01-9626. Mycogen c/o Dow and Pioneer; Availability of Environmental Assessment for Determination of Nonregulated Status

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that an environmental assessment has been prepared for a proposed determination that corn line developed by Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc., and designated as line 1507, which has been genetically engineered for insect resistance and tolerance to the herbicide glufosinate, would no longer be considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. We are making this environmental assessment available to the public for review and comment.

DATES:

We will consider all comments that we receive by May 18, 2001.

ADDRESSES:

Please send four copies of your comment (an original and three copies) to: Docket No. 00-070-2, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 00-070-2.

You may read the petition for a determination of nonregulated status submitted by Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc., the environmental assessment, and any comments we receive on this notice of availability 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.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. Susan Koehler, Biotechnology Assessments Section, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain a copy of the environmental assessment, contact Ms. Kay Peterson at [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Background

On May 15, 2000, the Animal and Plant Health Inspection Service (APHIS) received a petition (APHIS Petition No. 00-136-01p) from Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen c/o Dow) of Indianapolis, IN, and Pioneer Hi-Bred International, Inc. (Pioneer) of Johnston, IA, seeking a determination that a corn line designated as Zea mays L. cultivar line 1507 (line 1507), which has been genetically engineered for resistance to certain lepidopteran insect species and tolerance to the herbicide glufosinate, does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340.

On September 6, 2000, APHIS published a notice in the Federal Register (65 FR 53976-53977, Docket no. 00-070-1) announcing that the Mycogen c/o Dow and Pioneer petition had been received and was available for public review. The notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject corn line and food products derived from it. In the notice, APHIS solicited written comments from the public as to whether corn line 1507 posed a plant pest risk. The comments were to have been received by APHIS on or before November 6, 2000. APHIS received no comments on the subject petition during the designated 60-day comment period.

Corn line 1507 has been genetically engineered to express a Cry1F insecticidal protein derived from the common soil bacterium, Bacillus thuringiensis subsp. aizawai (Bt aizawai). The Cry1F protein is said to be effective in controlling the larvae of such common pests of corn as European corn borer, southwestern corn borer, black cutworm, and fall armyworm. The subject corn line also contains the pat gene derived from the bacterium Streptomyces viridochromogenes. The pat gene encodes the phosphinothricin acetyltransferase (PAT) protein, which confers tolerance to the herbicide glufosinate. Expression of these added genes is controlled in part by gene sequences from the plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. Microprojectile bombardment was used to transfer the added genes into the recipient inbred corn line Hi-II.

Corn line 1507 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. Field tests of the subject corn line have been conducted since 1997 under APHIS notifications under confined conditions. If the Mycogen c/o Dow and Pioneer petition for a determination of nonregulated status is approved, corn line 1507 would no longer be considered a regulated article under APHIS' regulations in 7 CFR part 340 and the requirements pertaining to regulated articles under those regulations would no longer apply to the subject corn line or its progeny.

To provide the public with documentation of APHIS' review and analysis of the environmental impacts and plant pest risk associated with a determination of nonregulated status for the Mycogen c/o Dow and Pioneer corn line 1507, 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).

Done in Washington, DC, this 12th day of April 2001.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.