Monsanto Company; Availability of Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance and Glyphosate Tolerance

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public of our determination that the Monsanto corn line designated as transformation event MON 88017, which has been genetically engineered for resistance to a corn rootworm complex and for tolerance to the herbicide glyphosate, 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 Monsanto 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 an environmental assessment. This notice also announces the availability of our written determination and our finding of no significant impact.

DATES:

Effective Date: December 14, 2005.

ADDRESSES:

You may read the petition, the environmental assessment, the determination, the finding of no significant impact, and the comments that we received on Docket No. 04-114-1 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.

FOR FURTHER INFORMATION CONTACT:

Dr. Robyn Rose, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0489. To obtain copies of the petition, EA, determination, FONSI, or response to comments, contact Ms. Ingrid Berlanger at (301) 734-4885; e-mail: Ingrid.E.Berlanger@aphis.usda.gov. The petition and the draft environmental assessment (EA) and the final EA with the determination, finding of no significant impact, and response to comments are also available on the Internet at: http://www.aphis.usda.gov/brs/aphisdocs/04_12501p.pdf,, http://www.aphis.usda.gov/brs/aphisdocs/04_12501p_pea.pdf,, and http://www.aphis.usda.gov/brs/aphisdocs2/04_12501p_com.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 § 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 § 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 May 4, 2004, APHIS received a petition (APHIS Petition Number 04-125-01p) from Monsanto Company (Monsanto) of St. Louis, MO, requesting a determination of nonregulated status under 7 CFR part 340 for corn (Zea mays L.) designated as transformation event MON 88017 which has been genetically engineered for resistance to corn rootworm and for tolerance to the herbicide glyphosate. The Monsanto petition states that the subject corn should not be regulated by APHIS because it does not present a plant pest risk.

In a notice published in the Federal Register on August 12, 2005 (70 FR 47168-47169, Docket No. 04-114-1), APHIS announced the availability of the Monsanto petition and an environmental assessment (EA). APHIS solicited comments on whether the subject corn would present a plant pest risk and on the EA. The August 2005 notice also discussed the role of APHIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) in regulating the subject corn and products developed from it.

APHIS received 19 comments by the close of the 60-day comment period, which ended on October 11, 2005. Comments were submitted by university professionals, growers associations, and private individuals. Eight comments supported granting nonregulated status to corn line MON 88017. These comments cited corn rootworm as a significant problem and supported the use of technologies to help combat the problem. One commenter submitted a request to “treat MON 88017 with suspicion until proven otherwise [safe],” but provided no basis for the concern and neither requested the petition be approved nor denied. Ten comments were opposed to the action. Several of those comments reflected a general disapproval of genetically engineered crops. Several other comments cited the similarity of MON 88017 to MON 863 and cited an article that reviewed the acute toxicology studies commissioned by European Food Safety Agency and did not address a plant-pest risk. APHIS conferred with both FDA and EPA about the results of that study. The response to these comments can be found in an attachment to the finding of no significant impact (FONSI).

APHIS has amended the EA. A list of changes is included as an attachment to the EA. The changes correct typographical errors and provide clarity to the reader; these changes are not substantive and do not change the analysis described in the EA.

As described in the petition, event MON 88017 corn has been genetically engineered to express a Cry3Bb1 insecticidal protein derived from Bacillus thuringiensis (Bt) subspecies kumamotoensis strain EG4691. This gene has been modified to encode six specific amino acid substitutions when compared to strain EG4691. Cry3Bb1 expression is regulated by the enhanced 35S promoter (e35S) from cauliflower mosaic virus, the rice actin intron (ract1 intron), 5′ leader sequence from wheat chlorophyll a/b-binding protein (wt CAB), and the 3′ nontranslated region of the 17.3 kDa heat shock protein from wheat. Event MON 88017 has also been genetically engineered to express a 5-enolpyruvylshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide glyphosate. Expression of cp4 epsps is regulated by the rice actin 1 (ract1) 5′ untranslated region containing the promoter and first intron and nopaline synthase 3′ polyadenylation signal (NOS 3′) from Agrobacterium tumefaciens. A construct containing both genes was delivered to the recipient corn variety, A xHi-II, through Agrobacterium-mediated gene transfer. The petitioner states that the Cry3Bb1 protein expressed in MON 88017 is 99.8 percent identical to the Cry3Bb1 protein expressed in nonregulated corn line MON 863. The CP4 EPSPS protein is identical to corn line NK603.

Determination

Based on its analysis of the data submitted by Monsanto, a review of other scientific data, field tests of the subject corn, and the comments submitted by the public, APHIS has determined that corn line MON 88017 is no longer a regulated article under APHIS' regulations at 7 CFR part 340 for the following reasons: (1) It exhibits no plant pathogenic properties (although a plant pathogen was used in the development of this corn, these plants are not infected by this organism, nor do they contain genetic material from this pathogen that can cause plant disease); (2) it exhibits no characteristics that would cause it to be weedier than the nontransgenic parent corn line or other cultivated corn; (3) gene introgression from MON 88017 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 nor adversely affect genetic diversity of related plants any more than would introgression from traditional corn hybrids; (4) disease and susceptibility and compositional profiles of the plants of MON 88017 are similar to those of its parent variety and other corn cultivars grown in the United States; therefore, no direct or indirect plant pest effect on raw or processed plant commodities is expected; (5) field observations, compositional analyses, and data on the safety of the engineered EPSPS and Cry3Bb1 proteins all indicate that MON 88017 should not have greater potential than other cultivated corn to damage or harm organisms beneficial to agriculture; (6) compared to current corn pest and weed management practices, cultivation of MON 88017 should not reduce the ability to control pests and weeds in corn or other crops. In addition to our finding of no plant pest risk, there will be no effect on the threatened or endangered species resulting from a determination of nonregulated status for MON 88017 and its progeny.

Therefore, APHIS has concluded that the subject corn and any progeny derived from hybrid crosses with other nontransformed corn varieties will be as safe to grow as corn varieties in traditional breeding programs that are not subject to regulation under 7 CFR part 340. The effect of this determination is that Monsanto corn line MON 88017 is no longer considered a regulated article under APHIS' regulations in 7 CFR part 340.

Therefore, the requirements pertaining to regulated articles under those regulations no longer apply to the subject corn or its progeny. However, the importation of corn line MON 88017 and seeds capable of propagation is still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319 and imported seed regulations in 7 CFR part 361.

National Environmental Policy Act

An EA was prepared to examine any potential environmental impacts and plant pest risk associated with the determination of nonregulated status for the Monsanto corn line MON 88017. 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, APHIS has reached a FONSI with regard to the determination that Monsanto corn line MON 88017 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 from the individual listed under FOR FURTHER INFORMATION CONTACT.

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