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. 


erowe on DSK2VPTVN1PROD with NOTICES
13304 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 

In section 403 of the PPA, ‘‘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 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 prepared a plant pest risk 

assessment (PPRA) and has concluded 

that maize line HCEM485 is similar to 

the antecedent organism and 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 

Stine Seed, 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 maize line 

HCEM485 and it would continue to be 

a regulated article, or (2) make a 

determination of nonregulated status of 

maize line HCEM485. 

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 of maize line 

HCEM485. 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); (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 APHIS’ analysis of field and 

laboratory data submitted by Stine Seed, 

references provided in the extension 

request, peer-reviewed publications, 

information analyzed in the EA, and the 

similarity of maize line HCEM485 to the 

antecedent organism, Roundup Ready®

corn line GA21, APHIS has determined 

that maize line HCEM485 is unlikely to 

pose a plant pest risk. We have therefore 

reached a preliminary decision to 

approve the request to extend the 

determination of nonregulated status of 

Roundup Ready® corn line GA21 to 

maize line HCEM485, whereby maize 

line HCEM485 would no longer be 

subject to our regulations governing the 

introduction of certain genetically 

engineered organisms. 

Paragraph (e) of § 340.6 provides that 

APHIS will publish a notice in the 

Federal Register announcing all 

preliminary decisions to extend 

determinations of nonregulated status 

for 30 days before the decisions become 

final and effective. In accordance with 

§ 340.6(e) of the regulations, we are 

publishing this notice to inform the 

public of our preliminary decision to 

extend the determination of 

nonregulated status of Roundup Ready®

corn line GA21 to maize line HCEM485. 

APHIS will accept written comments 

on the draft EA and PPRA regarding a 

determination of nonregulated status of 

maize line HCEM485 for a period of 30 

days from the date this notice is 

published in the Federal Register. The 

draft EA and PPRA, as well as the 

extension request and preliminary 

determination for maize line HCEM485, 

are available for public review as 

indicated under ADDRESSES and FOR

FURTHER INFORMATION CONTACT above. 

Copies of these documents may also be 

obtained by contacting the person listed 

under FOR FURTHER INFORMATION

CONTACT. 

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 EA 

and PPRA will be available for public 

review. After reviewing and evaluating 

the comments on the EA and PPRA, 

APHIS will furnish a response to the 

petitioner regarding our final regulatory 

determination. APHIS will also publish 

a notice in the Federal Register 

announcing the regulatory status of 

maize line HCEM485 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 22nd day of 

February 2013. 

Michael Gregoire, 

Deputy Administrator, Biotechnology 

Regulatory Services, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2013–04520 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0009] 

Notice of Decision To Issue Permits for 

the Importation of Strawberry Fruit 

From Egypt Into the Continental United 

States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our decision to begin issuing permits for 

the importation into the continental 

United States of fresh strawberry fruit 

from Egypt. Based on the findings of a 

pest risk analysis, which we made 

available to the public for review and 

comment through a previous notice, we 

believe that the application of one or 

more designated phytosanitary 

measures will be sufficient to mitigate 

the risks of introducing or disseminating 

plant pests or noxious weeds via the 

importation of fresh strawberry fruit 

from Egypt. 

DATES: Effective Date: February 27, 

2013. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Marc Phillips, Regulatory Policy 

Specialist, Regulations, Permits, and 

Manuals, PPQ, APHIS, 4700 River Road 

Unit 133, Riverdale, MD 20737–1231; 

(301) 851–2114. 

SUPPLEMENTARY INFORMATION: 

Background 

Under the regulations in ‘‘Subpart— 

Fruits and Vegetables’’ (7 CFR 319.56– 

1 through 319.56–58, referred to below 

as the regulations), the Animal and 

Plant Health Inspection Service (APHIS) 

of the U.S. Department of Agriculture 

prohibits or restricts the importation of 

fruits and vegetables into the United 

States from certain parts of the world to 

prevent plant pests from being 

introduced into and spread within the 

United States. 

Section 319.56–4 of the regulations 

contains a performance-based process 

for approving the importation of 

commodities that, based on the findings 

of a pest risk analysis (PRA), can be 

safely imported subject to one or more 

of the designated phytosanitary 

measures listed in paragraph (b) of that 

section. Under that process, APHIS 

publishes a notice in the Federal 

Register announcing the availability of 

the PRA that evaluates the risks 

associated with the importation of a 

particular fruit or vegetable. Following 

the close of the 60-day comment period, 


erowe on DSK2VPTVN1PROD with NOTICES