Biomedical Engineering Reference
In-Depth Information
been published and recently adopted at the OIE's General
Assembly (chapter 7.8). The added text references the
Three Rs, protocol and programme review, training of those
involved in veterinary care, the animal facilities, as well as
animal health control, with particular attention to health
issues related to nonhuman primate use.
endanger the public health, it may require their examina-
tion, treatment, detention, isolation, seizure, or destruction
at the owner's expense.
Primates that arrive in the USA but whose importation is
precluded by provisions of the CDC regulations are disposed
of, at the owner's expense, under arrangements approved by
the CDC. Under some circumstances, the disposal could be
donation to a scientific, educational, or exhibition facility.
The CDC regulations on importation of primates cite other
federal regulations such as the USDA Animal Welfare
regulations for husbandry and care standards.
World Health Organization
The World Health Organization (WHO) monitors infection
risk in humans, such as WHO Experts Consultation on
Ebola Reston Pathogenicity in Humans (2009) (
http://
www.who.int/csr/resources/publications/HSE_EPR_2009_
2.pdf
), which includes a discussion of the transmission of
Ebola virus from nonhuman primates to people and Regu-
latory Requirements for Xenotransplantation Clinical
Trials (2008) (
http://www.who.int/transplantation/xeno/
ChangshaCommunique.pdf
), which requires investigators
to provide a clear justification for clinical trials, including
adequate preclinical data on safety and efficacy, usually
derived from nonhuman primates.
Specific Requirements for Filovirus
The CDC placed increased restrictions on the importation
of rhesus, cynomolgus, and African green monkeys due to
the outbreaks of Ebola-like virus infections in several US
importers' facilities during late 1989 and early 1990.
Epizootics were identified in several shipments of cyn-
omolgus monkeys from the Philippines. Rhesus and
African green monkeys, even in closed colonies, were
found to have antibodies to the Ebola-like virus. Because of
the high human mortality experienced during Ebola and
Marburg virus infections in the past, CDC took a conser-
vative approach
US Centers for Disease Control and
Prevention
The Centers for Disease Control and Prevention (CDC)
(
http://www.cdc.gov/
) have an overarching public health
role in the US.
imposing more stringent primate quar-
antine requirements (MMWR, March 1990) and requiring
special one-time permits to import these three species and
to release them from quarantine (MMWR, April 1990).
e
Publications and Reports
The CDC publishes the Morbidity and Mortality Weekly
Report (MMWR) (
http://www.cdc.gov/mmwr/
) wherein it
disseminates public health information and recommenda-
tions to a broad audience of health professionals, researchers,
and other interested parties. Reports of interest to primate
users include Notice to Readers: Occupational Safety and
Health in the Care and Use of Nonhuman Primates
(September 26, 2003/52(38); 920
Importing Nonhuman Primates into the USA
Importation of Nonhuman Primates Title 42 US Code
264 (Public Health and Welfare) 42 CFR 71
The responsibilities of the PHS for preventing the introduc-
tion of communicable diseases into the USA have been
assigned to the CDC. The regulations of the CDC on foreign
quarantine contain a section on nonhuman primates (42 CFR
71.53) which limits their importation for scientific, educa-
tional, or exhibition purposes and expressly excludes
importation for use as pets. Importers, whomust be registered
with the director of the CDC, must document the intended use
and certify that the primates will not be transferred to other
persons without proof of intended legal use. They may not
ship primates to an unregistered organization until
a minimum of 31 days of quarantine has been achieved.
Detailed record keeping is required. An importer's registra-
tion can be revoked for violations of CDC requirements.
Importers must report to the CDC, within 24 hours, any
primate disease suspected of being yellow fever, mon-
keypox, or Marburg/Ebola disease (filovirus). The same
reporting requirement applies to any illness in a staff
member that may have been acquired from a nonhuman
primate. If the CDC has evidence that nonhuman primates
have been exposed to a communicable disease that may
920); US Public Health
Service Guideline on Infectious Disease Issues in Xeno-
transplantation (August 24, 2001/50(RR15); 1
e
46);
Updated US Public Health Service Guidelines for the
Management of Occupational Exposures to HBV, HCV, and
HIV and Recommendations for Postexposure Prophylaxis
(June 29, 2001/50(RR11);1
e
42); as well asMMWRs related
to filovirus and B virus. In addition, the CDC publishes the
online journal Emerging Infectious Diseases (
http://www.
cdc.gov/ncidod/eid/
).
e
Standards
The CDC and NIH jointly co-author the report Biosafety in
Microbiological and Biomedical Laboratories (2007)
(
http://www.cdc.gov.tw/public/Data/9651242771.pdf
) which
is the basis for biosafety practice in the USA and, due to its
