[Federal Register Volume 70, Number 186 (Tuesday, September 27, 2005)]
[Notices]
[Pages 56441-56443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-5178]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected]. 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/aphisdocs/04_22901p.ea.pdf.

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

[[Page 56443]]

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]
BILLING CODE 3410-34-P