Regulating the Environmental Release of Stacked Plant Products in Canada

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Before a plant with novel trait (PNT) can be grown in the Canadian environment, its developer must notify the CFIA's Plant Biosafety Office (PBO) and receive an explicit authorization. A decision to authorize a PNT is based on a rigorous, science-based environmental safety assessment (food safety and feed safety assessments are also required, depending on the plant's intended use). A database of authorized PNTs is available.

Environmental safety assessments of PNTs require that information be provided to demonstrate that the novel trait is stably inherited and that it has not caused unintended effects on the agronomy or composition of the plant. Another requirement is an analysis of any potential impacts of gene flow, i.e. crossing of the PNT with other plants that may occur once the PNT is released.

Based on the assessment of these and other factors Footnote 1, the authorization of a PNT for unconfined environmental release includes a permission to cross the PNT with other plants to develop new varieties. This way, plant breeders are free to introduce a novel trait into different varieties of a crop that are adapted to meet the needs of farmers. Similarly to these new varieties, many stacked products, defined in Canada as plant lines developed by conventional crossing of two or more authorized PNTs, do not require further assessment of their environmental safety. However, as a precaution, the PBO requires notification of all stacked products before they are introduced into the marketplace.

These notifications are required so that regulators may determine if:

  • any conditions of authorization placed on the parental PNTs are compatible and appropriate for the stacked plant product
  • additional information is required to assess the safety of the stacked plant product

Additional information and further assessment will be required if:

  • the conditions of authorization of the parental PNTs would not apply to the stack (for example, a product developer is applying for alterations to stewardship requirements, or the conditions described in the stewardship plans of parental PNTs are no longer effective for the stack)
  • the novel traits of the parental PNTs are expressed differently in the stacked plant product (e.g. greater or lower expression)
  • the stacked product expresses an additional novel trait

Table Footnote 2 of Stacked Plant Products Authorized for Unconfined Release into the Canadian Environment

Crop Name of the authorized stacked product LMO-status Table Note 3 OECD Unique Identifier Table Note 4 Stacked traits Date of authorization
Alfalfa KK179 × J101 LMO MON-ØØ179-5 × MON- 00101-8 Reduced lignin;
Herbicide tolerance
2014-10-27
Canola GT73 × RF3 LMO MON-00073-7 × ACS-BNØØ3-6 Fertility restoration;
Herbicide tolerance
2008-05-09
Canola MON 88302 × RF3 LMO MON-88302-9 × ACS-BNØØ3-6 Fertility restoration;
Herbicide tolerance
2014-01-31
Canola 73496 × RF3 LMO DP-073496-4 × ACS-BNØØ3-6 Fertility restoration;
Herbicide tolerance
2016-04-21
Corn MON810 × NK 603 LMO MON-00810-6 × MON-00603-6 Insect resistance;
Herbicide tolerance
2001-06-11
Corn MON810 × MON 863 LMO MON-00810-6 × MON-00863-5 Insect resistance 2003-09-04
Corn MON 863 × NK 603 LMO MON-00863-5 × MON-00603-6 Insect resistance;
Herbicide tolerance
2003-09-04
Corn MON810 × MON 863 × NK 603 LMO MON-00810-6 × MON-00863-5 × MON-00603-6 Insect resistance;
Herbicide tolerance
2004-06-17
Corn Bt11 × GA21 LMO SYN-BT011-1 × MON-00021-9 Insect resistance;
Herbicide tolerance
2005-05-06
Corn DAS 59122 × NK 603 LMO DAS-59122-7 × MON-603-6 Insect resistance;
Herbicide tolerance
2005-12-06
Corn TC 1507 × DAS 59122 × NK 603 LMO DAS-01507-1 × DAS-59122-7 × MON-00603-6 Insect resistance;
Herbicide tolerance
2006-01-19
Corn TC 1507 × DAS 59122 LMO DAS-01507-1 × DAS-59122-7 Insect resistance;
Herbicide tolerance
2006-01-19
Corn TC 1507 × NK 603 LMO DAS-01507-1 × MON-00603-6 Insect resistance;
Herbicide tolerance
2006-01-19
Corn MON810 × MON 88017 LMO MON-00810-6 × MON-88017-3 Insect resistance;
Herbicide tolerance
2006-03-01
Corn TUSC1× NK 603 LMO N/A × MON-00603-6 Herbicide tolerance 2007-05-24
Corn TUSC1 × NK 603 × TC 1507 LMO N/A × MON-00603-6 × DAS-01507-1 Insect resistance;
Herbicide tolerance
2007-05-24
Corn MIR 604 × Bt11 LMO SYN-IR604-5 × SYN-BT011-1 Insect resistance 2007-08-16
Corn MIR 604 × GA21 LMO SYN-IR604-5 × MON-00021-9 Insect resistance; Herbicide tolerance 2007-08-16
Corn MIR 604 × Bt11 × GA21 LMO SYN-IR604-5 × SYN-BT011-1 × MON-00021-9 Insect resistance;
Herbicide tolerance
2007-08-16
Corn MIR 604 × T25 LMO SYN-IR604-5 × ACS-ZM003-2 Insect resistance;
Herbicide tolerance
2007-08-16
Corn MON 89034 × MON 88017 LMO MON-89034-3 × MON-88017-3 Insect resistance;
Herbicide tolerance
2008-08-18
Corn MON 89034 × NK 603 LMO MON-89034-3 × MON-00603-6 Insect resistance; Herbicide tolerance 2008-08-18
Corn MON 89034 × TC 1507 × MON 88017 × DAS 59122 LMO MON-89034-3 × DAS-01507-1 × MON-88017-3 × DAS-59122-7 Insect resistance;
Herbicide tolerance
2009-07-17
This product was authorized with new stewardship conditions.
Corn Bt11 × DAS 59122 × MIR 604 × TC 1507 × GA21 LMO SYN-BT011-1 × DAS-59122-7 × SYN-IR604-5 × DAS-01507-1 × MON-00021-9 × SYN-IR162-4 Insect resistance;
Herbicide tolerance
2010-04-08
This product was authorized with new stewardship conditions.
Corn NK 603 × T25 LMO MON-00603-6 × ACS-ZM003-2 Herbicide tolerance 2010-03-09
Corn MON 89034 × TC 1507 × NK 603 LMO MON-89034-3 × DAS-01507-1 × MON-00603-6 Insect resistance; Herbicide Tolerance 2010-03-17
Corn NK 603 × TC 1507 × MON 810 × DAS 59122 LMO MON-00603-6 × DAS-01507-1 × MON-00810-6 × DAS-59122-7 Insect resistance; Herbicide tolerance 2010-08-13
Corn Bt11 × TC 1507 × GA21 × MIR 162 LMO SYN-BT011-1 × DAS-01507-1 × MON-00021-9 × SYN-IR162-4 Insect resistance;
Herbicide tolerance
2010-08-31
This product was authorized with new stewardship conditions.
Corn Bt11 × MIR 604 × GA21 × MIR 162 LMO SYN-BT011-1 × SYN-IR604-5 × MON-00021-9 × SYN-IR162-4 Insect resistance;
Herbicide tolerance
2010-08-31
Corn Bt11 × GA21 × MIR 162 LMO SYN-BT011-1 × MON-00021-9 × SYN-IR162-4 Insect resistance;
Herbicide tolerance
2010-08-31
Corn MON 89034 × TC 1507 LMO MON-89034-3 × DAS-01507-1 Insect resistance;
Herbicide tolerance
2010/11/19
Corn 3272 × Bt11 × MIR 604 × GA21 LMO SYN-E3272-5 × SYN-BT011-1 × SYN-IR604-5 × MON-00021-9 Insect resistance;
Herbicide tolerance
2010-12-13
Corn TC 1507 × MON 810 × NK 603 LMO DAS-01507-1 × MON-00810-6 × MON-00603-6 Insect resistance; Herbicide tolerance 2011-01-17
This product was authorized with new stewardship conditions
Corn MON 89034 × MON 88017 LMO MON-89034-3 × MON-88071-3 Insect resistance;
Herbicide tolerance
2011/01/24
Corn NK 603 × TC 1507 × MIR 604 LMO MON-00603-6 × DAS-01507-1 × SYN-IR604-5 Insect resistance; Herbicide tolerance 2011-05-24
Corn NK 603 × TC 1507 × MIR 604 × MON 810 × DAS 59122 LMO MON-00603-6 × DAS-01507-1 × SYN-IR604-5 × MON-00810-6 × DAS-59122-7 Insect resistance; Herbicide tolerance 2011-11-14
Corn MON 87460 × MON 89034 ×MON 88017 LMO MON-8746Ø-4 × MON-89034-3 × MON-88071-3 Insect resistance;
Drought tolerance;
Herbicide tolerance
2011-11-14
Corn NK 603 × TC 1507 × MON 810 × DAS 59122 × MIR 604 LMO MON-00603-6 × DAS-01507-1 × MON-00810-6 × DAS-59122-7 × SYN-IR604-5 Insect resistance;
Herbicide tolerance
2011-11-14
Corn MON 87460 × NK 603 LMO MON-8746Ø-4 × MON-00603-6 Drought tolerance;
Herbicide tolerance
2011-11-15
Corn MON 87460 × MON 89034 × NK 603 LMO MON-8746Ø-4 × MON-89034-3 × MON-00603-6 Insect resistance;
Drought tolerance;
Herbicide tolerance
2011-11-15
Corn NK 603 × TC 1507 × MON 810 × MIR 162 LMO MON-00603-6 × DAS-01507-1 × MON-00810-6 × SYN-IR162-4 Insect resistance;
Herbicide tolerance

2012-08-14

Corn DAS-40278 × MON 89034 × TC 1507 × MON 88017 × DAS 59122 LMO DAS-40278-9 × MON-89034-3 × DAS-01507-1 × MON-88071-3 × DAS-59122-7 Insect resistance;
Herbicide tolerance
2013-01-29
This product was authorized with new stewardship conditions.
Corn DAS-40278 × NK 603 LMO DAS-40278-9 × MON-00603-6 Herbicide tolerance 2013-01-29
Corn MON 87427 × MON 89034 × NK 603 LMO MON-87427-7 × MON-89034-3 × MON-00603-6 Insect resistance;
Herbicide tolerance
2013-03-25
Corn MON 87427 × MON 89034 × MON 88017 LMO MON-87427-7 × MON-89034-3 × MON-88071-3 Insect resistance;
Herbicide tolerance
2013-03-25
Corn MON 87427 × MON 89034 × TC 1507 × MON 88017 × DAS 59122 LMO MON-87427-7 × MON-89034-3 × DAS-01507-1 × MON-88071-3 × DAS-59122-7 Insect resistance;
Herbicide tolerance
2013-03-25
Corn Bt11 × MIR 604 × TC 1507 × 5307 × GA21 LMO SYN-BT011-1 × SYN-IR604-5 × DAS-01507-1 × SYN-Ø53Ø7-1 × MON-00021-9 Insect resistance;
Herbicide tolerance
2013-05-15
Corn Bt11 × MIR 162 × MIR 604 × TC 1507 × 5307 × GA21 LMO SYN-BT011-1 × SYN-IR162-4 × SYN-IR604-5 × DAS-01507-1 × SYN-Ø53Ø7-1 × MON-00021-9 Insect resistance;
Herbicide tolerance
2013-05-15
Corn NK 603 × MON 810 × 4114 × MIR 604 LMO MON-00603-6 × MON-00810-6 × DPØØ4114-3 × SYN-IR604-4 Insect resistance;
Herbicide tolerance
2013-12-20
Corn DAS 40278 × MON 89034 × TC 1507 × NK 603 LMO DAS 40278-9 × MON-89034-3 × DAS-01507-1 × MON-00603-6 Insect resistance;
Herbicide tolerance
2014-01-31
Corn GA21 × T25 LMO MON-00021-9 × ACS-ZM003-2 Herbicide tolerance 2014-05-30
Corn 3272 × Bt11 × MIR 604 × TC 1507 × 5307 × GA21 LMO SYN-E3272-5 × SYN-BT011-1 × SYN-IR604-5 × DAS-01507-1 × SYN-Ø53Ø7-1 × MON-00021-9 Insect resistance;
Herbicide tolerance
2014-10-27
Corn MON 87427 × MON 89034 × MIR 162 × NK 603 LMO MON-87427-7 × MON-89034-3 × SYN-IR162-4 × MON-00603-6 Insect resistance;
Herbicide tolerance
2015-08-19
Corn MON 87427 × MON 89034 × TC 1507 × MON 87411 × DAS 59122 LMO MON-87427-7 × MON-89034-3 × DAS-01507-1 × MON-87411-9 × DAS-59122-7 Insect resistance;
Herbicide tolerance
2016-05-03
Corn Bt11 × TC 1507 × GA21 LMO SYN-BT011-1 × DAS-01507-1 × MON-00021-9 Insect resistance;
Herbicide tolerance
2016-04-08
Corn MON 87460 × MON 87427 × MON 89034 × MIR 162 × NK 603 LMO MON-8746Ø-4 × MON-87427-7 × MON-89034-3 × SYN-IR162-4 × MON-00603-6 Insect resistance;
Herbicide tolerance
2016-06-24
Corn MON 87460 × MON 87427 × MON 89034 × TC 1507 × MON 87411 × DAS 59122 LMO MON-8746Ø-4 × MON-87427-7 × MON-89034-3 × DAS-01507-1 × MON-87411-9 × DAS-59122-7 Insect resistance;
Herbicide tolerance
2016-09-23
Corn MON 87427 × MON 89034 × MIR 162 × MON 87411 LMO MON-87427-7 × MON-89034-3 × SYN-IR162-4 × MON-87411-9 Insect resistance;
Herbicide tolerance
2016-09-23
Corn Bt11 × MIR 162 × MON 89034 × GA21 LMO SYN-BT011-1 × SYN-IR162-4 × MON-89034-3 × MON-00021-9 Insect resistance;
Herbicide tolerance
2016-11-18
Corn MON 89034 × MIR 162 LMO MON-89034-3 × SYN-IR162-4 Insect resistance 2016-12-23
Corn MON 89034 × MON 87411 × MON 87427 × TC 1507 × DAS 59122 × DAS 40278 LMO MON-89034-3 × MON-87411-9 × MON-87411-9 × DAS-01507-1 × DAS-59122-7 × DAS-40278-9 Insect resistance;
Herbicide tolerance
2017-03-06
Corn MON 89034 × TC 1507 × NK 603 × MIR 162 LMO MON-89034-3 × DAS-01507-1 × MON-00603-6 × SYN-IR162-4 Insect resistance;
Herbicide tolerance
2017-03-06
Corn Bt11 × MIR 162 × MIR 604 × MON 89034 × 5307 × GA21 LMO SYN-BT011-1 × SYN-IR162-4 × SYN-IR604-5 × MON-89034-3 × SYN-Ø53Ø7-1 × MON-00021-9 Insect resistance;
Herbicide tolerance
2017-04-07
Soybean DP 305423 × GTS 40-3-2 LMO DP-305423-1 × MON-04032-6 Modified fatty acid profile;
Herbicide Tolerance
2009-07-23
Soybean MON 87705 × MON 89788 LMO MON-87705-6 × MON-89788-1 Modified fatty acid profile;
Herbicide Tolerance
2011-11-29
Soybean MON 87769 × MON 89788 LMO MON-87769-7 × MON-89788-1 Modified fatty acid profile;
Herbicide Tolerance
2011-11-29
Soybean MON 87708 × MON 89788 LMO MON-87708-9 × MON-89788-1 Herbicide Tolerance 2012-12-27
Soybean DAS-68416-4 × MON 89788 LMO DAS-68416-4 × MON-89788-1 Herbicide Tolerance 2013-03-25
Soybean MON 87751 × MON 87701 × MON 89788 LMO MON-87751-7 × MON-87701-2 × MON-89788-1 Insect resistance; Herbicide Tolerance 2015-04-20
Soybean MON 87751 × MON 87701 × MON 87708 × MON 89788 LMO MON-87751-7 × MON-87701-2 × MON-87708-9 × MON-89788-1 Insect resistance; Herbicide Tolerance 2015-04-20
Soybean FG72 × LL55 LMO MST-FG072-2 × ACS-GM005-3 Herbicide Tolerance 2015-07-24
Soybean MON 87705 × MON 87708 × MON 89788 LMO MON-87705-6 × MON-87708-9 × MON-89788-1 Modified fatty acid profile;
Herbicide Tolerance
2015-09-29
Soybean MON 89788 × MON 87708 × A5547-127 LMO MON-89788-1 × MON-89788-1 × ACS-GM006-4 Insect resistance;
Herbicide Tolerance
2016-11-04
Wheat

ALS1 × ALS2
ALS1

(DD1999-31; DD2004-47; DD2007-66)
ALS2

(DD2003-44; DD2004-48; DD2006-63)

Non-LMO N/A Herbicide tolerance 2007-05-25
Wheat

ALS1 × ALS3
ALS1

(DD1999-31; DD2004-47; DD2007-66
ALS3
(DD2006-60, DD2007-64)

Non-LMO N/A Herbicide tolerance 2007-05-29

Footnotes

Footnote 1

The criteria for the environmental safety assessment of PNTs are described in Directive 94-08: Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.

Return to Footnote 1 referrer

Footnote 2

The information presented in this table may not be complete, as confidential business information (CBI) may be withheld upon written request of the proponent. The dissemination of potential CBI is subject to Access to Information legislation.

Return to Footnote 2 referrer

Table Note 3

Living Modified Organism (LMO): is defined by the Cartegena Protocol on Biosafety to the Convention on biological Diversity as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology.

  • "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids.
  • "Modern biotechnology" means the application of:
    • In vitro nucleic techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
    • Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.

Return to Table Note 3 referrer

Table Note 4

OECD Unique Identifier: The Organization for Economic Co-operation and Development's (OECD) Working Group on Harmonization of Regulatory Oversight in Biotechnology has developed guidance for a unique identifier for transgenic plants. The purpose is for the use as a "key" to access information in OECD's database of products of modern biotechnology which have been approved for commercial application. (N/A denotes Not-applicable). For more information see: OECD Environmental Directorate, Environment, Health and Safety Division, 2 rue Andre-Pascal, 75775 Paris Cedex 16, France

Return to Table Note 4 referrer

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