Biomedical Engineering Reference
In-Depth Information
( DeMarcus et al., 1999 ; Roberts and Andrews, 2008).
Importation of NHPs is restricted by Public Health Service
quarantine regulations and is permitted only for bona fide
scientific, educational, or exhibition purposes, by importers
registered with the Centers for Disease Control (CDC).
Nonhuman primates may not be imported into the USA as
pets.
There are two levels of NHP quarantine in the USA.
Primary quarantine applies to animals imported from
international sources and is performed at a relatively small
number of specialized CDC-registered facilities. No person
or organization may import live NHPs into the USA unless
registered as a primary quarantine facility with the CDC.
Any facility which holds, receives, or imports NHPs must
abide by all local, state, and federal regulations. These
facilities are required to keep animals for a minimum of 31
days upon arrival in the USA and must report specific
illnesses to the government.
Appropriate records on each shipment must be main-
tained. Importers must not only record the date of impor-
tation, number of animals received, country of origin, and
any unexpected animal deaths, but must also record the
recipients of each animal after their initial quarantine
period. The importer must obtain signed and dated docu-
ments from the recipient to establish that the animals will
be used solely for the permitted purposes.
Importers are required to report by telephone, within
24 hours of occurrence (including nights, weekends, and
holidays): (1) any illness in NHPs that is suspected of being
yellow fever, monkeypox, or Marburg/Ebola disease; and
(2) illness in any member of their staff suspected of having
an infectious disease acquired from NHPs ( Foreign Quar-
antine of Nonhuman Primates, 1985 ). Upon receipt of this
evidence, the director of the CDC is authorized to provide
for or require examination, treatment, detention, quaran-
tine, seizure, or destruction of exposed animals in order to
protect human health. At publication time, a proposal to
review and update these regulations is pending and these
rules will likely be updated in the coming years.
Import and export of many NHPs are regulated by the
US Department of the Interior, Fish and Wildlife Service
under the Endangered Species Act (1973) , and the
Convention on International Trade in Endangered Species
of Wild Fauna and Flora ( CITES, 1973 ).
All NHPs must enter and leave this country through
customs ports designated by the US Fish and Wildlife
Service. An Exception to Designated Port permit can be
obtained from the US Fish and Wildlife Service, Division
of Law Enforcement under special circumstances. A
“Declaration for Importation or Exportation of Fish and
Wildlife” form must be filed upon import or export.
All NHPs must be transported in accordance with the
Animal Welfare Act (1986) . In addition, it is the respon-
sibility of the facility veterinarian to be cognizant of all
state, city, and county regulations which may be more
stringent than federal regulations.
European Union
Animal transport and shipment is regulated in the
European Union (EU) by a number of binding European
Council (EC) resolutions (1986, 2005, 2010). As in the
USA, the rules are designed to protect animals from stress,
injury, and disease during housing and shipment and to
protect human handlers from physical injury or zoonotic
diseases.
The 1986 European Council Directive 86/609/EEC
regulated the use of animals in research and was similar to
the US Animal Welfare Act in scope ( European Union,
1986 ). This directive was recently updated (Directive 2010/
63/EU) to standardize regulations across EU member
nations and expand the scope of the directive to include
regulations on housing, euthanasia, temperature, lighting,
noise levels, etc. ( European Union, 2010 ). The newer
European regulations are much wider in scope than current
US laws and combine regulations in the Animal Welfare
Act 1986 and guidelines set forth in the Guide for the Care
and Use of Laboratory Animals ( ILAR, 2010 ). Individual
member nations may have their own regulations in addition
to those in the EU Directive.
Facilities that use animals for experimentation must be
registered with the country in which they reside and there
must be an attending veterinarian responsible for the health
and welfare of animals at each institution. Facilities are
inspected regularly to ensure they meet all of the require-
ments set forth in the agreement. Animal medical records
must be kept including records of acquisition, shipments,
and dates of arrival. The use of great apes is prohibited
unless special circumstances exist.
The use of wild-caught animals is strictly regulated and
generally prohibited unless a special exemption is granted
based on scientific justification ( ILAR, 2010 ). New regu-
lations limit the acquisition of NHPs to ensure that only
animals that are the offspring of captive bred NHPs are
used in research settings. This provision does not take
effect immediately. Marmosets must be acquired in this
manner beginning in 2013 and macaques sometime after
2017 based on the publication of a feasibility study
assessing the impact of this provision.
The transport of NHPs within the EU is regulated by
European Council Directive (EC) 1/2005 ( European Union,
2005 ) which updates a previous 1991 directive ( European
Union, 1991 ). Both shipping and receiving institutions
must meet all of the requirements of their respective home
countries and those set forth in the European Union
Protection of Animals Directive. There are strict regula-
tions regarding the fitness of animals for transport and all
animals must be documented as fit
to travel prior to
Search WWH ::




Custom Search