Biomedical Engineering Reference
In-Depth Information
Welfare Act applies to all vertebrate species, as defined by
the Secretary of Agriculture and excluding mice, rats and
birds used in research. Part 3 (standards) of the AWARs
specifies humane handling, care, treatment and trans-
portation standards for several species, including
nonhuman primates. Requirements for housing facilities,
primary enclosures (including cage space), husbandry
procedures (e.g. feeding, watering, sanitation), and care in
transit are detailed. The AWARs also require the provision
of environmental enhancement adequate to promote the
psychological well-being of primates. Key aspects of
enhancement that institutions must address are: (1) social
grouping; (2) environmental enrichment; (3) use of
restraint devices; and (4) special considerations. Exemp-
tions can be granted for the following criteria: (1) The
attending veterinarian determines that following the plan
could adversely affect the clinical care of primates under
medical treatment; this health-related exemption may
remain in effect for a maximum of 30 days and then must
be reviewed again by the attending veterinarian. (2) The
principal investigator justifies that, for scientific reasons,
the environmental enhancement program would interfere
with the objectives of the study. The Institutional Animal
Care and Use Committee (IACUC) must approve these
exceptions and review them at appropriate intervals, but at
least annually. The National Institutes of Health (NIH)
Nonhuman Primate Management Plan (
http://oacu.od.nih.
gov/regs/primate/primex.htm
) serves as a template plan
for designing and implementing an enrichment program.
Specific requirements of the USDA AWA regulations
include: (1) that “animal care, treatment, and practices and
experimental procedures
be considered in the care and use of these animals. For
example, Policy #3, “Veterinary Care,” includes a section
on the reduction of canine teeth in nonhuman primates and
references the American Veterinary Medical Association's
position statement on the subject: “
The AVMA is
opposed to removal of canine teeth in captive nonhuman
primates or exotic and wild (indigenous) carnivores, except
when required for medical treatment or scientific research
approved by an Institutional Animal Care and Use
Committee. Reduction of canine teeth may be necessary to
address medical and approved scientific research needs, or
animal or human safety concerns. If reductions expose the
pulp cavity, endodontic procedures must be performed by
a qualified person. To minimize bite wounds, recommended
alternatives to dental surgery include behavioral modifi-
cation, environmental enrichment, and changes in group
composition.” Policy #7 addresses group classification of
nonhuman primates, which then relates to the cage space
made available to these different primates per the AWAR.
Policy #18 addresses the need for a health certificate when
transporting primates. Several other more general policies
also have applicability to nonhuman primates.
.
Public Health Service Policy
The Public Health Service Policy on Humane Care and Use
of Laboratory Animals (PHS Policy) (
Office of Laboratory
Animal Welfare, National Institutes of Health, 1986, 2002
;
http://grants.nih.gov/grants/olaw/references/phspol.htm
)
was mandated by amendments to the Public Health Service
Act (Health Research Extension Act of 1985). The Health
Research Extension Act required the Secretary of the
Department of Health and Human Services, acting through
the Director of the NIH, to establish guidelines for the
proper care of animals used in research and funded by
the Public Health Service. OLAW is the component within
the NIH with responsibility for general administration and
coordination of the Policy and monitoring of compliance
with the Policy.
Institutions receiving PHS funds (e.g. an NIH grant) for
activities involving vertebrate animals are required to file
an Animal Welfare Assurance (assurance) with OLAW.
The Assurance, once approved by OLAW, serves as
a binding agreement between the institution and the PHS
legally committing the institution to bide by the PHS
Policy. It provides a description of the program of animal
care and use, and of the Institutional Animal Care and Use
Committee (IACUC) procedures for review and approval of
proposed activities. The animal care and use program must
be consistent with the Guide for the Care and Use of
Laboratory Animals and the AWARs (see section “The
guide for the care and use of laboratory animals” below)
(
National Research Council, 2011
). The description of the
animal care and use program provided in the Assurance
ensure that animal pain and
.
distress are minimized
”; (2) that the principal investi-
gators consider alternatives to painful or distressing
procedures; (3) that certain conditions are met in any
practice which could cause pain to animals; (4) that animals
not be used in more than one major survival operative
experiment except in cases of scientific necessity; (5) that
exceptions to standards be made only when specified by
research protocol; (6) that research facilities report annu-
ally to the secretary that professionally acceptable stan-
dards governing the care, treatment, and use of animals are
being followed; and (7) that research facilities provide to
the secretary: (a) information on painful or distressing
procedures and assurances that alternative procedures have
been considered, (b) assurances that unnecessary duplica-
tions of previous animal studies are avoided, (c) assurances
that the facility is abiding by the aforementioned standards,
and (d) an explanation for any deviation from these
standards.
The USDA has issued a policy manual with the objec-
tive of clarifying certain aspects of the AWARs (
http://
www.aphis.usda.gov/animal_welfare/policy.shtml
). Some
policies apply specifically to nonhuman primates and must
.
