E5-5178. 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 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 [phone] before coming.

FOR FURTHER INFORMATION CONTACT:

Dr. Levis Handley, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain copies of the petition or the environmental assessment (EA), contact Ms. Ingrid Berlanger at [phone]; e-mail: [e-mail]. 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 § 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 § 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 cordap A gene from Cornybacterium glutamicum. This gene encodes for lysine-insensitive dihydrodipicolinate synthase (cDHDPS) enzyme. The expression of cordap A 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 § 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 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.