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 


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Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 13313 

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 event 4114 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 

Pioneer, 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 event 4114 

and it would continue to be a regulated 

article, or (2) make a determination of 

nonregulated status of event 4114. 

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 event 4114. 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. 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 maize 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 event 4114 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. 2013–04518 Filed 2–26–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2013–0011] 

Codex Alimentarius Commission: 

Meeting of the Codex Committee on 

Contaminants in Foods 

AGENCY: Office of the Under Secretary 

for Food Safety, USDA. 

ACTION: Notice of public meeting and 

request for comments. 

SUMMARY: The Office of the Under 

Secretary for Food Safety, U.S. 

Department of Agriculture (USDA), and 

the Food and Drug Administration 

(FDA), U.S. Department of Health and 

Human Services, are sponsoring a 

public meeting on March 12, 2013. The 

objective of the public meeting is to 

provide information and receive public 

comments on agenda items and draft 

U.S. positions that will be discussed at 

the 7th Session of the Codex Committee 

on Contaminants in Foods (CCCF) of the 

Codex Alimentarius Commission 

(Codex), which will be held in Moscow, 

Russian Federation, April 8–12, 2013. 

The Under Secretary for Food Safety 

and FDA recognize the importance of 

providing interested parties the 

opportunity to obtain background 

information on the 7th Session of the 

CCCF and to address items on the 

agenda. 

DATES: The public meeting is scheduled 

for Tuesday, March 12, 2013, from 10:00 

a.m. to 12:00 noon. 

ADDRESSES: The public meeting will be 

held at the Harvey W. Wiley Federal 

Building, Room 1A–001, FDA, Center 

for Food Safety and Applied Nutrition 

(CFSAN), 5100 Paint Branch Parkway, 

College Park, MD 20740. Documents 

related to the 7th Session of the CCCF 

will be accessible via the World Wide 

Web at http:// 

www.codexalimentarius.org/meetingsreports/en/. 

Nega Beru, U.S. Delegate to the 7th 

Session of the CCCF invites interested 

U.S. parties to submit their comments 

electronically to the following email 

address henry.kim@fda.hhs.gov. 

Registration: Attendees may register 

electronically at the same email address 

provided above by March 8, 2013. The 

meeting will be held in a Federal 

building; therefore, early registration is 

encouraged as it will expedite entry into 

the building and its parking area. You 

should also bring photo identification 

and plan for adequate time to pass 

through security screening systems. If 

you require parking, please include the 

vehicle make and tag number when you 

register. Attendees that are not able to 

attend the meeting in-person but wish to 

participate may do so by phone. 

Call in Number: If you wish 

participate in the public meeting for the 

7th Session of CCCF by telephone 

conference, please use the call in 

number and participant code listed 

below: 

Call in Number: 1–888–858–2144. 

Participant Code: 6208658. 

FOR FURTHER INFORMATION CONTACT: 

Henry Kim, Ph.D., Office of Food Safety, 

CFSAN/FDA, HFS–317, 5100 Paint 

Branch Parkway, College Park, MD 

20740, Telephone: (240) 402–2023, Fax: 

(301) 436–2632, email: 

henry.kim@fda.hhs.gov or Barbara 

McNiff, U.S. Codex Office, 1400 

Independence Avenue, Washington, DC; 

Telephone (202) 690–4719, email: 

Barbara.McNiff@fsis.usda.gov. 

FOR FURTHER INFORMATION ABOUT THE

PUBLIC MEETING CONTACT: Henry Kim, 

Ph.D., Office of Food Safety, CFSAN/ 

FDA, HFS–317, 5100 Paint Branch 

Parkway, College Park, MD 20740, 

Telephone: (240) 402–2023, Fax: (301) 

436–2632, email: 

henry.kim@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION:

Background 

Codex was established in 1963 by two 

United Nations organizations, the Food 

and Agriculture Organization (FAO) and 

the World Health Organization (WHO). 


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