Decision Document DD2014-108
Determination of the Safety of Dow AgroSciences Canada Inc.'s Soybean (Glycine max L.) Event DAS-81419-2

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This Decision Document has been prepared to explain the regulatory decisions reached under Directive 94-08 (Dir94-08) - Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits, its companion document BIO1996-10 - The Biology of Glycine max (L.) Merr. (Soybean) and Section 2.6 - Guidelines for the Assessment of Novel Feeds: Plant Sources, of Chapter 2 of the RG-1 Regulatory Guidance: Feed Registration Procedures and Labelling Standards.

Taking into account these evaluations, unconfined release into the environment and use as livestock feed of soybean event DAS-81419-2 is therefore authorized by the Plant Biosafety Office of the Plant Health and Biosecurity Directorate and the Animal Feed Division of the Animal Health Directorate, respectively, as of November 13, 2014. Any soybean lines derived from soybean event DAS-81419-2 may also be released into the environment and used as livestock feed, provided that (i) no inter-specific crosses are performed, (ii) the intended uses are similar, (iii) it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to soybean varieties that are currently grown and permitted to be used as livestock feed in Canada, in terms of their potential environmental impact and livestock feed safety and nutrition, (iv) the novel genes are expressed at a level similar to that of the authorized line and (v) data used to establish the substantial equivalence of lines derived from soybean event DAS-81419-2 be made available to the CFIA upon request.

Soybean event DAS-81419-2 is subject to the same phytosanitary import requirements as unmodified soybean varieties. Soybean event DAS-81419-2 is required to meet the requirements of other jurisdictions, including but not limited to, the Food & Drugs Act and the Pest Control Products Act.

Please note that the livestock feed and environmental assessments of novel feeds and PNTs are critical steps in the potential commercialization of these plant types. Other requirements, such as the food assessment by Health Canada, have been addressed separately from this review.

November 13, 2014

This bulletin was created by the Canadian Food Inspection Agency. For further information, please contact the Plant Biosafety Office or the Animal Feed Division by visiting the contact page.

Table of Contents

I. Brief Identification of the Modified Plant

Designation of the Modified Plant:
Soybean event DAS-81419-2
OECD Unique Identifier DAS-81419-2
Applicant:
Dow AgroSciences Canada Inc.
Plant Species:
Soybean (Glycine max L.)
Novel Traits:
Resistance to lepidopteran pests, including Chrysodeixis includens (soybean looper), Anticarsia gemmatalis (velvetbean caterpillar), Spodoptera frugiperda (fall armyworm) and Heliothis virescens (tobacco budworm); tolerance to glufosinate-ammonium herbicide
Trait Introduction Method:
Agrobacterium-mediated transformation
Intended Use of the Modified Plant:
Soybean event DAS-81419-2 is intended to be grown for traditional soybean human food and livestock feed uses. Soybean event DAS-81419-2 is not intended to be grown outside the normal production area for soybean in Canada.

II. Background Information

Dow AgroSciences Canada Inc. has developed a soybean event that is resistant to lepidopteran insects and tolerant to the herbicide glufosinate-ammonium. Soybean event DAS-81419-2 was developed by Dow AgroSciences Canada Inc. using recombinant deoxyribonucleic acid (DNA) technology, resulting in the introduction of the cry1Ac, cry1F and pat genes. The cry1Ac and cry1F genes are derived from Bacillus thuringiensis and encode insecticidal Cry proteins. The pat gene is derived from the soil bacterium Streptomyces viridochromogenes and encodes a phosphinothricin acetyltransferase (PAT) enzyme. This enzyme inactivates the herbicide glufosinate-ammonium.

Dow AgroSciences Canada Inc. has provided information on the identity of soybean event DAS-81419-2, a detailed description of the transformation method and information on the gene insertion site, gene copy number, levels of gene expression in the plant and the role of the inserted genes and regulatory sequences. The novel proteins were identified and characterized. Information was provided for the evaluation of the potential toxicity of the novel proteins to livestock and non-target organisms and potential allergenicity of the novel proteins to humans and to livestock. Information was also provided for the evaluation of herbicide residues in the feed commodities derived from soybean event DAS-81419-2, following the intended herbicide application.

Soybean event DAS-81419-2 was field tested at 10 sites in the United States (US) in 2011. The locations of these trials share similar environmental and agronomic conditions to soybean production areas in Canada and were considered representative of major Canadian soybean growing regions. An unmodified control soybean variety, which shares the same genetic background as soybean event DAS-81419-2 but had not been modified, was included in the trials to act as a comparator for soybean event DAS-81419-2. Several reference soybean varieties were also included in the field trials to establish a typical soybean behaviour range for phenotypic parameters.

Agronomic characteristics of soybean event DAS-81419-2, such as early population, seedling vigour, days to 50% flowering, days to maturity, lodging, plant height, final population, plant morphology (number of pods and number of seeds), pod shattering, yield, 100 seed weight, disease incidence and insect damage, were compared to those of the unmodified control soybean variety and to the range established by the reference soybean varieties.

Nutritional components of soybean event DAS-81419-2 grain and forage, such as protein, fat, moisture and ash, carbohydrates, fiber, amino acids, fatty acids, vitamins, minerals and anti-nutrients were compared to those of the unmodified control soybean variety and to the range established by the reference soybean varieties.

The Plant and Biotechnology Risk Assessment (PBRA) Unit of the Plant Health Science Directorate, CFIA, has reviewed the above information, in light of the assessment criteria for determining environmental safety of PNTs, as described Directive 94-08 (Dir94-08) - Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits. The PBRA Unit has considered:

  • the potential of soybean event DAS-81419-2 to become a weed of agriculture or to be invasive of natural habitats;
  • the potential for gene flow from soybean event DAS-81419-2 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive;
  • the potential for soybean event DAS-81419-2 to become a plant pest;
  • the potential impact of soybean event DAS-81419-2 and its gene products on non-target organisms, including humans; and
  • the potential impact of soybean event DAS-81419-2 on biodiversity.

The Animal Feed Division (AFD) of the CFIA has also reviewed the above information with respect to the assessment criteria for determining the safety and nutrition of livestock feed, as described in Section 2.6 - Guidelines for the Assessment of Novel Feeds: Plant Sources, of Chapter 2 of the RG-1 Regulatory Guidance: Feed Registration Procedures and Labelling Standards.

The AFD has considered both intended and unintended effects and similarities and differences between soybean event DAS-81419-2 and unmodified soybean varieties relative to the safety and nutrition of feed ingredients derived from soybean event DAS-81419-2 for their intended purpose, including:

  • the potential impact of soybean event DAS-81419-2 on livestock nutrition; and
  • the potential impact of soybean event DAS-81419-2 on animal health and human safety, as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed.

The AFD has also considered whether feeds derived from soybean event DAS-81419-2 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

Dow AgroSciences Canada Inc. has provided the CFIA with a method for the detection and identification of soybean event DAS-81419-2.

III. Description of the Novel Trait

1. Development Method

Soybean event DAS-81419-2 was developed through Agrobacterium-mediated transformation of soybean cells and contains the pat gene of S. viridochromogenes and the cry1Ac and cry1F genes of B. thuringiensis, along with regulatory elements needed for their expression in soybean. Transformed cells were selected on the basis of tolerance to glufosinate-ammonium and regenerated to produce plants. Soybean event DAS-81419-2 was identified as a successful transformant based on molecular analyses, herbicide efficacy and agronomic evaluations and was thus chosen for further development.

2. Resistance to Lepidopteran Insects

B. thuringiensis var. aizawai, B. thuringiensis var. entomocidus and B. thuringiensis var. kurstaki are common gram-positive soil-borne bacterium. In their spore forming stage, they produce several insecticidal protein crystals such as Cry1Ac and Cry1F (i.e. Cry endotoxins). These proteins are active against certain lepidopteran insect pests, such as soybean looper, velvetbean caterpillar, fall armyworm and tobacco budworm. These proteins have been shown to be non-toxic to humans, other vertebrates and non-lepidopteran invertebrates. Foliar insecticides based on Cry endotoxins have been registered for over 30 years in Canada and have a long history of safe use.

A synthetic cry1Ac gene was developed. The Cry1Ac protein that it encodes in soybean event DAS-81419-2 is a chimeric full length δ-endotoxin comprised of the core toxin of the Cry1Ac1 protein from B. thuringiensis var. kurstaki, and the nontoxic portions of the Cry1Ca3 protein from B. thuringiensis var. entomocidus and the Cry1Ab1 protein from B. thuringiensis var. kurstaki. The Cry1Ca3 and Cry1Ab1 proteins comprise the chimeric C-terminal domain and are approximately those that are removed by alkaline proteases during the formation of the active Cry1Ac1 core toxin. The Cry1Ac protein is 131 kDa, while the active truncated form is 65 kDa.

A synthetic cry1F gene was developed. The Cry1F protein that it encodes in soybean event DAS-81419-2 is a chimeric full length δ-endotoxin comprised of the core toxin of the Cry1Fa2 protein from B. thuringiensis var. aizawai and the nontoxic portions of the Cry1Ca3 protein from B. thuringiensis var. entomocidus and the Cry1Ab1 protein from B. thuringiensis var. kurstaki. The Cry1Ca3 and Cry1Ab1 proteins comprise the chimeric C-terminal domain and are approximately those that are removed by alkaline proteases during the formation of the active Cry1Fa2 core toxin. The Cry1F protein is 130 kDa where the truncated form is 65 kDa.

These synthetic Cry1Ac and Cry1F proteins are insecticidal to Lepidoptera larvae after cleavage to their bio-active, trypsin resistant cores. Insecticidal activity is believed to depend on the binding of the active fragments to specific receptors on the insect midgut epithelial cells, forming a pore which disrupts osmotic balance and eventually results in cell lysis and insect death. Current knowledge indicates that only insects sensitive to Cry proteins possess such receptors. Specific lepidopteran pests of soybean sensitive to these proteins are soybean looper, velvetbean caterpillar, fall armyworm and tobacco budworm.

The Cry1Ac and Cry1F proteins produced in soybean event DAS-81419-2 are the same as the Cry1Ac and Cry1F proteins produced in insect-resistant cotton events 3006-210-23 (DD2005-51) and 281-24-236 (DD2005-52), respectively, which have already been authorized for animal feed use in Canada. The Cry1F protein is also present in insect-resistant corn events 1507 (DD2002-41) and DAS-06275-8 (DD2006-59), which have already been authorized for unconfined environmental release and animal feed use in Canada.

Cry1Ac and Cry1F protein expression in soybean event DAS-81419-2 is driven by constitutive promoters. Samples of soybean tissues were collected from plants from 10 field trials in the US. The average Cry1Ac protein expression, as evaluated by ELISA, was as follows: 25.44 micrograms per gram dry weight (μg/g dwt) in leaf at the V5 stage, 23.16 μg/g dwt in leaf at the V10-12 stage, 5.54 μg/g dwt in forage at the R3 stage, 0.39 μg/g dwt in root at the R3 stage and 1.04 μg/g dwt in grain at the R8 stage. The average Cry1F protein expression, as evaluated by ELISA, was as follows: 56.75 μg/g dwt in leaf at the V5 stage, 39.07 μg/g dwt in leaf at the V10-12 stage, 20.28 μg/g dwt in forage at the R3 stage, 5.23 μg/g dwt in root at the R3 stage and 13.80 μg/g dwt in grain at the R8 stage.

To obtain sufficient quantities of Cry1Ac and Cry1F proteins for assessment of environmental and feed safety, it was necessary to express the cry1Acand cry1F genes in a microbial production system. Equivalency was demonstrated between soybean event DAS-81419-2-produced Cry1Ac and Cry1F proteins and Pseudomonas fluorescens-produced Cry1Ac and Cry1F proteins that had been used in studies previously submitted by Dow AgroSciences Canada Inc. for their cotton events 3006-210-23 and 281-24-236, respectively. These determinations of equivalency were based on similar molecular weights, immunoreactivities, glycosylation patterns and tryptic peptide mass mapping results. Demonstration of equivalence between the Cry1Ac and Cry1F proteins produced in soybean event DAS-81419-2 and the P. fluorescens-produced Cry1Ac and Cry1F proteins used in studies submitted for cotton events 3006-210-23 and 281-24-236 allows utilization of information from these studies to confirm the safety of the Cry1Ac and Cry1F proteins produced in soybean event DAS-81419-2.

The potential allergenicity and toxicity of the Cry1Ac and Cry1F proteins to livestock and non-target organisms were evaluated. The weight of evidence indicates that these proteins are unlikely to be allergenic. The source of the cry1Ac and cry1F genes, B. thuringiensis, is not commonly associated with allergenicity, the Cry1Ac and Cry1F protein amino acid sequences lack relevant similarities to known allergens, P. fluorescens-produced Cry1Ac and Cry1F proteins that had been used in safety studies previously submitted for cotton events 3006-210-23 and 281-24-236 were shown experimentally to be rapidly degraded in simulated gastric fluid and soybean event DAS-81419-2 Cry1Ac and Cry1F proteins were shown experimentally to be unglycosylated.

It was also concluded that the Cry1Ac and Cry1F proteins are unlikely to be toxic to livestock and non-target organisms because they lack a mode of action to suggest that they are intrinsically toxic to livestock or non-target organisms, because the Cry1Ac and Cry1F protein amino acid sequences lack relevant similarities to known toxins and because no adverse effects were observed when P. fluorescens-produced Cry1Ac and Cry1F proteins that had been used in safety studies previously submitted for cotton events 3006-210-23 and 281-24-236 were ingested by mice at doses of approximately 700 and 600 mg/kg bwt, respectively. For a more detailed discussion of the potential allergenicity and toxicity of the PAT protein, see Section V, part 2: Potential Impact of Soybean Event DAS-81419-2 on Animal Health and Human Safety as it Relates to the Potential Transfer of Residues into Foods of Animal Origin and Worker/Bystander Exposure to the Feed.

3. Tolerance to Glufosinate-Ammonium

Glufosinate-ammonium herbicide inhibits the plant enzyme glutamine synthetase, resulting in the accumulation of lethal levels of ammonia in susceptible plants. Ammonia is produced by plants as a result of normal metabolic processes. Soybean event DAS-81419-2 was developed to be tolerant to the herbicide glufosinate-ammonium by incorporation of the pat gene. The pat gene encodes the enzyme PAT, which can acetylate the primary amino group of glufosinate-ammonium, rendering it inactive. Introduction of the pat gene into soybean event DAS-81419-2 confers commercial-level tolerance to the herbicide glufosinate-ammonium. The pat gene was derived from S. viridochromogenes, a gram-positive soil bacterium. The PAT protein produced in soybean event DAS-81419-2 is identical to the native enzyme.

The PAT protein produced in soybean event DAS-81419-2 is the same as the PAT protein produced in other glufosinate-ammonium-tolerant crops that have already been authorized for unconfined environmental release and livestock feed use in Canada. These include corn events DAS-44406-6 (DD2013-97), 1507 (DD2002-41) and 59122 (DD2005-55) and soybean event DAS-68416-4 (DD2012-93). Cotton events 3006-210-23 (DD2005-51) and 281-24-236 (DD2005-52) were also authorized for livestock feed use in Canada.

PAT protein expression in soybean event DAS-81419-2 is driven by a constitutive promoter. Samples of soybean tissues were collected from plants from 10 field trials in the US. The average PAT protein expression, as evaluated by ELISA, was as follows: 5.23 μg/g dwt in leaf at the V5 stage, 5.60 μg/g dwt in leaf at the V10-12 stage, 4.06 μg/g dwt in forage at the R3 stage, 0.63 μg/g dwt in root at the R3 stage and 0.86 μg/g dwt in grain at the R8 stage.

To obtain sufficient quantities of PAT protein for assessment of environmental and feed safety, it was necessary to express the pat gene in an Escherichia coli production system. Equivalency was demonstrated between the soybean event DAS-81419-2-produced PAT protein and E. coli-produced PAT protein by comparing their molecular weights, immunoreactivities, glycosylation patterns, tryptic peptide mass mapping results and functional activities. Based on the results, the proteins were found to be equivalent. Demonstration of equivalence between the PAT protein produced in E. coli and the PAT protein produced in soybean event DAS-81419-2 allows the PAT protein produced in E. coli to be used in studies to confirm the safety of the PAT protein produced in soybean event DAS-81419-2.

The potential allergenicity and toxicity of the PAT protein to livestock and non-target organisms were evaluated. The weight of evidence indicates that the PAT protein is unlikely to be allergenic, based on the following information. The source of the pat gene, S. viridochromogenes, is not commonly associated with allergenicity. The PAT protein amino acid sequence lacks relevant similarities to known allergens. Unlike many allergens, E. coli-produced PAT protein was shown experimentally to be rapidly degraded in simulated gastric fluid. Finally, unlike many allergens, soybean event DAS-81419-2-produced PAT protein was shown experimentally to be unglycosylated. It was also concluded that the PAT protein is unlikely to be toxic to livestock and non-target organisms because it lacks a mode of action to suggest that it is intrinsically toxic to livestock or non-target organisms, because the PAT protein amino acid sequence lacks relevant similarities to known toxins and because no adverse effects were observed when microbial PAT protein was ingested by mice at doses of approximately 2000 mg/kg bwt. For a more detailed discussion of the potential allergenicity and toxicity of the PAT protein, see Section V, part 2: Potential Impact of Soybean Event DAS-81419-2 on Animal Health and Human Safety as it Relates to the Potential Transfer of Residues into Foods of Animal Origin and Worker/Bystander Exposure to the Feed.

4. Stable Integration into the Plant Genome

Molecular characterization by Southern blot analysis and DNA sequencing demonstrated that soybean event DAS-81419-2 contains one intact copy of the gene cassette containing the cry1Ac, cry1Fand pat genes and their regulatory elements inserted at a single site in the soybean genome. Small rearrangements were observed at the junctions between the insert and the flanking soybean genomic sequence, and at the 5' junction, a 98 bp fragment of the cry1Ac gene was present. This fragment was not associated with potential regulatory sequences and is not expected to be expressed. No effects on the functionality of the DNA insert or the composition or performance of the plant itself were observed as a result of these changes. Such insertional effects are not uncommon in transformation events.

The stability of the insert within soybean event DAS-81419-2 was verified by Southern blot analysis over five generations. Based on event-specific PCR and lateral flow strip assay, the inheritance pattern of the insert and the PAT protein expression trait across two segregating generations of soybean event DAS-81419-2 showed that the insert segregates according to Mendelian rules of inheritance for a single genetic locus.

IV. Criteria for the Environmental Assessment

1. Potential of Soybean Event DAS-81419-2 to Become a Weed of Agriculture or be Invasive of Natural Habitatss

The biology of soybean, as described in the CFIA biology document BIO1996-10, "The Biology of Glycine max (L.) Merr. (Soybean)", is such that unmodified plants of this species are not invasive of unmanaged habitats in Canada. Soybean does not possess an intrinsic potential to become weedy in Canada due to traits such as the lack of seed dormancy and the poor competitive ability of seedlings. According to the information provided by Dow AgroSciences Canada Inc., soybean event DAS-81419-2 was determined not to be significantly different from unmodified soybean varieties in this respect.

The CFIA evaluated data submitted by Dow AgroSciences Canada Inc. on the reproductive biology and life history traits of soybean event DAS-81419-2. As previously mentioned, soybean event DAS-81419-2 was field tested in the US at 10 locations in 2011. It was determined that the US locations share similar environmental and agronomic conditions to southwestern Ontario and were considered to be representative of major Canadian soybean growing regions. During the field trials, soybean event DAS-81419-2 was compared to the unmodified control soybean variety. Reference soybean varieties were also included in these trials to establish ranges of comparative values that are representative of currently grown soybean varieties. Phenotypic and agronomic traits were evaluated, covering a broad range of characteristics that encompass the entire life cycle of the soybean plant. The traits included early population, seedling vigour, days to 50% flowering, days to maturity, lodging, plant height, final population, plant morphology (number of pods and number of seeds), pod shattering, yield and 100 seed weight. For the majority of the traits, no statistically significant differences were observed between soybean event DAS-81419-2 and the unmodified control soybean variety. Instances of statistically significant differences were observed between soybean event DAS-81419-2 and the unmodified control soybean variety in the individual-site analyses, however for most of the traits, there was no consistent trend in the data across locations that would indicate that the differences were due to the genetic modification. Combined-site analyses of soybean event DAS-81419-2 to the unmodified control soybean variety showed a trend occurring in which soybean event DAS-81419-2 had more days to flowering and a lower number of pods, however the values for soybean event DAS-81419-2 were within the range established for the reference soybean varieties included in the same field trials. Therefore, the statistical analysis of these observations showed no biologically meaningful differences between soybean event DAS-81419-2 and the unmodified control soybean variety and supports a conclusion of phenotypic equivalence to currently grown soybean varieties.

Dow AgroSciences Canada Inc. provided information on the germination of soybean event DAS-81419-2 seed under warm and cool temperature regimes. No difference was detected between soybean event DAS-81419-2 and the unmodified control soybean variety at either temperature regime. Therefore the introduction of the novel traits did not impact the germination of the soybean seed and did not confer dormancy to the soybean seed.

Soybean event DAS-81419-2 was exposed to moderate heat stress, cold stress, drought and moisture stress in the field during the agronomic characteristics studies. No trend in increased or decreased susceptibility to these abiotic stressors was observed in soybean event DAS-81419-2 compared to the unmodified control soybean variety.

The susceptibility of soybean event DAS-81419-2 to various soybean pests and pathogens was evaluated in the field at the same locations as the agronomic characteristic studies (further detail provided below in Section IV, part 3: Potential for Soybean Event DAS-81419-2 to Become a Plant Pest. No trend in increased or decreased susceptibility to pests or pathogens was observed in soybean event DAS-81419-2 compared to the unmodified control soybean variety.

No competitive advantage was conferred to plants of soybean event DAS-81419-2, other than that conferred by tolerance to glufosinate-ammonium herbicide and resistance to lepidopteran pests, as the reproductive characteristics, growth characteristics and tolerance to abiotic and biotic stressors of soybean event DAS-81419-2 were comparable to those of the unmodified control soybean variety. As feeding damage by lepidopteran pests is not known to be a major factor restricting the establishment or distribution of soybean in Canada, the introduction of the lepidopteran resistance trait will not make soybean event DAS-81419-2 weedier or more invasive of natural habitats. Tolerance to glufosinate-ammonium herbicide provides a competitive advantage only when this herbicide is used and this trait will not, in and of itself, make a glufosinate-ammonium tolerant plant weedier or more invasive of natural habitats. Soybean event DAS-81419-2 plants growing as volunteers will not be controlled if glufosinate-ammonium herbicide is used as the only weed control tool. However, control of soybean event DAS-81419-2 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 novel traits have no intended or observed effects on weediness or invasiveness. The CFIA has, therefore, concluded that soybean event DAS-81419-2 has no altered weediness or invasiveness potential in Canada compared to currently grown soybean varieties.

The CFIA considers the changes in usual agronomic practices that may arise from volunteer plants with novel herbicide tolerances. Similarly, the CFIA considers the potential that continued application of the same herbicide in subsequent rotations may lead to increased selection pressure for herbicide tolerant weed populations. In order to address these issues, an herbicide tolerance management plan, which includes integrated weed management strategies, should be implemented. These plans may include a recommendation to rotate or combine weed control products with alternate modes of action and to employ other weed control practices.

Dow AgroSciences Canada Inc. has submitted an herbicide tolerance management plan to the CFIA, which was determined to be satisfactory when evaluated by the PBRA Unit. Dow AgroSciences Canada Inc. will make this herbicide tolerance management plan readily available to users of soybean event DAS-81419-2 to promote careful management practices for soybean event DAS-81419-2. Dow AgroSciences Canada Inc. will provide an efficient mechanism to report agronomic problems to the company, which will facilitate the ongoing monitoring of soybean event DAS-81419-2. Dow AgroSciences Canada Inc. will monitor implementation of the plan to determine the effectiveness of the herbicide tolerance management plan and make any changes to the plan as appropriate.

2. Potential for Gene Flow from Soybean Event DAS-81419-2 to Sexually Compatible Plants Whose Hybrid Offspring May Become More Weedy or More Invasive

Natural hybridization between cultivated soybean and the wild annual species Glycine soja can occur. However, G. soja is not naturalized in North America, and although this species is occasionally grown in research plots, there are no reports of its escape to unmanaged habitats nor of it becoming a weed in Canadian agroecosystems. The biology of soybean, as described in the CFIA biology document (BIO1996-10), shows that soybeans exhibit a high degree of self-fertilization. Cross pollination is usually less than one percent, suggesting that any pollen flow from cultivated soybeans to related species is minimal.

This information, together with the fact that the novel traits have no intended effects on soybean reproductive biology, led the CFIA to conclude that there is minimal potential for gene flow from soybean event DAS-81419-2 to related species in Canada.

3. Potential for Soybean Event DAS-81419-2 to Become a Plant Pest

Soybean is not considered a plant pest in Canada and the glufosinate-ammonium herbicide tolerance and lepidopteran resistance traits introduced into soybean event DAS-81419-2 are unrelated to plant pest potential (the i.e. potential for the plant to harbour new or increased populations of pathogens or pests).

The susceptibility of soybean event DAS-81419-2 to various soybean pests and pathogens was evaluated in the field at the same locations as the agronomic characteristic studies. The stressors observed included grasshoppers, caterpillars, green cloverworms, bean leaf beetles, wooly bear caterpillars, soybean loopers, skippers, bacterial pustule, blight, mould and mildew. The evaluations of soybean event DAS-81419-2 did not show any increased or decreased susceptibility to these pests and pathogens compared to the unmodified control soybean variety.

The CFIA has therefore concluded that soybean event DAS-81419-2 does not display any altered pest potential compared to currently grown soybean varieties.

4. Potential Impact of Soybean Event DAS-81419-2 and Its Gene Products on Non-Target Organisms, Including Humans

The Cry1Ac and Cry1F proteins were introduced into soybean event DAS-81419-2 as protection against lepidopteran soybean pests. The history of use and available literature indicate that the insecticidal Cry proteins derived from B. thuringiensis are only active against specific insect groups and are not toxic to other organisms, including humans. In addition, foliar insecticides based on Cry proteins have been registered for over 30 years in Canada and have a long history of safe use.

The Cry1Ac and Cry1F proteins produced in soybean event DAS-81419-2 have been demonstrated to be active only against certain lepidopteran insects. The Cry1Ac and Cry1F proteins in soybean event DAS-81419-2 are 100% identical to the Cry1Ac and Cry1F proteins in cotton events 3006-210-23 (Cry1Ac), 281-24-236 (Cry1F), which have been subject to previous safety assessments for non-target organisms (see DD2005-51; DD2005-52). Thus, dietary toxicity studies on non-target organisms submitted in support of the environmental safety of the Cry1Ac and Cry1F protein in these cotton events were used in the evaluation of the potential impact on non-target organisms of the Cry1Ac and Cry1F proteins in soybean event DAS-81419-2. These studies showed that the Cry1Ac and Cry1F proteins had no negative effects on four species of beneficial insects (ladybird beetle, honey bee, green lacewing, parasitic wasp), two species of soil invertebrates (earthworms and Collembola), the aquatic invertebrate Daphnia magna, one species of bird (Northern bobwhite quail), one species of fish (rainbow trout) and one species of mammal (mouse) when ingested singly at doses greatly exceeding the anticipated levels of exposure to these proteins produced in plant tissues.

Estimated margins of exposure (MOE) for Cry1Ac and Cry1F were calculated on four non-target species: mouse, earthworm, Collembola and lady beetle. The MOE for all species was greater than 10 times the no observed effect concentration (NOEC), with the exception of lady beetles for Cry1Ac, where the MOE was four. The potential risk for lady beetles was examined, given that the known spectrum of activity of Cry1Ac is restricted to the order Lepidoptera. An additional high-dose laboratory study of the Cry1Ac protein against lady beetles as well as a field study using soybean event DAS-81419-2 demonstrated no adverse effects on lady beetle development, fecundity or abundance.

The safety of Cry proteins with respect to non-target lepidopterans is well known. Nevertheless, threatened or endangered Canadian lepidopteran species from the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) were considered in this assessment despite the fact that soybean is not listed as a source of nectar or pollen. The Aweme borer moth has been documented only from Aweme, Manitoba and from Grand Bend and Manitoulin Island in Ontario. While the exact locations of the specimens collected in the early 1900s are unknown, historical evidence suggests a sand dune and/or oak-prairie habitat. Bogbean buckmoth also occurs in Ontario, but appears to be restricted to fen habitats with bogbean as its main food source. Eastern persius duskywing has been documented in proximity to Ontario soybean growing regions, but is associated with lupines in oak savannah habitats. The Karner blue butterfly, whose larvae are restricted to lupines, occurs in soybean growing regions in the United States, but has been listed as extirpated in Canada. However, this species has historically been documented in oak savannah habitats in southern Ontario and was therefore considered in the assessment. Incidental exposure to Cry proteins could occur for lepidopteran species that do not directly feed on soybean, if pollen from soybean event DAS-81419-2 were deposited on their host plants and these were subsequently consumed. However, based on the biology of soybean, as described in the CFIA biology document (BIO1996-10), soybean anthers mature in the bud and directly pollinate the stigma of the same flower. Previous research in soybean concluded that (i) cross-pollination is usually less than 1%, (ii) there is little airborne pollen in and around soybean fields and (iii) pollen dispersal is restricted to a small area (less than 8 m) from the field edge even when soybean flowers are in full bloom. Thus, the exposure of threatened or endangered lepidopteran species to Cry proteins from soybean event DAS-81419-2 is highly unlikely. Furthermore, previous studies on first instar monarch butterflies (listed by COSEWIC as a species of concern) demonstrate that the dietary concentration resulting in 50% growth reduction exceeds the estimated environmental concentration from cotton containing Cry1Ac or Cry1F by over 10-fold (see DD2005-51; DD2005-52).

Detailed characterization of the Cry1Ac and Cry1F proteins expressed in soybean event DAS-81419-2 led to the conclusion that neither of these proteins displays any characteristic of a potential toxin or allergen (see Section V, part 2: Potential Impact of Soybean Event DAS-81419-2 on Animal Health and Human Safety as it Relates to the Potential Transfer of Residues into Foods of Animal Origin and Worker/Bystander Exposure to the Feed) to non-lepidopteran species. Therefore, no negative impacts resulting from exposure of organisms to the Cry1Ac and Cry1F proteins expressed in soybean event DAS-81419-2 are expected.

The glufosinate-ammonium herbicide tolerance trait introduced into soybean event DAS-81419-2, through the presence of the PAT protein, is considered to be unrelated to a potential impact on non-target organisms. The PAT protein in soybean event DAS-81419-2 is 100% identical in amino acid sequence to the PAT protein produced in corn lines 1507 and 59122 and cotton events 3006-210-23 and 281-24-236. These events were authorized as the result of previous CFIA safety assessments (DD2002-41; DD2005-55; DD2005-51; DD2005-52). Detailed characterization of the PAT protein expressed in these events led to the conclusion that this protein does not display any characteristic of a potential toxin or allergen (see Section V, part 2: Potential Impact of Soybean Event DAS-81419-2 on Animal Health and Human Safety as it Relates to the Potential Transfer of Residues into Foods of Animal Origin and Worker/Bystander Exposure to the Feed). Thus, no negative impacts resulting from exposure of organisms to the PAT protein expressed in soybean event DAS-81419-2 are expected.

Composition analyses showed that the levels of key nutrients and anti-nutrients in grain and forage from soybean event DAS-81419-2 are comparable to those in conventional soybean varieties (see Section V, part 1: Potential Impact of Soybean Event DAS-81419-2 on Livestock Nutrition). Therefore, it is very unlikely that the introduction of the novel traits may have caused unintended changes to the composition of soybean event DAS-81419-2 tissues that would negatively impact organisms interacting with soybean event DAS-81419-2.

Field evaluations designed to assess the potential for adverse effects of soybean event DAS-81419-2 on non-target arthropod populations were conducted at two field locations during a single growing season in which traditional crop protection pesticides were not applied to manage arthropod pests. Insects were collected using pitfall traps, sticky traps and vertical beat sheets at various points throughout the growing seasons. The results from this study indicated that soybean event DAS-81419-2 did not have any adverse effects on non-target arthropods, as compared with conventional soybean.

Similarly, field evaluations of soybean event DAS-81419-2 did not show any increased resistance to insect pests or pathogens compared to the unmodified control soybean variety (see Section IV, part 3: Potential for Soybean Event DAS-81419-2 to Become a Plant Pest).

Collectively, these information elements indicate that the interactions between soybean event DAS-81419-2 and the populations of non-target animals and microorganisms interacting with soybean crops will be similar in comparison to currently grown soybean varieties.

The CFIA has therefore determined that the unconfined release of soybean event DAS-81419-2 in Canada will not result in altered impacts on non-target organisms, including humans, compared to currently grown soybean varieties.

5. Potential Impact of Soybean Event DAS-81419-2 on Biodiversity

Soybean event DAS-81419-2 expresses no novel phenotypic characteristics that would extend its range beyond the current geographic range of soybean production in Canada. Soybean's only sexually compatible wild relative in Canada (G. soja) does not occur in unmanaged habitats and the possibility of soybean outcrossing to G. soja is very low. Soybean event DAS-81419-2 is unlikely to cause adverse effects on non-target organisms and does not display increased weediness, invasiveness or plant pest potential. It is therefore unlikely that soybean event DAS-81419-2 will have any direct effects on biodiversity, in comparison to the effects that would be expected from the cultivation of the soybean varieties that are currently grown in Canada.

Soybean event DAS-81419-2 has tolerance to the glufosinate-ammonium herbicide. The use of this herbicide 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, soybean event DAS-81419-2 or the cultivation of soybean. It is therefore unlikely that soybean event DAS-81419-2 will have any indirect effects on biodiversity, in comparison to the effects that would be expected from cultivation of currently grown soybean varieties.

At present, the use of chemical insecticides to control soybean pests is a common practice in Canada. Therefore, the reduction in local pest species as a result of the release of soybean event DAS-81419-2 does not present a significant change from existing agricultural practices.

The CFIA has concluded that the introduced novel genes and their corresponding novel traits do not confer to soybean event DAS-81419-2 any characteristic that would result in unintended environmental effects following unconfined release. The CFIA has therefore concluded that the potential impact on biodiversity of soybean event DAS-81419-2 is unlikely to be different from that of the soybean varieties that are currently grown in Canada.

6. Potential for Development of Insect Resistance to Soybean Event DAS-81419-2

In most circumstances involving PNTs with novel insect resistance traits, the CFIA requires that an insect resistance management (IRM) plan be implemented in order to minimize the likelihood of the development of resistant insect pests.

Current information indicates that an IRM plan specific to soybean event DAS-81419-2 is not scientifically justified at this time. This is due in part to the limited presence of lepidopteran pests in soybean that would be affected by the unconfined environmental release of this product in Canada. Moreover, all lepidopteran soybean pests that would be controlled by this product feed on multiple plant species, and would therefore have access to natural refuges. This in turn reduces the need for soybean-specific refuges. Furthermore, these lepidopteran pests are not known to over-winter in Canada, thus reducing the need for soybean refuges.

If new relevant information comes to light, the CFIA would review its conclusions and modify its requirements with respect to the IRM for soybean event DAS-81419-2 if deemed necessary.

V. Criteria for the Livestock Feed Assessment

The AFD considered nutrient and anti-nutrient profiles; the safety of feed ingredients derived from soybean event DAS-81419-2, including the presence of gene products, residues and metabolites in terms of animal health and human safety as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed; and whether feeds derived from soybean event DAS-81419-2 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

1. Potential Impact of Soybean Event DAS-81419-2 on Livestock Nutrition

Nutrient and anti-nutrient composition

The nutritional equivalence of soybean event DAS-81419-2 plants to the unmodified control soybean variety and six reference soybean varieties was determined from 10 replicated field trials in the US during the 2011 growing season. Forage and grain samples were analysed for moisture, ash, protein, crude fat, carbohydrates (calculated), acid detergent fibre (ADF), neutral detergent fibre (NDF), calcium and phosphorus. Grain samples were further analysed for amino acids, fatty acids, vitamins, additional minerals and anti-nutrients (phytic acid, lectin, raffinose, stachyose, trypsin inhibitor and total glycitein, daidzein and genistein equivalents) as recommended by the OECD consensus document for new varieties of soybean (OECD, 2001 PDF (190 kb)). Composition data was analyzed statistically using a mixed model analysis of variance and the significance of an overall treatment effect was estimated using an F-test with significant differences declared at (P≤0.05). The biological relevance of any significant difference among soybean varieties was assessed by comparing the observed values to the range of the values observed in the reference soybean varieties grown in the trials and in the published scientific literature (ILSI, 2010).

No statistically significant differences were observed for the moisture, ash, protein, crude fat, carbohydrates, ADF, NDF, calcium and phosphorus between forage from soybean event DAS-81419-2 and that of the unmodified control soybean variety. Also, no statistically significant differences were observed for protein, carbohydrates, ADF and NDF between grain of soybean event DAS-81419-2 and that of the unmodified control soybean variety. Statistically significant effects were found for fat, ash and moisture between grain of soybean event DAS-81419-2 and that of the unmodified control soybean variety, however, these differences were not biologically meaningful as the means were within the range of the values observed in the reference soybean varieties grown in the trial and in the published scientific literature (ILSI, 2010).

No statistically significant differences were observed between grain from soybean event DAS-81419-2 and that of the unmodified control soybean variety for all amino acids analysed and for stearic, oleic, linoleic, arachidic and behenic fatty acids. Statistically significant differences were observed for eicosenic, linolenic and palmitic fatty acids, however, these differences were not biologically meaningful as the means were within the range of the values observed in the reference soybean varieties grown in the trials and in the published scientific literature including (ILSI, 2010). All other fatty acids tested were below the limit of quantification.

No statistically significant differences were observed between grain from soybean event DAS-81419-2 and that of the unmodified control soybean variety for vitamins B1, B2, B3, B6 and B9. A statistically significant difference was observed for vitamin B5, however this difference was not biologically meaningful as the mean was within the range of the values observed in the reference soybean varieties grown in the trials. No statistically significant differences were observed between grain from soybean event DAS-81419-2 and that of the unmodified control soybean variety for ∝-tocopherol, δ-tocopherol and total tocopherol. A statistically significant difference was observed for ᵧ-tocopherol, however this difference was not biologically meaningful as the mean was within the range of the values observed in the reference soybean varieties grown in the trials. Levels of ᵦ –tocopherol were below the detection limit for grain from soybean event DAS 81419-2 and that of the unmodified control soybean variety. No statistically significant differences were observed between grain from soybean event DAS-81419-2 and that of the unmodified control soybean variety for the minerals calcium, copper, iron, magnesium, manganese, phosphorus, potassium, selenium and zinc.

No statistically significant differences were observed between grain from soybean event DAS-81419-2 and that of the unmodified control soybean variety for the antinutrients tested with the exception of total glycitein equivalent. A statistically significant difference was observed between levels of total glycitein equivalent, however, this difference was not biologically meaningful as the mean was within the range of the values observed in the reference soybean varieties grown in the trials and in the published scientific literature (OECD, 2001; ILSI, 2010).

Conclusion

It was concluded, based on the evidence provided by Dow AgroSciences Canada Inc., that the nutritional composition of soybean event DAS-81419-2 is similar to that of the reference soybean varieties grown in the trials and to that reported for other soybeans in the published scientific literature. Feed ingredients derived from soybean event DAS-81419-2 are considered to meet present ingredient definitions for soybean.

2. Potential Impact of Soybean Event DAS-81419-2 on Animal Health and Human Safety as it Relates to the Potential Transfer of Residues into Foods of Animal Origin and Worker/Bystander Exposure to the Feed

Soybean event DAS-81419-2 is resistant to lepidopteran insects and tolerant to glufosinate-ammonium herbicide due to production of the Cry1Ac, Cry1F and PAT proteins. The assessment of soybean event DAS-81419-2 evaluated the impact of the following potential hazards relative to the safety of feed ingredients derived from this event:

  • The presence of the novel proteins Cry1Ac and Cry1F
  • The presence of novel protein PAT
  • The chemical pesticide residue profile

Novel Cry1Ac and Cry1F Proteins

To obtain sufficient quantities of Cry1Ac and Cry1F proteins for evaluation of environmental and feed safety, it was necessary to express the cry1Acand cry1F genes in a microbial production system. Equivalency was demonstrated between soybean event DAS-81419-2-produced Cry1Ac and Cry1F proteins and P. fluorescens-produced Cry1Ac and Cry1F proteins that had been used in studies previously submitted by Dow AgroSciences Canada Inc. for their cotton events 3006-210-23 and 281-24-236, respectively. These determinations of equivalency were based on similar molecular weights, immunoreactivities and tryptic peptide mass mapping results. Demonstration of equivalence between the soybean event DAS-81419-2-produced Cry1Ac and Cry1F proteins and the microbially-produced Cry1Ac and Cry1F proteins used in studies submitted for cotton events 3006-210-23 and 281-24-236 allows utilization of information from these studies to confirm the safety of the Cry1Ac and Cry1F proteins produced in soybean event DAS-81419-2.

The potential allergenicity and toxicity of the Cry1Ac and Cry1F proteins to livestock were evaluated. With respect to their potential allergenicity, no single experimental method yields decisive evidence, thus a weight-of-evidence approach was taken, taking into account information obtained with various test methods. The source of the cry1Acand cry1F genes, B. thuringiensis, is not known to produce allergens and a bioinformatics evaluation of the Cry1Ac and Cry1F protein amino acid sequences confirmed the lack of relevant similarities between these proteins and known allergens. P. fluorescens-produced Cry1Ac and Cry1F protein safety studies previously provided for assessment of cotton events 3006-210-23 and 281-24-236 indicated that, unlike many allergens, these proteins are rapidly degraded in simulated gastric fluid. Soybean event DAS-81419-2 Cry1Ac and Cry1F proteins were also shown experimentally to be unglycosylated. The weight of evidence thus indicates that the Cry1Ac and Cry1F proteins are unlikely to be allergenic.

In terms of their potential toxicity to livestock, the Cry1Ac and Cry1F proteins lack a mode of action to suggest that they are intrinsically toxic to livestock, and bioinformatics evaluations of their protein amino acid sequences confirmed the lack of relevant similarities between the Cry1Ac and Cry1F proteins and known toxins. In addition, P. fluorescens-produced Cry1Ac and Cry1F protein safety studies previously provided for assessment of cotton events 3006-210-23 and 281-24-236 indicated that no adverse effects were observed when the Cry1Ac and Cry1F proteins were ingested by mice at doses of approximately 700 mg/kg bwt and 600 mg/kg bwt, respectively. This information indicates that the Cry1Ac and Cry1F proteins are unlikely to be toxic to livestock.

The livestock exposure to the Cry1Ac and Cry1F proteins is expected to be negligible as these proteins are expressed at very low levels in soybean event DAS-81419-2 and are rapidly degraded under conditions which simulate the mammalian digestive tract.

Novel PAT Protein

To obtain sufficient quantities of PAT protein for assessment of environmental and feed safety, it was necessary to express the pat gene in an E. coli production system. Equivalency was demonstrated between the soybean event DAS-81419-2-produced PAT protein and an E. coli-produced PAT protein by comparing their molecular weights, immunoreactivities, glycosylation patterns, tryptic peptide mass mapping results and functional activities. Based on the results, the proteins were found to be equivalent. Demonstration of equivalence between the PAT protein produced in E. coli and the PAT protein produced in soybean event DAS-81419-2 allows the PAT protein produced in E. coli to be used in studies to confirm the safety of the PAT protein produced in soybean event DAS-81419-2.

The potential allergenicity and toxicity of the PAT protein to livestock were evaluated. With respect to its potential allergenicity, no single experimental method yields decisive evidence, thus a weight-of-evidence approach was taken, taking into account information obtained with various test methods. The source of the pat gene, S. viridochromogenes, is not known to produce allergens and a bioinformatics evaluation of the PAT protein amino acid sequence confirmed the lack of relevant similarities between the PAT protein and known allergens. E. coli-produced PAT protein safety studies indicated that, unlike many allergens, this protein is rapidly degraded in simulated gastric fluid, and soybean event DAS-81419-2 PAT protein was shown experimentally to be unglycosylated. The weight of evidence thus indicates that the PAT protein is unlikely to be allergenic.

In terms of its potential toxicity to livestock, the PAT protein lacks a mode of action to suggest that it is intrinsically toxic to livestock and a bioinformatics evaluation of the PAT protein amino acid sequence confirmed the lack of relevant similarities between the PAT protein and known toxins. In addition, E. coli-produced PAT protein safety studies indicated that no adverse effects were observed when the PAT protein was ingested by mice at doses of approximately 2000 mg/kg bwt. This information indicates that the PAT protein is unlikely to be toxic to livestock.

The livestock exposure to the PAT protein is expected to be negligible as the PAT protein is expressed at very low levels in soybean event DAS-81419-2 and is rapidly degraded under conditions which simulate the mammalian digestive tract.

Chemical Pesticide Residue Profile

The safety of herbicide residues and metabolites in soybean event DAS-81419-2, following application of herbicide, was also evaluated as part of the feed safety assessment. It was determined that potential glufosinate residues and metabolites in livestock commodities derived from DAS-81419-2 soybean and its products would not present levels of concern to livestock, nor humans, via the potential transfer into foods of animal origin.

Conclusion

It was concluded, based on the evidence provided by Dow AgroSciences Canada Inc., that the novel Cry1Ac and Cry1F protein-based insect resistance and the novel PAT protein-based herbicide tolerance traits will not confer to soybean event DAS-81419-2 any characteristic that would raise concerns regarding the safety of soybean event DAS-81419-2. Feed ingredients derived from soybean event DAS-81419-2 are considered to meet present ingredient definitions for soybean.

VI. New Information Requirements

If at any time, Dow AgroSciences Canada Inc. becomes aware of any new information regarding risk to the environment, livestock or human health, which could result from release or livestock feed use of soybean event DAS-81419-2 or lines derived from it, Dow AgroSciences Canada Inc. is required to immediately provide such information to the CFIA. On the basis of such new information, the CFIA will re-evaluate the potential impact of soybean event DAS-81419-2 on the environment, livestock and human health and may re-evaluate its decision with respect to the livestock feed use and environmental release authorizations of soybean event DAS-81419-2.

VII. Regulatory Decision

Based on the review of the data and information submitted by Dow AgroSciences Canada Inc. and input from other relevant scientific sources, the Plant and Biotechnology Risk Assessment Unit of the Plant Health Science Directorate, CFIA, has concluded that the unconfined environmental release of soybean event DAS-81419-2 does not present altered environmental risk when compared to soybean varieties that are currently grown in Canada.

Based on the review of the data and information submitted by Dow AgroSciences Canada Inc. and input from other relevant scientific sources, the Animal Feed Division of the Animal Health Directorate, CFIA, has concluded that the novel PAT protein-based herbicide tolerance trait will not confer to soybean event DAS-81419-2 any characteristic that would raise concerns regarding the safety or nutrition of soybean event DAS-81419-2. Livestock feeds derived from soybeans are currently listed in IV of the Feeds Regulations and are, therefore authorized for use in livestock feeds in Canada. Soybean event DAS-81419-2 has been found to be as safe as and as nutritious as currently and historically grown soybean varieties. Soybean event DAS-81419-2 and its products are considered to meet present ingredient definitions and are authorized for use as livestock feed ingredients in Canada.

Unconfined release into the environment and use as livestock feed of soybean event DAS-81419-2 is therefore authorized by the Plant Biosafety Office of the Plant Health and Biosecurity Directorate and the Animal Feed Division of the Animal Health Directorate, respectively, as of November 13, 2014. Any soybean lines derived from soybean event DAS-81419-2 may also be released into the environment and used as livestock feed, provided that (i) no inter-specific crosses are performed, (ii) the intended uses are similar, (iii) it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to soybean varieties that are currently grown and permitted to be used as livestock feed in Canada, in terms of their potential environmental impact and livestock feed safety and nutrition, (iv) the novel genes are expressed at levels similar to those in the authorized line and (v) data used to establish the substantial equivalence of lines derived from soybean event DAS-81419-2 be made available to the CFIA upon request.

Soybean event DAS-81419-2 is subject to the same phytosanitary import requirements as unmodified soybean varieties. Soybean event DAS-81419-2 is required to meet the requirements of other jurisdictions, including but not limited to, the Food & Drugs Act and the Pest Control Products Act.

Please refer to Health Canada's Decisions on Novel Foods for a description of the food safety assessment of soybean event DAS-81419-2.

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