Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 41351 

1To view the notice, petition, draft EA, the PPRA, 

and the comments we received, go to http:// 

www.regulations.gov/#!docketDetail;D=APHIS2011-0095. 

FOR FURTHER INFORMATION CONTACT: Dr. 

John Turner, Director, Environmental 

Risk Analysis Programs, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737– 

1236; (301) 851–3954, email: 

john.t.turner@aphis.usda.gov. To obtain 

copies of the documents referenced in 

this notice, contact Ms. Cindy Eck at 

(301) 851–3892, email: 

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

SUPPLEMENTARY INFORMATION: 

Background 

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 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. The petition stated 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. 

In a notice 1 published in the Federal 

Register on December 27, 2011 (76 FR 

80871–80872, Docket No. APHIS–2011– 

0095), APHIS announced the 

availability of the Monsanto petition, a 

Plant Pest Risk Assessment (PPRA), and 

a draft Environmental Assessment (EA) 

for public comment. APHIS solicited 

comments on the petition, whether the 

subject soybean are likely to pose a 

plant pest risk, the draft EA, and the 

PPRA for 60 days ending on February 

27, 2012. 

APHIS received 226 comments during 

the comment period, with 21 

commenters expressing support of a 

determination of nonregulated status 

and the remaining 205 commenters 

expressing opposition. Issues raised 

during the comment period include 

socioeconomic impacts, changes in 

nutrition caused by the product, 

environmental impacts, changes in 

soybean properties, and product safety. 

APHIS has addressed the issues raised 

during the comment period and has 

provided responses to these 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 a determination 

of nonregulated status of Monsanto’s 

soybean event MON 87769, 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 

soybean event MON 87769 is unlikely to 

pose a plant pest risk and therefore is no 

longer subject to our regulations 

governing the introduction of certain 

genetically engineered 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 9th day of 

July 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–17168 Filed 7–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0034] 

Bayer CropScience LP; Availability of 

a Finding of No Significant Impact and 

a Preliminary Decision for an 

Extension of a Determination of 

Nonregulated Status of Cotton 

Genetically Engineered for Herbicide 

Tolerance and Insect Resistance 

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 prepared a 

finding of no significant impact and a 

preliminary decision regarding a request 

from Bayer CropScience LP to extend to 

cotton event T303–3, which has been 

genetically engineered to be tolerant to 

the herbicide glufosinate and resistant 

to several lepidopteran pests, our 

determination of nonregulated status of 

TwinLinkTM cotton (event T304–40). We 

are making available for public 

comment our finding of no significant 

impact for the proposed determination 

of nonregulated status. 

DATES: We will consider all comments 

that we receive on or before August 13, 

2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!documentDetail;D=APHIS-2012-0034- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0034, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

The Bayer CropScience LP extension 

request, our finding of no significant 

impact (FONSI), our preliminary 

determination, and any comments we 

receive on this docket may be viewed at 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2012-0034 or 

in our reading room, which is located in 


srobinson on DSK4SPTVN1PROD with NOTICES
41352 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 

1To view the notice, determination, supporting 

documents, and the comments we received go to 

http://www.regulations.gov/#!docketDetail;D=

APHIS-2010-0102. 

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. Supporting documents 

regarding our determination of 

nonregulated status of TwinLinkTM

cotton, the antecedent organism, 

including Bayer’s petition, our 

environmental assessment, FONSI, 

plant pest risk assessment, and 

determination, and any comments we 

received regarding our determination of 

nonregulated status of TwinLinkTM

cotton, can be viewed at http://www.

regulations.gov/#!docketDetail;D=

APHIS-2010-0102 or in our reading 

room. 

The extension request, finding of no 

significant impact, and preliminary 

determination for this docket, as well as 

Bayer’s petition and our combined 

environmental assessment, FONSI, 

plant pest risk assessment, and 

determination for TwinLinkTM cotton, 

the antecedent organism, are also 

available on the APHIS Web site at 

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

aphisdocs/12_03301p.pdf, http://www.

aphis.usda.gov/brs/aphisdocs/

12_03301p_fonsi.pdf, http://www.aphis.

usda.gov/brs/aphisdocs/12_03301p_

pdet.pdf, http://www.aphis.usda.gov/

brs/aphisdocs/08_34001p.pdf, and 

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

aphisdocs/08_34001p_com.pdf. 

FOR FURTHER INFORMATION CONTACT: Dr. 

John Turner, Director, Environmental 

Risk Analysis Programs, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737– 

1236; (301) 851–3954, email: 

john.t.turner@aphis.usda.gov. To obtain 

copies of the supporting documents, 

contact Ms. Cindy Eck at (301) 851– 

3892, 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. 

Further, the regulations in § 340.6(e)(2) 

provide that a person may request that 

APHIS extend a determination of 

nonregulated status to other organisms. 

Such a request must include 

information to establish the similarity of 

the antecedent organism and the 

regulated article in question. 

In a notice 1 published in the Federal 

Register on October 12, 2011 (76 FR 

63278–63279, Docket No. APHIS–2010– 

0102), APHIS announced our 

determination of nonregulated status of 

TwinLinkTM cotton (events T304–40 

and GHB119). APHIS has received a 

request for an extension of a 

determination of nonregulated status 

(APHIS Number 12–033–01p) of 

TwinLinkTM cotton event T304–40 from 

Bayer CropScience LP (BCS) of Research 

Triangle Park, NC, seeking a 

determination of nonregulated status of 

cotton (Gossypium spp.) designated as 

event T303–3, which has been 

genetically engineered to be tolerant to 

the herbicide glufosinate and resistant 

to several lepidopteran pests. In its 

request, BCS stated that this cotton is 

similar to TwinLinkTM cotton (event 

T304–40) and, based on the similarity to 

the antecedent organism, 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 extension request, 

cotton event T303–3 has been 

genetically engineered by 

Agrobacterium-mediated transformation 

utilizing vector pTDL004 containing a 

cry1Ab gene construct, encoding insect 

resistance, and the bar gene as a 

selectable marker conferring tolerance to 

glufosinate ammonium herbicides. The 

antecedent organism, cotton event 

T304–40, was also generated through 

Agrobacterium-mediated transformation 

utilizing a slightly different vector 

(pTDL008). Both cotton events produce 

the same insecticidal crystal protein 

(ICP) Cry1Ab (expression product of the 

cry1Ab gene) and PAT protein 

(expression product of the bar gene). 

Cotton event T303–3 is currently 

regulated under 7 CFR part 340. 

Interstate movements and field tests of 

cotton event T303–3 have been 

conducted under 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 

of persistence in the environment after 

completion of the test. Data are gathered 

on multiple parameters and used by the 

applicant to evaluate agronomic 

characteristics and product 

performance. These and other data are 

used by APHIS to determine if the new 

variety poses a plant pest risk. 

APHIS completed an environmental 

assessment (EA) and finding of no 

significant impact (FONSI) for 

TwinLinkTM cotton (see footnote 1). The 

EA and FONSI were prepared, in 

accordance with the National 

Environmental Policy Act (NEPA), to 

provide the APHIS decisionmaker with 

a review and analysis of any potential 

environmental impacts associated with 

the proposed determination of 

nonregulated status of TwinLinkTM

cotton. APHIS has carefully examined 

the NEPA documentation completed for 

TwinLinkTM cotton and has concluded 

that the BCS extension request for a 

determination of nonregulated status of 

cotton event T303–3 encompasses the 

same scope of environmental analysis as 

TwinLinkTM cotton. Therefore, the 

existing NEPA documentation 

completed for TwinLinkTM cotton is 

being used to evaluate and determine if 

there are any potentially significant 

impacts to the human environment from 

APHIS’ response to the BCS extension 

request for a determination of 

nonregulated status of cotton event 

T303–3. 

Based on APHIS’ analyses of data 

submitted by Bayer, a review of other 

scientific data, and field tests conducted 

under APHIS oversight, the TwinLinkTM

cotton EA presented two alternatives: 

(1) Take no action, i.e., APHIS would 

not change the regulatory status of 

TwinLinkTM cotton and it would 

continue to be a regulated article, or (2) 

make a determination of nonregulated 

status of TwinLinkTM cotton. Based on 

the similarity of cotton event T303–4 to 

the antecedent organism TwinLinkTM

cotton event T304–40, APHIS has 

concluded that the alternatives 

considered for TwinLinkTM cotton are 

relevant to APHIS’ regulatory actions 

associated with cotton event T303–3 

and are therefore being used in their 

entirety. 

The EA was prepared in accordance 

with (1) the NEPA, as amended (42 

U.S.C. 4321 et seq.), (2) regulations of 

the Council on Environmental Quality 

for implementing the procedural 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 41353 

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 previous NEPA review completed 

for TwinLinkTM cotton and our 

conclusion that the BCS extension 

request for a determination of 

nonregulated status of cotton event 

T303–3 encompasses the same scope of 

environmental analysis as TwinLinkTM

cotton, APHIS has reached a FONSI 

with regard to a determination of 

nonregulated status of cotton event 

T303–3. 

Based on APHIS’ analysis of field and 

laboratory data submitted by BCS, 

references provided in the extension 

request, peer-reviewed publications, 

information analyzed in the 

TwinLinkTM cotton EA, and the 

similarity of cotton event T303–3 to the 

antecedent organism, cotton event 

T304–40, APHIS has determined that 

cotton event T303–3 is unlikely to pose 

a plant pest risk. We have therefore 

reached a preliminary decision to 

approve the request to extend the 

determination of nonregulated status of 

cotton event T304–40 to cotton event 

T303–3, whereby cotton event T303–3 

would no longer be subject to our 

regulations governing the introduction 

of certain genetically engineered 

organisms. 

Paragraph (e) of § 340.6 provides that 

APHIS will publish a notice in the 

Federal Register announcing all 

preliminary decisions to extend 

determinations of nonregulated status 

for 30 days before the decisions become 

final and effective. In accordance with 

§ 340.6(e) of the regulations, we are 

publishing this notice to inform the 

public of our preliminary decision to 

extend the determination of 

nonregulated status of cotton event 

T304–40 to cotton event T303–3. 

APHIS will accept written comments 

on the FONSI regarding a determination 

of nonregulated status of event T303–3 

for a period of 30 days from the date of 

this notice. The extension request, 

FONSI, and preliminary determination 

for event T303–3, as well as the 

supporting documents, are available for 

public review as indicated under 

ADDRESSES and FOR FURTHER

INFORMATION CONTACT above. 

After the comment period closes, 

APHIS will review all written comments 

received during the comment period 

and any other relevant information. All 

comments received regarding the FONSI 

will be available for public review. After 

reviewing and evaluating the comments 

on the FONSI, if APHIS determines that 

no substantive information has been 

received that would warrant APHIS 

altering its preliminary regulatory 

determination or FONSI, our 

preliminary regulatory determination 

will become final and effective upon 

notification of the public through an 

announcement on our Web site at 

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

biotechnology/pet_proc_imp.shtml. 

APHIS will also furnish a response to 

the petitioner regarding our final 

regulatory determination. No further 

Federal Register notice will be 

published announcing the final 

regulatory determination regarding 

cotton event T303–3. 

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 9th day of 

July 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–17133 Filed 7–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0046] 

GENECTIVE SA; Availability of Petition 

for Determination of Nonregulated 

Status of Maize Genetically Engineered 

for Herbicide Tolerance 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service (APHIS) has received 

a petition from GENECTIVE SA seeking 

a determination of nonregulated status 

of maize designated as VCO-;1981–5, 

which has been genetically engineered 

for tolerance to the herbicide 

glyphosate. The petition has been 

submitted in accordance with our 

regulations concerning the introduction 

of certain genetically engineered 

organisms and products. We are making 

the GENECTIVE SA petition available 

for review and comment to help us 

identify potential environmental and 

interrelated economic issues and 

impacts that APHIS may determine 

should be considered in our evaluation 

of the petition. 

DATES: We will consider all comments 

that we receive on or before September 

11, 2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0046- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0046, 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-2012-0046 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. 

The petition is also available on the 

APHIS Web site at http:// 

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

11_34201p.pdf. 

FOR FURTHER INFORMATION CONTACT: Dr. 

John Turner, Director, Environmental 

Risk Analysis Programs, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737– 

1236; (301) 851–3954, email: 

john.t.turner@aphis.usda.gov. To obtain 

copies of the petition, contact Ms. Cindy 

Eck at (301) 851–3892, 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 (GE) 

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 


srobinson on DSK4SPTVN1PROD with NOTICES