Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public of our determination that a corn line developed by Pioneer Hi-Bred International, designated as transformation event 98140, which has been genetically engineered for tolerance to glyphosate and acetolactate synthase-inhibiting herbicides, 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 the Pioneer Hi-Bred International in its petition for a determination of nonregulated status, our analysis of other scientific data, and comments received from the public in response to a previous notice announcing the availability of the petition for nonregulated status and its associated environmental assessment. This notice also announces the availability of our written determination and finding of no significant impact.
You may read the petition, final environmental assessment, determination, finding of no significant impact, comments we received on our previous notice, and our responses to those comments in our reading room. The reading room is located in room
Dr. Michael Watson, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0846, email:
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.
In a notice
Based on APHIS’ analysis of field, greenhouse, and laboratory data submitted by Pioneer, references provided in the petition, information described in the EA, comments provided by the public, and information provided in APHIS’ response to those public comments, APHIS has determined that 98140 corn will not pose a plant pest risk and should be granted nonregulated status for the following reasons: (1) Gene introgression from Pioneer HT corn into wild relatives in the United States and its territories is extremely unlikely and is not likely to increase the weediness potential of any resulting progeny nor adversely affect genetic diversity of related plants any more than would introgression from traditional corn varieties; (2) it exhibits no characteristics that would cause it to be weedier than the non-genetically engineered parent corn line or any other cultivated corn; (3) horizontal gene transfer is unlikely to occur between Pioneer HT corn and soil bacteria; (4) based on its lack of toxicity and allergenicity, it does not pose a risk to non-target organisms, including beneficial organisms and federally listed threatened or endangered species, and species proposed for listing; (5) considering its cultivation in the agroecosystem, it does not pose a risk to non-target organisms, including threatened and endangered species, or designated critical habitat as a result of the use of EPA-registered glyphosate and ALS-inhibiting herbicides, as these have been safely used in corn for many years; (6) it does not pose a threat to biodiversity as it does not exhibit traits that increase its weediness, its unconfined cultivation should not lead to increased weediness of other cultivated corn, and it exhibits no changes in disease susceptibility; (7) its commercial use should not have significant effects on agricultural practices; (8) compared to current corn pest and weed management practices, cultivation of Pioneer HT corn should not impact standard agricultural practices in corn cultivation including those for organic growers; (9) it should not cause significant impacts on the development of herbicide resistant weeds or cumulative impacts in combination with other herbicide tolerant crops; (10) agronomic performance, disease and insect susceptibility, and compositional profiles of Pioneer HT corn are similar to those of its parent line and other corn cultivars grown in the United States, therefore no direct or indirect plant pest effects on raw or processed plant commodities are expected; (11) when considered in light of other actions, APHIS identified no significant environmental impacts that would result from a determination to grant nonregulated status to Pioneer HT corn.
To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the determination of nonregulated status for 98140 corn, 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
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 3