Syngenta Biotechnology, Inc.; Determination of Nonregulated Status for Lepidopteran-Resistant Cotton, 60448-60449 [2011-25086]

Download as PDF 60448 Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices 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 Florigene’s rose lines IFD–524;1–4 and IFD–529;1–9 are unlikely to pose a plant pest risk and therefore are 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 23rd day of September 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–25090 Filed 9–28–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2007–0130] Syngenta Biotechnology, Inc.; Determination of Nonregulated Status for Lepidopteran-Resistant Cotton Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public of our determination that a cotton line developed by Syngenta Biotechnology, Inc., designated as event COT67B, which has been genetically engineered to express a protein to protect cotton plants from lepidopteran insect damage, 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 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 tkelley on DSKG8SOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:29 Sep 28, 2011 Jkt 223001 announces the availability of our written determination and finding of no significant impact. DATES: Effective Date: September 29, 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-2007-0130. 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 07–108–01p) from PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 Syngenta Biotechnology, Inc. (Syngenta), seeking a determination of nonregulated status for cotton (Gossypium spp.) designated as event COT67B, which has been genetically engineered to express a Cry1Ab protein to protect cotton plants from lepidopteran insect damage. The petition stated that cotton event COT67B 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 May 11, 2011 (76 FR 27301– 27303, Docket No. APHIS–2007–0130), APHIS announced the availability of the Syngenta petition, our plant pest risk assessment, and our draft environmental assessment (EA) for public comment. APHIS solicited comments on the petition, whether the subject cotton is likely to pose a plant pest risk, and on the draft EA for 60 days ending on July 11, 2011. APHIS received 7 comments opposing a determination of nonregulated status during the comment period, with one comment having an additional 4,045 names attached. Commenters generally expressed opposition to genetically engineered organisms or crops but did not provide any specific disagreement with APHIS’ analysis. One commenter expressed concern with gene flow. 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 cotton event COT67B, 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 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-2007-0130. E:\FR\FM\29SEN1.SGM 29SEN1 Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices regard to the preferred alternative identified in the EA. Determination Based on APHIS’ analysis of field and laboratory data submitted by Syngenta, 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 Syngenta’s cotton event COT67B 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 23rd day of September 2011. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2011–25086 Filed 9–28–11; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2011–0077] Notice of Availability of a Pest Risk Analysis for the Importation of Fresh Tejocote Fruit From Mexico Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with the importation into the continental United States of fresh tejocote fruit from Mexico. Based on this analysis, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh tejocote fruit from Mexico. We are making the pest risk analysis available to the public for review and comment. tkelley on DSKG8SOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:29 Sep 28, 2011 Jkt 223001 We will consider all comments that we receive on or before November 28, 2011. ADDRESSES: You may submit comments by either of the following methods: • Federal eRulemaking Portal: Go to https://www.regulations.gov/ #!documentDetail;D=APHIS-2011-0077– 0001. • Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS–2011–0077, 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-2011-0077 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) 690–2817 before coming. FOR FURTHER INFORMATION CONTACT: Mr. David B. Lamb, Import Specialist, RPM, PHP, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 734– 0627. DATES: SUPPLEMENTARY INFORMATION: Background Under the regulations in ‘‘Subpart— Fruits and Vegetables’’ (7 CFR 319.56– 1 through 319.56–51, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States. Section 319.56–4 contains a performance-based process for approving the importation of commodities that, based on the findings of a pest-risk analysis, can be safely imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section. APHIS received a request from the national plant protection organization (NPPO) of Mexico to allow the importation of fresh tejocote fruit (Crataegus pubescens) from Mexico into the continental United States. Currently, fresh tejocote fruit is not authorized for entry from Mexico. We have completed a pest risk analysis for the purpose of evaluating the pest risks associated with the importation of fresh tejocote fruit PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 60449 into the continental United States. The analysis consists of a pest list identifying pests of quarantine significance that are present in Mexico and could follow the pathway of importation into the United States and a risk management document identifying phytosanitary measures that could be applied to the commodity to mitigate the pest risk. We have concluded that fresh tejocote fruit can be safely imported into the continental United States from Mexico using one or more of the five designated phytosanitary measures listed in § 319.56–4(b). The measures we selected are: • Fresh tejocote fruit may be imported into the continental United States in commercial consignments only. • Each consignment of fresh tejocote fruit must be accompanied by a phytosanitary certificate issued by the NPPO of Mexico stating that the fresh tejocote fruit in the consignment has been inspected and is free of pests. • Each shipment of fresh tejocote fruit is subject to inspection upon arrival at port of entry to the United States. Therefore, in accordance with § 319.56–4(c), we are announcing the availability of our pest risk analysis for public review and comment. The pest risk analysis may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the pest risk analysis by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to the subject of the pest risk analysis you wish to review when requesting copies. After reviewing any comments we receive, we will announce our decision regarding the import status of fresh tejocote fruit from Mexico in a subsequent notice. If the overall conclusions of the analysis and the Administrator’s determination of risk remain unchanged following our consideration of the comments, then we will begin issuing permits for the importation of fresh tejocote fruit from Mexico into the continental United States subject to the requirements specified in the risk management document. Authority: 7 U.S.C. 450, 7701–7772, and 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60448-60449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25086]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0130]


Syngenta Biotechnology, Inc.; Determination of Nonregulated 
Status for Lepidopteran-Resistant Cotton

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public of our determination that a cotton 
line developed by Syngenta Biotechnology, Inc., designated as event 
COT67B, which has been genetically engineered to express a protein to 
protect cotton plants from lepidopteran insect damage, 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 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: September 29, 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-2007-0130.

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 07-108-01p) from 
Syngenta Biotechnology, Inc. (Syngenta), seeking a determination of 
nonregulated status for cotton (Gossypium spp.) designated as event 
COT67B, which has been genetically engineered to express a Cry1Ab 
protein to protect cotton plants from lepidopteran insect damage. The 
petition stated that cotton event COT67B 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 May 11, 2011 
(76 FR 27301-27303, Docket No. APHIS-2007-0130), APHIS announced the 
availability of the Syngenta petition, our plant pest risk assessment, 
and our draft environmental assessment (EA) for public comment. APHIS 
solicited comments on the petition, whether the subject cotton is 
likely to pose a plant pest risk, and on the draft EA for 60 days 
ending on July 11, 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-2007-0130.
---------------------------------------------------------------------------

    APHIS received 7 comments opposing a determination of nonregulated 
status during the comment period, with one comment having an additional 
4,045 names attached. Commenters generally expressed opposition to 
genetically engineered organisms or crops but did not provide any 
specific disagreement with APHIS' analysis. One commenter expressed 
concern with gene flow. 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 cotton event 
COT67B, 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

[[Page 60449]]

regard to the preferred alternative identified in the EA.

Determination

    Based on APHIS' analysis of field and laboratory data submitted by 
Syngenta, 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 
Syngenta's cotton event COT67B 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 23rd day of September 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-25086 Filed 9-28-11; 8:45 am]
BILLING CODE 3410-34-P
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