Exhibit 8, 100416 Brazil FMD Risk Evaluation - R-Calf

10. Diagnostic laboratory capacity
The laboratory system, including test procedures for the diseases under evaluation, quality assurance
measures, and official oversight procedures, must be clearly documented to provide confidence in
disease surveillance activities and the ability to quickly detect and confirm a disease outbreak. This
section explains the laboratory capabilities of Santa Catarina for diagnosing and detecting FMD,
CSF, SVD, and ASF.
General information
Brazil’s Ministry of Agriculture has three laboratories that perform diagnostic tests for FMD. These
laboratories are located in Pedro Leopoldo, Pará, and Recife. The PANAFTOSA laboratory in Rio
de Janeiro is the reference laboratory. The laboratory in Recife performs CSF serological testing,
and SVD and ASF testing if necessary.
Brazil’s laboratories perform the following routine FMD tests:
Virus typing: Complement fixation and ELISA test (double antibody sandwich ELISA).
Assessment of antibody level: ELISA test in liquid phase (blocking ELISA) and serum
neutralization.
Detection of viral activity through the anti-virus infection associated antigen (VIAA),
ELISA 3ABC, and EITB tests.
Identification of the virus in esophageal-pharyngeal fluid through the Probang test.
Four State laboratories are part of a network of authorized laboratories that perform certain FMD
diagnostics to admit animals into the export region and for serological monitoring. The laboratories
perform EITB and VIAA tests and began ELISA 3ABC testing in 2002. Only MAPA laboratories
carry out diagnostic activities in response to suspected outbreaks of vesicular diseases and as a part
of viral activity studies to implement free zones.
The 2002 site visit team visited three of the abovementioned laboratories [6] and reported the
following:
Diagnostic laboratory in Pedro Leopolodo, Minas Gerais:
This Federal laboratory had a biosafety level (BSL) 2 facility for bacteriology
(brucellosis and TB testing) and chemistry laboratory.
The staff had about 94 people.
Behind the BSL-2 facility, a new BSL-3 laboratory was under construction.
The laboratory was about 2,500 square meters in size and had nine laboratories with a
double airlock and a separate air zone for each laboratory. There was a separate animal
facility with a separate entrance.
The facility had three rooms for large animals with an individual shower for each room,
and three rooms for small animals with a common shower in the hallway.
The necropsy room had two oversized autoclaves for decontaminating carcasses.
HEPA filters and the mechanical room were located on the third floor.
The basement had three 3,000-gallon tanks for decontaminating effluent by boiling at
100C.
Animal Products Analysis Laboratory (LAPA/Recife), Pernambuco
APHIS Evaluation of the Status of the Brazilian State of Santa Catarina 55