80870 Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices 

1To view the June 2010 and August 2011 notices, 

the CIEDs, and the comments we received, go to 

http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2010-0032. 

or crops but did not provide any 

specific disagreement with APHIS’ 

analysis. Several commenters 

questioned the performance and 

drought-tolerant capabilities of corn 

event MON 87460. Other issues raised 

by commenters include concerns 

regarding the adequacy of the analysis 

in the EA, effects of GE crops on 

biodiversity and organic agriculture, 

increased use of glyphosate, health and 

environmental effects of GE crops, and 

marketing and trade implications. 

APHIS has addressed the issues raised 

during the comment period and has 

provided responses to the comments as 

an attachment to the finding of no 

significant impact. 

National Environmental Policy Act 

To provide the public with 

documentation of APHIS’ review and 

analysis of any potential environmental 

impacts associated with the 

determination of nonregulated status of 

Monsanto’s corn event MON 87460, an 

EA has been prepared. The EA was 

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). Based on our EA, the response to 

public comments, and other pertinent 

scientific data, APHIS has reached a 

finding of no significant impact with 

regard to the preferred alternative 

identified in the EA. 

Determination 

Based on APHIS’ analysis of field and 

laboratory data submitted by Monsanto, 

references provided in the petition, 

peer-reviewed publications, information 

analyzed in the EA, the PPRA, 

comments provided by the public, and 

information provided in APHIS’ 

response to those public comments, 

APHIS has determined that Monsanto’s 

corn event MON 87460 is unlikely to 

pose a plant pest risk and therefore is no 

longer subject to our regulations 

governing the introduction of certain GE 

organisms. 

Copies of the signed determination 

document, as well as copies of the 

petition, PPRA, EA, finding of no 

significant impact, and response to 

comments are available as indicated in 

the ADDRESSES and FOR FURTHER

INFORMATION CONTACT sections of this 

notice. 

Authority: 7 U.S.C. 7701–7772 and 7781– 

7786; 31 U.S.C. 9701; 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. 2011–33011 Filed 12–22–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2010–0032] 

Notice of Determination of Pest-Free 

Areas in Mendoza Province, Argentina 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that we are recognizing the Southern 

and Central Oases in the southern half 

of Mendoza Province in Argentina as 

pest-free areas for Mediterranean fruit 

fly and South American fruit fly. Based 

on our site visit to the area and our 

review of the documentation submitted 

by Argentina’s national plant protection 

organization, which we made available 

to the public for review and comment 

through previous notices, the 

Administrator has determined that these 

areas meet the criteria in our regulations 

for recognition as pest-free areas for 

Mediterranean fruit fly and South 

American fruit fly. 

DATES: Effective Date: December 27, 

2011. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Meredith C. Jones, Regulatory 

Coordination Specialist, Regulatory 

Coordination and Compliance, APHIS, 

4700 River Road Unit 156, Riverdale, 

MD 20737; (301) 734–7467. 

SUPPLEMENTARY INFORMATION: 

Under the regulations in ‘‘Subpart— 

Fruits 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, can be safely 

imported subject to one or more of the 

designated phytosanitary measures 

listed in paragraph (b) of that section. 

One of the designated phytosanitary 

measures is that the fruits or vegetables 

are imported from a pest-free area in the 

country of origin that meets the 

requirements of § 319.56–5 for freedom 

from that pest and are accompanied by 

a phytosanitary certificate stating that 

the fruits or vegetables originated in a 

pest-free area in the country of origin. 

Under the regulations in § 319.56–5, 

APHIS requires that determinations of 

pest-free areas be made in accordance 

with the criteria for establishing 

freedom from pests found in 

International Standards for 

Phytosanitary Measures (ISPM) No. 4, 

‘‘Requirements For the Establishment of 

Pest Free Areas.’’ The international 

standard was established by the 

International Plant Protection 

Convention of the United Nations’ Food 

and Agriculture Organization and is 

incorporated by reference in our 

regulations in 7 CFR 300.5. In addition, 

APHIS must also approve the survey 

protocol used to determine and 

maintain pest-free status, as well as 

protocols for actions to be performed 

upon detection of a pest. Pest-free areas 

are subject to audit by APHIS to verify 

their status. 

In accordance with our process, we 

published a notice 1 in the Federal 

Register on June 25, 2010 (75 FR 36347– 

36348, Docket No. APHIS–2010–0032), 

in which we announced the availability, 

for review and comment, of a 

commodity import evaluation document 

(CIED) that evaluates the information 

presented by Argentina in support of its 

request to recognize additional areas as 

pest-free areas for Mediterranean fruit 

fly (Ceratitis capitata) in Argentina. We 

solicited comments on the notice for 60 

days ending on August 24, 2010. We 

received two comments by that date, 

one from a State agricultural official and 

the other from an official of Argentina’s 

national plant protection organization 

(NPPO). 

The first commenter acknowledged 

Argentina’s history of successful Medfly 

control efforts, but stated that APHIS 

should not relax its fruit fly-related 

restrictions until it can confirm that no 

other pest fruit flies—notably 

Anastrepha species fruit flies—are 

present in the area. The second 

commenter provided information to 

support a finding that the Mendoza 

Province is free of the South American 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices 80871 

fruit fly (Anastrepha fraterculus). As a 

result of these comments, APHIS 

contacted the Argentine NPPO, which 

requested that, in addition to the pestfree status for C. capitata, the Mendoza 

province of Argentina also be 

recognized as free of A. fraterculus. 

We published a second notice in the 

Federal Register on August 19, 2011 (76 

FR 51934–51935, Docket No. APHIS– 

2010–0032), in which we announced 

the availability, for review and 

comment, of a CIED evaluating the 

information presented by Argentina in 

support of its request to recognize 

additional areas as pest-free areas for the 

South American fruit fly and all other 

economically important species of 

Anastrepha in Argentina. We solicited 

comments on the notice for 60 days 

ending on October 18, 2011. We 

received no comments by that date. 

Therefore, in accordance with 

§ 319.56–5(c), we are announcing the 

Administrator’s determination that the 

Southern and Central Oases in the 

southern half of Mendoza Province in 

Argentina meet the criteria of § 319.56– 

5(a) and (b) with respect to freedom 

from Medfly, South American fruit fly, 

and all other economically important 

species of Anastrepha. Accordingly, we 

are recognizing these areas as pest-free 

areas for Medfly, South American fruit 

fly, and all other economically 

important species of Anastrepha and 

have added them to the list of pest-free 

areas. A list of pest-free areas currently 

recognized by APHIS can be found at 

http://www.aphis.usda.gov/import_

export/plants/manuals/ports/

downloads/DesignatedPest

FreeAreas.pdf. 

Done in Washington, DC, this 19th day of 

December 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–33110 Filed 12–23–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0095] 

Monsanto Co.; Availability of Petition, 

Plant Pest Risk Assessment, and 

Environmental Assessment for 

Determination of Nonregulated Status 

of Soybean Genetically Engineered To 

Produce Stearidonic Acid 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service has received a 

petition from the Monsanto Company 

seeking a determination of nonregulated 

status of soybean designated as MON 

87769, which has been genetically 

engineered to produce stearidonic acid, 

an omega-3 fatty acid not found in 

conventional soybean. The petition has 

been submitted in accordance with our 

regulations concerning the introduction 

of certain genetically engineered 

organisms and products. We are 

soliciting comments on whether this 

genetically engineered soybean is likely 

to pose a plant pest risk. We are making 

available for public comment the 

Monsanto petition, our plant pest risk 

assessment, and our draft environmental 

assessment for the proposed 

determination of nonregulated status. 

DATES: We will consider all comments 

that we receive on or before February 

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-2011-0095- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2011–0095, 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-2011-0095 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) 690–2817 

before coming. 

The petition, draft environmental 

assessment, and plant pest risk 

assessment are also available on the 

APHIS Web site at http:// 

www.aphis.usda.gov/brs/aphisdocs/ 

09_18301p.pdf, http:// 

www.aphis.usda.gov/brs/aphisdocs/ 

09_18301p _dea.pdf, and http:// 

www.aphis.usda.gov/brs/aphisdocs/ 

09_18301p _dpra.pdf. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Evan Chestnut, Policy Analyst, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 147, 

Riverdale, MD 20737–1236; (301) 734– 

0942, email: 

evan.a.chestnut@aphis.usda.gov. To 

obtain copies of the petition, draft 

environmental assessment, or plant pest 

risk assessment, contact Ms. Cindy Eck 

at (301) 734–0667, email: 

cynthia.a.eck@aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the authority of the plant pest 

provisions of the Plant Protection Act (7 

U.S.C. 7701 et seq.), the regulations in 

7 CFR part 340, ‘‘Introduction of 

Organisms and Products Altered or 

Produced Through Genetic Engineering 

Which Are Plant Pests or Which There 

Is Reason to Believe Are Plant Pests,’’ 

regulate, among other things, the 

introduction (importation, interstate 

movement, or release into the 

environment) of organisms and products 

altered or produced through genetic 

engineering that are plant pests or that 

there is reason to believe are plant pests. 

Such genetically engineered organisms 

and products are considered ‘‘regulated 

articles.’’ 

The regulations in § 340.6(a) provide 

that any person may submit a petition 

to the Animal and Plant Health 

Inspection Service (APHIS) seeking a 

determination that an article should not 

be regulated under 7 CFR part 340. 

Paragraphs (b) and (c) of § 340.6 

describe the form that a petition for a 

determination of nonregulated status 

must take and the information that must 

be included in the petition. 

APHIS has received a petition (APHIS 

Petition Number 09–183–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO, seeking a determination of 

nonregulated status of soybean (Glycine 

max) designated as event MON 87769, 

which has been genetically engineered 

to produce stearidonic acid, an omega3 fatty acid not found in conventional 

soybean, stating that this soybean is 

unlikely to pose a plant pest risk and, 

therefore, should not be a regulated 

article under APHIS’ regulations in 7 

CFR part 340. 

As described in the petition, soybean 

event MON 87769 has been genetically 

engineered to express high levels of the 

fatty acid stearidonic acid and smaller 

amounts of three other fatty acids, as 

well as for reduced expression of 

linoleic acid. Soybean event MON 

87769 is currently regulated under 7 

CFR part 340. Interstate movements and 

field tests of soybean event MON 87769 

have been conducted under permits 

issued or notifications acknowledged by 

APHIS. 

Field tests conducted under APHIS 

oversight allowed for evaluation in a 

natural agricultural setting while 

imposing measures to minimize the risk 


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