E5-3323. Monsanto Co. and Forage Genetics International; Availability Determination of Nonregulated Status for Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that the Monsanto Company and Forage Genetics International alfalfa lines designated as events J101 and J163, which have been genetically engineered for tolerance to the herbicide glyphosate, are no longer considered regulated articles under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto Company and Forage Genetics International in their 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 document and our finding of no significant impact.

EFFECTIVE DATE:

June 14, 2005.

ADDRESSES:

You may read the petition for a determination of nonregulated status submitted by Monsanto Company and Forage Genetics International, the environmental assessment, all comments received on the petition and the environmental assessment, the determination, and the finding of no significant impact with attached response to 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.

You may view APHIS documents published in the Federal Register and related information on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

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, the determination, the environmental assessment, or the finding of no significant impact, contact Ms. Ingrid Berlanger, at [phone]; e-mail: [e-mail]. Those documents are also available on the Internet at http://www.aphis.usda.gov/​brs/​aphisdocs/​04_​11001p.pdf and http://www.aphis.usda.gov/​brs/​aphisdocs/​04_​11001p_​ea.pdf.

SUPPLEMENTARY INFORMATION:

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 April 16, 2004, APHIS received a petition (APHIS petition number 04-110-01p) from Monsanto Company of St. Louis, MO, and Forage Genetics International of West Salem, WI (Monsanto/FGI), requesting a determination of nonregulated status under 7 CFR part 340 for alfalfa (Medicago sativa L.) designated as events J101 and J163, which have been genetically engineered for tolerance to the herbicide glyphosate. The Monsanto/FGI petition states that the subject alfalfa should not be regulated by APHIS because it does not present a plant pest risk.

On November 24, 2004, APHIS published a notice in the Federal Register (69 FR 68300-68301, Docket No. 04-085-1) announcing that the Monsanto/FGI petition and an environmental assessment were available for public review and soliciting comments for 60 days ending January 24, 2005. The notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject alfalfa and products developed from it. In a subsequent notice, APHIS extended the comment period until February 17, 2005 (see 70 FR 5601-5602, Docket No. 04-085-2, published February 3, 2005).

APHIS received 663 comments by the close of the extended comment period. Comments came from alfalfa growers and seed producers, organic growers, animal producers, growers associations, consumer groups, agriculture support industries, university professionals, and private citizens. Five hundred twenty respondents did not support granting nonregulated status to the events identified in the petition, while 137 supported the petition. The majority of the alfalfa growers and seed producers who submitted comments supported granting nonregulated status to alfalfa events J101 and J163, citing market demand for a weed-free product and stating that glyphosate tolerant alfalfa offered a tool to meet that demand. The majority of those academic professionals, agricultural support industries, and growers associations that submitted comments also supported the petition. Those commenters who did not support the petition raised concerns that certain domestic and foreign markets may be closed to growers who cannot guarantee a non-genetically engineered product. Organic growers generally opposed the petition because of concerns that pollination of their crops by the glyphosate tolerant variety will result in the inadvertent generation of unwanted genetically engineered products, resulting in market loss.

APHIS has carefully considered these comments and suggestions, and a response to the issues raised in the comments is included as an attachment to the finding of no significant impact.

Alfalfa events J101 and J163 have been genetically engineered to express a 5-enolpyruvyshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide glyphosate. Expression of the added genes is controlled in part by the 35S promoter derived from the plant pathogen figwort mosaic virus. The Agrobacterium tumefaciens transformation method was used to transfer the added genes into the proprietary alfalfa line R2336.

Alfalfa events J101 and J163 have been considered regulated articles under the regulations in 7 CFR part 340 because they contain gene sequences from plant pathogens. In the process of reviewing the notifications for field trials of the subject alfalfa, APHIS determined that the vectors and other elements 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.

Determination

Based on its analysis of the data submitted by Monsanto/FGI, a review of other scientific data, field tests of the subject alfalfa, and comments submitted by the public, APHIS has determined that alfalfa events J101 and J163: (1) Exhibit no plant pathogenic properties; (2) are no more likely to become weedy than the nontransgenic parental line or other cultivated alfalfa; (3) are unlikely to increase the weediness potential of any other cultivated or wild species with which it can interbreed; (4) will not cause damage to raw or processed agricultural commodities; (5) will not harm threatened or endangered species or organisms that are beneficial to agriculture; and (6) should not reduce the ability to control pests and weeds in alfalfa or other crops. Therefore, APHIS has concluded that the subject alfalfa and any progeny derived from hybrid crosses with other non-transformed alfalfa varieties will be as safe to grow as alfalfa varieties in traditional breeding programs that are not subject to regulation under 7 CFR part 340.

The effect of this determination is that Monsanto/FGI alfalfa events J101 and J163 are no longer considered regulated articles under APHIS' regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the subject alfalfa or its progeny. However, importation of J101 and J163 alfalfa and seeds capable of propagation are still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319 and imported seed regulations in 7 CFR part 361.

National Environmental Policy Act

An environmental assessment was prepared to examine any potential environmental impacts associated with the determination of nonregulated status for the subject alfalfa events. The environmental assessment 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 environmental assessment, APHIS has reached a finding of no significant impact with regard to the determination that Monsanto/FGI J101 and J163 alfalfa events and lines developed from them are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the environmental assessment and the finding of no significant impact are available from the individual listed under FOR FURTHER INFORMATION CONTACT.

Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Dated: Done in Washington, DC, this 21st day of June 2005.

Elizabeth E. Gaston,

Acting Administrator, Animal and Plant Health Inspection Service.