Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices 37769 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2010–0102] 

Bayer CropScience LP; Availability of 

Petition, Plant Pest Risk Assessment, 

and Environmental Assessment for 

Determination of Nonregulated Status 

for Cotton Genetically Engineered for 

Insect Resistance and 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 has received a 

petition from Bayer CropScience LP 

seeking a determination of nonregulated 

status for cotton designated as 

TwinLinkTM cotton (events T304–40 

and GHB119), which has been 

genetically engineered to be tolerant to 

the herbicide glufosinate and resistant 

to several lepidopteran pests. 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 

cotton is likely to pose a plant pest risk. 

We are making available for public 

comment the Bayer 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 August 29, 

2011. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS–2010– 

0102–0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2010–0102, 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–2010–0102 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) 690–2817 

before coming. 

Availability of Documents: The 

petition, draft environmental 

assessment, and plant pest risk 

assessment are available on the 

Regulations.gov Web site (see link 

above) and on the APHIS Web site at 

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

aphisdocs/08_34001p.pdf, http:// 

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

08_34001p_dea.pdf, and http:// 

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

08_34001p_dpra.pdf. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Evan Chestnut, Policy Analyst, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 146, 

Riverdale, MD 20737–1236; (301) 734– 

0942, e-mail: 

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, e-mail: 

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 08–340–01p) from 

Bayer CropScience LP (Bayer), seeking a 

determination of nonregulated status for 

TwinLinkTM cotton (events T304–40 

and GHB119), which has been 

genetically engineered to be tolerant to 

the herbicide glufosinate and resistant 

to several lepidopteran pests, stating 

that TwinLinkTM cotton 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, 

TwinLinkTM cotton is a combined-trait 

cotton developed using conventional 

breeding techniques to link two 

deoxyribonucleic acid (DNA) 

transformation events, each developed 

using DNA recombinant techniques. By 

crossing Bayer’s Cry1Ab Cotton (event 

T304–40) with Bayer’s Cry2Ae Cotton 

(event GHB119), Bayer has developed a 

cotton resistant to lepidopteran pests. 

The TwinLinkTM cotton also expresses a 

glufosinate ammonium herbicide 

tolerance trait based on LibertyLink® 

technology. TwinLinkTM cotton is 

currently regulated under 7 CFR part 

340. Interstate movement, importation, 

and field testing of TwinLinkTM cotton 

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. 

In section 403 of the Plant Protection 

Act, ‘‘plant pest’’ is defined as any 

living stage of any of the following that 

can directly or indirectly injure, cause 

damage to, or cause disease in any plant 

or plant product: A protozoan, a 

nonhuman animal, a parasitic plant, a 

bacterium, a fungus, a virus or viroid, an 

infectious agent or other pathogen, or 

any article similar to or allied with any 

of the foregoing. APHIS has prepared a 

plant pest risk assessment to determine 

if TwinLinkTM cotton is unlikely to pose 

a plant pest risk. 

APHIS has also prepared a draft 

environmental assessment (EA) in 

which it presents two alternatives based 

on its analyses of data submitted by 

Bayer, a review of other scientific data, 

and field tests conducted under APHIS 

oversight. APHIS is considering the 

following 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 for TwinLinkTM

cotton. 

The draft EA has been prepared to 

provide the APHIS decisionmaker with 

a review and analysis of any potential 

environmental impacts associated with 

the proposed determination of 

mstockstill on DSK4VPTVN1PROD with NOTICES

37770 Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices 

nonregulated status for TwinLinkTM

cotton. The draft 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). 

In accordance with § 340.6(d) of the 

regulations, we are publishing this 

notice to inform the public that APHIS 

will accept written comments regarding 

the petition for a determination of 

nonregulated status from interested or 

affected persons for a period of 60 days 

from the date of this notice. We are also 

soliciting written comments from 

interested or affected persons on the 

plant pest risk assessment and the draft 

EA prepared to examine any potential 

environmental impacts of the proposed 

determination of the nonregulated status 

of the subject cotton lines. The petition, 

draft EA, and plant pest risk assessment 

are available for public review, and 

copies of the petition, draft EA, and 

plant pest risk assessment are available 

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 

petition, draft EA, and plant pest risk 

assessment will be available for public 

review. After reviewing and evaluating 

the comments on the petition, the draft 

EA, plant pest risk assessment, and 

other data, APHIS will furnish a 

response to the petitioner, either 

approving or denying the petition. 

APHIS will also publish a notice in the 

Federal Register announcing the 

regulatory status of TwinLinkTM cotton 

and the availability of APHIS’ written 

environmental decision and regulatory 

determination. 

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 22nd day of 

June 2011. 

John R. Clifford, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–16126 Filed 6–27–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0038] 

Monsanto Co.; Availability of Petition, 

Plant Pest Risk Assessment, and 

Environmental Assessment for 

Determination of Nonregulated Status 

for Soybean Genetically Engineered 

for 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 received a 

petition from the Monsanto Company 

seeking a determination of nonregulated 

status for soybean designated as MON 

87701, which has been genetically 

engineered for insect resistance. 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 August 29, 

2011. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2011-0038- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2011–0038, 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-2011-0038 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_08201p.pdf, 

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

aphisdocs/09_08201p _dea.pdf, and 

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

aphisdocs/09_08201p _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; e-mail: 

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 09–082–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO, seeking a determination of 

nonregulated status for soybean (Glycine 

max) designated as event MON 87701, 

which has been genetically engineered 

for insect resistance, 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, event 

MON 87701 has been genetically 

engineered to express a Cry1Ac 

insecticidal protein derived from the 

mstockstill on DSK4VPTVN1PROD with NOTICES