41364 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. 

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

09_01501p.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 09–015–01p) 

from BASF Plant Science LP of Research 

Triangle Park, NC, seeking a 

determination of nonregulated status of 

soybean (Glycine max) designated as 

event BPS–CV127–9, which has been 

genetically engineered for tolerance to 

herbicides in the imidazolinone family, 

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 BPS–CV127–9 has been 

genetically engineered for tolerance to 

herbicides in the imidazolinone family 

through the introduction of the 

imidazolinone-tolerant 

acetohydroxyacid synthase large 

subunit (ahas) gene csr1–2 with its 

native promoter from the plant 

Arabidopsis thaliana. Soybean event 

BPS–CV127–9 is currently regulated 

under 7 CFR part 340. Interstate 

movements and field tests of soybean 

event BPS–CV127–9 have been 

conducted under notifications 

acknowledged by APHIS. 

For this petition, most field tests were 

conducted by BASF in Brazil, which 

allowed for evaluation in a natural 

agricultural setting. 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 

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 pestrisk 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. 2012–17139 Filed 7–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0031] 

Pioneer Hi-Bred International, Inc.; 

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 Pioneer Hi-Bred 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 41365 

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

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

0129. 

International, Inc., (Pioneer) seeking a 

determination of nonregulated status of 

canola designated as DP–073496–4, 

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 Pioneer 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-2012-0031-

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0031, 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-2012-0031 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_06301p.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 11–063–01p) from 

Pioneer Hi-Bred International, Inc., of 

Johnston, IA, seeking a determination of 

nonregulated status of canola (Brassica 

napus) designated as event DP–073496– 

4, which has been genetically 

engineered for tolerance to the herbicide 

glyphosate, 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 DP–073496–4 has been genetically 

engineered to express the glyphosate 

acetyltransferase (GAT4621) protein, 

which gives the plant tolerance to the 

herbicide glyphosate. The gat4621 gene 

is a variant of three gat genes from the 

common soil bacterium Bacillus 

licheniformis. The GAT4621 protein is 

encoded by the gat4621 gene, which 

confers tolerance to glyphosatecontaining herbicides by acetylating 

glyphosate and thereby rendering it 

nonphytotoxic. Canola event DP– 

073496–4 is currently regulated under 7 

CFR part 340. Interstate movements and 

field tests of canola event DP–073496– 

4 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. 

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 canola 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
41366 Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices 

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. 2012–17135 Filed 7–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0024] 

Syngenta Biotechnology, Inc.; 

Availability of Petition, Plant Pest Risk 

Assessment, and Environmental 

Assessment for Determination of 

Nonregulated Status of Corn 

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 Syngenta Biotechnology, 

Inc., seeking a determination of 

nonregulated status of corn designated 

as SYN–05307–1, which has been 

genetically engineered for resistance to 

corn rootworm, an insect pest of corn. 

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 

corn is likely to pose a plant pest risk. 

We are making available for public 

comment the Syngenta Biotechnology, 

Inc., 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 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-2012-0024- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0024, 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-2012-0024 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, draft environmental 

assessment, and plant pest risk 

assessment are also available on the 

APHIS Web site at http:// 

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

10_33601p.pdf, http:// 

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

10_33601p_dea.pdf, and http:// 

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

10_33601p_dpra.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, draft 

environmental assessment, or plant pest 

risk assessment, 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. 

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 10–336–01p) from 

Syngenta Biotechnology, Inc., 

(Syngenta) of Research Triangle Park, 

NC, seeking a determination of 

nonregulated status of corn (Zea mays 

L.) designated as event SYN–05307–1, 

which has been genetically engineered 

for resistance to corn rootworm, an 

insect pest of corn. The petition states 

that this corn 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, corn 

event SYN–05307–1 has been 

genetically engineered to contain the 

transgene ecry3.1Ab encoding a novel 

rootworm-control protein, eCry3.1Ab, 

and the transgene pmi (also known as 

manA) encoding the enzyme 

phosphomannose isomerase (PMI). The 

eCry3.1Ab protein is an engineered 

chimera of the modified Cry3A 

(mCry3A) and Cry1Ab proteins, 

members of a class of insecticidal 

proteins derived from Bacillus 

thuringiensis. Corn event SYN–05307–1 

is currently regulated under 7 CFR part 

340. Interstate movements and field 

tests of corn event SYN–05307–1 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 


srobinson on DSK4SPTVN1PROD with NOTICES