Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status of Maize Genetically Engineered for Herbicide and Insect Resistance, 37201-37202 [2013-14705]

Download as PDF Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices 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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: 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. TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:01 Jun 19, 2013 Jkt 229001 Effective Date: June 20, 2013. 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: DATES: ADDRESSES: 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 PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 37201 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 1 To view the notice, petition, draft EA, the PPRA, and the comments we received, go to http:// www.regulations.gov/#!docketDetail;D=APHIS2012-0026. E:\FR\FM\20JNN1.SGM 20JNN1 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] FOR FURTHER INFORMATION ABOUT THE 21ST SESSION OF THE CCRVDF CONTACT: 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 Office of the Under Secretary for Food Safety, USDA. ACTION: Notice of public meeting and request for comments. AGENCY: 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 TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:01 Jun 19, 2013 Jkt 229001 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. 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. PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 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 E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37201-37202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14705]


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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.

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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-[Oslash][Oslash]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.stankiewicz-gabel@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 Sec.  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 Sec.  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-[Oslash][Oslash]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.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, draft EA, the PPRA, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0026.
---------------------------------------------------------------------------

    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

[[Page 37202]]

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