Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices 37201 

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

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

www.regulations.gov/#!docketDetail;D=APHIS2012-0026. 

PeanutStandardsBoard, or from Jennie 

Varela. USDA seeks a diverse group of 

members representing the peanut 

industry. 

Equal opportunity practices will be 

followed in all appointments to the 

Board in accordance with USDA 

policies. To ensure that the 

recommendations of the Board have 

taken into account the needs of the 

diverse groups within the peanut 

industry, membership shall include, to 

the extent practicable, individuals with 

demonstrated abilities to represent 

minorities, women, persons with 

disabilities, and limited resource 

agriculture producers. 

Authority: 7 U.S.C. 7958. 

Dated: June 14, 2013. 

Rex A. Barnes, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2013–14714 Filed 6–19–13; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0026] 

Pioneer Hi-Bred International, Inc.; 

Determination of Nonregulated Status 

of Maize Genetically Engineered for 

Herbicide and Insect Resistance 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public of 

our determination that a maize line 

developed by Pioneer Hi-Bred 

International Inc., designated as maize 

event DP–;;4114–3, which has been 

genetically engineered to be resistant to 

certain lepidopteran and coleopteran 

pests and to the herbicide glufosinate, 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 Pioneer 

Hi-Bred International, 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: June 20, 2013. 

ADDRESSES: Supporting documents, 

comments we received on our previous 

notice announcing our preliminary 

determination, and our responses to 

those comments 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. Supporting documents 

are also available on the APHIS Web site 

at http://www.aphis.usda.gov/ 

biotechnology/petitions/ 

_table_pending.shtml under APHIS 

petition Number 11–244–01p. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Rebecca Stankiewicz Gabel, Chief, 

Environmental Risk Analysis Programs, 

Biotechnology Regulatory Services, 

APHIS, 4700 River Road Unit 147, 

Riverdale, MD 20737–1236; (301) 851– 

3927, email: rebecca.l.stankiewiczgabel@aphis.usda.gov. To obtain copies 

of the documents referred to 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 11–244–01p) from 

Pioneer Hi-Bred International, Inc., 

(Pioneer) of Johnston, IA, seeking a 

determination of nonregulated status for 

maize (Zea mays) designated as maize 

event DP–;;4114–3 (event 4114), 

which 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), as well as to the herbicide 

glufosinate. The petition stated 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. 

In a notice 1 published in the Federal 

Register on February 27, 2013 (78 FR 

13312–13313, Docket No. APHIS–2012– 

0026), APHIS announced the 

availability of the Pioneer 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 maize is likely to pose a plant 

pest risk, the draft EA, and the PPRA for 

60 days ending on April 29, 2013. 

APHIS received 12 comments during 

the comment period: Several of these 

comments included electronic 

attachments consisting of a consolidated 

document of identical letters for a total 

of 573 comments. Issues raised during 

the comment period include potential 

effects on human and animal health and 

non-target organisms, herbicide 

resistance, corn rootworm resistance, 

effects of stacked genes, and the length 

of the comment period. APHIS has 

addressed the issues raised during the 

comment period and has provided 

responses to 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 

Pioneer’s maize event 4114, 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 


TKELLEY on DSK3SPTVN1PROD with NOTICES
37202 Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices 

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 Pioneer, 

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 Pioneer’s 

maize event 4114 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. 

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 14th day of 

June 2013. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2013–14705 Filed 6–19–13; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2013–0014] 

Codex Alimentarius Commission: 

Meeting of the Codex Committee on 

Residues of Veterinary Drugs in Food 

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) are sponsoring a public meeting 

on August 5, 2013. The objective of the 

public meeting is to provide information 

and receive public comments on agenda 

items and draft United States positions 

that will be discussed at the 21st 

Session of the Codex Committee on 

Residues of Veterinary Drugs in Foods 

(CCRVDF) of the Codex Alimentarius 

Commission (Codex), which will be 

held in Minneapolis, Minnesota from 

August 26–30, 2013. The Under 

Secretary for Food Safety and the Food 

and Drug Administration recognize the 

importance of providing interested 

parties the opportunity to obtain 

background information on the 21st 

Session of CCRVDF, and to address 

items on the agenda. 

DATES: The public meeting is scheduled 

for Monday, August 5, 2013 from 1:00– 

4:00 p.m. 

ADDRESSES: The public meeting will be 

held at the Jamie L. Whitten Building, 

United States Department of 

Agriculture, 1400 Independence Ave. 

Room 107–A, Washington, DC 20250. 

Documents related to the 21st Session of 

CCRVDF will be accessible via the 

World Wide Web at the following 

address: http:// 

www.codexalimentarius.org/meetingsreports/en/. 

Kevin Greenlees, U.S. Delegate to the 

21st Session of the CCRVDF, invites 

U.S. interested parties to submit their 

comments electronically to the 

following email address: 

Kevin.Greenlees@fda.hhs.gov. 

Call-In Number: If you wish to 

participate in the public meeting for the 

21st Session of the CCRVDF by 

conference call, please use the call-in 

number and participant code listed 

below: 

Call-in Number: 1–888–858–2144. 

Participant code: 6208658. 

FOR FURTHER INFORMATION ABOUT THE

21ST SESSION OF THE CCRVDF CONTACT: 

Kevin Greenlees, Senior Advisor for 

Science and Policy, Office of New 

Animal Drug Evaluation, HFV–100, 

Food and Drug Administration, Center 

for Veterinary Medicine, 7520 Standish 

Place, Rockville, MD 20855, Telephone: 

(240) 276–8214, Fax: (240) 276–9538, 

Email: Kevin.Greenlees@fda.hhs.gov. 

FOR FURTHER INFORMATION ABOUT THE

PUBLIC MEETING CONTACT: Kenneth 

Lowery, U.S. Codex Office, 1400 

Independence Ave. SW., Room 4861, 

Washington, DC 20250, Telephone: 

(202) 690–4042, Fax: (202) 720–3157, 

Email: Kenneth.Lowery@fsis.usda.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Codex Alimentarius (Codex) was 

established in 1963 by two United 

Nations organizations, the Food and 

Agriculture Organization and the World 

Health Organization. Through adoption 

of food standards, codes of practice, and 

other guidelines developed by its 

committees, and by promoting their 

adoption and implementation by 

governments, Codex seeks to protect the 

health of consumers and ensure fair 

practices in the food trade. 

The CCRVDF is responsible for 

determining priorities for the 

consideration of residues of veterinary 

drugs in foods, recommending 

maximum levels of such substances; 

developing codes of practice as may be 

required, and considering methods of 

sampling and analysis for the 

determination of veterinary drug 

residues in foods. 

The Committee is hosted by the 

United States of America. 

Issues To Be Discussed at the Public 

Meeting 

The following items on the Agenda 

for the 21st Session of the CCRVDF will 

be discussed during the public meeting: 

• Matters referred by the Codex 

Alimentarius Commission and other 

Codex Committees and Task Forces 

• Matters arising from FAO/WHO and 

from the Joint FAO/WHO Expert 

Committee on Food Additives (JECFA) 

• Report on World Organization for 

Animal Health (OIE) activities, 

including the harmonization of 

technical requirements for registration 

of veterinary medicinal products (VICH) 

• Draft Maximum Residue Limits 

(MRLs) for veterinary drugs (at Step 6) 

• Proposed draft MRLs for veterinary 

drugs (at Step 4) 

• Risk Management 

Recommendations for Residues of 

Veterinary Drugs for which no ADI and/ 

or MRLs has been recommended by 

JECFA due to Specific Human Health 

Concerns 

• Proposed draft guidelines on 

performance characteristics for multiresidue methods 

• Risk Analysis Policy on 

Extrapolation of MRLs of Veterinary 

Drugs to Additional Species and Tissues 

• Proposed ‘‘concern form’’ for the 

CCRVDF (format and policy procedure 

for its use) 

• Draft priority list of veterinary 

drugs requiring evaluation or reevaluation by JECFA 

• Database on countries’ needs for 

MRLs 

• Discussion paper on Guidelines on 

the Establishment of MRLs or other 

Limits in Honey 

• Other business and future work 

Each issue listed will be fully 

described in documents distributed, or 

to be distributed, by the Secretariat prior 

to the Meeting. Members of the public 

may access or request copies of these 

documents (see ADDRESSES). 

Public Meeting 

At the August 5, 2013 public meeting, 

draft U.S. positions on the agenda items 

will be described and discussed, and 

attendees will have the opportunity to 


TKELLEY on DSK3SPTVN1PROD with NOTICES