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Association for Research in
Otolaryngology
Animal Research Committee
To endorse and promote humane and ethical
standards in the use of animals for
research
- ARO Policy
Statement on the Use of Animals in Research and
Teaching
- U.S. Governmental Laws, Regulations and
Guidelines Governing the Care and Use of Animals
in Research, Testing and Training
- A Few of the Many Organizations Concerned
with Humane and Ethical Standards for the Care
and Use of Laboratory Animals
- U.S. Governmental Laws, Regulations and
Guidelines Governing the Care and Use of Animals
in Research, Testing and Training
- Animal Welfare Act (7
U.S.C. 2131 et seq.) and USDA Regulations and
Policies
The federal Animal
Welfare Act (AWA) and its amendments
(Animal Welfare Act of August 24, 1966
[Public Law 89-544], [commonly
known as the Laboratory Animal Welfare
Act], as amended by the Act of December
24, 1970 [Pub. Law 91-579], [the
Animal Welfare Act of 1970], the Act of
April 22, 1976 [Pub. Law 94-279],
[the Animal Welfare Act of 1976], and
the Act of December 23, 1985 [Pub. Law
99-198], [the Food Security Act of
1985] and as it may be subsequently
amended) regulate the transportation,
purchase, care and treatment of animals used
in research, for exhibitions and sold as
pets. The AWA was amended May 13, 2002
[Pub. Law 107-171], [the Farm
Security and Rural Investment Act of
2002] to exclude from coverage
“birds, rats of the genus
‘Rattus’, and mice of the genus
‘Mus’ bred for use in
research”.
The AWA is administered by the United
States Department of Agriculture (USDA),
Animal and Plant Health Inspection Service
(APHIS), Division of Animal Care (AC). USDA
regulations (Code
of Federal Regulations Title 9, Chapter 1,
Subchapter A – Animal Welfare see
'Animal Care Regulations') specifically
include live or dead dogs, cats, nonhuman
primates, guinea pigs, hamsters, rabbits,
marine mammals, and other warm-blooded
animals, including wild animal species,
intended for use in research, teaching,
testing, and experimentation (also includes
those used for exhibition purposes and as
pets). USDA regulations do not cover
laboratory rats, mice or birds.
The USDA regulations address such issues
as registration requirements for different
types of facilities involved with animal use,
housing standards for different species of
animals, transportation requirements,
purchase of animals, duties and composition
of the Institutional Animal Care and Use
Committee (IACUC),
responsibilities of the attending
veterinarian, record-keeping and reporting
requirements, and training of all personnel
using laboratory animals. They also require
the IACUC to review all protocols using
animals to make certain that they meet
criteria listed in the amendments and to
conduct semiannual inspections of all animal
study areas and facilities. The USDA
Policy Manual clarifies the intent of
certain USDA regulations.
To conduct research using animals, the
institution is required to register with the
USDA as a Research Facility, and is subject
to unannounced inspections by USDA
veterinarians. The institution is required to
file an annual report listing the species,
the numbers and classification of animals
used in research, and certifying that
anesthetic, analgesic and tranquilizing
agents were used appropriately during
research and testing.
Noncompliance with USDA standards for the
humane handling, treatment, and
transportation of animals may lead to
substantial fines and/or suspension of animal
research activities.
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- Health
Research Extension Act and Public Health
Service Policy (PHS Policy)
Under Section 495 of the Health Research
Extension Act of 1985 (Public Law 99-158,
November 20, 1985 ["Animals in
Research”]), the Secretary of the
Department
of Health and Human Services acting
through the Director of the National
Institutes of Health (NIH) was charged
with the responsibility of establishing
guidelines for animals used in research.
These guidelines are defined in the Public
Health Service (PHS) Policy on Humane Care
and Use of Laboratory Animals, hereafter
referred to as PHS Policy. PHS Policy
requires each institution that receives PHS
funds for research involving animals to file
an approved Animal Welfare Assurance
Statement with the NIH Office
of Laboratory Animal Welfare (OLAW),
formerly known as the Office for Protection
from Research Risks (OPRR). No PHS award
involving the use of animals is made unless
an Animal Welfare Assurance has been approved
by OLAW. The Assurance statement commits the
institution to compliance with USDA
regulations, the ILAR
Guide for the Care and Use of Laboratory
Animals, the "U.S.
Government Principles for the Utilization and
Care of Vertebrate Animals Used in Testing,
Research and Training" (reprinted below)
and other applicable laws and regulations.
The Assurance Statement must describe in
detail the institution's program for the care
and use of animals (including mice and rats)
and its program for assuring compliance with
the PHS policy, following recommendations
from the "Guide". It is the responsibility of
the Institutional Official to ensure that
procedures are in place to enable staff to
remain cognizant of and compliant with state
and local laws and regulations that may
affect research programs. PHS Policy was
amended August 8, 2002 (FR Vo. 67, No. 152,
pgs. 51289-51290) to permit institutions with
PHS Animal Welfare Assurances to submit
verification of IACUC
approval for competing applications
subsequent to peer review but prior to award,
effective September 1, 2002 (i.e., for all
applications submitted for the May-June 2003
advisory council dates).
The Guide
for the Care and Use of Laboratory
Animals was developed in 1962, when NIH
contracted with the National Academy of
Sciences (NAS) Institute
for Laboratory Animal Research (ILAR) to
develop what is now called the
“Guide”. The “Guide”
underwent its sixth revision in 1996. Its
purpose is to assist scientific institutions
in using and caring for laboratory animals in
ways judged to be professionally appropriate.
The “Guide” represents PHS policy
by which grantees and contractors using live
vertebrate animals in projects or activities
supported by NIH (or any other PHS agency,
such as the FDA and CDC) should be
guided.
PHS Policy and guidelines cover all
laboratory animals, including all vertebrate
animals (e.g., traditional laboratory animals
such as rats and mice, farm animals,
wildlife, and aquatic animals) that will be
used in research, teaching, or testing. The
“Guide” does not specifically
address farm animals used in agricultural
research or teaching, wildlife and aquatic
animals studied in natural settings, or
invertebrate animals used in research;
however, many of the general principles in
the “Guide” apply to those species
and situations as well.
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- U.S. Government Principles
for the Utilization and Care of Vertebrate
Animals Used in Testing, Research, and
Training
The principles below were prepared by the
U.S. Government’s Research Animal
Committee. This committee, which was established
in 1983, serves as a focal point for federal
agencies' discussions of issues involving all
animal species needed for biomedical research
and testing. The committee's principal concerns
are the conservation, use, care, and welfare of
research animals. Its responsibilities include
information exchange, program coordination, and
contributions to policy development. PHS policy
requires that all research and teaching that
uses animals conform to the Principles listed
below.
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 animals
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.*
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 anesthesia. Surgical or other
painful procedures should not be performed on
unanesthetized animals paralyzed by chemical
agents.
VI. Animals that would otherwise suffer
severe or chronic pain or distress that cannot
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
decision 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.
* For guidance throughout these Principles,
the reader is referred to the Guide for the Care
and Use of Laboratory Animals prepared by the
Institute of Laboratory Animal Resources,
National Academy of Sciences.
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- American Veterinary Medical
Association (AVMA) Panel on Euthanasia
The recommendations of the American
Veterinary Medical Association (AVMA)
Panel
on Euthanasia (2000) are considered the
standards for acceptable methods of euthanasia
of laboratory animals by both the USDA and the
PHS. The most recent recommendations were
published in the Journal of the American
Veterinary Medical Association (JAVMA) Vol. 218,
No. 5, March 1, 2001, pp. 669-696.
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- Good Laboratory Practice
(GLP) Regulations
In 1978, the Food
and Drug Administration (FDA) adopted the
Good
Laboratory Practice (GLP) regulations (CFR
Title 21, Chapter 1, Part 58, Subparts A-K
– Good Laboratory Practice for Nonclinical
Laboratory Studies), which pertain to
nonclinical laboratory studies performed in
support of applications for research or
marketing permits for products regulated by the
FDA. The GLP regulations, as they apply to the
use of animals, address such issues as
construction and maintenance of facilities,
quarantine and isolation, disease diagnosis and
treatment, animal identification, caging and
routine care, sanitation, and documentation
requirements. The rules require the creation of
Standard Operating Procedures for all aspects of
the study including animal care and use. A
Quality Assurance Unit must be established to
conduct internal inspection of practices and
records to insure compliance with established
policies and procedures. GLP regulations were
also adopted by the Environmental
Protection Agency (40CFR160.90
and 40CFR792.90);
these regulations require that feed, soil and
water used for test systems be analyzed
periodically to ensure that contaminants that
might interfere with the study are
documented.
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- Controlled Substances Act
(CSA)
Many tranquilizers, anesthetic agents,
analgesics and other substances used in
laboratory animals are regulated by the
Controlled
Substances Act (CSA), Title II of the
Comprehensive Drug Abuse Prevention and Control
Act of 1970, (21 U.S.C. 801 et seq.) (Public Law
91-513, Title II, Oct. 27, 1970, 84 Stat. 1242).
This Act places all substances that are
regulated under existing federal law into one of
five schedules. This placement is based upon the
substance's medicinal value, harmfulness, and
potential for abuse or addiction. Schedule I is
reserved for the most dangerous drugs that have
no recognized medical use, while Schedule V is
the classification used for the least dangerous
drugs. The act also provides a mechanism for
substances to be controlled, added to a
schedule, decontrolled, removed from control,
rescheduled, or transferred from one schedule to
another. The Department
of Justice, Drug
Enforcement Administration (DEA) enforces
the law. A DEA license is required to order and
use scheduled drugs. All individuals and
institutions that are registered are required to
maintain complete and accurate inventories and
records of all transactions involving controlled
substances for review by DEA officials, as well
as security for the storage of controlled
substances.
The controlled substances and their
derivatives listed under the CSA can be found in
the CFR Title 21, Chapter II, Part 1308 –
“Schedules
of Controlled Substances.”
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- Endangered Species Act
(ESA), Marine Mammal Protection Act (MMPA) and
CITES
Both domestic laws and international treaties
have been implemented to promote long-term
global conservation of fish and wildlife
resources.
The Endangered
Species Act of 1973 (Public Law 93-205; 87
Statute 884; U.S.C. Title 16, Chapter 35) became
effective on December 28, 1973, supplanting the
Endangered Species Conservation Act of 1969
(Public Law 91-135; 83 Statute 275). The law is
intended for the conservation of ecosystems upon
which endangered species and threatened species
depend, to protect endangered and threatened
species, and to “take such steps as may be
appropriate to achieve the purposes of the
treaties and conservation of wild flora and
fauna worldwide”. Regulatory authority
under the Endangered Species Act is vested in
the secretary of the U.S.
Department of the Interior (USDI) and
implemented by the USDI’s Fish
and Wildlife Service (FWS). Implementing
rules and regulations are published in CFR Title
50 (Wildlife and Fisheries), Chapter 1 (U.S.
Fish and Wildlife Service, Department of the
Interior), Subchapter B, Part 17 (Endangered
and Threatened Wildlife and Plants). In
addition, the National
Marine Fisheries Service (NMFS) in the
National
Oceanic and Atmospheric Administration of
the Department
of Commerce shares responsibility for
administration of the Endangered Species Act.
Specifically, the authority to list species as
threatened or endangered is shared by the NMFS,
which is responsible for listing most marine
species, and the FWS, which administers the
listing of all other plants and animals.
Under the Marine
Mammal Protection Act (MMPA) of 1972 (16
U.S.C. 1361 et seq.), and the MMPA Amendments of
1994 (Public Law 103-238, April 30, 1994), which
is designed to protect marine mammals and their
habitats, the NMFS
and FWS
are charged with the authority to promulgate
regulations authorizing scientific research
which has the potential to disturb but not
injure a marine mammal without a formal permit.
Individuals must submit specified information to
NMFS or FWS at least 60 days prior to beginning
research. Also, “expedited scientific
research permits will be allowed when delay
could cause injury to a marine mammal or loss of
unique research opportunities”. NMFS and
FWS regulate the taking of marine mammals from
the wild under the MMPA, while subsequent care
and maintenance of captive marine mammals is
regulated by the USDA/APHIS.
CITES
(the Convention on International Trade in
Endangered Species of Wild Fauna and Flora) is
an international agreement between governments
which became effective July 1, 1975, and whose
purpose is to ensure that international trade in
specimens of wild animals and plants does not
threaten their survival.
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- International Air Transport
Association (IATA)
In addition to the regulations promulgated by
the USDA regarding the transportation of live
animals, the transport of live animals by
commercial airlines is regulated by the
International
Air Transport Association (IATA) Live Animal
Regulations (LAR), adopted in consultation with
the parties to the CITES,
the Office
International des Epizooties (OIE), and
government authorities that implement the LAR
for animal transportation.. The importation of
primates is also regulated by the PHS (42CFR71.53)
with specific guidelines for tuberculin testing
(CDC) and special requirements for importing and
transporting African green, cynomolgus, and
rhesus monkeys (CDC).
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- A Few of the Many Organizations Concerned
with Humane and Ethical Standards for the Care
and Use of Laboratory Animals
- Scientists
Center for Animal Welfare (SCAW)
The Scientists Center for Animal Welfare
(SCAW) is a “non-profit educational
association of individuals and institutions
whose mission is to promote the best
practices of humane care, use, and management
of animals involved in research, testing or
education in laboratory, agricultural,
wildlife or other settings.”
- Applied
Research Ethics National Association
(ARENA)
ARENA is a national organization for
professionals concerned with issues relating
to the humane care and treatment of animals
“and other ethical issues pertaining to
biomedical and behavioral
research.”
- Public
Responsibility in Medicine and Research
(PRIM&R)
PRIM&R is a national organization
“committed to the advancement of strong
research programs and to the consistent
application of ethical precepts in both
medicine and research.”
- American
Association of Laboratory Animal Science
AALAS is a national organization for
professionals concerned with issues relating
to the humane care and treatment of
animals.
- Animal
Welfare Information Center
The Animal Welfare Information Center is
part of the National Agricultural Library
(NAL), and was established in 1986 as
mandated by amendments to the Animal Welfare
Act. It is the focal point for those
interested in obtaining information or
publications covering many aspects of animal
welfare.
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