Syngenta; Availability of Petition and Environmental Assessment
for Determination of Nonregulated Status for Corn Genetically
Engineered for Insect Resistance
[Federal Register: January 10, 2007 (Volume 72, Number 6)]
[Notices]
[Page 1212-1214]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja07-29]
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Notices
Federal Register
________________________________________________________________________
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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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: catherine.a.preston@aphis.usda.gov.
To obtain copies of the petition or the environmental assessment,
contact Mr. Steve Bennett at (301) 734-5672, e-mail:
steven.m.bennett@aphis.usda.gov. 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]
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