Animal Welfare Act
Interpretive Summaries

To [Contents] [Q&A]

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 (CFR). These requirements are found in Title 9 C.F.R., Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. This paper 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 (see NOTE on last page).

Definition - 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).

I. Title 9 C.F.R., Section 2.33 - Attending Veterinarian and Adequate Veterinary Care

(a) Each research facility must have an attending veterinarian who is required to provide adequate veterinary care to the facilities animals (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) The attending veterinarian is to be employed under formal arrangements with the research facility. If the attending veterinarian is on a part-time or consulting basis, there must be a written program of veterinary care with a list of regularly scheduled visits to the research facility. The scheduled visits must be appropriate and frequent enough to provide adequate veterinary care to all animals at all times. The schedule should consider the number of animals, the species of animals, the type of housing for the animals, the type of work or research done on the animals, the possibility, or level, of pain or distress that may be involved, and any other conditions or factors that may affect the animals well-being (Sect. 2.33(a)(1)).

(2) The research facility must provide the attending veterinarian with sufficient and appropriate authority to ensure that adequate veterinary care is provided at all times and that he or she is able to oversee the adequacy of all aspects of animal care and use for all animals (Sect. 2.33(a)(2)).

(3) The attending veterinarian must be a voting member of the Institutional Animal Care and Use Committee (IACUC) and have direct or delegated responsibility for the animals at the research facility. If more than one veterinarian is employed by th e research facility the attending veterinarian may appoint another veterinarian to the IACUC. The appointed veterinarian must have delegated responsibilities for activities involving animals. A veterinarian engaged principally in research does not meet this requirement (Sect. 2.33(a)(3)).

(b) The research facility must establish and maintain programs of adequate veterinary care that include the following (Sect. 2.33(b)).

(1) That appropriate facilities, personnel, equipment, and services are available so as to comply with requirements (Sect. 2.33(b)(1)).

(2) The use of appropriate methods to control, prevent, diagnose, and treat diseases and injuries. Weekend, holiday, and emergency care must be readily available (Sect. 2.33(b)(2)).

(3) Daily observation of all animals to assess their health and well-being. Daily observation of the animals may be accomplished by someone other than the attending veterinarian, provided that a mechanism of direct and frequent communication is established 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 is to be provided to the principal investigator, and other personnel, involved in the care and use of animals regarding handling, immobilization, anesthesia, analgesia, tranquilization, and euthanasia (Sect. 2.33 (b)(4)).

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

II. Additional Areas of Responsibility for Attending Veterinarians

(1) Membership on the IACUC (Section 2.31).

(b)(3) Of the members of the Committee:

(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:

(A) Be performed with appropriate pain relieving drugs unless withholding such drugs is justified for scientific reasons, in writing, by the principal investigator and will continue only for the necessary period of time.

(B) Involve in their planning, consultation with the attending veterinarian or his or her designee.

(C) Not include the use of paralytics without anesthesia. (This is a flat prohibition).

(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.

(vi) The animals living conditions will be appropriate for their species in accordance with standards set forth in 9 CFR, Part 3, and will 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.

(vii) Medical care for animals will be available and provided as necessary by a qualified veterinarian.

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

(ix) Activities that involve surgery must 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, sterilized 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.

(x) No animal will be used in more that one major operative procedure from which it is allowed to recover unless:

(A) Justified for scientific reasons by the principal investigator, in writing.

(B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian.

(C) In other special circumstances as determined by the Administrator of APHIS on an individual basis.

(xi) Methods of euthanasia used must be in accordance with the definition of the term set forth in 9 CFR, Part 1, Section 1.1, unless a deviation is justified for scientific reasons, in writing, by the investigator. (Recommendations of the AVMA panel on euthanasia should be followed).

(3) Training and Personnel Qualifications. Section 2.32.

(a) It is 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 training and instruction to these 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 facilities responsibility. (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.

(ii) Proper handling and care for the various species of animals used by the facility.

(iii) Proper pre-procedural and post-procedural care of animals.

(iv) Aseptic surgical methods and procedures.

(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 pain relieving drugs 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 reported by facility employees (Sect. 2.32 (c)(4)).

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

(b)(1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of pain relieving 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 degrees F for dogs and cats not acclimated to lower temperatures, for those breeds that cannot tolerate lower temperatures without stress or discomfort, and for sick, aged, young, or infirm dogs or 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 and 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 degrees F for dogs and cats not acclimated to lower temperatures, for those breeds that cannot tolerate lower temperatures without stress and discomfort, and for sick, aged, young, or infirm dogs and 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 not acclimated to the temperatures prevalent in the area or region where they are maintained

(ii) Breeds of dogs or cats that cannot tolerate the prevalent temperatures of the area without stress or discomfort.

(iii) Sick, infirm, aged, or young dogs or cats.

(8) Primary enclosures:(Section 3.6).

(b) Additional requirements for cats.

(1) Space.

(iii) 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 five percent of the minimum requirement for the queen, such housing must be approved by the attending veterinarian of the research facility (Sect. 3.6 (b)(1)(iii)).

(c) Additional requirements for dogs.

(1) Space.

(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 five percent of the minimum requirement for the bitch, such housing must be approved by the attending veterinarian of the research facility (Sect. 3.6 (c)(1)(ii)).

(9) Compatible grouping. (Section 3.7).

(e) Dogs or 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 (Sect. 3.7 (e)).

(10) Exercise for dogs. (Section 3.8).

Research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. The plan must be approved by the attending veterinarian and must include written standard procedures to be followed in providing the opportunity for exercise.

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

(2) In the opinion of the attending veterinarian, such housing would adversely affect the health or well-being of the dogs (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 for exercise 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.

(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....

(12) Watering of dogs and cats (Section 3.10).

If potable water is not continually available to the dogs and cats, it must be offered to the dogs and cats as often as necessary to ensure their health and well-being, but not less than twice daily for at least one hour each time, unless restricted by the attending veterinarian.... (See also sections 3.30 and 3.55).

(13) 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)).

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

(a) Heating, cooling, and temperature.... The ambient temperature in the sheltered part of the facility must not fall below 45 degrees F for more than four consecutive hours when nonhuman primates are present, and must not rise above 85 degrees F for more than four consecutive hours when nonhuman primates are present, unless temperatures above 85 degrees F are approved by the attending veterinarian, in accordance with generally accepted husbandry practices. 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)).

(15) 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 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 degrees F, except as directed by the attending veterinarian, and in accordance with generally accepted professional and husbandry practices (Sect. 3.78(b)).

(16) 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, in accordance with generally accepted professional and husbandry practices (Sect. 3.79 (a)).

(17) Primary enclosures for nonhuman primates (Section 3.80).

(b) Minimum space requirements.

(2) On and after February 15, 1994.

(iii) 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 (Sect. 3.80 (b)(2)(iii)).

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

Research facilities must develop, document, and follow an appropriate plan for environmental 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, as directed by the attending veterinarian....

(a) Social grouping. The environmental 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 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 (Sect. 3.81 (a)(2)).

(3) 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.

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

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

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

(5) Great apes weighing over 110 lbs. Research facilities must include in the environmental enhancement plan special provisions for great apes weighing over 110 lbs., including additional opportunities to express species typical behavior.

(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 the research facility (Sect. 3.81(d)).

(e) Exemptions.

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

(19) 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 not less than twice daily for at least one hour each time, unless otherwise required by the attending veterinarian, or as required by the research proposal approved by the Committee at the research facility.

(20) Veterinary care for marine mammals. Please refer to section 3.110 for requirements.

NOTE: The information in this paper contains excerpts and paraphrasing of the published regulations and standards in 9 CFR, Chapter 1, Subchapter A- Animal Welfare. The appropriate section in 9 CFR should be consulted for the actual wording of that requirement.

To [Contents] [Q&A]

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 (CFR). These requirements are found in Title 9 CFR, Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. Th e requirement for the psychological well-being of primates is set forth under section 13(a)(2)(B) of the AWA (7 USC, 2143). The standards for environmental enhancement to promote psychological well-being in primates are set forth under 9 CFR, Chapter 1, Subchapter A - Animal Welfare, Part 3, Section 3.81. Section numbers are given for reference to the actual wording of each requirement (see NOTE on last page).

Environment enhancement to promote psychological well-being (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. The plan must be made available to APHIS and any funding Federal agency upon request. At a minimum, the plan must address each of the following:

(a) Social grouping. The environmental 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 journals or reference guides, and as directed by the attending veterinarian. The plan may provide for the following exceptions: (3.81(a)).

(1) If a nonhuman primate exhibits vicious or overly aggressive behavior, or is debilitated as a result of age or other condition, such as arthritis, it should be housed separately; (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. If an entire group of nonhuman primates is known to have or believed to be exposed to an infectious agent, the group may be kept intact during diagnosis, treatment, and control. (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 is to 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. (3.81(a)(3)).

(b) Environmental enrichment. The enclosure for the nonhuman primate must be enriched by providing means of expressing noninjurious species-typical activities. Species differences are to be considered when determining the type or methods of enrichment. Examples of enrichment include 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 th e care giver or other familiar and knowledgeable person consistent with safety precautions. (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: (3.81(c)).

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

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

(3) Those used in research for which the Committee-approved protocol requires restricted activity; (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 (3.81(c)(4)).

(5) Great apes weighing over 110 lbs. Facilities must include in the environment enhancement plan special provisions for great apes weighing over 110 lbs, including additional opportunities to express species-typical behavior. (3.81(c)(5)).

< / DD>

(d) Restraint devices. Nonhuman primates are not to 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. Maintenance under restraint must be for the shortest period possible. In instances where restraint over 12 hours is required, the nonhuman primate must be provided the opportunity for daily unrestricted 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. (3.81(d)).

(e) Exemptions.

(1) The attending veterinarian may exempt an individual nonhuman primate from 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 is to be reviewed at least every 30 days by the attending veterinarian. (3.81(e)(1)).

(2) The research facility Committee may exempt an individual nonhuman primate from some, or all, of the required environment enhancement plan for scientific reasons set forth in the research proposal. The basis of the exemption is to be documente d in the approved proposal and must be reviewed at appropriate intervals but not less than annually. (3.81(e)(2)).

(3) Records of any exemptions must be maintained and must be available to USDA officials, or officials of any funding Federal agency upon request. (3.81(e)(3)).

NOTE: The information in this paper contains excerpts and paraphrasing of the published regulations and standards in 9 CFR, Chapter 1, Subchapter A - Animal Welfare. The appropriate section in 9 CFR should be consulted for the actual wording of that requirement.

To [Contents] [Q&A]

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 (CFR). These requirements are found in Title 9 CFR, 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 CFR, Chapter 1, Subchapter A - Animal Welfare, Part 3, Section 3.8. Section numbers are given for reference to the actual wording of each requirement (see NOTE on last page).

Definition - Positive physical contact: means petting, stroking, or other touching which is beneficial to the well-being of the animal.

The requirements for the exercise of dogs are as follows:

I. Exercise for dogs (Sect. 3.8):

Dealers, exhibitors, and research facilities must develop, document, and follow an appropriate plan to provide dogs with the opportunity for exercise. The plan must be approved by the attending veterinarian and must include written standard procedures to be followed in providing the opportunity for exercise.

The plan must be made available to APHIS and any funding Federal agency upon request. At a minimum the plan must comply with the following;

(a) Dogs housed individually - Dogs over 12 weeks of age, except bitches with litters, must be provided a regular opportunity for exercise if they are individually in enclosures that provide less than two times the floor space required for that dog under section 3.6(c)(1) (i.e. length of dog in inches + 6) x (length of dog in inches + 6)/ 144 = required floor space in square feet. (3.8(a)).

(b) Dogs housed in groups - Dogs over 12 weeks of age maintained in groups do not require additional opportunity for exercise if they are maintained in enclosures that provide at least 100 percent of the required minimum floor space for each dog if maintained separately. These dogs may be maintained in compatible groups unless: (3.8(b)).

(1) Housing in compatible groups is not in accordance with the Committee approved research protocol; (3.8(b)(1)).

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

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

(c) Methods and period of providing exercise opportunity.

(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. (3.8(c)(1)).

(2) In developing the plan, the provision of positive physical contact with humans that encourages exercise through play or other similar activities should be considered. Any dog that is maintained without sensory contact with another dog must be provided with positive physical contact with humans at least daily. (3.8(c)(2)).

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

(i) Group housing if the enclosure provides at least 100 percent of the minimum required floor space for each dog if maintained separately under section 3.6(c)(1). (3.8(c)(3)(i)).

(ii) Maintaining individually housed dogs in enclosures that provide at least twice the minimum required floor space under section 3.6(c)(1); (3.8(c)(3)(ii)).

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

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

(4) Forced exercise methods such as swimming, treadmills, or carousel-type devices are not acceptable methods of exercise. (3.8(c)(4)).

(d) Exemptions.

(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, those dogs may be exempted from the exercise requirement. Such exemptions must be documented b y the attending veterinarian and reviewed at least every 30 days unless the basis for the exemption is a permanent condition. (3.8(d)(1)).

(2) Dogs at research facilities may be exempted from the exercise requirement if the principal investigator determines for scientific reasons set forth in the research proposal that it is inappropriate for certain dogs to exercise. The 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. (3.8(d)(2)).

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

NOTE: The information in this paper contains excerpts and paraphrasing of the published regulations and standards in 9CFR, Chapter 1, Subchapter A- Animal Welfare. The appropriate section in 9 CFR should be consulted for the actual wording of that requirement.

To [Contents] [Q&A]

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 (CFR). These requirements are found in Title 9 CFR, Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2, and 3. The requirements for field studies are set forth in Parts 1 and 2 of 9 CFR and are indicated below. Section numbers are provided for reference to the actual wording of each requirement (see NOTE on last page).

"Animal" is generally defined as any warm-blooded animal used for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. Excluded from this definition, at the present time, are birds, rats of the genus Rattus and mice of th e genus Mus bred for use in research, horses not used for research purposes, and other farm animals used for food, fiber, or production purposes (see definition is section 1.1).

"Field study means any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study." (Sect. 1.1)

Section 2.31 (c)(2) requires the Institutional Animal Care and Use Committee (IACUC) to: "Inspect, at least once every six months, all of the research facility`s animal facilities, including animal study areas, using Title 9, Chapter 1, 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:".

Section 2.31 (c)(6) and (7) requires the IACUC to review and approve, or make modifications to, proposed and ongoing activities related to the care and use of animals as specified in section 2.31(d).

Section 2.31(d) requires the IACUC to review the activities involving animals to determine that the proposed activities, or proposed significant changes in ongoing activities, are in accordance with regulations. There is a proviso that field studies a s defined in Part 1 are exempt from this requirement. Should the activity not meet the definition of field study it is NOT exempt from this requirement.

Summary.

In general, field research, or studies, that do not have the potential for pain or distress are exempt from regulation under the Animal Welfare Act. However, under certain circumstances the Act and its regulations and standards affect, and are applicable to, field research studies. In these cases the handling, care, transportation, euthanasia, protocol review, and site review must comply with the regulations and standards. If there is a potential for pain, harm, or distress to the animals the principal investigator must do a search for alternatives and the IACUC must carefully review the research proposal to assure compliance with the Animal Welfare Act. Thus, any wild animal study done on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study, is exempt. However, if the animals are confined in any way, an invasive procedure is involved, or the behavior of the animal is harmed or materially altered, then they are regulated and must comply with the regulations and standards.

NOTE: The information in this paper contains excerpts and paraphrasing of the published regulations and standards in 9 CFR, Chapter 1, Subchapter A - Animal Welfare. The appropriate section in 9 CFR should be consulted for the actual wording of that requirement.

To [Contents] [Q&A]

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 paper 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 (See NOTE on last page).

Definition - 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 C.F.R., Parts 1, 2, and 3 will be met.

I. Section 2.30 - Registration of Research Facility:

(a) Requirements and procedures.

(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 APHIS, REAC Sector Supervisor. The registration form is to be filed with the APHIS, REAC Sector Supervisor for the State in which the research facility has its principal place of business, and shall be updated every 3 years by completing and filing a new registration form....An official who has the legal authority to bind the parent organization shall sign the registration form (Sect. 2.30 (a)(1)).

(b) Acknowledgement of regulations and standards.

   APHIS will supply a copy of the regulations and standards in Subchapter A - Animal Welfare, with each registration form. The research facility shall acknowledge receipt of and agree to comply with the regulations and standards by signing a form provided by APHIS and by filing it with the APHIS, REAC Sector Supervisor (Sect. 2.30 (b)).

(c) Notification of change of operation.

(1) A research facility shall notify the APHIS, REAC Sector Supervisor by certified mail 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 (Sect. 2.30 (c)(1)).

(2) A research facility which has not used, handled, or transported animals for a period of at least 2 years may be placed in an inactive status by making a written request to the APHIS, REAC Sector Supervisor. A research facility shall file an annual report of its status (active or inactive). A research facility is to notify the APHIS, REAC Sector Supervisor in writing at least 10 days before using, handling or transporting animals again after being in an inactive status (Sect. 2.30 (c)(2)).

(3) A research facility which goes out of business or which ceases to function as a research facility, or which changes its method of operation so that it no longer uses, handles, or transports animals and which 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 APHIS, REAC Sector Supervisor. The research facility is responsible for reregistering and demonstrating its compliance with the Act and regulations should it start using, handling, or transporting animals at any time after its registration is canceled (Sect. 2.30 (c)(3)).

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

(a). The Chief Executive Officer (or Institutional Official) shall appoint an Institutional Animal Care and Use Committee (IACUC), qualified through experience and expertise of its members to asses the research facility's animal program, facilities, and procedures. (Sect. 2.31 (a)).

(b) IACUC Membership.

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

(c) IACUC Functions.

(3) The Institutional Official is to receive evaluation reports from the IACUC of its reviews and inspection findings. The reports are to contain a description of the nature and extent of the research facility's adherence to requirements and must specifically identify any departures from the provisions of the regulations and standards. The report must also state the reasons for each departure and must distinguish significant deficiencies from minor deficiencies. 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 to APHIS and any Federal agency funding that activity. (Sect. 2.31 (c)(3)).

(5) The IACUC is to 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.

(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. (Sect. 2.31 (d)(7)).

(8) Proposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subjected 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)).

III. Section 2.32 - Personnel qualifications.

(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 section 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 regulations or standards under the Act. (Sect. 2.23 (c)(4)).

IV. Section 2.33 - 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)).

(1) Each research facility shall employ an attending veterinarian under formal arrangements. In the case of part-time attending veterinarians or consultant arrangements, the formal arrangements shall include a written program of veterinary care an d 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 provisions of adequate veterinary care and to oversee the adequacy of other aspects of animal care and use. (Sect. 2.33 (a)(2)).

V. Section 2.35 - Recordkeeping requirements.

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

VI. Section 2.36 - Annual report.

(a) Each reporting facility shall submit an annual report to the APHIS, REAC Sector Supervisor for the State where the research facility is located on or before December 1 of each calendar year. The report shall be signed and certified by the Chie f Executive Officer or Institutional Official, and shall cover the previous Federal Fiscal year. (Sect. 2.36(a)).

(b) 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). (Sect. 2.36 (b)(1)-(8)).

VII. Section 2.37 - Federal Research facilities.

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 section 2.31 with the following exceptions:

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

VIII. Section 2.38 - Miscellaneous.

(a) Information as to business.

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. The information shall be furnished within a reasonable time as may be specified in the request for information. (Sect. 2.38(a)).

(b) Access and inspection of records and property.

(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. (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. (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. (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, footware, and masks where required, or to prevent the escape of an animal. (Sect. 2.38(d)(2)).

(e) Confiscation and destruction of animals.

   Please refer to section 2.38(e) for information on confiscation and destruction of animals.

(i) Holding of animals.

   If any research facility obtains prior approval of the APHIS, REAC Sector Supervisor, it may arrange to have another person to hold animals; Provided, That:

(1) The other person agrees, in writing, to comply with the regulations and standards, 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. (Sect. 2.38(i)(3)).

NOTE: The information in this publication contains excerpts and paraphrasing of the published regulations and standards 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.

To [Contents] [Q&A]

A Quick Reference to the Responsibilities and Functions of the Principal Investigator (P.I.) 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 paper 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 (see NOTE on last page).

Submit Proposed Activities and Significant Changes to Activities to the Institutional Animal Care and Use Committee for Approval.

I. Title 9 C.F.R.,Section 2.31 Institutional Animal Care and Use Committee.

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

(6) Review and approve, require modification 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 (section 2.31 (c)(6));

(7) Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changed in on going activities. (section 2.31 (c)(7)); and

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

Provide Acceptable Written Justification to the IACUC for Areas of Noncompliance With the Animal Welfare Act.

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

(1) In order to approve proposed activities or significant changes in ongoing activities, the IACUC shall....determine that the proposed activities are in accordance with the regulations and standards (Subchapter A) unless acceptable justification for a departure is presented in writing (by the P.I.) and that proposed activities or significant changes meet the following requirements: (2.31 (d)(1)).

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

(ii) The principal investigator has considered alternatives to procedures that may cause more than momentary of slight pain or distress to the animals (see definition of "Painful procedure" in section 1.1), 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; (section 2.31 (d)(1)(ii)).

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

(iv) Procedures that may cause more than momentary or slight pain or distress to the animals will: (section 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 only for the necessary period of time; (section 2.31 (d)(1)(iv)(A)).

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

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

(vi) The animals living conditions will be appropriate for their species in accordance with part 3 of Subchapter A, 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; (section 2.31 (d)(1)(vi)).

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

(x) No animal will be used in more than one major operative procedure (see definition of "Major operative procedure" in section 1.1) from which it is allowed to recover, unless: (section 2.31 (d)(1)(x)).

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

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

(C) In other special circumstances as determined by the Administrator on an individual basis. (section 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 C.F.R., Part 1, Section 1.1 of Subchapter A, unless a deviation is justified for scientific reasons, in writing, by the investigator. (section 2.31 (d)(1)(xi)).

(4) The IACUC shall notify the principal investigator 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. (section 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... . (section 2.31 (d)(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: (section 2.31 (e)).

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

(2) A rational for involving animals, and for the appropriateness of the species and number of animals used; (section 2.31 (e)(2)).

(3) A complete description of the proposed use of the animals; (section 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 (section 2.31 (e)(4)).

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

Other Requirements.

II. Section 2.32 Personnel qualifications.

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

(1) Humane methods of animal maintenance and experimentation, including; (section 2.32 (c)(1)).

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

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

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

(iv) Aseptic surgical methods and procedures: (section 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; (section 2.32 (c)(2)).

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animal used at the facility; (section 2.32 (c)(3)).

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

(i) On appropriate methods of animal use; (section 2.32 (c)(5)(i)).

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

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

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

III. Section 2.33 Attending Veterinarian and Adequate Veterinary Care. (section 2.33)

(b) Each research facility shall establish and maintain programs of adequate veterinary care that include: (section .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; (section 2.33 (b)(4)).

IV. Section 2.36 Annual report. (section 2.36).

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

(2) Assure that each principal investigator has considered alternatives to painful procedures; (section 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 facilities annual report.... (section 2.36 (b)(3)).

V. Section 3.8 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.... (section 3.8).

(d) Exemptions. (section 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. (section 3.8 (d)(2)).

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

(e) Exemptions. (section 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. (section 3.81 (e)(2)).

NOTE: The information in this publication 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.

To [Contents] [Q&A]

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 (CFR). 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 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 (see NOTE on last page).

Definition - 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 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).

The requirements, membership, duties, and responsibilities of the IACUC and the Research Facility are as follows:

I. IACUC Appointment & Membership (Sect. 2.31 (a) & (b)):

(a) The Chief Executive Officer (CEO) of each research facility is required, by law, to appoint an IACUC. Those persons appointed to this committee must be qualified through experience and expertise to assess the research facilities animal program , facilities and procedures (Sect. 2.31(a)).

(b) The members of the IACUC must be appointed by the CEO of the research facility. The IACUC is to consist of no less than three members as follows (Sect. 2.31 (b)):

(1) A Chairman.

(2) A Doctor of Veterinary Medicine (DVM) with training or experience in laboratory animal science and medicine and who has direct or delegated program responsibility for activities involving animals at the research facility. Th e DVM can not be a researcher who has no direct or delegated responsibility for animals at the facility. Although not specifically prohibited by the regulations, the attending veterinarian should not also be the IACUC chairman.

(3) A nonaffiliated member. This person is not to be affiliated with the research facility in any way other than as a member of the IACUC and can not be a member of the immediate family of a person who is affiliated with the research facility. This person is to provide representation for the general community interests in the proper care and treatment of animals. The nonaffiliated member can not be paid for his or her services on the committee. Expenses such as, travel or mileage, meals and parking may be reimbursed however.

(4) Should the committee consist of more than three members (NIH requires at least five members on the IACUC), no more than three members can be from the same administrative unit of the facility (Departmental level), (Sect. 2.31 (b)(4)).

II. IACUC Functions (Section 2.31 (c)):

With respect to activities involving animals, the IACUC, as an agent of the research facility shall:

(1) Review the research facilities program for humane care and use of animals at least once every six months (Sect. 2.31 (c)(1)).

(2) Inspect all of the research facilities animal facilities, including animal study areas (where animals are housed for more than 12 hours), for compliance with 9 C.F.R., Chapter 1, Subchapter A, at least once every six months (Sect. 2.31 (c)(2)) .

Exception: Field Studies - Areas with free living wild animals in their natural habitat do not require inspection. (See Sect. 1.1 for definition of Field Study).

(3) Prepare reports of the evaluations conducted above and submit them to the CEO of the research facility (Sect. 2.31 (c)(3)).

Provisos:

• The IACUC may determine the best means of conducting the above evaluations.

• No IACUC member wishing to participate in the evaluation may be excluded.

• The IACUC may use subcommittees composed of at least two IACUC members to conduct the above evaluations and may invite ad hoc consultants to assist them if desired.

• The IACUC is responsible for the required evaluations and reports even though it may have been done by a subcommittee.

• The reports must be reviewed and signed by a majority of the IACUC members and must include any minority views.

• The reports must be updated at least once every six months after the semiannual evaluation.

• The reports are to be maintained by the research facility and made available to APHIS and any funding Federal agencies for inspection and copying.

• The reports must contain the following:

  • A description of the nature and extent of the research facilities compliance with regulations.

  • Must specifically identify any departure from compliance with regulations and must state the reasons for each departure.

  • Must distinguish significant deficiencies from minor deficiencies. A significant deficiency is one which affects the health, safety, or well-being of the animal(s).

  • Must contain a reasonable and specific plan and schedule for correction with corrective dates for each deficiency.

• Failure to correct any significant deficiency within the established deadlines must be reported by the IACUC, in writing within fifteen days and through the Institutional Official, to APHIS and any funding Federal agency.

(4) Review and investigate concerns or complaints about the care and use of animals at the research facility whether received from the public or research facility personnel (Sect. 2.31 (c)(4)).

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

(6) Review, approve, require modifications in, or withhold approval of proposed activities related to the care and use of animals (Sect. 2.31(c)(6)).

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

(8) Be authorized to suspend an activity involving animals if that activity is not being conducted in accordance with the activities approved by the IACUC (Sect. 2.31(c))8)).

III. IACUC Review of Activities Involving Animals (Section 2.31 (d)):

(1) In order to approve proposed activities or proposed significant changes in activities, the IACUC shall (Sect. 2.31 (d)(1)):

• Conduct a review of the activities related to the care and use of animals to determine if the proposed activities are in accordance with regulations and standards unless, acceptable justification for departure is presented in writing. However, field studies, as defined in section 1.1, are exempt from this requirement. The IACUC must also determine that the proposed activities, or significant changes to activities, meet the following requirements:

  (i) Procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals.

  (ii) That 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 justification and description of the methods and sources used to determine that alternatives were not available (ex. data base names, search words, etc.).

  (iii) That the principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments.

  (iv) That procedures that may cause more than momentary or slight pain or distress to the animals will:

  (A) Be performed with appropriate pain relieving drugs unless withholding such drugs is scientifically justified, in writing, by the principal investigator and will continue only for the necessary period of time (Sect. 2.31 (d)(1) (iv)(A)).

  (B) Require involvement and consultation with the attending veterinarian during planning of the activity (Sect. 2.31 (d)(1)(iv)(B)).

  (C) Not include the use of paralytics without anesthesia. This is a firm prohibition and the use of paralytics without anesthesia is not allowed (Sect.2.31 (d)(1)(iv)(C)).

  (v) Any animal that may experience severe or chronic pain or distress, that can not be relieved, will be painlessly euthanized as soon as possible (Sect. 2.31 (d)(1)(v)). If such a protocol does not provide for an early termination and euthanasia of the animals then the principal investigator must justify this procedure, in writing, and the IACUC must review and approve such activity.

  (vi) The animals living conditions must be appropriate for their species, as set forth in 9 C.F.R., Part 3, and must contribute to their health and comfort. The husbandry, nutrition, and nonmedical care of the animals is to be directed by the attending veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being used (Sect. 2.31 (d)(1)(vi)).

  (vii) Medical care for the animals must be available and provided as necessary by a qualified veterinarian. This includes after hours, weekends, and holidays (Sect.2.31 (d)(1)(vii)).

  (viii) All personnel conducting procedures on the species being maintained or used must be appropriately qualified and trained in those procedures (Sect. 2.31 (d)(1)(viii)).

  (ix) Activities involving surgery must include appropriate provisions for pre- and post-operative care. This care must be in accordance with established veterinary medical and nursing practices (what is currently accepted as the norm in the veterinary profession) (Sect. 2.31 (d)(1)(ix)).

  • All survival surgery must use aseptic procedures (surgical gloves, masks, sterile instruments, and aseptic techniques).

  • Major operative procedures on non rodents are to be conducted only in facilities intended for that purpose and 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 done under aseptic procedures.

  • Operative procedures conducted at field sites do not require dedicated facilities but must be done using aseptic procedures.

  (x) No animal is to be used in more that one "major operative procedure"(see definition, section 1.1) from which it is allowed to recover unless (Sect. 2.31 (d)(1)(x)):

  (A) The procedure is justified for scientific reasons by the investigator, in writing (Sect. 2.31 (d)(1)(x)(A)).

  (B) The procedure is required as a routine veterinary procedure, or is necessary to protect the health or well-being of the animal as determined by the attending veterinarian (Sect. 2.31 (d)(1)(x)(B)).

  (C) The procedure is approved by the Administrator of APHIS on an individual basis (Sect. 2.31 (d)(1)(x)(C)).

  (xi) Methods of euthanasia must be in accordance with the definition in section 1.1 unless a deviation is justified for scientific reasons by the investigator, in writing, and is approved by the IACUC. Recommendations of the AVMA Panel on Euthanasia should be followed (Sect. 2.31 (d)(1)(xi)).

(2) IACUC Review & Expedited Review of Activities (Section 2.31 (d)(2):

• Prior to any IACUC review, all members of the committee must 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 must be available to all IACUC members.

• Any IACUC member may require a full committee review of any activity by requesting such.

• If a full committee review is not requested, at least one qualified member can be designated by the chairman to conduct the review. That person shall review the activities and has the authority to approve, require modifications, o r request a full committee review of the activities.

• If a full committee review is requested for a proposed activity, approval for that activity may be granted only after a review at a convened meeting of a quorum of the IACUC and with approval of a majority of the quorum present.

• No IACUC member can participate in a review or approval of an activity in which he or she has a conflicting interest, or personal involvement, except to provide information requested by the IACUC.

• No member who has a conflicting interest in an activity may be part of an IACUC quorum considering that activity.

(3) Consultants: The IACUC may invite consultants to assist in the review of complex issues arising during an activity review. The consultant(s) may not approve, withhold approval, or vote with the IACUC unless they are members of the IACUC (Sect. 2.31 (d)(3)).

(4) Notification: The IACUC is to notify the principal investigator and the research facility, in writing, of its decision to approve, withhold approval, or modify an activity related to the care and use of animals (Sect. 2.31 (d)(4)). If the IACUC withholds approval of an activity it shall advise the principal investigator, in writing, as to the reasons for its decision and give the principal investigator an opportunity to respond. The IACUC may reconsider its decision with documentation in the IACUC minutes, in light of the information provided by the principal investigator.

(5) Continuing Reviews: The IACUC is to conduct continuing reviews of activities involved with animals at intervals determined by the IACUC but not less than annually (Sect. 2.31 (d)(5)).

(6) Suspending Activities: The IACUC may suspend an activity if that activity is not being conducted in accordance with the description approved by the Committee. Any decision to suspend an activity must be made at a meeting of a quorum of the IACUC and a suspension vote by a majority of the quorum present (Sect. 2.31 (d)(6)).

(7) Reporting of Suspensions: 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 funding Federal agencies (Sect. 2.31(d)(7)).

(8) Final Approval of Activities Involving Animals: Proposed activities and proposed significant changes in ongoing activities previously approved by the IACUC, may be subject to further 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)).

IV. Requirements for Proposed Activities or Significant Changes in an Ongoing Activity:

A proposal to conduct an activity, or to make significant changes 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.

(2) A rational for involving animals and for the appropriateness of the species and numbers of animals to be used.

(3) A complete description of the proposed use of the animals.

(4) A description of procedures designed to assure that discomfort, pain, and distress to the animals will be limited to that which is unavoidable for the conduct of scientifically valuable research. This must include provisions for the use of pain relieving drugs, where appropriate, to minimize discomfort and pain to the animals.

V. Additional Reports & Records (Section 2.35):

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

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

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

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

(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 APHIS and funding Federal agency representatives. 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 (Sect. 2.35 (f)).

VI. Additional Concerns for the IACUC:

(1) Personnel Qualifications (Section 2.32):

(a) It is 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 is fulfilled in part by training and instruction to those personnel (Sect. 2.32(a)).

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

(c) Training and instruction of personnel is to 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 (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 pain relieving drugs 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 whether from an employee of the facility or the public. No facility employee, IACUC member, or laboratory personnel are to be discriminated against or subject to reprisal for reporting violations (Sect. 2.32(c)(4)).

(5) Utilization of services, such as NAL, AWIC or NLM, 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 (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:

(1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including the appropriate use of pain relieving 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 exceptions to the standards and regulations are specified and explained by the principal investigator and approved by the IACUC. A summary of all exceptions, including a brief explanation of the exceptions and the species and number of animals affected must be attached to the facilities annual report (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) Contain certain information required for animals used involving no pain, distress, or use of pain relieving drugs (Sect. 2.36(b)(5)).

(6) Contain certain information required for animals used involving accompanying pain or distress and for which appropriate pain relieving drugs were used (Sect. 2.36(b)(6)).

(7) Contain certain information required for animals used involving accompanying pain or distress and for which appropriate pain relieving drugs were not used (Sect. 2.36 (b)(7)).

(8) Contain certain information required for animals being bred, conditioned, or held for such use but not yet used (Sect. 2.36(b)(8)).

(3) Miscellaneous (Section 2.38).

(f) Handling:

(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 under these regulations (Sect. 2.38 (f)).

(4) Primary enclosures - dogs and cats (Section 3.6)

(d) Innovative primary enclosures may be used for dogs or cats when approved by the research facility IACUC (Sect. 3.6 (d)).

(5) 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....

(c) Methods and period of providing exercise opportunity.

(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.

(2) A research facility may be exempted from the requirements of exercise for dogs 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)).

(6) Primary enclosures for guinea pigs and hamsters (Section 3.28)

(c) Space requirements after August 15, 1995:

(3) Innovative primary enclosures that do not precisely meet the space requirements 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 IACUC. (Sect. 3.28 (c)(3)).

(7) Primary enclosures for rabbits (Section 3.53).

(c) Space requirements after August 15, 1995.

(3) Innovative primary enclosures that do not precisely meet the space requirements 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 IACUC. (Sect. 3.53 (c)(3)).

(8) Primary enclosures - nonhuman primates (Section 3.80):

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

(2)(iii) Research facilities exemptions from space requirements must be required by the research proposal or the judgement of the attending veterinarian and must be approved by the IACUC (Sect. 3.80 (b)(2)(iii)).

(c) Innovative primary enclosures for nonhuman primates may be used at research facilities when approved by the IACUC (Sect. 3.80 (c)).

(9) Environmental enhancement - Nonhuman primates (Section 3.81)

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

(e) Exemptions - Nonhuman primates: At research facilities the IACUC may exempt an individual nonhuman primate from participation in the required environmental enhancement plans for scientific reasons set forth in the research proposal. The basis of the exemption is to be documented in the approved proposal and must be reviewed at appropriate intervals, as determined by the IACUC, but not less than annually (Sect. 3.81 (e)(2)).

(10) 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 one hour each time, unless otherwise required by the attending veterinarian, or as required by the research proposal approved by the Committee at the research facility.

NOTE: The information in this paper contains excerpts and paraphrasing of the published regulations and standards in 9 CFR, Chapter 1, Subchapter A-Animal Welfare. The appropriate section in 9 CFR should be consulted for the actual wording of that requirement.

To [Contents] [Q&A]

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 (CFR). These requirements are found in Title 9 CFR, Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2 and 3. This paper 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 (See NOTE on last page).

Subpart A - Licensing.

Section 2.1 Requirements and application.

(a) (1) Any person who operates or wishes to operate as a dealer or exhibitor must have a valid license and must be at least 18 years old. Application is to be made on a form furnished by the APHIS, REAC Sector Supervisor and is to be filed with the APHIS, REAC Sector Supervisor. (Sect. 2.1 (a)(1)).

(2) All premises, facilities, or sites where such person operates or keeps animals are to be indicated on the application form, or on a separate sheet attached to it. The completed application, the application fee indicated in section 2.1 (d) and the annual license fee indicated in table 1 or 2 of section 2.6 are to be filed with the APHIS, REAC Sector Supervisor. (Sect. 2.1 (a)(2)).

(e) (1) On or before the expiration date of the license (the license is good for one year), a licensee who wishes to renew the license shall submit a completed application form, the application fee of $10, and the appropriate annual fee to the APHIS, REAC Sector Supervisor. (Sect. 2.1 (e) (1)).

Section 2.2 Acknowledgement of regulations and standards.

The applicant is to acknowledge receipt of the regulations and standards and agree to comply with them by signing the application form or the license will not be issued or renewed. (Sect. 2.2).

Section 2.5 Duration of license and termination of license.

(b) Any person who is licensed must file an application for a license renewal and an annual report form and pay the required fees, on or before the expiration date of the present license or the license will automatically terminate on its anniversary date. (Sect.2.5 (b)).

Section 2.7 Annual report by licensees.

(a) "Each year, within 30 days prior to the expiration date of his or her license, a licensee shall file with the APHIS, REAC Sector Supervisor an application for license renewal and annual report upon a form which the APHIS, REAC Sector Superviso r will furnish him or her upon request." (Sect. 2.7 (a)).

Section 2.8 Notification of change of name, address, control, or ownership of business.

"A licensee shall promptly notify the APHIS, REAC Sector Supervisor by certified mail of any change in name, address, management, or substantial control or ownership of his business operation, or of any additional sites, within 10 days of any change." (Sect. 2.8).

Subpart D - Attending Veterinarian and Adequate Veterinary Care.

Section 2.40 Attending veterinarian and adequate veterinary care.

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

(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;...". (Sect.2.40 (a)(1)).

(3) Daily observation of all animals is required to assess their health and well-being. A mechanism of direct and frequent communication is also required so that timely and accurate information on problems of animal health, behavior, and well-bein g is conveyed to the attending veterinarian. (Sect.2.40 (a)(3)).

Subpart E - Identification of Animals.

Section 2.50 Time and method of identification of animals.

(a) A class "A" dealer (breeder) shall identify all live dogs and cats as indicated 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.

Subpart G - Records.

Section 2.75 Records: Dealers and exhibitors.

(a) (1) Each dealer and exhibitor, except auction sales and brokers, shall make and maintain records or forms that correctly disclose the information required in section 2.75 (a) for each dog or cat acquired, held, transported, or disposed of. On e copy of the record must accompany each shipment of any dog or cat. (Sect.2.75 (a)(1)-(4)).

(b) (1) Every dealer and exhibitor, except auction sales and brokers, shall make and maintain records or forms for animals other than dogs and cats, acquired, held, transported, or disposed of, as required in section 2.75 (b)(1)-(3). One copy of the record must accompany each animal shipment. (Sect.2.75 (a) (b)).

Section 2.76 Records: Operators of auction sales and brokers.

(a) Every auction sale or broker shall make and maintain records or forms, as required by section 2.76, for each animal consigned or sold. (Sect.2.76 (a)(1)-(8)).

(b) One copy of the record shall be given to the consignor of each animal, one copy to the purchaser of each animal, and one copy shall be retained by the auction sale or broker. (Sect.2.76 (b)).

Section 2.78 Health certification and identification.

(a) No dealer, exhibitor, operator of an auction sale, broker, or department, agency, or instrumentality of the United States or any State or local government shall deliver to an intermediate handler or carrier for transport, or shall transport, i n commerce, any dog, cat, or nonhuman primate unless such animal is accompanied by a health certificate executed and issued by a licensed veterinarian in accordance with the requirements of section 2.78. (Sect.2.78 (a)-(d)).

Section 2.80 Records, disposition.

(a) "No dealer, exhibitor, broker, operator of an auction sale, carrier, or intermediate handler shall, for a period of one year, destroy or dispose of, without consent in writing of the Administrator, any books, records, documents, or other paper s 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 one 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. If the Administrator notifies a facility that specified records are to be retained pending an investigation or proceeding, the facility shall hold those records until their disposition is authorized by the Administrator. (Sect.2.80 (b)).

Subpart H - Compliance With Standards and Holding Period.

Section 2.102 Holding facility.

(a) "If any dealer or exhibitor obtains prior approval of the APHIS, REAC Sector Supervisor, he may arrange to have another person hold animals for the required period provided for in paragraph (a) of section 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 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)).

Subpart I - Miscellaneous.

Section 2.125 Information as to business.

Each dealer and exhibitor shall furnish any APHIS official any information concerning the business that the APHIS official may request in connection with the enforcement of the Act, regulations and standards. (Sect.2.125).

Section 2.126 Access and inspection of records and property.

(a) Each dealer and exhibitor, shall, during business hours, allow APHIS officials:

(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. (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 Act, regulations and standards. (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)).

Section 2.132 Procurement of random source dogs and cats, dealers.

(e) Any dealer or exhibitor who also operates a private or contract animal pound or shelter shall comply with the following: (Sect.2.132 (e)).

(2) Accurate and complete records are to be separately maintained by the licensee and by the pound or shelter. The records shall be in accordance with sections 2.75 and 2.76 unless the animals are lost or stray. If lost or stray, the pound or shelter records shall provide the information required in section 2.132 (e)(2)(i)-(iv). (Sect.2.132 (e)(2))

Section 2.133 Certification for random source dogs and cats.

(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...." (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 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)).

Part 3 - Standards

Subpart A - Dogs and Cats.

Section 3.8 Exercise for dogs.

Dealers and exhibitors 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 procedure s to be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request. The plan, at a minimum, must comply with the conditions and requirements set forth in section 3.8 (a) (b) and (c). (Sect.3.8).

(d) Exemptions.

(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 or exhibitor 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 the exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian. (Sect.3.8 (d)(1)).

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

Section 3.13 Consignment to carriers and intermediate handlers.

(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. 3.13 (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 b y the attending veterinarian. The certification must include the information required in section 3.13 (c)(1)-(4). (Sect. 3.13 (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 sections 3.18 and 3.19 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 ..., certifying that the animal is acclimated to temperatures lower than those required in sections 3.18 and 3.19 of this subpart.... A copy of the certification must accompany the dog or cat to its destination and must include the information required in section 3.13 (e)(1)-(4). (Sect. 3.13 (e)).

Section 3.14 Primary enclosures used to transport live dogs and cats.

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:

(a) (6) The primary enclosure is to be clearly marked on top and on one or more sides with the words "Live Animals", in letters at least 1 inch high, and with arrows or other markings to indicate the correct upright position. (Sect. 3.14 (a)(6)).

(h) Accompanying documents and records. Shipping documents that must accompany shipments of dogs and cats...must be securely attached in a readily accessible manner to the outside of any primary enclosure that is a part of the shipment, in a manne r that allows them to be detached for examination and securely reattached. Instructions for the 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 fo r examination, and to reattach securely. Food and water instructions must be attached in accordance with section 3.13 (c). (Sect. 3.14 (h)).

Section 3.16 Food and water requirements.

(b) Any dealer or exhibitor offering any dog or cat to a carrier or intermediate handler for transportation 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. 3.16 (b)).

Subpart B - Guinea Pigs and Hamsters.

Section 3.27 Facilities, outdoor.

(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)).

Section 3.35 Consignment to carriers and intermediate handlers.

(c) Carriers and intermediate handlers whose facilities fail to meet the minimum temperature requirements may accept live hamsters for transportation if the consignor furnishes a certificate executed by a veterinarian, no more than 10 days prior t o delivery for transport, stating that such live hamster is acclimated to air temperatures lower than those prescribed in sections 3.40 and 3.41. A copy of such certificate shall accompany the shipment to its destination and shall contain the information required in section 3.35 (c)(1)-(4). (Sect. 3.35 (c)).

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

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

(g) Primary enclosures used to transport live guinea pigs or hamsters shall be clearly marked on top and on one or more sides with the words "Live Animals" in letters not less than 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 the primary enclosure. (Sect. 3.36 (h)).

Subpart C - Rabbits.

Section 3.60 Consignments to carriers and intermediate handlers.

(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 section 3.6l of the standards: Provided, however, That any carrier or intermediate handler may accept....any live rabbit....if such consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with section 3.61 of the standard, 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 temperatures allowed by the standards may accept....any live rabbit....if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian....on a specified date which shall not be more than 10 days prior to delivery of such rabbit for transportation....stating that such live rabbit is acclimated to air temperatures lower than those prescribed in sections 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)).

Section 3.61 Primary enclosures used to transport live rabbits.

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

(f) Primary enclosures used to transport live rabbits....shall be clearly marked on top and on one or more sides with the words "Live Animals" in letters not less than 1 inch in height and with arrows or other markings to indicate the correct upright position if the container. (Sect. 3.61 (f)).

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

Subpart D - Nonhuman Primates.

Section 3.81 Environment enhancement to promote psychological well-being.

Dealers and exhibitors 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 professiona l 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....The plan must address the requirements set forth in section 3.81 (a)(b) (c) and (d). (Sect. 3.81).

(e) Exceptions.

(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 for exemption must be recorded by the attending veterinarian for each exempted nonhuman primate. Unless the basis for exemption is a permanent condition, the exemption must be reviewed at least every 30 days by the attending veterinarian." (Sect. 3.81 (e)).

(3) Records of any exemptions must be maintained by the dealer or exhibitor and must be made available to USDA officials upon request. (Sect.3.81 (e)(3)).

Section 3.86 Consignment to carriers and intermediate handlers.

(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." (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 feed or water are not acceptable unless directed by the attending veterinarian. Instructions must be in compliance with section 3.89. The certification must include the requirements set forth 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 sections 3.91 and 3.92, or unless the consignor provides them with a certificate signed by a veterinarian and dated no more than 10 days before delivery to the carrier or intermediate handler, certifying that the animal is acclimated to temperatures lower than those that are required in sections 3.91 and 3.92....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)).

Section 3.87 Primary enclosure used to transport nonhuman primates.

(f) Marking and labeling. Primary enclosures 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 high and with arrows or other markings to indicate the correct upright position of the primary enclosure. (Sect. 3.87 (f)).

(g) Accompanying documents and records. Shipping documents that must accompany shipments of nonhuman primates .... 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 .... 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. (Sect. 3.87 (g)).

Section 3.89 Food and water requirements.

(a) ".... Consignors who are subject to 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 section 3.86 (c) of this subpart." (Sect. 3.89 (a)).

(b) Any dealer or exhibitor 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)).

Subpart E - Marine Mammals.

Section 3.101 Facilities, general.

(b) Water and power supply. ".... Written contingency plans must be submitted to and approved by Veterinary Services 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 mammal housed therein." (Sect. 3.101 (b)). (The plan should be submitted to the REAC Sector Supervisor for approval).

Section 3.106 Water quality.

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

(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.... Records must be kep t 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." (3.106 (a)(3)) .

Section 3.110 Veterinary care.

(d) "A complete necropsy must be conducted by or under the direct supervision of a veterinarian on all marine mammals that die in captivity. A necropsy report must be prepared by the veterinarian listing all pathologic lesions observed and giving the apparent cause of death. All diagnostic rests conducted on post mortem specimens shall be listed in the report, and the results of each test recorded. The management of the facility, at which the marine mammal died, must maintain these necropsy records for a period of 3 years and present them to Department inspectors when requested." (Sect. 3.110 (d)).

Section 3.112 Consignment to carriers and intermediate handlers.

(b) Any carrier or intermediate handler shall only accept for transportation or transport, in commerce, any marine mammal in a primary enclosure which conforms to the requirements set forth in section 3.113 of the standards: Provided, however, That any carrier or intermediate handler may accept for transport, in commerce, any marine mammal .... if the consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with section 3.113 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 marine mammal without causing suffering or injury to such marine mammal. A copy of such certificate shall accompany the shipment to destination. The certificate shall include the information set forth in section 3.112 (b)(1)-(4). (Sect. 3.112 (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 marine mammal .... if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian .... 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 marine mammal is acclimated to air temperatures lower than those prescribed is sections 3.117 and 3.118. A copy of such certificate shall accompany the shipment to destination. The certificate is to include at least the information required in section 3.112 (c)(1)-(4). (Sect. 3.112 (c)).

Section 3.113 Primary enclosures used to transport marine mammals.

(f) Primary enclosures used to transport marine mammals .... shall be clearly marked on top and on one or more sides with the words "Live Animal" or "Wild Animal" .... in letters not less than 1 inch in height, and with arrows or other markings, t o indicate the correct upright position of the container. (Sect. 3.113 (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. 3.113 (g)).

Subpart F - Other animals.

Section 3.136 Consignment to carriers and intermediate handlers.

(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 section 3.137 of the standards: Provided, however, That any carrier or intermediate handler may accept for transportation or transport, in commerce, any live animal .... if the consignor furnishes to the carrier or intermediate handler a certificate, signed by the consignor, stating that the primary enclosure complies with section 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 certification 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 and 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 .... if the consignor furnishes to the carrier or intermediate handler a certificate executed by a veterinarian .... on a specific 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 sections 3.141 and 3.142. A copy of such certificate shall accompany the shipment to destination. The certificate shall include the information required by section 3.136 (c)(1)-(4). (Sect. 3.136 (c)).

Section 3.139 Food and water requirements.

(d) Any dealer or exhibitor 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 paper contains excerpts and paraphrasing of the published regulations and standards in 9 CFR, Chapter 1, Subchapter A - Animal Welfare, Parts 1, 2 and 3. The appropriate section in 9 CFR should be consulted for the actual wording and context of that requirement.

To [Contents] [Q&A]

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 (CFR). These requirements are found in Title 9 CFR, Chapter 1, Subchapter A- Animal Welfare, Parts 1, 2, and 3. This paper 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 (see NOTE on last page).

Section 2.30 Registration.

(a) Registration.

(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 APHIS, REAC Sector Supervisor for the State in which the research facility has its principal place of business, and shall be updated every 3 years by the completion and filing of a new registration form.

(c) Notification of Change of Operation.

(1) "A research facility shall notify the APHIS, REAC Sector Supervisor by certified mail 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."

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

(c) IACUC Functions.

(3) "Prepare reports of its evaluations conducted as required by paragraphs (c)(1) and (2) of this section, and submit reports to the Institutional Official of the research facility; ...., 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 facilities adherence to this subchapter, must identify specifically any departures from the provisions of title 9, chapter 1, 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,.... is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the report 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;"

(5) "Make recommendations to the Institutional Official regarding any aspect of the research facilities animal program, facilities, or personnel training;".

(d) IACUC Review of activities involving animals.

(1) ".... Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements:"

(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;"

(iii) "The principal investigator has provided written assurance that the activities do not unnecessarily duplicate previous experiments;"

(iv) "Procedures that may cause more than momentary or slight pain or distress to the animals will:"

(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;"

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

(A) "Justified for scientific reasons by the principal investigator, in writing;"

(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,...."

(4) "The IACUC shall notify the principal investigators and the research facility of its decision to approve or withhold approval of those activities related to the care and use of animals, or modifications required to secure IACUC approval. If th e 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;"

(7) "If the IACUC suspends an activity involving animals, the Institutional Official, in consultation with the IACUC, shall review the reasons for the suspension, take appropriate corrective action, and report that action with a full explanation t o APHIS and any Federal agency funding that activity;"

Section 2.33 Attending veterinarian and adequate veterinary care.

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

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

Section 2.35 Recordkeeping requirements.

(a) "The research facility shall maintain the following IACUC records:"

(1) "Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations;"

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

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

(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 acquired, transported, euthanized, sold or disposed of by the research facility.

(1) The name and address of the person from whom a dog or cat was purchased or acquired.

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

(3) The vehicle license number and state, and the drivers license number and state of the person.

(4) The date of acquisition of each dog or cat.

(5) The official USDA tag number or tattoo assigned to each dog or cat under section 2.38(g).

(6) A description of each dog or cat which shall include:

(i) The species and breed or type of animal;

(ii) The sex;

(iii) The date of birth or approximate age; and

(iv) The color and any distinctive markings.

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

(c) "In addition ...., 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:"

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

(2) "The date of transportation, sale, euthanasia, or other disposition of the animal' and"

(3) The method of transportation including the name of the carrier or person transporting the animal.

(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.... One copy of the record containing the information required by paragraphs (b) and (c) of this section shall be retained by the research facility."

(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 .... 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.

Section 2.36 Annual report.

(a) ".... Each reporting facility shall submit an annual report to the APHIS, REAC Sector Supervisor for the State where the facility is located on or before December 1 of each calendar year. The report shall be signed and certified by the CEO or Institutional Official, and shall cover the previous fiscal year."

(b) "The annual report shall:

(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;

(2) Assure that each principal investigator has considered alternatives to painful procedures;

(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 facilities 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;

(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;

(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,....;

(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, of tranquilizing drugs were used;

(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, o r tranquilizing drugs would have adversely affected the procedures, results, or interpretations of the teaching, research, experimentation, surgery, or tests. An explanation of the procedures producing pain or distress in these animals and the reason such drugs were not used shall be attached to the annual report;

(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."

Section 2.38 Miscellaneous.

(a) Furnishing information as to business.

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 provisions of the Act, the regulations, and the standards. The information shall be furnished within a reasonable time and as may be specified in the request for information.

(b) Access and inspection of records and property.

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

(i) to enter its place of business;

(ii) to examine records required to be kept by the Act and the regulations;

(iii) to make copies of the records;

(v) to document, by the taking of photographs and other means, conditions and areas of noncompliance.

(f) Handling.

(2)

(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."

(g) Identification of dogs and cats.

(1) All live dogs and cats.... shall be identified at the time of delivery for transportation, purchase, sale, disposal, or acquisition in one of the following ways:

(i) By the official tag or tattoo which was affixed to the animal at the time it was acquired by the research facility;

(ii) By the 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.

(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 section 2.35."

(8) Each research facility shall be held accountable for all official tags acquired .... If a 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.

(h) Health certification.

(1) No research facility shall deliver to any intermediate handler or carrier for transportation or shall transport, 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.

(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 no t eligible for certification.

(i) Holding of animals.

"If any research facility obtains prior approval of the APHIS, REAC Sector Supervisor, it may arrange to have another person hold animals: Provided, That:"

(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;"

(2) "The animals remain under the total control and responsibility of the research facility; and "

(3) "The Institutional Official agrees, in writing, that the other person or premises is a recognized animal site under its research facility registration...."

Section 2.133 Certification for random source dogs and cats.

(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."

(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."

Section 3.8 Exercise for dogs.

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 t o be followed in providing the opportunity for exercise. The plan must be made available to APHIS upon request and to officials of any pertinent funding Federal agency.

(d) Exemptions.

(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 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 the exemption is a permanent condition, must be reviewed at least every 30 days by the attending veterinarian.

(2) A research facility may be exempted from the requirements of this section if the principal investigator determines for scientific reasons set forth is 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.

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

Section 3.16 Food and water requirements - transportation.

(b) Any research facility 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.

Section 3.81 Environment enhancement to promote psychological well-being.

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 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 to officials of any pertinent funding Federal agency.

(c) Special considerations.

(5) Great apes weighing over 110 lbs (50Kg).
Research facilities must include in the environment enhancement plan special provisions for great apes weighing over 110 lbs (50Kg) including additional opportunities to express species-typical behavior.

(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 or its well-being. The basis for 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.

(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.

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

Section 3.89 Food and water requirements - transportation.

(a) "....Consignors who are subject to the Animal Welfare regulations (9CFR, 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 section 3.86(c) of this subpart."

(b) Any 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.

Section 3.106 Water quality - marine mammals.

(b) Bacterial standards.

(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 .... 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 on request."

Section 3.110 Veterinary care - marine mammals.

(d) "A complete necropsy must be conducted by or under the direct supervision of a veterinarian on all marine mammals that die in captivity. A necropsy report must be prepared by the veterinarian listing all pathological lesions observed and givin g the apparent cause of death. All diagnostic tests conducted on post mortem specimens shall be listed in the report, and the results of each test recorded. The management of the facility at which the marine mammal died, must maintain the necropsy records for a period of 3 years and present them to Department inspectors when requested."

Section 3.139 Food and water requirements - transportation of other animals.

(d) Any research facility offering any live animal to a 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.

NOTE: The information in this paper contains excerpts and paraphrasing of the published regulations and standards in 9CFR, Chapter 1, Subchapter A - Animal Welfare. The appropriate section in 9CFR should be consulted for the actual wording and context of that requirement.

To [Contents] [Q&A]

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 (CFR). 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 paper provides the section numbers and text of the regulations that pertain to the qualifications and training requirements for research facility personnel under the Animal Welfare Act (See NOTE on last page).

I. Institutional Animal Care & Use Committee (IACUC) (Sect. 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...." (Sect. 2.31 (a)).

(b) IACUC Membership (Sect. 2.31 (b)).

(3) Of the members of the Committee:

(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 affiliated with the facility. The Secretary intends that such person wil l provide representation for general community interests in the proper care and treatment of animals;" (Sect. 2.31 (b)(3)(ii)).

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

(1) "...Further, the IACUC shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements:" (Sect. 2.31 (d)(1)).

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

II. Personnel qualifications (Sect. 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 section 2.3l." (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 animal 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)).

III. Attending veterinarian and adequate veterinary care (Sect. 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; 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: While the above requirements are quotations of the applicable sections involved in qualifications and training required under the Animal Welfare Act, as set forth in 9 CFR, Chapter 1, Subchapter A- Animal Welfare, the appropriate section in 9 CFR should be consulted for the actual context of the requirement.

Return to:
Contents
Animal Welfare Information Center
National Agricultural Library

The Animal Welfare Information Center, awic@nal.usda.gov
http://www.nal.usda.gov/awic/pubs/legislat/awabrief.htm, March 6, 2001