Animal and Plant Health Inspection Service, USDA.
The Animal and Plant Inspection Service has received a supplemental request for “partial deregulation” from Forage Genetics International for the planting, harvesting, and movement interstate of Roundup Ready® alfalfa under measures designed to ensure any risks posed by cultivation are mitigated. This notice seeks to inform interested or affected persons of the availability of the documents submitted to the Agency from Forage Genetics International requesting a “partial deregulation.”
You may view the request for “partial deregulation” on the Regulations.gov Web site (see http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0044) or on the APHIS Web site (see http://www.aphis.usda.gov/brs/aphisdocs/04_11001p_pea2.pdf). Copies may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT.
Other Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Mr. Rick Coker, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 146, Riverdale, MD 20737-1236; (301) 734-5720. To obtain copies of the supplemental request for “partial deregulation,” contact Ms. Cindy Eck at (301) 734-0667, e-mail: email@example.com.End Further Info End Preamble Start Supplemental 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.”
On November 24, 2004, APHIS published a notice in the Federal Register (69 FR 68300-68301, Docket No. 04-085-1) announcing receipt of a petition from the Monsanto Company (Monsanto) and Forage Genetics International (FGI) requesting a determination of nonregulated status under 7 CFR part 340 for alfalfa (Medicago sativa L.) designated as Start Printed Page 68322events J101 and J163, which have been genetically engineered for tolerance to the herbicide glyphosate. The petition stated that this article should not be regulated by APHIS because it is unlikely to pose a plant pest risk. APHIS also announced in that notice the availability of a draft environmental assessment (EA) examining the potential environmental impacts of the proposed action in accordance with National Environmental Policy Act requirements for the proposed determination of nonregulated status. Following review of public comments and completion of the EA, we published another notice in the Federal Register on June 27, 2005 (70 FR 36917-36919, Docket No. 04-085-3), advising the public of our determination, effective June 14, 2005, that the Monsanto/FGI alfalfa events J101 and J163 were no longer considered regulated articles under APHIS regulations in 7 CFR part 340.
On February 13, 2007, the U.S. 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 our decision to deregulate alfalfa events J101 and J163 (referred to in the lawsuit as Roundup Ready® alfalfa, or “RRA”), pursuant to the Plant Protection Act (PPA), as amended, and in compliance with the Administrative Procedure Act and the National Environmental Policy Act (NEPA) of 1969, as amended (42 U.S.C. 4321 et seq.). Under the provisions of NEPA, agencies must examine the potential environmental impacts of proposed major Federal actions, and the District Court ruled that APHIS' EA failed to consider certain environmental and interrelated economic impacts. As a result, the Court ruled that APHIS is required to prepare an environmental impact statement (EIS).
On March 12, 2007, the Court vacated the deregulation determination, returning RRA to regulated status under 7 CFR part 340, and issued an injunction which enjoined the Agency from taking any further action related to RRA until an EIS was completed by APHIS. Accordingly, APHIS published a notice  of intent to prepare an EIS in the Federal Register on January 7, 2008 (73 FR 1198-1200, Docket No. APHIS-2007-0044) soliciting comments on the scope and nature of issues the Agency should consider in preparing the EIS. After reviewing the comments, we published (see footnote 1) a notice of availability of a draft EIS in the Federal Register on January 12, 2010 (75 FR 1585-1586, Docket No. APHIS-2007-0044) soliciting comments on the draft EIS.
Subsequently, on June 21, 2010, the U.S. Supreme Court reversed the decision of the lower court which had mandated an injunction of any further planting of RRA or any other regulatory action by APHIS related to RRA until completion of an EIS. The U.S. Supreme Court remanded the case back to the 9th Circuit Court of Appeals which further remanded the case back to the U.S. District Court for the Northern District of California.
Following the U.S. Supreme Court decision, FGI submitted a supplemental request for “partial deregulation” or similar administrative action for RRA, along with an accompanying “Environmental Report,” to allow the future planting, harvesting, and interstate movement of RRA crops under conditions designed to ensure any risks posed by the introduction of RRA into the environment are thoroughly mitigated.
APHIS is evaluating this supplemental request and will be making a decision on it in the future. Meanwhile, the Agency is working to complete and publish the final EIS and record of decision for RRA. APHIS is notifying the public that its receipt of this supplemental request for “partial deregulation” and this notice to the public regarding it in no way indicates that the Agency agrees with the petitioners' description, application, or implementation of a “partial deregulation.” Such matters and related issues are solely determined by APHIS pursuant to its PPA statutory authority and its biotechnology regulations in 7 CFR part 340.Start Signature
Done in Washington, DC, November 1, 2010.
Acting Administrator, Animal and Plant Health Inspection Service.
1. The notice, as well as comments received and supporting and related materials, can be viewed at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0044.Back to Citation
[FR Doc. 2010-27985 Filed 11-4-10; 8:45 am]
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