82 FR 37045 - Availability of an Environmental Assessment for Field Testing of a Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 82, Issue 151 (August 8, 2017)
Animal and Plant Health Inspection Service
Federal Register Volume 82, Issue 151 (August 8, 2017)
| Page Range | 37045-37045 | |
| FR Document | 2017-16673 |
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Page 37045] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16673] [[Page 37045]] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2017-0030] Availability of an Environmental Assessment for Field Testing of a Bursal Disease-Marek's 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 purposes of field testing, and then to field test, an unlicensed Bursal Disease-Marek's 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 September 7, 2017. ADDRESSES: You may submit comments by either of the following methods:Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0030. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2017-0030, 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-2017- 0030 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; 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 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: Zoetis Inc. Product: Bursal Disease-Marek's Disease Vaccine, Serotype 3, Live Marek's Disease Vector. Possible Field Test Locations: Alabama, Delaware, Georgia, Iowa, and North Carolina. The above-mentioned product is a live Marek's Disease serotype 3 vaccine virus containing a gene from the infectious bursal disease virus. The attenuated vaccine is intended for use in healthy 18-day-old or older chicken embryos by the in ovo route or day-old chicks by subcutaneous inoculation, as an aid in the prevention of Marek's disease and infectious bursal 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 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 2nd day of August 2017. Michael C. Gregoire, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2017-16673 Filed 8-7-17; 8:45 am] BILLING CODE 3410-34-P
![Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices 37045
DEPARTMENT OF AGRICULTURE For information regarding the The above-mentioned product is a
environmental assessment or the risk live Marek’s Disease serotype 3 vaccine
Animal and Plant Health Inspection analysis, or to request a copy of the virus containing a gene from the
Service environmental assessment (as well as infectious bursal disease virus. The
[Docket No. APHIS–2017–0030] the risk analysis with confidential attenuated vaccine is intended for use in
business information redacted), contact healthy 18-day-old or older chicken
Availability of an Environmental Dr. Patricia L. Foley, Risk Manager, embryos by the in ovo route or day-old
Assessment for Field Testing of a Center for Veterinary Biologics, Policy, chicks by subcutaneous inoculation, as
Bursal Disease-Marek’s Disease Evaluation, and Licensing, VS, APHIS, an aid in the prevention of Marek’s
Vaccine, Serotype 3, Live Marek’s 1920 Dayton Avenue, P.O. Box 844, disease and infectious bursal disease.
Disease Vector Ames, IA 50010; phone (515) 337–6100,
fax (515) 337–6120. The EA has been prepared in
AGENCY: Animal and Plant Health accordance with: (1) The National
SUPPLEMENTARY INFORMATION: Under the
Inspection Service, USDA. Environmental Policy Act of 1969
Virus-Serum-Toxin Act (21 U.S.C. 151
ACTION: Notice of availability. et seq.), the Animal and Plant Health (NEPA), as amended (42 U.S.C. 4321 et
Inspection Service (APHIS) is seq.), (2) regulations of the Council on
SUMMARY: We are advising the public authorized to promulgate regulations Environmental Quality for
that the Animal and Plant Health designed to ensure that veterinary implementing the procedural provisions
Inspection Service has prepared an biological products are pure, safe, of NEPA (40 CFR parts 1500–1508), (3)
environmental assessment concerning potent, and efficacious before a USDA regulations implementing NEPA
authorization to ship for the purposes of veterinary biological product license (7 CFR part 1b), and (4) APHIS’ NEPA
field testing, and then to field test, an may be issued. Veterinary biological Implementing Procedures (7 CFR part
unlicensed Bursal Disease-Marek’s products include viruses, serums, 372).
Disease Vaccine, Serotype 3, Live toxins, and analogous products of We are publishing this notice to
Marek’s Disease Vector. Based on the natural or synthetic origin, such as inform the public that we will accept
environmental assessment, risk analysis, vaccines, antitoxins, or the immunizing written comments regarding the EA
and other relevant data, we have components of microorganisms from interested or affected persons for a
reached a preliminary determination intended for the diagnosis, treatment, or period of 30 days from the date of this
that field testing this veterinary vaccine prevention of diseases in domestic notice. Unless substantial issues with
will not have a significant impact on the animals. adverse environmental impacts are
quality of the human environment. We APHIS issues licenses to qualified raised in response to this notice, APHIS
are making the documents available to establishments that produce veterinary
the public for review and comment. intends to issue a finding of no
biological products and issues permits
significant impact (FONSI) based on the
DATES: We will consider all comments to importers of such products. APHIS
EA and authorize shipment of the above
that we receive on or before September also enforces requirements concerning
product for the initiation of field tests
7, 2017. production, packaging, labeling, and
shipping of these products and sets following the close of the comment
ADDRESSES: You may submit comments period for this notice.
by either of the following methods: standards for the testing of these
• Federal eRulemaking Portal: Go to products. Regulations concerning Because the issues raised by field
http://www.regulations.gov/ veterinary biological products are testing and by issuance of a license are
#!docketDetail;D=APHIS-2017-0030. contained in 9 CFR parts 101 to 124. identical, APHIS has concluded that the
• Postal Mail/Commercial Delivery: A field test is generally necessary to EA that is generated for field testing
Send your comment to Docket No. satisfy prelicensing requirements for would also be applicable to the
APHIS–2017–0030, Regulatory Analysis veterinary biological products. Prior to proposed licensing action. Provided that
and Development, PPD, APHIS, Station conducting a field test on an unlicensed the field test data support the
product, an applicant must obtain conclusions of the original EA and the
3A–03.8, 4700 River Road Unit 118,
approval from APHIS, as well as obtain issuance of a FONSI, APHIS does not
Riverdale, MD 20737–1238.
APHIS’ authorization to ship the intend to issue a separate EA and FONSI
Supporting documents and any
product for field testing. to support the issuance of the associated
comments we receive on this docket To determine whether to authorize
may be viewed at http:// product license, and would determine
shipment and grant approval for the that an environmental impact statement
www.regulations.gov/ field testing of the unlicensed product
#!docketDetail;D=APHIS-2017-0030 or need not be prepared. APHIS intends to
referenced in this notice, APHIS issue a veterinary biological product
in our reading room, which is located in considers the potential effects of this
Room 1141 of the USDA South license for this vaccine following
product on the safety of animals, public satisfactory completion of the field test,
Building, 14th Street and Independence health, and the environment. Based
Avenue SW., Washington, DC. Normal provided no adverse impacts on the
upon a risk analysis and other relevant human environment are identified and
reading room hours are 8 a.m. to 4:30 data, APHIS has prepared an
p.m., Monday through Friday, except provided the product meets all other
environmental assessment (EA)
holidays. To be sure someone is there to requirements for licensing.
concerning the field testing of the
help you, please call (202) 799–7039
asabaliauskas on DSKBBXCHB2PROD with NOTICES
following unlicensed veterinary Authority: 21 U.S.C. 151–159.
before coming. biological product: Done in Washington, DC, this 2nd day of
FOR FURTHER INFORMATION CONTACT: Dr. Requester: Zoetis Inc. August 2017.
Donna Malloy, Operational Support Product: Bursal Disease-Marek’s
Section, Center for Veterinary Biologics, Michael C. Gregoire,
Disease Vaccine, Serotype 3, Live
Policy, Evaluation, and Licensing, VS, Marek’s Disease Vector. Acting Administrator, Animal and Plant
APHIS, 4700 River Road Unit 148, Possible Field Test Locations: Health Inspection Service.
Riverdale, MD 20737–1231; (301) 851– Alabama, Delaware, Georgia, Iowa, and [FR Doc. 2017–16673 Filed 8–7–17; 8:45 am]
3426, fax (301) 734–4314. North Carolina. BILLING CODE 3410–34–P
VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00006 Fmt 4703 Sfmt 9990 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/82_FR_37196/page/1.svg)
Document Created: 2017-08-08 00:18:09
Document Modified: 2017-08-08 00:18:09
| 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 September 7, 2017. | |
| 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. | |
| FR Citation | 82 FR 37045 |
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