Mycogen c/o Dow; 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 of our decision to extend to one additional corn line our determination that a corn line developed by Mycogen Seeds c/o Dow AgroSciences LLC, 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 decision is based on our evaluation of data submitted by Mycogen c/o Dow in its request for an extension of a determination of nonregulated status, an analysis of other scientific data, and a comment received from the public in response to a previous notice. This notice also announces the availability of our written determination and our finding of no significant impact.

EFFECTIVE DATE:

October 20, 2004.

ADDRESSES:

You may read the extension request, the environmental assessment and finding of no significant impact, and the comment we received on our previous notice 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.

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:

Ms. Robyn Rose, Biotechnology Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0489. To obtain a copy of the extension request or the environmental assessment and finding of no significant impact, contact Ms. Terry Hampton at (301) 734-5715; e-mail: Terry.A.Hampton@aphis.usda.gov. The extension request and the environmental assessment and finding of no significant impact 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:

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.

Background

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 pests and tolerance to the herbicide glufosinate. Mycogen/Dow requested 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 corn line 6275 to the antecedent corn line 1507, Mycogen/Dow requested 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.

On August 17, 2004, APHIS published a notice in the Federal Register (69 FR 51058-51059, Docket No. 04-030-1) announcing that an environmental assessment (EA) for the Mycogen/Dow extension request had been prepared and was available for public comment. APHIS received one comment on the subject EA during the designated 30-day public comment period, which ended September 16, 2004. The comment, which was from a private individual, stated, without reference to any supporting data, that corn line 6275 should continue to be regulated because it is harmful to humans and contains plant pathogens. APHIS evaluated the safety of corn line 6275 in the EA and has provided a response to this comment as an attachment to the finding of no significant impact (FONSI). The EA and FONSI are available as indicated under FOR FURTHER INFORMATION CONTACT.

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 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.

Determination

Based on an analysis of the data submitted by Mycogen/Dow and a review of other scientific data, APHIS has determined that corn line 6275: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than corn varieties developed by traditional breeding techniques and is unlikely to increase the weediness potential for any other cultivated or wild species with which it can interbreed; (3) will not cause damage to raw or processed agricultural commodities; (4) will not harm threatened or endangered species or other organisms, such as bees, that are beneficial to agriculture; and (5) is unlikely to have any significant adverse impact on agricultural practices. Therefore, APHIS has concluded that corn line 6275 and any progeny derived from crosses with other corn varieties will be as safe to grow as corn that is not subject to regulation under 7 CFR part 340.

Because APHIS has determined that the subject corn line does not present a plant pest risk based on its similarity to the antecedent organism, Mycogen/Dow corn line 6275 will 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 no longer apply to the field testing, importation, or interstate movement of the subject corn line or its progeny. However, importation of corn line 6275 and seeds capable of propagation are still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319 and imported seed regulations in 7 CFR part 361.

National Environmental Policy Act

An EA was prepared to examine any potential environmental impacts associated with the proposed extension of a determination of nonregulated status for the subject corn line. 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 FONSI with regard to the determination that Mycogen/Dow corn line 6275 and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and FONSI are available as indicated under FOR FURTHER INFORMATION CONTACT.