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



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, 

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to (http://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 (http://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: ([email protected]). To 
obtain copies of the petition, draft environmental assessment or plant 
pest risk assessment, contact Ms. Cindy Eck at (301) 734-0667, email: 
([email protected]). Those documents are also available on 
the Internet at (http://www.aphis.usda.gov/brs/aphisdocs/07_25301p.pdf), (http://

[[Page 1750]]

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



    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 
    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 
    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 
    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]