This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

77425 

Vol. 85, No. 232 

Wednesday, December 2, 2020 

1To view the notice, the supporting document, 

and the comments we have received, go to http:// 

www.regulations.gov/#!docketDetail;D=APHIS2020-0054. 

2Referred to in the Zoetis petition as FMD– 

LL3B3D A24 Cruzeiro vaccine platform virus. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2020–0054] 

Petition To Manufacture Foot-andMouth Disease Vaccine in the United 

States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of petition and request 

for information; reopening of comment 

period. 

SUMMARY: We are reopening the 

comment period for our notice of receipt 

of a petition from Zoetis, Inc. requesting 

approval for the manufacture within the 

continental United States of a vaccine 

derived from a leaderless strain of the 

foot-and-mouth disease (FMD) virus. 

Although introduction of live FMD 

virus into the United States is 

prohibited by law, the petition states 

that this leaderless strain should not be 

considered live FMD virus as it is noninfectious, non-transmissible, and 

incapable of causing FMD. We are 

taking this action in order to provide 

commenters with additional scientific 

information supporting our 

determination that the leaderless virus 

strain from which Zoetis, Inc. intends to 

produce FMD vaccine in the United 

States poses no risk of causing FMD 

infection in animals. This action gives 

interested persons the opportunity to 

review the additional information and 

submit comments. 

DATES: The comment period for the 

notice published on July 14, 2020 (85 

FR 42346–42347) is reopened. We will 

consider all comments that we receive 

on or before January 4, 2021. 

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 1620 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; Byron.e.rippke@

usda.gov. 

SUPPLEMENTARY INFORMATION: On July 

14, 2020, we published in the Federal 

Register (85 FR 42346–42347, Docket 

No. APHIS–2020–0054) a notice and 

request for information 1 on a petition 

submitted by Zoetis, Inc. (Zoetis), a U.S. 

vaccine manufacturer, seeking approval 

from the Animal and Plant Health 

Inspection Service (APHIS) to 

manufacture within the continental 

United States a vaccine produced using 

a leaderless strain 2 of the foot-andmouth disease (FMD) virus. A leaderless 

virus lacks part of the genetic code (the 

leader) critical for determining 

virulence in a host. Responses to this 

request for information will help us 

determine whether to authorize Zoetis 

to manufacture the vaccine in the 

United States for commercial 

distribution. 

In the notice, we invited commenters 

to respond to questions about the risks 

of manufacturing an FMD vaccine in the 

United States and what safeguards 

might be necessary to address risk. We 

also asked commenters whether the 

leaderless strain of the virus intended 

for manufacture of a vaccine should be 

considered as a live FMD virus based on 

the Zoetis petition and information we 

supplied in the notice. This question is 

important in determining whether the 

prohibition in 21 U.S.C. 113a on 

introducing live FMD virus into the 

United States is applicable to a 

leaderless virus strain shown to be 

incapable of causing FMD infection in 

animals. 

We solicited comments concerning 

our proposal for 60 days ending 

September 14, 2020. We received a total 

of 140 comments. While many 

commenters agreed that the Zoetis 

leaderless virus poses no FMD risk to 

U.S. livestock, several others raised 

safety concerns about using it to 

manufacture FMD vaccine in the United 

States. They stated that the notice and 

petition did not provide enough data to 

support a determination that the 

leaderless virus is not a live virus and 

that it poses no risk of causing FMD 

infection in animals. To address these 

concerns, we are providing additional 

data in this notice supporting the safety 

of the leaderless FMD virus and its use 

in manufacturing FMD vaccine and are 

reopening the comment period for 30 

days. 

Risk Assessment Summary 

In 2017, Zoetis requested from the 

U.S. Department of Agriculture (USDA) 

a select agent exclusion for a leaderless 

strain of FMD virus intended to be used 

as a platform for producing FMD 

vaccine. In accordance with the 

regulations in 9 CFR part 122, USDA 

issued a permit allowing Zoetis to bring 

attenuated live FMD virus into the 

mainland United States for possible 

vaccine development. Before issuing the 

permit, USDA reviewed multiple 

documents and studies related to the 

request. The review encompassed 

synthetic virus production, virulence 

and safety, seroconversion, and 

concerns related to diagnostic 

differentiation of vaccinated and 

naturally infected animals. We 

concluded from these reviews that the 

Zoetis leaderless virus is incapable of 

infecting animals with FMD, and that 

vaccines produced using the leaderless 

virus as a platform are safe and 

efficacious in cattle and swine. Further 

details of our review findings are 

included in a risk assessment summary 

available via the link in footnote 1. 

77426 Federal Register / Vol. 85, No. 232 / Wednesday, December 2, 2020 / Notices 

3See the following studies for leaderless FMD 

virus safety data: Uddowla S., et al. A Safe Footand-Mouth Disease Vaccine Platform with Two 

Negative Markers for Differentiating Infected from 

Vaccinated Animals. Journal of Virology Oct 2012, 

86(21) 11675–11685: DOI: 10.1128/JVI.01254–12; 

Eschbaumer M., et al. Foot-and-mouth disease virus 

lacking the leader 2 protein and containing two 

negative DIVA markers 3 (FMDV LL3B3D A24) is 

fully attenuated in pigs. Pathogens. (2020) 17:1–8: 

DOI: 10.3390/pathogens9020129; Hardham, John 

M., et al., Novel Foot-and-Mouth Disease Vaccine 

Platform: Formulations for Safe and DIVACompatible FMD Vaccines with Improved Potency. 

Frontiers in Veterinary Science, 25 September 2020; 

https://doi.org/10.3389/fvets.2020.554305. 

4 In a 2018 meeting report drafted by the Global 

Foot-and-Moth Disease Research Alliance that 

reviewed FMD vaccine platforms, the FMDLL3B3D 

platform received the highest score. Global Footand-Mouth Disease Research Alliance, Gap 

Analysis Report. December 2018: https://

go.usa.gov/xdrKh. 

In addition to the risk assessment 

summary, we wish to provide the 

following information regarding our 

evaluation. 

Development and Safety of the FMD– 

LL3B3D Leaderless FMD Virus 

The FMD–LL3B3D leaderless vaccine 

platform virus was created by deleting 

the leader (L) and one of three 3B 

genetic sequences of the FMD virus (L 

is a part of the virus that determines 

virulence), resulting in an attenuated 

virus that is innocuous for cattle and 

pigs but capable of growing in cell 

culture.3 As a result, if the FMD– 

LL3B3D leaderless virus were to escape 

a manufacturing facility, it would be 

incapable of causing FMD in any 

animals exposed to it, nor could such 

animals spread the virus to other 

animals. In contrast, the risk of escape 

from facilities using traditionally 

virulent FMD viruses to manufacture 

vaccine is why many countries restrict 

FMD vaccine production to only local 

endemic strains. The deletion of L and 

the relevant 3B genetic sequence was 

therefore a key consideration in our 

evaluation. 

Of similar importance was our review 

of available data regarding virulence of 

FMD–LL3B3D vaccines. Several FMD– 

LL3B3D vaccine viruses have been 

derived in vitro and characterized for 

their virulence in cattle and pigs. The 

cumulative data have shown that these 

FMD–LL3B3D marker viruses are highly 

attenuated in their natural hosts. Safety 

studies involving direct inoculation of 

live FMD–LL3B3D virus in cattle and 

pigs (see table 1) showed a high 

restriction of the novel vaccine virus to 

replicate and resulted in no clinical 

disease or transmission.4

TABLE 1—LIVE INNOCUITY STUDIES USING A VARIETY OF FMDLL3B3D VACCINE STRAINS IN CATTLE AND SWINE 1

Construct Inoculation route Number of 

animals Results 

Cattle: 

FMD–LL3B3D–A24 Cruzeiro ............ Intralingual (7×106) .................................. 2 • No clinical disease. 

FMD–LL3B3D–A24 Cruzeiro ............ Aerosol (1×106 to 3×106) ........................ 3 • No viral shedding. 

FMD–LL3B3D–A24 Cruzeiro ............ Aerosol and Contact/(1×106) ................... 9 • No fever spikes. 

• No contact transmission. 

• Very limited if any immune response. 

Swine: 

FMD–LL3B3D–A24 Cruzeiro ............ Heelbulb and Contact (1×105) ................ 4 • No clinical disease. 

FMD–LL3B3D–Asia1 Shamir ........... Heelbulb and Contact (1×106) ................ 5 • No viral shedding. 

FMD–LL3B3D–A Turkey 06 ............. Heelbulb and Contact (1×106) ................ 5 • No fever spikes. 

FMD–LL3B3D–O1 Campos ............. Heelbulb and Contact (1×106) ................ 4 • No contact transmission. 

FMD–LL3B3D–A Argentina .............. Heelbulb and Contact (2×106) ................ 4 • Very limited if any immune response. 

FMD–LL3B3D–C3 Indaial ................ Heelbulb and Contact (2.8×106) .............. 4 

1 Data prepared by Foreign Animal Disease Research Unit, USDA/ARS, Plum Island Animal Disease Center. 

We are therefore reopening the 

comment period on Docket No. APHIS– 

2020–0054 for an additional 30 days. 

This action will allow interested 

persons to prepare and submit 

comments on the additional information 

we provided. We will also consider all 

comments received between September 

14, 2020, and the date of this notice. 

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 25th day of 

November 2020. 

Mark Davidson, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2020–26560 Filed 12–1–20; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Forest Service 

Medicine Bow-Routt National Forests 

and Thunder Basin National 

Grassland; Wyoming; 2020 Thunder 

Basin National Grassland Plan 

Amendment 

AGENCY: Forest Service, USDA. 

ACTION: Notice of Grassland Plan 

amendment approval. 

SUMMARY: Russell M. Bacon, Forest 

Supervisor for the Medicine Bow-Routt 

National Forests and Thunder Basin 

National Grassland, Rocky Mountain 

Region, signed the final Record of 

Decision (ROD) for the 2020 Thunder 

Basin National Grassland Land and 

Resource Management Plan Amendment 

(Grassland Plan amendment). The Final 

ROD documents the rationale for 

approving the Grassland Plan 

amendment and is consistent with the 

Reviewing Officer’s response to 

objections and instructions. 

DATES: The effective date of the 

Grassland Plan amendment is 30 days 

after publication of notice of Grassland 

Plan amendment approval in the 

newspaper of record, the Laramie 

Boomerang. 

ADDRESSES: To view the final ROD, final 

environmental impact statement (FEIS), 

FEIS errata, objection responses, and 

other related documents, visit the 2020 

Thunder Basin National Grassland Plan 

Amendment website at https://

www.fs.usda.gov/project/ 

?project=55479. 

FOR FURTHER INFORMATION CONTACT: 

Monique Nelson, plan amendment team 

leader, by email at monique.nelson@

usda.gov or by telephone at 307–275– 

0956. 

Individuals who use 

telecommunication devices for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877–8339