13302 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 

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

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

www.regulations.gov/#!docketDetail;D=APHIS– 

2012–0024. 

Done in Washington, DC, this 20th day of 

February 2013. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2013–04496 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0024] 

Syngenta Biotechnology, Inc.; 

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 of 

our determination that a corn line 

developed by the Syngenta 

Biotechnology, Inc., designated as event 

SYN–05307–1, which has been 

genetically engineered for resistance to 

corn rootworm, an insect pest of corn, 

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 

Syngenta Biotechnology, Inc., 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: February 27, 

2013. 

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) 799–7039 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–2012–0024. 

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 documents referenced in 

this notice, contact Ms. Cindy Eck at 

(301) 851–3892, email: 

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 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. 

In a notice 1 published in the Federal 

Register on July 13, 2012 (77 FR 41366– 

41367, Docket No. APHIS–2012–0024), 

APHIS announced the availability of the 

Syngenta 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 corn is likely to pose a plant pest 

risk, the draft EA, and the PPRA for 60 

days ending on September 11, 2012. 

APHIS received 86 comments during 

the comment period, with 14 

commenters expressing support of the 

EA’s preferred alternative to make a 

determination of nonregulated status 

and the remaining 72 commenters 

expressing opposition. One of the 

comments opposing a determination of 

nonregulated status included submitted 

electronic attachments that consisted of 

many signed letters containing identical 

material (4,601 letters). Issues raised 

during the comment period included 

adequacy of the EA, effects on nontarget 

organisms, and potential effects on 

human and animal health. APHIS has 

addressed the issues raised during the 

comment period and has provided 

responses to these comments as an 

attachment to the finding of no 

significant impact. 

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 of 

Syngenta’s corn event SYN–05307–1, 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 Syngenta, 

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 Syngenta’s 

corn event SYN–05307–1 is unlikely to 

pose a plant pest risk and therefore is no 

longer subject to our regulations 

governing the introduction of certain 

genetically engineered organisms. 


erowe on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 13303 

1The terms ‘‘corn’’ and ‘‘maize’’ both refer to Zea 

mays. In this notice, we refer to ‘‘maize line 

HCEM485’’ as this is the name used by Stine Seed 

in its extension request to identify its GE corn. 

Otherwise, we use the more common term ‘‘corn’’ 

when referring to Zea mays. 

Copies of the signed determination 

document, as well as copies of the 

petition, PPRA, EA, finding of no 

significant impact, and response to 

comments 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 22nd day of 

February 2013. 

Michael Gregoire, 

Deputy Administrator, Biotechnology 

Regulatory Services, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–04517 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0033] 

Stine Seed Farm, Inc.; Availability of 

Plant Pest Risk Assessment, 

Environmental Assessment, and 

Preliminary Decision for an Extension 

of a Determination of Nonregulated 

Status of Corn 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 has prepared a 

preliminary decision regarding a request 

from Stine Seed Farm, Inc., to extend to 

maize line HCEM485, which has been 

genetically engineered to be tolerant to 

the herbicide glyphosate, our 

determination of nonregulated status of 

Roundup Ready® corn line GA21. We 

are seeking comment on whether this 

genetically engineered corn is likely to 

pose a plant pest risk. We are making 

available for public comment our plant 

pest risk assessment and draft 

environmental assessment for the 

proposed determination of nonregulated 

status. 

DATES: We will consider all comments 

that we receive on or before March 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-2012-0033- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0033, 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-2012-033 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 extension request, draft 

environmental assessment, and plant 

pest risk assessment are also available 

on the APHIS web site at http:// 

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

09_06301p.pdf, http:// 

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

09_06301p_dea.pdf, and http:// 

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

09_06301p_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 supporting documents, 

contact Ms. Cindy Eck at (301) 851– 

3885, 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 organisms (GE) 

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. 

Further, the regulations in § 340.6(e)(2) 

provide that a person may request that 

APHIS extend a determination of 

nonregulated status to other organisms. 

Such a request must include 

information to establish the similarity of 

the antecedent organism and the 

regulated article in question. 

In a notice published in the Federal 

Register on December 5, 1997 (62 FR 

64350–64351, Docket No. 97–052–2), 

APHIS announced our determination of 

nonregulated status of Roundup Ready®

corn line GA21. APHIS has received a 

request for an extension of a 

determination of nonregulated status 

(APHIS Number 09–063–01p) of 

Roundup Ready® corn line GA21 to 

maize line HCEM485 1 from Stine Seed 

Farm, Inc., (Stine Seed) of Research 

Triangle Park, NC. Stine Seed seeks a 

determination of nonregulated status of 

corn designated as maize line 

HCEM485, which has been genetically 

engineered to be glyphosate tolerant. In 

its request, Stine Seed stated that this 

corn is similar to Roundup Ready® corn 

line GA21 and, based on the similarity 

to the antecedent organism, 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 extension request, 

maize line HCEM485 has been 

genetically engineered by a 6.0 kb corn 

genomic fragment, originally isolated 

from a bacterial chromosome library 

derived from the corn inbred line B73, 

containing a modified form of the 

endogenous Zea mays EPSPS encoding 

gene. The antecedent organism, 

Roundup Ready® corn line GA21, was 

made with a 1.3kb restriction fragment 

of the corn EPSPS gene. Both corn lines 

were produced with the same mutations 

responsible for conferring glyphosate 

herbicide tolerance. Maize line 

HCEM485 is currently regulated under 7 

CFR part 340. Interstate movements and 

field tests of maize line HCEM485 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 whether 

the new variety poses a plant pest risk. 


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