[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]
[Page 70817-70819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de07-27]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2007-0030]
Monsanto Company; 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 the Monsanto Company
seeking a determination of nonregulated status for insect-resistant
corn derived from a transformation event designated as MON 89034. 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 or could be a
plant pest. 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 we receive on or before February
11, 2008.
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-2007-0030 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-
2007-0030, 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-2007-0030.
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. Robyn Rose, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-0489, e-mail: robyn.i.rose@aphis.usda.gov. To
obtain copies of the petition or the environmental assessment, contact
Ms. Cindy Eck at (301) 734-0667, e-mail: cynthia.a.eck@aphis.usda.gov.
The petition and the environmental assessment are also available on the
Internet at http://www.aphis.usda.gov/brs/aphisdocs/06_29801p.pdf and
http://www.aphis.usda.gov/brs/aphisdocs/06_29801p_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
[[Page 70818]]
must take and the information that must be included in the petition.
On October 26, 2006, APHIS received a petition seeking a
determination of nonregulated status (APHIS No. 06-298-01p) from the
Monsanto Company (Monsanto) of St. Louis, MO, for corn (Zea mays L.)
designated as transformation event MON 89034, which has been
genetically engineered for resistance to European corn borer (ECB) and
other lepidopteran pests, stating that corn line MON 89034 does not
present a plant pest risk and, therefore, should not be a regulated
article under APHIS' regulations in 7 CFR part 340. Monsanto responded
to APHIS' subsequent request for additional information and
clarification and submitted an addendum to their petition on January
23, 2007. The petition is available for public review and comment.
Analysis
As described in the petition, corn transformation event MON 89034
has been genetically engineered to express the transgenes cry1A.105 and
cry2Ab2, both of which were derived from a well-characterized gene
sequence from Bacillus thuringiensis, and encode insect control
proteins. The neomycin phosphotransferase II (nptII) gene was used as a
selectable marker, but was eliminated by traditional breeding methods
in the later stages of development of MON 89034. Thus, MON 89034
contains only the cry1A.105 and cry2Ab2 expression cassettes.
Expression of the transgenes by corn plants renders the corn line
resistant to European corn borer, as well as other lepidopteran pests.
Regulatory elements for the transgenes were obtained from 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 binary
transformation vector designated PV-ZMIR245.
Transformation event MON 89034 has been considered a regulated
article under the regulations in 7 CFR part 340 because it contains
gene sequences from plant pathogens. MON 89034 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 two alternatives in the draft environmental assessment (EA)
based on its analyses of data submitted by Monsanto, a review of other
scientific data, and field tests conducted under APHIS oversight. APHIS
may: (1) Take no action (MON 89034 remains a regulated article), or (2)
deregulate MON 89034.
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 to plant parts and plant products whether natural, manufactured, or
processed.
MON 89034 corn 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 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. On July 17, 2006, the EPA announced a
temporary exemption from the requirement of a tolerance for residues of
the Bacillus thuringiensis Cry1A.105 protein and the genetic material
necessary for its production in corn on field corn, sweet corn, and
popcorn when applied/used as a plant-incorporated protectant (PIP). The
temporary tolerance exemption will expire on June 30, 2009 (71 FR
40427-40431). On July 17, 2006, EPA announced a temporary exemption
from the requirement of a tolerance for residues of the Bacillus
thuringiensis Cry2Ab2 protein and the genetic material necessary for
its production in corn on field corn, sweet corn, and popcorn when
applied/used as a PIP. The temporary tolerance exemption will expire on
June 30, 2009 (71 FR 40431-40436). Pursuant to its authority under the
Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et seq.),
EPA conducted a comprehensive assessment of the Cry1A.105 and Cry2Ab2
proteins 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.
Under the FFDCA, 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. Monsanto submitted a summary of their safety
assessment to the FDA on October 13, 2006. The FDA consultation for MON
89034 corn as food and feed is currently underway.
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
MON 89034. 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 environmental impacts of the proposed determination for
the deregulation of 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 under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
After the comment period closes, APHIS will review all written
comments
[[Page 70819]]
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 or denying the petition. APHIS will then
publish a notice in the Federal Register announcing the regulatory
status of Monsanto's insect-resistant corn event MON 89034 and the
availability of APHIS' written regulatory and environmental decisions.
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 7th day of December 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-24174 Filed 12-12-07; 8:45 am]
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