Better Science
United
States Regulations of the
Use of Animals in Research Facilities—
The Paper Tiger
The AWA
Congress passed the AWA in 1966 and amended
the law in 1970, 1976, 1985 and 1990. The AWA is the only federal
law in the US that regulates the treatment of animals in research,
exhibition, transport, and by dealers.
The United States Department of Agriculture
(USDA) is charged with implementing the AWA’s regulations. The AWA
covers dogs, cats, nonhuman primates (including chimpanzees, baboons,
and monkeys), guinea pigs, hamsters, rabbits and other warm-blooded
animals. It excludes all cold-blooded animals and also horses and
other farmed animals used as food or fiber. Rats and mice (who make
up 90%-95% of all animals used in research) and birds were not covered
by the AWA until 2000 when the USDA agreed in an out-of-court settlement
to mandate inclusion of birds, mice and rats in labs under AWA regulations.
Opponents of the settlement, however, inserted a rider in the 2001
Agriculture Appropriations bill that blocked the USDA from implementing
the settlement for a year.
The AWA requires all animal research facilities
with either covered animals or those receiving federal funds to
establish an Institutional Animal Care and Use Committee (IACUC—pronounced
"I-uh-cook") with members appointed by each facility’s
Chief Executive Officer (CEO). The IACUC must consist of no less
than three members or if it is NIH funded, it requires at least
five members including a veterinarian and one person not affiliated
in any way with the facility.
The IACUC must inspect facilities of covered
animals at least twice a year, review research protocols, and file
an inspection report with the CEO. Since the IACUC is appointed
by the CEO it establishes that research facilities are essentially
self-regulating. Even the unaffiliated member is chosen by the animal
facility. Also the unaffiliated member can be outvoted since most
committees allow a majority vote and not a unanimous vote for approval.
Animal research facilities with regulated
animals must also be inspected yearly by the USDA’s Animal Plant
Health Inspection Service (APHIS) Animal Care inspectors.
In 2001 there are only 82 USDA/APHIS Animal Care inspectors to inspect
more than 1,200 animal research facilities across the nation. These
same 82 inspectors are also charged with regular inspections of
all USDA animal dealers, exhibitors, handlers, and carriers—some
5,000 additional facilities.
While it is impossible to determine the
precise number of animals in US laboratories since mice, rats, and
birds – comprising approximately 90%-95% of animals in labs – are
not currently covered in AWA reports, conservative estimates indicate
that between 25 – 40 million animals are used in US laboratories.
The 1985 AWA amendment called for the exercise
of dogs and psychological well-being of primates. The National Association
for Biomedical Research, a group representing animal researchers,
opposed it. In 1993 U.S. Federal District Court found that the USDA
had failed to implement the 1985 law. Today more research
facilities are abiding by the rules to exercise dogs and to provide
some "enrichment" for primates. However,
if investigators show "scientific necessity" they may
be exempt from even the minimal provisions for psycho-social wellbeing.
AWA regulations call for "adequate"
veterinary care, including use of anesthetics, analgesics (painkillers),
and tranquilizers. However, if it is deemed "scientifically
necessary" anesthetics, analgesics and tranquilizers can
be withheld. More than 100,000 animals in 1999 were reported
as used in painful or distressful research with no pain
relief. However, estimates suggest that
the number of animals actually subjected to pain and distress is
significantly higher.
The AWA also calls for investigators to
provide proof of having considered "alternatives" to painful
procedures. However, alternatives do not necessarily
have to eliminate the use of animals. Rather it is sufficient for
investigators to consider the "three R’s"—replacement
of animals, refinement of non-animal methods, and reduction of the
animals used. The AWA established the
Animal Welfare Information Center (AWIC) to assist investigators
in searching for "alternatives" to experiments that might
cause pain and distress.
The AWA prohibits multiple survival surgeries
(surgeries whereby the animal will recover from one experimental
surgery and then be subjected later to more surgery). However,
once again, if it is deemed "scientifically necessary,"
experimenters can perform repeated surgeries on animals.
The PHS Policy
On behalf of the federal Public Health Service,
the National Institutes of Health’s Office of Laboratory Animal
Welfare (OLAW) has responsibility for the administration and coordination
of the PHS Policy on Humane Care and Use of Laboratory Animals.
The PHS Policy applies to the use of live, vertebrate animals in
any activity supported or conducted by the Public Health Service.
The PHS Policy is very similar to the Animal Welfare Act, and both
require IACUCs at animal research facilities.
All scientists funded by the U.S. Public
Health Service, which includes funding by the National Institutes
of Health, are required to adhere to the Guide for the Care
and Use of Laboratory Animals by the Institute of Laboratory
Animal Resources (ILAR) Commission on Life Sciences, National Research
Council. In speaking about the most recent version, printed in 1996,
Dr. Thomas Wolfle, program director of ILAR states, "The guide
is deliberately written in general terms so recommendations can
be applied in diverse situations. It affirms the conviction that
all who care for or use animals in research, teaching, or testing
must assume responsibility for their well-being [emphasis added]."
In other words, the fox is guarding the hen house.
The Guide for the Care and Use of Laboratory
Animals provides little, if any, protection to animals. For
example, it states, "Animals should be fed palatable, noncontaminated,
and nutritionally adequate food daily or according to their particular
requirement unless [emphasis added] the protocol
in which they are being used requires otherwise."
The Guide further
states, "There is no minimal frequency of changing
bedding, but it typically varies from daily to weekly. In some instances,
frequent bedding changes are contraindicated… or when research objectives
do not permit changing the bedding."
Conclusion
The trusting public believes that animals in laboratories
are protected by the AWA and PHS Policy. However,
the minimal protections offered by the AWA and PHS provide no real
safety or relief to the millions of animals in labs and offer only
a false sense of security to the caring public. Rather so-called
"scientific necessity" remains in place for the continued
unbridled use of animals in all manners imaginable in experimental
protocol.
—October 2001
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