Decision Document DD2015-111
Determination of the Safety of Monsanto Canada Inc.'s Corn (Zea mays L.) Event MON 87411

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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 BIO1994-11 The Biology of Zea mays L. (Maize) 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.

The Canadian Food Inspection Agency (CFIA), specifically the Plant Biosafety Office of the Plant Health and Biosecurity Directorate, the Plant and Biotechnology Risk Assessment Unit of the Plant Health Science Directorate and the Animal Feed Division of the Animal Health Directorate, has evaluated information submitted by Monsanto Canada Inc. This information is in regard to glyphosate tolerant, insect resistant corn event MON 87411. The CFIA has determined that this plant with a novel trait (PNT) does not present altered environmental risk nor, as a novel feed, does it present livestock feed safety concerns when compared to corn varieties currently grown and permitted to be used as livestock feed in Canada.

Taking into account these evaluations, unconfined release into the environment and use as livestock feed of corn event MON 87411 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 as of October, 21st, 2015. Any corn lines derived from corn event MON 87411 may also be released into the environment and used as livestock feed, provided that:

  1. no inter-specific crosses are performed,
  2. the intended uses are similar,
  3. it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to corn 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,
  4. the novel genes are expressed at a level similar to that of the authorized line, and
  5. data used to establish the substantial equivalence of lines derived from corn event MON 87411 be made available to the CFIA upon request.

Additionally, with respect to its unconfined release into the environment, cultivation of corn event MON 87411 is subject to insect resistance management requirements.

Corn event MON 87411 is subject to the same phytosanitary import requirements as unmodified corn varieties. Corn event MON 87411 is required to meet the requirements of other Canadian legislation, including but not limited to, the Food and Drugs Act and the Pest Control Products Act.

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

(publié aussi en français)

October 21, 2015

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: Corn event MON 87411 OECD Unique Identifier MON-87411-9

Applicant: Monsanto Canada Inc.

Plant Species: Corn (Zea mays L.)

Novel Traits: Resistance to Western and Northern corn rootworm (Diabrotica spp.); tolerance to glyphosate herbicide

Trait Introduction Method: Agrobacterium-mediated transformation

Intended Use of the Modified Plant: Corn event MON 87411 is intended for traditional corn human food and livestock feed uses. Corn event MON 87411 is not intended to be grown outside the normal production area for corn in Canada.

II. Background Information

Monsanto Canada Inc. has developed a corn event tolerant to glyphosate herbicide and resistant to corn rootworm (Diabrotica spp.). Corn event MON 87411 was developed using recombinant deoxyribonucleic acid (rDNA) technology resulting in the introduction of the cp4 epsps and cry3Bb1 genes and the DvSnf7 suppression cassette. The cp4 epsps gene, derived from Agrobacterium sp. strain CP4, encodes a 5-enolpyruvoyl-shikimate-3-phosphate synthetase (EPSPS) protein, which imparts tolerance to glyphosate. The cry3Bb1 gene is derived from the bacterium Bacillus thuringiensis (B. thuringiensis) subsp. kumamotoensis and encodes the Cry3Bb1 protein, which confers resistance to corn rootworm. The DvSnf7 suppression cassette expresses an inverted repeat sequence designed to match the Snf7 sequence of western corn rootworm (Diabrotica virgifera virgifera), and confers resistance to western corn rootworm as well as northern corn rootworm (Diabrotica barberi).

Monsanto Canada Inc. has provided data on the identity of corn event MON 87411, a detailed description of the transformation method, data and information on the insert copy number and intactness and levels of protein expression in the plant, and the role of the inserted 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.

A hybrid, consisting of a cross between corn event MON 87411 and an unmodified corn variety (hereafter referred to as the corn event MON 87411 hybrid) was field tested at eight sites in the United States (US) in 2012 and at three sites in Canada in 2013. The locations of the US trials share similar environmental and agronomic conditions to corn production areas in Southern Ontario and Québec and were considered representative of major Canadian corn growing regions. In addition, the corn event MON 87411 hybrid was field tested at eight sites in Argentina in 2011/2012 to produce protein expression and composition analysis data. An unmodified control corn hybrid, which shares the same genetic background as the corn event MON 87411 hybrid, was included in the trials to act as a comparator for corn event MON 87411. Several reference corn hybrids were also included in the field trials to establish ranges of comparative values that are representative of currently grown corn varieties.

Agronomic characteristics of corn event MON 87411, such as plant vigor, early stand count, days to 50% pollen shed, days to 50% silking, stay green rating, ear height, plant height, dropped ear count, stalk lodge plants, root lodge plants, final stand count, grain moisture, test weight and yield, were compared to those of the unmodified control corn hybrid and to the range established by the reference corn hybrids.

Nutritional components of corn event MON 87411 hybrid grain and forage, such as proximate, amino acids, fatty acids, vitamins, minerals and anti-nutrients were compared to those of the unmodified control corn hybrid and to the range established by the reference control corn hybrids.

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 corn event MON 87411 to become a weed of agriculture or to be invasive of natural habitats;
  • the potential for gene flow from corn event MON 87411 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive;
  • the potential for corn event MON 87411 to become a plant pest;
  • the potential impact of corn event MON 87411 and its gene products on non-target organisms, including humans; and
  • the potential impact of corn event MON 87411 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 efficacy 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 corn event MON 87411 and unmodified corn varieties relative to the safety and efficacy of feed ingredients derived from corn event MON 87411 for their intended purpose, including:

  • the potential impact of corn event MON 87411 on livestock nutrition; and
  • the potential impact of corn event MON 87411 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 corn event MON 87411 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

III. Description of the Novel Traits

1. Development Method

Corn event MON 87411 was developed through Agrobacterium-mediated transformation of immature corn embryos, and contains cp4 epsps, cry3Bb1, the DvSnf7 suppression cassette and associated regulatory elements. Transformed cells were selected on the basis of tolerance to glyphosate and regenerated to produce plants. Corn event MON 87411 was identified as a successful transformant based on molecular analyses and herbicide tolerance. Corn event MON 87411 was chosen for further development based on agronomic performance.

2. Tolerance to Glyphosate

The cp4 epsps gene introduced into corn event MON 87411 is derived from an Agrobacterium sp. strain CP4, and imparts field-level tolerance to the herbicide glyphosate, the active ingredient in Roundup® brand herbicides. A plant-derived coding sequence expressing an optimized chloroplast transit peptide was fused to the cp4 epsps coding sequence. This transit peptide facilitates the import of the CP4 EPSPS enzyme into the chloroplast, the site of amino acid biosynthesis. EPSPS enzymes are involved in the shikimic acid metabolic pathway, which is essential for the production of the aromatic amino acids. Glyphosate can bind to the native corn EPSPS enzyme, which disrupts the shikimic acid pathway, leading to growth suppression or death of the plant. The CP4 EPSPS enzyme expressed in corn event MON 87411 confers tolerance to glyphosate since CP4 EPSPS has reduced binding to glyphosate in comparison to the native corn EPSPS, allowing it to continue to catalyze the production of aromatic amino acids in the presence of glyphosate.

The CP4 EPSPS protein produced in corn event MON 87411 is structurally and functionally similar to native plant EPSPS enzymes. This protein is the same or shares more than 99% sequence identity with the CP4 EPSPS proteins produced in Roundup Ready® crops which have already been authorized for unconfined release and animal feed uses in Canada. In particular, the CP4 EPSPS protein in corn event MON 87411 is identical to that expressed in corn event MON 88017 (DD2006-57).

CP4 EPSPS protein expression in corn event MON 87411 is driven by a constitutive promoter. Samples of corn tissues from plants sprayed with glyphosate were collected at various growth stages from five field trial sites in Argentina. The average CP4 EPSPS levels across all growth stages and sites, expressed in micrograms protein per gram dry weight tissue (µg/g dwt), as evaluated by enzyme-linked immunosorbent assay (ELISA) were as follows: 31 to 42 µg/g dwt in over season leaf, 30 to 48µg/g dwt in over season root, 25 to 63 µg/g dwt in over season whole plant, 19 µg/g dwt in pollen, 5.4 µg/g dwt in senescent root, 10 µg/g dwt in forage root, 8 µg/g dwt in forage and 1.9 µg/g dwt in grain.

To obtain sufficient quantities of CP4 EPSPS protein for assessment of environmental and feed safety, it was necessary to express the cp4 epsps gene in a microbial production system. Equivalency was demonstrated between corn event MON 87411-produced CP4 EPSPS protein and Escherichia coli (E. coli)-produced CP4 EPSPS protein that had been used in studies previously submitted by Monsanto Canada Inc. for corn event MON 88017. These determinations of equivalency were based on similar molecular weights, immunoreactivities, glycosylation, N-terminal sequence, tryptic peptide mass fingerprints and functional activity. Based on the results, both proteins were found to be equivalent. Demonstration of equivalence between the CP4 EPSPS protein produced in E. coli and the CP4 EPSPS protein produced in corn event MON 87411 allows the CP4 EPSPS protein produced in E. coli to be used in studies to confirm the safety of the CP4 EPSPS protein produced in corn event MON 87411.

The CP4 EPSPS protein expressed in corn event MON 87411 is similar to EPSPS enzymes present in many foods with a long history of safe use in Canada, and therefore is not be expected to be toxic or allergenic. However, the potential allergenicity and toxicity of the CP4 EPSPS protein to livestock and non-target organisms were evaluated. The weight of evidence indicates that the CP4 EPSPS protein is unlikely to be allergenic, based on the following information. The source of the cp4 epsps gene, Agrobacterium sp. strain CP4, is not commonly associated with allergenicity. The CP4 EPSPS protein amino acid sequence lacks relevant similarities to known allergens. The CP4 EPSPS protein in corn event MON 87411 is not glycosylated. Unlike many allergens, the E. coli-produced CP4 EPSPS protein was shown experimentally to be rapidly degraded in simulated gastric and intestinal fluids in safety studies previously submitted for corn event MON 88017.It was also concluded that the CP4 EPSPS 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 CP4 EPSPS protein amino acid sequence lacks similarities to known toxins and because no adverse effects were observed when E. coli-produced CP4 EPSPS protein was ingested by mice at doses of approximately 572 mg/kg bwt in a safety study previously submitted for corn event MON 88017. For a more detailed discussion of the potential allergenicity and toxicity of the CP4 EPSPS protein, see Section V, part 2.

3. Resistance to Corn Rootworm (Diabrotica spp.)

Cry3Bb1

B. thuringiensis subsp. kumamotoensis is a common gram-positive soil-borne bacterium. In the spore forming stage, it produces several insecticidal protein crystals, including the δ-endotoxin Cry3Bb1 protein, which is active against corn rootworm. The protein is insecticidal to corn rootworm after cleavage in the insect's gut to a bio-active, trypsin resistant core. Insecticidal activity is believed to depend on the binding of the active fragment to specific receptors present in susceptible insects on midgut epithelial cells, forming pores which disrupt osmotic balance and eventually result in cell lysis and insect death. This protein has been shown to be non-toxic to humans, other vertebrates and non-coleopteran invertebrates. Foliar insecticides using Cry proteins (generally known as B.t.) have been registered for over 40 years in Canada and have a long history of safe use.

The Cry3Bb1 protein produced in corn event MON 87411 contains a synthetic cry3Bb1 gene variant developed to maximize its expression in corn. The gene encodes a protein sharing >99% sequence identity with the wild type B. thuringiensis subsp. kumamotoensis Cry3Bb1 protein. The Cry3Bb1 variant produced in corn event MON 87411 corn is identical to that produced in corn event MON 88017 (see DD2006-57), which has been authorized for unconfined release and animal feed use in Canada.

The cry3Bb1 gene expressed in corn event MON 87411 is driven by a constitutive promoter. Samples of corn tissues from plants treated with glyphosate were collected at various growth stages from five field trial sites in Argentina. Average Cry3Bb1 levels across all growth stages and sites, expressed in micro-grams protein per gram dry weight tissue (µg/g dwt), as evaluated by ELISA are as follows: 170 to 270 µg/g dwt in over season leaf, 75 to 180 µg/g dwt in over season root, 120 to 340 µg/g dwt in over season whole plant, 36 µg/g dwt in pollen, 160 µg/g dwt in silk, 36 µg/g dwt in forage root, 19 µg/g dwt in senescent root, 39 µg/g dwt in forage and 4.0 µg/g dwt in grain.

To obtain sufficient quantities of Cry3Bb1 protein for assessment of environmental and feed safety, it was necessary to express the cry3Bb1 gene in a microbial production system. Equivalency was demonstrated between corn event MON 87411-produced Cry3Bb1 protein and E. coli-produced Cry3Bb1 protein that had been used in studies previously submitted by Monsanto Canada Inc. for corn event MON 88017. These determinations of equivalency were based on similar molecular weights, immunoreactivities, glycosylation, N-terminal sequence, tryptic peptide mass fingerprints and insecticidal activity. Based on the results, both proteins were found to be equivalent. Demonstration of equivalence between the Cry3Bb1 protein produced in E. coli and the Cry3Bb1 protein produced in corn event MON 87411 allows the Cry3Bb1 protein produced in E. coli to be used in studies to confirm the safety of the Cry3Bb1 protein produced in corn event MON 87411.

The potential allergenicity and toxicity of the Cry3Bb1 protein to livestock and non-target organisms were evaluated. The weight of evidence indicates that the Cry3Bb1 protein is unlikely to be allergenic, based on the following information. The source of the cry3Bb1 gene, B. thuringiensis subsp. kumamotoensis, is not commonly associated with allergenicity. The Cry3Bb1 protein amino acid sequence lacks relevant similarities to known allergens. The Cry3Bb1 protein in corn event MON 87411 is not glycolsylated. Unlike many allergens, the E. coli-produced Cry3Bb1 protein was shown experimentally to be rapidly degraded in simulated gastric and intestinal fluids in safety studies previously submitted for corn event MON 88017.

It was also concluded that the Cry3Bb1 protein is unlikely to be toxic to livestock and non-target organisms because the Cry3Bb1 protein amino acid sequence lacks similarities to known toxins and because no adverse effects were observed when E. coli-produced Cry3Bb1 protein was ingested by mice at doses of approximately 1930 mg/kg bwt in a safety study previously submitted for corn event MON 88017.

For a more detailed discussion of the potential allergenicity and toxicity of the Cry3Bb1 protein, see Section V, part 2.

DvSnf7

Corn event MON 87411 contains a suppression cassette that expresses an inverted repeat sequence designed to match the Snf7 sequence of western corn rootworm. Expression of the suppression cassette results in the formation of a double-stranded ribonucleic acid (dsRNA) transcript containing a 240 bp fragment of the western corn rootworm Snf7 gene (DvSnf7). When consumed by corn rootworm, the dsRNA is recognized by the corn rootworm cellular machinery, resulting in reduced expression of the corn rootworm DvSnf7 through a process known as RNA interference (RNAi). DvSnf7 plays a crucial role in cellular housekeeping by participating in the recycling of proteins. Disruption of this process leads to insect mortality.

The DvSnf7 suppression cassette in corn event MON 87411 is driven by a constitutive promoter. Samples of corn tissues were collected from plants from five field trial sites in Argentina. The average DvSnf7 RNA in μg/g dwt, as evaluated by QuantiGene® Plex 2.0 Assay, was as follows: 56.9×10-3 to 73.9×10-3 µg/g dwt in over season leaf, 6.84×10-3 to 23.9×10-3 µg/g dwt in over season root, 18.5×10-3 to 84.8×10-3 µg/g dwt in over season whole plant, 0.134×10-3 µg/g dwt in pollen, 1.39×10-3 µg/g dwt in senescent root, 2.37×10-3 µg/g dwt in forage root, 4.25×10-3 µg/g dwt in forage and 0.104×10-3 µg/g dwt in grain.

To obtain sufficient quantities of DvSnf7 dsRNA for evaluation of environmental and feed safety, it was necessary to use in vitro transcription. Equivalency was demonstrated between the corn event MON 87411-produced DvSnf7 dsRNA and in vitro transcribed DvSnf7 dsRNA by comparing their molecular weights, cDNA sequence analysis, and functional activity. Based on the results, the dsRNA were found to be equivalent. Demonstration of equivalence between the DvSnf7 dsRNA produced by in vitro transcription and the DvSnf7 dsRNA produced in corn event MON 87411 allows the DvSnf7 dsRNA produced by in vitro transcription to be used in studies to confirm the safety of the DvSnf7 dsRNA produced in corn event MON 87411.

The potential toxicity of the DvSnf7 dsRNA to livestock and non-target organisms was evaluated. Expression of the DvSnf7 suppression cassette does not result in the expression of novel proteins. Furthermore, small noncoding RNAs (ncRNAs) such as those present in corn are present in all plants and animals where they play central roles in endogenous gene regulation and response to exogenous DNA. The ncRNAs in corn event MON 87411 are expected to function in a similar manner. Finally, the systemic absorption of exogenous small ncRNA in crops by livestock or human bystanders is considered to be unlikely based on information in the scientific literature.

4. Stable Integration into the Plant Genome

Molecular characterization by DNA sequencing analysis and Southern blot analysis demonstrated that corn event MON 87411 contains one copy of cry3Bb1, cp4 epsps, and the DvSnf7 suppression cassette, and their associated regulatory elements inserted at a single site in the corn genome. No additional elements, including intact or partial DNA fragments or backbone sequences from the plasmid vector, linked or unlinked to the intact insert, were detected in corn event MON 87411.

The stability of the inserted DNA was demonstrated by DNA sequencing and western blot across five generations in the breeding history of corn event MON 87411. Analysis of the Cry3Bb1 and CP4 EPSPS proteins across five generations of corn event MON 87411 confirmed the stability of the inserted DNA and the stability of Cry3Bb1 and CP4 EPSPS protein expression. The inheritance pattern of the inserted DNA was demonstrated by PCR analysis across three generations. The results of the analysis are consistent with the finding of a single site of insertion that segregates according to the Mendelian law of genetics.

IV. Criteria for the Environmental Assessment

1. Potential of Corn Event MON 87411 to Become a Weed of Agriculture or be Invasive of Natural Habitats

The biology of corn, described in the CFIA biology document BIO1994-11, "The Biology of Zea mays L. (Maize)", states that unmodified plants of this species are not invasive of unmanaged habitats in Canada. Corn does not possess the potential to become weedy due to the lack of seed dormancy, the non-shattering nature of corn cobs and the poor competitive ability of seedlings. According to the information provided by Monsanto Canada Inc., corn event MON 87411 hybrid was determined not to be significantly different from unmodified corn varieties in this respect.

The CFIA evaluated data submitted by Monsanto Canada Inc. on the reproductive biology and life history traits of the corn event MON 87411 hybrid. As previously mentioned, the corn event MON 87411 hybrid was field tested at eight locations in the US in the 2012 growing season and at three locations in Canada in the 2013 growing season. During the field trials, the corn event MON 87411 hybrid was compared to the unmodified control corn hybrid. The US locations share similar environmental and agronomic conditions to Southern Ontario and Québec and were considered to be representative of major Canadian corn growing regions. Several reference corn hybrids were also included in these trials to establish ranges of comparative values that are representative of currently grown corn varieties. Phenotypic and agronomic traits were evaluated, covering a broad range of characteristics that encompass the entire life cycle of the corn plant. The traits included plant vigor, early stand count, days to 50% pollen shed, days to 50% silking, stay green rating, ear height, plant height, dropped ear count, stalk lodge plants, root lodge plants, final stand count, grain moisture, test weight and yield. Although instances of statistically significant differences were observed between the corn event MON 87411 hybrid and the unmodified control corn hybrid for some traits in the individual-site analyses, there was no consistent trend in the data across locations that would indicate the differences were due to the introduction of the novel traits, and the values for the corn event MON 87411 hybrid were within the range established for the reference corn hybrids included in the same field trials. Therefore, the analysis of these observations showed no biologically meaningful differences between the corn event MON 87411 hybrid and the unmodified control corn hybrid, and supports a conclusion of phenotypic and agronomic equivalence to currently grown corn varieties.

Monsanto Canada Inc. evaluated the germination of the corn event MON 87411 hybrid seed under seven temperature regimes. The following seed germination characteristics were evaluated: percent germinated seed (normal and abnormal), percent hard seed (viable and non-viable), percent dead seed, and percent swollen seed (viable and non-viable). The corn event MON 87411 hybrid was compared to the unmodified control corn hybrid. Eleven reference corn hybrids were also included to provide a range of comparative values for each germination characteristic. Seed lots were produced at three sites in the US. Although instances of statistically significant differences were observed between the corn event MON 87411 hybrid and the unmodified control corn hybrid in the individual-site analysis for percent dead seed, percent viable swollen seed, and percent germinated seed for four temperature regimes, these differences were not consistently detected across locations and therefore were not considered to be biologically meaningful. Therefore the introduction of the novel traits did not impact the germination of the corn seed and did not confer dormancy to the corn seed.

Monsanto Canada Inc. evaluated the viability, diameter, and morphology of pollen of the corn event MON 87411 hybrid. No statistically significant differences were detected between the corn event MON 87411 hybrid and the unmodified control corn hybrid for percent viable pollen or pollen diameter. Furthermore, no visual differences in general morphology were observed between the corn event MON 87411 hybrid and the unmodified control corn hybrid. Therefore the introduction of the novel traits did not impact the viability and morphology of corn pollen.

The corn event MON 87411 hybrid was exposed to cold, drought, flood, frost, hail, heat, nutrient deficiency, soil compaction, sunscald, and wind. No trend in increased or decreased susceptibility to these abiotic stressors was observed.

The susceptibility of the corn event MON 87411 hybrid to various corn pests and pathogens was evaluated in the field at the same US locations as the agronomic characteristic studies (further detail provided below in Section 3: Potential for Corn event MON 87411 to Become a Plant Pest). No trend in increased or decreased susceptibility to pests or pathogens was observed in the corn event MON 87411 hybrid compared to the unmodified control corn hybrid.

No competitive advantage was conferred to corn event MON 87411, other than resistance to corn rootworm and tolerance to glyphosate, as the reproductive and growth characteristics of the corn event MON 87411 hybrid were comparable to those of the unmodified control corn hybrid. As feeding damage by rootworm larvae is not known to be a major factor restricting the establishment or distribution of corn in Canada, the introduction of resistance to corn rootworm is unlikely to make corn event MON 87411 weedy or invasive of natural habitats. Tolerance to glyphosate provides a competitive advantage only when this herbicide is used and will not, in and of itself, make a herbicide tolerant plant weedier or more invasive of natural habitats. Corn event MON 87411 plants growing as volunteers will not be controlled if glyphosate is used as the only weed control tool. However, control of corn event MON 87411 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 corn event MON 87411 has no altered weed or invasiveness potential in Canada compared to corn varieties currently grown in Canada.

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, a 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.

With respect to its unconfined release into the environment, cultivation of corn event MON 87411 is subject to herbicide tolerance management requirements. According to Monsanto Canada Inc., corn event MON 87411 is not intended to be cultivated as an individual event in Canada. Therefore, a herbicide tolerance management plan specific to this product is not required at this time. However, if corn event MON 87411 is cultivated in Canada, a herbicide tolerance management plan must be implemented in order to delay the development of tolerance to glyphosate in local weed populations within agro-ecosystems.

2. Potential for Gene Flow from Corn Event MON 87411 to Sexually Compatible Plants Whose Hybrid Offspring May Become More Weedy or More Invasive

The biology of corn, as described in the CFIA biology document BIO1994-11 - The Biology of Zea mays L. (Maize), indicates that there are no sexually compatible relatives in Canada that can hybridize with corn. The novel traits introduced into corn MON 87411 (resistance to corn rootworm and tolerance to glyphosate) are unrelated to sexual compatibility.

The CFIA has therefore concluded that gene flow from corn event MON 87411 to sexually compatible relatives is not possible in Canada.

3. Potential for Corn Event MON 87411 to Become a Plant Pest

Corn is not considered a plant pest in Canada. The novel traits (resistance to corn rootworm and tolerance to glyphosate) are unrelated to the plant pest potential (i.e., the potential for the plant to harbour new or increased populations of pathogens).

The susceptibility of corn event MON 87411 hybrids to various corn pests and pathogens was evaluated in the field at the same locations as the agronomic characteristic studies. The stressors observed included aphids, armyworms, billbugs, cutworms, corn earworm, corn flea beetle, rootworm beetles, European corn borer, grasshoppers, Japanese beetle, sap beetles, spider mites, stink bugs, wireworm beetles, western bean cutworm, anthracnose, bacterial leaf spot, ear rot, eyespot, Fusarium sp., Goss's bacterial wilt, gray leaf spot, Northern leaf spot, leaf blight, Northern corn leaf blight, maize rough dwarf virus, Pythium sp., Rhizoctonia sp., rust, seedling blight, smut, stalk rot and Stewart's bacterial blight. No qualitative differences were observed between the corn event MON 87411 hybrid and the unmodified control corn hybrid for any of the 102 observations in the US field trial sites, for any of the 8 observations in the Canadian field trial sites for plant damage caused by arthropods, for any of the 119 observations in the US field trial sites, and for any of the 8 observations in the Canadian field trial sites for plant damage cause by diseases. The evaluations of the corn event MON 87411 hybrid did not show any increase or decrease in susceptibility to these pests and pathogens compared to the unmodified control corn hybrid.

Monsanto Canada Inc. has quantitatively assessed the pest arthropod abundance in the field at the same US locations as the agronomic characteristic studies at five collection times. The pest arthropods observed included aphids, corn flea beetle, delphacid planthopper, grasshoppers, leafhoppers, sap beetles, click beetles, Japanese beetle, lygus bug, and stink bug. Although instances of significant differences were detected between the corn event MON 87411 hybrid and the unmodified control corn hybrid for some of the pest arthropods in the individual-site analyses, there was no trend observed across collections or sites and therefore the differences were not considered biologically meaningful in terms of plant pest potential.

Monsanto Canada Inc. has quantitatively assessed corn earworm and European corn borer damage in the field at the same US locations as the phenotypic characteristic studies. Although a single significant difference was detected between the corn event MON 87411 hybrid and the unmodified control corn hybrid in the individual-site analyses for damage caused by corn earworm, there was no trend observed across collections or sites and therefore the difference was not considered biologically meaningful in terms of plant pest potential.

The unconfined environmental release of corn event MON 87411 without a proper management plan could potentially lead to the development of resistance to DvSnf7 dsRNA and Cry3Bb1 protein by their target pests. According to Monsanto Canada Inc., corn event MON 87411 is not intended to be cultivated as an individual event in Canada. Therefore, an insect resistance management plan specific to this product is not required at this time.

Thus, if used as intended, corn event MON 87411 will not display any altered plant pest potential compared to corn varieties currently grown in Canada.

4. Potential Impact of Corn Event MON 87411 and Its Gene Products on Non-Target Organisms, Including Humans

Corn event MON 87411 contains a suppression cassette that results in the formation of a dsRNA transcript containing a 240 base pair fragment of DvSnf7, the western corn rootworm Snf7 gene. When consumed by corn rootworm, the plant-produced DvSnf7 dsRNA in corn event MON 87411 is recognized by the insect's RNAi machinery, resulting in down-regulation of the targeted DvSnf7 gene and insect mortality.

The DvSnF7 suppression cassette introduced into corn event MON 87411 does not result in the expression of a novel protein. Therefore, there is no risk of new protein toxins or allergens being introduced into corn event MON 87411. The safety assessment of corn event MON 87411 also focused on ncRNAs and the suppression of corn rootworm DvSnf7 expression. The production of ncRNA for naturally occurring endogenous RNAi is common in plants and animals. Finally, based on the evidence presented by Monsanto Canada Inc., it is very unlikely that the plant-produced DvSnf7 dsRNA in corn event MON 87411 could mediate the disruption of gene expression in non-target organisms, including humans, which consume plant tissues or are indirectly exposed to these tissues through other means.

According to information provided by Monsanto Canada Inc., the activity spectrum of the DvSnf7 dsRNA expressed in corn event MON 87411 is limited to beetles of the subfamily Galerucinae (Coleoptera: Chrysomelidae), which in Canada includes agricultural pests such as the western corn rootworm, northern corn rootworm and southern corn rootworm (D. undecimpunctata howardi). To confirm specificity of the DvSnf7 dsRNA, a two-pronged testing approach was used. First, laboratory bioassays using DvSnf7 dsRNA were performed to test a variety of insect species based on phylogenetic relatedness to western corn rootworm. In total, 14 representative insect species from 10 families and four orders (namely, Coleoptera, Hemiptera, Hymenoptera and Lepidoptera) were tested. No impacts on survival, growth or development of these species were noted when fed extremely high doses (relative to levels present in corn event MON 87411) of DvSnf7 dsRNA over multi-day periods, with the exception of two species in the subfamily Galerucinae, namely the western corn rootworm and southern corn rootworm (as expected). Second, laboratory bioassays were performed to evaluate the potential effects of DvSnf7 dsRNA against a series of non-target organisms that represent valued ecological services in corn agroecosystems. The testing included two soil decomposers [earthworm (Eisenia andrei) and collembola (Folsomia candida)], a pollinator [larval and adult honeybee (Apis mellifera)], a parasitic wasp (Pediobius foveolatus) and three predator species [ladybird beetle (Coleomegilla maculata), carabid ground beetle (Poecilus chalcites) and insidious flower bug (Orius insidiosus)]. No adverse effects of DvSnf7 dsRNA were observed for any of the non-target organisms tested.

Furthermore, Monsanto Canada Inc. submitted information to address the potential for chronic and/or sub-lethal effects in representative vertebrate test systems, including a 28 day mouse study, a 42 day broiler chicken study, a 56 day catfish study and a 90 day rat study (discussed in greater detail in Section V: Criteria for the Livestock Feed Assessment). The results of these studies, together with the results from the laboratory bioassays described above, support a conclusion that no negative impacts on non-target organisms are likely as a result of the expression of the DvSnf7 dsRNA in corn event MON 87411.

Similar to the DvSnf7 suppression cassette, the Cry3Bb1 protein was introduced into corn event MON 87411 for protection against corn rootworm damage. The available scientific literature indicates that the insecticidal Cry proteins derived from B. thuringiensis are only active against specific insect groups and are not toxic to other non-target organisms, including humans. In addition, foliar insecticides using Cry proteins have been registered for over 40 years in Canada and have a long history of safe use. The Cry3Bb1 protein in corn event MON 87411 shares 100% amino acid identity with the Cry3Bb1 protein present in corn event MON 88017 and greater than 99% amino acid identity with the Cry3Bb1 protein present in corn event MON 863. The safety of the Cry3Bb1 protein for non-target organisms, including humans, has been previously established (see DD2006-57 and DD2003-43). Detailed characterization of the Cry3Bb1 protein expressed in corn event MON 87411 led to the conclusion that it does not display any characteristic of a potential toxin or allergen to non-coleopteran species (see Section V, part 2). Therefore, no negative impacts resulting from exposure of organisms to the Cry3Bb1 protein expressed in corn event MON 87411 are expected.

The CP4 EPSPS protein in corn event MON 87411 shares 100% amino acid identity with the CP4 EPSPS protein expressed in corn event MON 88017. The safety of the CP4 EPSPS protein for non-target organisms, including humans, has been previously established (see DD2006-57). Detailed characterization of the CP4 EPSPS protein expressed in corn event MON 87411 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 Corn Event MON 87411 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). Therefore, no negative impacts resulting from exposure of organisms to the CP4 EPSPS protein expressed in corn event MON 87411 are expected.

Composition analyses showed that the levels of key nutrients and anti-nutrients in grain and forage from corn event MON 87411 are comparable to those in conventional corn varieties (see Section V, part 1: Potential Impact of Corn Event MON 87411 on Livestock Nutrition). Therefore, it is very unlikely that the introduction of the novel traits may have caused unintended changes to the composition of corn event MON 87411 tissues that would negatively impact non-target organisms interacting with corn event MON 87411.

Field evaluations of corn event MON 87411 did not show any increased resistance to insect pests or pathogens compared to the unmodified control corn variety (see Section IV, part 3: Potential for Corn Event MON 87411 to Become a Plant Pest).

Monsanto Canada Inc. has quantitatively assessed the abundance of beneficial arthropods in the field at the same US locations as the agronomic characteristic studies at five collection times. The beneficial arthropods observed included brown lacewing, green lacewing, ladybird beetle, micro-parasitic hymenoptera, macro-parasitic hymenoptera, minute pirate bug, spider, ant-like flower beetle and shining flower beetle. Although instances of significant differences were detected between the corn event MON 87411 hybrid and the unmodified control corn hybrid for some of the beneficial arthropods in the individual-site analyses, there was no trend observed across collections or sites and therefore the differences were not considered biologically meaningful in terms of impact on non-target organisms interacting with corn event MON 87411.

Collectively, these information elements indicate that the interactions between corn event MON 87411 and the populations of non-target organisms in corn agroecosystems will be similar compared to currently grown corn varieties.

The CFIA has therefore determined that the unconfined environmental release of corn event MON 87411 in Canada will not result in altered impacts on non-target organisms, including humans, compared to currently grown corn varieties.

5. Potential Impact of Corn Event MON 87411 on Biodiversity

Corn event MON 87411 expresses no novel phenotypic characteristics that would extend its range beyond the current geographic range of corn production in Canada. Since corn has no sexually compatible relatives with which it can outcross in Canada, there will be no transfer of the novel traits to other species in unmanaged environments. Corn event MON 87411 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 corn event MON 87411 will have any direct effects on biodiversity, in comparison to the effects that would be expected from the cultivation of corn varieties currently grown in Canada.

At present, crop rotation, the use of corn rootworm resistant corn varieties and chemical insecticide treatments are common practices to control corn rootworm in Canada. Corn event MON 87411 provides an alternative method to existing methods to control corn rootworm. Therefore, the reduction in local corn rootworm populations as a result of the release of corn event MON 87411 does not present a significant change from existing agricultural practices.

Corn event MON 87411 has tolerance to glyphosate herbicides. 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 which 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, corn event MON 87411 or the cultivation of corn. It is therefore unlikely that corn event MON 87411 will have any indirect effects on biodiversity, in comparison to the effects that would be expected from cultivation of currently grown corn varieties.

The CFIA has concluded that the introduced genes and their corresponding novel traits do not confer to corn event MON 87411 any characteristic that would result in unintended environmental effects following unconfined release. The CFIA has therefore concluded that the potential impact on biodiversity of corn event MON 87411 is unlikely to be different from that of the corn varieties that are currently grown in Canada.

6. Potential for Development of Insect Resistance to Corn Event MON 87411

Additionally, with respect to its unconfined release into the environment, cultivation of corn event MON 87411 is subject to insect resistance management requirements. Since corn event MON 87411 is not intended to be cultivated as an individual event in Canada, an insect resistance management plan specific to this product is not required at this time. However, if corn event MON 87411 is cultivated in Canada as an individual event, an insect resistant management plan must be implemented in order to delay the development of resistance to Cry3Bb1 and DvSnf7 dsRNA in corn rootworm populations.

V. Criteria for the Livestock Feed Assessment

The AFD considered nutrient and anti-nutrient profiles; the safety of feed ingredients derived from corn event MON87411, 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 corn event MON87411 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

1. Potential Impact of Corn Event MON 87411 on Livestock Nutrition

Nutrient and Anti-Nutrient Composition

The nutritional equivalence of corn event MON 87411 to unmodified control corn variety (NL6169) and 20 conventional control corn varieties was determined from 8 (with 4 replicates at each site) field trials in Argentina during the 2011/2012 growing season.

Grain and forage samples were collected from corn event MON 87411, the unmodified control corn variety and conventional control corn from each plot and analysed for moisture, ash, protein, crude fat, carbohydrates (by calculation), acid detergent fibre (ADF) and neutral detergent fibre (NDF). Grain samples were further analysed for amino acids, fatty acids, vitamins, minerals, and anti-nutrients (phytic acid) as recommended by the OECD consensus document for new varieties of corn (OECD 2002).

Composition data was analysed statistically using a mixed model analysis of variance based on data combined across all field sites. Statistically significant differences among the corn types were identified and assessed (P<0.05). For each component analysis, individual mean comparison test of corn event MON 87411 vs. unmodified control corn variety was conducted. The biological relevance of any significant difference among corn varieties was assessed by comparing the observed values to the range of the values observed in the unmodified control corn variety and conventional control corn varieties grown in the trials, and in the published scientific literature (ILSI, 2011).

No statistically significant differences were observed in the forage between the unmodified control corn variety and corn event MON 87411 for protein, fat, carbohydrates, ADF and NDF. A statistically significant effect was found between corn event MON 87411 and the unmodified control corn forage for ash. However, the means were within the range of the values observed in the conventional control corn varieties grown within the trials and in the published literature (ILSI, 2011). No statistically significant differences were observed in the grain between the unmodified control corn variety and corn event MON 87411 for fat, ash, carbohydrates and ADF. Statistically significant effects were found between corn event MON 87411 and unmodified control corn variety for protein and NDF. However, the means were within the range of the values observed in the conventional control corn varieties grown within the trials and in the published literature (ILSI, 2011). No statistically significant difference was observed in between the unmodified control corn variety and corn event MON 87411 for both calcium and phosphorus. Statistically significant effects were found between corn event MON 87411 and unmodified control corn variety for copper, iron, manganese and zinc. However, these differences were not compositionally meaningful from feed safety perspective. Except for histidine and tyrosine, no statistically significant differences in amino acid composition were found between corn event MON 87411 and the unmodified control corn variety. Means levels of histidine and tyrosine were within the range of the values observed in the conventional control corn varieties grown in the trials and the published scientific literature (ILSI, 2011). Except for oleic acid, no statistically significant differences were observed in the fatty acids between the unmodified control corn variety and corn event MON 87411. The mean level of oleic acid was within the range of the values observed in the conventional control corn varieties grown in the trials and the published scientific literature (ILSI, 2011). Except for niacin and vitamin B1, no statistically significant differences were observed between the unmodified control corn variety and corn event MON 87411. The mean level of niacin and vitamin B1 were within the range of the values observed in the conventional control corn varieties grown in the trials and the published scientific literature (ILSI, 2011). No statistically significant differences were observed between corn event MON 87411 and the unmodified control corn varieties for anti-nutrients.

Conclusion

It was concluded, based on the evidence provided by Monsanto Inc. that the nutritional composition of corn event MON 87411 is similar to that of the conventional control corn varieties grown in the trials and to that reported for other corn in the published scientific literature. Feed ingredients derived from corn event MON 87411 are considered to meet present ingredient definitions for corn in Schedule IV of the Feeds Regulations.

2. Potential Impact of Corn Event MON 87411 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

Novel protein

To obtain sufficient quantities of CP4 EPSPS and Cry3Bb1 protein for assessment of environmental and feed safety, it was necessary to express the cp4 epsps and cry3Bb1 genes in an E. coli production system. Equivalency was demonstrated between corn event MON 87411-produced CP4 EPSPS and Cry3Bb1 protein and E. coli-produced CP4 EPSPS and Cry3Bb1 protein by comparing their molecular weights, immunoreactivity, N-terminal sequence analysis, MALDI-TOF mass spectrometry and functional activity. Based on the results, the proteins were found to be equivalent, which allowed for the CP4 EPSPS and Cry3Bb1 protein produced in E. coli to be used in studies to confirm the safety of the CP4 EPSPS and Cry3Bb1 protein produced in corn event MON 87411.

The potential allergenicity and toxicity of the CP4 EPSPS and Cry3Bb1 proteins to livestock were evaluated. With respect to its potential allergenicity, no single experimental method yields decisive evidence, thus a weight-of-evidence approach was used, taking into account information obtained with various test methods results submitted by Monsanto Canada Inc. The source of the cp4 epsps and cry3bb1 genes: Agrobacterium sp. and Bacillus thuringiensis respectively, are not known to produce allergens. A bioinformatics evaluation of the CP4 EPSPS and Cry3Bb1 protein amino acid sequences confirmed the lack of relevant similarities between the CP4 EPSPS and Cry3Bb1 proteins and known allergens. Protein safety studies of E. coli-produced CP4 EPSPS and Cry3Bb1 indicated that, unlike many allergens, these proteins are degraded in simulated gastric fluid and are not heat stable. The weight of evidence thus indicates that the CP4 EPSPS and Cry3Bb1 proteins are unlikely to be allergenic.

In terms of their potential toxicity to livestock, the CP4 EPSPS and Cry3Bb1 proteins lack a mode of action to suggest that they are intrinsically toxic to livestock. A bioinformatics evaluation of the CP4 EPSPS and Cry3Bb1 protein amino acid sequences confirmed the lack of relevant similarities between the CP4 EPSPS and Cry3Bb1 proteins to known toxins. In addition, protein safety studies of E. coli-produced CP4 EPSPS indicated that no adverse effects were observed when the CP4 EPSPS protein was ingested by mice at doses of approximately 572 mg/kg bwt in an acute study. A 42-day feeding study in broilers demonstrated that there were no biologically relevant differences in broiler performance or carcass yield or mortality between broilers fed diets containing corn event MON 87411 grain and those fed diets containing the near isogenic conventional control or commercial conventional corn varieties. A 56 day feeding study in Channel catfish showed no significant differences in fish behaviours, weight gain, diet consumption or survival among the fish fed diets containing corn event MON 87411 grain and those fed control diets. In a 90 day feeding study in rats, dietary administration of ground grain from corn event MON 87411 in the diet had no observed effects on growth or health of the rats. In addition, bacterially produced equivalent Cry3Bb1 protein safety studies previously provided for assessment of corn events MON 88017 and MON 863 indicated that no adverse effects were observed when the Cry3Bb1 protein was ingested by mice at doses of approximately 1930 mg/ kg body weight. This information indicates that the Cry3Bb1and CP4 EPSPS proteins are unlikely to be toxic to livestock.

The livestock exposure to the CP4 EPSPS and Cry3Bb1 protein is expected to be negligible as these proteins are expressed at very low levels in corn event MON 87411 and are rapidly degraded under conditions which simulate the mammalian digestive tract.

Novel DvSnf7 RNA products

Expression of the DvSnf7 RNA suppression cassette does not result in the production of novel proteins; therefore, there is no risk of new protein toxins or allergens being introduced into corn event MON 87411. Small ncRNAs present in corn event MON 87411 were not considered to present a risk to human or animal health or the environment based on a weight of evidence approach considering numerous factors. A bioinformatic analysis was conducted to determine if any matching sequences were present in various non-target genomes if the dsRNA was to be taken up and reach potential targets in biologically active concentrations. No ≥21 nt contiguous matches were found for the 23 species evaluated including various livestock species. This suggests a lack of a target for which the dsRNA could exert its effect in livestock or other non-target organisms.

In plants and animals, small noncoding RNAs play central roles in endogenous gene regulation and response to exogenous DNA. A 28-day gavage study of dsRNA and siRNA in mice demonstrated that 21-bp siRNAs and 218-bp dsRNAs with 100% sequence identity to a mouse gene did not result in adverse effects or alterations in gene expression when administered orally to mice at doses up to 100 mg/kg, further adding to the weight of evidence. Finally, the systemic absorption by livestock of exogenous small ncRNAs from crops is considered to be unlikely based on information in the scientific literature.

To obtain sufficient quantities of DvSnf7 RNA for further assessment of feed safety, it was necessary to produce it through in vitro transcription from the plasmid pMON14960. Equivalency was demonstrated between corn event MON 87411-produced DvSnf7 RNA and in vitro transcription from pMON149601. DvSnf7 RNA equivalency was demonstrated by northern and western blot analysis, sequencing of the transcript, identification of the presence of the dsRNA region which has been shown to be the active region of DvSnf7 and functional activity. Therefore, the DvSnf7 RNA produced in vitro and dosed in the 28 day gavage study in mice supports the safety of the DvSnf7 RNA produced in corn event MON 87411.

Toxicity and feeding trials were also conducted to demonstrate the safety of corn event MON 87411 to livestock. A 42-day feeding study in broilers demonstrated that there were no biologically relevant differences in broiler performance or carcass yield or mortality between broilers fed diets containing corn event MON 87411 grain and those fed diets containing the near isogenic conventional control or commercial conventional corn varieties. A 56 day feeding study in Channel catfish showed no significant differences in fish behaviours, weight gain, diet consumption or survival between the fish fed diets containing corn event MON 87411 grain and those fed control diets. In a 90 day feeding study in rats, dietary administration of ground grain from corn event MON 87411 in the diet had no observed effects on growth or health of the rats. A 28- day gavage study of DvSnf7_968 RNA in mice was also conducted. There was a lack of adverse effects following a daily dosing up to 100 mg/kg DvSnf7_968 RNA for 28 consecutive days. This dose level is several times greater than expected levels to be consumed by livestock through consumption of corn event MON 87411. The weight of evidence thus indicates that the inserted DvSnf7 expression cassette and resulting dsRNA in corn event MON 87411 are unlikely to pose a risk to human and animal health as compared to the non-transgenic control.

Chemical pesticide residue profile

The safety of herbicide residues and metabolites in corn event MON 87411, following application of herbicide, was also evaluated as part of the feed safety assessment. It was determined that potential glyphosate residues and metabolites in livestock commodities derived from corn event MON 87411 and its products would not present levels of concern to livestock or human health, via the potential transfer into foods of animal origin. The livestock feeding trial in broilers, which used corn meal derived from corn event MON 87411 treated with glyphosate herbicide, did not show any evidence of performance or health effects, providing additional support for the safety of corn meal derived from corn event MON 87411, relative to the proposed use pattern of glyphosate.

Conclusion

It was concluded, based on the evidence provided by Monsanto Canada Inc., that the novel CP4 EPSPS protein-based herbicide tolerance and the novel Cry3Bb1protein-based insect resistance as well as the novel DvSnf7 RNAi-based insect resistance traits will not confer to corn event MON 87411 any characteristic that would raise concerns regarding the safety of MON 87411 corn to livestock. Feed ingredients derived from corn event MON 87411 are considered to meet present ingredient definitions for corn, and as such are approved for use as livestock feed in Canada.

VI. New Information Requirements

If at any time, Monsanto 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 corn event MON 87411 or lines derived from it, Monsanto 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 corn event MON 87411 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 corn event MON 87411.

VII. Regulatory Decision

Based on the review of the data and information submitted by Monsanto 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 corn event MON 87411 does not present altered environmental risk when compared to corn varieties that are currently grown in Canada.

Based on the review of the data and information submitted by Monsanto Canada Inc. and input from other relevant scientific sources, the Animal Feed Division of the Animal Health Directorate, CFIA, has concluded that the novel genes and their corresponding traits will not confer to corn event MON 87411 any characteristic that would raise concerns regarding the safety or nutritional composition of corn event MON 87411. Livestock feeds derived from corn are currently listed in IV of the Feeds Regulations and are, therefore approved for use in livestock feeds in Canada. Corn event MON 87411 has been found to be as safe as and as nutritious as currently and historically grown corn varieties. Corn event MON 87411 and its products are considered to meet present ingredient definitions and are approved for use as livestock feed ingredients in Canada.

Unconfined release into the environment and use as livestock feed of corn event MON 87411 and of any lines derived from it 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 October 21st, 2015. Any corn lines derived from corn event MON 87411 may also be released into the environment and used as livestock feed, provided that:

  1. no inter-specific crosses are performed,
  2. the intended uses are similar,
  3. it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to corn 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
  4. the novel genes are expressed at a level similar to that of the authorized line.

Additionally, with respect to its unconfined release into the environment, cultivation of corn event MON 87411 is subject to insect resistance management requirements.

Corn event MON 87411 is subject to the same phytosanitary import requirements as unmodified corn varieties. Corn event MON 87411 is required to meet the requirements of other Canadian legislation, including but not limited to the requirements set out in the Food and 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 corn event MON 87411.

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