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Pioneer Hi-Bred International, Inc.; Determination of Nonregulated Status for Soybean Genetically Engineered for Tolerance to Glyphosate and Acetolactate Synthase-Inhibiting Herbicides

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Animal and Plant Health Inspection Service, USDA.




We are advising the public of our determination that a soybean line developed by Pioneer Hi-Bred International, Inc., designated as transformation event 356043, 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, Inc., 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.


Effective Date: July 24, 2008.


You may read the petition, environmental assessment, determination, finding of no significant impact, the comments we received on our previous notice, and our responses to those comments 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. To view those documents on the Internet, go to​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2007-0019.

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Mr. John Cordts, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) Start Printed Page 43204734-5531, To obtain copies of the petition, environmental assessment, or the finding of no significant impact, contact Ms. Cynthia Eck at (301) 734-0667; e-mail: Those documents are also available on the APHIS Web site at​brs/​aphisdocs/​06_​27101p.pdf and​brs/​aphisdocs/​06_​27101p_​ea.pdf.

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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 September 28, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS petition number 06-271-01p) from Pioneer Hi-Bred International, Inc., of Johnston, IA (Pioneer), for soybean (Glycine max L.) designated as transformation event 356043, which has been genetically engineered for tolerance to glyphosate and acetolactate synthase (ALS)-inhibiting herbicides, stating that soybean line 356043 does not present a plant pest risk.


As described in the petition, 356043 soybean plants have been genetically engineered to express modified glyphosate acetyltransferase (GAT 4601) and ALS proteins, which confers tolerance to glyphosate and ALS-inhibiting herbicides. The gat4601 gene is derived from gat genes from Bacillus licheniformis, a common soil bacterium. Expression of the gat4601 gene is driven by a synthetic constitutive promoter (SCP1). The gene that confers tolerance to ALS-inhibiting herbicides is gm-hra and is a modified soybean ALS gene. Expression of the gm-hra gene is driven by a constitutive soybean S-adenosyl-L-methionine synthetase (SAMS) promoter. A single copy of these genes and their regulatory sequences were introduced into soybean somatic embryos using microprojectile bombardment.

Pioneer's 356043 soybean plants have been considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens. Pioneer's 356043 soybean plants have been field tested in the United States since 2003 under permits issued by APHIS. In the process of reviewing the permits for field trials of the subject soybean plants, APHIS determined that the vectors and other elements were disarmed and that trials, which were conducted under conditions of reproductive and physical confinement or isolation, would not present a risk of plant pest introduction or dissemination.

In a notice [1] published in the Federal Register on October 5, 2007 (72 FR 56981-56983, Docket No. APHIS-2007-0019), APHIS announced the availability of the Pioneer petition and a draft environmental assessment (EA) for public comment. APHIS solicited public comments on whether the subject soybean would present a plant pest risk and on the EA. APHIS received 110 comments by the close of the 60-day comment period, which ended on December 4, 2007. There were 18 comments submitted in support of the petition to grant nonregulated status to 356043 soybean plants and 92 that were opposed. APHIS' responses to these comments can be found as an attachment to the finding of no significant impact.


Based on APHIS' analysis of field, greenhouse, and laboratory data submitted by Pioneer, references provided in the petition, other relevant information described in the EA, and comments provided by the public, APHIS has determined that 356043 soybean will not pose a plant pest risk for the following reasons: (1) Gene introgression from 356043 soybean into wild relatives in the United States and its territories is extremely unlikely; (2) APHIS does not expect 356043 soybean to have any impacts on non-target organisms, including beneficial organisms and threatened or endangered species, because all the studies conducted on 356043 soybean and specific proteins show no evidence of toxicity and GAT4601 and GM-HRA protein assessments showed low likelihood of allergenicity; (3) soybean (Glycine max) is not considered to be a weed and it does not persist in unmanaged ecosystems; (4) APHIS does not expect cultivation of 356043 soybean to have significant impacts on non-target organisms, including beneficial organisms and threatened or endangered species, as a result of the use of EPA-registered glyphosate and ALS-inhibitor herbicides as these have been used safely on soybeans for many years; (5) analysis of available information demonstrates that 356043 soybean does not exhibit any traits that should cause increased weediness, and that its unconfined cultivation should not lead to increased weediness of other sexually compatible relatives (of which there are none in the United States); (6) if 356043 soybeans were to be grown commercially, the effects on agricultural practices (e.g., cultivation, spray programs, crop rotation practices, planting rates, etc.) from introducing 356043 soybean into the environment should not be significantly different than previously deregulated glyphosate tolerant or RR®/STS® soybean lines; (7) APHIS does not expect 356043 soybean to cause significant impact on the development of herbicide tolerant weeds or cumulative impacts in combination with other glyphosate tolerant or Roundup Ready®/STS® (sulfonylurea tolerant soybean) crops; (8) if 356043 soybean were to be grown commercially, APHIS expects 356043 soybean will be used to breed soybean varieties suitable to a range of environments and maturity zones and replace some of the presently available glyphosate and ALS-inhibitor tolerant soybeans; deregulation of 356043 soybean should not alter the current potential impact to organic farming, organic farmers will still be able to purchase and grow non-transgenic soybeans and will be able to coexist with biotech soybean producers as they do now; (9) APHIS' analysis of agronomic performance, disease and insect susceptibility, and compositional profiles of 356043 soybean and its non-genetically engineered counterpart indicates no significant differences in composition between the two that would be expected to cause significant effects on raw or processed plant commodities from the deregulation of Start Printed Page 43205356043 soybean; and (10) when considered in light of other past, present, and reasonably foreseeable future actions, and considering potential environmental effects associated with adoption of 356043 soybean, APHIS could not identify significant environmental impacts that would result from granting nonregulated status to 356043 soybean.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the determination of nonregulated status for 356043 soybeans, 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 and other pertinent scientific data, APHIS has reached a finding of no significant impact with regard to the determination that Pioneer 356043 soybean line and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and finding of no significant impact are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

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Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

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Done in Washington, DC, this 18th day of July, 2008.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. E8-16950 Filed 7-23-08; 8:45 am]