Availability of an Environmental Assessment for Field Testing a Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's Disease Vector, 19955-19956 [2015-08602]

Download as PDF 19955 Notices Federal Register Vol. 80, No. 71 Tuesday, April 14, 2015 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. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2015–0002] Availability of an Environmental Assessment for Field Testing a Marek’s Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek’s Disease Vector Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. AGENCY: 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 Marek’s disease-Newcastle disease vaccine, serotype 3, live Marek’s disease vector. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine, examines the potential effects that field testing this veterinary vaccine could have on the quality of the human environment. Based on the 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, and that an environmental impact statement need not be prepared. We intend to authorize shipment of this vaccine for field testing following the close of the comment period for this notice unless new substantial issues bearing on the effects of this action are brought to our attention. We also intend to issue a U.S. Veterinary Biological Product license for this vaccine, provided the field test data support the conclusions of the environmental assessment and the issuance of a finding of no significant impact and the product meets all other requirements for licensing. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:49 Apr 13, 2015 Jkt 235001 We will consider all comments that we receive on or before May 14, 2015. DATES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2015-0002. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2015–0002, 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 https:// www.regulations.gov/ #!docketDetail;D=APHIS-2015-0002 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 removed), 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.), a veterinary biological product must be shown to be pure, safe, potent, and efficacious before a veterinary biological product license may be issued. 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’ ADDRESSES: PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 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. Using the 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: Marek’s Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek’s Disease Vector. Possible Field Test Locations: Arkansas, Georgia, Indiana, Iowa, Missouri, Ohio, Oklahoma, Pennsylvania, and Virginia. The above-mentioned product is a live Marek’s disease serotype 3 vaccine virus containing a gene from the Newcastle disease virus. The attenuated vaccine is intended for use in healthy 18-day-old or older embryonated eggs or day-old chickens, as an aid in the prevention of 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). 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 E:\FR\FM\14APN1.SGM 14APN1 19956 Federal Register / Vol. 80, No. 71 / Tuesday, April 14, 2015 / Notices to support the issuance of the 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 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 8th day of April 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2015–08602 Filed 4–13–15; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2015–0025] Secretary’s Advisory Committee on Animal Health; Meeting Animal and Plant Health Inspection Service, USDA. ACTION: Notice of meeting. AGENCY: This is a notice to inform the public of an upcoming meeting of the Secretary’s Advisory Committee on Animal Health. The meeting is being organized by the Animal and Plant Health Inspection Service to discuss matters of animal health. DATES: The meeting will be held on April 28 and 29, 2015, from 9 a.m. to 5 p.m. each day. ADDRESSES: The meeting will be held at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. FOR FURTHER INFORMATION CONTACT: Mrs. R.J. Cabrera, Designated Federal Officer, VS, APHIS, 4700 River Road Unit 34, Riverdale, MD 20737; phone (301) 851– 3478, email SACAH.Management@ aphis.usda.gov. SUMMARY: asabaliauskas on DSK5VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: The Secretary’s Advisory Committee on Animal Health (the Committee) advises the Secretary of Agriculture on matters of animal health, including means to prevent, conduct surveillance on, monitor, control, or eradicate animal diseases of national importance. In doing so, the Committee will consider public health, conservation of natural resources, and the stability of livestock economies. Tentative topics for discussion at the meeting include: VerDate Sep<11>2014 17:42 Apr 13, 2015 Jkt 235001 • Follow-on discussion of antimicrobial resistance, mitigations, and the U.S. Department of Agriculture (USDA) action plan, • Comprehensive discussion on porcine epidemic diarrhea, • Follow-on discussion on foot-andmouth disease, • USDA draft framework for emerging diseases, • Proposed national list of reportable animal diseases, • Avian influenza, and • Bovine tuberculosis program— understanding the disease. A final agenda will be posted on the Committee Web site by April 13, 2015. Those wishing to attend the meeting in person must complete a brief registration form by clicking on the ‘‘SACAH Meeting Sign-Up’’ button on the Committee’s Web site (https:// www.aphis.usda.gov/animalhealth/ sacah). Members of the public may also join the meeting via teleconference in ‘‘listen-only’’ mode. Participants who wish to listen in on the teleconference may do so by dialing 1–888–469–3079 and then entering the public passcode, 2061888#. Due to time constraints, members of the public will not have an opportunity to participate in the Committee’s discussions. However, questions and written statements for the Committee’s consideration may be submitted up to 5 working days before the meeting. They may be sent to SACAH.Management@ aphis.usda.gov or mailed to the person listed on the notice under FOR FURTHER INFORMATION CONTACT. Statements filed with the Committee should specify that they pertain to the April 2015 Committee meeting. This notice of meeting is given pursuant to section 10 of the Federal Advisory Committee Act (5 U.S.C. App. 2). Done in Washington, DC, this 8th day of April 2015. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2015–08603 Filed 4–13–15; 8:45 am] BILLING CODE 3410–34–P PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2015–0003] Availability of an Environmental Assessment for Field Testing a Marek’s Disease Vaccine, Serotype 1, Live Virus Animal and Plant Health Inspection Service, USDA. ACTION: Notice of availability. AGENCY: 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 Marek’s disease vaccine, serotype 1, live virus. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the field testing of this vaccine, examines the potential effects that field testing this veterinary vaccine could have on the quality of the human environment. Based on the 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, and that an environmental impact statement need not be prepared. We intend to authorize shipment of this vaccine for field testing following the close of the comment period for this notice unless new substantial issues bearing on the effects of this action are brought to our attention. We also intend to issue a U.S. Veterinary Biological Product license for this vaccine, provided the field test data support the conclusions of the environmental assessment and the issuance of a finding of no significant impact and the product meets all other requirements for licensing. DATES: We will consider all comments that we receive on or before May 14, 2015. SUMMARY: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!docketDetail;D=APHIS–2015–0003. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2015–0003, 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 https:// ADDRESSES: E:\FR\FM\14APN1.SGM 14APN1

Agencies

[Federal Register Volume 80, Number 71 (Tuesday, April 14, 2015)]
[Notices]
[Pages 19955-19956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08602]


========================================================================
Notices
                                                Federal Register
________________________________________________________________________

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.

========================================================================


Federal Register / Vol. 80, No. 71 / Tuesday, April 14, 2015 / 
Notices

[[Page 19955]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0002]


Availability of an Environmental Assessment for Field Testing a 
Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's 
Disease Vector

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 Marek's disease-Newcastle disease vaccine, 
serotype 3, live Marek's disease vector. The environmental assessment, 
which is based on a risk analysis prepared to assess the risks 
associated with the field testing of this vaccine, examines the 
potential effects that field testing this veterinary vaccine could have 
on the quality of the human environment. Based on the 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, and that an 
environmental impact statement need not be prepared. We intend to 
authorize shipment of this vaccine for field testing following the 
close of the comment period for this notice unless new substantial 
issues bearing on the effects of this action are brought to our 
attention. We also intend to issue a U.S. Veterinary Biological Product 
license for this vaccine, provided the field test data support the 
conclusions of the environmental assessment and the issuance of a 
finding of no significant impact and the product meets all other 
requirements for licensing.

DATES: We will consider all comments that we receive on or before May 
14, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2015-0002.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0002, 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 https://www.regulations.gov/#!docketDetail;D=APHIS-2015-
0002 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 removed), 
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.), a veterinary biological product must be shown to be pure, 
safe, potent, and efficacious before a veterinary biological product 
license may be issued. 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. Using the 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: Marek's Disease-Newcastle Disease Vaccine, Serotype 3, 
Live Marek's Disease Vector.
    Possible Field Test Locations: Arkansas, Georgia, Indiana, Iowa, 
Missouri, Ohio, Oklahoma, Pennsylvania, and Virginia.
    The above-mentioned product is a live Marek's disease serotype 3 
vaccine virus containing a gene from the Newcastle disease virus. The 
attenuated vaccine is intended for use in healthy 18-day-old or older 
embryonated eggs or day-old chickens, as an aid in the prevention of 
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).
    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 19956]]

to support the issuance of the 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 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 8th day of April 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-08602 Filed 4-13-15; 8:45 am]
 BILLING CODE 3410-34-P

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