83 FR 50884 - Availability of an Environmental Assessment for Field Testing of a Swine Influenza Vaccine, DNA

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 83, Issue 196 (October 10, 2018)

Page Range		50884-50885
FR Document		2018-21926

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Swine Influenza Vaccine, DNA. Based on the environmental assessment, risk analysis, and other relevant data, we have reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment. We are making the documents available to the public for review and comment.

Federal Register, Volume 83 Issue 196 (Wednesday, October 10, 2018)

[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50884-50885]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21926]


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Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / 
Notices

[[Page 50884]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2018-0042]


Availability of an Environmental Assessment for Field Testing of 
a Swine Influenza Vaccine, DNA

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has prepared an environmental assessment concerning 
authorization to ship for the purpose of field testing, and then to 
field test, an unlicensed Swine Influenza Vaccine, DNA. Based on the 
environmental assessment, risk analysis, and other relevant data, we 
have reached a preliminary determination that field testing this 
veterinary vaccine will not have a significant impact on the quality of 
the human environment. We are making the documents available to the 
public for review and comment.

DATES: We will consider all comments that we receive on or before 
November 9, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0042.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2018-0042, 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-2018-
0042 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. Donna Malloy, Operational Support 
Section, Center for Veterinary Biologics, Policy, Evaluation, and 
Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737-
1231; phone (301) 851-3426, fax (301) 734-4314.
    For information regarding the environmental assessment or the risk 
analysis, or to request a copy of the environmental assessment (as well 
as the risk analysis with confidential business information redacted), 
contact Dr. Patricia L. Foley, Risk Manager, Center for Veterinary 
Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton 
Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100, fax (515) 
337-6120.

SUPPLEMENTARY INFORMATION: Under the Virus-Serum-Toxin Act (21 U.S.C. 
151 et seq.), the Animal and Plant Health Inspection Service (APHIS) is 
authorized to promulgate regulations designed to ensure that veterinary 
biological products are pure, safe, potent, and efficacious before a 
veterinary biological product license may be issued. Veterinary 
biological products include viruses, serums, toxins, and analogous 
products of natural or synthetic origin, such as vaccines, antitoxins, 
or the immunizing components of microorganisms intended for the 
diagnosis, treatment, or prevention of diseases in domestic animals.
    APHIS issues licenses to qualified establishments that produce 
veterinary biological products and issues permits to importers of such 
products. APHIS also enforces requirements concerning production, 
packaging, labeling, and shipping of these products and sets standards 
for the testing of these products. Regulations concerning veterinary 
biological products are contained in 9 CFR parts 101 to 124.
    A field test is generally necessary to satisfy prelicensing 
requirements for veterinary biological products. Prior to conducting a 
field test on an unlicensed product, an applicant must obtain approval 
from the Animal and Plant Health Inspection Service (APHIS), as well as 
obtain APHIS' authorization to ship the product for field testing.
    To determine whether to authorize shipment and grant approval for 
the field testing of the unlicensed product referenced in this notice, 
APHIS considers the potential effects of this product on the safety of 
animals, public health, and the environment. Based upon a risk analysis 
and other relevant data, APHIS has prepared an environmental assessment 
(EA) concerning the field testing of the following unlicensed 
veterinary biological product:
    Requester: Antelope Valley Bios, Inc.
    Product: Swine Influenza Vaccine, DNA.
    Possible Field Test Locations: Minnesota, North Carolina, and 
Oklahoma.
    The above-mentioned product is a DNA vaccine containing a 
hemagglutinin gene from swine influenza virus, subtype H3. The vaccine 
is intended for use in healthy swine 3 weeks of age or older, 
administered by intramuscular inoculation, as an aid in the prevention 
of disease due to swine influenza virus, subtype H3.
    The EA has been prepared in accordance with: (1) The National 
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et 
seq.), (2) regulations of the Council on Environmental Quality for 
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    We are publishing this notice to inform the public that we will 
accept written comments regarding the EA from interested or affected 
persons for a period of 30 days from the date of this notice. Unless 
substantial issues with adverse environmental impacts are raised in 
response to this notice, APHIS intends to issue a finding of no 
significant impact (FONSI) based on the EA and authorize shipment of 
the above product for the initiation of field tests following the close 
of the comment period for this notice.
    Because the issues raised by field testing and by issuance of a 
license are identical, APHIS has concluded that the EA that is 
generated for field testing would also be applicable to the

[[Page 50885]]

proposed licensing action. Provided that the field test data support 
the conclusions of the original EA and the issuance of a FONSI, APHIS 
does not intend to issue a separate EA and FONSI to support the 
issuance of the associated product license, and would determine that an 
environmental impact statement need not be prepared. APHIS intends to 
issue a veterinary biological product license for this vaccine 
following satisfactory completion of the field test provided no adverse 
impacts on the human environment are identified and provided the 
product meets all other requirements for licensing.

    Authority: 21 U.S.C. 151-159.

    Done in Washington, DC, this 3rd day of October 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-21926 Filed 10-9-18; 8:45 am]
 BILLING CODE 3410-34-P

Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices 50885

proposed licensing action. Provided that Wildlife Services, 140–C Locust Grove Independence Avenue SW, Washington,
the field test data support the Road, Pittstown, NJ 08867; (908) 735– DC, between 8 a.m. and 4:30 p.m.,
conclusions of the original EA and the 5654, fax (908) 735–0821, email: Monday through Friday, except
issuance of a FONSI, APHIS does not beth.e.kabert@aphis.usda.gov. holidays. Persons wishing to inspect
intend to issue a separate EA and FONSI SUPPLEMENTARY INFORMATION: The copies are requested to call ahead on
to support the issuance of the associated Wildlife Services (WS) program in the (202) 799–7039 to facilitate entry into
product license, and would determine Animal and Plant Health Inspection the reading room. In addition, copies
that an environmental impact statement Service (APHIS) cooperates with may be obtained as described under FOR
need not be prepared. APHIS intends to Federal agencies, State and local FURTHER INFORMATION CONTACT.
issue a veterinary biological product governments, and private individuals to The 2018 supplement to the EA and
license for this vaccine following research and implement the best the FONSI have been prepared in
satisfactory completion of the field test methods of managing conflicts between accordance with: (1) The National
provided no adverse impacts on the wildlife and human health and safety, Environmental Policy Act of 1969
human environment are identified and agriculture, property, and natural (NEPA), as amended (42 U.S.C. 4321 et
provided the product meets all other resources. Wildlife-borne diseases that seq.); (2) regulations of the Council on
requirements for licensing. can affect domestic animals and humans Environmental Quality for
Authority: 21 U.S.C. 151–159. are among the types of conflicts that implementing the procedural provisions
Done in Washington, DC, this 3rd day of
APHIS–WS addresses. Wildlife is the of NEPA (40 CFR parts 1500–1508); (3)
October 2018. dominant reservoir of rabies in the USDA regulations implementing NEPA
Kevin Shea,
United States. (7 CFR part 1b); and (4) APHIS’ NEPA
On July 3, 2018, we published in the Implementing Procedures (7 CFR part
Administrator, Animal and Plant Health Federal Register (83 FR 31117–31118,
Inspection Service. 372).
Docket No. APHIS–2018–0033) a
[FR Doc. 2018–21926 Filed 10–9–18; 8:45 am]
notice 1 in which we announced the Done in Washington, DC, this 3rd day of
BILLING CODE 3410–34–P October 2018.
availability, for public review and
comment, of a supplement to an Kevin Shea,
environmental assessment (EA) that Administrator, Animal and Plant Health
DEPARTMENT OF AGRICULTURE Inspection Service.
examined the potential environmental
impacts associated with the proposed [FR Doc. 2018–21924 Filed 10–9–18; 8:45 am]
Animal and Plant Health Inspection
Service field trial to test the safety and efficacy BILLING CODE 3410–34–P
of an experimental oral rabies vaccine
[Docket No. APHIS–2018–0033] (ORV) for wildlife in New Hampshire,
New York, Ohio, Vermont, and West
Oral Rabies Vaccine Trial; Availability DEPARTMENT OF COMMERCE
Virginia. In addition, the supplement
of a Supplement to an Environmental
analyzed the potential impacts of
Assessment and Finding of No Economic Development Administration
Significant Impact expanding the geographic range of the
field trial zone to two additional Notice of Petitions by Firms for
AGENCY: Animal and Plant Health counties in Ohio and four additional Determination of Eligibility To Apply
Inspection Service, USDA. counties in West Virginia. for Trade Adjustment Assistance
ACTION: Notice. We solicited comments on the EA for
30 days ending August 2, 2018. We did AGENCY:Economic Development
SUMMARY: We are advising the public not receive any comments. Administration, U.S. Department of
that the Animal and Plant Health In this document, we are advising the Commerce.
Inspection Service has prepared a public of our finding of no significant
supplement to an environmental impact (FONSI) relative to the ORV field ACTION: Notice and opportunity for
assessment and finding of no significant trial in New Hampshire, New York, public comment.
impact relative to an oral rabies Ohio, Vermont, and West Virginia. The
vaccination field trial in New finding, which is based on the EA and SUMMARY: The Economic Development
Hampshire, New York, Ohio, Vermont, the 2013, 2015, and 2017 supplements Administration (EDA) has received
and West Virginia. Based on its finding to the EA, reflects our determination petitions for certification of eligibility to
of no significant impact, the Animal and that the distribution of this apply for Trade Adjustment Assistance
Plant Health Inspection Service has experimental wildlife rabies vaccine from the firms listed below.
determined that an environmental will not have a significant impact on the Accordingly, EDA has initiated
impact statement need not be prepared. quality of the human environment. investigations to determine whether
FOR FURTHER INFORMATION CONTACT: Mr. The 2018 supplement to the EA and increased imports into the United States
Richard Chipman, Rabies Program the FONSI may be viewed on the APHIS of articles like or directly competitive
Coordinator, Wildlife Services, APHIS, website at http://www.aphis.usda.gov/ with those produced by each of the
59 Chennell Drive, Suite 7, Concord, NH wildlifedamage/nepa and on the firms contributed importantly to the
03301; (603) 223–9623. To obtain copies Regulations.gov website (see footnote 1). total or partial separation of the firms’
of the supplement to the environmental Copies of the 2018 supplement to the workers, or threat thereof, and to a
assessment and the finding of no EA and the FONSI are also available for decrease in sales or production of each
petitioning firm.
amozie on DSK3GDR082PROD with NOTICES1

significant impact, contact Ms. Beth public inspection at USDA, Room 1141,
Kabert, Environmental Coordinator, South Building, 14th Street and SUPPLEMENTARY INFORMATION:

1 To view the notice, the EA, and the FONSI, go

to http://www.regulations.gov/#!docketDetail;D
=APHIS-2018-0033.

VerDate Sep<11>2014 21:20 Oct 09, 2018 Jkt 247001 PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 E:\FR\FM\10OCN1.SGM 10OCN1

Document Created: 2018-10-10 17:38:36
Document Modified: 2018-10-10 17:38:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		We will consider all comments that we receive on or before November 9, 2018.
Contact		Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737- 1231; phone (301) 851-3426, fax (301) 734-4314.
FR Citation		83 FR 50884

83 FR 50884 - Availability of an Environmental Assessment for Field Testing of a Swine Influenza Vaccine, DNA

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 83, Issue 196 (October 10, 2018)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service