The first animal
welfare regulation was the Twenty-Eight Hour Law of 1873. It stated that
livestock being transported must be rested and given water at least once
every twenty-eight hours.
The Animal Welfare Act:
The first law to protect research animals was enacted on August 26,
1966. Called the Laboratory Animal
Welfare Act, it required that minimum standards of care be
provided for certain animals used for research or other purposes. The
law authorized the development and enforcement of regulations by
the Animal and Plant Health Inspection Service in the U.S. Department of
Agriculture. It was initially written to protect dogs
and cats from theft and to ensure their humane treatment.
Research facilities that used dogs or cats were required to register with
the USDA. The law prohibited, however, any rules that would
interfere with actual research. According to the Act, an
"animal" was limited to the dog, cat, nonhuman primate, guinea
pig, hamster and rabbit.
Several amendments
have been made to the original Act and it was renamed the Animal Welfare
Act (AWA) in 1970. The definition of "animal" was
broadened to include all warm-blooded animals determined by the Secretary
of Agriculture as being used or intended for use in experimentation or
exhibition. Facilities that use any of these animals must register
with the USDA and file an annual report documenting the animals used and
the care provided to them. Interference of research by the USDA
continued to be prohibited.
The 1976 Animal Welfare Act amendments set standards for animal
transporters and outlawed animal fighting. In addition, rats and
mice bred specifically for research, birds, horses and farm animals used
for production research were
excluded from the definition of "animal."
The 1985 amendment entitled the "Improved Standards for
Laboratory Animals Act" radically changed the relationship of the
government to actual research activities. This amendment improved
the standards for research animal care by establishing a number of
different programs, increasing enforcement of the Act, and directly regulating research protocols.
The Chief Executive Officer (CEO) of the research facility is required to
appoint an Institutional Animal Care and Use Committee (IACUC), which is
responsible for overseeing the appropriate use and care of animals at the
facility. The IACUC must consist of at least three members,
including a veterinarian and someone unaffiliated with the
laboratory. The IACUC must meet at least once every six months and
inspect the research facility, review all activities and programs, and write a
report for submission to the CEO.
All activities related to the animals must be written as an Animal Care
and Use Plan (ACUP). These ACUPs must be submitted to the IACUC for
review and approval. The Animal Care and Use Plans are detailed
descriptions of the experiment and animal husbandry, and must
include:
The species and number of animals
Husbandry procedures
Exact description of the experimental
protocol
Description of any painful procedures
and measure taken to relieve pain
The disposition of the animals after the
experiment
All research
facilities must have an attending veterinarian (AV) and a Program of
Veterinary Care. The AV must have a formal relationship with the
research facility and may be a full-time employee or a consultant
available on an as-needed basis. The veterinarian should have
training and experience working with laboratory animals.
Employees responsible for working with the animals, from the animal
caretakers to the principal investigator, must receive training in:
Experimental techniques and statistical
methods
Husbandry procedures
Methods to minimize animal use
Methods to minimize animal pain and
stress
Methods to report deficiencies in animal
care or use
How to use the National Agriculture
Library to search for previous experiments
and alternatives to laboratory
animal use
Each registered
facility must submit an annual report to APHIS. This report includes assurances that acceptable standards of care have been met and any
procedures that produce pain or stress are justified. Research
that may result in pain or stress must include a statement from the
principal investigator that alternatives were considered and why pain was
not relieved.
All records, including ACUPs, minutes of the IACUC meetings, and records of
animals must be maintained for at least three years. They must be
presented to an APHIS inspector at their request.
An exercise program for dogs and provision of environmental enrichment for
nonhuman primates must be developed.
The Pet Protection Act is a 1990 amendment to the Animal Welfare Act that
established standards to minimize the chance that a lost pet (dog or cat)
would be sold by an animal shelter for research. (New York State law
prohibits the release of any animal from a shelter for use in
research.)
The current Animal Welfare Act definition of "animal" is:
Any live or
dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit or any other warm-blooded animal which is being used, or is intended for use for
research, teaching, testing, experimentation, or exhibition purposes, or as a
pet. This term excludes: birds, rats, of the genus Rattus and mice of the
genus Mus bred for use
in research, and horses not used for research purposes and other farm animals, such as but not limited to livestock or poultry, used for or
intended for
use as food or fiber, or livestock or poultry used or intended for use for improving
animal nutrition, breeding, management or
production...
The USDA was petitioned in January of 1999 to include
rats, mice and birds
in its definition of "animal". It settled out-of-court in October 2000
and agreed to consider the developing rules that would cover these
species. The 2002 Farm Bill permanently excluded rats, mice and
birds bred for research from coverage by the USDA.
Redefinition of pain and distress and improved methods of reporting pain
and distress in laboratory animals began in 2000. In response,
the Humane Society of the United States has developed a
"Pain
and Distress Initiative" with the goal of eliminating pain and distress in laboratory animals by the year 2020.
It is important for animal facility personnel to be aware of additions,
clarifications and developing issues related to the Animal Welfare
Act. These rules are designed to improve the welfare of the
animals in our care. The AWIC
website is an excellent source for information on government
regulations addressing animals.
The Controlled Substance Act:
This act is administered by the Drug Enforcement Administration (DEA),
part of the Justice Department. The DEA regulates the security and
management of potentially addictive or harmful drugs, including
anesthetics and euthanasia solutions.
The Good Laboratory Practices Act:
The Good Laboratory Practices Act (GLP) was enacted in 1987. It is
administered by the U.S. Food and Drug Administration to ensure
appropriate standards of care for animals used in the development and
safety testing of drugs. The GLP requires the research facility to
establish a Quality Assurance (QA) unit to develop Standard Operating
Procedures for all drug studies.
The Guide for the Care and Use of Laboratory
Animals:
Written by the Institute of Laboratory Animal Resources (ILAR) and the
Public Health Service (PHS) in 1966, The Guide details minimum
standards for research facilities. The Public Health Service, AAALAC
and New York State use The Guide for their standards. The most
recent update was completed in 1996 and includes information on:
Institutional policies and
responsibilities (including IACUC & research protocols)
Animal environment, housing and
management
Veterinary medical care
The physical plant (the facility,
surgical suite & construction guidelines)
The Health
Research Extension Act regulates experimental design and animal care
for any facility that receives funding from the United States Public
Health Service (a major supplier of funds for pure and applied research in
the United States). Rats and mice are covered by this act.
Failure to comply with the Act may result in withdrawal of funding for the
Principal Investigator.
Employee Protection:
The Occupational Safety and Health Administration (OSHA) and the National
Institute of Occupational Safety and Health (NIOSH) are the federal
agencies responsible for ensuring the health of employees in the work
place.
The most frequent health risk associated with research animals is allergy.
About 33% of animal handlers have laboratory animal allergies and 10% of
animal handlers have asthma.
Common allergens
include the urine, saliva and fur from rats, mice, guinea pigs, rabbits and
cats, especially males. Most allergies develop within 36 months of
starting work with animals, but may be delayed for years. Clinical
signs vary and may result in permanent disability. Signs may include
pruritis, conjunctivitis, rhinitis, asthma and anaphylaxis.
Other problems can be
associated with research animals. Direct injury can occur if an
animal bites, scratches or kicks the people working with it.
Laboratory animals can also be a source for zoonotic infections-- animal
diseases that are infective to man--such as:
Rat bite fever (Streptobacillus
moniliformis)
Tuberculosis (Mycobacterium
spp.- esp. from primates)
Contagious echthyma (a poxvirus of
sheep and goats)
Q fever (Coxiella burnetti-
from sheep and goats)
Herpes B (Cercopithecine
herpesvirus 1- from primates)
Parrot fever (Chlamydia
psittici- from birds)
Ringworm fungus (Microsporum spp.-
from cats, guinea pigs & others)
Diarrhea (Salmonella and
other bacteria from any animal)
Q fever (Coxiella
burnetti from sheep, goats and cattle)
Rabies (from almost any animal, except
small rodents)
Latex allergy
is an
additional problem that may arise as a reaction to the natural rubber in
the gloves worn to decrease the development to animal allergens. The
reactions associated with latex allergy are similar to those of
animal-associated allergy and should be reported to your supervisor
immediately. Alternate glove materials are available and should be
substituted for latex gloves.
Reading
ASSIGNMENT: Guide
for the Care and Use of Animals (