December 28, 2020

FMD Vaccine Production Comment Period Re-opened by APHIS

FMD Vaccine Production Comment Period Re-opened by APHIS

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) re-opened the public comment period for a petition from Zoetis, Inc., a vaccine manufacturer, pursuing approval to create a foot-and-mouth disease (FMD), consisting of a modified non-infectious and non-transmissible strain of the FMD in the United States. The comment period is now open an additional 30 days, ending January 4, 2021.

FMD is a severe, highly contagious viral illness of cows, pigs, sheep, goats, deer, and other animals with divided hooves. The virus weakens affected animals and permanently reduces their ability to produce meat and milk. FMD was eradicated in the United States in 1929, but the disease is currently found in parts of Africa, Asia, Europe, and South America.

The introduction of live FMD virus into the United States is prohibited by law, under  9 CFR part 121. Because of the severe threat FMD imposes, it is considered a Tier 1 select agent. Under 21 U.S.C. 113a, the Secretary of Agriculture is authorized to institute laboratories and make contracts for research and study, in the United States or elsewhere, of FMD or other diseases that constitute a threat to the livestock industry of the United States. No live FMD virus may be introduced for any purpose the United States unless the Secretary determines that it is necessary and in the public interest for research and study in the United States and issues a permit to protect animal health. In the petition, Zoetis states this attenuated strain of the virus is incapable of causing FMD symptoms or infections within animals. APHIS is requesting the public’s commentary, which will assist in determining how best to respond to Zoetis’ petition.

APHIS is asking the public to comment on the following questions:

  • Are there possible risks to livestock associated with the commercial manufacture of FMD vaccine in the United States? If so, are these offset by possible benefits associated with such development, assuming appropriate safeguarding?
  • If there are possible risks, do these risks differ depending on the location and method of the development? If so, how?
  • What safeguards should surround the commercial manufacture of FMD vaccine, if authorized?
  • How should the overall language of 21 U.S.C. 113a be interpreted in light of significant technical developments in the field of virology since its enactment?
  • APHIS notes that “introduced” is not defined within 21 U.S.C. 113a. How should “introduced . . . into the mainland United States” be interpreted?
  • Based on the information supplied, should the modified virus (master seed) be considered a “live virus of foot-and-mouth disease”? Specifically, should its inability to express as FMD be considered to place it outside the scope of 21 U.S.C. 113a?

Comments are welcome until January 4, 2021. Submit a public comment here.