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

This Federal laboratory conducted FMD serology for all of Brazil except the northern
part, where FMD was considered endemic.
Vaccine efficacy was assessed in 5- to 7-day-old mice. FMD vaccine safety testing was
tested in the baby hamster kidney-21 (BHK-21) cell line.
At the time of the visit, the laboratory had five professional staff and three technicians.
They tested 30,000 serum samples per month for FMD serology.
Criteria for conducting followup on the positive samples seemed correct and well carried
out through EITB and ELISA confirmatory tests. The laboratory used virus isolation,
ELISA, complement fixation and IDGA to confirm vesicular disease diagnosis from the
regional authorized laboratories.
The laboratory was also equipped to run the highly sensitive suckling mice inoculation
technique for antigen detection, which is used for vaccine security tests.
The laboratory used ELISA, complement fixation, virus isolation and seroneutralization
assays to diagnose differential diseases such as infectious bovine rhinotracheitis, bovine
viral diarrhea virus and vesicular stomatitis virus.
The 2008 site visit team visited the Recife laboratory in Pernambuco and found:
The laboratory visited provides FMD and CSF serology and FMD vaccine efficacy for all
of Brazil except for the northern part, where FMD is endemic.
The laboratory is working under MAPA Regulation N 0 1 issued January 16, 2007; 2 0
Art.; 5,741 Decree of March 30, 2006, and according to the process n 0
21000.004072/2005-19, which defines the criteria for accreditation of MAPA’s national
agricultural laboratories (Laboratorio Nacional Agropecuario, or LANAGRO). An
independent agency regularly audits facilities under this regulation.
The laboratory also diagnoses:
o FMDV and its differentials vesicular stomatitis virus, bovine viral diarrhea virus, and
bovine rhinotracheitis virus;
o CSFV and its differentials Aujeszky’s disease, swine colibacillosis, porcine erysipela,
pasteurellosis and salmonellosis; and
o 17 other animal diseases.
Brazil has five FMDV vaccine plants in production. Two are close to Santa Catarina, one
in Parana and one in Matto Grosso do Sul. The laboratory visited provided vaccine
efficacy for each lot of FMDV vaccine produced.
The laboratory tests vaccine efficacy and potency using inoculation in 5- to 7-day-old
mice and seroneutralization titers in sera from the vaccinated animals. The animals are
not given live virus.
FMD vaccine safety is tested using the BHK-21 cell line.
CSFV vaccine is produced only for export. The laboratory visited does safety tests in cell
cultures and potency tests with live virus challenges to vaccinated pigs, in facilities
located in endemic areas of the country. Although these techniques differ from OIE
recommendations, the site visit team considers them adequate because of the limitations
of BSL-3 agriculture animal facilities and the cost of bovine test techniques.
The laboratory has 27 professional staff members and 110 technicians or supporting
personnel. Seven professionals (veterinarians and chemical and agronomic engineers)
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