USDA Animal Care Policies 11-20

Last updated on 04/12/02

Policy #11 --- Painful/Distressful Procedures --- April 14, 1997

History: Replaces letters dated May 8, 1992, November 7, 1991, November 9, 1990, and March 1, 1990.

JBR Note: APHIS is considering amending this policy.

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.

Table of policies

Policy #12 -- Consideration of Alternatives to Painful/Distressful Procedures -- June 21, 2000

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.

Regardless of the alternatives source(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).

Table of policies

Policy #13 --- Microchip Implants --- April 14, 1997

History: Provides requested guidance. Replaces letters dated December 23, 1991 and February 5, 1991. Replaces policy #13 dated April 14, 1997.

Justification: All dogs and cats must be identified.

For the Animal Care to grant approval for a microchip implantation identification system in breeding stock or research animals, the following requirements must be met:

a. The microchip must be placed in a standard anatomical location.
b. The microchip scanner device must be readily available to the Animal & Plant Health Inspection Service (APHIS) representative and/or facility employee accompanying the APHIS representative.
c. The animal identification records must indicate the microchip number, the location on the animal, and the name of the microchip manufacturer.
d. Any animal with a microchip that goes to another licensee/registrant must have a tag/tattoo if a compatible scanner is not available at the receiving facility.

If the above conditions are met, then approval to utilize a microchip identification system can be granted by the USDA Animal Care inspector or the Regional Office.

The Animal Care Regional Director can revoke an approval if the system is found to be ineffective and corrections are not made promptly.

Table of policies

Policy #14 --- Major Survival Surgery Single vs. Multiple Procedures --- April 14, 1997

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:

a. An outline of the research proposals for which the procedure is requested
b. The species and the approximate number of animals involved in the exemption request
c. The time frame for the proposed exempt procedure
d. The number of major operative procedures to be performed on a given animal, the frequency of such procedures, and the period of time between each major operative procedure
e. Measures to be taken to ensure that pain/distress are minimized
f. A complete justification for the exemption in which cost is not normally a major criterion
g. An assurance that all other stipulated requirements of the AWA and regulations will be met in consideration of this exemption
h. An assurance that the facility's IACUC has approved the exemption.

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).

Table of policies

Policy #15 --- IACUC Membership --- April 14, 1997

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:

1. Institutional Official
2. IACUC Chairperson
3. Attending Veterinarian
4. Nonaffiliated Member

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.

Table of policies

Policy #16 --- Dealers Selling Surgically-Altered Animals to Research --- April 14, 1997

History: Provides requested guidance.

Justification: No animal is to be used in more than one major survival operative procedure except in cases of scientific necessity or veterinary care. The Institutional Animal Care and Use Committee (IACUC) is to ensure that survival surgery will avoid or minimize pain and is aseptically performed by qualified personnel.

A dealer performing surgery on animals as a necessary part of a proposed animal activity at a research facility must also register as a research facility and/or be a site of the research facility requesting the altered animals.

Dealers that register as research facilities will comply with all the regulations pertaining to research facilities. Their IACUCs must ensure that all requirements are met before approving the activities associated with the surgical alteration of the animal. If the alteration involves a major operative procedure, the animal must be identified to prevent its use in another major survival operative procedure.

Research facilities that list dealers' premises as sites under their registration are responsible for the animals at the dealers' facilities which are covered under their proposals. The IACUC must inspect all dealers' sites housing animals covered under their proposals. The research facility must also ensure that the person(s) at the dealers' sites performing the proposal procedures is qualified.

Dealers performing routine veterinary care or animal husbandry that involves surgery not required for a research proposal are not required to register as a research facility. Examples include, but are not limited to, neutering, dehorning, and debarking.

Table of policies

Policy #17 --- Annual Report For Research Facilities --- April 14, 1997

History: Replaces Policy #17 dated April 14, 1997. This revision updates the Veterans' Administration (VA) contact address and changes the date of Animal Care (AC) data entry from December 31 to December 15.

Justification: To further explain the Animal Welfare Act (AWA) and regulations regarding the "Animal Welfare Enforcement Report of the Secretary of Agriculture to the President of the Senate and the Speaker of the House of Representatives" hereafter referred to as the "Annual Report to Congress."

As required by Section 13 of the AWA and further explained in 9 CFR, Part 2, Section 2.36, each reporting research facility shall submit an annual report (APHIS Forms 7023 and 7023-A) to the AC Regional office (formerly Sector office) responsible for the State in which the facility is located. This report is due in the Regional office on or before December 1 of each year.

These forms shall be signed and certified as correct by the Chief Executive Officer (CEO) or legally responsible Institutional Official (IO), and must include all species covered by the AWA used in research, tests, experiments, or for teaching and those on hand at the end of the U.S. Department of Agriculture's (USDA) fiscal year (FY) (October 1 through September 30).

By signing the report, the CEO or IO is also certifying that the institution has adhered to the assurance statements at the bottom of the APHIS Form 7023.

Reporting of animals used (see form) is based on the USDA FY (October 1 through September 30). Animals are to be counted only once, regardless of the number of proposals in which they were used. If an animal was used in more than one proposal, it must be counted in the most painful category. Animals used in multi-year studies will be counted once each fiscal year.

Animals counted and listed in Column E must have a detailed statement explaining the procedure(s) and the basis for withholding pain-relieving medications.

I. Distribution

A. Veterans' Administration (VA) - No later than August 1 of each year, the AC Eastern Region will send the appropriate number of APHIS Forms 7023 and 7023-A to the VA at the following address:

Mr. Jack Mandel
VA Research and Development Computing Center
103 South Gay Street
4th Floor, Suite 400
Baltimore, MD 21202

(410) 962-1800 ex. 277

B. Federal and USDA Registered Research Facilities - On or before September 15 of each year, the AC Regional office will send a packet via regular mail containing APHIS Forms 7023 and 7023-A and a notification letter to the legally responsible IO at each USDA registered and Federal research facility.

II. Instructions for Completing APHIS Forms 7023 and 7023-A

A. APHIS Forms

General instructions for completing the forms are printed on the back. APHIS Form 7023:

- Items 1 through 3 completed by all facilities.
- Items 4 through 13 completed where applicable.

APHIS Form 7023-A - Continuation Sheet - Use only if necessary.

- Items 1, 2, 12, and/or 13 completed by all facilities.

B. Special Instructions for Column "E"

Entries in Column "E" must be explained in detail and attached to APHIS Form 7023. At a minimum, these statements should address the following:

1. A complete description of the procedure(s) producing pain and/or distress in the animal(s). This explanation should include, as appropriate, the name of the test, the reference from the Code of Federal Regulations if the test is mandated by federal regulations, or other relevant guidelines.

2. A complete explanation for withholding drugs for relieving pain and/or distress. For example, provide scientific justification that such drugs would adversely affect the test/study results, or cite all regulation(s) and/or Federal Agency policies that prohibit the use of these drugs.

C. Exceptions to the Regulations and Standards

A summary of IACUC-approved exceptions to the regulations or standards must be attached to APHIS Form 7023. At a minimum, this summary should include the following:

1. Identify IACUC-approved exception(s) to the regulations or standards, including exceptions to the dog exercise plan and/or the nonhuman primate plan for environmental enhancement.

2. Describe IACUC-approved exemption(s).

3. Identify the species and number of animals used.

D. Other Information

"Column F" contains only the total number of animals listed in "Columns C, D and E." Do not include animals from Column B.

It is not necessary to report birds, amphibians, rats of the genus Rattus and mice of the genus Mus specifically bred for use in research, or any other animals not defined as animal by 9 CFR, Part 1- Definitions of Terms, Section 1.1.

Wild rats and mice are covered and must be reported.

Scientific names are not required. Common names are preferred.

"Other Farm Animals" - List farm animals other than pigs and sheep such as goats, cattle, llamas, etc.

"Other Animals" refers to other covered animals (not farm animals). This would include, but not be limited to, animals such as seals, tigers, lions, sloths, kangaroos, opossums, raccoons, wolves, and bobcats.

Incomplete forms or inaccurate data will be returned to the issuing facility at the discretion of the Regional office.

III. Routing of Completed Part 1, 2, and 3 of APHIS Forms 7023 and 7023-A

A. VA Facilities

1. VA Facilities return completed Part 1 - Headquarters and Part 2 - Sector Office to the Department of Veterans' Affairs RDCC. Part 3 - Facility - retained by facility.

2. No later than December 1: RDCC returns completed Part 1 - Headquarters and Part 2 - Sector Office forms to the appropriate Regional office for the State in which the VA facility is located.

B. Federal and Other USDA Registered Facilities

1. No later than December 1: Federal and non-Federal USDA facilities must return completed Part 1- Headquarters and Part 2 - Sector Office to the appropriate Regional office. Part 3 - Facility - retained by facility.

2. Facilities with multiple sites should collect and combine their annual reports into one package before submitting.

Annual report forms from all facilities must be returned to the appropriate Regional office by December 1 of each year so that they may be reviewed, returned for correction if necessary, and entered into the database before December 31 of that year. Reports submitted after December 31 will not be included in the Annual Report to Congress.

"Part 1 - Headquarters" copies of APHIS Forms 7023 and 7023-A will be retained by the Regional office.

Established deadlines require that Animal Care headquarters develop, draft, and clear the Annual Report to Congress no later than March 31 of each year.

Click here for APHIS Form 7023

Click here for APHIS Form 7023A Continuation 

Table of policies

Policy #18 --- Health Certificate for Dogs, Cats, and Nonhuman Primates --- April 14, 1997

History: Replaces letter dated March 6, 1992.

Justification: Most dogs and cats transported by a dealer are usually moved for short distances and require only short periods of time in the dealer's private vehicle.

A health certificate issued within 10 days of shipment must accompany any dog, cat, or nonhuman primate that is transported in commerce by a licensee or registrant. Regulated dogs, cats, and nonhuman primates transported intrastate by commercial carrier, transported interstate, or in foreign commerce, are required to have properly executed health certificates. However, dogs, cats, and nonhuman primates transported within the State and in the licensee's/registrant's private vehicle may be transported without a health certificate.

Table of policies

Policy #19 --- Tattoo Identification of Dogs and Cats --- April 14, 1997

History: Replaces REAC Memorandum 430 dated July 20, 1992.

Justification: This policy is to clarify the procedure used in approving tattoo identification of dogs and cats for dealers under the authority of the Animal Welfare Act.

Each licensee who wishes to use a tattoo to identify his/her animals will be assigned a code for identification to include the type of business (Class A or Class B) and the State in which he/she is licensed. Examples of the system are as follows:

Class A dealer from Maryland: MDAA through MDAZZ

Class B dealer from Maryland: MDBAA through MDBZZ

In addition to the dealer's code assigned, the dealer will be required to add the necessary numbers to uniquely identify each animal. Dealers of purpose-bred dogs and cats sold only for research purposes may have special tattoos approved by the Administrator.

Table of policies

Policy #20 --- Identification of Puppies Less than 16 Weeks of Age --- April 14, 1997

History: Replaces memorandum dated December 30, 1993, "Identification of Puppies Under 16 Weeks of Age."

Justification: The Animal Care staff has been made aware of problems from using plastic collars to identify puppies that are less than 16 weeks of age.

After reviewing the Animal Welfare Act (AWA) and its intent, puppies under 16 weeks of age can be exempt from individual identification if the following requirements are met:

1. The puppies remain housed at the facility where they were whelped and are maintained as a litter.

2. The enclosure containing the puppies is identified with the information required by 9 CFR Section 2.50 until the puppies are sold or moved from the facility where they were whelped or reach the age of 16 weeks, whichever comes first.

©1999, Janet Becker Rodgers, DVM, MS, DipACLAM, MRCVS

All rights reserved.

Comments? Send an email to janet.rodgers@vet.ox.ac.uk