41356 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 

1To view the notice, go to http:// 

www.regulations.gov/#!docketDetail;D=APHIS2011-0129. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0047] 

Monsanto Co.; Availability of Petition 

for Determination of Nonregulated 

Status of Soybean 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 the Monsanto Company 

(Monsanto) seeking a determination of 

nonregulated status of soybean 

designated as MON 87708, which has 

been genetically engineered for 

tolerance to the herbicide dicamba. The 

petition has been submitted in 

accordance with our regulations 

concerning the introduction of certain 

genetically engineered organisms and 

products. We are making the Monsanto 

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-2012-0047- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0047, 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-2012-0047 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/ 

10_18801p.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 

must take and the information that must 

be included in the petition. 

APHIS has received a petition 

(APHIS Petition Number 10–188–01p) 

from the Monsanto Company 

(Monsanto) of St. Louis, MO, seeking a 

determination of nonregulated status of 

soybean (Glycine max) designated as 

event MON 87708, which has been 

genetically engineered for tolerance to 

the herbicide dicamba, 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 87708 has been genetically 

engineered to contain a gene from the 

bacteria Stenotrophomonas maltophilia 

that expresses a monooxygenase enzyme 

that rapidly demethylates dicamba 

rendering it inactive, thereby conferring 

tolerance to the herbicide dicamba. 

Soybean event MON 87708 is currently 

regulated under 7 CFR part 340. 

Interstate movements and field tests of 

soybean event MON 87708 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 

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. 

Paragraph (d) of § 340.6 provides that 

APHIS will publish a notice in the 

Federal Register providing 60 days for 

public comment for petitions for a 

determination of nonregulated status. 

On March 6, 2012, we published in the 

Federal Register (77 FR 13258–13260, 

Docket No. APHIS–2011–0129) a 

notice 1 describing our process for 

soliciting public comment when 

considering petitions for determinations 

of nonregulated status for GE organisms. 

In that notice we indicated that APHIS 

would accept written comments 

regarding a petition once APHIS 

deemed it complete. 

In accordance with § 340.6(d) of the 

regulations and our process for 

soliciting public input when 

considering petitions for determinations 

of nonregulated status for GE organisms, 

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. The petition is 

available for public review, and copies 

are available as indicated under 

ADDRESSES and FOR FURTHER

INFORMATION CONTACT above. We are 

interested in receiving comments 

regarding potential environmental and 

interrelated economic issues and 

impacts that APHIS may determine 

should be considered in our evaluation 

of the petition. We are particularly 

interested in receiving comments 

regarding biological, cultural, or 

ecological issues, and we encourage the 

submission of scientific data, studies, or 

research to support your comments. We 

also request that, when possible, 

commenters provide relevant 

information regarding specific localities 

or regions as soybean growth, crop 

management, and crop utilization may 

vary considerably by geographic region. 

After the comment period closes, 

APHIS will review all written comments 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 41357 

received during the comment period 

and any other relevant information; any 

substantive issues identified by APHIS 

based on our review of the petition and 

our evaluation and analysis of 

comments will be considered in the 

development of our decisionmaking 

documents. 

As part of our decisionmaking process 

regarding a GE organism’s regulatory 

status, APHIS prepares a plant pest risk 

assessment to assess its plant pest risk 

and the appropriate Environmental 

Documentation—either an 

Environmental Assessment (EA) or an 

Environmental Impact Statement (EIS)— 

in accordance with the National 

Environmental Policy Act (NEPA), to 

provide the Agency with a review and 

analysis of any potential environmental 

impacts associated with the petition 

request. For petitions for which APHIS 

prepares an EA, APHIS will follow our 

published process for soliciting public 

comment (see footnote 1) and publish a 

separate notice in the Federal Register 

announcing the availability of APHIS’ 

EA and plant pest risk assessment. 

Should APHIS determine that an EIS is 

necessary, APHIS will complete the 

NEPA EIS process in accordance with 

Council on Environmental Quality 

regulations (40 CFR part 1500–1508) 

and APHIS’ NEPA implementing 

regulations (7 CFR part 372). 

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. 2012–17129 Filed 7–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0035] 

Monsanto Co.; Availability of Petition 

for Determination of Nonregulated 

Status of Canola 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 the Monsanto Company 

(Monsanto) seeking a determination of 

nonregulated status of canola designated 

as MON 88302, which has been 

genetically engineered for tolerance to 

the herbicide glyphosate with more 

flexibility in the timing of herbicide 

application. The petition has been 

submitted in accordance with our 

regulations concerning the introduction 

of certain genetically engineered 

organisms and products. We are making 

the Monsanto 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-2012-0035- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0035, 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-2012-0035 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_18801p.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 

must take and the information that must 

be included in the petition. 

APHIS has received a petition (APHIS 

Petition Number 11–188–01p) from the 

Monsanto Company of St. Louis, MO, 

seeking a determination of nonregulated 

status of canola (Brassica napus) 

designated as event MON 88302, which 

has been genetically engineered for 

tolerance to the herbicide glyphosate 

with more flexibility in the timing of 

herbicide application, stating that this 

canola 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, canola 

event MON 88302 has been genetically 

engineered for tolerance to the herbicide 

glyphosate via the incorporation of a 

cp4 epsps coding sequence, producing 

the same 5-enolpyruvylshikimate-3- 

phosphate synthase (CP4 EPSPS) 

protein that is produced in commercial 

Roundup Ready® crop products. MON 

88302 utilizes an improved promoter 

sequence to enhance CP4 EPSPS 

expression in male reproductive tissues 

(i.e., pollen). Enhanced CP4 EPSPS 

expression in the male reproductive 

tissues of MON 88302 allows the greater 

flexibility of glyphosate herbicide 

applications as MON 88302 plants can 

be sprayed with higher rates of 

glyphosate and at later stages of 

development with no detectable impact 

to male fertility. Canola event MON 

88302 is currently regulated under 7 

CFR part 340. Interstate movements and 

field tests of canola event MON 88302 

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 


srobinson on DSK4SPTVN1PROD with NOTICES