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USDA Seeks Comments on FMD Vaccine

10 September 2010

US - The US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) is advising the public that it has released an environmental assessment for comment concerning authorization to ship and field test a foot-and-mouth disease (FMD) vaccine, live adenovirus vector.

The vaccine vector is replication-deficient and does not contain live FMD virus. Because there is no live FMD virus in the vaccine, the field test presents no risk for a disease outbreak.

Current regulations require that veterinary biological products are shown to be pure, safe, potent and efficacious before a US veterinary biological product license may be issued. A field test is generally necessary to satisfy prelicensing requirements for veterinary biological products. Applicants must obtain approval from APHIS to conduct a field test on an unlicensed product, as well as to ship the product for field testing.

The field tests would be conducted in Michigan, Missouri and Nebraska. Animals will be vaccinated and observed for any side effects. To determine whether to authorize shipment and grant approval for the field testing of this product, APHIS conducted a risk analysis to assess the potential effects of this product on the safety of animals, public health and the environment. As a result of this risk analysis, APHIS determined that there were no significant impacts expected.

APHIS has prepared an environmental assessment based on the risk analysis. The environmental assessment examines the potential effects of this product on the safety of animals, public health and the environment.

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