2010-25387. Monsanto Company and KWS SAAT AG; Supplemental Request for Partial Deregulation of Roundup Ready Sugar Beet

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

The Animal and Plant Health Inspection Service has received a supplemental request for “partial deregulation” or similar administrative action from the Monsanto Company and KWS SAAT AG for the planting, harvesting, and interstate movement of Roundup Ready® sugar beets under measures designed to ensure any risks posed by cultivation are mitigated. This notice is to inform the public of the availability of the documents submitted to the Agency from Monsanto Company and KWS SAAT AG requesting a “partial deregulation.”

ADDRESSES:

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-2010-0047) or on the APHIS Web site (see http://www.aphis.usda.gov/​brs/​aphisdocs2/​03_​32301p_​a1.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.

FOR FURTHER INFORMATION CONTACT:

Mr. Rick Coker, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1236; [phone]. To obtain copies of the supplemental request for “partial deregulation,” contact Ms. Cindy Eck at [phone], e-mail: [e-mail].

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.”

On October 19, 2004, APHIS published a notice in the Federal Register (69 FR 61466-61467, Docket No. 04-075-1) announcing receipt of a petition from the Monsanto Company (Monsanto) and KWS SAAT AG (KWS) requesting a determination of nonregulated status under 7 CFR part 340 for sugar beet (Beta vulgaris ssp. vulgaris) designated as event H7-1, which has 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 March 17, 2005 (70 FR 13007-13008, Docket No. 04-075-2), advising the public of our determination, effective March 4, 2005, that the Monsanto/KWS sugar beet event H7-1 was no longer considered a regulated article under APHIS regulations in 7 CFR part 340.

On September 21, 2009, the U.S. District Court for the Northern District of California issued a ruling in a lawsuit filed by two organic seed groups and two nonprofit organizations challenging our decision to deregulate sugar beet event H7-1 (referred to in the lawsuit as Roundup Ready® sugar beet, or “RRSB”), pursuant to the Plant Protection Act (PPA) 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 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). Accordingly, APHIS is preparing an EIS, for which we published a notice ^[1] in the Federal Register (75 FR 29969-29972, Docket No. APHIS-2010-0047) on May 28, 2010, to solicit comments on the proposed scope of the EIS. The EIS process is ongoing.

On August 13, 2010, the Court vacated the deregulation determination, remanding the issue back to APHIS. RRSB is therefore once again a regulated article under 7 CFR part 340, and Monsanto and KWS have submitted a supplemental request for “partial deregulation” or similar administrative action for RRSB, along with an accompanying “Environmental Report,” to allow the future planting, harvesting, and interstate movement of RRSB crops (both seed and root) under conditions designed to ensure any risks posed by the introduction of these sugar beets into the environment are thoroughly mitigated.

APHIS is evaluating this supplemental request and developing appropriate environmental analyses to inform its decisionmaking in reference to any APHIS decision or decisions to authorize future seed and root crop plantings under a combination of permits, administrative orders, or other regulatory options and measures. APHIS is considering regulatory options and measures that would include mitigating measures consistent with those it had proposed to the Court as interim measures while APHIS completes the EIS for the petition for determination of non-regulated status for RRSB. APHIS anticipates making a decision on the supplemental petition for “partial deregulation” and on other appropriate interim regulatory actions related to RRSB by the end of the year. There will be an opportunity for public comment on any environmental analyses developed for such decision or decisions. 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.

Done in Washington, DC, this 4th day of October 2010.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  The notice can be viewed at http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2010-0047.