Syngenta Biotechnology, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance, 1749-1751 [2010-407]

Download as PDF Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices DEPARTMENT OF AGRICULTURE Forest Service Notice of Meeting; Federal Lands Recreation Enhancement Act (Title VIII, Pub. L. 108–447) AGENCY: Pacific Northwest Region, Forest Service, USDA. ACTION: The Pacific Northwest Recreation Resource Advisory Committee will meet via a conference call. The purpose of the meeting is to review and provide recommendations on recreation fee proposals for facilities and services offered on lands managed by the Forest Service and Bureau of Land Management in Oregon and Washington, under the Federal Lands Recreation Enhancement Act of 2004. DATES: The conference call will be held on February 2, 2010 from 12:30 p.m. to 4:30 p.m. A public input session will be provided at 1 p.m. on February 2, 2010. Comments will be limited to three minutes per person. Individuals wishing to participate in the conference call or provide public comment should contact Jocelyn Biro, Recreation Program Coordinator (503) 808–2411 or jbiro@fs.fed.us. Send written comments to Dan Harkenrider, Designated Federal Official for the Pacific Northwest Recreation RAC, 902 Wasco Street, Suite 200, Hood River, OR 97031, 541–308– 1700 or dharkenrider@fs.fed.us. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Dan Harkenrider, Designated Federal Official, 902 Wasco Street, Suite 200, Hood River, OR 97031, 541–308–1700. The meeting is open to the public. Recreation RAC discussion is limited to Forest Service and Bureau of Land Management staff and Recreation RAC members. However, persons who wish to bring recreation fee matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. A public input session will be provided and individuals who have made written requests by January 29, 2010, to the Designated Federal Official will have the opportunity to address the Committee during the meeting on February 2, 2010, at 1 p.m. The Recreation RAC is authorized by the Federal Land Recreation Enhancement Act, which was signed into law by President Bush in December 2004. SUPPLEMENTARY INFORMATION: srobinson on DSKHWCL6B1PROD with NOTICES BILLING CODE 3410–11–M Forest Service SUMMARY: 16:51 Jan 12, 2010 [FR Doc. 2010–440 Filed 1–12–10; 8:45 am] DEPARTMENT OF AGRICULTURE Notice of Meeting. VerDate Nov<24>2008 Dated: January 6, 2010. Lenise Lago, Deputy Regional Forester, Pacific Northwest Region. Jkt 220001 Eastern Washington Cascades Provincial Advisory Committee and the Yakima Provincial Advisory Committee Forest Service, USDA. Notice of Meeting. AGENCY: ACTION: SUMMARY: The Eastern Washington Cascades Provincial Advisory Committee and the Yakima Provincial Advisory Committee will meet on February 3, 2010 at the OkanoganWenatchee National Forest Headquarters office, 215 Melody Lane, Wenatchee, WA. During this meeting information will be shared about Holden Mine clean-up operations, Stehekin River Corridor Implementation Plan/Environmental Impact Statement, and Bureau of Land Management Resource Management Plan update. All Eastern Washington Cascades and Yakima Province Advisory Committee meetings are open to the public. FOR FURTHER INFORMATION CONTACT: Direct questions regarding this meeting to Becki Heath, Designated Federal Official, USDA, Okanogan-Wenatchee National Forest, 215 Melody Lane, Wenatchee, Washington 98801, phone 509–664–9200. Dated: January 6, 2010. Rebecca Lockett Heath, Designated Federal Official, OkanoganWenatchee National Forest. [FR Doc. 2010–513 Filed 1–12–10; 8:45 am] BILLING CODE 3410–11–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2009–0072] Syngenta Biotechnology, Inc.; Availability of Petition and Environmental Assessment for 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 that the Animal and Plant Health PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 1749 Inspection Service has received a petition from Syngenta Biotechnology, Inc., seeking a determination of nonregulated status for corn designated as transformation event MIR162, which has been genetically engineered for insect resistance. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting comments on whether this genetically engineered corn is likely to pose a plant pest risk. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status. DATES: We will consider all comments we receive on or before March 15, 2010. ADDRESSES: You may submit comments by either of the following methods: ∑ Federal eRulemaking Portal: Go to (https://www.regulations.gov/ fdmspublic/component/ main?main=DocketDetail&d=APHIS– 2009–0072) to submit or view comments and to view supporting and related materials available electronically. ∑ Postal Mail/Commercial Delivery: Please send two copies of your comment to Docket No. APHIS–2009–0072, Regulatory Analysis and Development, PPD, APHIS, Station 3A–03.8, 4700 River Road Unit 118, Riverdale, MD 20737–1238. Please state that your comment refers to Docket No. APHIS– 2009–0072. Reading Room: You may read any comments that we receive on this docket 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. 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 petition, draft environmental assessment or plant pest risk assessment, contact Ms. Cindy Eck at (301) 734–0667, email: (cynthia.a.eck@aphis.usda.gov). Those documents are also available on the Internet at (https://www.aphis.usda.gov/ brs/aphisdocs/07_25301p.pdf), (https:// E:\FR\FM\13JAN1.SGM 13JAN1 1750 Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices www.aphis.usda.gov/brs/aphisdocs/ 07_25301p_pea.pdf) and (https:// www.aphis.usda.gov/brs/aphisdocs/ 07_25301p_pra.pdf). SUPPLEMENTARY INFORMATION: srobinson on DSKHWCL6B1PROD with NOTICES 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. 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. As described in the petition, the MIR162 corn line has been genetically engineered to express the VIP3Aa20 protein. The VIP3Aa20 gene is based on the sequences from Bacillus thuringiensis, a common soil bacterium. The VIP3Aa20 gene confers tolerance to certain lepidopteran (caterpillar) pests of corn. Expression of the VIP3Aa20 gene is driven by the corn ubiquitin promoter (ZmUbilnt), and uses the terminator sequence from 35S RNA of cauliflower mosaic virus (CaMV). MIR162 corn also contains the manA gene from E. coli, which encodes the enzyme phosphomannose isomerase (PMI), and was used only as a selectable marker during transformant selection and confers no other benefits to the transformed corn plant. The manA gene VerDate Nov<24>2008 16:51 Jan 12, 2010 Jkt 220001 is also driven by the ZmUbilnt promoter, and uses the Nopaline Synthase (NOS) gene from Agrobacterium tumefaciens as a terminator sequence. All of these sequences are well-characterized and are non-coding regulatory regions only. Therefore, these sequences will not cause the MIR162 corn line to promote plant disease. A single copy of these genes and other DNA regulatory sequences were introduced into the corn genome with the transformation vector pNOV1300 using disarmed (non-plant pest causing) A. tumefaciens transformation. Plant cells containing the introduced DNA were selected by culturing them in sugar mannose. After the initial transformation, the antibiotic cefotoxime was included in the culture medium to kill any remaining Agrobacterium. Therefore, no part of the plant pest A. tumefaciens remained in Syngenta MIR162 corn due to the transformation method. Syngenta’s MIR162 corn line has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. The MIR162 corn line has been field tested in the United States since 1999 as authorized by USDA APHIS notifications and permits (see appendix A of the petition). In the process of reviewing the permits for field trials of the subject corn, APHIS determined that the vectors and other elements used to introduce the new genes were disarmed and that the trials, which were conducted under conditions of reproductive and physical confinement or isolation, would not present a risk of plant pest introduction or dissemination. Field tests conducted under USDA 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 data are used by APHIS to determine if the new variety poses a plant pest risk. Syngenta has petitioned APHIS to make a determination that the MIR162 corn line and the progeny derived from its crosses with other nonregulated corn shall no longer be considered regulated articles under 7 CFR part 340. APHIS has prepared an environmental assessment (EA) in which it presents two alternatives based on its analyses of data submitted by Syngenta, a review of other scientific data, and field tests conducted under PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 APHIS oversight. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of the MIR162 corn line and it would continue to be a regulated article, or (2) grant nonregulated status to corn line MIR162 in whole. In § 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), ‘‘plant pest’’ is defined as any 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. The MIR162 corn line is subject to regulation by other Federal agencies. The U.S. Environmental Protection Agency (EPA) is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA requires that all pesticides, including herbicides, be registered prior to distribution or sale, unless exempt from EPA regulation. In order to be registered as a pesticide under FIFRA, it must be demonstrated that when used with common practices, a pesticide will not cause unreasonable adverse effects in the environment. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et seq.), pesticides added to (or contained in) raw agricultural commodities generally are considered to be unsafe unless a tolerance or exemption from tolerance has been established. Residue tolerances for pesticides are established by EPA under the FFDCA, and the U.S. Food and Drug Administration (FDA) enforce the tolerances set by EPA. Syngenta submitted the appropriate regulatory package to EPA on November 2, 2007, seeking an exemption from the requirement of a tolerance for residues from the Vip3Aa20 protein from B. thuringiensis. On August 6, 2008, EPA granted the exemption. FDA’s policy statement concerning regulation of products derived from new plant varieties, including those genetically engineered, was published in the Federal Register on May 29, 1992 (57 FR 22984–23005). Under this policy, FDA uses what is termed a consultation process to ensure that human and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution of a bioengineered food. In compliance with the FDA policy, Syngenta submitted a food and feed safety and nutritional assessment E:\FR\FM\13JAN1.SGM 13JAN1 Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices summary to FDA for their MIR162 corn line in 2007. FDA completed their consultation on MIR 162 corn on December 9, 2008, concluding that FDA had ‘‘no further questions concerning grain and forage derived from corn event MIR162.’’ srobinson on DSKHWCL6B1PROD with NOTICES National Environmental Policy Act 16:51 Jan 12, 2010 Jkt 220001 Done in Washington, DC, this 6th day of January 2010. Cindy Smith Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2010–407 Filed 1–12–10: 2:16 pm] A 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 for the MIR162 corn line. 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). 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 draft EA prepared to examine any potential environmental impacts of the proposed determination for the deregulation of the subject corn line, and the plant pest risk assessment. 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 public 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 then publish a notice in the Federal Register announcing the regulatory status of the MIR162 corn line and the availability of APHIS’ written regulatory and environmental decision. VerDate Nov<24>2008 Authority: 7 U.S.C. 7701–7772 and 7781– 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. BILLING CODE 3410–34–S COMMISSION ON CIVIL RIGHTS Hearing on the Department of Justice’s Actions Related to the New Black Panther Party Litigation and Its Enforcement of Section 11(b) of the Voting Rights Act 1751 authority to investigate allegations of voting irregularities even when alleged abuses do not involve discrimination. CONTACT PERSON FOR FURTHER INFORMATION: Lenore Ostrowsky, Acting Chief, Public Affairs Unit (202) 376– 8591. TDD: (202) 376–8116. Persons with a disability requiring special services, such as an interpreter for the hearing impaired, should contact Pamela Dunston at least seven days prior to the scheduled date of the hearing at 202–376–8105. TDD: (202) 376–8116. Dated: January 8, 2010. David Blackwood, General Counsel. [FR Doc. 2010–497 Filed 1–12–10; 8:45 am] BILLING CODE 6335–01–P United States Commission on Civil Rights. ACTION: Notice of hearing. AGENCY: DATE AND TIME: Friday, February 12, 2010; 9:30 a.m. EST. PLACE: U.S. Commission on Civil Rights, 624 Ninth Street, NW., Room 540, Washington, DC 20425. SUMMARY: Notice is hereby given pursuant to the provisions of the Civil Rights Commission Amendments Act of 1994, 42 U.S.C. 1975a, and 45 CFR 702.3, that public hearings before the U.S. Commission on Civil Rights will commence on Friday, February 12, 2010, beginning at 9:30 a.m. EST in Washington, DC at the Commission’s offices located at 624 Ninth Street, NW., Room 540, Washington, DC 20425. An executive session not open to the public may be convened at any appropriate time before or during the hearing. The purpose of this hearing is to collect information within the jurisdiction of the Commission, under 42 U.S.C. 1975a, related particularly to the Department of Justice’s actions in the New Black Panther Party Litigation and enforcement of Section 11(b) of the Voting Rights Act. The Commission is authorized to hold hearings and to issue subpoenas for the production of documents and the attendance of witnesses pursuant to 45 CFR 701.2. The Commission is an independent bipartisan, fact finding agency authorized to study, collect, and disseminate information, and to appraise the laws and policies of the Federal Government, and to study and collect information with respect to discrimination or denials of equal protection of the laws under the Constitution because of race, color, religion, sex, age, disability, or national origin, or in the administration of justice. The Commission has broad PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 DEPARTMENT OF COMMERCE International Trade Administration [A–489–815] Light–Walled Rectangular Pipe and Tube from Turkey: Extension of Time Limits for Preliminary Results of Antidumping Duty Administrative Review AGENCY: Import Administration, International Trade Administration, Department of Commerce. EFFECTIVE DATE: January 13, 2010. FOR FURTHER INFORMATION CONTACT: Tyler Weinhold or Robert James, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington DC 20230; telephone: (202) 482–1121 and (202) 482–0649, respectively. SUPPLEMENTARY INFORMATION: Background At the request of interested parties, on June 24, 2009, the Department published in the Federal Register a notice of initiation of this antidumping duty administrative review. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part, 74 FR 30052, August 25, 2009. The review covers the period January 30, 2008, through April 30, 2009. The preliminary results for this administrative review is currently due no later than January 31, 2010. Extension of Time Limits for Preliminary Results Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to complete the E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Notices]
[Pages 1749-1751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-407]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2009-0072]


Syngenta Biotechnology, Inc.; Availability of Petition and 
Environmental Assessment for 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 that the Animal and Plant Health 
Inspection Service has received a petition from Syngenta Biotechnology, 
Inc., seeking a determination of nonregulated status for corn 
designated as transformation event MIR162, which has been genetically 
engineered for insect resistance. The petition has been submitted in 
accordance with our regulations concerning the introduction of certain 
genetically engineered organisms and products. In accordance with those 
regulations, we are soliciting comments on whether this genetically 
engineered corn is likely to pose a plant pest risk. We are also making 
available for public comment an environmental assessment for the 
proposed determination of nonregulated status.

DATES: We will consider all comments we receive on or before March 15, 
2010.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to (https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0072) to submit or view comments 
and to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2009-0072, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2009-0072.
     Reading Room: You may read any comments that we receive on this 
docket 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.
     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 petition, draft environmental assessment or plant 
pest risk assessment, contact Ms. Cindy Eck at (301) 734-0667, email: 
(cynthia.a.eck@aphis.usda.gov). Those documents are also available on 
the Internet at (https://www.aphis.usda.gov/brs/aphisdocs/07_25301p.pdf), (https://

[[Page 1750]]

www.aphis.usda.gov/brs/aphisdocs/07_25301p_pea.pdf) and (https://www.aphis.usda.gov/brs/aphisdocs/07_25301p_pra.pdf).

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.
    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.
    As described in the petition, the MIR162 corn line has been 
genetically engineered to express the VIP3Aa20 protein. The VIP3Aa20 
gene is based on the sequences from Bacillus thuringiensis, a common 
soil bacterium. The VIP3Aa20 gene confers tolerance to certain 
lepidopteran (caterpillar) pests of corn. Expression of the VIP3Aa20 
gene is driven by the corn ubiquitin promoter (ZmUbilnt), and uses the 
terminator sequence from 35S RNA of cauliflower mosaic virus (CaMV). 
MIR162 corn also contains the manA gene from E. coli, which encodes the 
enzyme phosphomannose isomerase (PMI), and was used only as a 
selectable marker during transformant selection and confers no other 
benefits to the transformed corn plant. The manA gene is also driven by 
the ZmUbilnt promoter, and uses the Nopaline Synthase (NOS) gene from 
Agrobacterium tumefaciens as a terminator sequence. All of these 
sequences are well-characterized and are non-coding regulatory regions 
only. Therefore, these sequences will not cause the MIR162 corn line to 
promote plant disease.
    A single copy of these genes and other DNA regulatory sequences 
were introduced into the corn genome with the transformation vector 
pNOV1300 using disarmed (non-plant pest causing) A. tumefaciens 
transformation. Plant cells containing the introduced DNA were selected 
by culturing them in sugar mannose. After the initial transformation, 
the antibiotic cefotoxime was included in the culture medium to kill 
any remaining Agrobacterium. Therefore, no part of the plant pest A. 
tumefaciens remained in Syngenta MIR162 corn due to the transformation 
method.
    Syngenta's MIR162 corn line has been considered a regulated article 
under the regulations in 7 CFR part 340 because it contains gene 
sequences from plant pathogens. The MIR162 corn line has been field 
tested in the United States since 1999 as authorized by USDA APHIS 
notifications and permits (see appendix A of the petition). In the 
process of reviewing the permits for field trials of the subject corn, 
APHIS determined that the vectors and other elements used to introduce 
the new genes were disarmed and that the trials, which were conducted 
under conditions of reproductive and physical confinement or isolation, 
would not present a risk of plant pest introduction or dissemination.
    Field tests conducted under USDA 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 data are used by APHIS to determine if the new 
variety poses a plant pest risk. Syngenta has petitioned APHIS to make 
a determination that the MIR162 corn line and the progeny derived from 
its crosses with other nonregulated corn shall no longer be considered 
regulated articles under 7 CFR part 340.
    APHIS has prepared an environmental assessment (EA) in which it 
presents two alternatives based on its analyses of data submitted by 
Syngenta, 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 the MIR162 corn line and it would continue to be a regulated 
article, or (2) grant nonregulated status to corn line MIR162 in whole.
    In Sec.  403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), 
``plant pest'' is defined as any 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.
    The MIR162 corn line is subject to regulation by other Federal 
agencies. The U.S. Environmental Protection Agency (EPA) is responsible 
for the regulation of pesticides under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et 
seq.). FIFRA requires that all pesticides, including herbicides, be 
registered prior to distribution or sale, unless exempt from EPA 
regulation. In order to be registered as a pesticide under FIFRA, it 
must be demonstrated that when used with common practices, a pesticide 
will not cause unreasonable adverse effects in the environment. Under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 
301 et seq.), pesticides added to (or contained in) raw agricultural 
commodities generally are considered to be unsafe unless a tolerance or 
exemption from tolerance has been established. Residue tolerances for 
pesticides are established by EPA under the FFDCA, and the U.S. Food 
and Drug Administration (FDA) enforce the tolerances set by EPA. 
Syngenta submitted the appropriate regulatory package to EPA on 
November 2, 2007, seeking an exemption from the requirement of a 
tolerance for residues from the Vip3Aa20 protein from B. thuringiensis. 
On August 6, 2008, EPA granted the exemption.
    FDA's policy statement concerning regulation of products derived 
from new plant varieties, including those genetically engineered, was 
published in the Federal Register on May 29, 1992 (57 FR 22984-23005). 
Under this policy, FDA uses what is termed a consultation process to 
ensure that human and animal feed safety issues or other regulatory 
issues (e.g., labeling) are resolved prior to commercial distribution 
of a bioengineered food. In compliance with the FDA policy, Syngenta 
submitted a food and feed safety and nutritional assessment

[[Page 1751]]

summary to FDA for their MIR162 corn line in 2007. FDA completed their 
consultation on MIR 162 corn on December 9, 2008, concluding that FDA 
had ``no further questions concerning grain and forage derived from 
corn event MIR162.''

National Environmental Policy Act

    A 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 for 
the MIR162 corn line. 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).
    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 draft EA prepared 
to examine any potential environmental impacts of the proposed 
determination for the deregulation of the subject corn line, and the 
plant pest risk assessment. 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 public 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 then publish a notice in the Federal Register announcing the 
regulatory status of the MIR162 corn line and the availability of 
APHIS' written regulatory and environmental decision.

    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 6\th\ day of January 2010.

Cindy Smith
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-407 Filed 1-12-10: 2:16 pm]
BILLING CODE 3410-34-S
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