81468 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Notices 

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 January 27, 

2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2011-0114– 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2011–0114, 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-2011-0114 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) 6902817 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) 

734–8245, 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 

conducted a risk analysis to assess the 

potential effects of this product on the 

safety of animals, public health, and the 

environment. Based on the risk analysis, 

APHIS has prepared an environmental 

assessment (EA) concerning the field 

testing of the following unlicensed 

veterinary biological product: 

Requester: Harrisvaccines, Inc. 

Product: Swine Influenza Vaccine, 

RNA. 

Field Test Locations: North Carolina, 

Illinois, and Nebraska. 

The above-mentioned product 

consists of propagation-defective RNA 

particles that encode the hemagglutinin 

protein of swine influenza virus. The 

vaccine is for intramuscular use in 

healthy pigs, three weeks of age or 

older, as an aid in the prevention of 

disease caused by swine influenza virus, 

subtype H3. 

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 

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 19th day of 

December 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–33205 Filed 12–27–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0078] 

Notice of Decision to Authorize the 

Importation of Shredded Lettuce From 

Egypt Into the Continental United 

States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our decision to authorize the 

importation into the continental United 

States of fresh shredded lettuce from 

Egypt. Based on the findings of a pest 

risk analysis, which we made available 

to the public for review and comment 

through a previous notice, we have 

determined that the application of one 

or more designated phytosanitary 

measures will be sufficient to mitigate 

the risks of introducing or disseminating 

plant pests or noxious weeds via the 

importation of fresh shredded lettuce 

from Egypt. 

DATES: Effective Date: December 28, 

2011. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Marc Phillips, Import Specialist, RCC, 

RPM, PPQ, APHIS, 4700 River Road 

Unit 133, Riverdale, MD 20737; (301) 

734–4394. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the regulations in ‘‘SubpartFruits and Vegetables’’ (7 CFR 319.56– 

1 through 319.56–54, referred to below 

as the regulations), the Animal and 

Plant Health Inspection Service (APHIS) 

of the U.S. Department of Agriculture 

prohibits or restricts the importation of 

fruits and vegetables into the United 

States from certain parts of the world to 

prevent plant pests from being 

introduced into and spread within the 

United States. 

Section 319.56–4 of the regulations 

contains a performance-based process 

for approving the importation of 

commodities that, based on the findings 

of a pest risk analysis (PRA), can be 

safely imported subject to one or more 

of the designated phytosanitary 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Notices 81469 

1To view the notice, the PRA, and the comments 

we received, go to http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2011-0078. 

measures listed in paragraph (b) of that 

section. Under that process, APHIS 

publishes a notice in the Federal 

Register announcing the availability of 

the PRA that evaluates the risks 

associated with the importation of a 

particular fruit or vegetable. Following 

the close of the 60-day comment period, 

APHIS may begin issuing permits for 

importation of the fruit or vegetable 

subject to the identified designated 

measures if: (1) No comments were 

received on the PRA; (2) the comments 

on the PRA revealed that no changes to 

the PRA were necessary; or (3) changes 

to the PRA were made in response to 

public comments, but the changes did 

not affect the overall conclusions of the 

analysis and the Administrator’s 

determination of risk. 

In accordance with that process, we 

published a notice 1 in the Federal 

Register on August 17, 2011 (76 FR 

50992–50993, Docket No. APHIS–2011– 

0078), in which we announced the 

availability, for review and comment, of 

a PRA that evaluated the risks 

associated with the importation into the 

continental United States of fresh 

shredded lettuce (Lactuca sativa L.) 

from Egypt. The PRA consisted of a risk 

assessment identifying pests of 

quarantine significance that could 

follow the pathway of importation of 

fresh shredded lettuce from Egypt into 

the United States and a risk 

management document identifying 

phytosanitary measures to be applied to 

that commodity to mitigate the pest risk. 

We solicited comments on the notice for 

60 days ending on October 17, 2011. We 

received two comments by that date. 

One comment from a private citizen 

who opposed the importation of 

shredded lettuce from Egypt into the 

United States did not address any 

specific aspect of the PRA. 

The other comment, submitted by an 

agricultural official representing the 

State of Florida, questioned the efficacy 

of the post-harvest phytosanitary 

measures we included in the PRA. The 

commenter agreed with the PRA that 

lettuce from Egypt is potentially a host 

for several species of destructive leaf 

miners but stated that the phytosanitary 

measure of shredding lettuce does not 

remove the risk of their introduction 

into the United States. The commenter 

requested that shipments of shredded 

lettuce from Egypt not be permitted 

entry into Florida until the shipping 

protocol has had time to demonstrate 

the effectiveness of the mitigation 

measures listed in the PRA. 

Only commercial consignments of 

shredded lettuce will be allowed to be 

imported from Egypt. Commercial 

consignments, as defined in § 319.56–2, 

are consignments that an inspector 

identifies as having been imported for 

sale and distribution. Produce grown 

commercially is less likely to be infested 

with plant pests than noncommercial 

consignments. Noncommercial 

consignments are more prone to 

infestations because the commodity is 

often ripe to overripe, could be of a 

variety with unknown susceptibility to 

pests, and is often grown with little or 

no pest control. 

We identified in the PRA 12 pests of 

quarantine significance for lettuce from 

Egypt that are highly unlikely to follow 

the pathway due to the standard postharvest processing practices applied to 

commercial consignments of shredded 

lettuce from Egypt. Although these 11 

arthropods and 1 mollusk affect lettuce 

leaves, we took into account the 

standard commercial post-harvest 

procedures of: (1) Removing outer 

leaves; (2) visual inspection and culling, 

with cutting; (3) shredding; and (4) 

washing and centrifuging. We 

concluded that these procedures 

sufficiently mitigate the risk of 

introducing leaf miners or other plant 

pests through the importation of 

shredded lettuce from Egypt. The 

commenter provided no evidence to 

indicate that these measures would not 

effectively mitigate the pest risk. 

Consignments of shredded lettuce 

from Egypt will also be required to be 

accompanied by a phytosanitary 

certificate of inspection and pest 

freedom issued by the national plant 

protection organization (NPPO) of 

Egypt, with an additional declaration 

stating that the shredded lettuce in the 

consignment had been inspected and 

found free from quarantine pests. This 

condition provides additional 

assurances that the commercial 

production process has removed 

quarantine pests from the commodity. 

For these reasons, APHIS has 

concluded that the mitigations 

described will effectively mitigate the 

pest risk associated with shredded 

lettuce imported from Egypt. 

Accordingly, we have determined that 

no changes to the PRA are necessary 

based on the comment. 

Therefore, in accordance with the 

regulations in § 319.56–4(c)(2)(ii), we 

are announcing our decision to 

authorize the importation into the 

continental United States of fresh 

shredded lettuce from Egypt subject to 

the following phytosanitary measures: 

• The shredded lettuce must be 

imported in commercial consignments 

only. 

• Each consignment of shredded 

lettuce leaves must be accompanied by 

a phytosanitary certificate issued by the 

national plant protection organization of 

Egypt with an additional declaration 

stating the following: ‘‘Shredded lettuce 

leaves in this consignment were 

inspected and found free from 

quarantine pests.’’ 

These conditions will be listed in the 

Fruits and Vegetables Import 

Requirements database (available at 

http://www.aphis.usda.gov/favir). In 

addition to these specific measures, 

shredded lettuce from Egypt will be 

subject to the general requirements 

listed in § 319.56–3 that are applicable 

to the importation of all fruits and 

vegetables. 

Authority: 7 U.S.C. 450, 7701–7772, and 

7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 

2.22, 2.80, and 371.3. 

Done in Washington, DC, this 19th day of 

December 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–33207 Filed 12–27–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2010–0112] 

Notice of Decision to Authorize 

Importation of Fresh Litchi From the 

Republic of South Africa Into the 

Continental United States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our decision to authorize the 

importation of fresh litchi from the 

Republic of South Africa into the 

continental United States. Based on the 

findings in a pest risk analysis, which 

we made available to the public for 

review and comment through a previous 

notice, we believe that the application 

of one or more designated phytosanitary 

measures will be sufficient to mitigate 

the risks of introducing or disseminating 

plant pests or noxious weeds via the 

importation of litchi from the Republic 

of South Africa. 

DATES: Effective Date: December 28, 

2011. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Marc Phillips, Import Specialist, 


srobinson on DSK4SPTVN1PROD with NOTICES