Animal Welfare Act Quick Reference Guides

A Quick Reference of the Responsibilities & Functions of the Attending Veterinarians for Research Facilities under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. This reference guide provides the section numbers of the Regulations and Standards that pertain to the responsibilities and functions of the Attending Veterinarian for Research Facilities. Section numbers are given for reference to the actual wording of each requirement.

Definitions

Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes (Sect. 1.1).

Attending veterinarian means a person who has graduated from a veterinary school accredited by the American Veterinary Medical Association's Council on Education, or has a certificate issued by the American Veterinary Medical Association's Education Commission for Foreign Veterinary Graduates, or has received equivalent formal education as determined by the Administrator; has received training and/or experience in the care and management of the species being attended; and who has direct or delegated authority for activities involving animals at a facility subject to the jurisdiction of the Secretary (Sect. 1.1).

Attending Veterinarian and Adequate Veterinary Care

(a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section (Sect. 2.33 (a)). Adequate Veterinary Care is usually determined as what is currently the accepted professional practice or treatment for that particular circumstance or condition.

(1) Each research facility shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the research facility. (Sect. 2.33 (a)(1))

(2) Each research facility shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use. (Sect. 2.33 (a)(2))

(3) The attending veterinarian shall be a voting member of the IACUC; Provided, however, That a research facility with more than one Doctor of Veterinary Medicine (DVM) may appoint to the IACUC another DVM with delegated program responsibility for activities involving animals at the research facility. (Sect. 2.33 (a)(3))

(b) Each research facility shall establish and maintain programs of adequate veterinary care that include: (Sect. 2.33 (b))

(1) The availability of appropriate facilities, personnel, equipment, and services to comply with the provisions of this subchapter; (Sect. 2.33 (b)(1))

(2) The use of appropriate methods to prevent, control, diagnose, and treat diseases and injuries, and the availability of emergency, weekend, and holiday care; (Sect. 2.33 (b)(2))

(3) Daily observation of all animals to assess their health and well-being; Provided, however, That daily observation of animals may be accomplished by someone other than the attending veterinarian; and Provided, further, That a mechanism of direct and frequent communication is required so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian; (Sect. 2.33 (b)(3))

(4) Guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and (Sect. 2.33 (b)(4))

(5) Adequate pre-procedural and post-procedural care in accordance with current established veterinary medical and nursing procedures. (Sect. 2.33 (b)(5))

Additional Areas of Responsibility for Attending Veterinarians

1. Membership on the Institutional Animal Care and Use Committee (IACUC) (Section 2.31)

(b)(3) Of the members of the Committee: (Sect. 2.31 (b)(3))

(i) At least one shall be a Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the research facility. (Sect. 2.31 (b)(3)(i))

2. Consultation with the principal investigator to minimize pain and distress (Section 2.31(d) in general and section 2.31 (d)(1)(iv) through (xi) specifically)

(d)(1)(iv) Procedures that may cause more than momentary or slight pain or distress to the animals will: (Sect. 2.31 (d)(1)(iv))

(A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time; (Sect. 2.31 (d)(1)(iv)(A))

(B) Involve, in their planning, consultation with the attending veterinarian or his or her designee; (Sect. 2.31 (d)(1)(iv)(B))

(C) Not include the use of paralytics without anesthesia; (Sect. 2.31 (d)(1)(iv)(C))

(v) Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure; (Sect. 2.31 (d)(1)(v))

(vi) The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied; (Sect. 2.31 (d)(1)(vi))

(vii) Medical care for animals will be available and provided as necessary by a qualified veterinarian; (Sect. 2.31 (d)(1)(vii))

(viii) Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures; (Sect. 2.31 (d)(1)(viii))

(ix) Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures; (Sect. 2.31 (d)(1)(ix))

(x) No animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (Sect. 2.31 (d)(1)(x))

(A) Justified for scientific reasons by the principal investigator, in writing; (Sect. 2.31 (d)(1)(x)(A))

(B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian; or (Sect. 2.31 (d)(1)(x)(B))

(C) In other special circumstances as determined by the Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234; (Sect. 2.31 (d)(1)(x)(C))

(xi) Methods of euthanasia used must be in accordance with the definition of the term set forth in 9 CFR part 1, § 1.1 of this subchapter, unless a deviation is justified for scientific reasons, in writing, by the investigator. (Sect. 2.31 (d)(1)(xi))

3. Training and personnel qualifications (Section 2.32)

(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel. (Sect. 2.32 (a))

(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and § 2.31. (Sect. 2.32 (b))

(c) Training and instruction of personnel must include guidance in at least the following areas: (Sect. 2.32 (c))

(1) Humane methods of animal maintenance and experimentation, including: (Sect. 2.32 (c)(1))

(i) The basic needs of each species of animal; (Sect. 2.32 (c)(1)(i))

(ii) Proper handling and care for the various species of animals used by the facility; (Sect. 2.32 (c)(1)(ii))

(iii) Proper pre-procedural and post-procedural care of animals; and (Sect. 2.32 (c)(1)(iii))

(iv) Aseptic surgical methods and procedures; (Sect. 2.32 (c)(1)(iv))

(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress; (Sect. 2.32 (c)(2))

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility; (Sect. 2.32 (c)(3))

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act; (Sect. 2.32 (c)(4))

(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information: (Sect. 2.32 (c)(5))

(i) On appropriate methods of animal care and use; (Sect. 2.32 (c)(5)(i))

(ii) On alternatives to the use of live animals in research; (Sect. 2.32 (c)(5)(ii))

(iii) That could prevent unintended and unnecessary duplication of research involving animals; and (Sect. 2.32 (c)(5)(iii))

(iv) Regarding the intent and requirements of the Act. (Sect. 2.32 (c)(5)(iv))

4. Annual report assurances by the research facility (Section 2.36)

(b)(1) The annual report shall assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility; (Sect. 2.36 (b)(1))

5. Indoor housing facilities for dogs and cats (Section 3.2)

(a) Heating, cooling, and temperature....When dogs or cats are present, the ambient temperature in the facility must not fall below 50 °F (10 °C) for dogs and cats not acclimated to lower temperatures, for those breeds that cannot tolerate lower temperatures without stress or discomfort (such as short-haired breeds), and for sick, aged, young, or infirm dogs and cats, except as approved by the attending veterinarian...(Sect. 3.2 (a))

(b) Ventilation....The relative humidity must be maintained at a level that ensures the health and well-being of the dogs or cats housed therein, in accordance with the directions of the attending veterinarian and generally accepted professional and husbandry practices (Sect. 3.2 (b))

6. Sheltered housing facilities for dogs and cats (Section 3.3)

(a) Heating, cooling, and temperature....The ambient temperature in the sheltered part of the facility must not fall below 50 °F (10 °C) for dogs and cats not acclimated to lower temperatures, for those breeds that cannot tolerate lower temperatures without stress and discomfort (such as short-haired breeds), and for sick, aged, young, or infirm dogs or cats, except as approved by the attending veterinarian...(Sect. 3.3 (a))

7. Outdoor housing facilities for dogs and cats (Section 3.4)

(a)(1) The following categories of dogs or cats must not be kept in outdoor facilities, unless that practice is specifically approved by the attending veterinarian: (Sect. 3.4 (a)(1))

(i) Dogs or cats that are not acclimated to the temperatures prevalent in the area or region where they are maintained; (Sect. 3.4 (a)(1)(i))

(ii) Breeds of dogs or cats that cannot tolerate the prevalent temperatures of the area without stress or discomfort (such as short-haired breeds in cold climates); and (Sect. 3.4 (a)(1)(ii))

(iii) Sick, infirm, aged or young dogs or cats. (Sect. 3.4 (a)(1)(iii))

8. Primary enclosures (Section 3.6)

(b) Additional requirements for cats - (Sect. 3.6 (b))

(1) Space. Each cat, including weaned kittens, that is housed in any primary enclosure must be provided minimum vertical space and floor space as follows:  (Sect. 3.6 (b)(1))

(iv) Each queen with nursing kittens must be provided with an additional amount of floor space, based on her breed and behavioral characteristics, and in accordance with generally accepted husbandry practices. If the additional amount of floor space for each nursing kitten is equivalent to less than 5 percent of the minimum requirement for the queen, such housing must be approved by the attending veterinarian in the case of a research facility, and, in the case of dealers and exhibitors, such housing must be approved by the Administrator; (Sect. 3.6 (b)(1)(iv))

(c) Additional requirements for dogs - (Sect. 3.6 (c))

(1) Space. (Sect. 3.6 (c)(1))

(ii) Each bitch with nursing puppies must be provided with an additional amount of floor space, based on her breed and behavioral characteristics, and in accordance with generally accepted husbandry practices as determined by the attending veterinarian. If the additional amount of floor space for each nursing puppy is less than 5 percent of the minimum requirement for the bitch, such housing must be approved by the attending veterinarian in the case of a research facility, and, in the case of dealers and exhibitors, such housing must be approved by the Administrator. (Sect. 3.6 (c)(1)(ii))

9. Compatible grouping (Section 3.7)

(e) Dogs and cats that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony, as directed by the attending veterinarian. When an entire group or room of dogs and cats is known to have or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control. (Sect. 3.7 (e))

10. Exercise for dogs (Section 3.8)

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. In addition, the plan must be approved by the attending veterinarian. The plan must include written standard procedures to be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding Federal agency. The plan, at a minimum, must comply with each of the following: (Sect. 3.8)

(b) Dogs housed in groups...Such animals may be maintained in compatible groups, unless: (Sect. 3.8 (b))

(2) In the opinion of the attending veterinarian, such housing would adversely affect the health or well-being of the dog(s); (Sect. 3.8 (b)(2))

(c) Methods and period of providing exercise opportunity (Sect. 3.8 (c))

(1) The frequency, method, and duration of the opportunity for exercise shall be determined by the attending veterinarian and, at research facilities, in consultation with and approval by the Committee. (Sect. 3.8 (c)(1))

(d) Exemptions (Sect. 3.8 (d))

(1) If, in the opinion of the attending veterinarian, it is inappropriate for certain dogs to exercise because of their health, condition, or well-being, the dealer, exhibitor, or research facility may be exempted from meeting the requirements of this section for those dogs. Such exemption must be documented by the attending veterinarian and, unless the basis for exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.8 (d)(1))

11. Feeding of dogs and cats (Section 3.9)

(a) Dogs and cats must be fed at least once each day, except as otherwise might be required to provide adequate veterinary care... (Sect. 3.9 (a))

12. Watering of dogs and cats (Section 3.10)

(a) Potable water must be continuously available to the dogs, unless restricted by the attending veterinarian or except as provided in § 3.17(a). (Sect. 3.10 (a))

(b) If potable water is not continuously available to the cats, it must be offered to the cats as often as necessary to ensure their health and well-being, but not less than twice daily for at least 1 hour each time, unless restricted by the attending veterinarian. (Sect. 3.10 (b))

13. Veterinary care for dogs (Section 3.13)

(a) Each dealer, exhibitor, and research facility must follow an appropriate program of veterinary care for dogs that is developed, documented in writing, and signed by the attending veterinarian. Dealers, exhibitors, and research facilities must keep and maintain the written program and make it available for APHIS inspection. The written program of veterinary care must address the requirements for adequate veterinary care for every dealer and exhibitor in § 2.40 of this subchapter and every research facility in § 2.33 of this subchapter, and must also include: (Sect. 3.13 (a))

(1) Regularly scheduled visits, not less than once every 12 months, by the attending veterinarian to all premises where animals are kept, to assess and ensure the adequacy of veterinary care and other aspects of animal care and use; (Sect. 3.13 (a)(1))

(2) A complete physical examination from head to tail of each dog by the attending veterinarian not less than once every 12 months; (Sect. 3.13 (a)(2))

(3) Vaccinations for contagious and/or deadly diseases of dogs (including rabies, parvovirus and distemper) and sampling and treatment of parasites and other pests (including fleas, worms, coccidia, giardia, and heartworm) in accordance with a schedule approved by the attending veterinarian, unless otherwise required by a research protocol approved by the Committee at research facilities; and (Sect. 3.13 (a)(3))

14. General housing facilities for nonhuman primates (Section 3.75)

(c) Surfaces - (Sect. 3.75 (c))

(3) Cleaning. Hard surfaces with which nonhuman primates come in contact must be spot-cleaned daily and sanitized in accordance with § 3.84 of this subpart to prevent accumulation of excreta or disease hazards. If the species scent mark, the surfaces must be sanitized or replaced at regular intervals as determined by the attending veterinarian in accordance with generally accepted professional and husbandry practices... (Sect. 3.75 (c)(3))

15. Indoor housing facilities for nonhuman primates (Section 3.76)

(a) Heating, cooling, and temperature... The ambient temperature must be maintained at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices. (Sect. 3.76 (a))

(b) Ventilation... The relative humidity maintained must be at a level that ensures the health and well-being of the animals housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices. (Sect. 3.76 (b))

16. Sheltered housing facilities for nonhuman primates (Section 3.77)

(a) Heating, cooling, and temperature... The ambient temperature must be maintained at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices. (Sect. 3.77 (a))

(b) Ventilation... The relative humidity maintained must be at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, in accordance with generally accepted professional and husbandry practices. (Sect. 3.77 (b))

17. Outdoor housing facilities for nonhuman primates (Section 3.78)

(a) Acclimation. Only nonhuman primates that are acclimated, as determined by the attending veterinarian, to the prevailing temperature and humidity at the outdoor housing facility during the time of year they are at the facility, and that can tolerate the range of temperatures and climatic conditions known to occur at the facility at that time of year without stress or discomfort, may be kept in outdoor facilities. (Sect. 3.78 (a))

(b) Shelter from the elements... The shelter must safely provide heat to the nonhuman primates to prevent the ambient temperature from falling below 45 °F (7.2 °C), except as directed by the attending veterinarian and in accordance with generally accepted professional and husbandry practices. (Sect. 3.78 (b))

18. Mobile or traveling housing facilities for nonhuman primates (Section 3.79)

(a) Heating, cooling, and temperature... The ambient temperature must be maintained at a level that ensures the health and well-being of the species housed, as directed by the attending veterinarian, and in accordance with generally accepted professional and husbandry practices. (Sect. 3.79 (a))

19. Primary enclosures for nonhuman primates (Section 3.80)

(b) Minimum space requirements. (Sect. 3.8) (b))

(3) In the case of research facilities, any exemption from these standards must be required by a research proposal or in the judgment of the attending veterinarian and must be approved by the Committee. In the case of dealers and exhibitors, any exemption from these standards must be required in the judgment of the attending veterinarian and approved by the Administrator. (Sect. 3.80 (b)(3)) 

20. Environmental enhancement and psychological well-being of nonhuman primates (Section 3.81)

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan, at a minimum, must address each of the following: (Sect. 3.81)

(a) Social grouping. The environment enhancement plan must include specific provisions to address the social needs of nonhuman primates of species known to exist in social groups in nature. Such specific provisions must be in accordance with currently accepted professional standards, as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. The plan may provide for the following exceptions: (Sect. 3.81 (a))

(2) Nonhuman primates that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony as directed by the attending veterinarian. When an entire group or room of nonhuman primates is known to have or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control. (Sect. 3.81 (a)(2))

(3) Nonhuman primates may not be housed with other species of primates or animals unless they are compatible, do not prevent access to food, water, or shelter by individual animals. and are not known to be hazardous to the health and well-being of each other. Compatibility of nonhuman primates must be determined in accordance with generally accepted professional practices and actual observations, as directed by the attending veterinarian, to ensure that the nonhuman primates are in fact compatible. Individually housed nonhuman primates must be able to see and hear nonhuman primates of their own or compatible species unless the attending veterinarian determines that it would endanger their health, safety, or well-being. (Sect. 3.81 (a)(3))

(c) Special considerations. Certain nonhuman primates must be provided special attention regarding enhancement of their environment, based on the needs of the individual species and in accordance with the instructions of the attending veterinarian. Nonhuman primates requiring special attention are the following: (Sect. 3.81 (c))

(1) Infants and young juveniles; (Sect. 3.81 (c)(1))

(2) Those that show signs of being in psychological distress through behavior or appearance; (Sect. 3.81 (c)(2))

(3) Those used in research for which the Committee-approved protocol requires restricted activity; (Sect. 3.81 (c)(3))

(4) Individually housed nonhuman primates that are unable to see and hear nonhuman primates of their own or compatible species; and (Sect. 3.81 (c)(4))

(5) Great apes weighing over 110 lbs. (50 kg). Dealers, exhibitors, and research facilities must include in the environment enhancement plan special provisions for great apes weighing over 110 lbs. (50 kg), including additional opportunities to express species-typical behavior. (Sect. 3.81 (c)(5))

(d) Restraint devices. Nonhuman primates must not be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the Committee at research facilities... (Sect. 3.81 (d))

(e) Exemptions. (Sect. 3.81 (e))

(1) The attending veterinarian may exempt an individual nonhuman primate from participation in the environment enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted nonhuman primate. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.81 (e)(1)) 

21. Feeding nonhuman primates (Section 3.82)

(b) Nonhuman primates must be fed at least once each day except as otherwise might be required to provide adequate veterinary care. Infant and juvenile nonhuman primates must be fed as often as necessary in accordance with generally accepted professional and husbandry practices and nutritional standards, based upon the animals' age and condition. (Sect. 3.82 (b))

22. Watering for nonhuman primates (Section 3.83)

Potable water must be provided in sufficient quantity to every nonhuman primate housed at the facility. If potable water is not continually available to the nonhuman primates, it must be offered to them as often as necessary to ensure their health and well-being, but no less than twice daily for at least l hour each time, unless otherwise required by the attending veterinarian, or as required by the research proposal approved by the Committee at research facilities. Water receptacles must be kept clean and sanitized in accordance with methods provided in § 3.84(b)(3) of this subpart at least once every 2 weeks or as often as necessary to keep them clean and free from contamination. Used water receptacles must be sanitized before they can be used to provide water to a different nonhuman primate or social grouping of nonhuman primates. (Sect. 3.83)

23. Consignment to carriers and intermediate handlers (Section 3.86)

(c) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the nonhuman primate was offered food and water during the 4 hours before delivery to the carrier or intermediate handler. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easily noticed and read. Instructions for no food or water are not acceptable unless directed by the attending veterinarian... (Sect. 3.86 (c))

24. Responsibilities of the attending veterinarian and veterinary care for marine mammals

Please refer to section 3.104, 3.105, 3.107, 3.108, 3.109,  3.110, 3.111, 3.112, 3.115, 3.116, and 3.131 for requirements.

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations and Standards in 9 C.F.R., Chapter 1, Subchapter A- Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to the Responsibilities and Functions of the Principal Investigator (PI) in Research Facilities Under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A-Animal Welfare, Parts 1, 2, and 3. This reference guide provides the section numbers of the Regulations and Standards that pertain to the responsibilities and functions of the Principal Investigator submitting or carrying out animal research proposals at a research facility. Section numbers are given for reference to the actual wording of each requirement.

Definitions

Principal investigator means an employee of a research facility, or other person associated with a research facility, responsible for a proposal to conduct research and for the design and implementation of research involving animals. (Sect. 1.1)

Information Required by the Principal Investigator to the Institutional Animal Care and Use Committee (IACUC)

1. Submit proposed activities and significant changes to activities to the Institutional Animal Care and Use Committee for approval (Section 2.31)

(c) IACUC functions. With respect to activities involving animals, the IACUC, as an agent of the research facility, shall: (Sect. 2.31 (c))

(6) Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals, as specified in paragraph (d) of this section; (Sect. 2.31 (c)(6))

(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and (Sect. 2.31 (c)(7))

(8) Be authorized to suspend an activity involving animals in accordance with the specifications set forth in paragraph (d)(6) of this section. (Sect. 2.31 (c)(8)) 

2. Provide acceptable written justification to the IACUC for areas of noncompliance with the Animal Welfare Act (Section 2.31)

(d) IACUC review of activities involving animals (Sect. 2.31 (d))

(1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements: (Sect. 2.31 (d)(1))

(i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals; (Sect. 2.31 (d)(1)(i))

(ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g., the Animal Welfare Information Center, used to determine that alternatives were not available; (Sect. 2.31 (d)(1)(ii))

(iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments; (Sect. 2.31 (d)(1)(iii))

(iv) Procedures that may cause more than momentary or slight pain or distress to the animals will: (Sect. 2.31 (d)(1)(iv))

(A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time; (Sect. 2.31 (d)(1)(iv)(A))

(B) Involve, in their planning, consultation with the attending veterinarian or his or her designee; (Sect. 2.31 (d)(1)(iv)(B))

(C) Not include the use of paralytics without anesthesia; (Sect. 2.31 (d)(1)(iv)(C))

(v) Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure; (Sect. 2.31 (d)(1)(v))

(vi) The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied; (Sect. 2.31 (d)(1)(vi))

(vii) Medical care for animals will be available and provided as necessary by a qualified veterinarian; (Sect. 2.31 (d)(1)(vii))

(viii) Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures; (Sect. 2.31 (d)(1)(viii))

(ix) Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures; (Sect. 2.31 (d)(1)(ix))

(x) No animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (Sect. 2.31 (d)(1)(x))

(A) Justified for scientific reasons by the principal investigator, in writing; (Sect. 2.31 (d)(1)(x)(A))

(B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian; or (Sect. 2.31 (d)(1)(x)(B))

(C) In other special circumstances as determined by the Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234; (Sect. 2.31 (d)(1)(x)(C))

(xi) Methods of euthanasia used must be in accordance with the definition of the term set forth in 9 CFR part 1, § 1.1 of this subchapter, unless a deviation is justified for scientific reasons, in writing, by the investigator. (Sect. 2.31 (d)(1)(xi))

(2) Prior to IACUC review, each member of the Committee shall be provided with a list of proposed activities to be reviewed. Written descriptions of all proposed activities that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full Committee review of those activities. If full Committee review is not requested, at least one member of the IACUC, designated by the chairman and qualified to conduct the review, shall review those activities, and shall have the authority to approve, require modifications in (to secure approval), or request full Committee review of any of those activities. If full Committee review is requested for a proposed activity, approval of that activity may be granted 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. No member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of a quorum; (Sect. 2.31 (d)(2))

(4) The IACUC shall notify principal investigators and the research facility in writing 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 principal investigator an opportunity to respond in person or in writing. The IACUC may reconsider its decision, with documentation in Committee minutes, in light of the information provided by the principal investigator; (Sect. 2.31 (d)(4))

(6) The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the Committee. 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; (Sect. 2.31 (d)(1)(6))

(e) A proposal to conduct an activity involving animals, or to make a significant change in an ongoing activity involving animals, must contain the following: (Sect. 2.31 (e))

(1) Identification of the species and the approximate number of animals to be used;  (Sect. 2.31 (e)(1))

(2) A rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used;  (Sect. 2.31 (e)(2))

(3) A complete description of the proposed use of the animals;  (Sect. 2.31 (e)(3))

(4) A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals; and  (Sect. 2.31 (e)(4))

(5) A description of any euthanasia method to be used. (Sect. 2.31 (e)(5))

Other Requirements of the Principal Investigator

1. Personnel Qualifications (Section 2.32)

(c) Training and instruction of personnel must include guidance in at least the following areas: (Sect. 2.32 (c)) 

(1) Humane methods of animal maintenance and experimentation, including: (Sect. 2.32 (c)(1))

(i) The basic needs of each species of animal; (Sect. 2.32 (c)(1)(i))

(ii) Proper handling and care for the various species of animals used by the facility; (Sect. 2.32 (c)(1)(ii))

(iii) Proper pre-procedural and post-procedural care of animals; and (Sect. 2.32 (c)(1)(iii))

(iv) Aseptic surgical methods and procedures; (Sect. 2.32 (c)(1)(iv))

(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress; (Sect. 2.32 (c)(2))

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility; (Sect. 2.32 (c)(3))

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act; (Sect. 2.32 (c)(4))

(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information: (Sect. 2.32 (c)(5))

(i) On appropriate methods of animal care and use; (Sect. 2.32 (c)(5)(i))

(ii) On alternatives to the use of live animals in research; (Sect. 2.32 (c)(5)(ii))

(iii) That could prevent unintended and unnecessary duplication of research involving animals; and (Sect. 2.32 (c)(5)(iii))

(iv) Regarding the intent and requirements of the Act. (Sect. 2.32 (c)(5)(iv))

2. Attending veterinarian and adequate veterinary care (Section 2.33)

(b) Each research facility shall establish and maintain programs of adequate veterinary care that include: (Sect. 2.33 (b))

(4) Guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; (Sect. 2.33 (b)(4))

3. Annual report (Section 2.36)

(b) The annual report shall: (Sect. 2.36 (b))

(2) Assure that each principal investigator has considered alternatives to painful procedures; (Sect. 2.36 (b)(2))

(3) Assure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. A summary of all such exceptions must be attached to the facility's annual report. In addition to identifying the IACUC-approved exceptions, this summary must include a brief explanation of the exceptions, as well as the species and number of animals affected; (Sect. 2.36 (b)(3))

4. Exercise for dogs (Section 3.8) 

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. In addition, the plan must be approved by the attending veterinarian. The plan must include written standard procedures to be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding Federal agency. The plan, at a minimum, must comply with each of the following: (Sect. 3.8)

(d) Exemptions. (Sect. 3.8 (d))

(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.8 (d)(2))

5. Environmental enhancement to promote psychological well-being (nonhuman primates) (Section 3.81)

(d) Restraint devices. Nonhuman primates must not be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the Committee at research facilities. Maintenance under such restraint must be for the shortest period possible. In instances where long-term (more than 12 hours) restraint is required, the nonhuman primate must be provided the opportunity daily for unrestrained activity for at least one continuous hour during the period of restraint, unless continuous restraint is required by the research proposal approved by the Committee at research facilities (Sect. 3.81 (d))

(e) Exemptions. (Sect. 3.81 (e))

(2) For a research facility, the Committee may exempt an individual nonhuman primate from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.81 (e)(2))

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations and Standards in 9 C.F.R., Chapter 1, Subchapter A-Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to the Responsibilities and Functions of the Institutional Official (IO) for Research Facilities Under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. This reference guide provides excerpts, paraphrasing and section numbers of the regulations and standards that pertain to the responsibilities and functions of the Institutional Official for the research facility. Section numbers are given for reference to the actual wording of each requirement.

Definitions

Institutional Official means the individual at a research facility who is authorized to legally commit on behalf of the research facility that the requirements of 9 CFR parts 1, 2, and 3 will be met. (Sect. 1.1)

Requirements of the Institutional Official

1. Registration of research facility (Section 2.30)

(a) Requirements and procedures.(Sect. 2.30 (a))

(1) Each research facility, other than a Federal research facility, shall register with the Secretary by completing and filing a properly executed form which will be furnished, upon request, by the Deputy Administrator. The registration form shall be filed with the Deputy Administrator. Except as provided in paragraph (a)(2) of this section, where a school or department of a university or college uses or intends to use live animals for research, tests, experiments, or teaching, the university or college rather than the school or department will be considered the research facility and will be required to register with the Secretary. An official who has the legal authority to bind the parent organization shall sign the registration form. (Sect. 2.30 (a)(1))

(b) Acknowledgment of regulations and standards. APHIS will supply a copy of the regulations and standards in this subchapter with each registration form. The research facility shall acknowledge receipt of and shall agree to comply with the regulations and standards by signing a form provided for this purpose by APHIS, and by filing it with the Deputy Administrator. (Sect. 2.30 (b))

(c) Notification of change of operation. A research facility shall notify the Deputy Administrator in writing of any change in the name, address, or ownership, or other change in operations affecting its status as a research facility, within 10 days after making such change. The Notification of Change form (APHIS Form 7033) may be used to provide the information. (Sect. 2.30 (c))

(d) Duration of a registration and conditions for cancellation of a registration. (Sect. 2.30 (d))

(1) A research facility that goes out of business or ceases to function as a research facility, or that changes its method of operation so that it no longer uses, handles, or transports animals, and does not plan to use, handle, or transport animals at any time in the future, may have its registration canceled by making a written request to the Deputy Administrator.  (Sect. 2.30 (d)(1))

(2) If the Deputy Administrator has sufficient evidence showing that a research facility has ceased to function as a research facility, then the Deputy Administrator may cancel the registration on its own, without a written request from the research facility.  (Sect. 2.30 (d)(2))

(3) If a research facility plans to resume regulated activity, the facility is responsible for submitting a form (APHIS Form 7011A) to reregister at least 10 days prior to it using, handling, or transporting animals. There are no fees associated with such reregistration.  (Sect. 2.30 (d)(3))

2. Institutional Animal Care and Use Committee (IACUC) (Section 2.31)

(a) The Chief Executive Officer of the research facility shall appoint an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members to assess the research facility's animal program, facilities, and procedures. Except as specifically authorized by law or these regulations, nothing in this part shall be deemed to permit the Committee or IACUC to prescribe methods or set standards for the design, performance, or conduct of actual research or experimentation by a research facility. (Sect. 2.31 (a))

(b) IACUC membership. (Sect. 2.31 (b))

(1) The members of each Committee shall be appointed by the Chief Executive Officer of the research facility; (Sect. 2.31 (b)(1))

(c) IACUC functions. With respect to activities involving animals, the IACUC, as an agent of the research facility, shall: (Sect. 2.31 (c))

(1) Review, at least once every six months, the research facility's program for humane care and use of animals, using title 9, chapter I, subchapter A - Animal Welfare, as a basis for evaluation; (Sect. 2.31 (c)(1))

(2) Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; Provided, however, That animal areas containing free-living wild animals in their natural habitat need not be included in such inspection; (Sect. 2.31 (c)(2))

(3) Prepare reports of its evaluations conducted as required by paragraphs (c)(1) and (2) of this section, and submit the reports to the Institutional Official of the research facility; Provided, however, That the IACUC may determine the best means of conducting evaluations of the research facility's programs and facilities; and Provided, further, That no Committee member wishing to participate in any evaluation conducted under this subpart may be excluded. The IACUC may use subcommittees composed of at least two Committee members and may invite ad hoc consultants to assist in conducting the evaluations, however, the IACUC remains responsible for the evaluations and reports as required by the Act and regulations. The reports shall be reviewed and signed by a majority of the IACUC members and must include any minority views. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the research facility and made available to APHIS and to officials of funding Federal agencies for inspection and copying upon request. The reports must contain a description of the nature and extent of the research facility's adherence to this subchapter, must identify specifically any departures from the provisions of title 9, chapter I, subchapter A - Animal Welfare, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, with reference to Subchapter A, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the Institutional Official, to APHIS and any Federal agency funding that activity; (Sect. 2.31 (c)(3))

(4) Review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees; (Sect. 2.31 (c)(4))

(5) Make recommendations to the Institutional Official regarding any aspect of the research facility's animal program, facilities, or personnel training; (Sect. 2.31 (c)(5))

(6) Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals, as specified in paragraph (d) of this section; (Sect. 2.31 (c)(6))

(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and (Sect. 2.31 (c)(7))

(8) Be authorized to suspend an activity involving animals in accordance with the specifications set forth in paragraph (d)(6) of this section. (Sect. 2.31 (c)(8))

(d) IACUC review of activities involving animals. (Sect. 2.31 (d))

(7) 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 that action with a full explanation to APHIS and any Federal agency funding that activity; and (Sect. 2.31 (d)(7))

(8) Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC. (Sect. 2.31 (d)(8))

3. Personnel qualifications (Section 2.32)

(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel. (Sect. 2.32 (a))

(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and § 2.31. (Sect. 2.32 (b))

(c) Training and instruction of personnel must include guidance in at least the following areas: (Sect. 2.32 (c))

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act; (Sect. 2.32 (c)(4))

4. Attending veterinarian and adequate veterinary care (Section 2.33)

(a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section: (Sect. 2.33 (a))

(1) Each research facility shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the research facility; (Sect. 2.33 (a)(1))

(2) Each research facility shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use; and (Sect. 2.33 (a)(2))

(3) The attending veterinarian shall be a voting member of the IACUC; Provided, however, That a research facility with more than one Doctor of Veterinary Medicine (DVM) may appoint to the IACUC another DVM with delegated program responsibility for activities involving animals at the research facility. (Sect. 2.33 (a)(3))

 (b) See section 2.33(b) (1)-(5) for additional veterinary care requirements. (Sect. 2.33 (b))

5. Recordkeeping requirements (Section 2.35)

The research facility shall maintain records as required in this section. (Sect. 2.35 (a)(b)(c)(d)(e) and (f)).

6. Annual report (Section 2.36)

(a) The reporting facility shall be that segment of the research facility, or that department, agency, or instrumentality of the United States that uses or intends to use live animals in research, tests, experiments, or for teaching. Each reporting facility shall submit an annual report to the Deputy Administrator on or before December 1 of each calendar year. The report shall cover the previous Federal fiscal year. The Annual Report of Research Facility (APHIS Form 7023), Continuation Sheet for Annual Report of Research Facility (APHIS Form 7023A), and Annual Report of Research Facility Column E Explanation (APHIS Form 7023B) are forms which may be used to submit the information required by paragraph (b) of this section. (Sect. 2.36 (a))

The annual report shall contain the information required in section 2.36 (b)(1) through (8). Note the assurances set forth in paragraphs (1), (2) and (3).

7. Federal research facilities (Section 2.37)

Each Federal research facility shall establish an Institutional Animal Care and Use Committee which shall have the same composition, duties, and responsibilities required of nonfederal research facilities by § 2.31 with the following exceptions: (Sect. 2.37)

(a) The Committee shall report deficiencies to the head of the Federal agency conducting the research rather than to APHIS; and (Sect. 2.37 (a))

(b) The head of the Federal agency conducting the research shall be responsible for all corrective action to be taken at the facility and for the granting of all exceptions to inspection protocol. (Sect. 2.37 (b))

8. Miscellaneous (Section 2.38)

(a) Information as to business: furnishing of same by research facilities. Each research facility shall furnish to any APHIS official any information concerning the business of the research facility which the APHIS official may request in connection with the enforcement of the provisions of the Act, the regulations, and the standards in this subchapter. The information shall be furnished within a reasonable time and as may be specified in the request for information. (Sect. 2.38 (a))

(b) Access and inspection of records and property. (Sect. 2.38 (b))

(1) Each research facility shall, during business hours, allow APHIS officials: (2.38 (b)(1))

(i) To enter its place of business; (Sect. 2.38 (b)(1)(i))

(ii) To examine records required to be kept by the Act and the regulations in this part; (Sect. 2.38 (b)(1)(ii))

(iii) To make copies of the records; (Sect. 2.38 (b)(1)(iii))

(iv) To inspect the facilities, property, and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations, and the standards in this subchapter; and (Sect. 2.38 (b)(1)(iv))

(v) To document, by the taking of photographs and other means, conditions and areas of noncompliance. (Sect. 2.38 (b)(1)(v))

(2) The use of a room, table or other facilities necessary for the proper examination of the records and for inspection of the property or animals shall be extended to APHIS officials by the research facility. (Sect. 2.38 (b)(2))

(d) Inspection for missing animals. Each research facility shall allow, upon request and during business hours, police or officers of other law enforcement agencies with general law enforcement authority (not those agencies whose duties are limited to enforcement of local animal regulations) to enter its place of business to inspect animals and records for the purpose of seeking animals that are missing, under the following conditions: (Sect. 2.38 (d))

(1) The police or other law officer shall furnish to the research facility a written description of the missing animal and the name and address of its owner before making a search; (Sect. 2.38 (d)(1))

(2) The police or other law officer shall abide by all security measures required by the research facility to prevent the spread of disease, including the use of sterile clothing, footwear, and masks where required, or to prevent the escape of an animal. (Sect. 2.38 (d)(2))

Please refer to section 2.38 (e) for information on confiscation and destruction of animals. Section 2.38 (f) for handling, (g) for identification of dogs and cats, and (h) for health certification.

(i) Holding of animals. If any research facility obtains prior approval of the Deputy Administrator, it may arrange to have another person hold animals: Provided, That: (Sect. 2.38 (i))

(1) The other person agrees, in writing, to comply with the regulations in this part and the standards in part 3 of this subchapter, and to allow inspection of the premises by an APHIS official during business hours; (Sect. 2.38 (i)(1))

(2) The animals remain under the total control and responsibility of the research facility; and (Sect. 2.38 (i)(2))

(3) The Institutional Official agrees, in writing, that the other person or premises is a recognized animal site under its research facility registration. APHIS Form 7009 shall be used for approval. (Sect. 2.38 (i)(3))

(4) The other person or premises must either be directly included in the research facility's contingency plan required under paragraph (l) of this section or must develop its own contingency plan in accordance with paragraph (l) of this section. (Sect. 2.38 (i)(4))

 NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations in 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare. The appropriate section number in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference of the Responsibilities & Functions of the Institutional Animal Care & Use Committee (IACUC) Under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. The requirement for an Institutional Animal Care and Use Committee (IACUC) is set forth under the authority of section 13(b) of the Animal Welfare Act (AWA) (7 U.S.C. § 2143). The IACUC regulations promulgated under this authority are set forth in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Part 2, Section 2.31. Section numbers are given for reference to the actual wording of each requirement.

Definitions 

Committee means the Institutional Animal Care and Use Committee (IACUC) established under section 13(b) of the Act. It shall consist of at least three (3) members, one of whom is the attending veterinarian of the research facility and one of whom is not affiliated in any way with the facility other than as a member of the committee, however, if the research facility has more than one Doctor of Veterinary Medicine (DVM), another DVM with delegated program responsibility may serve. The research facility shall establish the Committee for the purpose of evaluating the care, treatment, housing, and use of animals, and for certifying compliance with the Act by the research facility. (Sect. 1.1)

Requirements, Membership, Duties, and Responsibilities of the IACUC and Research Facility

1. IACUC appointment and membership (Section 2.31)

(a) The Chief Executive Officer of the research facility shall appoint an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members to assess the research facility's animal program, facilities, and procedures. Except as specifically authorized by law or these regulations, nothing in this part shall be deemed to permit the Committee or IACUC to prescribe methods or set standards for the design, performance, or conduct of actual research or experimentation by a research facility. (Sect. 2.31 (a))

(b) IACUC membership. (Sect. 2.31 (b))

(1) The members of each Committee shall be appointed by the Chief Executive Officer of the research facility; (Sect. 2.31 (b)(1))

(2) The Committee shall be composed of a Chairman and at least two additional members; (Sect. 2.31 (b)(2))

(3) Of the members of the Committee: (Sect. 2.31 (b)(3))

(i) At least one shall be a Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the research facility; (Sect. 2.31 (b)(3)(i))

(ii) At least one shall not be affiliated in any way with the facility other than as a member of the Committee, and shall not be a member of the immediate family of a person who is affiliated with the facility. The Secretary intends that such person will provide representation for general community interests in the proper care and treatment of animals; (Sect. 2.31 (b)(3)(ii))

(4) If the Committee consists of more than three members, not more than three members shall be from the same administrative unit of the facility. (Sect. 2.31 (b)(4))

2. IACUC functions (Section 2.31)

(c) IACUC functions. With respect to activities involving animals, the IACUC, as an agent of the research facility, shall: (Sect. 2.31 (c))

(1) Review, at least once every six months, the research facility's program for humane care and use of animals, using title 9, chapter I, subchapter A - Animal Welfare, as a basis for evaluation; (Sect. 2.31 (c)(1))

(2) Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; Provided, however, That animal areas containing free-living wild animals in their natural habitat need not be included in such inspection; (Sect. 2.31 (c)(2))

(3) Prepare reports of its evaluations conducted as required by paragraphs (c)(1) and (2) of this section, and submit the reports to the Institutional Official of the research facility; Provided, however, That the IACUC may determine the best means of conducting evaluations of the research facility's programs and facilities; and Provided, further, That no Committee member wishing to participate in any evaluation conducted under this subpart may be excluded. The IACUC may use subcommittees composed of at least two Committee members and may invite ad hoc consultants to assist in conducting the evaluations, however, the IACUC remains responsible for the evaluations and reports as required by the Act and regulations. The reports shall be reviewed and signed by a majority of the IACUC members and must include any minority views. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the research facility and made available to APHIS and to officials of funding Federal agencies for inspection and copying upon request. The reports must contain a description of the nature and extent of the research facility's adherence to this subchapter, must identify specifically any departures from the provisions of title 9, chapter I, subchapter A - Animal Welfare, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, with reference to Subchapter A, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the Institutional Official, to APHIS and any Federal agency funding that activity; (Sect. 2.31 (c)(3))

(4) Review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees; (Sect. 2.31 (c)(4))

(5) Make recommendations to the Institutional Official regarding any aspect of the research facility's animal program, facilities, or personnel training; (Sect. 2.31 (c)(5))

(6) Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals, as specified in paragraph (d) of this section; (Sect. 2.31 (c)(6))

(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and (Sect. 2.31 (c)(7))

(8) Be authorized to suspend an activity involving animals in accordance with the specifications set forth in paragraph (d)(6) of this section. (Sect. 2.31 (c)(8))

3. IACUC review of activities involving animals (Section 2.31)

(1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements: (Sect. 2.31 (d)(1))

(i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals; (Sect. 2.31 (d)(1)(i))

(ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g., the Animal Welfare Information Center, used to determine that alternatives were not available; (Sect. 2.31 (d)(1)(ii))

(iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments; (Sect. 2.31 (d)(1)(iii))

(iv) Procedures that may cause more than momentary or slight pain or distress to the animals will: (Sect. 2.31 (d)(1)(iv))

(A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time; (Sect. 2.31 (d)(1)(iv)(A))

(B) Involve, in their planning, consultation with the attending veterinarian or his or her designee; (Sect. 2.31 (d)(1)(iv)(B))

(C) Not include the use of paralytics without anesthesia; (Sect. 2.31 (d)(1)(iv)(C))

(v) Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure; (Sect. 2.31 (d)(1)(v))

(vi) The animals' living conditions will be appropriate for their species in accordance with part 3 of this subchapter, and contribute to their health and comfort. The housing, feeding, and nonmedical care of the animals will be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied; (Sect. 2.31 (d)(1)(vi))

(vii) Medical care for animals will be available and provided as necessary by a qualified veterinarian; (Sect. 2.31 (d)(1)(vii))

(viii) Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures; (Sect. 2.31 (d)(1)(viii))

(ix) Activities that involve surgery include appropriate provision for pre-operative and post-operative care of the animals in accordance with established veterinary medical and nursing practices. All survival surgery will be performed using aseptic procedures, including surgical gloves, masks, sterile instruments, and aseptic techniques. Major operative procedures on non-rodents will be conducted only in facilities intended for that purpose which shall be operated and maintained under aseptic conditions. Non-major operative procedures and all surgery on rodents do not require a dedicated facility, but must be performed using aseptic procedures. Operative procedures conducted at field sites need not be performed in dedicated facilities, but must be performed using aseptic procedures; (Sect. 2.31 (d)(1)(ix))

(x) No animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (Sect. 2.31 (d)(1)(x))

(A) Justified for scientific reasons by the principal investigator, in writing; (Sect. 2.31 (d)(1)(x)(A))

(B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian; or (Sect. 2.31 (d)(1)(x)(B))

(C) In other special circumstances as determined by the Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234; (Sect. 2.31 (d)(1)(x)(C))

(xi) Methods of euthanasia used must be in accordance with the definition of the term set forth in 9 CFR part 1, § 1.1 of this subchapter, unless a deviation is justified for scientific reasons, in writing, by the investigator. (Sect. 2.31 (d)(1)(xi))

(2) Prior to IACUC review, each member of the Committee shall be provided with a list of proposed activities to be reviewed. Written descriptions of all proposed activities that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full Committee review of those activities. If full Committee review is not requested, at least one member of the IACUC, designated by the chairman and qualified to conduct the review, shall review those activities, and shall have the authority to approve, require modifications in (to secure approval), or request full Committee review of any of those activities. If full Committee review is requested for a proposed activity, approval of that activity may be granted 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. No member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of a quorum; (Sect. 2.31 (d)(2))

(3) The IACUC may invite consultants to assist in the review of complex issues arising out of its review of proposed activities. Consultants may not approve or withhold approval of an activity, and may not vote with the IACUC unless they are also members of the IACUC; (Sect. 2.31 (d)(3))

(4) The IACUC shall notify principal investigators and the research facility in writing 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 principal investigator an opportunity to respond in person or in writing. The IACUC may reconsider its decision, with documentation in Committee minutes, in light of the information provided by the principal investigator; (Sect. 2.31 (d)(4))

(5) The IACUC shall conduct complete reviews of activities covered by this subchapter at appropriate intervals as determined by the IACUC, but not less than every 3 years. The complete review shall address all requirements related to the care and use of animals under paragraphs (d) and (e) of this section. The IACUC shall be provided a written description of all activities that involve the care and use of animals for review and approval at the end of the term. (Sect. 2.31 (d)(5))

(6) The IACUC may suspend an activity that it previously approved if it determines that the activity is not being conducted in accordance with the description of that activity provided by the principal investigator and approved by the Committee. 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; (Sect. 2.31 (d)(6))

(7) 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 that action with a full explanation to APHIS and any Federal agency funding that activity; and (Sect. 2.31 (d)(7))

(8) Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC. (Sect. 2.31 (d)(8))

4. Requirements for proposed activities or significant changes in an ongoing activity (Section 2.31)

(e) A proposal to conduct an activity involving animals, or to make a significant change in an ongoing activity involving animals, must contain the following: (Sect. 2.31 (e))

(1) Identification of the species and the approximate number of animals to be used; (Sect. 2.31 (e)(1))

(2) A rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used; (Sect. 2.31 (e)(2))

(3) A complete description of the proposed use of the animals; (Sect. 2.31 (e)(3))

(4) A description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals; and (Sect. 2.31 (e)(4))

(5) A description of any euthanasia method to be used. (Sect. 2.31 (e)(5))

5. Additional reports and records (Section 2.35)

(a) The research facility shall maintain the following IACUC records: (Sect. 2.35 (a))

(1) Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations; (Sect. 2.35 (a)(1))

(2) Records of proposed activities involving animals and proposed significant changes in activities involving animals, and whether IACUC approval was given or withheld; and (Sect. 2.35 (a)(2))

(3) Records of semiannual IACUC reports and recommendations (including minority views), prepared in accordance with the requirements of § 2.31(c)(3) of this subpart, and forwarded to the Institutional Official. (Sect. 2.35 (a)(3))

Additional Concerns for the IACUC

1. Personnel qualifications (Section 2.32)

(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel. (Sect. 2.32 (a))

(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and § 2.31. (Sect. 2.32 (b))

(c) Training and instruction of personnel must include guidance in at least the following areas: (Sect. 2.32 (c))

(1) Humane methods of animal maintenance and experimentation, including: (Sect. 2.32 (c)(1))

(i) The basic needs of each species of animal; (Sect. 2.32 (c)(1)(i))

(ii) Proper handling and care for the various species of animals used by the facility; (Sect. 2.32 (c)(1)(ii))

(iii) Proper pre-procedural and post-procedural care of animals; and (Sect. 2.32 (c)(1)(iii))

(iv) Aseptic surgical methods and procedures; (Sect. 2.32 (c)(1)(iv))

(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress; (Sect. 2.32 (c)(2))

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility; (Sect. 2.32 (c)(3))

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act; (Sect. 2.32 (c)(4))

(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information: (Sect. 2.32 (c)(5))

(i) On appropriate methods of animal care and use; (Sect. 2.32 (c)(5)(i))

(ii) On alternatives to the use of live animals in research; (Sect. 2.32 (c)(5)(ii))

(iii) That could prevent unintended and unnecessary duplication of research involving animals; and (Sect. 2.32 (c)(5)(iii))

(iv) Regarding the intent and requirements of the Act. (Sect. 2.32 (c)(5)(iv))

2. Annual report (Section 2.36)

(b) The annual report shall: (Sect. 2.36 (b))

(1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility; (Sect. 2.36 (b)(1))

(2) Assure that each principal investigator has considered alternatives to painful procedures; (Sect. 2.36 (b)(2))

(3) Assure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. A summary of all such exceptions must be attached to the facility's annual report. In addition to identifying the IACUC-approved exceptions, this summary must include a brief explanation of the exceptions, as well as the species and number of animals affected; (Sect. 2.36 (b)(3))

(4) State the location of all facilities where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes; (Sect. 2.36 (b)(4))

(5) State the common names and the numbers of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs. Routine procedures (e.g., injections, tattooing, blood sampling) should be reported with this group; (Sect. 2.36 (b)(5))

(6) State the common names and the numbers of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used; (Sect. 2.36 (b)(6))

(7) State the common names and the numbers of animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used shall be attached to the annual report; (Sect. 2.36 (b)(7))

(8) State the common names and the numbers of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes. (Sect. 2.36 (b)(8))

3. Federal research facilities (Section 2.37)

Each Federal research facility shall establish an Institutional Animal Care and Use Committee which shall have the same composition, duties, and responsibilities required of nonfederal research facilities by § 2.31 with the following exceptions: (Sect. 2.37)

(a) The Committee shall report deficiencies to the head of the Federal agency conducting the research rather than to APHIS; and (Sect. 2.37 (a))

4. Miscellaneous (Section 2.38)

(f) Handling (Sect. 2.38 (f))

(ii) Deprivation of food or water shall not be used to train, work, or otherwise handle animals; Provided, however: That the short-term withholding of food or water from animals, when specified in an IACUC-approved activity that includes a description of monitoring procedures, is allowed by these regulations. (Sect. 2.38 (f)(2)(ii))

(k) Compliance with standards and prohibitions (Sect. 2.38 (k))

(1) Each research facility shall comply in all respects with the regulations set forth in subpart C of this part and the standards set forth in part 3 of this subchapter for the humane handling, care, treatment, housing, and transportation of animals; Provided, however, That exceptions to the standards in part 3 and the provisions of subpart C of this part may be made only when such exceptions are specified and justified in the proposal to conduct the activity and are approved by the IACUC. (Sect. 2.38 (k)(1))

5. Certifications (Section 2.151)

(b) Exceptions - (Sect. 2.151 (b))

(1) Research. The provisions of paragraphs (a)(1)(iii), (a)(1)(iv), (a)(1)(v), and/or (a)(2) of this section do not apply to any person who imports a live dog from any part of the world into the States for resale for use in research, tests, or experiments at a research facility, provided that: Such person submits satisfactory evidence to Animal Care at the time of his or her application for an import permit that the specific provision(s) would interfere with the dog's use in such research, tests, or experiments in accordance with a research proposal and the proposal has been approved by the research facility IACUC. (Sect. 2.151 (b)(1))

6. Primary enclosures for dogs and cats (Section 3.6)

(d) Innovative primary enclosures not precisely meeting the floor area and height requirements provided in paragraphs (b)(1) and (c)(1) of this section, but that provide the dogs or cats with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Committee, and by dealers and exhibitors when approved by the Administrator. (Sect. 3.6 (d))

7. Exercise for dogs (Section 3.8)

(b) Dogs housed in groups. Dogs over 12 weeks of age housed, held, or maintained in groups by any dealer, exhibitor, or research facility, including Federal research facilities, do not require additional opportunity for exercise regularly if they are maintained in cages, pens, or runs that provide in total at least 100 percent of the required space for each dog if maintained separately. Such animals may be maintained in compatible groups, unless: (Sect. 3.8 (b))

(1) Housing in compatible groups is not in accordance with a research proposal and the proposal has been approved by the research facility Committee; (Sect. 3.8 (b)(1))

(c) Methods and period of providing exercise opportunity. (Sect. 3.8 (c))

(1) The frequency, method, and duration of the opportunity for exercise shall be determined by the attending veterinarian and, at research facilities, in consultation with and approval by the Committee. (Sect. 3.8 (c)(1))

(d) Exemptions. (Sect. 3.8 (d))

(1) If, in the opinion of the attending veterinarian, it is inappropriate for certain dogs to exercise because of their health, condition, or well-being, the dealer, exhibitor, or research facility may be exempted from meeting the requirements of this section for those dogs. Such exemption must be documented by the attending veterinarian and, unless the basis for exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.8 (d)(1))

(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.8 (d)(2))

(3) Records of any exemptions must be maintained and made available to USDA officials or any pertinent funding Federal agency upon request. (Sect. 3.8 (d)(3))

8. Veterinary care for dogs (Section 3.13)

(a) Each dealer, exhibitor, and research facility must follow an appropriate program of veterinary care for dogs that is developed, documented in writing, and signed by the attending veterinarian. Dealers, exhibitors, and research facilities must keep and maintain the written program and make it available for APHIS inspection. The written program of veterinary care must address the requirements for adequate veterinary care for every dealer and exhibitor in § 2.40 of this subchapter and every research facility in § 2.33 of this subchapter, and must also include: (Sect. 3.13 (a))

(3) Vaccinations for contagious and/or deadly diseases of dogs (including rabies, parvovirus and distemper) and sampling and treatment of parasites and other pests (including fleas, worms, coccidia, giardia, and heartworm) in accordance with a schedule approved by the attending veterinarian, unless otherwise required by a research protocol approved by the Committee at research facilities; and (Sect. 3.13 (a)(3))

(4) Preventative care and treatment to ensure healthy and unmatted hair coats, properly trimmed nails, and clean and healthy eyes, ears, skin, and teeth, unless otherwise required by a research protocol approved by the Committee at research facilities. (Sect. 3.13 (a)(4))

9. Primary enclosures for guinea pigs and hamsters (Section 3.28)

(c) Space requirements for primary enclosures acquired on or after August 15, 1990 - (Section 3.28 (c))

(3) Innovative primary enclosures that do not precisely meet the space requirements of paragraph (c)(1) or (c)(2) of this section, but that do provide guinea pigs or hamsters with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Institutional Animal Care and Use Committee, and by dealers and exhibitors when approved by the Administrator. (Sect. 3.28 (c)(3))

10. Primary enclosures for rabbits (Section 3.53)

(c) Space requirements for primary enclosures acquired on or after August 15, 1990 - (Section 3.53 (c))

(3) Innovative primary enclosures that do not precisely meet the space requirements of paragraph (c)(2) of this section, but that do provide rabbits with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Institutional Animal Care and Use Committee, and by dealers and exhibitors when approved by the Administrator. (Sect. 3.53 (c)(3))

11. Primary enclosures for nonhuman primates (Section 3.80)

(b) Minimum space requirements (Sect. 3.80 (b))

(3) In the case of research facilities, any exemption from these standards must be required by a research proposal or in the judgment of the attending veterinarian and must be approved by the Committee. In the case of dealers and exhibitors, any exemption from these standards must be required in the judgment of the attending veterinarian and approved by the Administrator. (Sect. 3.80 (b)(3))

(c) Innovative primary enclosures not precisely meeting the floor area and height requirements provided in paragraph (b) of this section, but that do provide nonhuman primates with a sufficient volume of space and the opportunity to express species-typical behavior, may be used at research facilities when approved by the Committee, and by dealers and exhibitors when approved by the Administrator. (Sect. 3.80 (c))

12. Environmental enhancement to promote psychological well-being for nonhuman primates (Section 3.81)

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan, at a minimum, must address each of the following: (Sect. 3.81)

(d) Restraint devices. Nonhuman primates must not be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the Committee at research facilities. Maintenance under such restraint must be for the shortest period possible. In instances where long-term (more than 12 hours) restraint is required, the nonhuman primate must be provided the opportunity daily for unrestrained activity for at least one continuous hour during the period of restraint, unless continuous restraint is required by the research proposal approved by the Committee at research facilities. (Sect. 3.81 (d))

(e) Exemptions.

(1) The attending veterinarian may exempt an individual nonhuman primate from participation in the environment enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted nonhuman primate. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.81 (e)(1))

(2) For a research facility, the Committee may exempt an individual nonhuman primate from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.81 (e)(2))

13. Watering - nonhuman primates (Section 3.83)

Potable water must be provided in sufficient quantity to every nonhuman primate housed at the facility. If potable water is not continually available to the nonhuman primates, it must be offered to them as often as necessary to ensure their health and well-being, but no less than twice daily for at least l hour each time, unless otherwise required by the attending veterinarian, or as required by the research proposal approved by the Committee at research facilities. Water receptacles must be kept clean and sanitized in accordance with methods provided in § 3.84(b)(3) of this subpart at least once every 2 weeks or as often as necessary to keep them clean and free from contamination. Used water receptacles must be sanitized before they can be used to provide water to a different nonhuman primate or social grouping of nonhuman primates. (Sect. 3.83)

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations and Standards in 9 C.F.R., Chapter 1, Subchapter A-Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to the Requirement for Environmental Enhancement for Primates Under the Animal Welfare Act

The requirements of the Animal Welfare Act (AWA) are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. The requirement for the psychological well-being of primates is set forth under section 13(a)(2)(B) of the AWA (7 U.S.C. § 2143). The standards for environmental enhancement to promote psychological well-being in primates are set forth under 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Part 3, Section 3.81. Section numbers are given for reference to the actual wording of each requirement.

Environment enhancement to promote psychological well-being in primates

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan, at a minimum, must address each of the following:

(a) Social grouping. The environment enhancement plan must include specific provisions to address the social needs of nonhuman primates of species known to exist in social groups in nature. Such specific provisions must be in accordance with currently accepted professional standards, as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. The plan may provide for the following exceptions: (Sect. 3.81 (a))

(1) If a nonhuman primate exhibits vicious or overly aggressive behavior, or is debilitated as a result of age or other conditions (e.g., arthritis), it should be housed separately; (Sect. 3.81 (a)(1))

(2) Nonhuman primates that have or are suspected of having a contagious disease must be isolated from healthy animals in the colony as directed by the attending veterinarian. When an entire group or room of nonhuman primates is known to have or believed to be exposed to an infectious agent, the group may be kept intact during the process of diagnosis, treatment, and control. (Sect. 3.81 (a)(2))

(3) Nonhuman primates may not be housed with other species of primates or animals unless they are compatible, do not prevent access to food, water, or shelter by individual animals. and are not known to be hazardous to the health and well-being of each other. Compatibility of nonhuman primates must be determined in accordance with generally accepted professional practices and actual observations, as directed by the attending veterinarian, to ensure that the nonhuman primates are in fact compatible. Individually housed nonhuman primates must be able to see and hear nonhuman primates of their own or compatible species unless the attending veterinarian determines that it would endanger their health, safety, or well-being. (Sect. 3.81 (a)(3))

(b) Environmental enrichment. The physical environment in the primary enclosures must be enriched by providing means of expressing noninjurious species-typical activities. Species differences should be considered when determining the type or methods of enrichment. Examples of environmental enrichments include providing perches, swings, mirrors, and other increased cage complexities; providing objects to manipulate; varied food items; using foraging or task-oriented feeding methods; and providing interaction with the care giver or other familiar and knowledgeable person consistent with personnel safety precautions. (Sect. 3.81 (b))

(c) Special considerations. Certain nonhuman primates must be provided special attention regarding enhancement of their environment, based on the needs of the individual species and in accordance with the instructions of the attending veterinarian. Nonhuman primates requiring special attention are the following: (Sect. 3.81 (c))

(1) Infants and young juveniles; (Sect. 3.81 (c)(1))

(2) Those that show signs of being in psychological distress through behavior or appearance; (Sect. 3.81 (c)(2))

(3) Those used in research for which the Committee-approved protocol requires restricted activity; (Sect. 3.81 (c)(3))

(4) Individually housed nonhuman primates that are unable to see and hear nonhuman primates of their own or compatible species; and (Sect. 3.81 (c)(4))

(5) Great apes weighing over 110 lbs. (50 kg). Dealers, exhibitors, and research facilities must include in the environment enhancement plan special provisions for great apes weighing over 110 lbs. (50 kg), including additional opportunities to express species-typical behavior. (Sect. 3.81 (c)(5))

(d) Restraint devices. Nonhuman primates must not be maintained in restraint devices unless required for health reasons as determined by the attending veterinarian or by a research proposal approved by the Committee at research facilities. Maintenance under such restraint must be for the shortest period possible. In instances where long-term (more than 12 hours) restraint is required, the nonhuman primate must be provided the opportunity daily for unrestrained activity for at least one continuous hour during the period of restraint, unless continuous restraint is required by the research proposal approved by the Committee at research facilities. (Sect. 3.81 (d))

(e) Exemptions. (Sect. 3.81 (e))

(1) The attending veterinarian may exempt an individual nonhuman primate from participation in the environment enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted nonhuman primate. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.81 (e)(1))

(2) For a research facility, the Committee may exempt an individual nonhuman primate from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.81 (e)(2))

(3) Records of any exemptions must be maintained by the dealer, exhibitor, or research facility and must be made available to USDA officials or officials of any pertinent funding Federal agency upon request. (Sect. 3.81 (e)(3))

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Standards in 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to the Requirement for the Exercise of Dogs Under the Animal Welfare Act

The requirements of the Animal Welfare Act (AWA) are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1,2, and 3. The requirement for the exercise of dogs is set forth under section 13(a)(2)(B) of the AWA (7 U.S.C. § 2143). The standards for the exercise of dogs are set forth in 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Part 3, Section 3.8. Section numbers are given for reference to the actual wording of each requirement.

Definitions 

Positive physical contact means petting, stroking, or other touching, which is beneficial to the well-being of the animal. (Sect. 1.1)

Exercise for Dogs

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. In addition, the plan must be approved by the attending veterinarian. The plan must include written standard procedures to be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding Federal agency. The plan, at a minimum, must comply with each of the following:

(a) Dogs housed individually. Dogs over 12 weeks of age, except bitches with litters, housed, held, or maintained by any dealer, exhibitor, or research facility, including Federal research facilities, must be provided the opportunity for exercise regularly if they are kept individually in cages, pens, or runs that provide less than two times the required floor space for that dog, as indicated by § 3.6(c)(1) of this subpart. (Sect. 3.8 (a))

(b) Dogs housed in groups. Dogs over 12 weeks of age housed, held, or maintained in groups by any dealer, exhibitor, or research facility, including Federal research facilities, do not require additional opportunity for exercise regularly if they are maintained in cages, pens, or runs that provide in total at least 100 percent of the required space for each dog if maintained separately. Such animals may be maintained in compatible groups, unless: (Sect. 3.8 (b))

(1) Housing in compatible groups is not in accordance with a research proposal and the proposal has been approved by the research facility Committee;  (Sect. 3.8 (b)(1))

(2) In the opinion of the attending veterinarian, such housing would adversely affect the health or well-being of the dog(s); or (Sect. 3.8 (b)(2))

(3) Any dog exhibits aggressive or vicious behavior. (Sect. 3.8 (b)(3))

(c) Methods and period of providing exercise opportunity. (Sect. 3.8 (c))

(1) The frequency, method, and duration of the opportunity for exercise shall be determined by the attending veterinarian and, at research facilities, in consultation with and approval by the Committee. (Sect. 3.8 (c)(1))

(2) Dealers, exhibitors, and research facilities, in developing their plan, should consider providing positive physical contact with humans that encourages exercise through play or other similar activities. If a dog is housed, held, or maintained at a facility without sensory contact with another dog, it must be provided with positive physical contact with humans at least daily. (Sect. 3.8 (c)(2))

(3) The opportunity for exercise may be provided in a number of ways, such as: (Sect. 3.8 (c)(3))

(i) Group housing in cages, pens or runs that provide at least 100 percent of the required space for each dog if maintained separately under the minimum floor space requirements of § 3.6(c)(1) of this subpart; (Sect. 3.8 (c)(3)(i))

(ii) Maintaining individually housed dogs in cages, pens, or runs that provide at least twice the minimum floor space required by § 3.6(c)(1) of this subpart; (Sect. 3.8 (c)(3)(ii))

(iii) Providing access to a run or open area at the frequency and duration prescribed by the attending veterinarian; or (Sect. 3.8 (c)(3)(iii))

(iv) Other similar activities. (Sect. 3.8 (c)(3)(iv))

(4) Forced exercise methods or devices such as swimming, treadmills, or carousel-type devices are unacceptable for meeting the exercise requirements of this section. (Sect. 3.8 (c)(4))

(d) Exemptions. (Sect. 3.8 (d))

(1) If, in the opinion of the attending veterinarian, it is inappropriate for certain dogs to exercise because of their health, condition, or well-being, the dealer, exhibitor, or research facility may be exempted from meeting the requirements of this section for those dogs. Such exemption must be documented by the attending veterinarian and, unless the basis for exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.8 (d)(1))

(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.8 (d)(2))

(3) Records of any exemptions must be maintained and made available to USDA officials or any pertinent funding Federal agency upon request. (Sect. 3.8 (d)(3))

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Standards in 9 C.F.R., Chapter 1, Subchapter A- Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to the Regulation of Field Research Under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. This reference guide provides the section numbers of the Regulations pertaining to field research. Section numbers are provided for reference to the actual wording of each requirement.

Definitions

Animal means any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warmblooded animal, which is being used, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. This term excludes birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research; horses not used for research purposes; and other farm animals, such as, but not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs, including those used for hunting, security, or breeding purposes. (Sect. 1.1)

Field study means a study conducted on free-living wild animals in their natural habitat. However, this term excludes any study that involves an invasive procedure, harms, or materially alters the behavior of an animal under study. (Sect. 1.1)

Requirements of the Institutional Animal Care and Use Committee (IACUC) 

(c) IACUC functions. With respect to activities involving animals, the IACUC, as an agent of the research facility, shall: (Sect. 2.31 (c))

(2) Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; Provided, however, That animal areas containing free-living wild animals in their natural habitat need not be included in such inspection; (Sect. 2.31 (c)(2))

(6) Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals, as specified in paragraph (d) of this section; (Sect. 2.31 (c)(6))

(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities; and (Sect. 2.31 (c)(7))

(d) IACUC review of activities involving animals. (Sect. 2.31 (d))

(1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. (Sect. 2.31 (d)(1))

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations in 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to Reports, Notifications, Certifications and Record Keeping for Dealers and Exhibitors Under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the regulations and standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2 and 3. This reference guide provides a brief summary and section numbers of the Regulations and Standards that pertain to reports, notifications, certifications, and recordkeeping for dealers and exhibitors as required under the Animal Welfare Act. Section numbers are given for reference to the actual wording of each requirement.

Definitions

Dealer means any person who, in commerce, for compensation or profit, delivers for transportation, or transports, except as a carrier, buys, or sells, or negotiates the purchase or sale of: Any dog or other animal whether alive or dead (including unborn animals, organs, limbs, blood, serum, or other parts) for research, teaching, testing, experimentation, exhibition, or use as a pet; or any dog at the wholesale level for hunting, security, or breeding purposes. This term does not include: A retail pet store, as defined in this section; and any retail outlet where dogs are sold for hunting, breeding, or security purposes. (Sect. 1.1)

Exhibitor means any person (public or private) exhibiting any animals, which were purchased in commerce or the intended distribution of which affects commerce, or will affect commerce, to the public for compensation, as determined by the Secretary. This term includes carnivals, circuses, animal acts, zoos, and educational exhibits, exhibiting such animals whether operated for profit or not. This term excludes retail pet stores, horse and dog races, an owner of a common, domesticated household pet who derives less than a substantial portion of income from a nonprimary source (as determined by the Secretary) for exhibiting an animal that exclusively resides at the residence of the pet owner, organizations sponsoring and all persons participating in State and country fairs, livestock shows, rodeos, field trials, coursing events, purebred dog and cat shows, and any other fairs or exhibitions intended to advance agricultural arts and sciences, as may be determined by the Secretary. (Sect. 1.1)

Requirements for Record Keeping in Part 2: Regulations

1. Subpart A - Licensing 

Requirements and application (Section 2.1)

(a)

(1) No person shall operate as a dealer, exhibitor, or operator of an auction sale, without a valid license, except persons who are exempt from the licensing requirements under paragraph (a)(3) of this section. A person must be 18 years of age or older to obtain a license. A person seeking a license shall apply on a form which will be furnished by the Deputy Administrator. The applicant shall provide the information requested in section 2.1 (a)(1)(i)-(vii) on the application form. (Sect. 2.1 (a)(1))

(2) The completed application form, along with a $120 license fee, shall be submitted to the appropriate Animal Care office. (Sect. 2.1 (a)(2))

(b)

(1) No person shall have more than one license. Licenses are issued to specific persons, and are issued for specific activities, types and numbers of animals, and approved sites. A new license must be obtained upon change of ownership, location, activities, or animals. A licensee shall notify Animal Care no fewer than 90 days and obtain a new license before any change in the name, address, substantial control or ownership of his business or operation, locations, activities, and number or type of animals described in paragraph (b)(2) of this section. Any person who is subject to the regulations in this subchapter and who intends to exhibit any animal at any location other than the person's approved site must provide that information on their application form in accordance with paragraph (a) of this section and submit written itineraries in accordance with § 2.126. (Sect. 2.1 (b)(1))

Acknowledgement of regulations and standards (Section 2.2)

Animal Care will supply a copy of the Act and the regulations and standards in this subchapter to an applicant upon request. Signing the application form is an acknowledgement that the applicant has reviewed the Act and the regulations and standards and agrees to comply with them. (Sect. 2.2)

Duration of license and termination of license (Section 2.5)

(a) A license issued under this part shall be valid and effective for 3 years (Sect. 2.5 (a))

2. Subpart D - Attending Veterinarian and Adequate Veterinary Care

Attending veterinarian and adequate veterinary care (dealers and exhibitors) (Section 2.40)

(a) Each dealer or exhibitor shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section. (Sect. 2.40 (a))

(1) Each dealer and exhibitor shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the premises of the dealer or exhibitor; and (Sect. 2.40 (a)(1))

(b) Each dealer or exhibitor shall establish and maintain programs of adequate veterinary care that include: (Sect. 2.40 (b))

(3) Daily observation of all animals to assess their health and well-being; Provided, however, That daily observation of animals may be accomplished by someone other than the attending veterinarian; and Provided, further, That a mechanism of direct and frequent communication is required so that timely and accurate information on problems of animal health, behavior, and well-being is conveyed to the attending veterinarian; (Sect. 2.40 (b)(3))

(4) Adequate guidance to personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and (Sect. 2.40 (b)(4))

(5) Adequate pre-procedural and post-procedural care in accordance with established veterinary medical and nursing procedures. (Sect. 2.40 (b)(5))

3. Subpart E - Identification of Animals 

Time and method of identification (Section 2.50)

(a) A class “A” dealer (breeder) shall identify all live dogs and cats in section 2.50 (a).

(b) A class "B" dealer shall identify all live dogs and cats as indicated in section 2.50 (b).

(c) A class "C" exhibitor shall identify live dogs and cats as indicated in section 2.50 (c).

(e) All animals, except dogs and cats, shall be identified as indicated in section 2.50 (e) by each dealer or exhibitor.

4. Subpart G - Records 

Records: Dealers and exhibitors (Section 2.75)

(a)(1) Each dealer, other than operators of auction sales and brokers to whom animals are consigned, and each exhibitor shall make, keep, and maintain records or forms which fully and correctly disclose the information in section 2.75 (a) concerning each dog or cat purchased or otherwise acquired, owned, held, or otherwise in his or her possession or under his or her control, or which is transported, euthanized, sold, or otherwise disposed of by that dealer or exhibitor. The records shall include any offspring born of any animal while in his or her possession or under his or her control. (Sect. 2.75 (a)(1))

(4) One copy of the record containing the information required by paragraph (a)(1) of this section shall accompany each shipment of any dog or cat purchased or otherwise acquired by a dealer or exhibitor. One copy of the record containing the information required by paragraph (a)(1) of this section shall accompany each shipment of any dog or cat sold or otherwise disposed of by a dealer or exhibitor: Provided, however, that, except as provided in § 2.133(b) of this part for dealers, information that indicates the source and date of acquisition of a dog or cat need not appear on the copy of the record accompanying the shipment. One copy of the record containing the information required by paragraph (a)(1) of this section shall be retained by the dealer or exhibitor. (Sect. 2.75 (a)(4))

(b)(1) Every dealer other than operators of auction sales and brokers to whom animals are consigned, and exhibitor shall make, keep, and maintain records or forms which fully and correctly disclose the information in section 2.75 (b) concerning animals other than dogs and cats, purchased or otherwise acquired, owned, held, leased, or otherwise in his or her possession or under his or her control, or which is transported, sold, euthanized, or otherwise disposed of by that dealer or exhibitor. The records shall include any offspring born of any animal while in his or her possession or under his or her control. (Sect. 2.75 (b)(1))

(3) One copy of the record containing the information required by paragraph (b)(1) of this section shall accompany each shipment of any animal(s) other than a dog or cat purchased or otherwise acquired by a dealer or exhibitor. One copy of the record containing the information required by paragraph (b)(1) of this section shall accompany each shipment of any animal other than a dog or cat sold or otherwise disposed of by a dealer or exhibitor; Provided, however, That information which indicates the source and date of acquisition of any animal other than a dog or cat need not appear on the copy of the record accompanying the shipment. The dealer or exhibitor shall retain one copy of the record containing the information required by paragraph (b)(1) of this section. (Sect. 2.75 (b)(3))

Records: Operators of auction sales and brokers (Section 2.76)

(a) Every operator of an auction sale or broker shall make, keep, and maintain records or forms which fully and correctly disclose the information set forth in section 2.76 (a)(1)-(8) concerning each animal consigned for auction or sold, whether or not a fee or commission is charged (Sect. 2.76 (a))

(b) One copy of the record containing the information required by paragraph (a) of this section shall be given to the consignor of each animal, one copy of the record shall be given to the purchaser of each animal: Provided, however, That information which indicates the source and date of consignment of any animal need not appear on the copy of the record given the purchaser of any animal. One copy of the record containing the information required by paragraph (a) of this section shall be retained by the operator of such auction sale, or broker, for each animal sold by the auction sale or broker. (Sect. 2.76 (b))

Health certification and identification (Section 2.78)

(a) No dealer, exhibitor, operator of an auction sale, broker, or department, agency, or instrumentality of the United States or of any State or local government shall deliver to any intermediate handler or carrier for transportation, in commerce, or shall transport in commerce any dog, cat, or nonhuman primate unless the dog, cat, or nonhuman primate is accompanied by a health certificate executed and issued by a licensed veterinarian. The health certificate shall state the information set forth in section 2.78 (a)(1) and (2). (Sect. 2.78 (a))

Records, disposition (Section 2.80)

(a) No dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall, for a period of 1 year, destroy or dispose of, without the consent in writing of the Administrator, any books, records, documents, or other papers required to be kept and maintained under this part. (Sect. 2.80 (a))

(b) Unless otherwise specified, the records required to be kept and maintained under this part shall be held for 1 year after an animal is euthanized or disposed of and for any period in excess of one year as necessary to comply with any applicable Federal, State, or local law. Whenever the Administrator notifies a dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall hold those records until their disposition is authorized by the Administrator. (Sect. 2.80 (b))

5. Subpart H - Compliance with Standards and Holding Period

Holding facility (Section 2.102)

(a) If any dealer or exhibitor obtains the prior approval of the Deputy Administrator, he may arrange to have another person hold animals for the required period provided for in paragraph (a) of § 2.101: Provided, That: (Sect. 2.102 (a))

(1) The other person agrees in writing to comply with the regulations in part 2 and the standards in part 3 of this subchapter and to allow inspection of his premises by an APHIS official during business hours; and (Sect. 2.102 (a)(1))

(2) The animals remain under the total control and responsibility of the dealer or exhibitor. (Sect. 2.102 (a)(2))

6. Subpart I. Miscellaneous

Information as to business; furnishing of same by dealers, exhibitors, operators of auction sales, intermediate handlers, and carriers (Section 2.125)

Each dealer, exhibitor, operator of an auction sale, intermediate handler, and carrier shall furnish to any APHIS official any information concerning the business of the dealer, exhibitor, operator of an auction sale, intermediate handler or carrier which the APHIS official may request in connection with the enforcement of the provisions of the Act, the regulations and the standards in this subchapter. The information shall be furnished within a reasonable time and as may be specified in the request for information. (Sect. 2.125)

Access and inspection of records and property; submission of itineraries (Section 2.126)

(a) Each dealer, exhibitor, intermediate handler, or carrier, shall, during business hours, allow APHIS officials: (Sect. 2.126 (a))

(1) To enter its place of business; (Sect. 2.126 (a)(1))

(2) To examine records required to be kept by the Act and the regulations in this part; (Sect. 2.126 (a)(2))

(3) To make copies of the records; (Sect. 2.126 (a)(3))

(4) To inspect and photograph the facilities, property and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations and the standards in this subchapter; and (Sect. 2.126 (a)(4))

(5) To document, by the taking of photographs and other means, conditions and areas of noncompliance. (Sect. 2.126 (a)(5))

Procurement of dogs, cats, and other animals; dealers (Section 2.132)

(c) Any dealer, exhibitor, research facility, carrier, or intermediate handler who also operates a private or contract animal pound or shelter shall comply with the following: (Sect. 2.132 (c))

(2) Accurate and complete records shall be separately maintained by the licensee or registrant and by the pound or shelter. The records shall be in accordance with §§ 2.75 and 2.76, unless the animals are lost or stray. If the animals are lost or stray, the pound or shelter records shall provide: (Sect. 2.132 (c)(2))

(i) An accurate description of the animal; (Sect. 2.132 (c)(2)(i))

(ii) How, where, from whom, and when the dog or cat was obtained; (Sect. 2.132 (c)(2)(ii))

(iii) How long the dog or cat was held by the pound or shelter before being transferred to the dealer; and (Sect. 2.132 (c)(2)(iii))

(iv) The date the dog or cat was transferred to the dealer. (Sect. 2.132 (c)(2)(iv))

Certification of random source dogs and cats (Section 2.133)

(b) A dealer shall not sell, provide, or make available to any person a live random source dog or cat unless the dealer provides the recipient of the dog or cat with certification that contains the information set forth in section 2.133 (b)(1)-(6). (Sect. 2.133 (b))

(c) The original certification required under paragraph (b) of this section shall accompany the shipment of a live dog or cat to be sold, provided, or otherwise made available by the dealer. (Sect. 2.133 (c))

(d) A dealer who acquires a live dog or cat from another dealer must obtain from that dealer the certification required by paragraph (b) of this section and must attach that certification (including any previously attached certification) to the certification which he or she provides pursuant to paragraph (b) of this section (a photocopy of the original certification will be deemed a duplicate original if the dealer does not dispose of all of the dogs or cats in a single transaction). (Sect. 2.133 (d))

(e) A dealer who completes, provides, or receives a certification required under paragraph (b) of this section shall keep, maintain, and make available for APHIS inspection a copy of the certification for at least 1 year following disposition. (Sect. 2.133 (e))

Record Keeping Requirements in Part 3: Standards

1. Subpart A - Dogs and Cats

Exercise of dogs (Section 3.8)

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. In addition, the plan must be approved by the attending veterinarian. The plan must include written standard procedures to be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding Federal agency. The plan, at a minimum, must comply with the conditions and requirements set forth in section 3.8 (a)-(c). (Sect. 3.8)

(d) Exemptions.(Sect. 3.8 (d))

(1) If, in the opinion of the attending veterinarian, it is inappropriate for certain dogs to exercise because of their health, condition, or well-being, the dealer, exhibitor, or research facility may be exempted from meeting the requirements of this section for those dogs. Such exemption must be documented by the attending veterinarian and, unless the basis for exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.8 (d)(1))

(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.8 (d)(2))

(3) Records of any exemptions must be maintained and made available to USDA officials or any pertinent funding Federal agency upon request. (Sect. 3.8 (d)(3))

Consignments to carriers and intermediate handlers (Section 3.14)

(b) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless they are provided with the name, address, and telephone number of the consignee. (Sect. 3.14 (b))

(c) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the dog or cat was offered food and water during the 4 hours before delivery to the carrier or intermediate handler. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easily noticed and read. Instructions for no food or water are not acceptable unless directed by the attending veterinarian. Instructions must be in compliance with § 3.17. The certification must include the information set forth in section 3.14 (c)(1)-(4) for each dog and cat: (Sect. 3.14 (c))

(e) Carriers and intermediate handlers must not accept a dog or cat for transport in commerce unless their animal holding area meets the minimum temperature requirements provided in §§ 3.19 and 3.20, or unless the consignor provides them with a certificate signed by a veterinarian and dated no more than 10 days before delivery of the animal to the carrier or intermediate handler for transport in commerce, certifying that the animal is acclimated to temperatures lower than those required in §§ 3.19 and 3.20. Even if the carrier or intermediate handler receives this certification, the temperatures the dog or cat is exposed to while in a terminal facility must not be lower than 45 °F (2.2 °C) for more than 4 consecutive hours when dogs or cats are present, as set forth in § 3.19, nor lower than 45 °F (2.2 °C) for more than 45 minutes, as set forth in § 3.20, when moving dogs or cats to or from terminal facilities or primary conveyances. A copy of the certification must accompany the dog or cat to its destination and must include the information set forth in section 3.14 (e)(1)-(4). (Sect. 3.14 (e))

Primary enclosures used to transport live dogs and cats (Section 3.15)

Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must not transport or deliver for transport in commerce a dog or cat unless the following requirements are met: (Sect. 3.15)

(a) Construction of primary enclosures. The dog or cat must be contained in a primary enclosure such as a compartment, transport cage, carton, or crate. Primary enclosures used to transport dogs and cats must be constructed so that: (Sect. 3.15 (a))

(6) Unless the enclosure is permanently affixed to the conveyance, it is clearly marked on top and on one or more sides with the words “Live Animals,” in letters at least 1 inch (2.5 cm.) high, and with arrows or other markings to indicate the correct upright position of the primary enclosure; (Sect. 3.15 (a)(6))

(h) Accompanying documents and records. Shipping documents that must accompany shipments of dogs and cats may be held by the operator of the primary conveyance, for surface transportation only, or must be securely attached in a readily accessible manner to the outside of any primary enclosure that is part of the shipment, in a manner that allows them to be detached for examination and securely reattached, such as in a pocket or sleeve. Instructions for administration of drugs, medication, and other special care must be attached to each primary enclosure in a manner that makes them easy to notice, to detach for examination, and to reattach securely. Food and water instructions must be attached in accordance with § 3.14(c). (Sect. 3.15 (h))

Food and water requirements (Section 3.17)

(b) Any dealer, research facility, including a Federal research facility, or exhibitor offering any dog or cat to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the dog or cat, written instructions for the in-transit food and water requirements for a 24-hour period for the dogs and cats contained in the enclosure. The instructions must be attached in a manner that makes them easily noticed and read. (Sect. 3.17 (b))

2. Subpart B - Guinea Pigs and Hamsters

Facilities, outdoor (Section 3.27)

(a) Hamsters shall not be housed in outdoor facilities. (Sect. 3.27 (a))

(b) Guinea pigs shall not be housed in outdoor facilities unless such facilities are located in an appropriate climate and prior approval for such outdoor housing is obtained from the Deputy Administrator. (Sect. 3.27 (b))

Consignments to carriers and intermediate handlers (Section 3.35)

(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live hamster consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such hamster for transportation in commerce, stating that such live hamster is acclimated to air temperatures lower than those prescribed in §§ 3.40 and 3.41. A copy of such certificate shall accompany the shipment to destination. The certificate shall include the information required in section 3.35 (c)(1)-(4). (Sect. 3.35 (c))

Primary enclosures used to transport live guinea pigs and hamsters (Section 3.36)

No person subject to the Animal Welfare regulations shall offer for transportation, or transport, in commerce any live guinea pig or hamster in a primary enclosure that does not conform to the following requirements: (Sect. 3.36)

(g) Primary enclosures used to transport live guinea pigs or hamsters, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the words “Live Animals” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings, to indicate the correct upright position of the container. (Sect. 3.36 (g))

(h) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment. (Sect. 3.36 (h))

3. Subpart C -Rabbits

Consignments to carriers and intermediate handlers (Section 3.60)

(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any live rabbit in a primary enclosure which conforms to the requirements set forth in § 3.61 of the standards: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any live rabbit consigned by any department, agency, or instrumentality of the United States having laboratory animal facilities or exhibiting animals or any licensed or registered dealer, research facility, exhibitor, or operator of any auction sale, if such consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with § 3.61 of the standards, unless such primary enclosure is obviously defective or damaged and it is apparent that it cannot reasonably be expected to contain the live rabbit without causing suffering or injury to such live rabbit. A copy of such certificate shall accompany the shipment to destination. The certificate shall include the information required in section 3.60 (b)(1)-(4). (Sect. 3.60 (b))

(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live rabbit consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such rabbit for transportation in commerce, stating that such live rabbit is acclimated to air temperatures lower than those prescribed in §§ 3.65 and 3.66. A copy of such certificate shall accompany the shipment to destination. The certificate shall include the information required in section 3.60  (c)(1)-(4). (Sect. 3.60 (c))

Primary enclosures used to transport live rabbits (Section 3.61)

No person subject to the Animal Welfare regulations shall offer for transportation or transport in commerce any live rabbit in a primary enclosure that does not conform to the requirements in section 3.61. (Sect. 3.61)

(f) Primary enclosures used to transport live rabbits, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, shall be clearly marked on top and on one or more sides with the words “Live Animal” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings, to indicate the correct upright position of the container. (Sect. 3.61 (f))

(g) Documents accompanying the shipment shall be attached in an easily accessible manner to the outside of a primary enclosure which is part of such shipment. (Sect. 3.61 (g))

4. Subpart D - Nonhuman Primates

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan, at a minimum, must address the requirements set forth in section 3.81 (a)-(d). (Sect. 3.81)

(e) Exemptions. (Sect. 3.81 (e))

(1) The attending veterinarian may exempt an individual nonhuman primate from participation in the environment enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted nonhuman primate. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian.  (Sect. 3.81 (e)(1))

(3) Records of any exemptions must be maintained by the dealer, exhibitor, or research facility and must be made available to USDA officials or officials of any pertinent funding Federal agency upon request.  (Sect. 3.81 (e)(3))

Consignments to carriers and intermediate handlers (Section 3.86)

(b) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless they are provided with the name, address, telephone number, and telex number, if applicable, of the consignee. (Sect. 3.86 (b))

(c) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless the consignor certifies in writing to the carrier or intermediate handler that the nonhuman primate was offered food and water during the 4 hours before delivery to the carrier or intermediate handler. The certification must be securely attached to the outside of the primary enclosure in a manner that makes it easily noticed and read. Instructions for no food or water are not acceptable unless directed by the attending veterinarian. Instructions must be in compliance with § 3.89 of this subpart. For each nonhuman primate, the certification must include the information required in section 3.86 (c)(1)-(4). (Sect. 3.86 (c))

(e) Carriers and intermediate handlers must not accept a nonhuman primate for transport in commerce unless their animal holding area facilities meet the minimum temperature requirements provided in §§ 3.91 and 3.92 of this subpart, or unless the consignor provides them with a certificate signed by a veterinarian and dated no more than 10 days before delivery of the animal to the carrier or intermediate handler for transport in commerce, certifying that the animal is acclimated to temperatures lower than those that are required in §§ 3.91 and 3.92 of this subpart. Even if the carrier or intermediate handler receives this certification, the temperatures the nonhuman primate is exposed to while in the carrier's or intermediate handler's custody must not be lower than the minimum temperature specified by the veterinarian in accordance with paragraph (e)(4) of this section, and must be reasonably within the generally and professionally accepted temperature range for the nonhuman primate, as determined by the veterinarian, considering its age, condition, and species. A copy of the certification must accompany the nonhuman primate to its destination and must include the information set forth in section 3.86 (e)(1)-(5) for each primary enclosure. (Sect. 3.86 (e))

Primary enclosures used to transport nonhuman primates (Section 3.87)

Any person subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must not transport or deliver for transport in commerce a nonhuman primate unless it is contained in a primary enclosure, such as a compartment, transport cage, carton, or crate, and the requirements set forth in section 3.87 (a)-(g) must be met. (Sect. 3.87)

(f) Marking and labeling. Primary enclosures, other than those that are permanently affixed to a conveyance, must be clearly marked in English on the top and on one or more sides with the words “Wild Animals,” or “Live Animals,” in letters at least 1 inch (2.5 cm.) high, and with arrows or other markings to indicate the correct upright position of the primary enclosure. Permanently affixed primary enclosures must be clearly marked in English with the words “Wild Animals” or “Live Animals,” in the same manner. (Sect. 3.87 (f))

(g) Accompanying documents and records. Shipping documents that must accompany shipments of nonhuman primates may be held by the operator of the primary conveyance, for surface transportation only, or must be securely attached in a readily accessible manner to the outside of any primary enclosure that is part of the shipment, in a manner that allows them to be detached for examination and securely reattached, such as in a pocket or sleeve. Instructions for administration of drugs, medication, and other special care must be attached to each primary enclosure in a manner that makes them easy to notice, to detach for examination, and to reattach securely. Food and water instructions must be attached in accordance with § 3.86(c) of this subpart. (Sect. 3.87 (g))

Food and water requirements (Section 3.89)

(a) Each nonhuman primate that is 1 year of age or more must be offered food[5] at least once every 24 hours. Each nonhuman primate that is less than 1 year of age must be offered food at least once every 12 hours. Each nonhuman primate must be offered potable water at least once every 12 hours. These time periods apply to dealers, exhibitors, and research facilities, including Federal research facilities, who transport nonhuman primates in their own primary conveyances, starting from the time the nonhuman primate was last offered food and potable water before transportation was begun. These time periods apply to carriers and intermediate handlers starting from the date and time stated on the certification provided under § 3.86(c) of this subpart. Each nonhuman primate must be offered food and potable water within 4 hours before being transported in commerce. Consignors who are subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must certify that each nonhuman primate was offered food and potable water within the 4 hours preceding delivery of the nonhuman primate to a carrier or intermediate handler for transportation in commerce, and must certify the date and time the food and potable water was offered, in accordance with § 3.86(c) of this subpart. (Sect. 3.89 (a))

(b) Any dealer, exhibitor, or research facility, including a Federal research facility, offering a nonhuman primate to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the nonhuman primate, written instructions for a 24-hour period for the in-transit food and water requirements of the nonhuman primate(s) contained in the enclosure. The instructions must be attached in a manner that makes them easily noticed and read. (Sect. 3.89 (b))

5. Subpart E - Marine Mammals

Facilities, general (Section 3.101)

(b) Water and power supply. Reliable and adequate sources of water and electric power must be provided by the facility housing marine mammals. Written contingency plans must be submitted to and approved by the Deputy Administrator regarding emergency sources of water and electric power in the event of failure of the primary sources, when such failure could reasonably be expected to be detrimental to the good health and well-being of the marine mammals housed in the facility. Contingency plans must include, but not be limited to, specific animal evacuation plans in the event of a disaster and should describe back-up systems and/or arrangements for relocating marine mammals requiring artificially cooled or heated water. If the emergency contingency plan includes release of marine mammals, the plan must include provision for recall training and retrieval of such animals. Facilities handling marine mammals must also comply with the requirements of § 2.134 of this subchapter. (Sect. 3.101 (b))

Water quality (Section 3.106)

(a) General. The primary enclosure shall not contain water which would be detrimental to the health of the marine mammal contained therein. (Sect. 3.106 (a))

(b) Bacterial standards. (Sect. 3.106 (b))

(3) Water samples shall be taken and tested at least weekly for coliform count and at least daily for pH and any chemical additives (e.g. chlorine and copper) that are added to the water to maintain water quality standards. Facilities using natural seawater shall be exempt from pH and chemical testing unless chemicals are added to maintain water quality. However, they are required to test for coliforms. Records must be kept documenting the time when all such samples were taken and the results of the sampling. Records of all such test results shall be maintained by management for a 1-year period and must be made available for inspection purposes on request. (Sect. 3.106 (b)(3))

Veterinary care (Section 3.110)

(f) All marine mammals must be visually examined by the attending veterinarian at least semiannually and must be physically examined under the supervision of and when determined to be necessary by the attending veterinarian. All cetaceans and sirenians must be physically examined by the attending veterinarian at least annually, unless APHIS grants an exception from this requirement based on considerations related to the health and safety of the cetacean or sirenian. These examinations must include, but are not limited to, a hands-on physical examination, hematology and blood chemistry, and other diagnostic tests as determined by the attending veterinarian. (Sect. 3.110 (f))

(g)

(1) A complete necropsy, including histopathology samples, microbiological cultures, and other testing as appropriate, must be conducted by or under the supervision of the attending veterinarian on all marine mammals that die in captivity. A preliminary necropsy report must be prepared by the veterinarian listing all pathologic lesions observed. The final necropsy report must include all gross and histopathological findings, the results of all laboratory tests performed, and a pathological diagnosis. (Sect. 3.110 (g)(1))

(2) Necropsy records will be maintained at the marine mammal's home facility and at the facility at which it died, if different, for a period of 3 years and must be presented to APHIS inspectors when requested. (Sect. 3.110 (g)(2))

Consignments to carriers and intermediate handlers (Section 3.112)

(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any marine mammal in a primary transport enclosure that conforms to the requirements in § 3.113 of this subpart: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any marine mammal consigned by any department, agency, or instrumentality of the United States having laboratory animal facilities or exhibiting animals or any licensed or registered dealer, research facility, exhibitor, or operator of an auction sale if the consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary transport enclosure complies with § 3.113 of this subpart, unless such primary transport enclosure is obviously defective or damaged and it is apparent that it cannot reasonably be expected to contain the marine mammal without causing suffering or injury to the marine mammal. A copy of any such certificate must accompany the shipment to destination. The certificate must include at least the information required in section 3.112 (b)(1)-(4). (Sect. 3.112 (b))

(c) Carriers or intermediate handlers whose facilities fail to maintain a temperature within the range of 7.2 °C (45 °F) to 23.9 °C (75 °F) allowed by § 3.117 of this subpart may accept for transportation or transport, in commerce, any marine mammal consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by the attending veterinarian on a specified date that is not more than 10 days prior to delivery of the animal for transportation in commerce, stating that the marine mammal is acclimated to a specific air temperature range lower or higher than those prescribed in §§ 3.117 and 3.118. A copy of the certificate must accompany the shipment to destination. The certificate must include at least the information required in section 3.112 (c)(1)-(4). (Sect. 3.112 (c))

Primary enclosures used to transport marine mammals (Section 3.113)

(f) Primary enclosures used to transport marine mammals, except where such primary enclosures are permanently affixed in the animal cargo space of the primary conveyance, must be clearly marked on top (when present) and on at least one side, or on all sides whenever possible, with the words “Live Animal” or “Wild Animal” in letters not less than 2.5 centimeters (1 inch) in height, and with arrows or other markings to indicate the correct upright position of the container. (Sect. 3.113 (f))

(g) Documents accompanying the shipment must be attached in an easily accessible manner to the outside of a primary enclosure that is part of such shipment or be in the possession of the shipping attendant. (Sect. 3.113 (g))

6. Subpart F - Other Animals

Separation (Section 3.133)

Animals housed in the same primary enclosure must be compatible. Animals shall not be housed near animals that interfere with their health or cause them discomfort. (Sect. 3.133)

Consignments to carriers and intermediate handlers (Section 3.136)

(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any live animal in a primary enclosure which conforms to the requirements set forth in § 3.137 of the standards: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any live animal consigned by any department, agency, or instrumentality of the United States having laboratory animal facilities or exhibiting animals or any licensed or registered dealer, research facility, exhibitor, or operator of an auction sale if the consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with § 3.137 of the standards, unless such primary enclosure is obviously defective or damaged and it is apparent that it cannot reasonably be expected to contain the live animal without causing suffering or injury to such live animal. A copy of such certificate shall accompany the shipment to destination. The certificate shall include at least the information required in section 3.136 (b)(1)-(4). (Sect. 3.136 (b))

(c) Carriers or intermediate handlers whose facilities fail to meet the minimum temperature allowed by the standards may accept for transportation or transport, in commerce, any live animal consigned by any department, agency, or instrumentality of the United States or of any State or local government, or by any person (including any licensee or registrant under the Act, as well as any private individual) if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian accredited by this Department pursuant to part 160 of this title on a specified date which shall not be more than 10 days prior to delivery of such animal for transportation in commerce, stating that such live animal is acclimated to air temperatures lower than those prescribed in §§ 3.141 and 3.142. A copy of such certificate shall accompany the shipment to destination. The certificate shall include at least the information required in section 3.136 (c)(1)-(4). (Sect. 3.136 (c))

Food and water requirements (Section 3.139)

(b) Any dealer, research facility, exhibitor or operator of an auction sale offering any live animal to any carrier or intermediate handler for transportation in commerce shall affix to the outside of the primary enclosure used for transporting such live animal, written instructions concerning the food and water requirements of such animal while being so transported. (Sect. 3.139 (b))

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations and Standards in 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to Reports, Notifications and Recordkeeping for Research Facilities Under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A- Animal Welfare, Parts 1, 2, and 3. This reference guide provides a brief summary and section numbers of the Regulations and Standards that pertain to reports, notifications, certifications, and recordkeeping for research facilities required under the Animal Welfare Act. Section numbers are given for reference to the actual wording of each requirement.

Definitions

Research facility means any school (except an elementary or secondary school), institution, organization, or person that uses or intends to use live animals in research, tests, or experiments, and that

(1) purchases or transports live animals in commerce, or

(2) receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States for the purpose of carrying out research, tests, or experiments: Provided, That the Administrator may exempt, by regulation, any such school, institution, organization, or person that does not use or intend to use live dogs or cats, except those schools, institutions, organizations, or persons, which use substantial numbers (as determined by the Administrator) of live animals the principal function of which schools, institutions, organizations, or persons, is biomedical research or testing, when in the judgment of the Administrator, any such exemption does not vitiate the purpose of the Act. (Sect. 1.1)

Record Keeping Requirements in Part 2: Regulations

1. Subpart C - Research Facilities

Registration (Section 2.30)

(a) Requirements and procedures.(Sect. 2.30 (a))

(1) Each research facility, other than a Federal research facility, shall register with the Secretary by completing and filing a properly executed form which will be furnished, upon request, by the Deputy Administrator. The registration form shall be filed with the Deputy Administrator. Except as provided in paragraph (a)(2) of this section, where a school or department of a university or college uses or intends to use live animals for research, tests, experiments, or teaching, the university or college rather than the school or department will be considered the research facility and will be required to register with the Secretary. An official who has the legal authority to bind the parent organization shall sign the registration form. (Sect. 2.30 (a)(1))

(c) Notification of change of operation. A research facility shall notify the Deputy Administrator in writing of any change in the name, address, or ownership, or other change in operations affecting its status as a research facility, within 10 days after making such change. The Notification of Change form (APHIS Form 7033) may be used to provide the information. (Sect. 2.30 (c))

Institutional Animal Care and Use Committee (IACUC) (Section 2.31)

(c) IACUC functions. With respect to activities involving animals, the IACUC, as an agent of the research facility, shall: (Sect. 2.31 (c))

(1) Review, at least once every six months, the research facility's program for humane care and use of animals, using title 9, chapter I, subchapter A - Animal Welfare, as a basis for evaluation; (Sect. 2.31 (c)(1))

(2) Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas, using title 9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; Provided, however, That animal areas containing free-living wild animals in their natural habitat need not be included in such inspection; (Sect. 2.31 (c)(2))

(3) Prepare reports of its evaluations conducted as required by paragraphs (c)(1) and (2) of this section, and submit the reports to the Institutional Official of the research facility; Provided, however, That the IACUC may determine the best means of conducting evaluations of the research facility's programs and facilities; and Provided, further, That no Committee member wishing to participate in any evaluation conducted under this subpart may be excluded. The IACUC may use subcommittees composed of at least two Committee members and may invite ad hoc consultants to assist in conducting the evaluations, however, the IACUC remains responsible for the evaluations and reports as required by the Act and regulations. The reports shall be reviewed and signed by a majority of the IACUC members and must include any minority views. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the research facility and made available to APHIS and to officials of funding Federal agencies for inspection and copying upon request. The reports must contain a description of the nature and extent of the research facility's adherence to this subchapter, must identify specifically any departures from the provisions of title 9, chapter I, subchapter A - Animal Welfare, and must state the reasons for each departure. The reports must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which, with reference to Subchapter A, and, in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the Institutional Official, to APHIS and any Federal agency funding that activity; (Sect. 2.31 (c)(3))

(5) Make recommendations to the Institutional Official regarding any aspect of the research facility's animal program, facilities, or personnel training; (Sect. 2.31 (c)(5))

(d) IACUC review of activities involving animals (Sect. 2.31 (d))

(1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements: (Sect. 2.31 (d)(1))

(i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals; (Sect. 2.31 (d)(1)(i))

(ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g., the Animal Welfare Information Center, used to determine that alternatives were not available; (Sect. 2.31 (d)(1)(ii))

(iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments; (Sect. 2.31 (d)(1)(iii))

(iv) Procedures that may cause more than momentary or slight pain or distress to the animals will: (Sect. 2.31 (d)(1)(iv))

(A) Be performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue for only the necessary period of time; (Sect. 2.31 (d)(1)(iv)(A))

(B) Involve, in their planning, consultation with the attending veterinarian or his or her designee; (Sect. 2.31 (d)(1)(iv)(B))

(C) Not include the use of paralytics without anesthesia; (Sect. 2.31 (d)(1)(iv)(C))

(x) No animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (Sect. 2.31 (d)(1)(x))

(A) Justified for scientific reasons by the principal investigator, in writing; (Sect. 2.31 (d)(1)(x)(A))

(2) Prior to IACUC review, each member of the Committee shall be provided with a list of proposed activities to be reviewed. Written descriptions of all proposed activities that involve the care and use of animals shall be available to all IACUC members, and any member of the IACUC may obtain, upon request, full Committee review of those activities. If full Committee review is not requested, at least one member of the IACUC, designated by the chairman and qualified to conduct the review, shall review those activities, and shall have the authority to approve, require modifications in (to secure approval), or request full Committee review of any of those activities. If full Committee review is requested for a proposed activity, approval of that activity may be granted 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. No member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of a quorum; (Sect. 2.31 (d)(2))

(4) The IACUC shall notify principal investigators and the research facility in writing 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 principal investigator an opportunity to respond in person or in writing. The IACUC may reconsider its decision, with documentation in Committee minutes, in light of the information provided by the principal investigator; (Sect. 2.31 (d)(4))

(7) 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 that action with a full explanation to APHIS and any Federal agency funding that activity; and (Sect. 2.31 (d)(7))

Personnel qualifications (Section 2.32)

(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel (Sect. 2.32 (a))

(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and § 2.31 (Sect. 2.32 (b))

(c) Training and instruction of personnel must include guidance in at least the following areas: (Sect. 2.32 (c))

(1) Humane methods of animal maintenance and experimentation, including: (Sect. 2.32 (c)(1))

(i) The basic needs of each species of animal; (Sect. 2.32 (c)(1)(i))

(ii) Proper handling and care for the various species of animals used by the facility; (Sect. 2.32 (c)(1)(ii))

(iii) Proper pre-procedural and post-procedural care of animals; and (Sect. 2.32 (c)(1)(iii))

(iv) Aseptic surgical methods and procedures; (Sect. 2.32 (c)(1)(iv))

(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress; (Sect. 2.32 (c)(2))

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility; (Sect. 2.32 (c)(3)).

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act; (Sect. 2.32 (c)(4))

(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information: (Sect. 2.32 (c)(5))

(i) On appropriate methods of animal care and use; (Sect. 2.32 (c)(5)(i))

(ii) On alternatives to the use of live animals in research; (Sect. 2.32 (c)(5)(ii))

(iii) That could prevent unintended and unnecessary duplication of research involving animals; and (Sect. 2.32 (c)(5)(iii))

(iv) Regarding the intent and requirements of the Act. (Sect. 2.32 (c)(5)(iv))

Attending veterinarian and adequate veterinary care (Section 2.33)

(a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section: (Sect. 2.33 (a))

(1) Each research facility shall employ an attending veterinarian under formal arrangements. In the case of a part-time attending veterinarian or consultant arrangements, the formal arrangements shall include a written program of veterinary care and regularly scheduled visits to the research facility (Sect. 2.33 (a)(1))

(2) Each research facility shall assure that the attending veterinarian has appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use (Sect. 2.33 (a)(2))

(3) The attending veterinarian shall be a voting member of the IACUC; Provided, however, That a research facility with more than one Doctor of Veterinary Medicine (DVM) may appoint to the IACUC another DVM with delegated program responsibility for activities involving animals at the research facility (Sect. 2.33 (a)(3))

(b) Each research facility shall establish and maintain programs of adequate veterinary care as set forth in section 2.33 (b)(1)-(5). (Sect. 2.33 (b))

Recordkeeping requirements (Section 2.35)

(a) The research facility shall maintain the following IACUC records: (Sect. 2.35 (a))

(1) Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations; (Sect. 2.35 (a)(1))

(2) Records of proposed activities involving animals and proposed significant changes in activities involving animals, and whether IACUC approval was given or withheld; and (Sect. 2.35 (a)(2))

(3) Records of semiannual IACUC reports and recommendations (including minority views), prepared in accordance with the requirements of § 2.31(c)(3) of this subpart, and forwarded to the Institutional Official. (Sect. 2.35 (a)(3))

(b) Every research facility shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each live dog or cat purchased or otherwise acquired, owned, held, or otherwise in their possession or under their control, transported, euthanized, sold, or otherwise disposed of by the research facility. The records shall include any offspring born of any animal while in the research facility's possession or under its control: (Sect. 2.35 (b))

(1) The name and address of the person from whom a dog or cat was purchased or otherwise acquired, whether or not the person is required to be licensed or registered under the Act;  (Sect. 2.35 (b)(1))

(2) The USDA license or registration number of the person if he or she is licensed or registered under the Act; (Sect. 2.35 (b)(2))

(3) The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act; (Sect. 2.35 (b)(3))

(4) The date of acquisition of each dog or cat; (Sect. 2.35 (b)(4))

(5) The official USDA tag number or tattoo assigned to each dog or cat under § 2.38(g) of this subpart; (Sect. 2.35 (b)(5))

(6) A description of each dog or cat which shall include: (Sect. 2.35 (b)(6))

(i) The species and breed or type of animal; (Sect. 2.35 (b)(6)(i))

(ii) The sex; (Sect. 2.35 (b)(6)(ii))

(iii) The date of birth or approximate age; and (Sect. 2.35 (b)(6)(iii))

(iv) The color and any distinctive markings; (Sect. 2.35 (b)(6)(iv))

(7) Any identification number or mark assigned to each dog or cat by the research facility; (Sect. 2.35 (b)(7))

(c) In addition to the information required to be kept and maintained by every research facility concerning each live dog or cat under paragraph (a) of this section, every research facility transporting, selling, or otherwise disposing of any live dog or cat to another person, shall make and maintain records or forms which fully and correctly disclose the following information: (Sect. 2.35 (c))

(1) The name and address of the person to whom a live dog or cat is transported, sold, or otherwise disposed of; (Sect. 2.35 (c)(1))

(2) The date of transportation, sale, euthanasia, or other disposition of the animal; and (Sect. 2.35 (c)(2))

(3) The method of transportation, including the name of the initial carrier or intermediate handler, or if a privately owned vehicle is used to transport the dog or cat, the name of the owner of the privately owned vehicle. (Sect. 2.35 (c)(3))

(e) One copy of the record containing the information required by paragraphs (b) and (c) of this section shall accompany each shipment of any live dog or cat sold or otherwise disposed of by a research facility; Provided, however, That, except as provided in § 2.133 of this part, information that indicates the source and date of acquisition of any dog or cat need not appear on the copy of the record accompanying the shipment. One copy of the record containing the information required by paragraphs (b) and (c) of this section shall be retained by the research facility. (Sect. 2.35 (e))

(f) All records and reports shall be maintained for at least three years. Records that relate directly to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be available for inspection and copying by authorized APHIS or funding Federal agency representatives at reasonable times. APHIS inspectors will maintain the confidentiality of the information and will not remove the materials from the research facilities' premises unless there has been an alleged violation, they are needed to investigate a possible violation, or for other enforcement purposes. Release of any such materials, including reports, summaries, and photographs that contain trade secrets or commercial or financial information that is privileged or confidential will be governed by applicable sections of the Freedom of Information Act. Whenever the Administrator notifies a research facility in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the research facility shall hold those records until their disposition is authorized in writing by the Administrator. (Sect. 3.25 (f))

Annual report (Section 2.36)

(a) The reporting facility shall be that segment of the research facility, or that department, agency, or instrumentality of the United States that uses or intends to use live animals in research, tests, experiments, or for teaching. Each reporting facility shall submit an annual report to the Deputy Administrator on or before December 1 of each calendar year. The report shall cover the previous Federal fiscal year. The Annual Report of Research Facility (APHIS Form 7023), Continuation Sheet for Annual Report of Research Facility (APHIS Form 7023A), and Annual Report of Research Facility Column E Explanation (APHIS Form 7023B) are forms which may be used to submit the information required by paragraph (b) of this section. (Sect. 2.36 (a))

(b) The annual report shall: (Sect. 2.36 (b))

(1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility; (Sect. 2.36 (b)(1))

(2) Assure that each principal investigator has considered alternatives to painful procedures; (Sect. 2.36 (b)(2))

(3) Assure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. A summary of all such exceptions must be attached to the facility's annual report. In addition to identifying the IACUC-approved exceptions, this summary must include a brief explanation of the exceptions, as well as the species and number of animals affected; (Sect. 2.36 (b)(3))

(4) State the location of all facilities where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes; (Sect. 2.36 (b)(4))

(5) State the common names and the numbers of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs. Routine procedures (e.g., injections, tattooing, blood sampling) should be reported with this group; (Sect. 2.36 (b)(5))

(6) State the common names and the numbers of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used; (Sect. 2.36 (b)(6))

(7) State the common names and the numbers of animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used shall be attached to the annual report; (Sect. 2.36 (b)(7))

(8) State the common names and the numbers of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes. (Sect. 2.36 (b)(8))

Miscellaneous (Section 2.38)

(a) Information as to business: furnishing of same by research facilities. Each research facility shall furnish to any APHIS official any information concerning the business of the research facility which the APHIS official may request in connection with the enforcement of the provisions of the Act, the regulations, and the standards in this subchapter. The information shall be furnished within a reasonable time and as may be specified in the request for information. (Sect. 2.38 (a))

(b) Access and inspection of records and property. (Sect. 2.38 (b))

(1) Each research facility shall, during business hours, allow APHIS officials: (2.38 (b)(1))

(i) To enter its place of business; (Sect. 2.38 (b)(1)(i))

(ii) To examine records required to be kept by the Act and the regulations in this part; (Sect. 2.38 (b)(1)(ii))

(iii) To make copies of the records; (Sect. 2.38 (b)(1)(iii))

(iv) To inspect the facilities, property, and animals, as the APHIS officials consider necessary to enforce the provisions of the Act, the regulations, and the standards in this subchapter; and (Sect. 2.38 (b)(1)(iv))

(v) To document, by the taking of photographs and other means, conditions and areas of noncompliance. (Sect. 2.38 (b)(1)(v))

(d) Inspection for missing animals. Each research facility shall allow, upon request and during business hours, police or officers of other law enforcement agencies with general law enforcement authority (not those agencies whose duties are limited to enforcement of local animal regulations) to enter its place of business to inspect animals and records for the purpose of seeking animals that are missing, under the conditions set forth in section 2.38 (d)(1) and (2). (Sect. 2.38 (d))

(e) Confiscation and destruction of animals.(Sect. 2.38 (e))

(1) If an animal being held by a research facility is not being used to carry out research, testing, or experimentation, and is found by an APHIS official to be suffering as a result of the failure of the research facility to comply with any provision of the regulations or the standards set forth in this subchapter, the APHIS official shall make a reasonable effort to notify the research facility of the condition of the animal(s) and request that the condition be corrected and that adequate care be given to alleviate the animal's suffering or distress, or that the animal(s) be destroyed by euthanasia. In the event that the research facility refuses to comply with this request, the APHIS official may confiscate the animal(s) for care, treatment, or disposal as indicated in paragraph (e)(2) of this section, if, in the opinion of the Administrator, the circumstances indicate the animal's health is in danger. (Sect. 2.38 (e)(1))

(f) Handling (Sect. 2.38 (f))

(1) Handling of all animals shall be done as expeditiously and carefully as possible in a manner that does not cause trauma, overheating, excessive cooling, behavioral stress, physical harm, or unnecessary discomfort. (Sect. 2.38 (f)(1))

(2)

(i) Physical abuse shall not be used to train, work, or otherwise handle animals. (Sect. 2.38 (f)(2)(i))

(ii) Deprivation of food or water shall not be used to train, work, or otherwise handle animals; Provided, however: That the short-term withholding of food or water from animals, when specified in an IACUC-approved activity that includes a description of monitoring procedures, is allowed by these regulations. (Sect. 2.38 (f)(2)(ii))

(g) Identification of dogs and cats. (Sect. 2.38 (g))

(1) All live dogs or cats, including those from any exempt source, delivered for transportation, transported, purchased or otherwise acquired, sold, or disposed of by a research facility, shall be identified at the time of such delivery for transportation, purchase, sale, disposal, or acquisition in one of the following ways: (Sect. 2.38 (g)(1))

(i) By the official tag or tattoo which was affixed to the animal at the time it was acquired by the research facility, as required by this section; or (Sect. 2.38 (g)(1)(i))

(ii) By a tag, tattoo, or collar, applied to the live dog or cat by the research facility and which individually identifies the dog or cat by number. (Sect. 2.38 (g)(1)(ii))

(2) All official tag or tattoo numbers shall be correctly listed in the records of purchase, acquisition, disposal, or sale which shall be maintained in accordance with § 2.35. (Sect. 2.38 (g)(2))

(8) Each research facility shall be held accountable for all official tags acquired. In the event an official tag is lost from a dog or cat while in the possession of a research facility, the facility shall make a diligent effort to locate and reapply the tag to the proper animal. If the lost tag is not located, the research facility shall affix another official tag to the animal in the manner prescribed in this section and record the tag number on the official records. (Sect. 2.38 (g)(8))

(h) Health certification. (Sect. 2.38 (h))

(1) No research facility, including a Federal research facility, shall deliver to any intermediate handler or carrier for transportation, in commerce, or shall transport in commerce any dog, cat, or nonhuman primate unless the dog, cat, or nonhuman primate is accompanied by a health certificate executed and issued by a licensed veterinarian. The health certificate shall state that: (Sect. 2.38 (h)(1))

(i) The licensed veterinarian inspected the dog, cat, or nonhuman primate on a specified date which shall not be more than 10 days prior to the delivery of the dog, cat, or nonhuman primate for transportation; and (Sect. 2.38 (h)(1(i)))

(ii) When so inspected, the dog, cat, or nonhuman primate appeared to the licensed veterinarian to be free of any infectious disease or physical abnormality which would endanger the animal(s) or other animals or endanger public health. (Sect. 2.38 (h)(1)(ii))

(2) The Secretary may provide exceptions to the health certification requirement on an individual basis for animals shipped to a research facility for purposes of research, testing, or experimentation when the research facility requires animals not eligible for certification. Requests should be addressed to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234. (Sect. 2.38 (h)(2))

(i) Holding of animals. If any research facility obtains prior approval of the Deputy Administrator, it may arrange to have another person hold animals: Provided, That: (Sect. 2.38 (i))

(1) The other person agrees, in writing, to comply with the regulations in this part and the standards in part 3 of this subchapter, and to allow inspection of the premises by an APHIS official during business hours; (Sect. 2.38 (i)(1))

(2) The animals remain under the total control and responsibility of the research facility; and (Sect. 2.38 (i)(2))

(3) The Institutional Official agrees, in writing, that the other person or premises is a recognized animal site under its research facility registration. APHIS Form 7009 shall be used for approval. (Sect. 2.38 (i)(3))

2. Subpart I - Miscellaneous

Certification for random source dogs and cats (Section 2.133)

(a) Each of the entities listed in paragraphs (a)(1) through (a)(3) of this section that acquire any live dog or cat shall, before selling or providing the live dog or cat to a dealer, hold and care for the dog or cat for a period of not less than 5 full days after acquiring the animal, not including the date of acquisition and excluding time in transit. This holding period shall include at least one Saturday. (Sect. 2.133 (a))

(b) A dealer shall not sell, provide, or make available to any person a live random source dog or cat unless the dealer provides the recipient of the dog or cat with certification that contains the information set forth in section 2.133 (b)(1)-(6). (Sect. 2.38 (b))

(d) A dealer who acquires a live dog or cat from another dealer must obtain from that dealer the certification required by paragraph (b) of this section and must attach that certification (including any previously attached certification) to the certification which he or she provides pursuant to paragraph (b) of this section (a photocopy of the original certification will be deemed a duplicate original if the dealer does not dispose of all of the dogs or cats in a single transaction). (Sect. 2.38 (d))

(e) A dealer who completes, provides, or receives a certification required under paragraph (b) of this section shall keep, maintain, and make available for APHIS inspection a copy of the certification for at least 1 year following disposition. (Sect. 2.38 (e))

(f) A research facility which acquires any live random source dog or cat from a dealer must obtain the certification required under paragraph (b) of this section and shall keep, maintain, and make available for APHIS inspection the original for at least 3 years following disposition. (Sect. 2.38 (f))

(g) In instances where a research facility transfers ownership of a live random source dog or cat acquired from a dealer to another research facility, a copy of the certification required by paragraph (b) of this section must accompany the dog or cat transferred. The research facility to which the dog or cat is transferred shall keep, maintain, and make available for APHIS inspection the copy of the certification for at least 3 years following disposition. (Sect. 2.38 (g))

Record Keeping Requirements from Part 3: Standards

1. Subpart A - Dogs and Cats

Exercise for dogs (Section 3.8)

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. In addition, the plan must be approved by the attending veterinarian. The plan must include written standard procedures to be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding Federal agency. The plan must comply with section 3.8 (a)-(c). (Sect. 3.8)

(d) Exemptions. (Sect. 3.8 (d))

(1) If, in the opinion of the attending veterinarian, it is inappropriate for certain dogs to exercise because of their health, condition, or well-being, the dealer, exhibitor, or research facility may be exempted from meeting the requirements of this section for those dogs. Such exemption must be documented by the attending veterinarian and, unless the basis for exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian. (Sect. 3.8 (d)(1))

(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. Such exemption must be documented in the Committee-approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.8 (d)(2))

(3) Records of any exemptions must be maintained and made available to USDA officials or any pertinent funding Federal agency upon request. (Sect. 3.8 (d)(3))

Food and water requirements (Section 3.17)

(b) Any dealer, research facility, including a Federal research facility, or exhibitor offering any dog or cat to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the dog or cat, written instructions for the in-transit food and water requirements for a 24-hour period for the dogs and cats contained in the enclosure. The instructions must be attached in a manner that makes them easily noticed and read. (Sect. 3.17 (b))

2. Subpart D - Nonhuman Primates

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan for environment enhancement adequate to promote the psychological well-being of nonhuman primates. The plan must be in accordance with the currently accepted professional standards as cited in appropriate professional journals or reference guides, and as directed by the attending veterinarian. This plan must be made available to APHIS upon request, and, in the case of research facilities, to officials of any pertinent funding agency. The plan must address social grouping (section 3.81 (a)), environmental enrichment (section 3.81 (b)), special considerations (section 3.81 (c)), and restraint devices (section 3.81 (d)). (Sect. 3.81)

(e) Exemptions. (Sect. 3.81 (e))

(1) The attending veterinarian may exempt an individual nonhuman primate from participation in the environment enhancement plan because of its health or condition, or in consideration of its well-being. The basis of the exemption must be recorded by the attending veterinarian for each exempted nonhuman primate. Unless the basis for the exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian.  (Sect. 3.81 (e)(1))

(2) For a research facility, the Committee may exempt an individual nonhuman primate from participation in some or all of the otherwise required environment enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption shall be documented in the approved proposal and must be reviewed at appropriate intervals as determined by the Committee, but not less than annually. (Sect. 3.81 (e)(2))

(3) Records of any exemptions must be maintained by the dealer, exhibitor, or research facility and must be made available to USDA officials or officials of any pertinent funding Federal agency upon request.  (Sect. 3.81 (e)(3))

Food and water requirements (Section 3.89)

(a) Each nonhuman primate that is 1 year of age or more must be offered food[5] at least once every 24 hours. Each nonhuman primate that is less than 1 year of age must be offered food at least once every 12 hours. Each nonhuman primate must be offered potable water at least once every 12 hours. These time periods apply to dealers, exhibitors, and research facilities, including Federal research facilities, who transport nonhuman primates in their own primary conveyances, starting from the time the nonhuman primate was last offered food and potable water before transportation was begun. These time periods apply to carriers and intermediate handlers starting from the date and time stated on the certification provided under § 3.86(c) of this subpart. Each nonhuman primate must be offered food and potable water within 4 hours before being transported in commerce. Consignors who are subject to the Animal Welfare regulations (9 CFR parts 1, 2, and 3) must certify that each nonhuman primate was offered food and potable water within the 4 hours preceding delivery of the nonhuman primate to a carrier or intermediate handler for transportation in commerce, and must certify the date and time the food and potable water was offered, in accordance with § 3.86(c) of this subpart. (Sect. 3.89 (a))

(b) Any dealer, exhibitor, or research facility, including a Federal research facility, offering a nonhuman primate to a carrier or intermediate handler for transportation in commerce must securely attach to the outside of the primary enclosure used for transporting the nonhuman primate, written instructions for a 24-hour period for the in-transit food and water requirements of the nonhuman primate(s) contained in the enclosure. The instructions must be attached in a manner that makes them easily noticed and read. (Sect. 3.89 (b))

3. Subpart E - Marine Mammals

Water quality (Section 3.106)

(a) General. The primary enclosure shall not contain water which would be detrimental to the health of the marine mammal contained therein. (Sect. 3.106 (a))

(b) Bacterial standards. (Sect. 3.106 (b))

(1) The coliform bacteria count of the primary enclosure pool shall not exceed 1,000 MPN (most probable number) per 100 ml. of water. Should a coliform bacterial count exceed 1,000 MPN, two subsequent samples may be taken at 48-hour intervals and averaged with the first sample. If such average count does not fall below 1,000 MPN, then the water in the pool shall be deemed unsatisfactory, and the condition must be corrected immediately. (Sect. 3.106 (b)(1))

(3) Water samples shall be taken and tested at least weekly for coliform count and at least daily for pH and any chemical additives (e.g. chlorine and copper) that are added to the water to maintain water quality standards. Facilities using natural seawater shall be exempt from pH and chemical testing unless chemicals are added to maintain water quality. However, they are required to test for coliforms. Records must be kept documenting the time when all such samples were taken and the results of the sampling. Records of all such test results shall be maintained by management for a 1-year period and must be made available for inspection purposes on request. (Sect. 3.106 (b)(3))

Veterinary care (Section 3.110)

(d) Individual animal medical records must be kept and made available for APHIS inspection. These medical records must include at least the following information: (Sect. 3.110 (d))

(1) Animal identification/name, a physical description, including any identifying markings, scars, etc., age, and sex; and (Sect. 3.110 (d)(1))

(2) Physical examination information, including but not limited to length, weight, physical examination results by body system, identification of all medical and physical problems with proposed plan of action, all diagnostic test results, and documentation of treatment. (Sect. 3.110 (d)(2))

4. Subpart F - Other Animals

Food and water requirements (Section 3.139)

(a)All live animals shall be offered potable water within 4 hours prior to being transported in commerce. Dealers, exhibitors, research facilities and operators of auction sales shall provide potable water to all live animals transported in their own primary conveyance at least every 12 hours after such transportation is initiated, and carriers and intermediate handlers shall provide potable water to all live animals at least every 12 hours after acceptance for transportation in commerce: Provided, however, That except as directed by hibernation, veterinary treatment or other professionally accepted practices, those live animals which, by common accepted practices, require watering more frequently shall be so watered. (Sect. 3.139 (a))

(d) Any dealer, research facility, exhibitor or operator of an auction sale offering any live animal to any carrier or intermediate handler for transportation in commerce shall affix to the outside of the primary enclosure used for transporting such live animal, written instructions concerning the food and water requirements of such animal while being so transported. (Sect. 3.139 (d))

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations and Standards in 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.

A Quick Reference to the Qualifications & Training Required for Research Facility Personnel Under the Animal Welfare Act

The requirements of the Animal Welfare Act are set forth under the Regulations and Standards in the Code of Federal Regulations (C.F.R.). The requirements for the qualifications and training of research facility personnel are found in Title 9 C.F.R., Chapter 1, Subchapter A- Animal Welfare, Part 2. This reference guide provides the section numbers of the Regulations that pertain to the qualifications and training requirements for research facility personnel under the Animal Welfare Act.

Qualifications and Training at Research Facilities

1. Institutional Animal Care and Use Committees (IACUC) (Section 2.31)

(a) The Chief Executive Officer of the research facility shall appoint an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members to assess the research facility's animal program, facilities, and procedures. Except as specifically authorized by law or these regulations, nothing in this part shall be deemed to permit the Committee or IACUC to prescribe methods or set standards for the design, performance, or conduct of actual research or experimentation by a research facility. (Sect. 2.31 (a))

(b) IACUC membership. (Sect. 2.31 (b))

(3) Of the members of the Committee: (Sect. 2.31 (b)(3))

(i) At least one shall be a Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the research facility; (Sect. 2.31 (b)(3)(i))

(ii) At least one shall not be affiliated in any way with the facility other than as a member of the Committee, and shall not be a member of the immediate family of a person who is affiliated with the facility. The Secretary intends that such person will provide representation for general community interests in the proper care and treatment of animals; (Sect. 2.31 (b)(3)(ii))

(4) If the Committee consists of more than three members, not more than three members shall be from the same administrative unit of the facility. (Sect. 2.31 (b)(4))

(d) IACUC review of activities involving animals (Sect. 2.31 (d))

(1) In order to approve proposed activities or proposed significant changes in ongoing activities, the IACUC shall conduct a review of those components of the activities related to the care and use of animals and determine that the proposed activities are in accordance with this subchapter unless acceptable justification for a departure is presented in writing; Provided, however, That field studies as defined in part 1 of this subchapter are exempt from this requirement. Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements: (Sect. 2.31 (d)(1))

(i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals; (Sect. 2.31 (d)(1)(i))

(ii) The principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e. g., the Animal Welfare Information Center, used to determine that alternatives were not available; (Sect. 2.31 (d)(1)(ii))

(iii) The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments; (Sect. 2.31 (d)(1)(iii))

(viii) Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures; (Sect. 2.31 (d)(1)(viii))

2. Personnel qualifications (Section 2.32)

(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled in part through the provision of training and instruction to those personnel. (Sect. 2.32 (a))

(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and § 2.31. (Sect. 2.32 (b))

(c) Training and instruction of personnel must include guidance in at least the following areas: (Sect. 2.32 (c))

(1) Humane methods of animal maintenance and experimentation, including: (Sect. 2.32 (c)(1))

(i) The basic needs of each species of animal; (Sect. 2.32 (c)(1)(i))

(ii) Proper handling and care for the various species of animals used by the facility; (Sect. 2.32 (c)(1)(ii))

(iii) Proper pre-procedural and post-procedural care of animals; and (Sect. 2.32 (c)(1)(iii))

(iv) Aseptic surgical methods and procedures; (Sect. 2.32 (c)(1)(iv))

(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress; (Sect. 2.32 (c)(2))

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility; (Sect. 2.32 (c)(3))

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act; (Sect. 2.32 (c)(4))

(5) Utilization of services (e.g., National Agricultural Library, National Library of Medicine) available to provide information: (Sect. 2.32 (c)(5))

(i) On appropriate methods of animal care and use; (Sect. 2.32 (c)(5)(i))

(ii) On alternatives to the use of live animals in research; (Sect. 2.32 (c)(5)(ii))

(iii) That could prevent unintended and unnecessary duplication of research involving animals; and (Sect. 2.32 (c)(5)(iii))

(iv) Regarding the intent and requirements of the Act. (Sect. 2.32 (c)(5)(iv))

3. Attending veterinarian and adequate veterinary care (Section 2.33)

(a) Each research facility shall have an attending veterinarian who shall provide adequate veterinary care to its animals in compliance with this section. (Sect. 2.33 (a))

(b) Each research facility shall establish and maintain programs of adequate veterinary care that include: (Sect. 2.33 (b))

(4) Guidance to principal investigators and other personnel involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia; and (Sect. 2.33 (b)(4))

(5) Adequate pre-procedural and post-procedural care in accordance with current established veterinary medical and nursing procedures. (Sect. 2.33 (b)(5))

NOTE: The information in this reference guide contains excerpts and paraphrasing of the published Regulations in 9 C.F.R., Chapter 1, Subchapter A- Animal Welfare. The appropriate section in 9 C.F.R. should be consulted for the actual wording of that requirement.