E7-5344. Return to Regulated Status of 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 that the United States District Court for the Northern District of California has vacated the Animal and Plant Health Inspection Service's (APHIS') June 2005 determination of nonregulated status with respect to 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. The effect of this action is that those alfalfa events, known as Roundup Ready alfalfa, are once again considered regulated articles under APHIS' regulations in 7 CFR part 340 and the requirements pertaining to regulated articles under those regulations will once again apply to the subject alfalfa and its progeny. This notice also advises Roundup Ready alfalfa sellers and growers that no Roundup Ready alfalfa seed may be planted after March 30, 2007; that only seed purchased by growers before March 12, 2007, may be planted by March 30, 2007; and that all sales of Roundup Ready alfalfa seed are prohibited pending the Court's issuance of permanent injunctive relief.

DATES:

Effective Date: March 12, 2007.

FOR FURTHER INFORMATION CONTACT:

Thomas Sim, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone].

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.

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. 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. In a second notice published February 3, 2005, APHIS extended the comment period until February 17, 2005 (see 70 FR 5601-5602, Docket No. 04-085-2). Subsequently, in a notice published in the Federal Register on June 27, 2005 (70 FR 36917-36919, Docket No. 04-085-3), APHIS advised the public of its determination, effective June 14, 2005, that the Monsanto/FGI alfalfa events J101 and J163 were no longer considered regulated articles under our regulations governing the introduction of certain genetically engineered organisms.

Recent Legal Decisions

On February 13, 2007, the United States District Court for the Northern District of California issued a ruling in a lawsuit filed by the Center for Food Safety—along with several other nonprofit organizations and alfalfa growers—challenging APHIS' decision to deregulate alfalfa events J101 and J163 (referred to in the lawsuit as Roundup Ready alfalfa). The lawsuit alleged violations of the National Environmental Policy Act (NEPA), the Endangered Species Act, and the Plant Protection Act. The court ruled that the deregulation may have significant environmental impacts that require the preparation of an environmental impact statement (EIS), and that APHIS violated NEPA by not preparing an EIS.

Subsequently, on March 12, 2007, the court issued a preliminary injunction order in the case. As of March 12, 2007, all sales of Roundup Ready alfalfa seed are prohibited pending the Court's issuance of permanent injunctive relief. The court decided that growers who have already planted Roundup Ready alfalfa will not be required to remove the plants. Additionally, they will be permitted to harvest, use, and sell such Roundup Ready alfalfa. The court also prohibited all future planting of Roundup Ready alfalfa beginning March 30, 2007. Growers who intended to plant Roundup Ready alfalfa before that date and who had already purchased the seed prior to the March 12, 2007, preliminary injunction order may plant the seed. Growers who intended to plant alfalfa after March 30, 2007, or who did not purchase Roundup Ready alfalfa seed prior to March 12, 2007, must plant non-genetically engineered alfalfa.

In addition, the court vacated APHIS' June 2005 decision deregulating Roundup Ready alfalfa, and the plant line is once again a regulated article. In accordance with the court's order, APHIS is issuing the appropriate notices informing Roundup Ready alfalfa sellers and growers of the terms of the court's preliminary injunction order. The court has scheduled a hearing on a permanent injunction for April 27, 2007.

By the terms of the court's order, the Monsanto/FGI alfalfa lines that were the subject of APHIS' June 2005 determination of nonregulated status cited above are once again regulated articles under APHIS' regulations in 7 CFR part 340 and the requirements pertaining to regulated articles under those regulations will once again apply to the subject alfalfa and its progeny.

Done in Washington, DC, this 19th day of March 2007.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.