2011-2878. Monsanto Company and KWS SAAT AG; Decision With Respect to the Petition for Partial Deregulation of Genetically Engineered Roundup Ready Sugar Beets

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our decision to “partially deregulate” Roundup Ready® sugar beets developed by the Monsanto Company (Monsanto) and KWS SAAT AG (KWS), designated as event H7-1, in response to a supplemental Monsanto/KWS petition requesting partial deregulation of event H7-1. APHIS has determined that it will, for an interim period of time, grant the petition in part. APHIS will grant a partial deregulation for event H7-1 sugar beet root crop production activities when conducted under certain mandatory conditions. APHIS has decided not to grant partial deregulation for event H7-1 sugar beet seed crop production. Rather, APHIS has decided that event H7-1 sugar beet seed production shall remain regulated under APHIS' regulations governing the introduction of certain genetically engineered organisms. Our decision granting the petition in part on an interim basis is based on our evaluation of data submitted by Monsanto and KWS in its supplemental petition for a determination of “partial deregulation,” our analysis of other scientific data, and comments received from the public in response to our previous notice announcing the availability of the environmental assessment (EA) associated with the supplemental petition for partial deregulation. This notice also announces the availability of our written decision, final EA, and finding of no significant impact.

DATES:

Effective Date: February 8, 2011.

ADDRESSES:

You may read the documents referenced in this notice and the comments we received 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.

Documents referenced in this notice are also available on the Internet at http://www.regulations.gov/​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2010-0047.

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. David Reinhold, Assistant Director, Environmental Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1238; [phone].

To enter into a compliance agreement to introduce event H7-1 sugar beet root crop, contact APHIS' Regulatory Operations Programs at [phone]. To obtain copies of the documents referenced in this notice, contact Ms. Cindy Eck at [phone], e-mail: [e-mail].

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.”

On November 4, 2010, the Animal and Plant Health Inspection Service (APHIS) published a notice ^[1] in the Federal Register (75 FR 67945-67946, Docket No. APHIS-2010-0047) announcing the availability of an environmental assessment for a supplemental petition from the Monsanto Company (Monsanto) and KWS SAAT AG (KWS) requesting “partial deregulation” or similar administrative action under 7 CFR part 340 (referred to below as the regulations) for sugar beets (Beta vulgaris ssp. vulgaris) designated as event H7-1. These sugar beets have been genetically engineered for tolerance to the herbicide glyphosate and are considered regulated articles under the regulations in 7 CFR part 340. The supplemental petition seeks action by APHIS that would authorize the continued cultivation of H7-1 sugar beets, subject to carefully tailored interim measures.

APHIS received 3,722 comments during the comment period. There were 3,058 comments from groups or individuals who supported the “partial deregulation” and 633 from those who opposed the “partial deregulation.” APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact.

The supplemental petition is related to a petition submitted by Monsanto and KWS to APHIS on November 19, 2003, seeking a determination of nonregulated status for event H7-1 sugar beets (Petition 03-323-01). On October 19, 2004, APHIS published a notice in the Federal Register (69 FR 61466-61467, Docket No. 04-075-1) announcing that the Monsanto/KWS petition and an environmental assessment (EA) were available for public review. On March 17, 2005, we published a notice in the Federal Register (70 FR 13007-13008, Docket No. 04-075-2) advising the public of our determination, effective March 4, 2005, that event H7-1 sugar beets were fully deregulated and no longer considered a regulated article under the regulations. On September 21, 2009, the U.S. District Court for the Northern District of California issued a ruling in a lawsuit challenging APHIS' decision to deregulate event H7-1 sugar beets, finding that APHIS should have completed an environmental impact statement (EIS) prior to granting full deregulation of H7-1 sugar beets. Later, on August 13, 2010, the Court vacated APHIS' decision to deregulate event H7-1 sugar beets until APHIS prepares a full EIS prior to a further decision on the petition for full deregulation and remanded the matter to APHIS. Accordingly, event H7-1 sugar beets once again became a regulated article subject to APHIS' regulatory oversight under 7 CFR part 340 and the Plant Protection Act.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with Monsanto/KWS' petition for “partial deregulation” for event H7-1 sugar beets, an 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).

The draft EA considered and evaluated a range of alternatives. APHIS' preferred alternative is an interim partial deregulation—a combination of alternatives 2 and 3. The preferred alternative incorporates specific aspects of both alternatives 2 and 3. Under this preferred alternative, pursuant to § 340.6 of the regulations, APHIS will partially deregulate the event H7-1 sugar beet root crop. APHIS has determined that they will not be subject to requirements of 7 CFR part 340 if they are grown under the mandatory conditions established by APHIS. Event H7-1 sugar beet root crop production activities conducted under these mandatory conditions will not be considered regulated under 7 CFR part 340. Event H7-1 sugar beet seed crop will remain regulated subject to requirements of 7 CFR part 340, requiring a permit or notification for movement and environmental release.

Under the partial, conditional deregulation, APHIS will require compliance with mandatory conditions for the root crop that will restrict its movement and environmental release via APHIS compliance agreements authorized under the Plant Protection Act. Any person who wants to enter into a compliance agreement must first contact APHIS' Regulatory Operations Programs by calling the phone number listed under FOR FURTHER INFORMATION CONTACT to enter into a compliance agreement in advance of the introduction.

This preferred alternative, including a conditional, partial deregulation, is an interim action that is limited in scope and duration and will neither result in significant impacts to the human environment nor prejudice any decision to be analyzed in the forthcoming EIS for a determination regarding full deregulation of event H7-1 sugar beets. APHIS has determined that the mandatory conditions imposed pursuant to the partial deregulation of event H7-1 sugar beet root crop, as well as permitting of the seed crop under 7 CFR part 340, ensures that the implementation of this interim regulatory action will not result in any environmental impacts which may significantly affect the quality of the human environment. The mandatory conditions will also effectively ensure that no potentially harmful economic or marketing impacts will occur in the interim while APHIS completes its EIS prior to making a determination on whether or not to grant full nonregulated status to event H7-1 sugar beets.

Determination

Based on APHIS' analysis of data submitted by Monsanto and KWS, references provided in the petition, information analyzed in the plant pest risk assessment and the EA, comments provided by the public, and information provided in APHIS' response to those public comments, APHIS has determined that event H7-1 sugar beet root crop grown under mandatory conditions is unlikely to pose a plant pest risk and should not be subject to the requirements of 7 CFR part 340. APHIS has reached this determination based on its plant pest risk assessment. APHIS has determined that event H7-1 sugar beet root crop production does not pose a plant pest risk and should not be subject to the requirements of our regulations in 7 CFR part 340 if grown under the mandatory conditions established by APHIS. Further, APHIS has concluded that granting partial deregulation of the H7-1 sugar beet root crop under certain conditions and allowing the seed crop to be planted under the requirements of 7 CFR part 340 will have no significant environmental effect on the human environment.

This granting of a partial deregulation for root crop production is an interim partial deregulation for the root crop with required conditions until an EIS is completed regarding the Monsanto/KWS petition for a full deregulation of event H7-1. APHIS expects to complete the EIS by May 2012, but unforeseen conditions may affect the specific completion date of the EIS. This interim partial deregulation of event H7-1 root crop and root production activities, along with the interim permitting of event H7-1 seed crop under 7 CFR part 340, will remain in effect through December 31, 2012, to allow the harvesting and processing of the 2012 commercial root crop and seed crop unless APHIS issues a final EIS, record of decision, and a determination decision for a full deregulation of event H7-1 sugar beets before those harvests are completed in 2012.

Copies of the signed determination document, as well as copies of the petition, pest risk assessment, EA, finding of no significant impact, and response to comments are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

Done in Washington, DC, this 4th day of February 2011.

Cindy J. Smith,

Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  To review the notice and the supporting and related material, go to http://www.regulations.gov;​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2010-0047.