Office of Laboratory Animal Welfare
Frequently Asked Questions about the Public Health Service
Policy on Humane Care and Use of Laboratory Animals
|From: Contemporary Topics 36(2):47-50, 1997
STEPHEN POTKAY, VMD, NELSON GARNETT, DVM, JOHN G. MILLER, DVM,
CYNTHIA L. POND, DVM, MS, AND DENIS J. DOYLE, MA
Division of Animal Welfare, Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, MD 20892-7507. [The Animal Welfare Division of OPRR was renamed Office of Laboratory Animal Welfare (OLAW) in 2000.]
Abstract: Adherence to the provisions of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and related U.S. Department of Agriculture Animal Welfare regulations is a prerequisite for receiving PHS support for conducting animal-related activities. As one of its duties specified in the PHS Policy, the Office for Protection from Research Risks (OPRR) here provides guidance regarding questions that have been raised by institutions seeking to comply with those requirements. These questions include institutional reporting requirements, collaborative activities, performance of multiple survival surgeries, care and use of cold-blooded vertebrates, tracking of animal use, animal study areas, and other Animal Care and Use Committee issues. In reviewing these questions and answers, readers are asked to keep in mind that many of these issues are highly context-specific and that over-generalization is to be avoided.
The Office for Protection from Research Risks (OPRR) of the
National Institutes of Health (NIH) develops, implements, and
oversees compliance with the Public Health Service (PHS) Policy
on Humane Care and Use of Laboratory Animals (1). The PHS Policy
and the U.S. Department of Agriculture (USDA) Animal Welfare
Regulations (2) are the two principal federal documents setting
forth requirements for animal care and use by institutions that
use animals in research, testing, and education. One of the
primary functions of OPRR is to assist institutions in
implementing PHS Policy by responding to policy-related questions
(3-5). The following are several questions frequently asked by institutions and the OPRR
1. Could you provide examples of "significant" and
"minor" deficiencies and suggest appropriate methods for
reporting them in the Institutional Semiannual and Annual
The term "significant deficiency," used in the PHS Policy and the
USDA Animal Welfare Regulations, refers to any facility or
program deficiency that is or may be a threat to the health or
safety of animals. Program or facility deficiencies, including
accidents and natural disasters, which cause injury, death, or
severe distress to animals, are, by definition, "significant."
Although it is not possible to provide an exhaustive listing of
examples, some illustrations of significant facility deficiencies
include failures in heating, ventilating, and air conditioning systems
and their associated electrical systems; inoperative watering
systems; and general power failures of sufficient duration to
affect critical areas such as isolators, barriers, surgical
suites, and intensive care units. Minor deficiencies in animal
facilities include infrequent findings of peeling or chipped
paint, burnt-out light bulbs, missing floor drain covers, and
similar problems for which immediate solutions generally are not
necessary to protect life or prevent distress. Repeated
detection of minor, area-specific problems, however, should
suggest to management that there are substantial program
deficiencies resulting failure to develop effective
policies or plans or to take corrective actions to prevent
Significant program deficiencies generally originate in an
institution's failure to fully understand or implement some
aspect of its animal care and use program, as required by the PHS
Policy (6). Most commonly, they are related to failure of the
Institutional Animal Care and Use Committee (IACUC) to function
according to commitments made in its institutional assurance.
Specific difficulties often are connected with the animal
research proposal review process, veterinary care, or
institutional training programs, inadequacies of which may pose
real or potential threats to the health or safety of animals.
Institutional semiannual reports should categorize any
deficiencies found during the IACUC's semiannual program and
facility review as being major or minor. For both categories, a
reasonable and specific plan must be described for the correction
of each deficiency and a schedule for accomplishing the
correction. When deficiencies involve serious or continuing
noncompliance with the PHS Policy, serious deviations from the
Guide for the Care and Use of Laboratory Animals (henceforth
referred to as the Guide)(7), or the IACUC suspension of any
activity, the circumstances and actions taken must be reported
promptly to OPRR as required in section IV.F.3.a-c. of the PHS
Policy. Reporting of such deficiencies should not be deferred
for inclusion in the institutional annual report. It also should
be noted that the USDA Animal Welfare Act regulations require
that significant deficiencies not corrected within the time frame
of the initial corrective plan and schedule be reported within 15
business days to the Animal and Plant Health Inspection Service
(APHIS) and to any Federal agency funding that activity.
2. Investigators at our institution often collaborate
with scientists in other countries and sometimes go abroad to
collect samples from captive wild animals maintained in
zoological collections and in research colonies. Is it necessary
for our IACUC to review and approve their protocols? What about
samples that are obtained by citizens of the foreign country and
sent to our institution?
All animal activities supported by the PHS must be reviewed by
the IACUC of the domestic-assured awardee institution that
receives such support. Foreign institutions that serve as
performance sites must also have Assurances on file with OPRR.
The OPRR considers institutions whose scientists are engaged in
such collaborative work accountable for the animal-related
activities from which they receive animals or animal parts. When
a foreign institution holds a PHS Assurance, it also is expected
that the institution will conduct the study in accordance with
the applicable host-nation's policies and regulations. In the
specific case of sample collection, the review should take into
account the species involved, nature of the specimen, and the
degree of invasiveness of the procedure, giving appropriate
consideration to the use of anesthetics and analgesics. In cases
in which samples are obtained directly by citizens of a foreign
country for subsequent shipment, recipient PHS-supported
investigators should determine the proposed methods of collection
and present that information to their IACUC for review. Prior to
sample collection and regardless of whether specimens are
obtained by an awardee institution's investigator directly or by
persons in a foreign country, the OPRR strongly recommends that
each awardee institution consult with other agencies of the U.S.
government concerning importation requirements. Depending on the
species involved and the nature of the specimen, the following
may be of assistance: the U.S. Fish and Wildlife Service,
Department of the Interior (for compliance with the International
Convention on Trade in Endangered Species of Fauna and Flora
[CITES]), APHIS, U.S. Department of Agriculture (regarding
potential animal pathogens), and the Centers for Disease Control
and Prevention (concerning importation of nonhuman primates and
potential pathogens of human beings).
3. The PHS Policy requires that the IACUC consist of at
least 5 members, whereas the Health Research Extension Act states
that the committee be composed of at least 3 members.
Regulations of the Animal Welfare Act are consistent with the
latter. In constituting our committee, which requirement should
we adhere to? Also, would you explain the difference between
Institutional Official and Chief Executive Officer
When your institution is a recipient of PHS support for animal-related activities, its IACUC must
consist of at least 5 members
who are appointed by the institution's CEO. It is required that
these individuals be qualified through experience and expertise
to provide oversight for the institution's animal programs,
facilities, and procedures. At a minimum, IACUCs must include a
veterinarian, a practicing scientist experienced in animal
research, a person whose primary concerns are in nonscientific
areas, and a person who is unaffiliated with the institution
except as a member of the IACUC. It should be noted that the
unaffiliated individual may not be a member of the immediate family of
a person who is affiliated with the institution. The
veterinarian, in addition to possessing training or experience in
laboratory animal science and medicine, must have direct or
delegated program responsibility for animal-related activities at
the institution. Although an individual who qualifies to fill more
than one of the aforementioned categories may be appointed to do
so, it is still required that the committee consist of 5 members.
For purposes of the PHS Policy, the institutional official is
that person in the organization having the administrative and
operational authority to commit institutional resources to ensure
that the animal care and use program will comply with
requirements of the PHS Policy. In some institutions, the
institutional official and the CEO may be one and the same,
whereas in other institutions, particularly large ones, the CEO
may be further removed from the day-to-day program oversight.
4. To describe the responsibilities and qualifications of
veterinarians who will participate in our animal program,
will the provision of a curriculum vitae suffice? May the
veterinarian be unaffiliated with the institution?
It has been OPRR's experience that curricula vitae of
veterinarians provided with the submissions of new or renewal
Assurances of Compliance usually do not contain the specific
information required by the PHS Policy. Therefore, this office
recommends that Section III.B. of the Assurance be used to
provide the names, professional degrees, and the number of years
of pertinent training in laboratory animal medicine for each
veterinarian participating in the animal care and use program.
An indication of the individuals' training and experience in
managing the species involved also is helpful. This should be
followed by a description of the duties and responsibilities of
those persons and a statement regarding the direct or delegated
authority of the individuals to implement the PHS Policy and the
provisions of the Guide. It also is important to indicate the
approximate percentage of time that those individuals will
contribute to the program. In cases in which there is not a full-time veterinarian on the staff, the
anticipated number and
frequency of visits by the veterinarian should be indicated.
Failure to provide the required information will necessitate
follow-up requests by OPRR and can result in lengthy processing
In all cases, the veterinarian responsible for implementing the
program is, by definition, affiliated with the institution,
whether as an official employee or through a written contract for
service. It may be noted that some institutions find it helpful
to retain the services of a Diplomate of the American College of
Laboratory Animal Medicine who is available to consult with its
institutional veterinarian for the resolution of certain problems
5. Our IACUC has received a proposal in which nonhuman
primates from our institution's breeding colonies would be
subjected to multiple cesarean sections in order to obtain viable
offspring and to maximize cost effectiveness and the reproductive
utility of the colony of a threatened species. Because cesarean
sections commonly are performed in other species such as
companion animals, will our IACUC have to consider the proposal
in the context of a multiple survival surgery?
While discouraging the performance of multiple survival
procedures on specific animals, the Guide states that the IACUC
may consider special circumstances involving requests to do so.
An example of a potentially justifiable request given in the
Guide involves performing multiple procedures on an animal when
the procedures are related components of a research project. The
USDA Animal Welfare Regulations, which are applicable under the
PHS Policy, provide further guidance on this matter. Under the
regulations, multiple major operative procedures are permitted
when 1) scientifically justified by the investigator (in writing)
and approved by the IACUC or 2) when needed as a routine veterinary
procedure or to protect the health and well-being of an animal, as
determined by the attending veterinarian. Proposals that involve
exposing an animal to multiple major surgery under conditions not
covered by items 1 or 2 must receive prior authorization
by the Administrator, APHIS, USDA. When considering proposals
such as the one described, specific requests should be made to
APHIS on a cases-by-case basis. In its evaluation of such
requests, the IACUC must understand that it was the intent of
Congress to prohibit subjecting animals to multiple major
(survival) surgeries in unrelated research protocols, and that
species that are threatened or endangered were not distinguished
from those that are not on a threatened or endangered list.
Neither the PHS Policy nor the USDA Regulations consider cost
savings alone as an adequate justification for performing
multiple major surgeries on an animal.
6. Use of amphibians, reptiles, and fishes in research
appears to be increasing at our institution. However, neither the
PHS Policy nor the Guide provide specific guidelines for our
IACUC to follow in its consideration of research proposals
involving the care and use of these animals. What advice can
OPRR offer to assist our IACUC?
The PHS Policy is intentionally broad in scope and does not
prescribe specifics about the care and use of any species,
assigning that task to the IACUC and allowing for professional
judgment. Many of the principles embodied in the Guide, although
not specifically addressing cold-blooded vertebrates, generally
can be adapted to animal care and use programs for various kinds
of amphibians, reptiles, and fishes. Substantive guidance
pertinent to specific species and situations is available in
publications prepared by organizations having interest in the
appropriate care and use of these species in laboratory and
field studies (9-18). It is clear, however, that individual
requirements for these 3 classes of vertebrates, which
contain more than 28,000 species that have a diversity of
requirements, cannot be addressed in a single set of guidelines.
Consequently, the OPRR recommends that the advice of experts be
obtained to design and develop studies and suitable housing and
care procedures when species not commonly used in research are
being considered. The OPRR also suggests that the results of
their efforts to devise methods for the care and use of these
species be published to serve as an aid to others.
7. Is it necessary for our IACUC to track the numbers of
animals used in the various protocols it has approved to ensure
that the numbers do not exceed those that were approved in the
proposal review process? If so, could you provide guidance on
the best means for accomplishing this?
Although neither the PHS Policy nor the USDA regulations explicitly
require an institutional mechanism to track animal usage by
investigators under IACUC-approved activities, both require that
proposals to the IACUC specify and include a rationale for the
approximate number of animals proposed to be used. These
provisions implicitly require that institutions establish
mechanisms to monitor and document the number of animals acquired
and used in approved activities. The OPRR is aware of many
institutions at which such mechanisms preclude an investigator
from using a single animal in excess of the number approved by
the IACUC. Other institutions have reported mechanisms that
allow the number of rodents acquired to exceed the number
approved by a small percentage (e.g., 5%), although they still
may require investigators to obtain and use only the precise
number of nonrodent mammalian species approved by the IACUC.
Administrative linkage of animal acquisitions to IACUC approval
numbers is the method of choice used by many institutions to
track the numbers of animals being acquired under approved
activities. Many also have described relatively simple automated
data processing systems that will alert the systems' operator and
generate a report when an investigator has reached a preset
percentage (e.g., 80-90% of the animals approved for that
activity). This report then is submitted to the investigator
with a request to provide a specific justification if they
anticipate that the number of animals ultimately required will
exceed the number approved. Small institutions that use limited
numbers of animals may choose to maintain a hard-copy log of each
IACUC-approved activity, merely subtracting the number of animals
acquired for each order from the number approved, with verbal or
written notification to the investigator as the number of animals
approved is approached. Whatever mechanism an institution
chooses, however, it must satisfy the PHS Policy requirement that
the number of animals used be limited to the appropriate number
necessary to obtain valid results.
8. In conducting its semiannual facility reviews, is it
necessary for our IACUC to consider laboratories or other sites
where animal procedures or holding activities are conducted only
sporadically or for periods of less than 24 h? How does our
IACUC determine whether to follow the requirements of the PHS or
the USDA regarding the definition of "study area?"
Each assured institution, acting through its IACUC or facility
veterinarian, is responsible for all animal-related activities at
the institution regardless of where the animals are maintained or
the duration of their stay. The degree, frequency, and method of
IACUC oversight often depends on the nature of the activity. For
example, satellite holding facilities and areas in which surgical
manipulations are performed must always be included in semiannual
reviews, whereas laboratories in which only routine immunization,
dosing, and weighing take place may be monitored by other means
such as random site visits and evaluations. Regardless of
whether such laboratories are included in the semiannual review
process or are monitored by other means, the IACUC must have
reasonable access to them for the purpose of verifying that
activities involving animals are being conducted in accordance
with the proposal approved by the IACUC. The PHS Policy requires
compliance with the USDA regulations regarding areas where USDA-covered species are
maintained for any purpose for more than 12 h. The term "satellite facility", as defined in the PHS
remains unchanged and is applicable to the housing or holding
facilities provided for all vertebrate animals. It is important
to keep in mind that the institution is accountable for all
activities involving animals, regardless of technical differences
in definitions and time limits, and that institutional policies
should be designed to obtain the desired outcome of both the PHS
Policy and the Animal Welfare Act (namely, the appropriate,
humane care of all animals at each institution).
- Public Health Service. 1996. Public Health
Service Policy on Humane Care and Use of Laboratory Animals. U.S.
Department of Health and Human Services, Washington, D.C.
[Reprint of 1986 edition].
- Animal Welfare Regulations. 1985. Code of
federal regulations, title 9 (animals and animal subproducts),
subchapter A (animal welfare), parts 1-3 (9 CFR 1-3). U.S.
Department of Agriculture, Washington, D.C.
- Division of Animal Welfare, Office for Protection
from Research Risks. 1991. The public health service
responds to commonly asked questions. ILAR News
- Division of Animal Welfare, Office for Protection
from Research Risks. 1993. Frequently asked questions
about the public health service policy on care and use of
Laboratory Animals. ILAR News 35:47-49.
- Potkay, S., N. L. Garnett, J. G. Miller, et
al. 1995. Frequently asked questions about the
public health service policy on humane care and use of laboratory
animals. Lab. Anim. 24:24-26.
- McLaughlin, R M. 1993. Institutional animal
care and use committee review of animal care and use programs.
Contemp. Top. Lab. Anim. 32:12-15.
- National Research Council. 1986. Guide for
the care and use of laboratory animals. NIH Publication No. 86-23. Public Health Service,
- American College of Laboratory Animal
Medicine. 1996. Report of the American College of
Laboratory Animal Medicine on adequate veterinary care in
research, testing, and teaching. American College of Laboratory
Animal Medicine, Cary, NC.
- Ferguson HW. 1984. Fish, p. 1-10. In: Guide
to the care and use of experimental animals, vol 2., Canadian
Council on Animal Care, Ottawa, Ontario, Canada.
- Institute for Laboratory Animal Resources.
1974. Amphibians. In: Guidelines for the breeding, care and
management of laboratory animals. National Academy of Sciences,
- Institute for Laboratory Animal Resources.
1991. Recommendations for the care of amphibians and reptiles in
academic institutions. National Academy of Sciences, Washington,
- Scientists Center for Animal Welfare. 1992.
The care and use of amphibians, reptiles, and fish in research.
Schaeffer, D. O., K. M. Kleinow, L. Krulisch (eds.).
Scientists Center for Animal Welfare, Greenbelt, MD.
- American Society of Ichthyologists and
Herpetologists, American Fisheries Society, American Institute of
Fisheries Research Biologists. 1987. Guidelines for the
use of fishes in field research. Fish. J. 13(2):1-14.
- American Society of Ichthyologists and
Herpetologists, The Herpetologists' League, and Society for the
Study of Amphibians and Reptiles. 1987. Guidelines for
the use of live amphibians and reptiles in field research. J.
Herpetology (Suppl) 4:1-14.
- Orlans, F. B. 1988. Field research
guidelines: impact on animal care and use committees. Scientists
Center for Animal Welfare, Greenbelt, MD.
- DeTolla, L. J., S. Srinivas, B. R. Whitaker, et
al. 1995. Guidelines for the care and use of fish
in research. ILAR J. 37:159-173.
- DeNardo, D. 1995. Amphibians as laboratory
animals. ILAR J. 37:173-181.
- Greene, H. W. 1995. Nonavian reptiles as
laboratory animals. ILAR J. 37:182-186.