GM Crop Database

Database Product Description

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
pat	phosphinothricin N-acetyltransferase	HT	CaMV 35S	CaMV 35S poly(A) signal	3 or 1*	Modified for enhanced expression; PEG mediated uptake into plant protoplasts; 3 copies in T14, 1 copy in T25
bla	beta lactamase	SM	bacterial promoter			Truncated beta-lactamase gene missing about 25 % of the gene from the 5' end; not expressed
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
Streptomyces viridochromogenes	pat	S. viridochromogenes is ubiquitous in the soil. It exhibits very slight antimicrobial activity, is inhibited by streptomycin, and there have been no reports of adverse affects on humans, animals, or plants.
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

T25 X MON810 (OECD identifier: ACS-ZMØØ3-2 X MON-ØØ81Ø-6) maize is an F1 hybrid resulting from the hybridization of the herbicide-tolerant maize inbred T25 (ACS-ZMØØ3-2) with the insect-resistant inbred maize MON810 (MON-ØØ81Ø-6). 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 T25 X MON810 expresses two novel proteins: the PAT protein which confers tolerance to the herbicide glufosinate ammonium, and the delta-endotoxin Cry1Ab which confers resistance to the European Corn Borer and other lepidopterans, The PAT protein is produced by the pat gene from T25, and the insecticidal protein is produced by the cry1Ab from MON810. The novel traits of each parental line have been combined, through traditional plant breeding, to produce this new hybrid. For a full description of each parental line please refer to the individual product descriptions in the crop database for T25 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. The Cry1Ab protein is not an enzyme and therefore does not affect plant metabolism. The PAT protein has a high affinity for L-Phosphinothricin, the active ingredient in the herbicide glufosinate ammonium. Cry1Ab and PAT are not expected to interact within, nor affect the metabolism of the stacked hybrid.
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 G21 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 interact synergistically.

Links to Further Information Expand

Japanese Biosafety Clearing House, Ministry of Environment

• Outline of the biological diversity risk assessment report: Type 1 use approval for T25 x MON810
  [PDF Size: 162.43K bytes]

This record was last modified on Friday, June 9, 2017