E6-20516. Bayer CropScience; Extension of Determination of Nonregulated Status to Rice Genetically Engineered for Glufosinate Herbicide Tolerance

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our decision to extend a determination of nonregulated status to a rice line developed by Bayer CropScience, which has been genetically engineered to be tolerant to the herbicide glufosinate. Therefore, APHIS no longer considers the rice line to be a regulated article under Agency regulations governing the introduction of certain genetically engineered organisms. Our decision is based on our evaluation of data submitted by Bayer CropScience in its request for an extension of a determination of nonregulated status, an analysis of other scientific data, and comments received from the public in response to a previous notice and preliminary determination. This notice also announces the availability of our written determination, final environmental assessment, and our finding of no significant impact.

EFFECTIVE DATE:

November 24, 2006.

ADDRESSES:

You may read the extension request, the final environmental assessment, finding of no significant impact, the comments we received on our previous notice, and our responses to those comments in our reading room or on the Internet. 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. To view those documents on the Internet, go to http://www.regulations.gov,, click on the “Advanced Search” tab, and select “Docket Search.” In the Docket ID field, enter APHIS-2006-0140, then click “Submit.” Clicking on the Docket ID link in the search results page will produce a list of all documents in the docket.

FOR FURTHER INFORMATION CONTACT:

Dr. Neil Hoffman, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone], [e-mail]. To obtain copies of the extension request or the environmental assessment (EA) and finding of no significant impact (FONSI), contact Mr. Steve Bennett at [phone]; e-mail: [e-mail]. The extension request, final EA, response to comments, and FONSI are also available on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​23401p.pdf and http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​23401p_​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 August 18, 2006, APHIS received a request for an extension of a determination of nonregulated status (APHIS No. 06-234-01p) from Bayer CropScience (Bayer) of Research Triangle Park, NC, for rice (Oryza sativa L.) designated as Liberty Link® Transformation Event LLRICE601, which has been genetically engineered for tolerance to the herbicide glufosinate. Bayer requested an extension of a determination of nonregulated status issued in response to APHIS petition number 98-329-01p for glufosinate-tolerant rice transformation events LLRICE06 and LLRICE62, the antecedent organisms (See 64 FR 22595, published April 27, 1999, Docket No. 98-126-2). Based on the similarity of the antecedent rice lines LLRICE06 and LLRICE62 and rice line LLRICE601, Bayer CropScience requested a determination that rice line LLRICE601 does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340.

On July 31, 2006, Bayer CropScience notified APHIS that trace levels of LLRICE601 were detected in long grain commercial rice. Subsequently, Bayer CropScience supplied APHIS and the Food and Drug Administration (FDA) with information about the molecular characterization and agronomic performance of LLRICE601. APHIS completed a preliminary risk assessment and determined that LLRICE601 did not pose any plant pest or environmental concerns. This risk assessment is attached as appendix I to the final environmental assessment (EA).

On September 8, 2006, APHIS published a notice in the Federal Register (71 FR 53076-53077, Docket No. APHIS-2006-0140) announcing that an EA and a preliminary decision for the Bayer extension request had been prepared and was available for public comment. The analysis upon which APHIS based its preliminary decision was also published within that notice. APHIS received 15,871 comments on the subject EA and preliminary decision during the designated 30-day public comment period, which ended October 10, 2006. Of the 15,871 comments, 15,517 opposed the extension request. Respondents opposing the extension request were 12 public interest groups, academic professionals, organic food producers, and individuals. Of these comments, 10,500 nearly identical comments were submitted by members of 1 public interest group and 4,796 nearly identical comments were submitted by members of another public interest group. There were 354 comments supporting the extension of nonregulated status to LLRICE601. Respondents supporting the petition were rice growers, millers (or from related industries), rice industry groups, academia, a commodity company, a State government agency, and individuals. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as attachments to the finding of no significant impact (FONSI).

Decision

Based on an analysis of the data submitted by Bayer and a review of other scientific data, APHIS has determined that rice transformation event LLRICE601 is very similar to the antecedent organisms in APHIS petition number 98-329-01p and poses no more potential for plant pest risk than the antecedent organisms. Therefore, APHIS has concluded that rice line LLRICE601 and any progeny derived from crosses with other rice varieties will be as safe to grow as rice that is not subject to regulation under 7 CFR part 340.

Because APHIS has determined that the subject rice line does not present a plant pest risk based on its similarity to the antecedent organisms, Bayer rice line LLRICE601 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 LLRICE601 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 the extension of a determination of nonregulated status for LLRICE601, an EA was 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). Based on that EA, APHIS has reached a FONSI with regard to the determination that Bayer rice line LLRICE601 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 in the FOR FURTHER INFORMATION CONTACT section of this notice.

Done in Washington, DC, this 29th day of November 2006.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.