Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 41359 

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

regulations.gov/#!docketDetail;D=APHIS-2011-

0129. 

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 09–328–01p) from 

Bayer CropScience LP (Bayer), seeking a 

determination of nonregulated status of 

soybean designated as event FG72, 

which has been genetically engineered 

to tolerate the herbicides glyphosate and 

isoxaflutole. The petition states 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 FG72 contains the stably 

integrated 2mepsps gene, which confers 

tolerance to the herbicide glyphosate, 

and the hppdPfW336 gene, which 

confers tolerance to HPPD inhibitors 

such as the herbicide isoxaflutole. 

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 soybean event FG72 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 soybean event FG72 

and it would continue to be a regulated 

article, or (2) make a determination of 

nonregulated status for soybean event 

FG72. 

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 

nonregulated status for soybean event 

FG72. 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). 

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 updated process 

for soliciting public comment when 

considering such petitions. As described 

in the notice, all petitions received by 

APHIS on or after March 6, 2012, will 

be handled using the updated process, 

whereby APHIS will publish two 

separate notices in the Federal Register 

for petitions for which APHIS prepares 

an environmental assessment. For 

petitions received before this date, 

however, we indicated that petitions 

may follow our previous process, i.e., 

the petition, draft EA, and PPRA will be 

made available in a single Federal 

Register notice for a 60-day comment 

period. For this petition, APHIS will 

follow our previous process. 

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 nonregulated status of 

the subject soybean line. 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 soybean event FG72 

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 9th day of 

July 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–17136 Filed 7–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0027] 

Monsanto Co.; Availability of Petition 

for Determination of Nonregulated 

Status of Maize Genetically Engineered 

With Tissue-Selective Glyphosate 

Tolerance Facilitating the Production 

of Hybrid Maize Seed 

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 

seeking a determination of nonregulated 

status of maize designated as MON 

87427, which has been genetically 


srobinson on DSK4SPTVN1PROD with NOTICES
41360 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. 

engineered with tissue-selective 

tolerance to glyphosate in order to 

facilitate the production of hybrid maize 

seed. 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-2012-0027- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0027, 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-2012-0027 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_28101p.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 10–281–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO, seeking a determination of 

nonregulated status of maize (Zea mays 

L.) designated as event MON 87427, 

which has been genetically engineered 

for tissue-selective tolerance to 

glyphosate in order to facilitate the 

production of hybrid maize seed, stating 

that this maize 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, maize 

event MON 87427 has been genetically 

engineered to facilitate the production 

of hybrid maize seed through the 

incorporation of a cp4 epsps coding 

sequence. The CP4 EPSPS protein 

confers tolerance to the herbicide 

glyphosate, and tissue-selective 

expression of this protein in MON 

87427 enables an extension of the use of 

glyphosate-tolerant maize as a tool in 

hybrid maize seed production. Maize 

event MON 87427 is currently regulated 

under 7 CFR part 340. Interstate 

movements and field tests of maize 

event MON 87427 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 maize growth, crop 

management, and crop utilization may 

vary considerably by geographic region. 

After the comment period closes, 

APHIS will review all written comments 

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 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 41361 

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

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

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. 2012–17142 Filed 7–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0032] 

Dow AgroSciences LLC; 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 Dow AgroSciences LLC 

(DAS) seeking a determination of 

nonregulated status of soybean 

designated as DAS–44406–6, which has 

been genetically engineered for 

tolerance to broadleaf herbicides in the 

phenoxy auxin group (such as the 

herbicide 2,4-D) and the herbicides 

glyphosate and glufosinate. The petition 

has been submitted in accordance with 

our regulations concerning the 

introduction of certain genetically 

engineered organisms and products. We 

are making the DAS 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-2012-0032- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0032, 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-2012-0032 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_23401p.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 11–234–01p) from Dow 

AgroSciences LLC of Indianapolis, IN, 

seeking a determination of nonregulated 

status of soybean (Glycine max) 

designated as event DAS–44406–6, 

which has been genetically engineered 

for tolerance to broadleaf herbicides in 

the phenoxy auxin group (such as the 

herbicide 2,4-D) and the herbicides 

glyphosate and glufosinate, 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 DAS–44406–6 has been 

genetically engineered to express the 

aryloxyalkanoate dioxygenase-12 (AAD– 

12), the double mutant 5- 

enolpyruvylshikimate-3-phosphate 

synthase (2mEPSPS), and 

phosphinothricin acetyltransferase 

(PAT) proteins. Soybean event DAS– 

44406–6 is currently regulated under 7 

CFR part 340. Interstate movements and 

field tests of soybean event DAS–44406– 

6 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 


srobinson on DSK4SPTVN1PROD with NOTICES