[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60613-60614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25445]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0062]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for Field Use of Vaccines Against Avian Influenza H5 
Virus Strains

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: We are advising the public that an environmental assessment 
has been prepared by the Animal and Plant Health Inspection Service 
relative to the use of one or more veterinary biological products as a 
treatment for and as an aid in the reduction of highly pathogenic avian 
influenza (HPAI) incidence caused by strains such as Eurasian H5 
viruses of clade 2.3.4.4 lineage. Any biological products would become 
part of the measures to reduce the incidence of HPAI in the nation's 
commercial poultry flocks. Based on the environmental assessment, we 
have concluded that the use of vaccines as described in the 
environmental assessment will not have a significant impact on the 
human environment. We are making this environmental assessment and 
finding of no significant impact available to the public for review and 
comment.

DATES: We will consider all comments that we receive on or before 
November 6, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0062.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0062, 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-2015-
0062 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.

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. 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.
    Veterinary biological products meeting the requirements of the 
regulations may be considered for addition to the U.S. National 
Veterinary Stockpile (NVS). The NVS is the nation's repository of 
vaccines and other

[[Page 60614]]

critical veterinary supplies and equipment. It exists to augment State 
and local resources in responding to high-consequence livestock 
diseases that could potentially devastate U.S. agriculture, seriously 
affect the economy, and threaten public health. NVS vaccines would be 
used in APHIS programs or under department control or supervision. The 
addition of vaccines to the stockpile would not preclude private 
development and use of other poultry vaccines meeting the requirements 
of the Virus-Serum-Toxin Act.
    The arrival in December 2014 of Eurasian H5 strains of highly 
pathogenic avian influenza (HPAI) and their subsequent dissemination in 
North America caused a catastrophic outbreak in both domestic poultry 
and avian wildlife. It is thought that wild, migratory waterfowl 
carried an H5 virus into North America, which generated reassortants 
(genetic variants resulting from crosses among AI strains) that spilled 
over into the domestic poultry population. The H5 viruses are likely to 
persist within the endemic wild, migratory waterfowl population, which 
is the primary reservoir of the virus. This viral reservoir will 
continue to pose a significant threat to U.S. poultry and avian 
collections.
    Two poultry production sectors, commercial meat turkeys and laying 
chickens, were heavily impacted by these H5 viruses, resulting in the 
loss or destruction of over 48 million birds between December 2014 and 
June 2015. Response by regulatory agencies combined with migration of 
wild waterfowl and the natural disinfectant action of the summer heat 
temporarily halted new disease outbreaks. The return of potentially 
infected migratory waterfowl in autumn, however, may precipitate a new 
round of outbreaks on an expanded national scale.
    Therefore, we are advising the public that we have prepared an 
environmental assessment (EA) entitled ``For Field Use of Avian 
Influenza Vaccines Against Avian Influenza H5 Virus Strains (August 
2015)'' to analyze the potential use of one or more veterinary 
biological products as a treatment for and as an aid in the reduction 
of HPAI incidence caused by H5 strain viruses. 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. Based on an individual vaccine's 
risk analysis and the findings in this EA, APHIS would authorize 
deployment (including shipment, field testing, addition to the NVS, and 
use in commercial poultry production) of safe, well-characterized 
biological products upon making a finding of no significant impact 
(FONSI).
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. If APHIS receives substantive comments that were not 
previously considered, the Agency would consider issuing a supplement 
to the EA and FONSI. Because timeliness is essential, it is imperative 
that APHIS authorize shipment and field use of safe, well-characterized 
vaccines as soon as possible, and possibly prior to the close of the 
comment period of this notice.
    Possible Field Use Locations: Where Federal and State authorities 
agree on use.
    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).

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

    Done in Washington, DC, this 1st day of October 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-25445 Filed 10-6-15; 8:45 am]
 BILLING CODE 3410-34-P