01-20307. Mycogen c/o Dow and Pioneer; Availability of Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance and Glufosinate Herbicide Tolerance

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that the Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc., corn line designated as line 1507, which has been genetically engineered for insect resistance and tolerance to the herbicide glufosinate, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Mycogen Seeds c/o Dow AgroSciences LLC and Pioneer Hi-Bred International, Inc., in their petition for a determination of nonregulated status and our analysis of other scientific data. This notice also announces the availability of our written determination document and a finding of no significant impact.

EFFECTIVE DATE:

June 14, 2001.

ADDRESSES:

You may read the determination, an environmental assessment and finding of no significant impact, and the petition 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. 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.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Dr. Susan Koehler, Biotechnology Assessments Section, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain a copy of the determination or the environmental assessment and finding of no significant impact, 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.

APHIS then published a notice in the Federal Register on April 18, 2001 (66 FR 19915-19916, Docket No. 00-070-2), announcing the availability for public comment of an environmental assessment (EA) for a proposed determination that corn line 1507 would no longer be considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Comments were to have been received by APHIS on or before May 18, 2001. We received no comments on the EA during the designated 30-day comment period.

Analysis

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 common pests of corn such as European corn borer, southwestern corn borer, black cutworm, fall armyworm, and corn ear worm. The subject corn line also contains the pat gene derived from the bacterium Streptomyces viridochromogenes. The pat gene encodes a phosphinothricin acetyltransferase (PAT) protein, which confers tolerance to the herbicide glufosinate. Expression of the added genes is controlled in part by gene sequences from the plant pathogens cauliflower mosaic virus and Agrobacterium tumefaciens. The microprojectile bombardment method 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 APHIS' regulations in 7 CFR part 340 because it contains gene sequences derived from plant pathogens. However, evaluation of data from field tests conducted under APHIS notifications since 1997 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of the environmental release of the subject corn line.

Determination

Based on its analysis of the data submitted by Mycogen c/o Dow and Pioneer and a review of other scientific data and field tests of the subject corn line, APHIS has determined that corn line 1507: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than insect-resistant and herbicide-tolerant corn varieties developed by traditional plant breeding; (3) is unlikely to increase the weediness potential for any sexually compatible cultivated or wild species; (4) will not cause damage to raw or processed agricultural commodities; (5) will not harm nontarget organisms, including threatened or endangered species or organisms that are recognized as beneficial to the agricultural ecosystem; and (6) should not reduce the ability to control insects or weeds in corn or other crops. Therefore, APHIS has concluded that the subject corn line and any progeny derived from hybrid crosses with other corn varieties will be as safe to grow as corn in traditional breeding programs that is not subject to regulation under 7 CFR part 340.

The effect of this determination is that the Mycogen c/o Dow and Pioneer corn line 1507 is no longer considered a regulated article under APHIS' regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the subject corn line or its progeny. However, importation of corn line 1507 or seeds capable of propagation are still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319.

National Environmental Policy Act

An EA has been prepared to examine the potential environmental impacts associated with this determination. 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). Based on that EA, APHIS has reached a finding of no significant impact (FONSI) with regard to its determination that the Mycogen c/o Dow and Pioneer corn line 1507 and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and the FONSI are available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 2nd day of August 2001.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.