Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance: Monsanto Co.
Federal Register: July 24, 2008 (Volume 73, Number 143)
Notices
Page 43202-43203
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr24jy08-38
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
Docket No. APHIS-2007-0030
Monsanto Company; Availability of Determination of Nonregulated
Status for Corn Genetically Engineered for Insect Resistance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
SUMMARY: We are advising the public of our determination that a corn line developed by the Monsanto Company, designated as transformation event MON 89034, which has been genetically engineered for insect resistance, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by the Monsanto Company 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 its associated environmental assessment. This notice also announces the availability of our written determination and our finding of no significant impact.
DATES: Effective Date: July 24, 2008.
ADDRESSES: You may read the petition, environmental assessment, determination, finding of no significant impact, the comments we received on our previous notice, and our responses to those 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 (202) 690-2817 before coming. Those documents may also be viewed on the Internet at http://www.regulations.gov/fdmspublic/ component/main?main=DocketDetail&d=APHIS-2007-0030.
FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0489, e-mail: robyn.i.rose@aphis.usda.gov. To obtain copies of the petition, environmental assessment, or the finding of no significant impact, contact Ms. Cindy Eck at (301) 734-0667, e- mail: cynthia.a.eck@aphis.usda.gov. To view those documents on the
Internet, go to http://www.aphis.usda.gov/brs/aphisdocs/06_29801p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/06_29801p_ea.pdf.
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 Sec. 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 Sec. 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 October 26, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS No. 06-298-01p) from the
Monsanto Company (Monsanto) of St. Louis, MO, for corn (Zea mays L.) designated as transformation event MON 89034, which has been genetically engineered for resistance to European corn borer and other lepidopteran pests, stating that corn line MON 89034 does not present a plant pest risk and, therefore, should not be a regulated article under
APHIS' regulations in 7 CFR part 340. Monsanto responded to APHIS' subsequent request for additional information and clarification and submitted an addendum to their petition on January 23, 2007.
Analysis
As described in the petition, corn transformation event MON 89034 has been genetically engineered to express the transgenes cry1A.105 and cry2Ab2, both of which were derived from a well-characterized gene sequence from Bacillus thuringiensis, and encode insect control proteins. The neomycin phosphotransferase II (nptII) gene was used as a selectable marker, but was eliminated by traditional breeding methods in the later stages of development of MON 89034. Thus, MON 89034 contains only the cry1A.105 and cry2Ab2 expression cassettes.
Expression of the transgenes by corn plants renders the corn line resistant to European corn borer, as well as other lepidopteran pests.
Regulatory elements for the transgenes were obtained from Agrobacterium tumefaciens. These regulatory sequences are not transcribed and do not encode proteins. The DNA was introduced into corn cells using
Agrobacterium-mediated transformation methodology with the T-DNA binary transformation vector designated PV ZMIR245.
In a notice \1\ published in the Federal Register on December 13, 2007 (72 FR 70817-70819, Docket No. APHIS-2007-0030), we announced our receipt of the Monsanto petition and solicited comments on whether MON 89034 corn is or could be a plant pest. In that notice, we also made available for public comment a draft environmental assessment we prepared to analyze any potential environmental effects associated with the proposed
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determination of nonregulated status for the MON 89034 corn event.
\1\ To view the notice, petition, environmental assessment, and the comments we received, go to http://www.regulations.gov/ fdmspublic/component/main?main=DocketDetail&d=APHIS-2007-0030.
We received 29 comments by the close of the 60-day comment period, which ended on February 11, 2008. There were 5 comments submitted in support of the petition to grant nonregulated status to MON 89034 corn and 24 that were opposed. APHIS' responses to these comments can be found as an attachment to the finding of no significant impact.
Determination
Based on APHIS' analysis of field, greenhouse and laboratory data submitted by Monsanto, references provided in the petition, other relevant information described in the environmental assessment, and comments provided by the public, APHIS has determined that MON 89034 will not pose a plant pest risk for the following reasons: (1) Gene introgression from MON 89034 corn into wild relatives in the United
States and its territories is extremely unlikely and is not likely to increase the weediness potential of any resulting progeny or adversely affect genetic diversity of related plants any more than would introgression from traditional corn hybrids; (2) it exhibits no characteristics that would cause it to be more weedy than the non- genetically engineered parent corn line or other cultivated corn; (3) it does not pose a risk to non-target organisms, including beneficial organisms and threatened or endangered species, because the insecticidal activity of the Cry1A.105 and Cry2Ab2 proteins are limited to lepidopteran target pest species; (4) it does not pose a threat to biodiversity as it does not exhibit traits that increase its weediness and its unconfined cultivation should not lead to increased weediness of other cultivated corn, it exhibits no changes in disease susceptibility, and it is unlikely to harm non-target organisms common to the agricultural ecosystem or threatened or endangered species recognized by the U.S. Fish and Wildlife Service; (5) compared to current corn pest and weed management practices, cultivation of MON 89034 corn should not impact standard agricultural practices in corn cultivation and controlling volunteer corn any differently than any other deregulated corn line expressing Cry proteins. Moreover, MON 89034 should not present any new or different impacts on organic farmers from those Bt corn lines that are currently cultivated; and (6) disease susceptibility and compositional profiles of MON 89034 corn are similar to those of its parent variety and other corn cultivars grown in the United States, therefore no direct or indirect plant pest effects on raw or processed plant commodities are expected.
In conclusion, APHIS has determined that there will be no effect on the federally listed threatened or endangered species, species proposed for listing, or their designated or proposed critical habitat resulting from a determination of nonregulated status for MON 89034 and its progeny. APHIS also concludes that new varieties bred from MON 89034 corn are unlikely to exhibit new plant pest properties, i.e., properties substantially different from any observed for corn event MON 89034, or those observed for other corn varieties not considered regulated articles under 7 CFR part 340.
National Environmental Policy Act
An EA was prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the determination of nonregulated status for MON 89034. The 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). Based on that EA, and other pertinent scientific data, APHIS has reached a FONSI with regard to the determination that Monsanto corn line MON 89034 and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and FONSI 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 18th day of July 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
FR Doc. E8-16947 Filed 7-23-08; 8:45 am
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