Zoetis, Inc. has petitioned the Animal and Plant Health Inspection Service (APHIS) for the manufacture of a “vaccine derived from a leaderless strain of the foot-and-mouth disease (FMD) virus,” according to a notice in the Federal Register.
The petition by Zoetis states the strain has been genetically modified to make the virus unable to reacquire its infectious abilities through mutation. No live virus may be introduced in the U.S. for any purpose, and the Plum Island Animal Disease Center is the only place where it is held and worked with under stringent biocontainment procedures.
The secretary of agriculture is authorized to establish laboratories and determine if it is necessary and in the public interest to issue a permit. The vaccine was developed jointly with the USDA’s Agricultural Research Service.
The Ranchers-Cattlemen Action Legal Fund United Stockgrowers of America (R-CALF USA) submitted comments stating APHIS has no authority to approve the petition. The group says that under the context of 21 U.S.C. § 113a, APHIS is overreaching Congress by allowing for the manufacture of the vaccine. R-CALF USA also states the “three-paragraph self-serving position paper by Zoetis” does not substantiate their claim the proposed FMD vaccine manufacture is safe.
