Daily Rules, Proposed Rules, and Notices of the Federal Government
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. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
On June 1, 2007, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition Number 07-152-01p) from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer), for corn (
As described in the petition, the 98140 corn line has been genetically engineered to express modified glyphosate acetyltransferase (GAT4621) and modified maize acetolactate synthase (ZM-HRA) proteins. The GAT4621 protein, encoded by the
The genetic insert also contains the terminator sequence from
A single copy of these genes and other DNA regulatory sequences were introduced into the corn genome with the transformation vector PHP24279 using disarmed (non-plant pest causing)
Pioneer's 98140 corn line has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. The 98140 corn line has been field tested in the United States since 2005 as authorized by APHIS notifications and permits. In the process of reviewing the permits for field trials of the subject corn, APHIS determined that the vectors and other elements used to introduce the new genes 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. Field tests conducted under APHIS regulatory oversight allowed for evaluation in a natural agricultural setting while imposing measures to minimize the risk of persistence in the environment after completion of the test. Data are gathered on multiple parameters and used by the applicant to evaluate agronomic characteristics and product performance. These field test data, in turn, are used by APHIS to determine if the regulated corn event poses a plant pest risk. Pioneer has petitioned APHIS to make a determination that the 98140 corn line and the progeny derived from its crosses with other nonregulated corn will no longer be considered regulated articles under 7 CFR part 340.
APHIS has prepared an environmental assessment (EA) in which it presents two alternatives for the determination of nonregulated status based on its analyses of data submitted by Pioneer, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of the 98140 corn line and it would continue to be a regulated article, or (2) grant nonregulated status to corn line 98140 in whole.
In section 403 of the Plant Protection Act (7 U.S.C. 7701
The 98140 corn line and any pesticides contained in or added to it are also subject to regulation by other Federal agencies. The U.S. Environmental Protection Agency (EPA) is responsible for the regulation of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136
The FDA's policy statement concerning regulation of products derived from new plant varieties, including those genetically engineered, was published in the
A draft EA has been prepared to inform the public of, and provide the APHIS decisionmaker with, a review and analysis of potential environmental impacts associated with the proposed determination of nonregulated status for the 98140 corn line. The draft EA was prepared in accordance with (1) the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
In accordance with § 340.6(d) of the regulations, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. We are also soliciting written comments from interested or affected persons on the draft EA prepared to examine potential environmental impacts of the proposed determination for the deregulation of the subject corn line. The petition and the draft EA are available for public review, and copies of these documents are available as indicated under
After the comment period closes, APHIS will evaluate all written comments received during the comment period and any other relevant information. All public comments received regarding the petition and draft EA will be available for public review. After reviewing and evaluating the comments on the petition and the draft EA and other data, APHIS will furnish a response to the petitioner, either approving or denying the petition. APHIS will then publish a notice in the
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.