Mycogen c/o Dow; Availability of Environmental Assessment for Extension 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 that the Animal and Plant Health Inspection Service has prepared an environmental assessment for a preliminary decision to extend to one additional corn line our determination that a corn line developed by Mycogen Seeds c/o Dow AgroSciences LLC is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. We are making this environmental assessment available for public comment.

DATES:

We will consider all comments we receive on or before September 16, 2004.

ADDRESSES:

You may submit comments by any of the following methods:

• Postal mail/commercial delivery: Please send four copies of your comments (an original and three copies) to Docket No. 04-030-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 04-030-1.
• E-mail: Address your comment to regulations@aphis.usda.gov. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 04-030-1” on the subject line.
• Agency Web site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through the APHIS Web site.
• Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this docket and submitting comments.

Reading Room: You may read the extension request, the environmental assessment, and any comments we receive on this notice in our reading room. The reading room is located in room 1141, 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 that someone is available to help you, please call (202) 690-2817 before coming.

Other Information: You may view APHIS documents published in the Federal Register, and related information, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Ms. Robyn Rose, Biotechnology Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0489. To obtain copies of the extension request or the environmental assessment, contact Ms. Terry Hampton at (301) 734-5715; e-mail: Terry.A.Hampton@aphis.usda.gov. The extension request and the environmental assessment are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/ 03_18101p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_18101p_ea.pdf.

SUPPLEMENTARY INFORMATION:

Background:

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. Further, the regulations in 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question.

On June 30, 2003, APHIS received a request for an extension of a determination of nonregulated status (APHIS No. 03-181-01p) from Mycogen Seeds c/o Dow AgroSciences LLC (Mycogen/Dow) of Indianapolis, IN, for corn (Zea mays L.) designated as maize line 6275 (corn line 6275), which has been genetically engineered for resistance to certain lepidopteran insect pests and tolerance to the herbicide glufosinate. The Mycogen/Dow request seeks an extension of a determination of nonregulated status issued in response to APHIS petition number 00-136-01p for insect resistant and glufosinate-tolerant corn line 1507, the antecedent organism (see 66 FR 42624-42625, published August 14, 2001, Docket No. 00-070-3). Based on the similarity of the antecedent organism corn line 1507 and corn line 6275, Mycogen/Dow requests a determination that corn line 6275 does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340.

Analysis

Like the antecedent organism, corn line 6275 has been genetically engineered to express a Cry1F insecticidal protein derived from the common soil bacterium Bacillus thuringiensis subsp. Aizawi (Bt aizawi). The Cry1F protein is said to be effective in controlling certain lepidopteran pests of corn, including European corn borer, black cutworm, fall army worm, and southwestern corn borer. Corn line 6275 also contains the bar gene isolated from the bacterium Streptomyces hygroscopicus. The bar gene encodes a phosphinothricin acetyltransferase enzyme which confers tolerance to the herbicide glufosinate. The antecedent organism contains the pat gene derived from the bacterium Streptomyces viridochromogenes. The pat gene encodes a phosphinothricin acetyltransferase (PAT) protein, which also confers tolerance to glufosinate herbicides. Corn line 6275 was developed through use of Agrobacterium-mediated transformation, while microprojectile bombardment was used to transfer the added genes into the antecedent organism, corn line 1507. The recipient line used in both the antecedent organism and corn line 6275 was the public line designated Hi-II.

Corn line 6275 expresses an insecticidal crystal protein identical in amino acid sequence to the Cry1F protein expressed in line 1507, both lines express an identical protein which confers tolerance to the herbicide glufosinate, and the recipient line used in both lines was the same public line Hi-II. Accordingly, we have determined that corn line 6275 is similar to the antecedent organism in APHIS petition number 00-136-01p and we are proposing that corn line 6275 should no longer be regulated under the regulations in 7 CFR part 340.

Corn line 6275 has been considered a regulated article under APHIS regulations in 7 CFR part 340 because it contains gene sequences derived from plant pathogens. However, corn line 6275 has been field tested since 1999 under APHIS authorizations. 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.

Should APHIS approve the Mycogen/Dow request for an extension of a determination of nonregulated status, corn line 6275 would no longer be considered a regulated article under APHIS' regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations would no longer apply to the field testing, importation, or interstate movement of the subject corn line or its progeny.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with a proposed extension of a determination of nonregulated status for Mycogen/Dow's corn line 6275, 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). Copies of the Mycogen/Dow extension request and the EA are available as indicated in the FOR FURTHER INFORMATION CONTACT section of this notice.