PART 9—STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY SUPPORTED SANCTUARY SYSTEM Authority: 42 U.S.C. 216, 287a-3a. Source: 73 FR 60423, Oct. 10, 2008, unless otherwise noted. § 9.1 Applicability and purpose. (a) General. (b) What is the purpose of the federally supported chimpanzee sanctuary system and the authority for establishing these standards of care regulation? (c) To what chimpanzee sanctuaries do the standards of care in this part apply? § 9.2 Definitions. As used in this part: Adequate veterinary care American Zoo and Aquarium Association (AZA) American Zoo and Aquarium Association (AZA) Accreditation Standards Animal Care and Use Committee Animal protection organization Animal Resource Manager (or Animal Resource Supervisor) Animal Welfare Act/Regulations Animal Welfare Assurance Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) Behaviorist Biosafety Officer Board of Directors (BOD) Chair of the Board of Directors Chief Executive Officer (CEO) CHIMP Act Chimpanzee Pan troglodytes. Pan paniscus Chimpanzee caregivers (caregivers) Contractor/Primary Contractor/Sanctuary Contractor Euthanasia Exhibition Facility director Facility Veterinarian Federal Acquisition Regulations (FAR) Federal agency Federally owned chimpanzees Guide The Guide for the Care and Use of Laboratory Animals Housing facility Indoor housing facility Interstate air transport live animals (IATA) regulations Invasive research (studies) (1) Experimental exposure to a substance that may be detrimental to a chimpanzee's health (e.g., infectious disease, radiation). This does not include accidental exposures to infectious diseases transmitted from cage mates or from radiation or other exposures at the time of regularly scheduled or necessary veterinary examinations and treatments; (2) Any invasion of a body cavity; (3) Surgery and surgical implantation of devices that are not a part of a veterinary medical treatment or colony management purposes. (4) Behavioral studies that cause distress or discomfort, such as induction of a fear response; (5) Testing of any drug; (6) Purposeful manipulation of social groups or the removal from their social group or addition of individuals in order to conduct behavioral research (for example, on aggression). Creation and refinement of social groups will be necessary when the animals arrive at the Sanctuary and this should take place only when necessary in regards to colony management and should not be driven by independently initiated research studies; (7) Restraint unless it is in conjunction with the annual exam or clinical care; and (8) Darting or anesthesia induction other than at annual exam or in the case of an emergency in which the chimpanzee's well-being is at stake. National Primate Research Center (NPRC) National Research Council Nonfederally owned chimpanzees Noninvasive research (studies) (1) Visual observation; (2) Behavioral studies designed to improve the establishment and maintenance of social groups. These activities may cause stress as a result of novel interactions between chimpanzees and caregivers, but they are not considered invasive as long as they are intended to maximize the well-being of the chimpanzees; (3) Medical examinations as deemed necessary to oversee the health of the chimpanzees, in the least invasive manner possible. Collection of samples routinely obtained during a physical examination for processing during this time is also considered noninvasive since a separate event is not required; (4) Administration and evaluation of environmental enrichment used to promote the psychological well-being of the chimpanzees; and (5) Actions taken to provide essential medical treatment to an individual chimpanzee exhibiting symptoms of illness. This applies only to serious illness that cannot be treated while the chimpanzee remains within the colony. Outdoor housing facility (area) Outdoor ranging Project Officer Sanctuary Chimpanzee Care Committee (SCCC) or similar designated committee Sanctuary Contractor Sanctuary Director Sanctuary or federally supported chimpanzee sanctuary system Secretary Subcontractor Surplus chimpanzees USDA licensed intermediate handler/carrier Zoonotic disease(s) [73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020] § 9.3 Sanctuary policies and responsibilities. (a) What are the policies and responsibilities governing the sanctuary system? (1) Appoint a Board of Directors (BOD) responsible for the overall governance and direction of the Sanctuary. The BOD shall designate the Chief Executive Officer (CEO), who is responsible for the management and oversight of the daily operations of the sanctuary and the performance of other delegated tasks. Subcontractors, if applicable, shall be governed by the policies that are developed by the Board of Directors of the primary contractor. (2) Direct the BOD to: (i) Ensure that chimpanzees accepted into the sanctuary are not discharged; (ii) Develop guidelines for accepting chimpanzees not owned by the Federal Government into the sanctuary if the conditions are met as outlined in 42 U.S.C. 287; (iii) Ensure that the Board of Directors of the primary contractor consists of no more than thirteen (13) individuals, and that the conditions governing the terms of the Board members are in compliance with the CHIMP Act; (iv) Include individuals with the following expertise and experience as set forth in the CHIMP Act; (A) At least one veterinarian who is qualified in veterinary care of nonhuman primates. These qualifications may be met through postdoctoral training, experience, or both; (B) Individual(s) with expertise and experience in zoological science and with knowledge in behavioral primatology; (C) Individual(s) with experience in the animal protection field; (D) Individual(s) with experience and expertise in the field of business and management of nonprofit organizations; (E) Individual(s) knowledgeable and experienced in accrediting programs of animal care; (F) Individual(s) with experience and expertise in containing biohazards; (v) Ensure that a member of the Board of Directors serves as the Chair of the Board of Directors, who may be elected or appointed by the Board from among the individuals identified in paragraphs (a) (1) (iv) (A) through (F) of this section; (vi) Ensure that no member of the board shall have been fined for, or signed a consent decree for, any violation of the Animal Welfare Act; (vii) Create a safe and species-appropriate physical and social environment for the lifetime care of chimpanzees; (viii) Comply with all applicable provisions of the animal welfare regulations and other federal, state and local laws, regulations, and policies; (ix) Achieve accreditations from appropriate accrediting bodies within a reasonable time frame mutually agreed upon by the Contractor and ORIP/DPCPSI; (x) Prohibit any invasive research on the resident chimpanzees, but permit noninvasive studies (Definitions for the terms invasive non-invasive (xi) Prohibit exhibition of chimpanzees in the sanctuary (This policy does not prohibit educational activities that may involve limited viewing of chimpanzees in their environment and that are designed to promote an understanding of chimpanzee behavior, well-being, or importance to the ecological system that does not adversely affect the chimpanzees' routine.); (xii) Staff the organization with people with appropriate experience; and (xiii) Authorize the establishment of a Sanctuary Chimpanzee Care Committee (SCCC) that is appointed by and reports to the CEO or President of the company or corporationThe SCCC is responsible for overseeing the chimpanzee care program and operations to ensure the health and well-being of the chimpanzees and the occupational safety of the staff are being addressed. The Committee must consist of no fewer than five people who must include: (A) A chair (person) knowledgeable of the needs of chimpanzees; (B) A veterinarian with chimpanzee care experience; (C) A behaviorist with experience in chimpanzee behavior; (D) A member of the chimpanzee care staff; and (E) Member or members from the community, including at least one with affiliation or employment with an animal protection organization as defined in § 9.2 of this part. (F) The SCCC will: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 (b) Who is responsible for developing or revising sanctuary policies? (2) The federal agency (ORIP/DPCPSI/NIH) designated by the Secretary must concur with any changes that substantially change existing policies. The Secretary, or designee, will determine if a policy change will have a substantial impact upon current policy after consultation with the Sanctuary Contractor. [73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020] Editorial Note: At 85 FR 54273, Sept. 1, 2020, § 9.3 was amended, however, the amendment could not be incorporated because paragraph (a)(8) does not exist. § 9.4 Physical facility policies and design. (a) What standards apply to the facility design and physical plant? The Guide for the Care and Use of Laboratory Animals (Guide) Guide Guide http://www.nap.edu http://oacu.od.nih.gov/regs/guide/guidex.htm. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (1) The facility design and physical plant consist of the following components: Indoor design features; outdoor design features; construction and construction materials; physical barriers; shelter; service support space, including storage areas for food, supplies, and equipment; personnel and administrative support space; quarantine and isolation facilities; treatment area; heating, ventilation, and air conditioning (HVAC); food preparation area; and animal waste treatment. (2) A housing system shall include indoor and outdoor enclosures that must be kept in good repair to prevent escape and injury to the chimpanzees, promote physical comfort, facilitate sanitation and servicing, and address the psychological well-being and social needs of the chimpanzees. Chimpanzees must be able to retreat from areas where they feel threatened or agitated by close human encounters or encounters with other chimpanzees. (3) Indoor areas shall have special areas for social introductions and medical treatment. Quarantine and isolation facilities are required for the sanctuary. These facilities must be designed to prevent the spread of undesirable agents from quarantine and isolation rooms to other parts of the facility. (4) Outdoor areas must provide sufficient ranging space and either natural or artificial structures that chimpanzees can use for shelter or nesting areas to sleep, rest, or seek refuge from rain, direct sun, wind, and extreme temperatures. (5) Animal waste from the Sanctuary must be properly treated to remove known hazardous agents before discharging it into the environment in accordance with currently acceptable and effective waste treatment procedures, including current industry standards and Federal laws, regulations or guidelines, as applicable. (6) An area for treatment of and performing veterinary clinical procedures on chimpanzees must be provided at each Sanctuary site. This area must be constructed and provisioned to perform emergency procedures, including minor surgery and emergency surgical procedures, complete physical examinations, and facilities for extended care of medical conditions as needed. (b) What security measures are required for the sanctuary? Guide (c) Is the sanctuary required to develop disaster and escaped animal contingency plans? Guide [73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020] § 9.5 Chimpanzee ownership, fees, and studies. (a) Who owns the chimpanzees in the federally supported sanctuary? (b) Is there a charge for placing chimpanzees in the sanctuary? (c) May the sanctuary agree to accept chimpanzees that are not owned by the Federal Government? (1) Ownership of the chimpanzee must be transferred to the sanctuary; (2) Fees for these chimpanzees may be levied based on a range of considerations that include most importantly, the well-being of the chimpanzee and, secondarily, factors that include (but are not limited to) the resources available to support the chimpanzee; the health, age, and social history of the chimpanzee; and other relevant factors affecting the cost of caring for the chimpanzee. While chimpanzees not owned or supported by the Federal Government may be admitted to the sanctuary, federal funds may not be used for their support unless authorized by the Secretary or an authorized designee; (3) Available space exists in the sanctuary; and (4) An agreement exists between the sanctuary system and the ORIP/DPCPSI/NIH documenting that the chimpanzee may be brought into the sanctuary. (d) What additional conditions apply when nongovernmental owned chimpanzees transfer to the chimpanzee sanctuary? (1) Chimpanzees transferred to the sanctuary sites must be permanently incapable of reproduction, for example, by vasectomy, tubal ligation, or another reliable procedure; (2) Complete histories must accompany each chimpanzee. Any chimpanzee missing documentation for any period of research or other use may not be transferred to the Sanctuary without the concurrent authorization of the Sanctuary Contractor's Board of Directors and the ORIP/DPCPSI/NIH; the records may be created and retained in electronic form; and (3) Appropriate screening of each chimpanzee must be performed to assess the likelihood of the chimpanzee being a health or safety threat to the care staff and/or other chimpanzees. (e) What are the criteria for acceptance and the fees for admission into the sanctuary for nongovernmental owned chimpanzees? (f) Under what circumstances might a chimpanzee from the sanctuary be returned to research at a United States research facility? [73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020] § 9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia. (a) What are the requirements for promoting the well-being of sanctuary chimpanzees? (b) What are the provisions for daily chimpanzee husbandry and care? (1) Chimpanzees must have access to food, water, and bedding at all times, unless medical or behavioral conditions dictate otherwise. Husbandry procedures shall represent current policies and practices and conform to standards set by a nationally recognized accrediting association in accordance with the Guide (2) Indoor primary enclosures must be cleaned as often as required to maintain a clean and healthy environment, with a minimum of once daily. Outdoor enclosures must be monitored daily and cleaned on a routine basis. Outdoor ranging areas will not require a routine cleaning schedule but must be monitored for excessive accumulation of waste or other unhealthy conditions. Housing areas shall provide sufficient space for chimpanzees to perform species-typical behavior and expression. Examples of such activities include but are not limited to natural movements, climbing, swinging, resting, running, group interactions, sleeping, etc. Feeding and watering implements must be sanitized at intervals required to maintain them in a sanitary condition, in accordance with the Guide (3) The federally supported chimpanzee sanctuary must employ a behavioral scientist knowledgeable in primate behavior and socialization requirements. This individual shall provide primary leadership in developing, implementing, and monitoring the chimpanzee behavioral guidelines for the sanctuary. Enrichment techniques used shall be currently accepted practices. The sanctuary must provide for the expertise to plan, administer, and evaluate the effectiveness of the well-being program. (4) Many chimpanzees can be trained through positive reinforcement to cooperate with a variety of veterinary and chimpanzee care procedures. Efforts must be made to develop or maintain this capability for chimpanzees housed in the sanctuary to the extent possible. Trainers must use currently acceptable practices that do not include physical punishment. (c) What are the requirements for an adequate veterinary care and animal health program? Guide http://www.aclam.org. (1) If the sanctuary houses chimpanzees with infectious diseases, it must have a veterinarian knowledgeable in the infectious diseases and care of chimpanzees. The Facility Veterinarian is responsible for establishing and implementing a health monitoring system specifically designed to meet the health requirements of chimpanzees in the sanctuary. Routine observation and the prevention of disease, metabolic conditions, abnormal behavior and injury must be a priority focus of the Facility Veterinarian and staff. (2) Newly received chimpanzees must be quarantined for a period for physiological, psychological, and nutritional stabilization before their introduction to the rest of the group. The stabilization period must be lengthened appropriately if the chimpanzee has a significant medical problem or if abnormal medical findings are detected during the quarantine period. If the chimpanzee has not been given a complete physical examination within six months, an examination must be conducted during the stabilization period. (3) The sanctuary must implement appropriate methods for disease surveillance and diagnosis of diseases, which may include the following: (4) Tuberculin (TB) tests must be negative for two (2) consecutive tests before the chimpanzee is released from quarantine. Any chimpanzee that is suspected of harboring the TB organism, or that is diagnosed with TB will be isolated and treated until determined by the Facility Veterinarian to be of no health risk to other chimpanzees or humans. The Facility Veterinarian may recommend euthanasia in those cases that do not respond to therapy and in which the chimpanzee consequently experiences undue pain and suffering that cannot be alleviated. The procedures noted under § 9.6 (d) must be observed if euthanasia is necessary. (5) Fecal samples must be checked for parasites and parasitic ova. (6) A complete blood count and serum chemical panel must be obtained. (7) Additional serum for banking and/or testing shall be obtained as appropriate by the Facility Veterinarian and is considered beneficial for chimpanzee health. (8) If the donating facility did not test for the appropriate viruses, the sanctuary must perform a viral panel and serology for the various chronic hepatitis viruses and HIV. (9) Additional tests or procedures that are deemed beneficial to the chimpanzees' health may be required by the Facility Veterinarian. (10) Chimpanzees are susceptible to many of the vaccine preventable diseases of human childhood. Appropriate vaccines must be considered and administered if deemed necessary, at the discretion of the Facility Veterinarian, to protect the chimpanzees in the sanctuary. Methods of disease prevention, diagnosis, and therapy must comply with those currently accepted in veterinary medical practice. Arrangements with diagnostic laboratories must be established before chimpanzees arrive at the sanctuary. (11) The sanctuary must minimize the use of physical and chemical restraint. Chimpanzees in the sanctuary shall be trained to permit certain procedures with minimal or no restraint. Such procedures may include injections, dosing or other treatments, and cage-side health observations. However, chemical sedation sometimes may be appropriate for certain necessary medical interventions or for the safety of the chimpanzee and caregivers. If physical restraint measures are necessary, due consideration must be given to the temporary or permanent effects upon the chimpanzee and human and animal safety concerns. (12) Methods used to relieve pain must be documented in the chimpanzee medical or surgical records. These records will be available for review by USDA and NIH representatives. The Facility Veterinarian must ensure that pain management is current and in accordance with acceptable veterinary medical practices. (13) Chimpanzees must be cared for by qualified personnel on a daily basis, including weekends and holidays, to safeguard their well-being. Emergency veterinary care must also be available during these times. Notification procedures must be documented in the form of operating procedures. (d) Under what circumstances is euthanasia permitted? (1) Methods of euthanasia will be consistent with the most recent report of the American Veterinary Medical Association Panel on Euthanasia (2002), unless more reliable data becomes available. When euthanasia is performed, the veterinarian will determine the appropriate agent, and it will be administered only by properly trained personnel under the direction of the Facility Veterinarian. The decision to perform euthanasia will be made by the veterinarian in consultation with the Facility Director or Deputy Director. (2) The SCCC will participate in the decision in nonmedical emergencies. All euthanasia decisions must be reviewed by the SCCC, preferably prior to euthanasia. In emergencies, where euthanasia has to be performed immediately by the Facility Veterinarian, the circumstances and the decision by the Facility Veterinarian will be presented at the next scheduled or special meeting of the SCCC. The ORIP/DPCPSI Project Officer must be notified of the euthanasia event within 72 hours by electronic or telephonic means. Euthanasia of individual chimpanzees may negatively affect the care staff and appropriate counseling and psychological support shall be considered. [73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020] § 9.7 Reproduction. Chimpanzee reproduction is prohibited in the sanctuary. Therefore, all males must be sterilized by vasectomy before acceptance into the system, or, as a temporary measure, housed apart from females until they are sterilized. Vasectomies are advisable because they are minimally invasive and because effectiveness of the vasectomy may be validated through laboratory testing for semen. Seminal collection techniques must be carefully evaluated to avoid painful stimuli. Other proven methods of birth control may be used under special conditions deemed appropriate by the Facility Veterinarian and SCCC. The Facility Veterinarian must determine the appropriate test(s) to use to validate sterility. A veterinarian experienced in performing vasectomies in chimpanzees should perform the operation. Documentation must accompany each male accepted to the sanctuary system attesting to the fact that the male has been vasectomized and laboratory tests confirm that a segment of the Vas Deferens has been removed, or that the test used is reliable and is negative for sperm. The sanctuary must have a contingency plan for handling accidental births that includes the length of time the offspring is expected to remain with the mother. § 9.8 Animal records. (a) What records must be maintained for chimpanzees in the sanctuary and how are they managed? (2) The animal records currently required by the USDA Animal Welfare Regulations are also required for these standards. Chimpanzees must be individually and permanently identifiable. (3) Retrievable records must be maintained for a minimum of three years beyond the disposition or death of each chimpanzee in accordance with the Animal Welfare Regulations section 2.35(f) (9 CFR 2.35(f)). Original records or a copy must be transferred if the chimpanzee moves to a different facility. The records must include standard information, including permanent individual identification, research use(s), reproductive status (past and present), a summary or copy of the medical and behavioral history, the sire's identification number (if available), the dam's identification number, birth date, sex, and date acquired by the sanctuary. The disposition date must also be noted, if applicable, including whether the chimpanzee died or was transferred to another site in the federal sanctuary system. The records may be created and retained in electronic form. (4) The contractor and any subcontractor(s) operating the federally supported chimpanzee sanctuary must provide special, quarterly, and annual progress reports to the designated Federal officials as identified in the contract. The annual report must also contain a statement that certifies the sanctuary is in full compliance with these standards of care regulation. (b) What are the rules governing the disposition of necropsy records? § 9.9 Facility staffing. How many personnel are required to staff the chimpanzee sanctuary and what qualifications and training must the staff possess? (b) There must be a sufficient number of appropriately trained animal care and technical personnel to provide appropriate care to the chimpanzees at all times, including evenings, weekends, and holidays. The number of animal care staff to chimpanzee ratio shall be adjusted as experience is gained during the operation of the sanctuary. Sufficiently trained staff also must be available to maintain adequate behavioral enrichment; (c) The Facility Director must be a person with experience in chimpanzee care and socialization techniques. In addition, the Director must have management and administrative experience; (d) The Biosafety Officer must have experience in developing and monitoring biohazards and dealing with biosafety issues related to captive nonhuman primates. Experience in these areas dealing specifically with chimpanzees is desirable; (e) The remaining staff, which may include part-time, full-time, or contractor Facility Veterinarian(s) and Behaviorist(s), must possess the skills, knowledge, and/or experience required to perform their duties, as elaborated within the regulation. [73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020] § 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements. (a) How are employee Occupational Health and Safety Program risks and concerns addressed? Guide (b) How are biosafety concerns addressed? § 9.11 Animal transport. The transportation of chimpanzees by surface or air must be in accordance with the requirements set forth in the Animal Welfare Act and Regulations and the International Air Transport Association (IATA) Live Animal Regulations and guidelines, as applicable. § 9.12 Compliance with the Standards of Care, and USDA and PHS policies and regulations. (a) How will compliance with the standards set forth in this part be monitored and what are the consequences of noncompliance with the standards? (b) To what type of outside review or inspection will the federally supported sanctuary be subjected? [73 FR 60423, Oct. 10, 2008, as amended at 85 FR 54273, Sept. 1, 2020] § 9.13 Other federal laws, regulations, and statutes that apply to the sanctuary. (a) Animal Welfare Act (7 U.S.C. 2131-2159). (b) Animal Welfare Regulations, 9 CFR, subchapter A, parts 1 and 2; part 3, subpart D—Specifications for the Humane Handling, Care, Treatment, and Transport of Nonhuman Primates.