[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42346-42347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15031]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / 
Notices  

[[Page 42346]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0054]


Petition To Manufacture Foot-and-Mouth Disease Vaccine in the 
United States

AGENCY: Animal and Plant Health Inspection Service, Agriculture (USDA).

ACTION: Notice of petition and request for information.

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SUMMARY: We are notifying the public that the Animal and Plant Health 
Inspection Service has received a petition from Zoetis, Inc. to approve 
the manufacture within the continental United States of a vaccine 
derived from a leaderless strain of the foot-and-mouth disease (FMD) 
virus. While introduction of live FMD virus into the United States is 
prohibited by law, the petition states that this attenuated strain of 
the virus is incapable of causing FMD symptoms or infection in animals. 
We are soliciting comments from the public regarding the petition and 
requesting information that will aid us in determining how best to 
respond to the petition.

DATES: We will consider all comments that we receive on or before 
September 14, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0054.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0054, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-
0054 or in our reading room, which is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Byron Rippke, Director, Center for 
Veterinary Biologics, APHIS, Veterinary Services, Diagnostics and 
Biologics, 1920 Dayton Ave., Ames, IA 50010; (515) 337-6101; 
[email protected].

SUPPLEMENTARY INFORMATION: 

Background

    Foot-and-mouth disease, or 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. While FMD has been 
eradicated from the United States since 1929, the disease is currently 
found in parts of Africa, Asia, Europe, and South America.
    Federal regulations restrict or prohibit the importation of live 
ruminants and swine, or fresh meat and certain products of ruminants or 
swine, from any region where FMD exists. In addition, the Federal 
Select Agent Program, managed jointly by the U.S. Department of Health 
and Human Services and the U.S. Department of Agriculture (USDA), 
oversees the possession, use, and transfer of biological select agents 
and toxins. Within USDA, APHIS regulates those agents that can cause 
disease in animals under 9 CFR part 121. As FMD has the potential to 
pose a severe threat to animal health and animal products, it is listed 
in Sec.  121.3 of the regulations as a Tier 1 select agent.
    Under 21 U.S.C. 113a, the Secretary of Agriculture is authorized to 
establish 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 virus of FMD may be introduced for any purpose into any part of 
the mainland of the United States unless the Secretary determines that 
it is necessary and in the public interest for the conduct of research 
and study in the United States and issues a permit under such rules so 
as to protect animal health.
    APHIS has received a petition from Zoetis, Inc. to approve the 
manufacture of a vaccine derived from an attenuated, leaderless strain 
of the FMD virus. In accordance with the regulations in 9 CFR part 122, 
USDA issued a permit to the petitioner to bring attenuated live FMD 
virus into the mainland United States for the purpose of developing a 
vaccine.
    The FMD virus strain brought into the United States under permit 
was genetically modified by removing the leader protease gene, 
rendering the strain incapable of becoming infectious, pathogenic, 
contagious, or of producing clinical or subclinical signs of FMD. This 
modification makes the virus unable to reacquire its infectious 
abilities through mutation. The petitioner also introduced unique 
restriction enzyme sites into the genome for emerging vaccine strain 
development, as well as markers that allow for differentiation of 
infected from vaccinated animals.
    Based on these modifications, the petitioner asserts that 
manufacturing FMD vaccine using the modified FMD virus as the master 
seed should not be considered within the scope of prohibitions in 21 
U.S.C. 113a on the grounds that their virus strain is no longer a live 
virus of FMD.
    This request for information (RFI) seeks public comment on this 
interpretation, as well as whether public support exists for the 
development of an FMD vaccine within the United States. Comments 
received on this RFI will inform our determination whether to authorize 
the petitioner to manufacture the vaccine for possible commercial 
distribution.\1\
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    \1\ To view the petition, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0054.
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    As we review the petition, we are soliciting public comments 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 development? If so, how?

[[Page 42347]]

     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?
    We welcome all comments on the petition and the issues outlined 
above.

    Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 8th day of July 2020.
Mark Davidson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-15031 Filed 7-13-20; 8:45 am]
BILLING CODE 3410-34-P