[Federal Register: September 27, 2005 (Volume 70, Number 186)]
[Notices]
[Page 56441-56443]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se05-41]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-112-1]
Monsanto Company; Availability of Petition and Environmental
Assessment for Determination of Nonregulated Status for Corn
Genetically Engineered To Express High Lysine Levels
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 Monsanto Company,
seeking a determination of nonregulated status for corn designated as
transformation event LY038, which has been genetically engineered to
express a lysine-insensitive dihydrodipicolinate synthase (cDHDPS)
enzyme, which allows for the accumulation of higher levels of lysine in
the germ of the seed. Corn-soybean meal based diets formulated for
poultry and swine are characteristically deficient in lysine and
require the addition of supplemental lysine for optimal animal growth
and production. This corn product may provide an alternative to
supplementation of feed with lysine. The petition has been submitted in
accordance with our regulations
[[Page 56442]]
concerning the introduction of certain genetically engineered organisms
and products. In accordance with those regulations, we are soliciting
public comments on whether this corn presents 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 November
28, 2005.
ADDRESSES: You may submit comments by either of the following methods:
EDOCKET: Go to http://www.epa.gov/feddocket to submit or
view public comments. Once you have entered EDOCKET, click on the
``View Open APHIS Dockets'' link to locate this document.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-112-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-112-1.
Reading Room: You may read the petition, the environmental
assessment, and 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.
FOR FURTHER INFORMATION CONTACT: Dr. Levis Handley, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5721. To obtain copies of the petition or the
environmental assessment (EA), contact Ms. Ingrid Berlanger at (301)
734-4885; e-mail: ingrid.e.berlanger@aphis.usda.gov. The petition and
the EA are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_22901p.pdf and http://www.aphis.usda.gov/brs/
is.usda.gov/brs/
SUPPLEMENTARY INFORMATION: 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 August 16, 2004, APHIS received a petition (APHIS Petition
Number 04-229-01p) from Monsanto Company (Monsanto) of St. Louis, MO,
on behalf of Renessen LLC of Deerfield, IL, requesting a determination
of nonregulated status under 7 CFR part 340 for corn (Zea mays L.)
designated as transformation event LY038 which has been genetically
engineered to produce higher levels of lysine in the seed than is
typically found in corn. The Monsanto petition states that the subject
corn should not be regulated by APHIS because it does not present a
plant pest risk.
As described in the petition, the LY038 corn has been genetically
modified to express the cordapA gene from Cornybacterium glutamicum.
This gene encodes for lysine-insensitive dihydrodipicolinate synthase
(cDHDPS) enzyme. The expression of cordapA is under the control of the
maize Glb1 promoter, which directs cDHDPS expression predominately in
the germ of the seed, resulting in accumulation of lysine in the grain.
Corn-soybean meal based diets formulated for poultry and swine are
characteristically deficient in lysine and require the addition of
supplemental lysine for optimal animal growth and production.
Development of LY038 corn may provide an alternative to direct addition
of supplemental lysine to poultry and swine diets.
Event LY038 has been considered a regulated article under the
regulations in 7 CFR part 340 because it was originally engineered with
regulatory sequences derived from plant pathogens. This corn event has
been field tested since 2000 in the United States under APHIS
notifications. In the process of reviewing the notifications for field
trials of the subject corn, APHIS determined that the vectors and other
elements 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.
In section 403 of the Plant Protection Act (7 U.S.C. 7702), 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 very broadly. The definition
covers direct or indirect injury, disease, or damage not just to
agricultural crops, but also to plants in general, for example, native
species, as well as to organisms that may be beneficial to plants, for
example, honeybees, rhizobia, etc.
The Food and Drug Administration (FDA) published a statement of
policy on foods derived from new plant varieties in the Federal
Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of
policy includes a discussion of FDA's authority for ensuring food
safety under the Federal Food, Drug, and Cosmetic Act and provides
guidance to industry on the scientific considerations associated with
the development of foods derived from new plant varieties, including
those plants developed through the techniques of genetic engineering.
Monsanto is consulting with FDA on the subject corn event.
To provide the public with documentation of APHIS' review and
analysis of the environmental impacts and plant pest risk associated
with a proposed determination of nonregulated status for Monsanto's
event LY038 corn, an environmental assessment (EA) has been prepared.
The 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 persons for a period of 60 days
from the date of this notice. We are also soliciting written comments
from interested persons on the environmental assessment prepared to
examine any
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environmental impacts of the proposed determination for the subject
corn event. The petition and the environmental assessment and any
comments received are available for public review, and copies of the
petitions and the environmental assessment are available as indicated
in the FOR FURTHER INFORMATION CONTACT section of this notice.
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. After reviewing and
evaluating the comments on the petition and the environmental
assessment 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 Monsanto's
high lysine corn event LY038 and the availability of APHIS' written
decision.
Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 21st day of September 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E5-5178 Filed 9-26-05; 8:45 am]
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