E7-15001. Monsanto Company; Determination of Nonregulated Status for Soybean Genetically Engineered for Glyphosate Herbicide Tolerance

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that a soybean line developed by the Monsanto Company, designated as transformation event MON 89788, which has been genetically engineered for tolerance to the herbicide glyphosate, 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 Monsanto Company 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 an environmental assessment. This notice also announces the availability of our written determination and finding of no significant impact.

DATES:

Effective Date: July 23, 2007.

ADDRESSES:

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 [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-2006-0195, 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. Virgil Meier, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain copies of the petition, environmental assessment, or the finding of no significant impact, contact Ms. Cynthia Eck at [phone]; [e-mail]. Those documents may also be viewed on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​17801p.pdf and http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​17801p_​ea.pdf.

SUPPLEMENTARY INFORMATION:

Background

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 27, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS Petition Number 06-178-01p) from Monsanto Company of St. Louis, MO (Monsanto), for soybean (Glycine max L.) designated as transformation event MON 89788, which has been genetically engineered for tolerance to the herbicide glyphosate, stating that soybean line MON 89788 does not present a plant pest risk and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

As described in the petition, MON 89788 soybean plants have been genetically engineered to express a 5-enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide glyphosate. Expression of the added gene is controlled, in part, by gene sequences derived from Arabidopsis thaliana and the plant pathogen figwort mosaic virus. The Agrobacterium tumefaciens transformation method was used to transfer the added genetic material into the recipient parental soybean line A3244.

MON 89788 soybean plants have been considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens. MON 89788 soybean plants have been field tested in the United States since 2001 under notifications authorized by APHIS. In the process of reviewing the notifications for field trials of the subject soybean plants, APHIS determined that the vectors and other elements were disarmed and that field 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 February 5, 2007 (72 FR 5261-5263, Docket No. APHIS-2006-0195), APHIS announced the availability of Monsanto's petition and the associated environmental assessment (EA). APHIS solicited comments on whether the subject soybean would present a plant pest risk for 60 days ending April 6, 2007. APHIS received 23 comments during the comment period, with 12 comments submitted in support of the conclusions drawn in the EA and 11 opposed. APHIS' responses to these comments can be found in an attachment to the finding of no significant impact.

Determination

Based on APHIS' analysis of field, greenhouse, and laboratory data submitted by Monsanto, references provided in the petition, other relevant information described in the EA, and comments provided by the public, APHIS has determined that Monsanto's soybean line, designated as MON 89788, will not pose a plant pest risk for the following reasons: (1) Gene introgression from MON 89788 soybean into its sexually compatible relatives in the United States and its territories is extremely unlikely and consequently the potential impact of introgression is not foreseeable; (2) the subgenus Glycine max, on which MON 89788 is based, is not considered to be a weed and does not persist in unmanaged ecosystems; (3) it does not pose a risk to non-target organisms, including beneficial organisms and threatened or endangered species, because the CP4 EPSPS protein is not known to have any toxic properties and has minimal potential to be a food allergen; (4) MON 89788 exhibits no 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); (5) if MON 89788 were to be grown commercially, the effect on agricultural practices from introducing MON 89788 into the environment should be no different than for the previously deregulated Roundup Ready 40-3-2 soybean line expressing the same CP4 EPSPS protein from Agrobacterium sp. Strain CP4, with which APHIS has over 10 years of experience; (6) APHIS does not expect MON 89788 to have any impacts on the development of herbicide resistant weeds or a cumulative impact in combination with other glyphosate tolerant crops; (7) there should be no significant impact from the stacking of herbicide resistant traits; (8) if MON 89788 were to be grown commercially, the potential impact on organic farming should not change from the current situation where close to 90 percent of soybeans produced are Roundup Ready and organic farmers or other farmers who choose not to plant or sell Roundup Ready soybean or other transgenic soybeans will still be able to purchase and grow nontransgenic soybeans and will be able to coexist with biotech soybean producers as they do now; (9) APHIS' analysis of data on agronomic performance, disease and insect susceptibility, and compositional profiles of MON 89788 and its non-genetically engineered counterpart indicates no significant differences between the two that would be expected to cause either a direct or indirect plant pest effect on raw or processed plant commodities from the deregulation of MON 89788; (10) APHIS has reviewed field performance data submitted by the petitioner, and these data indicate that the engineered plant is not different in any fitness characteristics from its parent that might cause MON 89788 to become invasive; and (11) none of the alternatives proposed in the EA are expected to have significant human health or environmental effects.

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 MON 89788, 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 finding of no significant impact with regard to the determination that Monsanto soybean line MON 89788 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.

Authority: 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 27th day of July 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To view the notice, the EA, and the comments we received, go to http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2006-0195.