[Federal Register Volume 72, Number 6 (Wednesday, January 10, 2007)]
[Notices]
[Pages 1212-1214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-194]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
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  Federal Register / Vol. 72, No. 6 / Wednesday, January 10, 2007 / 
Notices  

[[Page 1212]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0157]


Syngenta; 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.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from Syngenta Seeds, Inc., 
seeking a determination of nonregulated status for corn rootworm-
resistant corn derived from a transformation event designated as 
MIR604. 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 corn presents a 
plant pest risk. We are also making available for public comment a 
draft environmental assessment for the proposed determination of 
nonregulated status.

DATES: We will consider all comments on the petition that are received 
on or before March 12, 2007. We will consider all comments on the draft 
environmental assessment that are received on or before February 9, 
2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0157 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0157, 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-2006-0157.
    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. Catherine Preston, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5874, e-mail: [email protected]. 
To obtain copies of the petition or the environmental assessment, 
contact Mr. Steve Bennett at (301) 734-5672, e-mail: 
[email protected]. The petition and the environmental 
assessment are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_36201p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_36201p_ea.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 December 27, 2004, APHIS received a request seeking a 
determination of nonregulated status (APHIS No. 04-362-01p) from 
Syngenta Seeds, Inc. (Syngenta) of Research Triangle Park, NC, for corn 
(Zea mays L.) designated as transformation event MIR604, which has been 
genetically engineered for resistance to corn rootworm (CRW), stating 
that corn line MIR604 does not present a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340. Syngenta responded to APHIS' subsequent request for 
additional information and clarification and submitted a revised 
petition on May 17, 2006. Another request for information and 
clarification was sent to Syngenta on July 25, 2006. Syngenta 
subsequently revised and resubmitted their petition and response to 
APHIS' request on August 2, 2006. The final two versions of the 
petition, submitted on May 17, 2006, and August 2, 2006, as well as 
Syngenta's written responses to APHIS' request sent on July 25, 2006, 
are available for public review and comment.

Analysis

    As described in the petition, corn transformation event MIR604 has 
been genetically engineered to express two transgenes: (1) The modified 
cry3A (mcry3A) gene derived from a well-characterized gene sequence 
from Bacillus thuringiensis, encoding the mCRY3A insect control protein 
and (2) the pmi (manA) gene from Escherichia coli, which encodes the 
enzyme phosphomannose isomerase (PMI) for use as a selectable marker. 
Expression of the mcry3A gene by corn plants renders

[[Page 1213]]

the corn line resistant to CRW. Regulatory elements for the mcry3A and 
pmi genes were derived from maize and Agrobacterium tumefaciens. These 
regulatory sequences are not transcribed and do not encode proteins. 
The DNA was introduced into corn cells using Agrobacterium-mediated 
transformation methodology with the T-DNA transformation vector 
designated pZM26. In addition to transgenes necessary for insertion 
into the plant genome, the T-DNA vector also contained two additional 
genetic elements: (1) A gene conferring bacterial resistance to the 
antibiotics erythromycin, streptomycin, and spectinomycin and (2) the 
bacterial origin of replication. Plant cells containing the introduced 
DNA were then selected by culturing in the presence of mannose. After 
the initial incubation with Agrobacterium, the broad-spectrum 
antibiotic cefotaxime was included in the culture medium to kill any 
remaining Agrobacterium.
    Transformation event MIR604 has been considered a regulated article 
under the regulations in 7 CFR part 340 because it contains gene 
sequences from plant pathogens. MIR604 corn has been field tested in 
the United States since 2001 under notifications and permits authorized 
by the U.S. Department of Agriculture (USDA). APHIS has presented three 
alternatives in the draft environmental assessment (EA) based on its 
analyses of data submitted by Syngenta, a review of other scientific 
data, and field tests conducted under APHIS oversight. APHIS may: (1) 
Take no action, (2) deregulate MIR604, or (3) deregulate MIR604 in 
part.
    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. APHIS views this definition broadly to cover 
direct or indirect injury, disease, or damage not just to agricultural 
crops, but also to other plants, for example, native species, as well 
as organisms that may be beneficial to plants, such as honeybees.
    MIR604 corn is subject to regulation by other 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 cases in which 
genetically engineered plants allow for a new use of a pesticide or 
involve a different use pattern for the pesticide, EPA must approve the 
new or different use. Accordingly, Syngenta submitted two petitions to 
the EPA, which announced its receipt of the petitions in two notices 
published in the Federal Register on October 27, 2004. The first 
petition requested an exemption from tolerance from the requirement of 
a tolerance for residues of the mCRY3A protein and the genetic material 
necessary for their production in corn (69 FR 62688-62692), and the 
second was an application to register a pesticide product containing a 
new active ingredient (69 FR 62678-62680). On April 6, 2005, a 
temporary tolerance exemption was granted for residues of the mCRY3A 
protein and the genetic material necessary for their production in 
corn, concluding that there was a reasonable certainty of no harm from 
consumption of the protein, as it is digestible in gastric fluid and 
not considered an allergen (70 FR 17323-17327). This temporary 
exemption was subsequently renewed (69 FR 11431-11433) and is currently 
set to expire on October 15, 2007 (71 FR 13269-13274). On January 25, 
2006, EPA announced the receipt of an application filed by Syngenta to 
amend an application for an Experimental Use Permit (EUP) to include 
the plant-incorporated protectant Event MIR604 mCry3A corn (71 FR 4141-
4142). Also on January 25, 2006, EPA announced Syngenta applied for an 
extension to the tolerance exemption expiring on October 15, 2006 (69 
FR 11431-11433). On January 25, 2006, the EPA announced a 2-day meeting 
(March 14-15, 2006) for the FIFRA Scientific Advisory Panel to consider 
and review human health and environmental issues associated with MIR604 
Modified Cry3A Protein Bt Corn-Plant Incorporated Protectant (71 FR 
4130-4133).
    Under the Federal Food, Drug, and Cosmetic Act (FFDCA) (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 Food and Drug 
Administration (FDA) enforces tolerances set by EPA under the FFDCA.
    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. Syngenta submitted a summary of their safety 
assessment on February 25, 2005, and additional information on March 
21, 2006. The Syngenta assessment submitted to the FDA indicated no 
changes in composition, safety, or other relative parameters. The 
consultation process for MIR604 corn as food and feed is nearing 
completion.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
proposed determination of nonregulated status for MIR604, a draft EA 
has been prepared. 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)(2), 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 for a period of 30 days 
from the date of this notice on the EA prepared to examine any 
environmental impacts of the proposed determination for the subject 
corn event. The petition, the draft EA, and any comments received are 
available for public review, and copies of the petitions and the draft 
EA are available as indicated in the FOR FURTHER INFORMATION CONTACT 
section of this notice.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. After reviewing and evaluating the comments on the 
petition and the EA and other data and information, APHIS will furnish 
a response to the petitioner, either approving the petition in whole or 
in part, or denying the petition. APHIS will then publish a notice in 
the Federal Register announcing the regulatory status of Syngenta's 
insect-

[[Page 1214]]

resistant corn event MIR604 and the availability of APHIS' written 
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 5th day of January 2007.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-194 Filed 1-9-07; 8:45 am]
BILLING CODE 3410-34-P