E7-19801. Pioneer Hi-Bred International, Inc.; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Soybean Genetically Engineered for Tolerance to Glyphosate and Acetolactate Synthase-Inhibiting ...

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Pioneer Hi-Bred International, Inc., seeking a determination of nonregulated status for soybean designated as transformation event 356043, which has been genetically engineered for tolerance to glyphosate and acetolactate synthase-inhibiting herbicides. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting comments on whether this genetically engineered soybean is or could be a plant pest. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.

DATES:

We will consider all comments we receive on or before December 4, 2007.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov,, select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2007-0019 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2007-0019, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2007-0019.

Reading Room: You may read any comments that we receive on this docket 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.

Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Mr. John Cordts, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone], [e-mail]. To obtain copies of the petition or environmental assessment (EA), contact Ms. Cynthia Eck at [phone]; [e-mail]. The petition and EA may be viewed on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​27101p.pdf and http://www.aphis.usda.gov/​brs/​aphisdocs/​06_​27101p_​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 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 and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340.

As described in the petition, 356043 soybean plants have been genetically engineered to express modified glyphosate acetyltransferase (GAT 4601) and acetolactate synthase (ALS) proteins, which confers tolerance to glyphosate and acetolactate synthase-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 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.

APHIS has prepared an environmental assessment (EA) in which it presents two alternatives based on its analyses of data submitted by Pioneer, a review of other scientific data, and field tests conducted under APHIS oversight. APHIS may: (1) Take no action, i.e., APHIS would not change the regulatory status of 356043 soybeans and they would continue to be regulated articles, or (2) deregulate 356043 soybeans in whole.

In § 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), “plant pest” is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing. APHIS views this definition broadly to cover direct or indirect injury, disease, or damage not just to agricultural crops, but also to other plants, for example, native species, as well as organisms that may be beneficial to plants, such as honeybees.

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 et seq.). FIFRA requires that all pesticides, including herbicides, be registered prior to distribution or sale, unless exempt from EPA regulation. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et seq.), pesticides added to (or contained in) raw agricultural commodities generally are considered to be unsafe unless a tolerance or exemption from tolerance has been established. Residue tolerances for pesticides are established by the EPA under the FFDCA, and the Food and Drug Administration (FDA) enforces tolerances set by the EPA. Pioneer submitted the appropriate regulatory package to the EPA for registering the use of glyphosate herbicide on 356043 soybeans.

The FDA's policy statement concerning regulation of products derived from new plant varieties, including those genetically engineered, was published in the Federal Register on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a consultation process to ensure that human and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution of a bioengineered food. Pioneer submitted a food and feed safety and nutritional assessment summary to the FDA for 356043 soybeans. A final FDA decision is pending.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status for 356043 soybeans, an EA has been 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).

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. During the same comment period, we are also soliciting written comments from interested or affected persons on the EA prepared to examine any environmental impacts of the proposed deregulation determination for the subject soybean event. The petition and the EA and any comments we receive are available for public review, and copies of the petition and the EA are available as indicated in the FOR FURTHER INFORMATION CONTACT section of this notice.

After the comment period closes, APHIS will review the data submitted by the petitioner, all written comments received during the comment period, and any other relevant information. After reviewing and evaluating the comments on the petition and the EA and other data and information, APHIS will furnish a response to the petitioner, either approving the petition in whole or in part, or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Pioneer's glyphosate and ALS-inhibiting, herbicide-tolerant soybean and the availability of APHIS' written decision.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.8, and 371.3.

Done in Washington, DC, this 3rd day of October 2007.

Cindy J. Smith,

Administrator, Animal and Plant Health Inspection Service.