GM Crop Database

Database Product Description

MON863 x MON810 (MON-ØØ863-5 x MON-ØØ81Ø-6)

Host Organism

Zea mays (Maize)

Trait

Insect resistant, Coleoptera; Insect resistant, Lepidoptera.

Trait Introduction

Traditional plant breeding and selection

Proposed Use

Production for human consumption and livestock feed.

Product Developer

Monsanto Company

Summary of Regulatory Approvals

Introduction Expand

This stacked maize hybrid is a product of traditional plant breeding, and is therefore not automatically subject to regulation in all countries, unlike transgenic plants resulting from recombinant-DNA technologies. The approvals table above does not include entries from these countries. Other countries may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment, and these countries’ decisions are reflected in the approvals table.

Summary of Introduced Genetic Elements Expand

Code	Name	Type	Promoter, other	Terminator	Copies	Form
nptII	neomycin phosphotransferase II	SM	CaMV 35S	A. tumefaciens nopaline synthase (nos) 3'-untranslated region	1	The nptII cassette also contains 153 bp portion of bleomycin binding protein gene
cry3Bb1	cry3Bb1 delta-endotoxin	IR	4-AS1 (single CaMV 35S plus four repeats of activating sequence) 5' untranslated leader sequence from wheat chlorphyll a/b binding protein, and rice actin intron	3' untranslated sequence of wheat heat shock protein 17.3 (tahsp17)	1	Addition of alanine residue at position 2 of protein
cry1Ab	Cry1Ab delta-endotoxin (Btk HD-1)	IR	enhanced CaMV 35S, maize HSP70 intron	None. Lost through 3' truncation during integration	1	Truncated

Characteristics of Zea mays (Maize) Expand

Center of Origin	Reproduction	Toxins	Allergenicity
Mesoamerican region, now Mexico and Central America	Cross-pollination via wind-borne pollen is limited, pollen viability is about 30 minutes. Hybridization reported with teosinte species and rarely with members of the genus Tripsacum.	No endogenous toxins or significant levels of antinutritional factors.	Although some reported cases of maize allergy, protein(s) responsible have not been identified.

Donor Organism Characteristics Expand

Latin Name	Gene	Pathogenicity
Bacillus thuringiensis subsp. kumamotoensis	cry3Bb1	While coleopterans are susceptible to oral doses of Cry3Bb1 protein, there is no evidence of toxic effects in laboratory mammals or birds. There are no significant mammalian toxins or allergens associated with the host organism.
Bacillus thuringiensis subsp. kurstaki	EC2.4.2.19	While target insects are susceptible to oral doses of Bt proteins, no evidence of toxic effects in laboratory mammals or birds given up to 10 µg protein/g body weight.

Modification Method Expand

Coming soon. 

Characteristics of the Modification Expand

Coming soon. 

Environmental Safety Considerations Expand

Coming soon.

Food and/or Feed Safety Considerations Expand

Coming soon.

Abstract Collapse

MON863 X MON810 (OECD identifier: MON-ØØ863-5 x MON-ØØ81Ø-6) maize is an F1 hybrid resulting from the hybridization of two insect-resistant maize lines: MON863 (OECD identifier: MON-ØØ863-5) which is resistant to coleopterans, such as the Corn Rootworm, and MON810 (OECD identifier: MON-ØØ81Ø-6), which is resistant to lepidopterans, such as the European Corn Borer. This stacked maize hybrid is a product of traditional plant breeding, and therefore is not automatically subject to regulation in all jurisdictions as are transgenic plants resulting from recombinant DNA technologies. Certain jurisdictions may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment. Examples of jurisdictions that require either notification or information about stacked hybrids prior to their release into the environment, and for use in human food and livestock feed are Canada and Japan.

The stacked hybrid MON863 X MON810 expresses two novel insecticidal proteins: Cry3Bb1, a delta-endotoxin which confers resistance to coleopterans, and the delta-endotoxin Cry1Ab which confers resistance to the lepidopterans. Cry3Bb1 is produced by the cry3Bb1 gene from MON863, and Cry1Ab, by the cry1Ab gene from MON810. The novel traits of each parent line have been combined, through traditional plant breeding, to produce this new hybrid. For a full description of each parent line please refer to the individual product descriptions in the crop database for MON863 and MON810.
The inserted genes and their gene products have a history of safe use, and have undergone review and approval by several regulatory agencies. No interactions among the gene products or negative synergistic effects are expected in the stacked hybrid. Neither Cry1Ab, nor Cry3Bb1 are enzymes and therefore have no effect on plant metabolism. These Cry proteins are therefore not expected to interact within, nor affect the metabolism of the stacked hybrid.
Studies were conducted to compare the resistance to coleopterans and lepidopterans in the stacked hybrid and each parental line. There were no statistically significant differences in the levels of resistance to the target insects between the stacked hybrid and either of the parental lines. Non-target insects that were found to be unaffected by the insecticidal proteins in MON863 and MON810 were also unaffected by the combination of the proteins in the stacked hybrid. Thus, the hybridization of MON863 and MON810 did not affect the expression levels of the cry1Ab and cry3Bb genes, and there was no observed synergistic effect of simultaneous exposure to both proteins.
Heterosis is expected in F1 hybrids. An example of heterosis is a substantial increase in yield in the F1 hybrid compared to the parental lines. The stacked hybrid MON863 X MON810 is therefore expected to display heterosis, as would any conventional F1 hybrid. Heterosis in this hybrid is not expected to be caused by the introduced genes, since the gene products are not expected to affect plant metabolism, or interact synergistically.

Links to Further Information Expand

European Commission

• COMMISSION DECISION of 16 January 2006 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., hybrid MON 863 × MON 810) genetically modified for resistance to corn rootworm and certain lepidopteran pests of maize
  [PDF Size: 47.25K bytes]

European Commission: Community Register of GM Food and Feed

• Notification of the placing on the Community Register of MON-ØØ863-5 x MON-ØØ81Ø-6.
  [PDF Size: 14.07K bytes]

European Food Safety Authority

• Opinion of the Scientific Panel on Genetically Modified Organisms on an application (Reference EFSA-GMO-DE-2004-03) for the placing on the market of insect-protected genetically modified maize MON 863 x MON 810, for food and feed use, under Regulation (EC) No 1829/2003 from Monsanto (Question No EFSA-Q-2004-112). Opinion adopted on 8 June 2005
  [PDF Size: 255.94K bytes]

Japanese Biosafety Clearing House, Ministry of Environment

• Outline of the Biological Diversity Risk Assessment Report: Type 1 Use for MON-00863-5 x MON-00810-6 insect resistant maize
  [PDF Size: 154.98K bytes]

Philippines Department of Agriculture, Bureau of Plant Industry

• Determination of the Safety of Monsanto’s Combined Trait Product Corn: MON810 x MON863 for Direct use as Food, Feed, and Processing
  [PDF Size: 27.19K bytes]

U.K. Advisory Committee on Releases to the Environment

• Advice on a notification for marketing of insect resistant maize (MON863 and MON863 x MON810)
  [PDF Size: 82.99K bytes]

U.K. Department for Environment, Food and Rural Affairs

• Comments or objections to the placing on the market of a GMO under Part C of Directive 2001/18/EC (Article 15): Insect resistant maize (MON863 and MON863 x MON810)
  [PDF Size: 19.25K bytes]

This record was last modified on Monday, May 8, 2017