USDA Seeks Comments on Request to Produce FMD Vaccine on U.S. Mainland

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USDA’s Animal and Plant Health Inspection Service (APHIS) is seeking public comment on a petition from a vaccine manufacturer seeking approval to produce a foot-and-mouth disease (FMD) vaccine consisting of a modified non-infectious and non-transmissible strain of the virus on the U.S. mainland, according to a USDA release.

“Access to FMD vaccine is an important part of our FMD preparedness efforts, but to protect against the introduction of this devastating livestock disease, the live virus of FMD is not allowed anywhere in the country except for the Plum Island Animal Disease Center where it is held and worked with under very strict biocontainment procedures,” USDA said in a release. “That exemption will also apply to its successor facility, the National Bio and Agro-Defense Facility, after the facility is complete.”

The vaccine, which was developed jointly with USDA’s Agricultural Research Service, is non-infectious, non-transmissible and incapable of causing the disease because it has been modified so that it is no longer able to produce infection.

Because the FMD virus is no longer able to produce infection, it should not be considered live virus of FMD and should be able to be produced on the U.S. mainland, the manufacturer said.  

FMD is a highly contagious viral disease affecting cows, pigs, sheep, goats, deer and other animals with divided hooves. It was eradicated in 1929 from the U.S. However, if the disease were to infect the U.S. livestock industry today, it would cause devastating economic effects, USDA said.

According to the release, APHIS is seeking the public’s comments as part of the petition review process on two topics: the manufacturer’s interpretation of live virus and whether there is support for manufacturing the vaccine in the U.S. Public comments will be accepted through September 14 at https://www.federalregister.gov/d/2020-15031.

APHIS will then review all comments before making a final decision.


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