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, 13312-13313 [2013-04518]

Download as PDF 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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. erowe on DSK2VPTVN1PROD with NOTICES AGENCY: 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. VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 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 https://www.regulations.gov/ #!documentDetail;D=APHIS-2012-00260001. • 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 https:// 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 https:// www.aphis.usda.gov/brs/aphisdocs/ 11_24401p.pdf, https:// www.aphis.usda.gov/brs/aphisdocs/ 11_24401p _dea.pdf, and https:// 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: DATES: 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 PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27FEN1.SGM 27FEN1 erowe on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices 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. VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 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 Office of the Under Secretary for Food Safety, USDA. ACTION: Notice of public meeting and request for comments. AGENCY: 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. PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 13313 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 https:// 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. DATES: 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). E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13312-13313]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04518]


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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-[Oslash][Oslash]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 https://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 https://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 https://www.aphis.usda.gov/brs/aphisdocs/11_24401p.pdf, https://www.aphis.usda.gov/brs/aphisdocs/11_24401p _dea.pdf, and https://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 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 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-[Oslash][Oslash]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

[[Page 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 Sec.  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 Sec.  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