[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR2.31]

[Page 21-25]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 2_REGULATIONS--Table of Contents
 
                      Subpart C_Research Facilities
 
Sec. 2.31  Institutional Animal Care and Use Committee (IACUC).

    (a) The Chief Executive Officer of the research facility shall 
appoint an Institutional Animal Care and Use Committee (IACUC), 
qualified through the experience and expertise of its members to assess 
the research facility's animal program, facilities, and procedures. 
Except as specifically authorized by law or these regulations, nothing 
in this part shall be deemed to permit the Committee or IACUC to 
prescribe methods or set standards for the design, performance, or 
conduct of actual research or experimentation by a research facility.
    (b) IACUC membership. (1) The members of each Committee shall be 
appointed by the Chief Executive Officer of the research facility;
    (2) The Committee shall be composed of a Chairman and at least two 
additional members;
    (3) Of the members of the Committee:
    (i) At least one shall be a Doctor of Veterinary Medicine, with 
training or experience in laboratory animal science and medicine, who 
has direct or

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delegated program responsibility for activities involving animals at the 
research facility;
    (ii) At least one shall not be affiliated in any way with the 
facility other than as a member of the Committee, and shall not be a 
member of the immediate family of a person who is affiliated with the 
facility. The Secretary intends that such person will provide 
representation for general community interests in the proper care and 
treatment of animals;
    (4) If the Committee consists of more than three members, not more 
than three members shall be from the same administrative unit of the 
facility.
    (c) IACUC functions. With respect to activities involving animals, 
the IACUC, as an agent of the research facility, shall:
    (1) Review, at least once every six months, the research facility's 
program for humane care and use of animals, using title 9, chapter I, 
subchapter A--Animal Welfare, as a basis for evaluation;
    (2) Inspect, at least once every six months, all of the research 
facility's animal facilities, including animal study areas, using title 
9, chapter I, subchapter A-Animal Welfare, as a basis for evaluation; 
Provided, however, That animal areas containing free-living wild animals 
in their natural habitat need not be included in such inspection;
    (3) Prepare reports of its evaluations conducted as required by 
paragraphs (c)(1) and (2) of this section, and submit the reports to the 
Institutional Official of the research facility; Provided, however, That 
the IACUC may determine the best means of conducting evaluations of the 
research facility's programs and facilities; and Provided, further, That 
no Committee member wishing to participate in any evaluation conducted 
under this subpart may be excluded. The IACUC may use subcommittees 
composed of at least two Committee members and may invite ad hoc 
consultants to assist in conducting the evaluations, however, the IACUC 
remains responsible for the evaluations and reports as required by the 
Act and regulations. The reports shall be reviewed and signed by a 
majority of the IACUC members and must include any minority views. The 
reports shall be updated at least once every six months upon completion 
of the required semiannual evaluations and shall be maintained by the 
research facility and made available to APHIS and to officials of 
funding Federal agencies for inspection and copying upon request. The 
reports must contain a description of the nature and extent of the 
research facility's adherence to this subchapter, must identify 
specifically any departures from the provisions of title 9, chapter I, 
subchapter A--Animal Welfare, and must state the reasons for each 
departure. The reports must distinguish significant deficiencies from 
minor deficiencies. A significant deficiency is one which, with 
reference to Subchapter A, and, in the judgment of the IACUC and the 
Institutional Official, is or may be a threat to the health or safety of 
the animals. If program or facility deficiencies are noted, the reports 
must contain a reasonable and specific plan and schedule with dates for 
correcting each deficiency. Any failure to adhere to the plan and 
schedule that results in a significant deficiency remaining uncorrected 
shall be reported in writing within 15 business days by the IACUC, 
through the Institutional Official, to APHIS and any Federal agency 
funding that activity;
    (4) Review, and, if warranted, investigate concerns involving the 
care and use of animals at the research facility resulting from public 
complaints received and from reports of noncompliance received from 
laboratory or research facility personnel or employees;
    (5) Make recommendations to the Institutional Official regarding any 
aspect of the research facility's animal program, facilities, or 
personnel training;
    (6) Review and approve, require modifications in (to secure 
approval), or withhold approval of those components of proposed 
activities related to the care and use of animals, as specified in 
paragraph (d) of this section;
    (7) Review and approve, require modifications in (to secure 
approval), or withhold approval of proposed significant changes 
regarding the care and use of animals in ongoing activities; and

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    (8) Be authorized to suspend an activity involving animals in 
accordance with the specifications set forth in paragraph (d)(6) of this 
section.
    (d) IACUC review of activities involving animals. (1) In order to 
approve proposed activities or proposed significant changes in ongoing 
activities, the IACUC shall conduct a review of those components of the 
activities related to the care and use of animals and determine that the 
proposed activities are in accordance with this subchapter unless 
acceptable justification for a departure is presented in writing; 
Provided, however, That field studies as defined in part 1 of this 
subchapter are exempt from this requirement. Further, the IACUC shall 
determine that the proposed activities or significant changes in ongoing 
activities meet the following requirements:
    (i) Procedures involving animals will avoid or minimize discomfort, 
distress, and pain to the animals;
    (ii) The principal investigator has considered alternatives to 
procedures that may cause more than momentary or slight pain or distress 
to the animals, and has provided a written narrative description of the 
methods and sources, e. g., the Animal Welfare Information Center, used 
to determine that alternatives were not available;
    (iii) The principal investigator has provided written assurance that 
the activities do not unnecessarily duplicate previous experiments;
    (iv) Procedures that may cause more than momentary or slight pain or 
distress to the animals will:
    (A) Be performed with appropriate sedatives, analgesics or 
anesthetics, unless withholding such agents is justified for scientific 
reasons, in writing, by the principal investigator and will continue for 
only the necessary period of time;
    (B) Involve, in their planning, consultation with the attending 
veterinarian or his or her designee;
    (C) Not include the use of paralytics without anesthesia;
    (v) Animals that would otherwise experience severe or chronic pain 
or distress that cannot be relieved will be painlessly euthanized at the 
end of the procedure or, if appropriate, during the procedure;
    (vi) The animals' living conditions will be appropriate for their 
species in accordance with part 3 of this subchapter, and contribute to 
their health and comfort. The housing, feeding, and nonmedical care of 
the animals will be directed by the attending veterinarian or other 
scientist trained and experienced in the proper care, handling, and use 
of the species being maintained or studied;
    (vii) Medical care for animals will be available and provided as 
necessary by a qualified veterinarian;
    (viii) Personnel conducting procedures on the species being 
maintained or studied will be appropriately qualified and trained in 
those procedures;
    (ix) Activities that involve surgery include appropriate provision 
for pre-operative and post-operative care of the animals in accordance 
with established veterinary medical and nursing practices. All survival 
surgery will be performed using aseptic procedures, including surgical 
gloves, masks, sterile instruments, and aseptic techniques. Major 
operative procedures on non-rodents will be conducted only in facilities 
intended for that purpose which shall be operated and maintained under 
aseptic conditions. Non-major operative procedures and all surgery on 
rodents do not require a dedicated facility, but must be performed using 
aseptic procedures. Operative procedures conducted at field sites need 
not be performed in dedicated facilities, but must be performed using 
aseptic procedures;
    (x) No animal will be used in more than one major operative 
procedure from which it is allowed to recover, unless:
    (A) Justified for scientific reasons by the principal investigator, 
in writing;
    (B) Required as routine veterinary procedure or to protect the 
health or well-being of the animal as determined by the attending 
veterinarian; or
    (C) In other special circumstances as determined by the 
Administrator on an individual basis. Written requests and supporting 
data should be sent to the Animal and Plant Health Inspection Service, 
Animal Care, 4700 River Road, Unit 84, Riverdale, Maryland 20737-1234;
    (xi) Methods of euthanasia used must be in accordance with the 
definition of

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the term set forth in 9 CFR part 1, Sec. 1.1 of this subchapter, unless 
a deviation is justified for scientific reasons, in writing, by the 
investigator.
    (2) Prior to IACUC review, each member of the Committee shall be 
provided with a list of proposed activities to be reviewed. Written 
descriptions of all proposed activities that involve the care and use of 
animals shall be available to all IACUC members, and any member of the 
IACUC may obtain, upon request, full Committee review of those 
activities. If full Committee review is not requested, at least one 
member of the IACUC, designated by the chairman and qualified to conduct 
the review, shall review those activities, and shall have the authority 
to approve, require modifications in (to secure approval), or request 
full Committee review of any of those activities. If full Committee 
review is requested for a proposed activity, approval of that activity 
may be granted only after review, at a convened meeting of a quorum of 
the IACUC, and with the approval vote of a majority of the quorum 
present. No member may participate in the IACUC review or approval of an 
activity in which that member has a conflicting interest (e.g., is 
personally involved in the activity), except to provide information 
requested by the IACUC, nor may a member who has a conflicting interest 
contribute to the constitution of a quorum;
    (3) The IACUC may invite consultants to assist in the review of 
complex issues arising out of its review of proposed activities. 
Consultants may not approve or withhold approval of an activity, and may 
not vote with the IACUC unless they are also members of the IACUC;
    (4) The IACUC shall notify principal investigators and the research 
facility in writing of its decision to approve or withhold approval of 
those activities related to the care and use of animals, or of 
modifications required to secure IACUC approval. If the IACUC decides to 
withhold approval of an activity, it shall include in its written 
notification a statement of the reasons for its decision and give the 
principal investigator an opportunity to respond in person or in 
writing. The IACUC may reconsider its decision, with documentation in 
Committee minutes, in light of the information provided by the principal 
investigator;
    (5) The IACUC shall conduct continuing reviews of activities covered 
by this subchapter at appropriate intervals as determined by the IACUC, 
but not less than annually;
    (6) The IACUC may suspend an activity that it previously approved if 
it determines that the activity is not being conducted in accordance 
with the description of that activity provided by the principal 
investigator and approved by the Committee. The IACUC may suspend an 
activity only after review of the matter at a convened meeting of a 
quorum of the IACUC and with the suspension vote of a majority of the 
quorum present;
    (7) If the IACUC suspends an activity involving animals, the 
Institutional Official, in consultation with the IACUC, shall review the 
reasons for suspension, take appropriate corrective action, and report 
that action with a full explanation to APHIS and any Federal agency 
funding that activity; and
    (8) Proposed activities and proposed significant changes in ongoing 
activities that have been approved by the IACUC may be subject to 
further appropriate review and approval by officials of the research 
facility. However, those officials may not approve an activity involving 
the care and use of animals if it has not been approved by the IACUC.
    (e) A proposal to conduct an activity involving animals, or to make 
a significant change in an ongoing activity involving animals, must 
contain the following:
    (1) Identification of the species and the approximate number of 
animals to be used;
    (2) A rationale for involving animals, and for the appropriateness 
of the species and numbers of animals to be used;
    (3) A complete description of the proposed use of the animals;
    (4) A description of procedures designed to assure that discomfort 
and pain to animals will be limited to that which is unavoidable for the 
conduct of scientifically valuable research, including provision for the 
use of analgesic, anesthetic, and tranquilizing drugs

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where indicated and appropriate to minimize discomfort and pain to 
animals; and
    (5) A description of any euthanasia method to be used.

[54 FR 36147, August 31, 1989, as amended by 59 FR 67611, Dec. 30, 1994; 
63 FR 62926, Nov. 10, 1998]