Syngenta Biotechnology, Inc.; Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance, 20560-20561 [2010-9198]

Download as PDF 20560 Federal Register / Vol. 75, No. 75 / Tuesday, April 20, 2010 / Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2009-0072] Syngenta Biotechnology, Inc.; Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice. We are advising the public of our determination that a corn line developed by Syngenta Biotechnology, Inc., designated as transformation event MIR162, which has been genetically engineered for insect resistance, 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 Syngenta Biotechnology, Inc., in its petition for a determination of nonregulated status, our analysis of other scientific data, and our response to comments received from the public on 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 of nonregulated status and finding of no significant impact. EFFECTIVE DATE: April 20, 2010. 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/brs/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/fdmspublic/ component/main?main=DocketDetail &d=APHIS-2009-0072). Other Information: Additional information about APHIS and its programs is available on the Internet at (https://www.aphis.usda.gov). FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Biotechnology Regulatory Services, APHIS, 4700 River erowe on DSK5CLS3C1PROD with NOTICES SUMMARY: VerDate Nov<24>2008 14:55 Apr 19, 2010 Jkt 220001 Road Unit 147, Riverdale, MD 207371236; (301) 734-0810, email: (subray.hegde@aphis.usda.gov). To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at (301) 734-0667, 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 may be 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. On September 10, 2007, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition Number 07-253-01p) from Syngenta Biotechnology, Inc., of Research Triangle Park, NC (Syngenta), for corn (Zea mays L.) designated as transformation event MIR162, which has been genetically engineered for insect resistance, stating that corn line MIR162 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 notice1 published in the Federal Register on January 13, 2010 (75 FR 1749-1751, Docket No. APHIS-20090072), APHIS announced the availability of Syngenta’s petition and the associated draft environmental assessment (EA) and plant pest risk assessment for public comment. APHIS solicited comments for 60 days ending on March 15, 2010, on whether the genetically engineered corn is or could 1 To view the notice, petition, EA, risk assessment, and the comments we received, go to (https://www.regulations.gov/fdmspublic/ component/main?main=DocketDetail&d=APHIS2009-0072). PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 be a plant pest and on the EA and the risk assessment. APHIS received 35 comments during the comment period. There were 19 comments from groups or individuals who supported deregulation and 13 from those who opposed deregulation. 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 Syngenta’s MIR162 corn, 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 that 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, i.e., that Syngenta’s MIR162 corn line and lines developed from it should not result in any significant impacts once they are granted nonregulated status and are no longer regulated articles under its regulations in 7 CFR part 340. Determination Based on APHIS’ analysis of field, greenhouse, and laboratory data submitted by Syngenta, references provided in the petition, 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 Syngenta’s MIR162 corn will not pose a plant pest risk and should be granted nonregulated status. 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 77817786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. E:\FR\FM\20APN1.SGM 20APN1 Federal Register / Vol. 75, No. 75 / Tuesday, April 20, 2010 / Notices Done in Washington, DC, this 16th day of April 2010. Cindy J. Smith Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2010–9198 Filed 4–16–10; 4:15 pm] BILLING CODE 3410–34–S DEPARTMENT OF COMMERCE erowe on DSK5CLS3C1PROD with NOTICES Submission for OMB Review; Comment Request The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Agency: National Telecommunications and Information Administration (NTIA). Title: State Broadband Data and Development Grant Program. OMB Control Number: 0660–0032. Form Number(s): None. Type of Request: Regular submission (extension of a currently approved collection). Number of Respondents: 56 respondents and 2,000 subrespondents. Average Hours per Response: 3,120 hours for respondents and 50 hours for subrespondents. Burden Hours: 549,440. Needs and Uses: The State Broadband Data and Development (SBDD) Grant Program implements the joint goals of the American Recovery and Reinvestment Act of 2009 and the Broadband Data Improvement Act by assisting, through grants, states or their designees in gathering and verifying state-specific data on the availability, speed, location, technology and infrastructure of broadband services. The data will be used to develop publicly available state-wide broadband maps and to help populate the comprehensive and searchable national broadband map that NTIA is required under the Recovery Act to create and make publicly available by February 17, 2011. Affected Public: States, Territories and the District of Columbia, or their designees. Subrespondents include facilities-based providers of broadband connections, incumbent and competitive local exchange carriers, facilities-based mobile telephony service providers, and wireless Internet service providers. Frequency: Semi-annually. Respondent’s Obligation: Required to retain benefits. VerDate Nov<24>2008 14:55 Apr 19, 2010 Jkt 220001 OMB Desk Officer: Nicholas Fraser, (202) 395–5887. Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482–0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at dHynek@doc.gov). Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Nicholas Fraser, OMB Desk Officer, FAX number (202) 395–5806, or via the Internet at Nicholas_A._Fraser@omb.eop.gov. Dated: April 15, 2010. Gwellnar Banks, Management Analyst, Office of the Chief Information Officer. [FR Doc. 2010–9058 Filed 4–19–10; 8:45 am] BILLING CODE 3510–06–P DEPARTMENT OF COMMERCE Patent and Trademark Office Patent Term Extension ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104– 13 (44 U.S.C. 3506(c)(2)(A)). DATES: Written comments must be submitted on or before June 21, 2010. ADDRESSES: You may submit comments by any of the following methods: • E-mail: InformationCollection@uspto.gov. Include A0651–0020 comment@ in the subject line of the message. • Fax: 571–273–0112, marked to the attention of Susan Fawcett. • Mail: Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450. • Federal Rulemaking Portal: https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Raul Tamayo, Legal Advisor, Office of Patent Legal Administration, United States Patent PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 20561 and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450; by telephone at 571–272–7728; or by e-mail to Raul.Tamayo@uspto.gov. SUPPLEMENTARY INFORMATION: I. Abstract The Federal Food, Drug, and Cosmetic Act at 35 U.S.C. 156 permits the United States Patent and Trademark Office (USPTO) to restore the patent term lost due to certain types of regulatory review by the Federal Food and Drug Administration or the Department of Agriculture. Only patents for drug products, medical devices, food additives, and color additives are eligible for extension. The maximum length that a patent may be extended in order to restore the lost portion of the patent term is five years. The USPTO may in some cases extend the term of an original patent due to certain delays in the prosecution of the patent application, including delays caused by interference proceedings, secrecy orders, or appellate review by the Board of Patent Appeals and Interferences or a Federal court in which the patent is issued pursuant to a decision reversing an adverse determination of patentability. The patent term provisions of 35 U.S.C. 154(b), as amended by Title IV, Subtitle D of the Intellectual Property and Communications Omnibus Reform Act of 1999, require the USPTO to notify the applicant of the patent term adjustment in the notice of allowance and give the applicant an opportunity to request reconsideration of the USPTO’s patent term adjustment determination. The USPTO may also reduce the amount of patent term adjustment granted if delays were caused by an applicant’s failure to make a reasonable effort to respond within three months of the mailing date of a communication from the USPTO. Applicants may petition for reinstatement of a reduction in patent term adjustment with a showing that, in spite of all due care, the applicant was unable to respond to a communication from the USPTO within the three month period. The USPTO administers 35 U.S.C. 154 and 156 through 37 CFR 1.701–1.791. These rules permit the public to submit applications to the USPTO to extend the term of a patent past its original expiration date, to request interim extensions and review of final eligibility decisions, and to withdraw an application requesting a patent term extension after it is submitted. Under 35 U.S.C. 156(d), an application for patent term extension must identify the approved product, the patent to be extended, and the claims included in E:\FR\FM\20APN1.SGM 20APN1

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[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20560-20561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9198]



[[Page 20560]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2009-0072]


Syngenta Biotechnology, Inc.; Determination of Nonregulated 
Status for Corn Genetically Engineered for Insect Resistance

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 Syngenta Biotechnology, Inc., designated as 
transformation event MIR162, which has been genetically engineered for 
insect resistance, 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 Syngenta Biotechnology, Inc., in its petition for a 
determination of nonregulated status, our analysis of other scientific 
data, and our response to comments received from the public on 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 of nonregulated status 
and finding of no significant impact.

EFFECTIVE DATE: April 20, 2010.

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/brs/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/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0072).
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at (https://www.aphis.usda.gov).

FOR FURTHER INFORMATION CONTACT: Dr. Subray Hegde, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0810, email: (subray.hegde@aphis.usda.gov). To 
obtain copies of the documents referenced in this notice, contact Ms. 
Cindy Eck at (301) 734-0667, 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 may be 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.
    On September 10, 2007, APHIS received a petition seeking a 
determination of nonregulated status (APHIS Petition Number 07-253-01p) 
from Syngenta Biotechnology, Inc., of Research Triangle Park, NC 
(Syngenta), for corn (Zea mays L.) designated as transformation event 
MIR162, which has been genetically engineered for insect resistance, 
stating that corn line MIR162 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 13, 
2010 (75 FR 1749-1751, Docket No. APHIS-2009-0072), APHIS announced the 
availability of Syngenta's petition and the associated draft 
environmental assessment (EA) and plant pest risk assessment for public 
comment. APHIS solicited comments for 60 days ending on March 15, 2010, 
on whether the genetically engineered corn is or could be a plant pest 
and on the EA and the risk assessment.
---------------------------------------------------------------------------

    \1\ To view the notice, petition, EA, risk assessment, and the 
comments we received, go to (https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0072).
---------------------------------------------------------------------------

    APHIS received 35 comments during the comment period. There were 19 
comments from groups or individuals who supported deregulation and 13 
from those who opposed deregulation. 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 Syngenta's MIR162 corn, 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 that 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, i.e., that Syngenta's 
MIR162 corn line and lines developed from it should not result in any 
significant impacts once they are granted nonregulated status and are 
no longer regulated articles under its regulations in 7 CFR part 340.

Determination

    Based on APHIS' analysis of field, greenhouse, and laboratory data 
submitted by Syngenta, references provided in the petition, 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 Syngenta's MIR162 corn will 
not pose a plant pest risk and should be granted nonregulated status.
    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.

[[Page 20561]]

    Done in Washington, DC, this 16\th\ day of April 2010.

Cindy J. Smith
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-9198 Filed 4-16-10; 4:15 pm]
BILLING CODE 3410-34-S
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