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PHS Policy on
Humane Care and Use of Lab Animals


                         Public Health
                         Service Policy on
                         Humane Care and
                         Use of Laboratory
                         Animals







          U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
          Public Health Service
          National Institutes of Health


Revised as of September 1986


                HEALTH RESEARCH EXTENSION ACT OF 1985

                PUBLIC LAW 99-158, November 20, 1985

"ANIMALS IN RESEARCH"


   "Sec. 495. (a) The Secretary, acting through the Director of
NIH, shall establish guidelines for the following:

   "(1) The proper care of animals to be used in biomedical and
behavioral research.
   "(2) The proper treatment of animals while being used in such
research.  Guidelines under this paragraph shall require-

       "(A) the appropriate use of tranquilizers, analgesics,
anesthetics, paralytics, and euthanasia for animals in such
research; and
       "(B) appropriate presurgical and post-surgical veterinary
medical and nursing care for animals in such research.

    Such guidelines shall not be construed to prescribe methods
of research.

   "(3) The organization and operation of animal care committees
in accordance with subsection (b).

      "(b)(1) Guidelines of the Secretary under subsection (a)(3)
shall require animal care committees at each entity which
conducts biomedical and behavioral research with funds provided
under this Act (including the National Institutes of Health and
the national research institutes) to assure compliance with the
guidelines established under subsection (a).

   "(2) Each animal care conunittee shall be appointed by the
chief executive officer of the entity for which the committee is
established, shall be composed of not fewer than three members,
and shall include at least one individual who has no association
with such entity and at least one doctor of veterinary medicine.

   "(3) Each animal care committee of a research entity shall-

      "(A) review the care and treatment of animals in all animal
study areas and facilities of the research entity at least
semiannually to evaluate compliance with applicable guidelines
established under subsection (a) for appropriate animal care and
treatment;
      "(B) keep appropriate records of reviews conducted under
sub-paragraph (A); and
      "(C) for each review conducted under subparagraph (A), file
with the Director of NIH at least annually (i) a certification
that the review has been conducted, and (ii) reports of any
violations of guidelines established under subsection (a) or
assurances required under paragraph (1) which were observed in
such review and which have continued after notice by the
committee to the research entity involved of the violations.

Reports filed under subparagraph (C) shall include any minority
views filed by  members of the committee.

      "(c) The Director of NIH shall require each applicant for a
grant, contract, or cooperative agreement involving research on
animals which is administered by the National Institutes of
Health or any national research institute to include in its
application or contract proposal, submitted after the expiration
of the twelve-month period beginning on the date of enactment
this section-
    "(1) assurances satisfactory to the Director of NIH that-
        "(A) the applicant meets the requirements of the
guidelines established under paragraphs (1) and (2) of subsection
(a) and has an animal care committee which meets the requirements
of subsection (b); and
        "(B) scientists, animal technicians, and other personnel
involved with animal care, treatment, and use by the appheant
have available to them instruction or training in the humane
practice of animal maintenance and experimentation, and the
concept, availability, and use of research or testing methods
that li@t the use of animals or limit animal distress; and
     "(2) a statement of the reasons for the use of animals in
the research to be conducted with funds provided under such grant
or contract.

Notwithstanding subsection (a)(2) of section 553 of title 5,
United States Code, regulations under this subsection shall be
promulgated in accordance with the notice and comment
requirements of such section.

    "(d) If the Director of NIH determines that-
       "(1) the conditions of animal care, treatment, or use in
an entity which is receiving a grant, contract, or cooperative
agreement involving research on animals under this title do not
meet applicable guidelines established under subsection (a);
       "(2) the entity has been notified by the Director of NIH
of such determination and has been given a reasonable opportunity
to take corrective action; and
       "(3) no action has been taken by the entity to correct
such conditions; the Director of NIH shall suspend or revoke such
grant or contract under such conditions as the Director
determines appropriate.
      "(e) No guideline or regulation promulgated under
subsection (a) or (c) may require a research entity to disclose
publicly trade secrets or commercial or financial information
which is privileged or confidential."




                          LOCATION OF DOCUMENTS



DOCUMENT                                                     
PAGE

Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . .i

Table of Contents for the Public Health Service (PHS) Policy
  on Humane Care and Use of Laboratory Animals . . . . . . . .iii

Public Health Service (PHS) Policy on Humane Care
  and Use of Laboratory Animals. . . . . . . . . . . . . . . . .1

Instructions for Implementation of the Amended Public
  Health Service (PHS) Policy on Humane Care and Use
  of Laboratory Animals. . . . . . . . . . . . . . . . . . . . 18

Sample Animal Welfare Assurance. . . . . . . . . . . . . . . . 22

U.S. Government Principles for the Utilization and
   Care of Vertebrate Animals Used in Testing,
   Research, and Training. . . . . . . . . . . . . . . . . . . 33




                              SUMMARY

This amended version of the Public Health Service Policy on
Humane Care and Use of Laboratory Animals by Awardee
Institutions, now entitled Public Health Service (PHS) Policy on
Humane Care and Use of Laboratory Animals, incorporates the
changes in the Public Health Service Act (PHS Act) mandated by
the Health Research Extension Act of l985, Public Law 99-l58. The
amended Policy also contains various minor editorial changes,
including both technical and clarifying amendments to the
original Policy.  All applications and proposals for award, which
are either submitted to the PHS on or after November 1, 1986, or
being conducted on or after July 1, 1987, must meet the
requirements of the PHS Policy as amended.  Institutions which
currently have an approved or provisionally-acceptable Animal
Welfare Assurance on file with the Office for Protection from
Research Risks (OPRR) must submit to OPRR by July 1, 1987, a
document in the form of an appendix or amendment which states the
changes that the institution has made to conform to the amended
Public Health Service Policy.

The most significant changes required by the Health Research
Extension Act are:

      The Policy will now apply to research that the Public
Health Service (PHS) conducts intramurally.

      The Institutional Animal Care and Use Committee (IACUC)
will be appointed by the Chief Executive Officer of the
Institution.  This change is required by Section 495(b)(2) of the
PHS Act.

      The Policy now requires that the program description of
the Assurance include an explanation of the training or
instruction available to scientists, animal technicians, and
other personnel involved in animal care, treatment, or use.  The
training or instruction must include information on the humane
practice of  animal care and use and the concept, availability,
and use of research or testing methods that minimize the number
of animals required to obtain valid results and minimize animal
distress.  This change is mandated by Section 495(c)(1)(B) of the
PHS Act.

      The IACUC now must reevaluate and prepare reports on all
of the institution's programs and facilities (including satellite
facilities) for activities involving animals at least twice,
instead of once, each year.  This change is in accordance with
Section  495(b)(3)(A) of the PHS Act.

      The IACUC, through the Institutional Official, shall be
responsible for reporting requirements.  This language change
reflects the language used in Section 495(b)(3) of the PHS Act.

      Minority views filed by members of the IACUC must be
included in reports filed under IV.F. of this Policy.  The last
sentence of Section 495(b)(3) of the PHS Act requires this
change.

            PUBLIC HEALTH SERVICE (PHS) POLICY ON HUMANE CARE
                     AND USE OF LABORATORY ANIMALS

                           Table of Contents


 I.  Introduction. . . . . . . . . . . . . . . . . . . . . . . 1

II.  Applicability and Effective Dates . . . . . . . . . . . . 1

III. Definitions . . . . . . . . . . . . . . . . . . . . . . . 2

IV.  Implementation by Institutions. . . . . . . . . . . . . . 3

     A.  Animal Welfare Assurance. . . . . . . . . . . . . . . 3

       1.  Institutional Program for Animal Care and Use . . . 4
       2.  Institutional Status. . . . . . . . . . . . . . . . 5
       3.  Institutional Animal Care and Use Committee (IACUC) 6

     B.  Functions of the Institutional Animal Care and
          Use Committee (IACUC). . . . . . . . . . . . . . . . 7

     C.  Review of PHS-Conducted or Supported Research
          Projects . . . . . . . . . . . . . . . . . . . . . . 9

     D.  Information Required in Applications and Proposals
          for Awards Submitted to PHS. . . . . . . . . . . . .12

       1.  All Institutions. . . . . . . . . . . . . . . . . .12
       2.  Institutions That Have an Approved or
           Provisionally-Acceptable Assurance. . . . . . . . .13

       3.  Institutions That Do Not Have an Approved or
           Provisionally-Acceptable Assurance. . . . . . . . .13

     E.  Recordkeeping Requirements. . . . . . . . . . . . . .14

     F.  Reporting Requirements. . . . . . . . . . . . . . . .15

 V.  Implementation by PHS . . . . . . . . . . . . . . . . . .16

     A.  Responsibilities of the Office for Protection
         from Research Risks (OPRR). . . . . . . . . . . . . .16

     B.  Responsibilities of PHS Awarding Units. . . . . . . .16

     C.  Conduct of Special Reviews/Site Visits. . . . . . . .17

     D.  Waiver. . . . . . . . . . . . . . . . . . . . . . . .17

                PUBLIC HEALTH SERVICE (PHS) POLICY ON HUMANE CARE
                        AND USE OF LABORATORY ANIMALS


  I.   Introduction

     It is the Policy of the Public Health Service (PHS) to
require institutions to establish and maintain proper measures to
ensure the appropriate care and use of all animals involved in
research, research training, and biological testing activities
(hereinafter referred to as activities) conducted or supported by
the PHS.  The PHS endorses the "U.S. Government Principles for
the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training" developed by the Interagency Research
Animal Committee (IRAC).  This Policy is intended to implement
and supplement those Principles.

 II.   Applicability and Effective Dates

     This Policy is applicable to all PHS-conducted or supported
activities involving animals, whether the activities are
performed at a PHS agency, an awardee institution, or any other
institution and conducted in the United States, the Commonwealth
of Puerto Rico, or any territory or possession of the United
States.  The requirements of this Policy are effective for
applications and proposals for PHS research and research training
awards involving animals that are submitted for PHS consideration
on or after November 1, 1986, and for all PHS-conducted or
supported research and research training activities involving
animals that are being conducted on or after July 1, 1987. 
Institutions in foreign countries receiving PHS support for
activities involving animals shall comply with this Policy, or
provide evidence to the PHS that acceptable standards for the
humane care and use of the animals in PHS-conducted or supported
activities will be met.  No PHS support for an activity involving
animals will be provided to an individual unless that individual
is affiliated with or sponsored by an institution which can and
does assume responsibility for compliance with this Policy,
unless the individual makes other arrangements with the PHS. 
This Policy does not affect applicable state or local laws or
regulations which impose more stringent standards for the care
and use of laboratory animals.  All institutions are required to
comply, as applicable, with the Animal Welfare Act, and other
Federal statutes and regulations relating to animals.

III.   Definitions

   A.  Animal
       Any live, vertebrate animal used or intended for use in
research, research training, experimentation, or biological
testing or for related purposes.

   B.  Animal Facility
       Any and all buildings, rooms, areas, enclosures, or
vehicles, including satellite facilities, used for animal
confinement, transport, maintenance, breeding, or experiments
inclusive of surgical manipulation.  A satellite facility is any
containment outside of a core facility or centrally designated or
managed area in which animals are housed for more than 24 hours.

   C.  Animal Welfare Act

       Public Law 89-544, l966, as amended, (P.L. 9l-579, P.L.
94-279 and P.L. 99-l98) 7 U.S.C. 2l3l et. seq.  Implementing
regulations are published in the Code of Federal Regulations
(CFR), Title 9, Subchapter A, Parts l, 2, 3, and 4, and are
administered by the U.S. Department of Agriculture.

   D.  Animal Welfare Assurance or Assurance

       The documentation from an institution assuring
institutional compliance with this Policy.

   E.  Guide

       Guide for the Care and Use of Laboratory Animals (Guide),
HHS, NIH Pub. No. 85-23, l985 edition or succeeding revised
editions.

   F.  Institution

       Any public or private organization, business, or agency
(including components of Federal, state, and local governments).

   G.  Institutional Official

       An individual who signs, and has the authority to sign the
institution's Assurance, making a commitment on behalf of the
institution that the requirements of this Policy will be met.

   H.  Public Health Service

       The Public Health Service or PHS includes the Alcohol,
Drug Abuse, and Mental Health Administration; the Centers for
Disease Control; the Food and Drug Administration; the Health
Resources and Services Administration; the National Institutes of
Health; and the Office of the Assistant Secretary for Health,
Department of Health and Human Services.

   I.  Quorum

       A majority of the members of the Institutional Animal Care
and Use Committee (IACUC).

IV.   Implementation by Institutions

   A.  Animal Welfare Assurance

       No activity involving animals may be conducted or
supported by the PHS until the institution conducting the
activity has provided a written Assurance acceptable to the PHS,
setting forth compliance with this Policy.  Assurances shall be
submitted to the Office for Protection from Research Risks
(OPRR), Office of the Director, National Institutes of Health,
9000 Rockville Pike, Building 3l, Room 4B09, Bethesda, Maryland 
20892.  The Assurance shall be typed on the institution's
letterhead and signed by the Institutional Official.  OPRR will
provide the institution with necessary instructions and an
example of an acceptable Assurance.  All Assurances submitted to
the PHS in accordance with this Policy will be evaluated by OPRR
to determine the adequacy of the institution's proposed program
for the care and use of animals in PHS-conducted or supported
activities.  On the basis of this evaluation OPRR may approve or
disapprove the Assurance, or negotiate an approvable Assurance
with the institution.  Approval of an Assurance will be for a
specified period of time (no longer than five years) after which
time the institution must submit a new Assurance to OPRR.  OPRR
may limit the period during which any particular approved
Assurance shall remain effective or otherwise condition,
restrict, or withdraw approval.  Without an applicable
PHS-approved or provisionally-acceptable Assurance no
PHS-conducted or supported activity involving animals at the
institution will be permitted to continue.

  1.  Institutional Program for Animal Care and Use

     The Assurance shall fully describe the institution's program
for the care and use of animals in PHS-conducted or supported
activities.  The PHS requires institutions to use the Guide for
the Care and Use of Laboratory Animals (Guide) as a basis for
developing and implementing an institutional program for
activities involving animals.  The program description must
include the following:

   a. a list of every branch and major component of the
institution, as well as a list of every branch and major
component of any other institution, which is to be included under
the Assurance;

   b.  the lines of authority and responsibility for
administering the program and ensuring compliance with this
Policy;

   c.  the qualifications, authority, and responsibility of the
veterinarian(s) who will participate in the program and the
percent of time each will contribute to the program;

   d.  the membership list of the Institutional Animal Care and
Use Committee(s)(1) (IACUC) established in accordance with the
requirements set forth in IV.A.3. of this Policy;

   e.  the procedures which the IACUC will follow to fulfill the
requirements set forth in this Policy;

   f.  the health program for personnel who work in laboratory
animal facilities or have frequent contact with animals;

   g.  a synopsis of training or instruction in the humane prac
tice of animal care and use, as well as training or instruction
in research or testing methods that minimize the number of
animals required to obtain valid results and minimize animal
distress, offered to scientists, animal technicians, and other
personnel involved in animal care, treatment, or use;

   h.  the gross square footage of each animal facility
(including satellite facilities), the species housed therein and
the average daily inventory, by species, of animals in each
facility; and

   i.  any other pertinent information requested by OPRR.

  2.  Institutional Status

     Each institution must assure that its program and facilities
are in one of the following categories:

    Category 1 - Accredited by the American Association for
Accreditation of Laboratory Animal Care (AAALAC).  All of the
institution's programs and facilities (including satellite
facilities) for activities involving animals have been evaluated
and accredited by AAALAC, or another accrediting body recognized
by PHS(2).  All of the institution's programs and facilities
(including satellite facilities) for activities involving animals
have also been evaluated by the IACUC and will be reevaluated by
the IACUC at least once every six months, in accordance with
IV.B.1. and 2. of this Policy, and reports prepared in accordance
with IV.B.3. of this Policy.

     (Footnote 1:  The name Institutional Animal Care and Use
Committee (IACUC) as used in this Policy is intended as a generic
term for a committee whose function is to ensure that the care
and use of animals in PHS-conducted or supported activities is
appropriate and humane in accordance with this Policy.  However,
each institution may identify the committee by whatever name it
chooses).
     (Footnote 2: As of the issuance date of this Policy, the
only accrediting body recognized by PHS is the American
Association for Accreditation of Laboratory Animal Care
(AAALAC)).

    Category 2 - Evaluated by the Institution.  All of the
institution's programs and facilities (including satellite
facilities) for activities involving animals have been evaluated
by the IACUC and will be reevaluated by the IACUC at least once
every six months, in accordance with IV.B.1. and 2. of this
Policy, and reports prepared in accordance with IV.B.3. of this
Policy.  The initial report of the IACUC evaluation shall be
submitted to OPRR with the Assurance.

  3.  Institutional Animal Care and Use Committee (IACUC)

   a.  The Chief Executive Officer shall appoint an Institutional
Animal Care and Use Committee (IACUC), qualified through the
experience and expertise of its members to oversee the
institution's animal program, facilities, and procedures.

   b.  The Assurance must include the names, position titles, and
credentials of the IACUC chairperson and the members.  The
committee shall consist of not less than five members, and shall
include at least:

   (l)  one Doctor of Veterinary Medicine, with training or
experience in laboratory animal science and medicine, who has
direct or delegated program responsibility for activities
involving animals at the institution;

   (2)  one practicing scientist experienced in research
involving animals;

   (3)  one member whose primary concerns are in a nonscientific
area (for example, ethicist, lawyer, member of the clergy); and

   (4)  one individual who is not affiliated with the institution
in any way other than as a member of the IACUC, and is not a
member of the immediate family of a person who is affiliated with
the institution.

   c.  An individual who meets the requirements of more than one
of the categories detailed in IV.A.3.b.(l)-(4) of this Policy may
fulfill more than one requirement.  However, no committee may
consist of less than five members.

  B.  Functions of the Institutional Animal Care and Use
Committee (IACUC)

     As an agent of the institution, the IACUC shall with respect
to PHS-conducted or supported activities:

   l.  review at least once every six months the institution's
program for humane care and use of animals, using the Guide as a
basis for evaluation;

   2.  inspect at least once every six months all of the
institution's animal facilities (including satellite facilities)
using the Guide as a basis for evaluation;

   3.  prepare reports of the IACUC evaluations conducted as
required by IV.B.1. and 2. of this Policy, and submit the reports
to the Institutional Official(3).  (NOTE: the reports shall be
updated at least once every six months upon completion of the
required semiannual evaluations and shall be maintained by the
institution and made available to OPRR upon request.  The reports
must contain a description of the nature and extent of the
institution's adherence to the Guide and this Policy and must
identify specifically any departures from the provisions of the
Guide and this Policy, and must state the reasons for each
departure.  The reports must distinguish significant deficiencies
from minor deficiencies.  A significant deficiency is one which,
consistent with this Policy, 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 for correcting each deficiency.  If
some or all of the institution's facilities are accredited by
AAALAC or another accrediting body recognized by PHS, the report
should identify those facilities as such.);

   4.  review concerns involving the care and use of animals at
the institution;

   5.  make recommendations to the Institutional Official
regarding any aspect of the institution's animal program,
facilities, or personnel training;

   6.  review and approve, require modifications in (to secure
approval) or withhold approval of those components of
PHS-conducted or supported activities related to the care and use
of animals as specified in IV.C. of this Policy;

   7.  review and approve, require modifications in (to secure
approval), or withhold approval of proposed significant changes
regarding the use of animals in ongoing activities; and

   8.  be authorized to suspend an activity involving animals in
accordance with the specifications set forth in IV.C.6 of this
Policy.

     (Footnote 3:  The Institutional Animal Care and Use
Committee (IACUC) may, at its discretion, determine the best
means of conducting an evaluation of the institution's programs
and facilities.  the IACUC may invite ad hoc consultants to
assist in conducting the evaluation.  However, the IACUC remains
responsible for the evaluation and report).

  C.  Review of PHS-Conducted or Supported Research Projects

    1.  In order to approve proposed research projects or
proposed significant changes in ongoing research projects, the
IACUC  shall conduct a review of those components related to the
care and use of animals and determine that the proposed research
projects are in accordance with this Policy.  In making this
determination, the IACUC shall confirm that the research project
will be conducted in accordance with the Animal Welfare Act
insofar as it applies to the research project, and that the
research project is consistent with the Guide unless acceptable
justification for a departure is presented.  Further, the IACUC
shall determine that the research project conforms with the
institution's Assurance and meets the following requirements:

    a.  Procedures with animals will avoid or minimize
discomfort, distress, and pain to the animals, consistent with
sound research design.

    b.  Procedures that may cause more than momentary or slight
pain or distress to the animals will be performed with
appropriate sedation, analgesia, or anesthesia, unless the
procedure is justified for scientific reasons in writing by the
investigator.

    c.  Animals that would otherwise experience severe or chronic
pain or distress that cannot be relieved will be painlessly
sacrificed at the end of the procedure or, if appropriate, during
the procedure.

    d.  The living conditions of animals will be appropriate for
their species and contribute to their health and comfort.  The
housing, feeding, and nonmedical care of the animals will be
directed by a veterinarian or other scientist trained and
experienced in the proper care, handling, and use of the species
being maintained or studied.

   e.  Medical care for animals will be available and provided as
necessary by a qualified veterinarian.

   f.  Personnel conducting procedures on the species being
maintained or studied will be appropriately qualified and trained
in those procedures.

   g.  Methods of euthanasia used will be consistent with the
recommendations of the American Veterinary Medical Association
(AVMA) Panel on Euthanasia(4), unless a deviation is justified
for scientific reasons in writing by the investigator.

     (Footnote 4:  Journal of the American Veterinary Medical
Association (JAVMA), 1986, Vol. 188, No. 3, pp. 252-268, or
succeeding revised editions).

  2.  Prior to the review, each IACUC member shall be provided
with a list of proposed research projects to be reviewed. 
Written descriptions of research projects 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 research projects.  If full committee review is
not requested, at least one member of the IACUC, designated by
the chairperson and qualified to conduct the review, shall review
those research projects and have the authority to approve,
require modifications in (to secure approval) or request full
committee review of those research projects.  If full committee
review is requested, approval of those research projects 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 a research project in which the member has a
conflicting interest (e.g., is personally involved in the
project) 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.  Consultants may not approve or withhold approval
of an activity or vote with the IACUC unless they are also
members of the IACUC.

   4.  The IACUC shall notify investigators and the institution
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 investigator an opportunity to respond in
person or in writing.

   5.  The IACUC shall conduct continuing review of activities
covered by this Policy at appropriate intervals as determined by
the IACUC, but not less than once every three years.

   6.  The IACUC may suspend an activity that it previously
approved if it determines that the activity is not being
conducted in accordance with applicable provisions of the Animal
Welfare Act, the Guide, the institution's Assurance, or
IV.C.l.a.-g. of this Policy.  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 OPRR.

   8.  Applications and proposals that have been approved by the
IACUC may be subject to further appropriate review and approval
by officials of the institution.  However, those officials may
not approve an activity involving the care and use of animals if
it has not been approved by the IACUC.

   D.  Information Required in Applications and Proposals for
Awards Submitted to PHS

   1.  All Institutions

     Applications and proposals (competing and non-competing) for
awards submitted to PHS that involve the care and use of animals
shall contain the following information:

   a.  identification of the species and approximate number of
animals to be used;

   b.  rationale for involving animals, and for the
appropriateness of the species and numbers to be used;

   c.  a complete description of the proposed use of the animals;

   d.  a description of procedures designed to assure that
discomfort and injury 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; and

   e.  a description of any euthanasia method to be used.

     Non-competing applications and contract proposals for other
than full and open competitions need not repeat the information
required by IV.D.1.a.-e. if the information was complete in the
last competing application or proposal and there are no
significant changes to that information.  However, the
application or proposal must contain a statement to that effect. 
If there are significant changes in the information, then the
application or proposal must specifically identify them and state
the reasons for the changes.

   2.  Institutions That Have an Approved or Provisionally
Acceptable Assurance

     Applications or proposals (competing and non-competing)
covered by this Policy from institutions which have an approved
or provisionally acceptable Assurance on file with OPRR shall
include verification of approval (including the date of the most
recent approval) by the IACUC of those components related to the
care and use of animals.  With the authorization of PHS, such
verification may be filed at a time not to exceed 60 days after
submission of applications or proposals(5).  If verification of
IACUC approval is submitted subsequent to the submission of the
application or proposal, the verification shall state the
modifications, if any, required by the IACUC.  The verification
shall be signed by an individual authorized by the institution,
but need not be signed by the Institutional Official.

  3.  Institutions That Do Not Have an Approved or Provisionally
Acceptable Assurance

     Applications and proposals covered by this Policy from
institutions that do not have an approved or provisionally
acceptable Assurance on file with OPRR shall contain a
declaration that the institution will establish an IACUC and
submit an Assurance upon request by OPRR.  After OPRR has
requested the Assurance, the institution shall prepare an
Assurance in accordance with IV.A. of this Policy and the
established IACUC shall review those components of the
application or proposal as required by IV.C. of this Policy.  The
institution shall then submit to OPRR the Assurance and
verification of IACUC approval.  The verification shall state the
modifications, if any, required by the IACUC.  The verification
shall be signed by an individual authorized by the institution,
but need not be signed by the Institutional Official who signed
the Assurance.

  E.  Recordkeeping Requirements

   1.  The awardee institution shall maintain:

     a.  an Assurance which has been either approved or deemed
provisionally acceptable by the PHS;

    b.  minutes of IACUC meetings, including records of
attendance, activities of the committee, and committee
deliberations;

    c.  records of applications, proposals, and proposed
significant changes in the care and use of animals and whether
IACUC approval was given or withheld;

     (Footnote 5:  Until further notice, PHS hereby authorizes
all institutions with approved or provisionally-acceptable
Assurances to file verification of IACUC approval either along
with the competing appliication or proposal or within 60 days of
submission of the application or proposal.  From time to time PHS
will reevaluate this blanket authorization.  Any decision to
withdraw this authorization will take place only after ample
opportunity is provided for comment by the public).



    d.  records of semiannual IACUC reports and recommendations
(including minority views) as forwarded to the Institutional
Official; and

    e.  records of accrediting body determinations.

  2.  All records shall be maintained for at least three years;
records that relate directly to applications, proposals, and
proposed significant changes in ongoing activities reviewed and
approved by the IACUC shall be maintained for the duration of the
activity and for an additional three years after completion of
the activity.  All records shall be accessible for inspection and
copying by authorized OPRR or other PHS representatives at
reasonable times and in a reasonable manner.


   F.  Reporting Requirements

   1.  At least once every 12 months, the IACUC, through the 
Institutional Official, shall report in writing to OPRR:

    a.  any change in the institution's program or facilities
which would place the institution in a different category than
specified in its Assurance (see IV.A.2. of this Policy);

    b.  any change in the description of the institution's
program for animal care and use as required by IV.A.1.a.-i. of
this Policy;

    c.  any changes in the IACUC membership; and

    d.  notice of the dates that the IACUC conducted its
semiannual evaluations of the institution's program and
facilities and submitted the evaluations to the Institutional
Official.

  2.  At least once every 12 months, the IACUC, at an institution
which has no changes to report as specified in IV.F.l. a.-c. of
this Policy, shall submit a letter, through the Institutional
Official, to OPRR stating that there are no changes and informing
OPRR of the dates of the required IACUC evaluations and
submissions to the Institutional Official.

  3.  The IACUC, through the Institutional Official, shall
promptly provide OPRR with a full explanation of the
circumstances and actions taken with respect to:

   a.  any serious or continuing noncompliance with this Policy;

   b.  any serious deviation from the provisions of the Guide; or

   c.  any suspension of an activity by the IACUC.

  4.  Reports filed under IV.F. of this Policy shall include any
minority views filed by members of the IACUC.

V.   Implementation by PHS

  A.  Responsibilities of the Office for Protection from Research
Risks (OPRR) OPRR is responsible for the general administration
and coordination of this Policy and will:

   1.  request and negotiate, approve or disapprove, and, as
necessary, restrict or withdraw approval of Assurances;

   2.  distribute to executive secretaries of initial review and
technical evaluation groups, and to PHS awarding units, lists of
institutions that have an approved Assurance;

   3.  advise awarding units and awardee institutions concerning
the implementation of this Policy;

   4.  evaluate allegations of noncompliance with this Policy;

   5.  have the authority to review and approve or disapprove
waivers to this Policy (see V.D. of this Policy); and

   6.  conduct site visits to selected institutions.

   B.  Responsibilities of PHS Awarding Units

      PHS awarding units may not make an award for an activity
involving animals unless the prospective awardee institution and
all other participating institutions have approved or
provisionally acceptable Assurances on file with OPRR, and the
awardee institution has provided verification of approval by the
IACUC of those components of the application or proposal related
to the care and use of animals.  If any one of these institutions
does not have an approved or provisionally-acceptable Assurance
on file with OPRR, the awarding unit will ask OPRR to negotiate
an Assurance with the institution(s) before an award is made.  No
award shall be made until all required Assurances have been
submitted by the institution(s), been approved or designated
provisionally acceptable by OPRR, and the institution(s) have
provided verification of approval by the IACUC of those
components of the application or proposal related to the care and
use of animals.

   C.  Conduct of Special Reviews/Site Visits

      Each awardee institution is subject to review at any time
by PHS staff and advisors, which may include a site visit, in
order to assess the adequacy or accuracy of the institution's
compliance or expressed compliance with this Policy.

   D.  Waiver

      Institutions may request a waiver of a provision or
provisions of this Policy by submitting a request to OPRR.  No
waiver will be granted unless sufficient justification is
provided and the waiver is approved in writing by OPRR.




                    INSTRUCTIONS FOR IMPLEMENTATION OF THE
                  AMENDED PUBLIC HEALTH SERVICE (PHS) POLICY
                 ON HUMANE CARE AND USE OF LABORATORY ANIMALS

     The Public Health Service (PHS) Policy on Humane Care and
Use of Laboratory Animals, incorporating the changes mandated by
the Health Research Extension Act of 1985, will become effective
November 1, 1986.  Institutions which currently have an approved
or provisionally-acceptable Animal Welfare Assurance on file with
the Office for Protection from Research Risks (OPRR) must submit
to OPRR by July 1, 1987, a document in the form of an appendix 
or amendment which states the changes that the institution has
made in order to conform to the amended PHS Policy.  These
institutions are to begin implementing this Policy as soon as
possible and are expected to begin operating under the amended
Policy no later than November 1, 1986.

     All applications and proposals for award which are either
submitted to the PHS on or after November 1, 1986, or being
conducted on or after July 1, 1987, must meet the requirements of
the PHS Policy as amended.  Section IV.D. of the Policy requires
all applications and proposals to contain specific information
regarding the proposed use of laboratory animals.  Applications
and proposals submitted to PHS that do not contain the
information required in Section IV.D. of this Policy will be
considered considered incomplete and may be deferred for a later
review.  (The information required by Section IV.D.1. of this
Policy should appear in the appropriate component of each
application or proposal, for example, Section 2.F. of the PHS
Grant Application Form 398.)



        Institutions That Have an Approved or Provisionally
                          Acceptable Assurance

     Applications and proposals for award (competing and
non-competing) submitted to the PHS must contain verification
that the Institutional Animal Care and Use Committee (IACUC) has
approved those components of the application or proposal related
to the care and use of laboratory animals.  PHS prefers that
verification of IACUC approval be submitted along with the
application or proposal, however, it may be submitted within 60
days of submission of the application or proposal.  If
verification of IACUC approval is submitted subsequent to the
submission of the application or proposal, the verification must
state any modifications required by the IACUC.

     In the near future, PHS will institute a standardized method
for institutional submission of IACUC approval.  In the interim,
verification of IACUC approval must be submitted via a letter
from the institution to the PHS.  The letter must be signed by
either the Institutional Official who signed the institution's
Animal Welfare Assurance or by another individual authorized by
the institution to provide verification of IACUC approval.

     The following example may be used in preparing such letters
of verification:

                EXAMPLE OF ACCEPTABLE VERIFICATION LETTER

                                           Date


Division of Research Grants*
National Institutes of Health
5333 Westbard Avenue
Westwood Building, Room 240
Bethesda, MD  20205

Dear Sir:

The following application submitted to the Public Health
Service was reviewed and approved by this Institution's Animal
Care and Use Committee on (insert date of approval).

Title of Application:
Name of Principal Investigator:
Name of Institution:

This institution has an Animal Welfare Assurance on file with the
Office for Protection from Research Risks.  The Assurance number
is                .  (Insert old Assurance number until a new
Assurance number is assigned.)

As a condition of approval, this Institution's Animal Care and
Use Committee (IACUC) required the following modifications to the
above-referenced referenced application:**

                                   (Signature)
                                   (Title)


* This address should be used for submission with grant
applications.  If verification is submitted subsequent to the
submission of the application, it should be addressed to the
Executive Secretary of the initial review group designated on the
card returned to the institution acknowledging receipt of the
application.  For noncompeting grant applications, verification
should be addressed to the appropriate Program Administrator
Grants Management Officer.  For contract proposals,
verification should be addressed to the Contract Officer.

** This information is required when the modifications are not
reflected in the grant application or contract proposal.


                 Institutions That Do Not Have an Approved or
                      Provisionally Acceptable Assurance

Institutions that do not have an approved or provisionally
acceptable Animal Welfare Assurance on file with OPRR must
submit, with the application or proposal, a declaration that the
institution will establish an Institutional Animal Care and Use
Committee and submit an Assurance upon request by OPRR.  The
following letter is an example of an Acceptable Declaration
Letter:

                EXAMPLE OF AN ACCEPTABLE DECLARATION LETTER

                                           Date

Division of Research Grants*
National Institutes of Health
3333 Westbard Avenue
Westwood Building, Room 240
Bethesda, MD  20205

Dear Sir:

This institution does not have an Animal Welfare Assurance on
file with the Office for Protection from Research Risks (OPRR) to
cover the following application:

Title of Application:
Name of Principal Investigator:
Name of Institution:

This institution will establish an Institutional Animal Care and
Use Committee (IACUC), have the application reviewed by the IACUC
and submit an Animal Welfare Assurance, upon request, to OPRR.

                              (Signed by Institutional Official)
                              (Title)

* For contract proposals, this letter should be addressed to the
Contract Officer.

When appropriate, OPRR will request that the institution submit
an Assurance.  The Institutional Animal Care and Use Committee
(IACUC) must review those sections of the application or proposal
related to the care and use of animals and submit the Assurance
and verification of IACUC approval to OPRR.  The Example of an
Acceptable Verification Letter (see preceding page of this
document) may be followed in submitting verification of IACUC
approval.

NOTE:  After January 1, 1986, all sections of applications and
proposals related to the care and use of live vertebrate animals
must be reviewed and approved by an IACUC before PHS will award
funds for an activity involving animals.



                   SAMPLE ANIMAL WELFARE ASSURANCE

Background Information


A sample Animal Welfare Assurance has been prepared by the Office
for Protection from Research Risks to assist institutions in
developing an Assurance in accordance with the Public Health
Service (PHS) Policy on Humane Care and Use of Laboratory Animals
(see pps. 19-26 of this document).  This sample Assurance
includes all of the necessary elements for compliance with the
PHS Policy.  There are several areas in an Assurance which
require that the institution provide specific information
regarding procedures, policies, and the responsibilities and
qualifications of the personnel of the institution.  The Animal
Welfare Assurance will need to be tailored to meet the
administrative and research requirements for each institution. 
This sample Assurance document provides suggestions and examples
of the kind of information that is to be provided by the
institution in accordance with this PHS Policy.  The sample
refers to an Institutional Animal Care and Use Committee (IACUC),
a generic name for the institutional committee established in
accordance with the PHS Policy to fulfill the functions outlined
in the Policy.  In preparing its Assurance document each
institution should consistently use whatever name it has assigned
to that committee.  More than one IACUC may be established to
meet the needs of an institution.  The Assurance must identify
each IACUC established by the institution.

This sample is intended to aid your institution in developing an
Animal Welfare Assurance.  Please note that the text of the
sample Assurance contains regular type as well as italics.  The
italic print indicates where you should provide information
specific to your institution.  Close adherence to the format will
facilitate the review process.  Questions should be directed to
the Office for Protection from Research Risks, Policy and
Assurance Staff, National Institutes of Health, Building 3l, Room
4B09, Bethesda, Maryland, 20892, (30l) 496-7041.
                        INSTITUTIONAL LETTERHEAD

                          (Name of Institution)

           Assurance of Compliance with Public Health Service
                  (PHS) Policy on Humane Care and Use
                        of Laboratory Animals

(Name of Institution), hereinafter referred to as institution,
hereby gives assurance that it will comply with the Public Health
Service Policy on Humane Care and Use of Laboratory Animals,
hereinafter referred to as PHS Policy.

I.  Applicability

     This Assurance is applicable to all research, research
training, experimentation, and biological testing and related
activities, herein-after referred to as activities, involving
live, vertebrate animals supported by the Public Health Service
(PHS) and conducted at this institution, or at another
institution as a consequence of the sub-granting or
subcontracting of a PHS-conducted or supported activity by this
institution.  "Institution" includes the following branches and
major components of (name of institution) (list every branch and
major component covered by this Assurance).  (If applicable),
"Institution" also includes the following branches and major
components of (name(s) of any other institution(s) to be included
under this Assurance) (list every branch and major component of
other institution(s) to be covered by this Assurance).

II.  Institutional Policy

   A.  This institution will comply with all applicable
provisions of the Animal Welfare Act and other Federal statutes
and regulations relating to animals.

   B.  This institution is guided by the "U.S. Government
Principles for the Utilization and Care of Vertebrate Animals
Used in Testing, Research, and Training."

   C.  This institution acknowledges and accepts responsibility
for the care and use of animals involved in activities covered by
this Assurance.  As partial fulfillment of this responsibility
this institution will make a reasonable effort to ensure that all

individuals involved in the care and use of laboratory animals
understand their individual and collective responsibilities for
compliance with this Assurance as well as all otherapplicable
laws and regulations pertaining to animal care and use.

   D.  This institution has established and will maintain a
program for activities involving animals in accordance with the
Guide for the Care and Use of Laboratory Animals (Guide).

III.  Institutional Program for Animal Care and Use

   A.  The lines of authority and responsibility for
administering the program and ensuring compliance with this
Policy are:

       (Describe or diagram the organization of the
administration and staff, including the Institutional Animal Care
and Use Committee, the Institutional Official, and the
veterinarian.)

   B.  The qualifications, authority, and percent of time
contributed by veterinarian(s) who will participate in the
program are:

       (Indicate professional or academic degrees and the number
of years of pertinent training or experience in laboratory animal
medicine.  Describe the veterinarians' functions, percentage of
time contribution and responsibilities insofar as they relate to
implementation of this Policy and the recommendations in the
Guide for the Care and Use of Laboratory Animals.)

   C.  This institution has established an Institutional Animal
Care and Use Committee (IACUC), which is qualified through the
experience and expertise of its members to oversee the
institution's animal program, facilities, and procedures.  The
IACUC consists of at least five members, and its membership meets
the compositional requirements set forth in the PHS Policy at
IV.A.3.b.  Attached is a list of the names, position titles,
earned degrees and other credentials of the IACUC chairperson and
members.

   D.  The IACUC will:

     1.  Review at least once every six months the institution's
program for humane care and use of animals, using the Guide as a
basis for evaluation.

     2.  Inspect at least once every six months all of the
institution's animal facilities (including satellite facilities)
using the Guide as a basis for evaluation.

     3.  Prepare reports of the IACUC evaluations as set forth in
the  PHS Policy at IV.B.3. and submit the reports to (insert name
or title of the Institutional Official signing the Assurance).

     4.  Review concerns involving the care and use of animals at
the institution.

     5.  Make written recommendations to (insert name or title of
the Institutional Official signing the Assurance) regarding any
aspect of the institution's animal program, facilities, or 
personnel training.

     6.  Review and approve, require modifications in (to secure
approval) or withhold approval of those activities related to the
care and use of animals as set forth in the PHS Policy at IV.C.

     7.  Review and approve, require modifications in (to secure
approval) or withhold approval of proposed significant changes
regarding the use of animals in ongoing activities as set forth
in the PHS Policy at IV.C.

     8.  Notify investigators and the institution 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 as set forth in the PHS Policy
at IV.C.4.

     9.  Be authorized to suspend an activity involving animals
as set forth in the PHS Policy at IV.C.6.

   E.  The procedures which the IACUC will follow to fulfill the
requirements set forth in the PHS Policy at IV.B. are:

      (Describe how the IACUC will fulfill each of the functions
set forth in the PHS Policy at IV.B.  Include how often the IACUC
will meet, how often it will inspect facilities, and how the
inspections will take place.  Describe the procedures the IACUC
will follow to address any concerns, and how recommendations will
be developed and forwarded to the Institutional Official.  The
channels for receiving proposed activities, and for reporting the
results of IACUC review of applications and proposals should be
addressed.)

   F.  The individual(s) authorized by this institution to verify
IACUC approval of those sections of applications and proposals
related to the care and use of animals is (insert name of
individual).

   G.  The health program for personnel who work in laboratory
animal facilities or have frequent contact with animals is:

       (Describe the institution's occupational health program,
including the frequency of tuberculosis tests, if any,
requirements for medical examinations, etc.  The institution may
submit a memorandum or pamphlet (if one exists) which informs
animal care and use staff of institutional policies regarding
health screening or tests.)

   H.  The total gross number of square feet in each animal
facility (including each satellite facility), the species of
animals housed therein and the average daily inventory, by
species, of animals in each facility. (This information may be
provided in an attached chart.)

   I.  The training or instruction available to scientists,
animal technicians, and other personnel involved in animal care,
treatment, or use are:

      (Provide a synopsis of the training or instruction
available in the humane practice of animal care and use, as well
as training or instruction in research and testing methods that
minimize the number of animals required to obtain valid results
and minimize animal distress.)

IV.  Institutional Status

     As specified in the PHS Policy at IV.A.2., as Category 1,
all of this institution's programs and facilities (including
satellite facilities) for activities involving animals have been
evaluated and accredited by the American Association for
Accreditation of Laboratory Animal Care.  All of this
institution's programs and facilities (including satellite
facilities) for activities involving animals have also been
evaluated by the IACUC and will be reevaluated by the IACUC at
least once every six months.

                            - OR -

     As specified in the PHS Policy at IV.A.2, as Category 2, all
of this institution's programs and facilities (including
satellite facilities) for activities involving animals have been
evaluated by the IACUC and will be reevaluated by the IACUC at
least once every six months.  The report of the IACUC evaluation
has been submitted to (insert name or title of the Institutional
Official signing the Assurance) and a copy of the report is
attached.  The report contains a description of the nature and
extent of this institution's adherence to the Guide.  Any
departures from the Guide are identified specifically and reasons
for each departure are stated.  Where program or facility
deficiencies are noted, the report contains a reasonable and
specific plan and schedule for correcting each deficiency.  The
report distinguishes significant deficiencies from minor
deficiencies.  Semiannual reports of the IACUC evaluation
submitted to the Institutional Official (insert name or title of
the Institutional Official signing the Assurance) will also
contain a reasonable and specific plan and schedule for
correcting each deficiency and distinguish significant
deficiencies from minor deficiencies.  Semiannual reports of
IACUC evaluations will be maintained by this institution and made
available to OPRR upon request.

V.  Recordkeeping Requirements

   A.  This institution will maintain for at least three years:

     1.  A copy of this Assurance and any modifications thereto,
as as approved by PHS.

     2.  Minutes of IACUC meetings, including records of
attendance, activities of the committee, and committee
deliberations.

     3.  Records of applications, proposals, and proposed
significant changes in the care and use of animals and whether
IACUC approval was given or withheld.

     4.  Records of semiannual IACUC reports and recommendations
as forwarded to (insert name or title of the Institutional
Official signing the Assurance).

     5.  Records of accrediting body determinations.

   B.  This institution will maintain records that relate
directly to applications, proposals, and proposed changes in
ongoing activities reviewed and approved by the IACUC for the
duration of the activity and for an additional three years after
completion of the activity.

   C.  All records shall be accessible for inspection and copying
by authorized OPRR or other PHS representatives at reasonable
times and in a reasonable manner.

VI.  Reporting Requirements

   A.  At least once every 12 months, the IACUC, through the
Institutional Official, will report in writing to the Office for
Protection from Research Risks (OPRR):

     1.  Any change in the status of the institution (e.g., if
the institution becomes accredited by AAALAC or AAALAC
accreditation is revoked), any change in the description of the
institution's program for animal care and use as described in
this Assurance, or any changes in IACUC membership.  If there are
no changes to report, this institution will submit a letter to
OPRR stating that there are no changes.

     2.  Notification of the date that the IACUC conducted its
semiannual evaluations of the institution's program and
facilities (including satellite facilities) and submitted the
evaluations to (insert name or title of the Institutional
Official signing the Assurance).

   B.  The IACUC, through the Institutional Official, will
provide the OPRR promptly with a full explanation of the
circumstances and actions taken with respect to:

     1.  Any serious or continuing noncompliance with the PHS
Policy.

     2.  Any serious deviations from the provisions of the Guide.

     3.  Any suspension of an activity by the IACUC.

   C.  Reports filed under VI.A.2. and VI.B. above shall include
any minority views filed by members of the IACUC.

VII.     Institutional Endorsement and PHS Approval

     A.     Authorized Institutional Official
            Name:____________________________________
            Title:_____________________________________
            Address:___________________________________
            ___________________________________________
            ___________________________________________
            Phone:______________________________________
            Signature:________________________Date:_________ 


     B.     PHS Approving Official

          Name:________________________________________
          Title:_______________________________________
          Address:_____________________________________
                  _____________________________________
                  _____________________________________
                  _____________________________________
          Phone:  ____________________________
          Signature:___________________ Date:___________

     C.     Effective Date of Assurance

     D.     Expiration Date of Assurance


                   U.S. GOVERNMENT PRINCIPLES FOR THE

             UTILIZATION AND CARE OF VERTEBRATE ANIMALS USED

                   IN TESTING, RESEARCH, AND TRAINING


The development of knowledge necessary for the improvement of the
health and well-being of humans as well as other animals requires
in vivo experimentation with a wide variety of animal species. 
Whenever U.S. Government agencies develop requirements for
testing, research, or training procedures involving the use of
vertebrate animals, the following principles shall be considered;
and whenever these agencies actually perform or sponsor such
procedures, the responsible Institutional official shall ensure
that these principles are adhered to:

   I.  The transportation, care, and use of animals should be in
accordance with the Animal Welfare Act (7 U.S.C. 2131 et. seq.)
and other applicable Federal laws, guidelines, and policies(1).

   II.  Procedures involving animals should be designed and
performed with due consideration of their relevance to human or
animal health, the advancement of knowledge, or the good of
society.

   III.  The animals selected for a procedure should be of an
appropriate species and quality and the minimum number required
to obtain valid results.  Methods such as mathematical models,
computer simulation, and in vitro biological systems should be
considered.

   IV.  Proper use of animals, including the avoidance or
minimization of discomfort, distress, and pain when consistent
with sound scientific practices, is imperative.  Unless the
contrary is established, investigators should consider that
procedures that cause pain or distress in human beings may cause
pain or distress in other animals.

   V.  Procedures with animals that may cause more than momentary
or slight pain or distress should be performed with appropriate
sedation, analgesia, or anethesia.  Surgical or other painful
procedures should not be performed on unanesthetized animals
paralyzed by chemical agents.


    (Footnote 1:  For guidance throughout these Principles, the
reader is referred to the Guide for the Care and Use of
Laboratory Animals preparted by the Institute of Laboratory
Animal Resources, National Academy of Sciences.

   VI.  Animals that would otherwise suffer severe or chronic
pain or distress that camot be relieved should be painlessly
killed at the end of the procedure or, if appropriate, during the
procedure.

   VII.  The living conditions of animals should be appropriate
for their species and contribute to their health and comfort. 
Normally, the housing, feeding, and care of all animals used for
biomedical purposes must be directed by a veterinarian or other
scientist trained and experienced in the proper care, handling,
and use of the species being maintained or studied.  In any case,
veterinary care shall be provided as indicated.

   VIII.  Investigators and other personnel shall be
appropriately qualified and experienced for conducting procedures
on living animals.  Adequate arrangements shall be made for their
in-service training, including the proper and humane care and use
of laboratory animals.

   IX.  Where exceptions are required in relation to the
provisions of these Principles, the decisions should not rest
with the investigators directly concerned but should be made,
with due regard to Principle II, by an appropriate review group
such as an institutional animal care and use committee.  Such
exceptions should not be made solely for the purposes of teaching
or demonstration.


        U.S. GOVERNMENT PRINTING OFFICE: 1991--294-776