R-CALF USA Action Alert

From:            Bill Bullard, CEO

Date:              September 1, 2020


Background:  Zoetis, Inc. petitioned the U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) to approve the manufacture of a vaccine derived from an attenuated (which means weakened), leaderless strain (which means the infectious agent is lacking) of the FMD virus. APHIS has already granted Zoetis a permit to bring attenuated live FMD virus into the mainland United States for the purpose of developing a vaccine.

In other words, the claim that it is an “attenuated, leaderless strain of the FMD virus” means the live virus has been genetically altered so it is no longer capable of causing the disease. That is the claim but neither the petition nor the APHIS’ Notice of Petition and Request for Information (Docket No. APHIS-2020-0054 available at www.regulations.gov) provide any studies to substantiate Zoetis’ claim.

Zoetis now wants to begin manufacturing a FMD vaccine in Texas and APHIS’ Notice of Petition and Request for Information is specifically seeking comments on the following questions regarding whether FMD vaccines should be manufactured commercially in the United States:

  • 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 development? If so, how?
  • What safeguards should surround the commercial manufacture of FMD vaccine, if authorized?

In addition, APHIS is seeking comments on how it should interpret the statute at 21 U.S.C. 113a that states:

That no live virus of foot-and-mouth disease may be introduced for any purpose into any part of the mainland of the United States (except coastal islands separated therefrom by water navigable for deep-water navigation and which shall not be connected with the mainland by any tunnel) unless the Secretary determines that it is necessary and in the public interest for the conduct of research and study in the United States (except at Brookhaven National Laboratory in Upton, New York) and issues a permit . . .

See https://codes.findlaw.com/us/title-21-food-and-drugs/21-usc-sect-113a.html for the entire statue.

Based on that statute, APHIS seeks comments on the following questions:

  • 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 (meaning its claimed inability to cause FMD) be considered to place it outside the scope of 21 U.S.C. 113a?

Here’s the gist of APHIS’ Notice of Petition and Request for Information:

If the altered live FMD virus that Zoetis wants to use to manufacture an FMD vaccine is still considered a live FMD virus – note that APHIS calls it a “attenuated live FMD virus” – then existing law does not allow its use for manufacturing on the mainland. That’s because existing law only allows a permit to bring the live FMD virus onto the mainland for “research and study.”

Zoetis knows this and claims the altered live FMD virus should not be considered a live FMD virus and should not be subject to the above-mentioned statute. Zoetis further understands that if the altered live FMD virus is still considered a live FMD virus, then Congress would have to pass new legislation in order for it to be used to manufacture a FMD vaccine from the altered live FMD virus.

The comment deadline is September 14, 2020.

Action: Submit comments on or before September 14. Here’s a suggestion of what you can say:

“I am a cattle producer and the notice of petition lacks any scientific studies to show that the Zoetis’ attenuated live FMD virus is completely incapable of causing FMD.  Furthermore, the statute at 21 U.S.C. 113a is very clear that the live FMD virus is prohibited from being brought to the mainland of the United States for any purpose other than research and study. Therefore, Zoetis’ petition to manufacture FMD vaccine using its attenuated live FMD virus should be denied.

Instead, APHIS should cease its high-risk practice of allowing imports of raw beef from countries where FMD is known to exist, such as Brazil, Argentina, Uruguay and Namibia. More than anything else, this will protect the U.S. from the introduction of this dangerous disease.”

If you are so inclined, you should also answer the specific questions listed above that APHIS has posed in its notice.

To submit comments, go to www.regulations.gov and type in:  APHIS-2020-0054.  Then click on the comment box and type your comments.

Good luck with your comments and thank you for your support!

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R-CALF USA (Ranchers-Cattlemen Action Legal Fund, United Stockgrowers of America) is the largest producer-only lobbying and trade association representing U.S. cattle producers. It is a national, nonprofit organization dedicated to ensuring the continued profitability and viability of the U.S. cattle industry. Visit www.r-calfusa.com or, call 406-252-2516 for more information.