Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 13309 

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

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

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 12–185–01p) from the 

Monsanto Company (Monsanto) of St. 

Louis, MO, seeking a determination of 

nonregulated status of cotton designated 

as event MON 88701, which has been 

genetically engineered for tolerance to 

the herbicides dicamba and glufosinate. 

The petition states that this 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, cotton 

event MON 88701 has been genetically 

engineered to allow in-crop applications 

of dicamba herbicide for the control of 

broadleaf weeds from preemergence to 7 

days preharvest and glufosinate 

herbicide for broad spectrum weed 

control from emergence through early 

bloom growth stage. Cotton event MON 

88701 provides dicamba tolerance that 

allows for the in-crop application of 

dicamba beyond the current preplant 

uses in cotton and also provides 

glufosinate tolerance equivalent to 

current commercial glufosinate-tolerant 

cotton events. Cotton event MON 88701 

is currently regulated under 7 CFR part 

340. Interstate movements and field 

tests of cotton event MON 88701 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 cotton 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 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 22nd day of 

February 2013. 

Michael Gregoire, 

Deputy Administrator, Biotechnology 

Regulatory Services, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–04522 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0030] 

ArborGen Inc.; Availability of Petition, 

Notice of Intent To Prepare an 

Environmental Impact Statement for 

Determination of Nonregulated Status 

of Freeze Tolerant Eucalyptus Lines, 

and Notice of Virtual Public Meetings 

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 ArborGen Inc. seeking a 

determination of nonregulated status of 

Freeze Tolerant Eucalyptus lines 

designated 427 and 435, which have 

been genetically engineered (GE) to be 

more tolerant of cold conditions. The 

incorporation of the GE trait allows 

these eucalyptus hybrid trees to be 

grown in a broader geographic area than 

non-GE eucalyptus hybrid trees. The 

petition has been submitted in 

accordance with our regulations 

concerning the introduction of certain 


erowe on DSK2VPTVN1PROD with NOTICES
13310 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 

1The notices and environmental assessments are 

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

#!docketDetail;D=APHIS-2007-0027, http:// 

www.regulations.gov/#!docketDetail;D=APHIS2008-0059, and http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2011-0130. 

GE organisms and products. We are 

making available for public comment 

the ArborGen Inc. petition and are 

soliciting comments on whether these 

GE eucalyptus lines are likely to pose a 

plant pest risk. We are also announcing 

to the public our intent to prepare an 

environmental impact statement (EIS) 

on the action with regard to the petition 

for nonregulated status, identifying 

potential issues and alternatives that 

may be studied in the EIS, and 

requesting public comments to further 

delineate the scope of the alternatives 

and environmental impacts and issues. 

We are also announcing that APHIS will 

be hosting two virtual meetings during 

the comment period. The purpose of the 

meetings will be to further delineate the 

scope of alternatives and environmental 

impacts and issues discussed in the EIS. 

DATES: We will consider all comments 

that we receive on or before April 29, 

2013. We will also consider comments 

made at virtual public meetings that 

will be held during the comment period. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0030- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0030, 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-2012-0030 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) 7997039 

before coming. 

The petition is also available on the 

APHIS Web site at http:// 

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

11_01901p.pdf. 

Other Information: Details regarding 

the virtual meetings, including times, 

dates, and how to participate, will be 

available at http:// 

www.aphisvirtualmeetings.com. 

FOR FURTHER INFORMATION CONTACT: Dr. 

John Turner, Director, Environmental 

Risk Analysis Programs, Biotechnology 

Regulatory Services, APHIS, 4700 River 

Road Unit 147, Riverdale, MD 20737– 

1238; (301) 851–3954. To obtain copies 

of the petition, contact Ms. Cindy Eck at 

(301) 851–851–3882, email: 

cynthia.a.eck@aphis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the authority of the plant pest 

provisions of the Plant Protection Act 

(PPA) (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. 

Proposed Action 

APHIS has received a petition (APHIS 

Petition Number 11–019–01p) from 

ArborGen Inc. of Summerville, SC, 

seeking a determination of nonregulated 

status of two Freeze Tolerant Eucalyptus 

(FTE) lines designated 427 and 435. The 

petition states that these eucalyptus 

trees are unlikely to pose a plant pest 

risk and, therefore, should not be a 

regulated article under APHIS’ 

regulations in 7 CFR part 340. These 

regulations are authorized by the PPA to 

prevent the introduction or 

dissemination of plant pests, and the 

decision on whether or not to grant the 

petition will be based on this standard. 

As described in the petition, FTE 

lines 427 and 435 have been genetically 

engineered to express the CBF2 gene to 

be more tolerant of cold conditions and 

a gene expression cassette that prevents 

pollen development. FTE lines 427 and 

435 are currently regulated under 7 CFR 

part 340. Field tests of FTE lines 427 

and 435 have been conducted under 

permits issued by APHIS at multiple 

sites representing both freeze stress and 

freeze stress-free environments in the 

southeastern United States, Alabama, 

Florida, Georgia, Louisiana, Mississippi, 

South Carolina, and Texas. 

APHIS has conducted three separate 

environmental assessments (EA) on 

actions related to permitting confined 

field releases of FTE trees under 

conditions designed to prevent spread 

of the trees outside the field test area, 

and in each case announced the 

availability of the EA in the Federal 

Register. These notices 1 were published 

on April 20, 2007 (Docket No. APHIS– 

2007–0027, 72 FR 19876–19877), June 3, 

2009 (Docket No. APHIS–2008–0059, 74 

FR 26648–26649), and February 10, 

2012 (Docket No. APHIS–2011–0130; 77 

FR 7123–7124). In these assessments, 

APHIS concluded that the field trials 

would not pose a plant pest risk and 

that issuing permits for the field trials 

would not significantly affect the 

quality of the human environment. 

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. 

After the comment period closes, 

APHIS will review all written comments 

received during the comment period 

and any other relevant information. All 

comments received will be available for 

public review. Any substantive issues 

identified by APHIS based on our 

review of the petition and our 

evaluation and analysis of the 

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 EA or an 

environmental impact statement (EIS)— 

in accordance with the National 

Environmental Policy Act of 1969, as 

amended (42 U.S.C. 4321 et seq.) 

(NEPA), to provide the Agency with a 

review and analysis of any potential 

environmental impacts associated with 

the petition request. Upon completion 

of these documents, APHIS will furnish 


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Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 13311 

a response to the petitioner and will 

notify the public of our regulatory 

determination. 

Under the provisions of NEPA, 

Federal agencies must examine the 

potential environmental impacts of 

proposed Federal actions before actions 

are taken. In accordance with NEPA, 

regulations of the Council on 

Environmental Quality for 

implementing the procedural provisions 

of NEPA (40 CFR parts 1500–1508), U.S. 

Department of Agriculture (USDA) 

regulations implementing NEPA (7 CFR 

part 1b) and APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372), APHIS has considered how to 

properly examine these potential 

environmental impacts. In each of the 

previous three APHIS actions 

concerning FTE trees, we determined 

that an EA was the appropriate means 

to consider and document 

environmental impacts. Also, in 

response to a legal challenge to the 

adequacy of these EAs and the NEPA 

process, the United States District Court 

for the Southern District of Florida 

granted summary judgment affirming 

the APHIS actions (Case No. 10–14175– 

ClV–MOORE/LYNCH). 

An EA might also be used in this case, 

where the relevant Federal action would 

be determination of nonregulated status 

of two FTE lines. However, APHIS is 

choosing the option of preparing an EIS 

to analyze the potential environmental 

impacts of responding to this petition 

request. 

APHIS is exercising its option to 

prepare an EIS rather than an EA to 

address unresolved proposed or adopted 

local, regional, State, interstate, or 

Federal land use plans or policies that 

may result in adverse environmental 

impacts. In preparing an EIS, APHIS 

would be responsive to other agencies 

that have an interest in the possible 

future establishment of FTE trees in 

forest areas. Federal and State agencies 

have expressed interest in this issue 

from several perspectives. The USDA 

Forest Service has agreed to serve as a 

cooperating agency in the preparation of 

this EIS and will provide expertise in 

hydrology, to assess the effects of 

eucalyptus on water resources, and 

economic modeling, to predict where in 

the United States FTE trees may be 

adopted. The United States Department 

of Energy considers eucalyptus as a 

candidate bioenergy feedstock. The 

United States Fish and Wildlife Service 

has expressed interest in studies of the 

impacts of eucalyptus tree plantations 

on wildlife diversity and ecosystem 

sustainability. Various States, including 

Georgia and Florida, have conducted 

studies or hearings on the possible use 

of tree plantations as sources of 

bioenergy feedstocks. APHIS believes 

that choosing to prepare an EIS rather 

than an EA would allow us to fully 

consider potential environmental 

impacts of the Federal action under 

consideration and would also provide, 

in an efficient way, data that could 

address a wide variety of government 

interests and could shed light on issues 

relevant to possible future actions under 

the jurisdiction of interested agencies. 

By preparing an EIS at this time, APHIS 

may provide agencies with an 

opportunity to adopt all or part of the 

EIS for future actions in accordance 

with the adoption provisions of the 

Council on Environmental Quality’s 

NEPA implementing regulations (40 

CFR 1506.3). 

Alternatives 

This notice identifies reasonable 

alternatives and potential issues that 

may be studied in the EIS. We are 

requesting public comments to further 

delineate the scope of alternatives and 

environmental impacts and issues. We 

will be hosting two virtual meetings 

during the comment period to discuss 

the scope of the EIS (see ADDRESSES

above). 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. 

The EIS will consider a range of 

reasonable alternatives. APHIS is 

considering including a ‘‘no action’’ and 

‘‘approve the petition request’’ 

alternatives. Under the ’’no action’’ 

alternative, in accordance with 7 CFR 

part 340, FTE would continue to be 

regulated and the environmental release 

and interstate movement of FTE lines 

427 and 435 would require permits 

issued or notifications acknowledged by 

APHIS. APHIS might choose this 

alternative if there was insufficient 

evidence to demonstrate that the 

regulated eucalyptus events were not 

plant pests or the lack of plant pest risk 

from the unconfined cultivation of FTE 

lines 427 and 435. Under the ‘‘approve 

the petition request’’ alternative, FTE 

lines 427 and 435 would no longer be 

regulated articles under the regulations 

at 7 CFR part 340. 

Environmental Issues for Consideration 

We have also identified the following 

potential environmental issues for 

consideration in the EIS: 

• Alteration in susceptibility to 

disease or insects—Potential of FTE 

lines 427 and 435 to harbor plant pests 

or diseases and the impacts of these 

pests or diseases on natural resources, 

forestry, or agriculture within the range 

of FTE lines 427 and 435. 

• Alteration in weediness 

characteristics—Potential of FTE lines 

427 and 435 to be invasive in certain 

environments and the impacts to natural 

resources and sociocultural resources if 

it is invasive. 

• Potential impacts of growing FTE 

lines 427 and 435 on soil hydrology and 

water resources and how potential 

changes in soil hydrology or water use 

may affect natural resources and 

sociocultural resources. 

• Potential impacts of FTE lines 427 

and 435 on fire incidence and ecology 

and how this may affect natural 

resources and sociocultural resources. 

• Potential impacts of allelopathy of 

FTE lines 427 and 435 on forestry 

practices or land use. 

• Potential direct or indirect effects of 

FTE lines 427 and 435 on human health. 

• Potential direct or indirect effects of 

FTE lines 427 and 435 on wildlife and 

their habitats. 

In considering reasonable alternatives, 

the EIS will also study whether these 

potential environmental issues pose any 

potential plant pest risks that FTE may 

exhibit. In addition to plant pest risks 

that may be posed by characteristics of 

an individual GE eucalyptus, like 

allelopathy (suppression of growth of 

nearby plants due to toxin release), the 

EIS will also examine potential plant 

pest risks associated with 

environmental issues arising from the 

potential scale of nonregulated GE 

eucalyptus plantings. Plantings under 

the earlier permits were of small scale 

and limited duration. A decision to 

approve the petition would allow for 

larger sized plantings, closer together, 

over a longer period of time. 

Additionally, it is the first time APHIS 

has received a petition for deregulation 

for a GE tree like eucalyptus, where the 

species tends to be the dominant species 

in many forest areas, and the engineered 

change will increase the range of the 

species. These changes in scope from 

the small trials require analysis of the 

potential environmental and plant pest 

risk effects of large-scale FTE planting of 

local hydrology, fire ecology, and other 

potential issues discussed above. 

While the EIS will consider a 

comprehensive range of potential 

environmental impacts that FTE 

eucalyptus may cause, impacts that are 

not plant pest risks will not affect 

APHIS’ decision as to whether or not to 

make a determination of nonregulated 

status of FTE. As explained above, 

under the PPA, APHIS must make a 

determination of nonregulated status 

based on the GE organism’s potential to 

pose a plant pest risk and nothing more. 


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13312 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 

Comments that identify other issues 

or alternatives that should be 

considered for examination in the EIS 

would be especially helpful. All 

comments received during the comment 

period will be carefully considered in 

developing the final scope of the EIS. 

Upon completion of the draft EIS and 

the plant pest risk assessment for FTE 

lines 427 and 435, a notice announcing 

their availability and an opportunity to 

comment on them will be published in 

the Federal Register. 

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 

February 2013. 

Michael Gregoire, 

Deputy Administrator, Biotechnology 

Regulatory Services, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–04519 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0026] 

Pioneer Hi-Bred International, Inc.; 

Availability of Petition, Plant Pest Risk 

Assessment, and Environmental 

Assessment for Determination of 

Nonregulated Status of Maize 

Genetically Engineered for Herbicide 

Tolerance and 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 Pioneer Hi-Bred 

International, Inc., (Pioneer) seeking a 

determination of nonregulated status of 

maize designated as maize event DP– 

;;4114–3, which has been genetically 

engineered to be resistant to certain 

lepidopteran and coleopteran pests and 

tolerant to the herbicide glufosinate. 

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 

maize is likely to pose a plant pest risk. 

We are making available for public 

comment the Pioneer 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 April 29, 

2013. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0026- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0026, 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-2012-0026 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/ 

11_24401p.pdf, http:// 

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

11_24401p _dea.pdf, and http:// 

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

11_24401p _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 11–244–01p) from 

Pioneer Hi-Bred International, Inc., 

(Pioneer) of Johnston, IA, seeking a 

determination of nonregulated status of 

maize (Zea mays) designated as maize 

event DP–;;4114–3 (event 4114). Event 

4114 has been genetically engineered to 

be resistant to certain lepidopteran 

pests, including European corn borer 

(Ostrinia nubilalis), and certain 

coleopteran pests, including western 

corn rootworm (Diabrotica virgifera 

virgifera), and tolerant to the herbicide 

glufosinate. The petition states 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, event 

4114 has been genetically engineered to 

produce the Cry proteins Cry1F, 

Cry34Ab1, and Cry35Ab1, as well as the 

herbicide tolerance protein 

phosphinothricin acetyltransferase 

(PAT). The Cry1F protein confers 

resistance to certain lepidopteran pests, 

including European corn borer; the 

Cry34Ab1 and Cry35Ab1 proteins 

confers resistance to certain coleopteran 

pests, including the western corn 

rootworm; and the PAT protein confers 

tolerance to the herbicidal active 

ingredient glufosinate-ammonium at 

current labeled rates. Event 4114 is 

currently regulated under 7 CFR part 

340. Interstate movements and field 

tests of event 4114 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. 

In section 403 of the Plant Protection 

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


erowe on DSK2VPTVN1PROD with NOTICES