Army Regulation 40–33

SECNAVINST 3900.38C
AFMAN 40–401(I)
DARPAINST 18
USUHSINST 3203

Medical Services

The Care and

Use of
Laboratory
Animals in DOD
Programs

Departments of the Army,

Navy,
Air Force,
Defense Advanced Research Projects
Agency, and the Uniformed Services
University of the Health Sciences
Washington, DC
16 February 2005

UNCLASSIFIED
 SUMMARY of CHANGE
AR 40–33/SECNAVINST 3900.38C/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203
The Care and Use of Laboratory Animals in DOD Programs

This administrative revision dated 16 February 2005--

o Adds Lieutenant General George Peach Taylor, Jr. as U.S. Air Force surgeon
general.

o Adds Dr. Larry Laughlin, as the interim president of the Uniformed Services
University of the Health Sciences.

This revision--

o Changes the title of the regulation to reflect current areas of coverage and
changes the series number to more accurately reflect the content.

o Delineates the responsibilities of the Director, Defense Research and

Engineering, the Secretary of the Army, the Director, Department of Defense
Veterinary Service Activity, the institutional official, the Institutional
Animal Care and Use Committee, the principal investigator, and the attending
veterinarian (paras 4a, 4c, 4d, 4e, 4f, 4g, and 4h).

o Updates the responsibilities for the heads of Department of Defense

components (para 4b).

o Exempts extramural facilities accredited by the Association for the

Assessment and Accreditation for Laboratory Animal Care, International, from
initial site visits (para 5c(1)(c)).

o Prohibits the wounding of dogs, cats, and nonhuman primates for medical or
surgical training and their use in advanced trauma life support training
(paras 5h(2) and 5h(3)).

o Provides for the review of proposals involving the use of chimpanzees by the
Interagency Animal Model Committee (para 6j(2)).

o Adds policy for managing complaints concerning violations of animal care and
use standards (para 7).

o Requires the submission of a semiannual review report on facility inspection

to the institutional official and prescribes the use of a new form for this
purpose, DD Form 2856 (DOD Semiannual Program Review/Facility Inspection
Checklist) (para 8a(1) and app D).

o Specifies the requirement to release information to the public in an

accessible database (para 9).

o Adds an animal use protocol format for submitting proposals concerning animal
use in Department of Defense programs (app C).
Departments of the Army, *Army Regulation 40–33
Navy, *SECNAVINST 3900.38C
Air Force, *AFMAN 40–401(I)
Defense Advanced Research
Projects Agency, *DARPAINST 18
and the Uniformed Services *USUHSINST 3203
University of the Health Sciences
Washington, DC
16 February 2005
Effective 16 March 2005

Medical Services

The Care and Use of Laboratory Animals in DOD Programs

History. This publication is an training, or testing. This regulation is ap- management controls that must be
administrative revision. The portions plicable during mobilization. evaluated.
affected by this revision are listed in the
Proponent and exception authority. Supplementation. Supplementation of
summary of change.
The proponent of this regulation is The this regulation and establishment of com-
Summary. This regulation, delineates Surgeon General. The proponent has the mand and local forms are prohibited with-
the Secretary of the Army as the Depart- authority to approve exceptions or waivers out prior approval from The Surgeon
ment of Defense Executive Agent for Vet- to this regulation that are consistent with General (DASG–ZA).
erinary Services to develop and issue controlling laws and regulations. The pro-
Suggested improvements. Users are
Service regulations to implement Depart- ponent may delegate this approval author-
invited to send comments and suggested
ment of Defense Directive 3216.1. It cre- ity, in writing, to a division chief within
improvements on DA Form 2028 (Recom-
ates uniform policies, procedures, and the proponent agency or a direct reporting
mended Changes to Publications and
responsibilities among Department of De- unit or field operating agency of the pro-
Blank Forms) directly to The Surgeon
fense components involved in the use of ponent agency in the grade of colonel or
General (DOD–VSA), 5109 Leesburg
animals outlined in this regulation. This the civilian equivalent. Activities may re-
Pike, Falls Church, VA 22041–3258.
regulation references pertinent Federal quest a waiver to this regulation by pro-
statutes and regulations and other stand- viding justification that includes a full Committee Continuance Approval.
ards related to the care and use of ani- analysis of the expected benefits and must The Department of the Army Committee
mals. It establishes policies regarding the include formal review by the activity’s Management Officer concurs with the es-
care and use of animals, whether per- senior legal officer. All waiver requests tablishment of institutional animal care
formed by Department of Defense person- will be endorsed by the commander or and use committees.
nel or contract or grant recipients. senior leader of the requesting activity Distribution. This publication is availa-
Applicability. This regulation applies to and forwarded through their higher head- ble in electronic media only and is in-
the military departments, the Uniformed quarters to the policy proponent. Refer to tended for command levels B, C, D, and
Services University of the Health Sci- AR 25–30 for specific guidance. E for the Active Army, command level C
ences, and the defense agencies (hereafter Army management control process. for the Army National Guard of the
referred to collectively as “DOD compo- This regulation contains management con- United States, and command level D for
nents”) that perform or sponsor activities trol provisions in accordance with Army the U.S. Army Reserve. Navy: SNDL. Air
using animals for research, education, regulation 11–2, but does not identify key Force: F. DARPA: Special. USUHS:
Special.

*This regulation supersedes AR 40–33/SECNAVINST 3900.38B/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203, dated 1 December 2003.

AR 40–33/SECNAVINST 3900.38C/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203 • 16 February 2005 i

UNCLASSIFIED
Contents (Listed by paragraph and page number)
Purpose • 1, page 1
References • 2, page 1
Explanation of abbreviations and terms • 3, page 1
Responsibilities • 4, page 1
Policies and procedures • 5, page 2
Statutes, regulations, standards, and guidelines • 6, page 3
Management of complaints • 7, page 4
Reports • 8, page 4
Release of information • 9, page 5
Navy distribution • 10, page 5

Appendixes
A. References, page 6
B. DOD Component Offices, page 8
C. DOD Animal Use Protocol Format, page 10
D. Instructions for Use of DD Form 2856 (DOD Semiannual Program Review/Facility Inspection Checklist),
page 22

Figure List

Figure C–1: DOD animal use protocol cover sheet, page 10

Figure C–2: DOD animal use protocol format, page 12
Figure C–2: DOD animal use protocol format—Continued, page 13
Figure C–2: DOD animal use protocol format—Continued, page 14
Figure C–3: DOD animal use protocol format with completion aids, page 15
Figure C–3: DOD animal use protocol format with completion aids—Continued, page 16
Figure C–3: DOD animal use protocol format with completion aids—Continued, page 17
Figure C–3: DOD animal use protocol format with completion aids—Continued, page 18
Figure C–3: DOD animal use protocol format with completion aids—Continued, page 19
Figure C–3: DOD animal use protocol format with completion aids—Continued, page 20
Figure C–3: DOD animal use protocol format with completion aids—Continued, page 21
Figure D–1: Sample completed DD Form 2856, page 23
Figure D–1: Sample completed DD Form 2856—Continued, page 24

Glossary

ii AR 40–33/SECNAVINST 3900.38C/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203 • 16 February 2005

1. Purpose
a. This regulation sets forth policies, procedures, and responsibilities for the care and use of laboratory animals
within Department of Defense (DOD) programs.
b. This regulation covers any live vertebrate animal that is being used or is intended for use in research, training, or
testing, or for experimentation purposes.
c. This regulation does not cover animals used for ceremonial or recreational purposes, military working animals,
and farm animals, such as, but not limited to, livestock or poultry, used or intended for use as food or fiber, or
livestock or poultry used or intended for use in improving animal nutrition, breeding, management, or production
efficiency, or for improving the quality of food or fiber.

2. References
Required and related publications and prescribed and referenced forms are listed in appendix A.

3. Explanation of abbreviations and terms

Abbreviations and special terms used in this regulation are explained in the glossary.

4. Responsibilities
a. The Director, Defense Research and Engineering (DDR&E), (acting for the Under Secretary of Defense for
Acquisition and Technology) or his or her designee will—
(1) Issue policies and procedural guidance under DODD 3216.1 concerning animal use consistent with all applicable
Federal regulations and policies.
(2) Designate a DOD representative to the Interagency Research Animal Committee (IRAC); this veterinarian will
be a veterinarian of appropriate rank, grade, and experience, and preferably a diplomate of the American College of
Laboratory Animal Medicine (ACLAM).
(3) Establish the Joint Technical Working Group (Animal Use) (JTWG) to act in a central advisory capacity to the
Armed Services Biomedical Research Evaluation and Management (ASBREM) Committee on all matters pertaining to
the care and use of laboratory animals in DOD programs. The co-chairpersons of the ASBREM Committee will
designate the chairperson of the JTWG.
b. The heads of the DOD components will—
(1) Establish appropriate mechanisms to implement and monitor compliance with this regulation and other applica-
ble Federal statutes, policies, and guidelines.
(2) Provide members to the JTWG as requested and appointed by the DDR&E.
(3) Designate the appropriate oversight office(s) within DOD components (see appendix B) that will—
(a) Perform the headquarters-level administrative review of all proposals requiring the use of nonhuman primates
(NHPs), dogs, cats, and marine mammals.
(b) Receive reports of protocol suspensions and significant deficiencies.
(c) Serve as reviewing and approving authorities of animal use proposals from extramural facilities proposing
research under contract(s), award(s), or grant(s).
(4) Support and, as necessary, ensure the development of animal care and use training programs for researchers and
members of Institutional Animal Care and Use Committees (IACUCs) and applicable certification programs for all
personnel involved in the care, use, and treatment of animals.
c. The Secretary of the Army, as the DOD Executive Agent for Veterinary Services, will—
(1) In consultation with the other DOD components, develop, issue, and implement this regulation.
(2) Designate the Director, DOD Veterinary Service Activity (DODVSA) (a field operating agency of the Army,
Office of The Surgeon General) as the consultant to the Assistant Secretary of Defense for Health Affairs (ASD(HA))
and the DDR&E for technical and professional matters related to this regulation.
d. The Director, DODVSA will serve as consultant to ASD(HA) and the DDR&E for technical and professional
matters concerning this regulation.
e. The institutional official will—
(1) Ensure that DOD animal care and use programs and facilities conform to applicable standards, guidelines, and
policies cited in this regulation. If there is a conflict between this regulation and the standards of humane care and use
of animals as cited in the publications referenced in paragraph 6, the more stringent standard shall apply.
(2) Ensure that all research, education, training, or testing using animals is documented in an approved protocol.
(3) Recommend appointments to a duly constituted IACUC to monitor and ensure humane care and use of animals.
(4) Ensure that all deficiencies noted by the IACUC during semiannual reviews of animal care and use programs
and facilities are corrected.
(5) Ensure that local animal care and use, procurement, and transportation policies and procedures comply with this
regulation.
(6) Ensure that DOD organizations or facilities maintaining animals for use in research, testing, or training make

AR 40–33/SECNAVINST 3900.38C/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203 • 16 February 2005 1

application for and maintain accreditation with the Association for the Assessment and Accreditation of Laboratory
Animal Care, International (AAALAC) and that the animal care unit is adequately resourced.
(7) Support and, as necessary, develop animal care and use training programs, and encourage and resource appropri-
ate certification for all personnel involved in the care, use, and treatment of laboratory animals.
f. IACUCs within DOD will—
(1) Review all proposals or protocols for DOD animal care and use programs conducted or sponsored by DOD
components, organizations, or facilities.
(2) Ensure that proposals or protocols are submitted in the DOD animal use protocol format. (See app C.)
(3) Perform semiannual reviews of animal care and use programs and facilities. (See app D.)
(4) Perform other duties as listed in Title 9, Code of Federal Regulations.
g. The principal investigator (P.I.) will—
(1) Submit proposals or protocols in the DOD animal use protocol format.
(2) Ensure that protocols are executed as approved by the IACUC.
(3) Maintain accurate records and provide an audit trail of animal expenditures and use that correlates to the
approved protocols.
h. The attending veterinarian will—
(1) Serve as a voting member of the IACUC and have direct or delegated responsibility for the animals at the
facility.
(2) If employed on a part-time or consulting basis, provide a written program of veterinary care with a written list of
regularly scheduled visits to the facility. The scheduled visits will be conducted with sufficient frequency to provide
adequate veterinary care for the animals.

5. Policies and procedures

a. Decision to use animals. The inclusion of animals in DOD programs is the responsibility of DOD component and
sub-level directors and commanders. The proponent of this regulation is not the authority for initiating and conducting
programs that involve animals.
b. Other methods. Alternative methods to the use of animals must be considered and used if such alternatives
produce scientifically valid or equivalent results to attain the research, education, training, and testing objectives.
c. Contracts and grants.
(1) DOD components that sponsor animal care and use programs under a grant or contract will ensure that—
(a) Extramural research proposals using live animals are administratively reviewed and approved by a DOD
veterinarian trained or experienced in laboratory animal medicine and science prior to release of funding for animal
research.
(b) All contract or grant facilities subject to inspection by the U.S. Department of Agriculture (USDA) must provide
the most recent inspection report (USDA, Animal and Plant Health Inspection Service (APHIS) Form 7008 (Animal
Care Inspection Report)) to the DOD oversight component office. Prior to release of funding for animal research, a
DOD veterinarian will review the USDA Animal Care Inspection Reports. Electronic review of inspection reports is
permissible. During the term of the award, a DOD veterinarian will review annually the most recent USDA Animal
Care Inspection Reports.
(c) A DOD veterinarian trained and experienced in laboratory animal medicine will conduct an initial site visit to
evaluate animal care and use programs and facilities at all institutions conducting DOD-sponsored research using
nonhuman primates, dogs, cats, or marine mammals. Additionally, this veterinarian will perform site visits to any
institution conducting DOD-sponsored research using animals where research procedures, program, or facility condi-
tions necessitate. The timing of the initial visit is at the discretion of the DOD veterinarian conducting the visit and is
based upon an administrative review of the proposed research, the institution’s animal care and use program, its
AAALAC accreditation status, its Public Health Service Office of Laboratory Animal Welfare assurance status, and its
USDA Animal Care Inspection Reports. For sites outside the continental United States, similar information is required.
(d) Any facility receiving a DOD-funded contract or grant for animal-based research notifies the DOD component
sponsor and has a site inspection within 30 days of notification of loss of AAALAC accreditation or notification that
the facility is under USDA investigation. Site inspections for cause will evaluate and ensure the adequacy of animal
care and use in DOD-sponsored programs and provide recommendations to the sponsoring DOD component about
continued funding support.
(e) All procurement contracts contain the Defense Federal Acquisition Regulation Supplement clause DFARS
252.235–7002, “Animal Welfare”.
(f) All grants, cooperative agreements and other agreements contain appropriate animal welfare terms and conditions
as specified by agency policy and procedures.
(2) Extramural contractors that propose to use animals in DOD-sponsored programs will submit all pertinent
information required in the DOD animal use protocol format in their contract proposal.
d. Centralized review and oversight of NHPs.

2 AR 40–33/SECNAVINST 3900.38C/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203 • 16 February 2005

 (1) A headquarters-level administrative review of all NHP protocols will be conducted at the appropriate DOD-
component oversight office by a veterinarian trained or experienced in laboratory animal medicine and science to
ensure 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. (See app
B.)
(2) Proposals intending to use chimpanzees require further review and approval by the Interagency Animal Model
Committee that coordinates national priorities for research utilization of this species.
(3) The JTWG will encourage coordination and cooperation in the transfer of Government-owned NHPs between
facilities to maximize conservation and proper utilization.
e. AAALAC accreditation. DOD organizations or facilities maintaining animals for use in DOD programs will—
(1) Attain and maintain accreditation with the AAALAC.
(2) Provide the Director, Biosystems, ODDR&E, Suite 9030, 1777 North Kent Street, Rosslyn, VA 22209, with
documentation of any change in AAALAC accreditation status.
(3) Explain the absence of accreditation and submit a plan of action and milestones to obtain accreditation.
f. Composition and training of the IACUC.
(1) The IACUC will be constituted in accordance with chapter I, subchapter A, Animal Welfare, part 2, section
2.31(b)-IACUC Membership and additionally will—
(a) Be composed of a minimum of five members.
(b) Have a primary and an alternate nonaffiliated member. (This requirement is intended to facilitate community
representation at each IACUC meeting, facility inspection, and semiannual program review.)
(c) Have at least one non-scientific member.
(2) All IACUC member(s) and alternate(s) will—
(a) Receive initial training that consists of at least 4 hours of training in regulatory responsibilities and proper
techniques of the animal protocol review process.
(b) Receive at least 4 additional hours of training on humane care and ethical issues dealing with animal use.
(c) Be either a Federal employee, covered under the Intergovernmental Personnel Act (IPA), or a consultant
consistent with the requirements established by Section 3109, Title 5, United States Code (5 USC 3109).
g. Suppliers. Animals must be obtained from suppliers licensed by the USDA under Federal Animal Welfare
Regulations (Title 9, CFR, Chapter I, Subchapter A, Parts 1, 2, and 3), unless specifically exempted from licensing
requirements by such regulations.
h. Prohibited uses. Prohibited uses for dogs, cats, nonhuman primates, and marine mammals are the following:
(1) Research conducted for development of biological, chemical, or nuclear weapons.
(2) Inflicting wounds with any type of weapon(s) to conduct training in surgical or other medical treatment
procedures.
(3) Advanced trauma life-support (ATLS) training.
i. Training uses. DOD organizations or facilities wishing to conduct training programs using animals will—
(1) Ensure training protocols, submitted in the DOD animal use protocol format (see app C), are reviewed and
approved by a duly constituted IACUC. Organizations without an IACUC should contact the appropriate component
office (see app B) for guidance and assistance.
(2) Ensure adequate care for animals.
(3) Have the animal housing facilities inspected and approved by a veterinarian prior to the receipt of animals.
(4) Restrict the use of dogs, cats, nonhuman primates, or marine mammals to research and training not listed in
paragraph 5h.
j. Use of DOD facilities. The use of animals in a collaborative effort with or on behalf of other Federal, DOD, or
civilian agencies in DOD facilities will comply fully with this regulation.
k. Animal programs in foreign countries. Activities covered by this regulation performed or sponsored in foreign
countries will be conducted in accordance with the regulations and standards of the host country and applicable U.S.
statutory requirements. If differences exist between U.S. and host country regulations or standards, unless prohibited by
the host country, the more stringent standard shall apply.

6. Statutes, regulations, standards, and guidelines

a. Public Law 101–511, Department of Defense Appropriations Act, FY 1991, Section 8019 (10 USC 2241)
prohibits the purchase or use of dogs, cats, or NHPs for inflicting wounds from any type of weapon(s) in order to
conduct training in surgical or other medical treatment procedures.
b. The Laboratory Animal Welfare Act of 1966 (7 USC 2131 et seq.), as amended, and implementing regulations
promulgated by the USDA (Title 9, Code of Federal Regulations, Parts 1–4 (9 CFR 1–4)) require licensing of dealers,
identification of animals, maintenance of records, submission of reports, establishment of an IACUC, and compliance
with standards for the humane handling, care, treatment, and transportation of animals by dealers and research
facilities.

AR 40–33/SECNAVINST 3900.38C/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203 • 16 February 2005 3

 c. The Endangered Species Act of 1973 (16 USC 1531–1543; and 50 CFR Parts 10–14, 17, and 217–227), as
amended, and implementing regulations provide a program, under the Department of the Interior, for conserving
threatened and endangered species. This act requires the U.S. Government to acquire import/export permits, maintain
records, make reports, and perform inspections on the care and handling of endangered, threatened, and conserved
species covered by the act. Additional guidance is found in the Convention on International Trade in Endangered
Species of Wild Fauna and Flora and 50 CFR 23.
d. The Marine Mammal Protection Act of 1972 (16 USC 1361–1384; and 50 CFR Parts 10–14, 18, 23, and 216), as
amended, and implementing regulations promulgated by the National Oceanic and Atmospheric Administration,
provide a program for protection of marine mammals. This act requires the acquisition of permits, maintenance of
records, submission of reports, and inspections on the care and handling of marine mammals.
e. The Lacey Act (Section 42, Title 18, United States Code (18 USC 42)); and Title 50, Code of Federal
Regulations, Part 16, Subpart B (50 CFR 16, Subpart B)), as amended, prohibits the importation of certain wild
animals or their eggs if the Secretary of the Interior determines that they are injurious to humans or a detriment to the
interests of agriculture or to other specified national interests. These wild animals and their eggs are identified within
the Lacey Act.
f. Regulations on the use of harmful or dangerous viruses, serums, toxins, and other similar agents used in animal
research facilities producing or testing biological products are provided for in Section 154, Title 21, United States Code
(21 USC 154) and Part 117, Title 9, Code of Federal Regulations (9 CFR 117).
g. Regulations on the import and export of animals, their intra- and interstate shipment, and the requirements for
their quarantine and inspection are presented in the following documents: 5 USC 301; 21 USC 111–113, 114a,
115–117, 120–126, and 151–158; 9 CFR 71–97 and 122; 42 USC 216 and 264–272; and 42 CFR 71–72.
h. Additional guidance on housing, caring for, and using laboratory animals is provided for in the “Guide for the
Care and Use of Laboratory Animals,” 1996, published by the National Academy Press, Washington, DC.

7. Management of complaints
a. Personnel with complaints of violation(s) of this regulation may report such violations to one or all of the
following:
(1) IACUC chairperson/IACUC member.
(2) Attending veterinarian.
(3) Facility commander or institutional official.
(4) Inspector General.
b. The IACUC will review and, if warranted, investigate complaints involving animal use or noncompliance with
applicable laws, regulations, directives, or guidelines. Protocol suspensions and significant deficiencies shall be
reported to the appropriate DOD component oversight office. (See app B.)

8. Reports
a. At least once every 6 months, all IACUCs within DOD will submit a written evaluation of the animal care and
use program to the institutional official. The report must contain a description of the nature and extent of the research
facility’s adherence to Subchapter A of the Animal Welfare Act Regulations, identify specifically any departure from
Subchapter A, and state the reasons for each departure.
(1) The evaluation will be documented using DD Form 2856. Additional information is provided in appendix D.
(2) As a minimum, the report consists of DD Form 2856. DD Form 2856 is used as the basis of the program and
facility review (minority views must be included, if applicable), and describes any facility or program deficiencies, the
corrective actions taken or planned, and timelines where appropriate.
(3) Any failure to adhere to the plan and schedule that results in a significant deficiency that is or may be a threat to
the health or safety of the animals will be reported within 15 business days by the institutional official for forwarding
to the appropriate DOD component oversight office. (See app B for addresses.)
(4) After the institutional official signs the report, it is returned to the IACUC and retained for a minimum of 3
years.
b. DOD organizations will submit APHIS Form 7023 (Annual Report of Research Facility) to the USDA as required
and in accordance with USDA implementing regulations of the Animal Welfare Act.
c. All DOD organizations using animals subject to this regulation will submit copies of each APHIS Form 7023, and
other data as directed, to the proper DOD component oversight office. (See app B.)
d. All organizations using animals in accordance with the provisions of this regulation will prepare and submit
summaries of their research in the format specified by the JTWG for inclusion in the DOD Biomedical Research
Database.

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9. Release of information
DOD components will report all animal-based protocols for public release to the Defense Technical Information Center
(DTIC).

10. Navy distribution

The Navy has determined that the guidance in this regulation is intended for:
a. A1 (Immediate Office of the Secretary) (ASSTSECNAV MRA and ASSTSECNAV RES).
b. A2A (Department of the Navy Staff Offices) (Chief of Naval Research and Naval Criminal Investigative Services
only).
c. A3 (Chief of Naval Operations).
d. 21A (Fleet Commanders).
e. 22A (Fleet Commanders).
f. 23 (Force Commanders).
g. 24 (Type Commanders).
h. E3A (Laboratory Research).
i. E8A (Criminal Investigation Service).
j. FHI (Medical and Surgery).
k. FKA1G (Sea Systems Command).

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Appendix A
References

Section I
Required Publications
This section contains no entries.

Section II
Related Publications

AFI 31–202
Military Working Dog Program. (Available at http://www.e-publishing.af.mil.)

AR 11–2
Management Control

AR 40–905/SECNAVINST 6401.B/AFI 48–131

Veterinary Health Services

AR 70–45
Scientific and Technical Information Program

AR 190–12
Military Police Working Dogs

AR 700–81/AFR 400–8/NAVINST 10570.1/MCO 105–0.1

DOD Dog Program

42 CFR 71–72
Foreign Quarantine; Interstate Shipment of Etiologic Agents. (Available at http://www.gpoaccess.gov/cfr/index.html.)

50 CFR Part 23
Endangered Species Convention. (Available at http://www.gpoaccess.gov/cfr/index.html.)

DA Pam 190–12
Military Working Dog Program

DFARS
Defense Federal Acquisition Regulation Supplement. (Available at http://deskbook.dau.mil.)

DOD Directive 3216.1

Use of Laboratory Animals in DOD Programs. (Available at http://www.dtic.mil/whs/directives.)

Guide for the Care and Use of Laboratory Animals

1996 edition or succeeding revised editions. (Available at http://www.nap.edu.)

PL 101–511, section 8019

Department of Defense Appropriations Act for Fiscal Year 1991 (10 USC 2241 note). (Available at http://
thomas.loc.gov/bss.)

SECNAVINST 3900.41
Acquisition, Transport, Care and Maintenance of Marine Mammals. (Available at http://neds.daps.dla.mil/Directives/
3900d41.pdf.)

Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)
A voluntary international agreement on endangered species (Available at http://www.cites.org.)

5 USC 301
Departmental regulations. (Available at http://www.gpoaccess.gov/uscode/index.html.)

6 AR 40–33/SECNAVINST 3900.38C/AFMAN 40–401(I)/DARPAINST 18/USUHSINST 3203 • 16 February 2005

5 USC 3109
Employment of Experts and Consultants: Temporary or Intermittent. (Available at http://www.gpoaccess.gov/uscode/
index.html.)

7 USC 2131 et seq. and 9 CFR parts 1–4

The Laboratory Animal Welfare Act. (Available at http://www.gpoaccess.gov/uscode/index.html.)

16 USC 1361–1384 and 50 CFR Parts 10–14, 18, 23, and 216
The Marine Mammal Protection Act. (Available at http://www.gpoaccess.gov/uscode/index.html.)

16 USC 1531–1543 and 50 CFR Parts 10–14, 17, and 217–227

The Endangered Species Act. (Available at http://www.gpoaccess.gov/uscode/index.html.)

18 USC 42 and 50 CFR Part 16, Subpart B

The Lacey Act. (Available at http://www.gpoaccess.gov/uscode/index.html.)

21 USC 111–113, 114a, 115–17, 120–26, and 151–158 and 9 CFR 71–97
Licensing for import, export,and shipment of animals. (Available at http://www.gpoaccess.gov/uscode/index.html.)

42 USC 216 and 264–272

Quarantine and Inspection. (Available at http://www.gpoaccess.gov/uscode/index.html.)

Section III
Prescribed Forms

DD Form 2856
DOD Semiannual Program Review/Facility Inspection Checklist. (Prescribed in para 8a(1) and app D) (Available at
http://www.dtic.mil/whs/directives/infomgt/forms/formsprogram.htm.)

Section IV
Referenced Forms

APHIS Form 7008

USDA Animal Care Inspection Report

APHIS Form 7023

Annual Report of Research Facility (This form supersedes USDA Form VS 18–23.) APHIS Form 7008 and APHIS
Form 7023 may be obtained from the local regional office of the APHIS/USDA or by contacting APHIS/USDA/
Animal Care, 4700 River Road, Riverdale, MD 20737–1234; telephone number: (301) 734–7833; fax: (301) 734–4978;
e-mail: ace@usda.gov; Internet address: http://www.aphis.usda.gov/ac/)

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Appendix B
DOD Component Offices
B–1. Oversight offices
The following DOD component agencies have been designated as oversight offices.

Commander
U.S. Army Medical Research and Materiel Command
ATTN: MCMR–RCQ–AR
504 Scott Street – Fort Detrick
Frederick, MD 21702–5012

HQ, AFMOA/SGOT
110 Luke Avenue, Room 400
Bolling Air Force Base, DC 20332–7050

Chief, Naval Bureau of Medicine and Surgery

Assistant Chief for Operational Medicine and Fleet Support (MED–02)
ATTN: Special Assistant for Veterinary Medicine (MED–26E)
2300 E Street NW
Washington, DC 20372–5300

President
Uniformed Services University of the Health Sciences
ATTN: Director, Department of Laboratory Animal Medicine
4301 Jones Bridge Road
Bethesda, MD 20814

Commander
U.S. Army Chemical and Biological Defense Command
ATTN: SCBRD–RTL
Veterinary Support Team
Aberdeen Proving Ground, MD 21010–5423

Director
Armed Forces Institute of Pathology
14th and Alaska Avenue NW
Washington, DC 20306–6000

Commander – Army Medical Department Center and School

Clinical Investigations Regulatory Office
ATTN: MCCS–GCI
1608 Stanley Road, Suite 2
Fort Sam Houston, TX 78234–5055

Commander
U.S. Army Special Operations Command
ATTN: Command Surgeon
Fort Bragg, NC 28307–5000

Office of the Director for Defense Research and Engineering

Room 3E808
3080 Defense Pentagon
Washington, DC 20301–3080

Director
Defense Advanced Research Projects Agency
ATTN: Administrative Office
3701 North Fairfax Drive
Arlington, VA 22203–1714

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Defense Threat Reduction Agency
8725 John J. Kingman Drive
MSG 6201
Fort Belvoir, VA 22060–6201

B–2. Functions of the oversight offices

These oversight offices carry out the responsibilities listed in paragraph 4b(3) of this regulation, and they will provide
guidance and assistance upon request.

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Appendix C
DOD Animal Use Protocol Format
C–1. Requirements
All DOD animal use protocols must use the format shown in this appendix. This protocol format includes requirements
of the Animal Welfare Act Regulations, the Guide, and other applicable Federal regulations and DOD directives.

C–2. Protocol cover sheet

Before the protocol is submitted for IACUC review, at least three signatures are required on the protocol cover sheet
(fig C–1). They must include those of the Principal Investigator (P.I.); either the department or division chief or the
scientific review committee chairperson; and the individual performing the statistical review.

Figure C–1. DOD animal use protocol cover sheet

a. Scientific/division review. This signature verifies that the animal use proposal received appropriate scientific peer
review and is consistent with good scientific practice.
b. Attending veterinarian. The Animal Welfare Act Regulations require that an attending veterinarian must be
consulted in the planning of procedures/manipulations that may cause more than slight or momentary pain or distress,
even if relieved by anesthetics or analgesics.
c. Statistical review. A person knowledgeable in biostatistics is required to review all proposals to ensure that the
number of animals used is appropriate to obtain sufficient data and/or is not excessive, and the statistical design is
appropriate for the intent of the study.

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C–3. DOD animal use protocol format
a. The format shown in figure C–2 is designed to be used with several word-processing programs on a personal
computer as a “fill-in-the-blank” type of document. It is available electronically through the appropriate DOD
component oversight office listed in appendix B. Each paragraph and subparagraph in the format must have a response.
Title headings do not require a response. Portions of the protocol format that are not applicable will be marked “N/A.”
There are no space limitations for the responses. Pertinent standing operating procedures or similar documents that are
readily available to the IACUC may be referenced to assist in the description of specific procedures.

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 Figure C–2. DOD animal use protocol format

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 Figure C–2. DOD animal use protocol format—Continued

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 Figure C–2. DOD animal use protocol format—Continued

b. Some information may be added to the format to meet local needs. However, all labeled paragraphs and
subparagraphs will remain in the same relative order. The added information will be similar or complementary to the
information requested. Other types of requirements specific to a given Service, command, or locale (such as budgeting
information, local coordinating requirements, or specific scientific review requirements, and so forth) can be added by
placing them in front or behind the standard format.

C–4. Protocol format with completion aids

The format shown in figure C–3 is the same protocol format as in figure C–2. Explanations have been added to aid in
completing the protocol proposal.

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 Figure C–3. DOD animal use protocol format with completion aids

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 Figure C–3. DOD animal use protocol format with completion aids—Continued

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 Figure C–3. DOD animal use protocol format with completion aids—Continued

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 Figure C–3. DOD animal use protocol format with completion aids—Continued

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 Figure C–3. DOD animal use protocol format with completion aids—Continued

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 Figure C–3. DOD animal use protocol format with completion aids—Continued

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 Figure C–3. DOD animal use protocol format with completion aids—Continued

C–5. Personnel qualifications.

a. A Study Personnel Qualifications/Training table must be included in section VI of the protocol description. The
table format is preferred by the IACUC for ease of reviewing the protocol. The table will contain the following four
column headings:
(1) Name of the activity (for example, the procedure, observation, or manipulation to be performed, such as the
venous catheterization of a dog).
(2) Name of the person performing the activity.
(3) Qualifications of the person performing the activity (for example, assistant laboratory animal technician (ALAT),
2 years experience).
(4) Training of the person performing the activity (for example, Canine Procedures Workshop, 1999).
b. Itemize each activity being performed in the protocol. List per species if there are multiple species in the
protocol. If more than one individual is performing the activity, list each individual separately.

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Appendix D
Instructions for Use of DD Form 2856 (DOD Semiannual Program Review/Facility Inspection
Checklist)
D–1. The checklist and the inspection report
The IACUC must complete the DOD Semiannual Program Review/Facility Inspection Checklist during the IACUC
semi-annual program review and facility inspection in accordance with Title 9, Code of Federal Regulations, Subchap-
ter A, Part 2, Subpart C. Individual checklists must be kept on file in the IACUC office but do not require attachment
to the finished IACUC Semiannual Program Review/Facility Inspection Report.

D–2. Use of the form

The use of the form is self-explanatory; simply place a checkmark in the most appropriate category for each item on
the inspection list. A sample completed DD Form 2856 is shown in figure D–1.

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 Figure D–1. Sample completed DD Form 2856

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 Figure D–1. Sample completed DD Form 2856—Continued

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D–3. Evaluation guidelines
The DOD Semiannual Program Review/Facility Inspection Checklist was created using the National Research Coun-
cil’s 1996 The Guide for Care and Use of Laboratory Animals (Guide) as a template. Refer to the corresponding
section of the Guide for more information on evaluation guidelines.

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Glossary
Section I
Abbreviations

AAALAC
Association for the Assessment and Accreditation of Laboratory Animal Care, International

ACLAM
American College of Laboratory Animal Medicine

AFI
Air Force Instruction

AFR
Air Force Regulation

APHIS
Animal and Plant Health Inspection Service

ASBREM
Armed Services Biomedical Research Evaluation and Management

ASD(HA)
Assistant Secretary of Defense for Health Affairs

AVMA
American Veterinary Medical Association

AWIC
Animal Welfare Information Center

BRD
Biomedical Research Database

CFA
Complete Freund’s Adjuvant

CFR
Code of Federal Regulations

CRISP
Computer Retrieval of Information of Scientific Projects

DAR
Defense Acquisition Regulation

DARPAINST
Defense Advanced Research Projects Agency Instruction

DDR&E
Director, Defense Research and Engineering

DFARS
Defense Federal Acquisition Regulation Supplement

DNAINST
Defense Nuclear Agency Instruction

DOD
Department of Defense

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DODD
Department of Defense Directive

DODVSA
Department of Defense Veterinary Service Activity

DTIC
Defense Technical Information Center

FEDRIP
Federal Research in Progress

IACUC
Institutional Animal Care and Use Committee

IRAC
Interagency Research Animal Committee

JTWG
Joint Technical Working Group

Mabs
monoclonal antibodies

NHP
nonhuman primate

P.I.
principal investigator

PL
public law

RDT&E
research, development, test, and evaluation

SECNAVINST
Secretary of the Navy Instruction

STO
science and technology objective

USC
U.S. Code

USDA
U.S. Department of Agriculture

USUHSINST
Uniformed Services University of the Health Sciences Instruction

VMD
Veterinary Medicine Division

3 Rs
refine, reduce, replace

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Section II
Terms

Accredited
Refers to accreditation of animal care and use programs and facilities by the Association for the Assessment and
Accreditation of Laboratory Animal Care. The accreditation process is designed to provide a mechanism that ensures a
high regard for animal welfare and enhances the quality of scientific research that uses experimental animals.

Alternative methods
Any system or method that covers one or more of the following:
a. Replacing the use of laboratory animals altogether.
b. Reducing the number of animals required.
c. Refining an existing procedure or technique to minimize the level of stress perceived by the animal.

Animal
Any live vertebrate animal that is being used or is intended for use in research, education, training, or testing.

Approved source
Refers to dealers who provide animals for research, testing, and/or education and are either USDA-approved or USDA-
exempted.

Centralized administrative review

A review performed by a laboratory animal veterinarian assigned to or working on behalf of the appropriate compo-
nent’s headquarters. The reviewer will determine if the DOD protocol format has been properly completed and will
ensure that animal resources are shared and conserved when appropriate.

Clinical investigations
All activities directed toward 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 for Health Affairs
and is supported by Major Force Program 8 funds.

Commander
Laboratory or unit commander, institute director, or other official having equivalent authority.

Consultant
A senior U.S. Army laboratory animal medicine veterinarian who acts in an advisory capacity to the Army Surgeon
General on matters concerning laboratory animal medicine and on use of laboratory animals in DOD programs.

Dealer
Any person who, in commerce, for compensation or profit, delivers for transportation (or transports, except as a
carrier), buys, sells, or negotiates the purchase or sale of animals.

DOD Component Office

Applies to the Office of the Secretary of Defense, the Military Departments, the Chairman of the Joint Chiefs of Staff,
the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies,
the DOD Field Activities and all other organizational entities in the Department of Defense (hereafter referred to
collectively as “the DOD Components”).

DOD-sponsored program
Any study, proposal, or design for animal experimentation or demonstration in research, education, training, or testing
conducted or funded by appropriation, grant, award, loan, contract, or cooperative research and development
agreement.

Endangered species
A species or subspecies of mammal or non-mammal listed as “endangered” under the Endangered Species Act.

Exhibition
The use of animals, including working, recreational, or ceremonial animals, in displays, demonstrations, or ceremonies.

Injurious wildlife
Any wildlife for which a permit is required under the Lacey Act before being imported into or shipped between the

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continental United States and Alaska, Hawaii, the Commonwealth of Puerto Rico, or any possessions of the United
States.

Institutional official
The individual who is authorized to legally commit on behalf of a research facility that the requirements of Title 9,
Code of Federal Regulations, Subchapter A, Parts 1, 2, and 3 will be met.

Instructional programs
All educational and training activities, except training of ceremonial and recreational animals and training associated
with military working animals or survival skills training.

Marine mammal
Mammals that are morphologically adapted to the marine environment (including sea otters and members of the orders
Sirenia, Pinnipedia, and Cetacea) or primarily inhabit the marine environment (for example, polar bears).

Minority opinion
A belief or judgment based on evidence insufficient to produce complete certainty and which represents the view of the
smaller part of a group; that is, less than one-half of the whole group.

Nonhuman primate
Any nonhuman member of the highest order of mammals, including prosimians, monkeys, and apes.

Principal investigator
An employee of a research facility, or other person associated with a research facility, responsible for a proposal to
conduct research and for the design and implementation of research involving animals.

Reduction
Procedures or measures taken to reduce the number of animals used.

Refinement
Procedures or measures taken to eliminate or minimize pain or distress in the animal or enhance animal well-being.

Replacement
Procedures or measures that eliminate the use of animals.

Research, development, test, and evaluation

All activities which form the RDT&E program of the Director, Defense Research and Engineering, and are supported
by Major Force Program 6 funds.

Research facility
Any school (except an elementary or secondary school), institution, organization, or person that uses or intends to use
live animals in research, tests, experiments, or instructional programs.

Significant deficiency
A deficiency, which in the judgment of the IACUC and the institutional official, is or may be a threat to the health or
safety of the animals (reference Title 9, Code of Federal Regulations, Subchapter A).

Threatened species
A species of mammal or non-mammal listed as “threatened” under the Endangered Species Act.

Training
A requirement of the Animal Welfare Act Regulations, which states that all personnel participating in the use of
animals under an IACUC-approved protocol receive appropriate training in humane methods of animal maintenance
and experimentation, limiting pain and/or distress of the animal, proper use of anesthetics, analgesic and tranquilizers,
deficiency reporting, and utilization of services available to provide information on alternatives to the use of live
animals in research and prevention of unnecessarily duplicative research.

Section III
Special Abbreviations and Terms
This section contains no entries.

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UNCLASSIFIED PIN 079971–000