prepare and submit a report of their semiannual evaluation to the institutional official. The report must include the following information:

         1. description of the nature and extent of the institutions adherence to the Guide and PHS policy, including any departures and reason for each departure;

         2. identification of any deficiencies in the program or facility, including classification as either significant or minor and a reasonable and specific plan and schedule for correction;

         3. minority views of the IACUC;

         4. identification of facilities accredited by AAALAC; and

         5. signature of a majority of the IACUC members, if applicable.

      6. IACUC will prepare reports of the IACUC evaluations conducted as required by PHS policy and will submit the reports to the institutional official.

         1. The reports will contain a description of the nature and extent of Texas State’s adherence to the appropriate guides, will identify specifically any departures from the provisions of the appropriate guides and PHS policy, and will state the reasons for each departure.

         2. The reports will distinguish significant deficiencies from minor deficiencies. A significant deficiency is one that, in the judgment of the IACUC and the institutional official, is or may constitute a threat to the animals’ health and safety.

         3. When program or facility deficiencies are noted, the reports will contain a reasonable and specific plan and schedule for correcting each deficiency.

         4. At least every six months, upon completion of the required semi-annual evaluations, the IACUC will update the reports, making certain to maintain the reports and make them available to OLAW upon request.

5. HEALTH AND SAFETY REQUIREMENTS

   1. Occupational Health and Safety (OHS)

      1. The OHS program is a required component of the university’s Program for Animal Care and Use. The primary function of OHS is to protect Texas State animal users, and others having contact with animals used for research or scholarship, by evaluating and mitigating potential risks to health and safety. Enrollment in the OHS program is mandatory for all individuals who have or will have frequent or substantial contact with animals or will be exposed to potential risk to health and safety due to direct or indirect contact with living vertebrate animals in a lab, classroom, animal facility, natural wildlife area, or other off-campus location, unfixed animal tissue or animal bodily fluids, pathogens related to living animals, including animals extraneous to, but in the same area as, research or scholarship activity, or other environmental health and safety hazards associated with the location of research or scholarship involving animals.

      2. Potential hazards and the possibility of zoonoses transmission will be considered by the IACUC during protocol review.

      3. On the protocol application for animal use, PIs are required to identify potential health and safety risks, including but not limited to:

         1. chemical, biological, and radiological hazards;

         2. risk of zoonoses transmission; and

         3. animal-related injuries to personnel.

      4. At least one staff member from EHSREM will serve as a consultant of the IACUC to provide safety consultation and expertise.

      5. PIs will be responsible for notifying EHSREM for the pick-up and disposal of hazardous waste and sharps generated in animal facilities.

      6. The Guide contains recommendations for disposal of animal carcasses. Prior to disposal, the institution may store carcasses in dedicated cool rooms, refrigerators, or freezers.

      7. The institution will place animal carcasses in plastic bags and transport to containment facilities by licensed, commercial-waste disposal firms.

      8. Animals exposed to radioactive materials will be disposed of with other radioactive waste.

      9. Researchers utilizing vehicles, equipment, or other potential vectors of bio-pollution in their research or investigations will act in accordance with Hazard Analysis and Critical Control Point Natural Resource Management (HACCP-NRM). The HACCP-NRM methods for preventing the spread or introduction of nuisance species provide a long-term benefit to the systems in which research, education, and outreach activities are conducted.

      10. All aquatic laboratories under IACUC purview are required to post the Occupational Safety Fact Sheet notice that describes the risks in handling animals, dangers and risks of zoonotic diseases, and the importance of personal hygiene and protection.

   2. Occupational Health Assessment Questionnaire

      1. To help identify any medical conditions that may pose a health risk as a result of contact with animals, all individuals listed on the protocol must submit documentation that they have had an occupational health assessment.

      2. The occupational health assessment must be completed and reviewed by a qualified health professional.

      3. Individuals working with animals on the protocol should discuss the following with a qualified health professional:

         1. known allergies;

         2. illnesses or medication; and

         3. pregnancy, nursing, or other conditions that may suppress the immune system.

   3. Required Immunization

      A tetanus booster within the last 10 years is highly recommended for all individuals who have recurrent animal contact. This is based upon guidance from The Center for Disease Control and Prevention.

      1. Documentation of other immunizations may be required depending on the animals used in the approved protocol.

6. TRAINING REQUIREMENTS

   1. IACUC Member Training

      1. IACUC members are required to complete an online or in-person training that includes the following topics:

         1. federal regulations related to animal care and use;

         2. standards and best practices for the humane care and use of animals in research;

         3. zoonoses and other potential health risks related to the care and use of animals;

         4. general safety practices and biosafety procedures;

         5. Texas State policy and procedures;

         6. responsibilities of the IACUC;

         7. authority of the IACUC;

         8. reviewing and voting procedures;

         9. inspection and program review;

         10. identifying and correcting program deficiencies; and

         11. investigating allegations of improper animal care or use.

      2. IACUC members will be required to take a refresher training course every three years.

   2. Training of Persons Involved in Care and Use of Animals

      1. All employees, students, and researchers listed on IACUC-approved protocols must complete the basic online training entitled, “Working with the IACUC,” covering:

         1. federal regulations related to animal care and use;

         2. standards and best practices for the humane care and use of animals in research;

         3. zoonoses and other potential health risks related to the care and use of animals;

         4. general safety practices and biosafety procedures;

         5. Texas State policy and procedures applicable to all individuals; and

         6. species-specific information.

      2. All employees, students, and researchers who have taken the basic Collaborative Institutional Training Initiative (CITI) training are required to take a refresher course every three years. It is the ultimate responsibility of the PI to ensure all individuals working in the lab have completed training.

      3. The PI is responsible for ensuring that all employees and students participating on the protocol have completed hands-on training relevant to the protocol, including species-specific information on animal behavior and animal handling techniques.

      4. The IACUC may require the PI, staff, or students to complete additional training that may include:

         1. provision of materials to remediate areas of deficiency in the knowledge of animal care; and

         2. further examination until proficiency in animal care and knowledge of regulations regarding animal care is demonstrated.

7. DIVISION OF RESEARCH AND PROCUREMENT PROCEDURES

   1. Applications and proposals for awards submitted to external funding sources that involve the care and use of animals shall contain the following information:

      1. identification of the species and approximate number of animals to be used;

      2. rationale for involving animals and for the appropriateness of the species and numbers to be used;

      3. a complete description of the proposed use of the animals;

      4. a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and

      5. a description of any euthanasia method used.

      The budget for grant funds to cover procurement and per diem costs of animals will include labor costs associated with animal maintenance.

   2. In the event that a proposed project involving the care and use of animals is awarded funding, the institutional official shall require documentation of IACUC approval prior to grant account set up.

   3. Procurement

      1. An approved animal use protocol must be in place prior to procurement of animals for use at Texas State.

      2. Before procuring animals, the PI should confirm that there are sufficient facilities and expertise to house and manage the species being acquired. Procurement of animals should be linked to the prior approval of animal use and number by the IACUC, as required by the Guide.

      Animal orders are routed to the IACUC office staff, via SAP, to confirm an approved protocol and sufficient animal numbers.

8. REVIEWERS OF THIS UPPS

   1. Reviewers of this UPPS include the following:

      Position	Date
      Chief Operating Officer Division of Research	January 1 E3Y
      Chair, Institutional Animal Care and Use Committee	January 1 E3Y
      Director, Office of Research Integrity and Compliance	January 1 E3Y

9. CERTIFICATION STATEMENT

   This UPPS has been approved by the following individuals in their official capacities and represents Texas State policy and procedure from the date of this document until superseded.

   Chief Operating Officer, Division of Research; senior reviewer of this UPPS

   Vice President for Research

   President