[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Notices]
[Pages 5412-5413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02855]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2018-0082]
Availability of an Environmental Assessment for Field Testing of
a Vaccine for Use Against Bursal Disease, Marek's Disease, and
Newcastle Disease
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of availability.
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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 Bursal Disease-Marek's Disease-Newcastle
Disease Vaccine, Serotype 3, Live Marek's Disease Vector. 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 March
25, 2019.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2018-0082.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2018-0082, 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-
0082 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; (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; (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 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: Merial, Inc.
Product: Bursal Disease-Marek's Disease-Newcastle Disease Vaccine,
Serotype 3, Live Marek's Disease Vector.
Possible Field Test Locations: Alabama, Arkansas, Georgia,
Mississippi, Missouri, North Carolina, Ohio, Oklahoma, Pennsylvania,
Tennessee, Texas, and Virginia.
The above-mentioned product is a live Marek's disease serotype 3
vaccine virus containing a gene from the infectious bursal disease
virus and a gene from the Newcastle disease virus. It has been shown to
be effective for the vaccination of 18 to 19-day-old embryonated
chicken eggs or the subcutaneous vaccination of healthy day-old
chickens against bursal disease, Marek's disease, and Newcastle
disease.
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 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
[[Page 5413]]
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; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 14th day of February 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-02855 Filed 2-20-19; 8:45 am]
BILLING CODE 3410-34-P