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

63278 

Vol. 76, No. 197 

Wednesday, October 12, 2011 

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

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

www.regulations.gov/#!docketDetail;D=APHIS2010-0102. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2010–0102] 

Bayer CropScience LP; 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 of 

our determination that a genetically 

engineered cotton developed by Bayer 

CropScience LP, 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, is no 

longer considered a regulated article 

under our regulations governing the 

introduction of certain genetically 

engineered organisms. Our 

determination is based on our 

evaluation of data submitted by Bayer 

CropScience LP in its petition for a 

determination of nonregulated status, 

our analysis of available scientific data, 

and comments received from the public 

in response to our previous notice 

announcing the availability of the 

petition for nonregulated status and its 

associated environmental assessment 

and plant pest risk assessment. This 

notice also announces the availability of 

our written determination and finding 

of no significant impact. 

DATES: Effective Date: October 12, 2011. 

ADDRESSES: You may read the 

documents referenced in this notice and 

the comments we received in our 

reading room. The reading room 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. Those documents are also 

available on the Internet at http:// 

www.aphis.usda.gov/biotechnology/

not_reg.html and are posted with the 

previous notice and the comments we 

received on the Regulations.gov Web 

site at http://www.regulations.gov/

#!docketDetail;D=APHIS–2010–0102. 

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 documents 

referenced in this notice, contact Ms. 

Cindy Eck at (301) 734–0667, e-mail: 

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 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. 

In a notice1 published in the Federal 

Register on June 28, 2011 (76 FR 37769– 

37770, Docket No. APHIS–2010–0102), 

APHIS announced the availability of the 

Bayer 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 cotton is likely to pose a plant 

pest risk, the draft EA, and the PPRA for 

60 days ending on August 29, 2011. 

APHIS received two comments during 

the comment period. The commenters 

expressed general opposition to 

genetically engineered crops but did not 

provide any specific comments 

regarding the petition, draft EA, or 

PPRA. 

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 for 

Bayer’s TwinLinkTM cotton, 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 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 Bayer, 

references provided in the petition, 

peer-reviewed publications, information 

analyzed in the EA, the PPRA, and 

comments provided by the public, 

APHIS has determined that Bayer’s 

TwinLinkTM cotton is unlikely to pose 

a plant pest risk and therefore is no 


jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 63279 

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

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

www.regulations.gov/#!docketDetail;D=APHIS2011-0038. 

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, and finding of no 

significant impact 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 5th day of 

October 2011. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–26349 Filed 10–11–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2011–0038] 

Monsanto Co.; 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 of 

our determination that a soybean line 

developed by the Monsanto Co., 

designated as event MON 87701, which 

has been genetically engineered for 

insect resistance, is no longer 

considered a regulated article under our 

regulations governing the introduction 

of certain genetically engineered 

organisms. Our determination is based 

on our evaluation of data submitted by 

the Monsanto Company in its petition 

for a determination of nonregulated 

status, our analysis of available 

scientific data, and comments received 

from the public in response to our 

previous notice announcing the 

availability of the petition for 

nonregulated status and its associated 

environmental assessment and plant 

pest risk assessment. This notice also 

announces the availability of our 

written determination and finding of no 

significant impact. 

DATES: Effective Date: October 12, 2011. 

ADDRESSES: You may read the 

documents referenced in this notice and 

the comments we received in our 

reading room. The reading room 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. Those documents are also 

available on the Internet at http:// 

www.aphis.usda.gov/biotechnology/ 

not_reg.html and are posted with the 

previous notice and the comments we 

received on the Regulations.gov Web 

site at http://www.regulations.gov/ 

#!docketDetail;D=APHIS–2011–0038. 

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 documents 

referenced in this notice, contact Ms. 

Cindy Eck at (301) 734–0667, e-mail: 

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 09–082–01p) 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. 

In a notice1 published in the Federal 

Register on June 28, 2011 (76 FR 37770– 

37771, Docket No. APHIS–2011–0038), 

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 soybeans are likely to pose a 

plant pest risk, the draft EA, and the 

PPRA for 60 days ending on August 29, 

2011. 

APHIS received four comments 

during the comment period. Two 

commenters referenced a different 

soybean line. One commenter expressed 

general opposition to genetically 

engineered crops but did not provide 

any specific comments on the petition, 

draft EA, or PPRA. One commenter 

suggested that APHIS should analyze 

the impacts of MON 87701 on bees and 

groundwater. APHIS has addressed the 

issues raised by this commenter in an 

attachment to the finding of no 

significant impact, and impacts to nontarget insects and impacts on water are 

both addressed in the EA. 

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 for 

Monsanto’s soybean event MON 87701, 

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 


jlentini on DSK4TPTVN1PROD with NOTICES