All USDA Animal Care Policies is available at http://www.aphis.usda.gov/ac/polman.html
Expired Medical Materials
Pharmaceutical-Grade Compounds in Research
Pre- and Post-Procedural Care
Program of Veterinary Care
References: AWA Section 13 and 9 CFR, Part 2, Sections 2.31,
2.32, 2.33, 2.40 and 9 CFR, Part 3, Section 3.110
History: Provides requested guidance. Replaces memoranda dated May 31, 1990, November 29, 1991, April 6, 1992, and September 25, 1992. The previous version of this policy released on April 14, 1997, has been modified to include "Health Records."
Justification: The Animal Welfare Act (AWA) requires that all regulated animals be provided adequate veterinary care.
Expired Medical Materials
The use of expired medical materials such as drugs, fluids, or sutures on regulated animals is not considered to be acceptable veterinary practice and does not constitute adequate veterinary care as required by the regulations promulgated under the Animal Welfare Act. All expired medical materials found in a licensed or registered facility are to be brought to the attention of the responsible official. The facility must either dispose of all such materials or segregate them in an appropriately labeled, physically separate location from non-expired medical materials. The Animal & Plant Health Inspection Service (APHIS) has no jurisdiction over facilities using expired medical materials for non-regulated animals or non-regulated activities. For acute terminal procedures, APHIS does not oppose the use of expired medical materials if their use does not adversely affect the animal's well-being or compromise the validity of the scientific study. Proper anesthesia, analgesia, and euthanasia are required for all such procedures. Drugs administered to relieve pain or distress and emergency drugs must not be used beyond their expiration date. Facilities allowing the use of expired medical materials in acute terminal procedures should have a policy covering the use of such materials and/or require investigators to describe in their animal activity proposals the intended use of expired materials. The attending veterinarian and the Institutional Animal Care and Use Committee (IACUC) are responsible for ensuring that proposed animal activities avoid or minimize discomfort, distress, and pain to the animal. These responsibilities cannot be met unless the veterinarian and the IACUC maintain control over the use of expired medical materials.
Pharmaceutical-Grade Compounds in Research
Investigators are expected to use pharmaceutical-grade medications whenever they are available, even in acute procedures. Non-pharmaceutical-grade chemical compounds should only be used in regulated animals after specific review and approval by the IACUC for reasons such as scientific necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product. Cost savings alone are not an adequate justification for using non-pharmaceutical-grade compounds in regulated animals.
AWA regulations require that survival surgeries be performed using aseptic techniques and that major operative procedures on nonrodents be performed only in dedicated surgical facilities. Nonsurvival surgeries require neither aseptic techniques nor dedicated facilities if the subjects are not anesthetized long enough to show evidence of infection. Research facilities doing surgical demonstrations while traveling must use aseptic techniques and dedicated surgical facilities. Motel meeting rooms and auditoriums do not qualify as dedicated surgical facilities. Nonsurvival surgeries not performed aseptically or in a dedicated facility must at least be performed in a clean area, free of clutter, and using acceptable veterinary sanitation practices analogous to those used in a standard examination/treatment room. Personnel present in the area must observe reasonable cleanliness practices for both themselves and the animals. Eating, drinking, or smoking are not acceptable in surgery areas, and locations used for food handling purposes do not qualify as acceptable areas for performing surgeries.
Pre- and Post-Procedural Care
All animal activity proposals involving surgery must provide specific details of pre- through post-procedural care and relief of pain and distress. The specific details must be approved by the attending veterinarian or his/her designee. However, the attending veterinarian retains the authority to change post-operative care as necessary to ensure the comfort of the animal. The withholding of pain and/or distress relieving care must be scientifically justified in writing and approved by the IACUC. The appropriate use of drugs to relieve pain and/or distress must be specified in the animal activity proposal to avoid possible delays due to investigator concerns that a treatment regimen may interfere with the study. Furthermore, the specified drugs for relief of pain and/or distress must be readily available for use as described in the proposal. While an animal is under post-surgical care, the ownership of the animal is not to change. If the animal is taken to an off-site location, such as a farm, for post-operative care, that location should be identified as a site of the research facility. An animal is not to be taken to an off-site location before it fully recovers from anesthesia unless justified in the animal activity proposal. Appropriate post-operative records must be maintained in accordance with professionally accepted veterinary procedures regardless of the location of the animal.
Program of Veterinary Care
Facilities which do not have a full-time attending veterinarian must have a written Program of Veterinary Care (PVC). This Program must consist of a properly completed APHIS Form 7002 or an equivalent format providing all of the information required by the APHIS form. The attending veterinarian must visit the facility on a regular basis, i.e., often enough to provide adequate oversight of the facility's care and use of animals but no less than annually. The PVC must be reviewed annually and updated whenever necessary (e.g., as a new species of animal or a new attending veterinarian is obtained, or the preventive medical program changes). It must be initialed and dated by both the attending veterinarian and the facility representative whenever it is changed or reviewed without change. The preventive medical program described in the PVC is expected to be in accordance with common good veterinary practices (e.g., appropriate vaccinations, diagnostic testing). It should include zoonotic disease prevention measures and, if necessary, special dietary prescriptions.
Health records are meant to convey necessary information to all people involved in an animal's care. Every facility is expected to have a system of health records sufficiently comprehensive to demonstrate the delivery of adequate health care. For those facilities that employ one or more full-time veterinarians, it is expected there will be an established health records system consistent with professional standards that meets and probably exceeds, the minimum requirements set forth in this policy. For facilities that do not employ a full-time veterinarian, it is suggested the health records system be explained as part of the written PVC, to ensure involvement of the attending veterinarian in developing the system. For all facilities, health records must be current, legible, and include, at a minimum, the following information:
Examples of procedures which should be adequately documented
in health records include, but are not limited to, vaccinations,
fecal examinations, radiographs, surgeries, and necropsies. Routine
husbandry and preventive medical procedures (e.g., vaccinations
and dewormings) performed on a group of animals may be recorded
on herd-health-type records. However, individual treatment of
an animal must be on an entry specific to that animal. As long
as all required information is readily available, records may
be kept in any format convenient to the licensee/registrant (e.g.,
on cage cards for rodents).
Health records may be held by the licensee/registrant (including, but not limited to, the investigators at research facilities) or the attending veterinarian or divided between both (if appropriately cross-referenced), but it is the responsibility of the licensee/registrant to ensure that all components of the records are readily available and that the record as a whole meets the requirements listed above.
An animal's health records must be held for at least 1 year after its disposition or death. (Note: Some records may need to be held longer to comply with other applicable laws or policies.) When an animal is transferred to another party or location, a copy of the animal's health record must be transferred with the animal. The transferred record should contain the animal's individual medical history, information on any chronic or ongoing health problems, and information on the most current preventive medical procedures (for example, the most recent vaccinations and dewormings). For traveling exhibitors, information on any chronic or ongoing health problems and information on the most current preventive medical procedures must accompany any traveling animals, but the individual medical history records may be maintained at the home site.
The method of euthanasia must be consistent with the current Report of the AVMA Panel on Euthanasia. Gunshot is not an acceptable method of routine euthanasia for any animal. Gunshot as a routine method of euthanasia not only endangers surrounding animals, buildings, and personnel, but it is likely to cause distress to other animals. It should only be used in situations where other forms of acceptable euthanasia cannot be used (such as emergency or field conditions where the animal cannot be appropriately restrained) or in cases where gunshot will reduce danger to other animals or humans. Only personnel skilled in the use of firearms, using appropriate firearms, and familiar with the "kill point" of an animal should perform the euthanasia. If the firearm is not aimed so that the projectile enters the brain and causes rapid unconsciousness and subsequent death without evidence of pain or distress, this method does not meet the definition of euthanasia. (All State and local laws relevant to gunshot must also be met.)
References: AWA Section 16 (a) and
9 CFR, Part 2, Sections 2.38(b), 2.1
History: Provides requested guidance. Replaces letter dated July 5, 1991.
Justification: The Animal & Plant Health Inspection Service (APHIS) must have access to inspect all covered animals at a regulated facility to ensure compliance with the Animal Welfare Act (AWA).
Animals housed in barrier facilities are required to be maintained in accordance with the AWA's regulations and standards.
In some cases, APHIS inspections of bonafide barrier facilities may be performed by analysis of environmental records, visual inspection through an adequate viewing window, and random selection of animals to be visually inspected. Various non-entry methods, such as video viewing from outside the barrier room, may substitute for an inadequate viewing window.
If the APHIS inspector determines it is necessary to enter a barrier room to adequately complete an inspection or to resolve a suspected problem, the inspector may, by following entry procedures normally used by facility personnel, enter and complete the inspection. The inspector cannot be expected to comply with procedures not used by facility employees. The facility must supply a copy of their barrier entry procedures upon request. The facility will need to provide the inspector with protective clothing and items needed to complete the inspection (pens, paper, tape measure, flashlight, etc.).
Prior to an inspection of a barrier facility, the facility may ask the inspector (as part of the standard entry procedure) to verify that he/she has not been in contact with, or exposed to, certain animals for a specified time period.
Such verification is acceptable. Generally, barrier facilities require a period of no animal or specific species contact for 72 hours.
The APHIS inspector will not sign any statement in which he or she accepts responsibility for the health of the animals in that barrier facility.
References: AWA Sections 13(a)(3), 13(a)(7), 13(e)(2, 3) and 9 CFR, Part 2, Sections
2.31(d)(1)(i,ii,iii,iv), 2.31(e)(4), 2.33(b)(4) and 9 CFR, Part 3, Section 3.6(b)(5,6,7)
History: Replaces letters dated May 8, 1992, November 7, 1991, November 9, 1990, and
March 1, 1990.
Justification: Provides requested guidance. Procedures involving animals will avoid or
minimize discomfort, distress and/or pain.
A painful procedure is defined as any procedure that would reasonably be expected to cause more than slight or momentary pain and/or distress in a human being to which that procedure is applied. The Institutional Animal Care and Use Committee (IACUC) is responsible for ensuring that investigators have appropriately considered alternatives to any procedures that may cause more than slight or momentary pain or distress. A written narrative description of the methods and sources used to search for alternatives must be provided. Where specific testing procedures are required by Federal law, the CFR references or other legal guidelines requiring them should be noted.
Examples of procedures that can be expected to cause more than momentary or slight pain include, but are not limited to, the following:
Examples of procedures that may cause more than momentary or slight distress include, but are not limited to, the following:
Many procedures, including any of those in the lists above,
may cause both pain and distress.
An example of a procedure that can be expected to cause more than momentary or slight pain as well as distress would be a study involving extensive irradiation.
Animals exhibiting signs of pain, discomfort, or distress such as decreased appetite/activity level, adverse reactions to touching inoculated areas, open sores/necrotic skin lesions, abscesses, lameness, conjunctivitis, corneal edema, and photophobia are expected to receive appropriate relief unless written scientific justification is provided in the animal activity proposal and approved by the IACUC.
Research facilities must have a mechanism in place for ensuring that animals are reported in the appropriate pain category on the annual report (APHIS Form 7023). Individual animals that do not experience pain/distress from testing procedures should be reported in column C. Individual animals experiencing pain/distress which is alleviated with anesthetics, analgesics, sedatives and/or tranquilizers should be reported in column D. This category includes terminal surgery under anesthesia. Individual animals in which needed anesthetics, analgesics, sedatives, and/or tranquilizers are withheld should be reported in column E. For all column E animals, a written justification, approved by the IACUC, must be provided, including CFR references or other guidelines if appropriate.
References: AWA Section 13(a)(3)(B), 9 CFR, Part 2, Section
2.31 (d)(1)(ii)and (e), 9 CFR, Part 2, Section 2.32 (c)(2) and
(5)(ii), Animal Welfare Information Center
History: Provides guidance on the requirement to provide a written narrative of the consideration of alternatives to painful and distressful procedures. Replaces Policy #12 dated April 14, 1997.
Justification: The Animal Welfare Act (AWA) regulations require principal investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals and provide a written narrative of the methods used and sources consulted to determine the availability of alternatives, including refinements, reductions, and replacements.
Alternatives or alternative methods are generally regarded as those that incorporate some aspect of replacement, reduction, or refinement of animal use in pursuit of the minimization of animal pain and distress consistent with the goals of the research. These include methods that use non-animal systems or less sentient animal species to partially or fully replace animals (for example, the use of an in vitro or insect model to replace a mammalian model), methods that reduce the number of animals to the minimum required to obtain scientifically valid data, and methods that refine animal use by lessening or eliminating pain or distress and, thereby, enhancing animal well-being. Potential alternatives that do not allow the attainment of the goals of the research are not, by definition, alternatives.
A fundamental goal of the AWA and the accompanying regulations is the minimization of animal pain and distress via the consideration of alternatives and alternative methods. Toward this end, the regulations state that any proposed animal activity, or significant changes to an ongoing animal activity, must include:
1. a rationale for involving animals, the appropriateness of the species, and the number of animals to be used;
2. a description of procedures or methods designed to assure that discomfort and pain to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals;
3. a written narrative description of the methods and sources used to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals; and
4. the written assurance that the activities do not unnecessarily duplicate previous experiments.
We believe that the performance of a database search remains the most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures. However, in some circumstances (as in highly specialized fields of study), conferences, colloquia, subject expert consultants, or other sources may provide relevant and up-to-date information regarding alternatives in lieu of, or in addition to, a database search. When other sources are the primary means of considering alternatives, the Institutional Animal Care and Use Committee (IACUC) and the inspecting Veterinary Medical Officer should closely scrutinize the results. Sufficient documentation, such as the consultant's name and qualifications and the date and content of the consult, should be provided to the IACUC to demonstrate the expert's knowledge of the availability of alternatives in the specific field of study. For example, an immunologist cited as a subject expert may or may not possess expertise concerning alternatives to in vivo antibody production.
When a database search is the primary means of meeting this requirement, the narrative must, at a minimum, include:
1. the names of the databases searched;
2. the date the search was performed;
3. the period covered by the search; and
4. the key words and/or the search strategy used.
The Animal Welfare Information Center (AWIC) is an information service of the National Agricultural Library specifically established to provide information about alternatives. AWIC offers expertise in formulation of the search strategy and selection of key words and databases, access to unique databases, on- and off-site training of institute personnel in conducting effective alternatives searches, and is able to perform no-cost or low-cost electronic database searches. AWIC can be contacted at (301) 504-6212, Contact us: http://www.nal.usda.gov/awic/contact.php , or via its web site at http://awic.nal.usda.gov.
Other excellent resources for assistance with alternative searches are available and may be equally acceptable.
Regardless of the alternatives sources(s) used, the written narrative should include adequate information for the IACUC to assess that a reasonable and good faith effort was made to determine the availability of alternatives or alternative methods. If a database search or other source identifies a bona fide alternative method (one that could be used to accomplish the goals of the animal use proposal), the written narrative should justify why this alternative was not used.
The written narrative for federally-mandated animal testing (for example, testing product safety/efficacy/potency) needs only to include a citation of the appropriate government agency's regulation and guidance documents. Mandating agency guidelines should be consulted since they may provide alternatives (for example, refinements such as humane endpoints or replacements such as the Murine Local Lymph Node Assay) that are not included in the Code of Federal Regulations. If a mandating agency-accepted alternative is not used, the principal investigator should explain the reason in the written narrative.
Alternatives should be considered in the planning phase of the animal use proposal. When a proposal is modified during its performance, significant changes are subject to prior review by the IACUC, including the review of the implications of those changes concerning the availability of alternatives. Although additional attempts to identify alternatives or alternative methods are not required by Animal Care at the time of each annual review of the animal protocol, Animal Care would normally expect the principal investigator to reconsider alternatives at least once every 3 years, consistent with the triennial review requirements of the Public Health Service Policy (IV,C,5).
References: AWA Section 13(a)(3)(D,E)
and 9 CFR, Part 2, Section 2.31 (d)(1)(x)
History: Provides requested guidance. Replaces letters dated April 21, 1992 and June 5, 1990.
Justification: No animal is to be used in more than one major survival operative procedure except in cases of scientific necessity or veterinary care.
No animal assigned to a proposal is to be used in more than one major survival operative procedure unless the multiple procedures are included within one proposal, justified for scientific reasons by the Principal Investigator, and preapproved by the Institutional Animal Care and Use Committee (IACUC). However, an animal that has an emergency major operative procedure as part of proper veterinary care may still be used in a proposal that requires a major survival operative procedure.
A major survival operative procedure must not be performed a second time on an animal in a separate proposal. In order to comply with the intent of the Animal Welfare Act (AWA), animals surviving a major operative procedure must be identified (written documentation) to prevent their use in a second major survival operative procedure.
The AWA and its regulations allow an exemption to limiting animals from being used in only one proposal with a major survival operative procedure. The Institutional Official of the research facility should make the exemption request to the appropriate Animal Care Regional Director, who forwards it to the Animal Care Assistant Deputy Administrator for review and recommendation to the Deputy Administrator. The request for exemption should include the following information:
The Animal & Plant Health Inspection Service (APHIS) may respond to the formal request by approving the request as written, granting a portion of the request, imposing additional limitations, or denying the request. An annual IACUC evaluation of the exemption is required, which consists of an IACUC assessment of the animals and the effectiveness and soundness of the methods and procedures used. This information is to be included in the report of the IACUC functions. Considerations for the renewal or continuation of the exemption will be based on the IACUC's recommendations following their review. The exemption must be included in the Annual Report (APHIS Form 7023).
References: AWA Section 13(b)(1) and
9 CFR, Part 2, Section 2.31(b)(2,3)
History: Provides requested guidance. Replaces letters dated June 6, 1994 and October 23, 1992.
Justification: To provide clarification of specified individual roles in the Animal Care and Use Program at research facilities.
For Animal Welfare Act (AWA) enforcement purposes, the nonaffiliated member of the Institutional Animal Care and Use Committee (IACUC) is to "provide representation for general community interests." The outside nonaffiliated member cannot be a laboratory animal user at any research facility. Compensation of the nonaffiliated member is permissible only when it does not jeopardize the member's status as a nonaffiliated member. Compensation varies but is normally limited to payment for travel and related expenses, such as parking and meals, to modest monetary payments for participation. The dollar amount of compensation, if any, should not be so substantial as to be considered an important source of income or to influence voting on the IACUC.
The regulations provide for four specific roles within the Animal Care and Use Program:
These positions are meant to provide a system of checks and balances which is not normally achieved if any one person fills more than one of these roles. While the regulations do not specifically prohibit one person from filling more than one role, the Animal and Plant Health Inspection Service (APHIS) strongly discourages such assignments because of the potential for conflicts of interest and/or undue influence by one person over the facility's program. However, a veterinarian who is not the attending veterinarian may assume any one of the other program positions.
No IACUC member can review his/her own proposal.
References: AWA Section 13, 9 CFR, Part 3, Subpart F
History: Clarifies existing internal policy
Justification: The Animal Welfare Act (AWA) regulations cover farm animals that are used in activities that are regulated by the AWA.
Farm animals, such as domestic cattle, horses, sheep, swine, and goats that are used for traditional, production agricultural purposes are exempt from coverage by the AWA. Traditional production agricultural purposes includes use as food and fiber, for improvement of animal nutrition, breeding, management, or production efficiency, or for improvement of the quality of food or fiber.
Farm animals that are used to manufacture and test veterinary biological products intended for use in the diagnosis, treatment, or prevention of diseases in agricultural animals are, therefore, exempt from U.S. Department of Agriculture's (USDA) regulatory authority under the AWA. USDA considers this use to be agricultural research, thus, not a regulated activity.
Farm animals that are used to test and produce biologicals for nonagricultural or nonproduction animals are covered by Part 3, Subpart F of the regulations. We consider this to be nonagricultural research and testing that is covered by the AWA and the regulations. As such, when farm animals are used to test or manufacture vaccines, bacterins, toxoids, and other related veterinary biologicals that will be used exclusively in nonproduction animals such as dogs and cats and other pet animals, or in both nonproduction, as well as, farm animals, they are regulated and monitored for compliance with the regulations. An example of the latter may include rabies vaccine or other product that has a multi-species label recommendation.
Farm animals that are used as models for human subjects in order to test or manufacture biologicals that will ultimately be used in humans are also regulated. USDA considers this to be biomedical research which is a regulated activity.
References: AWA Section 2, 13, 9 CFR, Part 3, Subpart F
History: This is a new policy. Farm animals used in activities regulated under the AWA are maintained in both agricultural and nonagricultural environments. Animal Care inspectors, the research and exhibition communities, as well as other members of the public, have requested that we provide more specific guidance than what the regulations contain for the humane care of farm animals used in regulated activities.
Justification: The AWA authorizes APHIS to regulate farm animals, such as cattle, sheep,pigs, and goats, when the animals are used for biomedical or other nonagricultural research or nonagricultural exhibition. In light of the increased use of farm animals for covered purposes and because the needs of farm animals can be different from other kinds of animals typically used in research and exhibition, we developed this policy.
This policy offers guidance on how regulated entities can comply with the standards in the regulations as they apply to farm animals. Animal Care has adopted two guides, the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, published by the Federation of Animal Science Societies, and the Guide for the Care and Use of Laboratory Animals, published by the Institute for Laboratory Animal Research (ILAR). The two publications are commonly known as the Ag Guide and the ILAR Guide, respectively.
We adopted these two specific guides because they represent the most current scientific information available on handling, housing, care, treatment, and transportation of farm animals for nonagricultural purposes. They are widely used, are the most complete guides available, are relatively inexpensive and easily obtained, and are being used by most institutions that receive funding from the Public Health Service or are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International).
The Ag Guide contains recommendations to ensure the humane care of farm animals that are maintained in agricultural or typical farm-like settings. It contains principles that apply to all farm animals, as well as species specific recommendations. The ILAR Guide is a general guide that recommends practices that may be applied to the care and use of farm animals when they are housed in typical laboratory settings.
Regulated entities may use applicable sections of the guides to supplement their understanding of how to meet the standards in the regulations. Use of these guides should help ensure consistent enforcement by Animal Care inspectors.
Adoption of these guides is intended only as additional guidance on how to meet the already existing standards in the regulations. They are to be used only to supplement or interpret the regulations. Both guides contain recommendations concerning animals such as poultry and areas such as environmental enhancement and individual animal identification that are not covered or required under the regulations. Those portions of the guides that do not relate to or support the current standards in the regulations cannot be enforced by Animal Care inspectors. At the same time, nothing in the guides will be used to reduce or lessen any of the requirements in the current regulations.
As there are other published guides, as well as other sources of information that provide recommendations on the humane care of farm animals in various settings, licensees and registrants may use recommendations from other sources, as long as the chosen practice satisfies the standards in the regulations.
All Animal Care inspectors have been provided these guides; however, since they are not published by APHIS, we cannot provide copies to the public. To obtain a copy of the Ag Guide and ILAR Guide
contact the following:
Ag Guide--Federation of Animal Science Societies, 111 North Dunlap Avenue 2101, Savory, IL 61874, phone: 217-356-3182 ($10 per copy)
ILAR Guide--National Academy Press, Constitution Avenue NW, Lock Box 285, Washington, DC 20055, phone: 1-800-624-6242 or 202-334-3313 ($9.95 per copy)
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Last updated February 22, 2001