Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Corn Genetically Engineered To Produce Male Sterile/Female Inbred Plants, 37767-37768 [2011-16128]

Download as PDF Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250–0237; Telephone: (202) 720–2491, Fax: (202) 720–8938, or E-mail: Laurel.May@ams.usda.gov. Title: Specified Commodities Imported Into the United States Exempt from Import Requirements. OMB Number: 0581–0167. Expiration Date of Approval: December 31, 2011. Type of Request: Extension of a currently-approved information collection. Abstract: Section 8e of the Agricultural Marketing Agreement Act of 1937 as amended (7 U.S.C. 601–674; Act) requires that whenever the Secretary of Agriculture issues grade, size, quality, or maturity regulations under domestic marketing orders, the same or comparable regulations must be issued for imported commodities. Import regulations apply only during those periods when domestic marketing order regulations are in effect. Currently, the following commodities are subject to section 8e import regulations: Avocados; grapefruit; kiwifruit; olives; oranges; fresh prunes; table grapes; potatoes; onions; tomatoes; dates (other than dates for processing); walnuts; dried prunes (suspended); raisins; and hazelnuts. Imports of these commodities are exempt from section 8e requirements if they are imported for such outlets as processing, charity, animal feed, seed, and distribution to relief agencies when those outlets are exempt under the applicable marketing orders. Safeguard procedures in the form of importer and receiver reporting requirements are used to ensure that the imported commodities are, in fact, shipped to authorized, exempt outlets. Reports required under the safeguard procedure are similar to the reports currently required by most domestic marketing orders, and are required of importers and receivers under the following import regulations: (1) Fruits; import regulations (7 CFR 944.350); (2) vegetables; import regulations (7 CFR 980.501); and (3) specialty crops; import regulations (7 CFR 999.500). Under these regulations, importers wishing to import commodities for exempt purposes must complete form FV–6, the ‘‘Importer’s Exempt Commodity Form,’’ prior to importation, through the Marketing Order Online System (MOLS). Launched in August 2008, MOLS is an Internet-based application, managed by the USDA, mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:46 Jun 27, 2011 Jkt 223001 which allows importers and receivers of fruit, vegetable, and specialty crops to review and search for FV–6 certificates online. If an importer correctly inputs his shipment data into MOLS, he will receive and be able to print a certificate that accompanies the shipment. Data are simultaneously transmitted to the receiver and to AMS, where it is reviewed for compliance purposes by Marketing Order Administration Branch (MOAB) staff, in the USDA’s Fruit and Vegetable Programs. In rare instances a paper form FV–6 may be used. The hardcopy form has four parts, which are distributed as follows: Copy one is presented to the U.S. Customs and Border Protection, Department of Homeland Security; copy two is filed with MOAB within two days of the commodity entering the United States; copy three accompanies the exempt shipment to its intended destination, where the receiver certifies its receipt and that it will be used for exempt purposes, and files that copy with MOAB within two days of receipt; and copy four is retained by the importer. USDA utilizes this information to ensure that imported goods destined for exempt outlets are given no less favorable treatment that that afforded to domestic goods destined for the same exempt outlets. These exemptions are consistent with section 8e import regulations under the Act. In addition to renewing the FV–6 form, this information collection package does the same for the FV–7 form, ‘‘Civil Penalty Stipulation Agreement.’’ Produce importers sign the FV–7 form, for which there is no burden associated because only a signature is required, to admit that they violated section 8e import requirements and are seeking a reduced fine or penalty. The information collected through this package is used primarily by authorized representatives of the USDA, including AMS Fruit and Vegetable Programs regional and headquarters staff. Estimate of Burden: The public reporting burden for this collection of information is estimated to average 5 minutes per response. Respondents: Importers and receivers of exempt commodities. Estimated Number of Respondents: 250. Estimated Number of Total Annual Responses: 8,454.70. Estimated Number of Responses per Respondent: 33.82 Estimated Total Annual Burden on Respondents: 697.59 hours. Comments are invited on: (1) Whether the proposed collection of information PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 37767 is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (2) the accuracy of the Agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All comments to this document will be summarized and included in the request for OMB approval, and will become a matter of public record. Dated: June 22, 2011. Rayne Pegg, Administrator, Agricultural Marketing Service. [FR Doc. 2011–16129 Filed 6–27–11; 8:45 am] BILLING CODE 3410–02–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2010–0041] Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Corn Genetically Engineered To Produce Male Sterile/Female Inbred Plants Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our determination that a corn line developed by Pioneer Hi-Bred International, Inc., designated as event DP–32138–1, which has been genetically engineered to produce male sterile/female inbred plants for the generation of hybrid corn seed that is non-transgenic, 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 SUMMARY: E:\FR\FM\28JNN1.SGM 28JNN1 37768 Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact. DATES: Effective Date: June 28, 2011. ADDRESSES: You may read the documents referenced in this notice and the comments we received in our reading room. The reading room 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) 690–2817 before coming. Those documents are also available on the Internet at https:// www.aphis.usda.gov/biotechnology/ not_reg.html and are posted with the previous notice and the comments we received on the Regulations.gov Web site at https://www.regulations.gov/ #!docketDetail;D=APHIS-2010-0041. FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737–1236; (301) 734– 0942, e-mail: evan.a.chestnut@aphis.usda.gov. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 734–0667, e-mail: 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 08–338–01p) from VerDate Mar<15>2010 16:46 Jun 27, 2011 Jkt 223001 Pioneer Hi-Bred International, Inc. (Pioneer) of Johnston, IA, seeking a determination of nonregulated status for corn (Zea mays L.) designated as event DP–32138–1, which has been genetically engineered to produce male sterile/female inbred plants for the generation of hybrid corn seed that is non-transgenic. The petition stated that corn event DP–32138–1 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 January 3, 2011 (76 FR 83– 84, Docket No. APHIS–2010–0041), APHIS announced the availability of the Pioneer petition and a draft environmental assessment (EA) for public comment. APHIS solicited comments on the petition, whether the subject corn is likely to pose a plant pest risk, and on the draft EA for 60 days ending on March 4, 2011. APHIS received 52 comments during the comment period, with 8 comments providing support of the EA’s preferred alternative and 43 comments expressing general opposition. Those providing support cited several points regarding Pioneer’s Seed Production Technology (SPT) process and its benefits including: (1) The SPT process does not introduce a new transgenic gene or trait through commercial hybrid seed or grain production; (2) the SPT process is used to increase productivity and efficiency in seed corn production; and (3) the transgenic material is used two generations before hybrid seed production occurs or three times before commercial grain production. The majority of those opposing expressed general opposition to GE crops and genetically modified organisms but did not provide any specific disagreement with APHIS’ analysis. Commenters also expressed concern with genetic contamination; with the effects of GE corn pollen on honeybees, other insects, and/or the whole ecosystem; food and feed safety; and health effects. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact. Pioneer’s corn event DP–32138–1, 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 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 plant pest risk assessment, comments provided by the public, and information provided in APHIS’ response to those public comments, APHIS has determined that Pioneer’s corn event DP–32138–1 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, plant pest risk assessment, 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 June 2011. John R. Clifford, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–16128 Filed 6–27–11; 8:45 am] BILLING CODE 3410–34–P 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 for 1 To view the notice, petition, draft EA, the plant pest risk assessment and the comments we received, go to https://www.regulations.gov/ #!docketDetail;D=APHIS-2010-0041. PO 00000 Frm 00003 Fmt 4703 Sfmt 9990 E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37767-37768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16128]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0041]


Pioneer Hi-Bred International, Inc.; Determination of 
Nonregulated Status for Corn Genetically Engineered To Produce Male 
Sterile/Female Inbred Plants

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public of our determination that a corn 
line developed by Pioneer Hi-Bred International, Inc., designated as 
event DP-32138-1, which has been genetically engineered to produce male 
sterile/female inbred plants for the generation of hybrid corn seed 
that is non-transgenic, 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

[[Page 37768]]

pest risk assessment. This notice also announces the availability of 
our written determination and finding of no significant impact.

DATES: Effective Date: June 28, 2011.

ADDRESSES: You may read the documents referenced in this notice and the 
comments we received in our reading room. The reading room 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) 690-2817 before coming. Those 
documents are also available on the Internet at https://www.aphis.usda.gov/biotechnology/not_reg.html and are posted with the 
previous notice and the comments we received on the Regulations.gov Web 
site at https://www.regulations.gov/#!docketDetail;D=APHIS-2010-0041.

FOR FURTHER INFORMATION CONTACT: Mr. Evan Chestnut, Policy Analyst, 
Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, 
Riverdale, MD 20737-1236; (301) 734-0942, e-mail: 
evan.a.chestnut@aphis.usda.gov. To obtain copies of the documents 
referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, e-
mail: 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 08-338-01p) from 
Pioneer Hi-Bred International, Inc. (Pioneer) of Johnston, IA, seeking 
a determination of nonregulated status for corn (Zea mays L.) 
designated as event DP-32138-1, which has been genetically engineered 
to produce male sterile/female inbred plants for the generation of 
hybrid corn seed that is non-transgenic. The petition stated that corn 
event DP-32138-1 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 January 3, 
2011 (76 FR 83-84, Docket No. APHIS-2010-0041), APHIS announced the 
availability of the Pioneer petition and a draft environmental 
assessment (EA) for public comment. APHIS solicited comments on the 
petition, whether the subject corn is likely to pose a plant pest risk, 
and on the draft EA for 60 days ending on March 4, 2011.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, draft EA, the plant pest risk 
assessment and the comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2010-0041.
---------------------------------------------------------------------------

    APHIS received 52 comments during the comment period, with 8 
comments providing support of the EA's preferred alternative and 43 
comments expressing general opposition. Those providing support cited 
several points regarding Pioneer's Seed Production Technology (SPT) 
process and its benefits including: (1) The SPT process does not 
introduce a new transgenic gene or trait through commercial hybrid seed 
or grain production; (2) the SPT process is used to increase 
productivity and efficiency in seed corn production; and (3) the 
transgenic material is used two generations before hybrid seed 
production occurs or three times before commercial grain production. 
The majority of those opposing expressed general opposition to GE crops 
and genetically modified organisms but did not provide any specific 
disagreement with APHIS' analysis. Commenters also expressed concern 
with genetic contamination; with the effects of GE corn pollen on 
honeybees, other insects, and/or the whole ecosystem; food and feed 
safety; and health effects. APHIS has addressed the issues raised 
during the comment period and has provided responses to these 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 for Pioneer's corn event DP-32138-
1, 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 
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 plant pest risk 
assessment, comments provided by the public, and information provided 
in APHIS' response to those public comments, APHIS has determined that 
Pioneer's corn event DP-32138-1 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, plant pest risk assessment, 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 June 2011.
John R. Clifford,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-16128 Filed 6-27-11; 8:45 am]
BILLING CODE 3410-34-P
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