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(a) DoD Directive 3216.1, "Use of Animals in DoD
Programs , " February 1, 1982 (hereby canceled)
(b) Title 9, Code of Federal Regulations, "Animals
and Animal Products, " Chapter 1, Subchapter A,
"Animal Welfare, " Parts 1, 2, and 3
(c) Public Law 101-511, Department of Defense
Appropriations Act for Fiscal Year 1991, Section
8019, Title 10 United States Code, Section 2241
(d) Sections 2131 through 2156 of Title 7, United
States Code "The Laboratory Animal Welfare Act
of 1966, " as amended
(e) through (f) , see enclosure 1.
A. REISSUANCE AND PURPOSE
1. Reissues reference (a) to update policy governing activities using animals within the Department of Defense.
2. Designates the Secretary of the Army as the DoD Executive Agent to develop and issue Service regulations to implement this Directive.
This Directive applies to the Office of the Secretary of Defense, the Military Departments, the Uniformed Services University of the Health Sciences, and the Defense Agencies (hereafter referred to collectively as "DoD Components") that perform or sponsor activities using animals.
Terms used in this Directive are defined in enclosure 2.
D. DoD POLICY
1. Federal statutes, regulations, and publications that provide national standards and guidance for the acquisition, transportation, housing, control, maintenance, handling, protection, treatment, care, use, and disposal of animals shall be applicable to all activities using animals. A summary of the applicable documents cited as references is in enclosure 3.
2. Animals shall be legally obtained from suppliers licensed by the U.S. Department of Agriculture (USDA) in accordance with reference (b) unless specifically exempted from the licensing requirements stated in reference (b) .
3. DoD organizations or facilities maintaining animals for use in research, testing or training shall apply for accreditation by the American Association for Accreditation of
Laboratory Animal Care (AAALAC) .
4. Alternative methods to animal species shall be considered, whenever possible, if such alternatives produce scientifically valid or equivalent results to attain the research
testing and training objectives.
5. The purchase or use of dogs, cats, or nonhuman primates in research conducted for developing biological, chemical or nuclear weapons is prohibited.
6. The purchase or use of dogs, cats, or nonhuman primates for inflicting wounds from any type of weapon(s) to conduct training in surgical or other medical treatment procedures is prohibited. (reference (c)).
7. DoD organizations or facilities wishing to hold training programs using animals, such as advanced trauma life support (ATLS) training programs, shall have the training protocol
reviewed and approved by a duly constituted Institutional Animal Care and Use Committee (IACUC) in accordance with references (d) u and (e) and paragraph D.8. of this Directive to ensure the humane use of animals. DoD organizations or facilities conducting ATLS
training that require housing of animals for short periods of time shall ensure adequate care and shall have the animal housing facilities inspected and approved by a veterinarian prior to
receipt of the animals.
8. All proposals or protocols for animal experiments or demonstrations in RDT&E, clinical investigation, instructional, or training programs conducted or sponsored by a DoD organization
or facility shall be reviewed and approved by a duly constituted IACUC composed of a minimum of five members. There shall be at least one non-scientific member on each IACUC. In addition,
there also shall be a member who represents the general community interest and is non-affiliated with the facility sponsoring IACUC. The non-affiliated and the non-scientific membership can
be filled by the same person. To ensure community representation at each meeting and inspection, an alternate to the non-affiliated member shall be designated for IACUCS having a single non-affiliated membership. Since the DoD IACUCS perform a Government function in an approval process and do not serve merely as an advisory body, the non-affiliated and the non
scientific member(s) to DoD IACUCS shall either be a Federal employee, with demonstrated commitment to the community or a consultant consistent with the requirements established by reference (f) .
9. A headquarters-level administrative review shall be conducted for proposals involving the use of nonhuman primates conducted or sponsored by subordinate activities of the DoD
Component for conformance with all applicable Federal regulations and policies. A DoD component may delegate this responsibility to another DoD component for purposes of efficiency and consolidation of functional offices.
10. The DoD Components shall coordinate and cooperate in the transfer of Government-owned nonhuman primates between facilities to maximize conservation and proper utilization.
11. Proposals intending to use chimpanzees must be further reviewed and approved by the Interagency Animal Model Committee, which coordinates national priorities for research utilization of this species.
12. The DoD components that sponsor animal based research, testing, and training under a DoD grant or contract shall ensure that:
13. In the case of differences between the standards of care
and use of animals as cited in enclosure 3, the most stringent
standard shall apply.
14. Activities covered by this Directive that are performed or sponsored in foreign countries shall be conducted in accordance with applicable U.S. statutory requirements, and regulations and standards of the host country. If differences exist between U.S. and host country regulations or standards, unless prohibited by the host country, the more stringent standard shall apply.
15. While not specifically addressed in this Directive, ceremonial, recreational, and working animals, such as military working dogs, shall be treated in a humane manner.
16. Personnel with complaints of violation of this directive shall report such violations to either of the following members of the organization or facility: IACUC chairperson, attending veterinarian, the facility Commander, or Inspector General. The IACUC shall review and, if warranted, investigate all reports of complaints of animal use or noncompliance with 7 U.S.C. 2131- 2 of reference (d), applicable Directives, and regulations.
1. The Director, Defense, Research and Engineering (under the Under Secretary of Defense for Acquisition and Technology) or designee shall:
2. The Heads of the DoD Components shall:
3. The Secretary of the Army shall:
F. EFFECTIVE DATE
This Directive is effective immediately.
Enclosures - 3
3. Guidance Documents
John M. Deutch
Deputy Secretary of Defense
April 17, 1995
3216.1 Enclosure 1
(e) National Institutes of Health (NIH) Publication
No. 86-23, "Guide for the Care and Use of Laboratory
Animals", United States Department of Health and Human
Services, National Institutes of Health, Revised 1985.
(f) Title 5, United States Code, Section 3109.
Apr 17, 95
3216.1 (Encl 2)
DEFINITION OF TERMS
1. Animal- Any dog, cat, non-human primate, guinea pig, hamster, rabbit or any other live vertebrate animal, which is being used or is intended for use for research, training, testing, or experimentation purposes. For this Directive, it includes birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, training, testing or experimentation purposes. The term excludes animals used for ceremonial or recreational purposes, military working animals, and animals intended for use as livestock and poultry as food or fiber; or, livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber.
2. Clinical Investigation- All activities directed towards clinical research conducted principally within medical treatment facilities. The Clinical Investigations program is part of the Defense Health Program of the Assistant Secretary of Defense (Health Affairs) and is supported by Major Force Program 8 (MFP-8) funds.
3. Instructional Program- All educational and training activities, except training of ceremonial and recreational animals and training associated with military working animals or survival skills training.
4. Research, Development, Test, and Evaluation- All activities which form the RDT&E program of the Director, Defense Research and Engineering (DDR&E) and are supported by Major Force Program 6 (MFP-6) funds.
5. Alternatives- Any system or method that covers one or more of the following: replacing or reducing the number of laboratory animals required for an investigation by computer simulation, cell culture techniques, etc; or, refining an existing procedure or technique to minimize the level of stress endured by the animal.
6. DoD Sponsored Programs- All proposals or designs for animal experiments or demonstration in RDT&E, clinical investigation, or instructional programs conducted or funded by grant, award, loan, contract, or cooperative research and development agreement (CRADA).
Apr 17, 1995
3216.1 (Encl 3)
The following documents provide national standards and guidance for the protection, treatment and use of animals:
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Updated March 12, 2002