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.

Notices Federal Register

6531 

Vol. 79, No. 23 

Tuesday, February 4, 2014 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2013–0102] 

Availability of an Environmental 

Assessment for Field Testing a 

Porcine Reproductive and Respiratory 

Syndrome Vaccine, Respiratory Form, 

Modified Live Virus 

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 Porcine Reproductive and 

Respiratory Syndrome Vaccine, 

Respiratory Form, Modified 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 March 6, 

2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/#!document

Detail;D=APHIS-2013-0102-0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2013–0102, 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-2013-0102 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: ProtaTek International, Inc. 

Product: Porcine Reproductive and 

Respiratory Syndrome Vaccine, 

Respiratory Form, Modified Live Virus. 

Possible Field Test Locations: Iowa, 

North Carolina, and Texas. 

The above-mentioned product is a 

live chimeric virus constructed from an 

infectious clone and a field isolate of 

porcine reproductive and respiratory 

syndrome virus to produce an 

attenuated vaccine. The vaccine is 

intended for use in swine, 3 weeks of 

age or older, as an aid in the reduction 

of lung lesions caused by porcine 

reproductive and respiratory syndrome 

virus. 

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 

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6532 Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Notices 

issuance of a FONSI, APHIS does not 

intend to issue a separate EA and FONSI 

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 29th day of 

January 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–02273 Filed 2–3–14; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2013–0100] 

International Sanitary and 

Phytosanitary Standard-Setting 

Activities 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice and request for 

comments. 

SUMMARY: In accordance with legislation 

implementing the results of the Uruguay 

Round of negotiations under the General 

Agreement on Tariffs and Trade, we are 

informing the public of the international 

standard-setting activities of the World 

Organization for Animal Health, the 

Secretariat of the International Plant 

Protection Convention, and the North 

American Plant Protection Organization, 

and we are soliciting public comment 

on the standards to be considered. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/#!document

Detail;D=APHIS-2012-0082-0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0082, 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-2012-0082 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: For 

general information on the topics 

covered in this notice, contact Mrs. 

Jessica Mahalingappa, Acting Associate 

Deputy Administrator for SPS 

Management, International Services, 

APHIS, room 1132, USDA South 

Building, 14th Street and Independence 

Avenue SW., Washington, DC 20250; 

(202) 799–7121. 

For specific information regarding 

standard-setting activities of the World 

Organization for Animal Health, contact 

Dr. Michael David, Director, 

International Animal Health Standards 

Team, National Center for Import/

Export, VS, APHIS, 4700 River Road 

Unit 33, Riverdale, MD 20737–1231; 

(301) 851–3302. 

For specific information regarding the 

standard-setting activities of the 

International Plant Protection 

Convention, contact Ms. Julie E. Aliaga, 

Program Director, International 

Phytosanitary Standards, PPQ, APHIS, 

4700 River Road Unit 140, Riverdale, 

MD 20737–1236; (301) 851–2032. 

For specific information on the North 

American Plant Protection Organization, 

contact Dr. Christina Devorshak, PPQ 

Technical Director for NAPPO, PPQ, 

APHIS, 1730 Varsity Drive, Suite 300, 

Raleigh, NC 27606; (919) 855–7547. 

SUPPLEMENTARY INFORMATION: 

Background 

The World Trade Organization (WTO) 

was established as the common 

international institutional framework for 

governing trade relations among its 

members in matters related to the 

Uruguay Round Agreements. The WTO 

is the successor organization to the 

General Agreement on Tariffs and 

Trade. U.S. membership in the WTO 

was approved by Congress when it 

enacted the Uruguay Round Agreements 

Act (Pub. L. 103–465), which was 

signed into law on December 8, 1994. 

The WTO Agreements, which 

established the WTO, entered into force 

with respect to the United States on 

January 1, 1995. The Uruguay Round 

Agreements Act amended Title IV of the 

Trade Agreements Act of 1979 (19 

U.S.C. 2531 et seq.). Section 491 of the 

Trade Agreements Act of 1979, as 

amended (19 U.S.C. 2578), requires the 

President to designate an agency to be 

responsible for informing the public of 

the sanitary and phytosanitary (SPS) 

standard-setting activities of each 

international standard-setting 

organization. The designated agency 

must inform the public by publishing an 

annual notice in the Federal Register 

that provides the following information: 

(1) The SPS standards under 

consideration or planned for 

consideration by the international 

standard-setting organization; and (2) 

for each SPS standard specified, a 

description of the consideration or 

planned consideration of that standard, 

a statement of whether the United States 

is participating or plans to participate in 

the consideration of that standard, the 

agenda for U.S. participation, if any, and 

the agency responsible for representing 

the United States with respect to that 

standard. 

‘‘International standard’’ is defined in 

19 U.S.C. 2578b as any standard, 

guideline, or recommendation: (1) 

Adopted by the Codex Alimentarius 

Commission (Codex) regarding food 

safety; (2) developed under the auspices 

of the World Organization for Animal 

Health (OIE, formerly known as the 

Office International des Epizooties) 

regarding animal health and welfare, 

and zoonoses; (3) developed under the 

auspices of the Secretariat of the 

International Plant Protection 

Convention (IPPC) in cooperation with 

the North American Plant Protection 

Organization (NAPPO) regarding plant 

health; or (4) established by or 

developed under any other international 

organization agreed to by the member 

countries of the North American Free 

Trade Agreement (NAFTA) or the 

member countries of the WTO. 

The President, pursuant to 

Proclamation No. 6780 of March 23, 

1995 (60 FR 15845), designated the 

Secretary of Agriculture as the official 

responsible for informing the public of 

the SPS standard-setting activities of 

Codex, OIE, IPPC, and NAPPO. The 

United States Department of 

Agriculture’s (USDA’s) Food Safety and 

Inspection Service (FSIS) informs the 

public of Codex standard-setting 

activities, and USDA’s Animal and 

Plant Health Inspection Service (APHIS) 

informs the public of OIE, IPPC, and 

NAPPO standard-setting activities. 

FSIS publishes an annual notice in 

the Federal Register to inform the 

public of SPS standard-setting activities 

for Codex. Codex was created in 1962 by 

two United Nations organizations, the 

Food and Agriculture Organization 

(FAO) and the World Health 

Organization. It is the major 

international organization for 

encouraging international trade in food 

and protecting the health and economic 

interests of consumers. 

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