DD2023-142: Determination of the safety of Bioriginal Food and Science Corp.'s borage (Borago officinalis L.) lines ST-1 and ST-2

May 18, 2023

This decision document has been prepared to explain the regulatory decision reached under the Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits, and its companion document BIO2023-02 - The Biology of Borago officinalis L. (Borage).

The Canadian Food Inspection Agency (CFIA) has evaluated information submitted by Bioriginal Food and Science Corp. This information concerns the herbicide tolerant borage lines ST-1 and ST-2, developed through chemical mutagenesis and conventional breeding. Foods and feeds derived from these lines are not novel. The CFIA has determined that these plants with novel traits (PNTs) do not present an altered environmental risk when compared to borage varieties currently grown in Canada when an herbicide tolerance management plan is implemented. Unconfined release into the environment of borage lines ST-1 and ST-2 is authorized as of May 18, 2023, subject to the provisions outlined in this decision document.

On this page

• 1. Brief identification of the modified plant
• 2. Background information
• 3. Criteria for the environmental assessment
  • 3.1 Potential for borage lines ST-1 and ST-2 to become a weed of agriculture or be invasive of natural habitats
  • 3.2 Potential for gene flow from borage lines ST-1 and ST-2 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive
  • 3.3 Potential for borage lines ST-1 and ST-2 to become a plant pest
  • 3.4 Potential impact of borage line ST-1 and ST-2 or its gene products on non-target organisms, including humans
  • 3.5 Potential impact of borage line ST-1 and ST-2 on biodiversity
• 4. New information requirements
• 5. Regulatory decision

1. Brief identification of the modified plant

Designation or identifier: Borage lines ST-1 and ST-2

Applicant: Bioriginal Food and Science Corp.

Plant species: Borage, Borago officinalis L.

Novel trait: Tolerance to imidazolinone herbicides

Trait introduction method: Chemical mutagenesis and conventional breeding

Intended end use: Borage lines ST-1 and ST-2 will be grown under contract production as a source of oil high in gamma-linolenic acid.

Intended area of cultivation: Borage lines ST-1 and ST-2 are intended to be grown within the typical production area for borage in Canada.

2. Background information and description of the novel trait

Bioriginal Food and Science Corp. has developed borage lines that are tolerant to imidazolinone herbicides. Imidazolinone herbicides block the normal function of acetohydroxyacid synthase (AHAS) enzymes, resulting in a decrease in protein synthesis that leads to the death of the plant. AHAS is an enzyme found in bacteria, certain other micro-organisms, and plants. This enzyme catalyses the first step in the biosynthesis of the branched chain amino acids valine, leucine, and isoleucine. AHAS enzymes are also referred to as acetolactate synthase (ALS) enzymes.

Borage line ST-1 was developed using chemical mutagenesis to introduce a single nucleotide mutation to the ahas1 gene, causing a single amino acid substitution of serine to asparagine at position 651 of the AHAS1 enzyme. Borage line ST-2 was identified in a field as an individual borage plant with a spontaneous mutation that provided tolerance to imidazolinone herbicides. Borage line ST-2 has a single nucleotide mutation in the ahas2 gene, causing an amino acid substitution of serine to asparagine at position 647 of the AHAS2 enzyme.

Unmodified borage is not tolerant to imidazolinone herbicides. The amino acid substitutions in borage lines ST-1 and ST-2 prevent binding of imidazolinone herbicides to the AHAS enzymes, and therefore confer tolerance to these herbicides.

Bioriginal Food and Science Corp. provided:

• information on the identity of borage lines ST-1 and ST-2
• a description of the modified genes
• information on the impact of imidazolinone-tolerant borage on the Canadian environment compared to non-modified borage, and
• a herbicide tolerance management plan

3. Criteria for the environmental assessment

The Plant Biotechnology Risk Assessment (PBRA) Unit of the Plant Health Science Directorate has reviewed information provided by Bioriginal Food and Science Corp, as described in the Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits. The PBRA unit has considered:

• the potential for borage lines ST-1 and ST-2 to become a weed of agriculture or to be invasive of natural habitats
• the potential for gene flow from borage lines ST-1 and ST-2 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive
• the potential for borage lines ST-1 and ST-2 to become a plant pest
• the potential impact of borage lines ST-1 and ST-2 and their gene products on non-target organisms, including humans, and
• the potential impact of borage lines ST-1 and ST-2 on biodiversity

In lieu of data from field trials, the CFIA used information on the biology of borage, scientific rationales developed by Bioriginal Food and Science Corp., and conclusions from previous assessments of imidazolinone-tolerant plants including wheat, rice, sunflower and corn to inform the environmental assessment of borage lines ST-1 and ST-2.

3.1. Potential for borage lines ST-1 and ST-2 to become a weed of agriculture or be invasive of natural habitats

As indicated in BIO2023-02 – The Biology of Borago Officinalis (L.) (Borage), borage does not invade unmanaged habitats in Canada. The CFIA has previously assessed data from agronomic field trials and seed dormancy tests conducted on imidazolinone-tolerant crops including:

• wheat
  • DD2004-48
  • DD2006-60
  • DD2006-63
  • DD2007-64
• rice
  • DD2002-40
  • DD2002-42
  • DD2006-62
• sunflower
  • DD2005-50
  • DD2010-80
• corn
  • DD1998-29

Borage plants can grow as volunteers in cultivated fields in the seasons following a borage crop, but they are readily eliminated by soil cultivation or the use of herbicides. Plants of borage lines ST-1 and ST-2 growing as volunteers will not be controlled if imidazolinone herbicides are used as the only weed control tool. However, control of borage lines ST-1 and ST-2 as a volunteer weed in subsequent crops or in fallow ground can be achieved by the use of other classes of herbicides or by mechanical means.

The CFIA considers the changes in usual agronomic practices that may arise from volunteer plants with novel herbicide tolerances. To address this issue, a herbicide tolerance management plan which includes sustainable volunteer management strategies should be implemented. Bioriginal Food and Science Corp. has submitted a herbicide tolerance management plan to the CFIA, which was determined to be satisfactory for the management of volunteer borage when evaluated by the PBRA Unit.

The CFIA has therefore concluded that borage lines ST-1 and ST-2 have no altered weediness potential in Canada compared to currently grown borage varieties, when a herbicide tolerance management plan is implemented.

3.2. Potential for gene flow from borage lines ST-1 and ST-2 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive

Borage in not native to North America and is cultivated on a limited acreage in Canada. Borage can grow outside of cultivation in all Canadian provinces. However, borage is not reported as a problematic weed in managed ecosystems in Canada or anywhere in the world, nor it is recorded as being invasive of natural ecosystems. Borage may recur in the wild on a near-annual basis, usually close to agricultural cultivation or gardens where it was intentionally planted. Gene flow from borage lines ST-1 and ST-2 to other cultivated borage or wild borage is possible. Other species from the Boraginacae family are found in Canada and some are considered weeds. The ability and likelihood of B. officinalis to hybridize with these species has not been well studied. However, there are no reports of borage hybridizing with any of these species, in Canada or elsewhere. The potential for the introgression of genetic information from B. officinalis into other sexually compatible species is undetermined.

If imidazolinone-tolerant individuals arose through intraspecific or interspecific hybridization, the novel trait would confer no competitive advantage to these plants unless challenged by imidazolinone herbicides. This would only occur in managed ecosystems where an imidazolinone herbicide is used for weed control. These herbicide tolerant plants, should they arise, could be controlled using herbicides other than imidazolinone or by mechanical means. Hybrids, if they developed, could potentially result in the loss of imidazolinone herbicide as a tool to control these species. This, however, can be avoided by the use of sound crop management practices. Bioriginal Food and Science Corp.'s herbicide tolerance management plan for borage lines ST-1 and ST-2 contains suitable measures to minimize and manage outcrossing to sexually compatible plants.

Based on the above information, the CFIA has concluded that gene flow from borage lines ST-1 and ST-2 to sexually compatible plants is possible, but would not result in increased weediness or invasiveness of the resulting progeny when a herbicide tolerance management plan is implemented.

3.3. Potential for borage lines ST-1 and ST-2 to become a plant pest

Borage is not considered a plant pest in Canada and the imidazolinone-tolerance trait is unrelated to plant pest potential (that is, the potential for the plant to harbour new or increased populations of pathogens or pests).

Therefore, the CFIA has concluded that borage lines ST-1 and ST-2 are not expected to display altered plant pest potential compared to borage varieties that are currently grown in Canada.

3.4. Potential impact of borage lines ST-1 and ST-2 and its gene products on non-target organisms, including humans

The potential impacts on non-target organisms of the novel trait expressed by borage lines ST-1 and ST-2, as well as the proteins which confer the novel trait, were evaluated. The imidazolinone-tolerance trait is unrelated to potential toxicity of borage lines ST-1 and ST-2 to non-target organisms. The AHAS enzyme is not a known toxin or allergen and is commonly found in a wide variety of plants and micro-organisms with a history of safe use. The single amino acid changes within the AHAS1 and AHAS2 enzymes in borage lines ST-1 and ST-2 are not anticipated to modify the safety of the AHAS enzyme.

Based on the above, the CFIA has determined that the unconfined release of borage lines ST-1 and ST-2 in Canada will not result in altered impacts on non-target organisms, including humans, when compared to borage varieties that are currently grown in Canada.

3.5. Potential impact of borage lines ST-1 and ST-2 on biodiversity

Borage lines ST-1 and ST-2 have no novel phenotypic characteristics that would extend their geographic range beyond the current range of borage production in Canada. Borage lines ST-1 and ST-2 are unlikely to cause adverse effects on non-target organisms and are not expected to display increased invasiveness or plant pest potential compared to borage varieties currently grown in Canada, or increased weediness when a herbicide tolerance plan is implemented. Gene transfer from borage lines ST-1 and ST-2 to sexually compatible plants is possible, but would not result in increased weediness or invasiveness of the resulting progeny when a herbicide tolerance management plan is implemented.

Borage lines ST-1 and ST-2 have tolerance to imidazolinone herbicides. The use of these herbicides in cropping systems has the intended effect of reducing local weed populations within agro-ecosystems. This may result in a reduction in local weed species biodiversity, and may have effects on other trophic levels that utilize these weed species. It must be noted, however, that the goal of reduction in weed biodiversity in agricultural fields is not unique to the use of PNTs, borage lines ST-1 and ST-2, or the cultivation of borage. It is therefore unlikely that borage lines ST-1 and ST-2 will have any indirect effects on biodiversity, in comparison to the effects that would be expected from borage varieties that are currently grown in Canada.

The CFIA considered the potential that continued application of the same herbicide in subsequent rotations may lead to increased selection pressure for herbicide resistant weed populations. To address this, a herbicide tolerance management plan which includes integrated weed management strategies should be implemented. Bioriginal Food and Science Corp.'s herbicide tolerance management plan for borage lines ST-1 and ST-2 contains recommendations to minimize and manage the development of herbicide resistant weed populations. The herbicide tolerance management plan was determined to be satisfactory for controlling the development of herbicide tolerant weeds when evaluated by the PBRA Unit.

The CFIA has therefore concluded that the potential impact on biodiversity of borage lines ST-1 and ST-2 is unlikely to be different from that of the borage varieties that are currently grown in Canada, when a herbicide tolerance management plan is implemented.

4. New Information requirements

If at any time, Bioriginal Food and Science Corp. becomes aware of any new information regarding risk to the environment or human health, that could result from the unconfined environmental release of borage lines ST-1 and ST-2 or lines derived there from them, Bioriginal Food and Science Corp. is required to immediately provide such information to CFIA. On the basis of such new information, CFIA will re-evaluate the potential impact of borage lines ST-1 and ST-2 on the environment, and may re-evaluate its decision with respect to unconfined environmental release authorizations of borage lines ST-1 and ST-2.

5. Regulatory Decision

Environmental release

Based on the review of the data and information submitted by Bioriginal Food and Science Corp. and input from other relevant scientific sources, the Plant Biotechnology Risk Assessment Unit of the Plant Health Science Directorate has concluded that the unconfined environmental release of borage lines ST-1 and ST-2 does not present altered environmental risk when compared to borage varieties that are currently grown in Canada when a suitable herbicide tolerance management plan is implemented.

Bioriginal Food and Science Corp. submitted a herbicide tolerance management plan to the CFIA, which was determined to be satisfactory when evaluated by the PBRA Unit. As outlined in the plan, Bioriginal Food and Science Corp. will make this herbicide tolerance management plan readily available to growers and agronomists involved in the cultivation borage lines ST-1 and ST-2 to promote careful management practices. Bioriginal Food and Science Corp. will provide an efficient mechanism for growers to report agronomic problems to the company, which will facilitate the ongoing monitoring of borage lines ST-1 and ST-2. Bioriginal Food and Science Corp. will also monitor grower implementation to determine the effectiveness of the herbicide tolerance management plan and make any changes to the plan as appropriate.

Unconfined release into the environment of borage lines ST-1 and ST-2 is therefore authorized by the Plant Health and Biosecurity Directorate as of May 18, 2023.

Lines derived from the authorized line

Any borage lines derived from borage lines ST-1 and ST-2 may also be released into the environment provided that:

• no inter-specific crosses are performed
• the intended uses are similar, and
• it is known, following characterization, that these plants do not display any additional novel traits and are substantially equivalent to borage varieties that are currently grown in Canada, in terms of their potential environmental impact

Cultivation of plants derived from borage lines ST-1 or ST-2 is subject to herbicide tolerance management requirements.

Other regulatory requirements

Borage lines ST-1 and ST-2 are subject to the same phytosanitary import requirements as unmodified borage varieties. Borage lines ST-1 and ST-2 must also meet the requirements of other Canadian legislation as applicable, including but not limited to, the Food & Drugs Act, the Feeds Act, and the Pest Control Products Act.