Decision Document DD 2012-89: Determination of the Safety of Monsanto Canada Inc. Corn Zea mays L.) Event MON 87427

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This Decision Document has been prepared to explain the regulatory decision reached under Directive 94-08 (Dir94-08), entitled "Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits", its companion biology document BIO1994-11, "The Biology of Zea mays L. (Maize)", and Chapter 2.6 of the Regulatory Guidance: Feed Registration Procedures and Labelling Standards, entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources".

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 the glyphosate-tolerant corn event MON 87427. 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 currently commercialized corn varieties in Canada.

Taking into account these evaluations, unconfined release into the environment and use as livestock feed of corn event MON 87427 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 June 8, 2012. Any corn lines derived from corn event MON 87427 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 currently grown corn in Canada, in terms of their potential environmental impact and livestock feed safety, and
  4. the novel gene is expressed at a level similar to that of the authorized line.

Corn event MON 87427 is subject to the same phytosanitary import requirements as its unmodified counterparts. Corn event MON 87427 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 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.

This bulletin is published by the Canadian Food Inspection Agency. For further information, please contact the Plant Biosafety Office or the Animal Feed Division at:

Plant Biosafety Office
Plant Health and Biosecurity Directorate
59 Camelot Drive
Ottawa ON  K1A 0Y9
613-773-5000
Animal Feed Division
Animal Health Directorate
59 Camelot Drive
Ottawa ON  K1A 0Y9
613-225-2342

Table of Contents

  1. Brief Identification of the Modified Plant
  2. Background Information
  3. Description of the Novel Trait
    1. Development Method
    2. Tolerance to Glyphosate
    3. Stable Integration into the Plant Genome
  4. Criteria for the Environmental Assessment
    1. Potential of Corn Event MON 87427 to Become a Weed of Agriculture or be Invasive of Natural Habitats
    2. Potential for Gene Flow from Corn Event MON 87427 to Sexually Compatible Plants Whose Hybrid Offspring May Become More Weedy of More Invasive
    3. Altered Plant Pest Potential of Corn Event MON 87427
    4. Potential Impact of Corn Event MON 87427 on Non-Target Organisms
    5. Potential Impact of Corn Event MON 87427 on Biodiversity
  5. Criteria for the Livestock Feed Assessment
    1. Potential Impact of Corn event MON 87427 on Livestock Nutrition
    2. Potential Impact of Corn event MON 87427 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
  6. New Information Requirements
  7. Regulatory Decision

I. Brief Identification of the Modified Plant

Designation of the Modified Plant: Corn event MON 87427, OECD Unique Identifier MON-87427-7
Applicant: Monsanto Canada Inc.
Plant Species: Corn (Zea mays L.)
Novel Traits: Glyphosate tolerance – tissue specific
Trait Introduction Method: Agrobacterium–mediated transformation
Intended Use of the Modified Plant: Production of male sterile corn for use in production of hybrid corn for human consumption (wet mill products, dry mill products and seed oil) and oil, meal, grain, silage and other by-products for livestock feed. These plants are not intended to be grown outside the normal production area for corn in Canada.

II. Background Information

Corn event MON 87427 was developed by Monsanto Company using recombinant DNA technology, resulting in the introduction of the cp4 epsps gene. The cp4 epsps gene encodes a CP4-EPSPS protein, derived from Agrobacterium sp. strain CP4, which confers tolerance to glyphosate-based herbicides. Corn event MON 87427 utilizes a specific promoter and intron combination which drives CP4 EPSPS protein expression in vegetative and female reproductive tissues, conferring tolerance to glyphosate in the leaves, stalk and root tissues and tissues that develop into seed or grain and silks but not in two key male reproductive tissues. Thus, in corn event MON 87427, male reproductive tissues, critical for male gametophyte development, are not tolerant to glyphosate and application of glyphosate during the tassel development stages (approximate V8-V13) will produce a male sterile phenotype through tissue-selective glyphosate tolerance, eliminating or greatly reducing the need for detasseling during the production of hybrid corn seed. Tissue-specific expression of CP4 EPSPS protein in corn event MON 87427 enables an extension of the use of glyphosate-tolerant corn as a tool in hybrid corn seed production.

Monsanto Canada Inc. has provided data on the identity of corn event MON 87427, a detailed description of the transformation method, data and information on the gene insertion site, gene copy number and levels of gene expression in the plant, and the role of the inserted gene and regulatory sequences. The novel protein was identified and characterized. Data was provided for the evaluation of the potential toxicity of the novel protein to livestock and non-target organisms and potential allergenicity of the novel protein to humans and to livestock.

Corn event MON 87427 has been field tested at 16 sites located within the major corn producing regions of the United States (US) in 2008. Some of the locations (Michigan, Wisconsin, and Jefferson and Benton Counties in Iowa) of these trials share similar environmental and agronomic conditions to corn production areas in Southern Ontario and Quebec and were considered representative of major Canadian corn growing regions.

Agronomic characteristics of corn event MON 87427, including seedling vigour, early stand count, days to 50% pollen shed, days to 50% silking, stay green, ear height, plant height, dropped ears, stalk lodge plants, root lodge plants, final stand count, grain moisture, test weight, yield, susceptibilities to various corn pests and pathogens, dormancy/germination, volunteer potential, and potential to survive in unmanaged ecosystems, were compared to those of the unmodified control.

Nutritional components of corn event MON 87427, such as proximates, acid detergent fibre, neutral detergent fibre, amino acids, fatty acids, minerals, vitamins, anti-nutrients, and secondary metabolites, were compared with those of the unmodified control.

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

The PBRA Unit has considered:

  • the potential of corn event MON 87427 to become a weed of agriculture or be invasive of natural habitats;
  • the potential for gene flow from corn event MON 87427 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive;
  • the potential for corn event MON 87427 to become a plant pest;
  • the potential impact of corn event MON 87427 or the gene products on non-target species, including humans; and
  • the potential impact of corn event MON 87427 on biodiversity.

The Animal Feed Division of the Animal Health Directorate, 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 Chapter 2.6 of the Regulatory Guidance: Feed Registration Procedures and Labelling Standards, entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources".

The Animal Feed Division has considered both intended and unintended effects and similarities and differences between the modified plant and its counterpart relative to the safety and efficacy of feed ingredients derived from corn event MON 87427 for their intended purpose; including:

  • potential impact of corn event MON 87427 on livestock nutrition and
  • potential impact of corn event MON 87427 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 Animal Feed Division has also considered whether feeds derived from corn event MON 87427 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

Monsanto Canada Inc. has provided the CFIA with a method for the detection and identification of corn event MON 87427.

III. Description of the Novel Trait

1. Development Method

Corn event MON 87427 was developed through Agrobacterium-mediated transformation of immature corn embryos. After infection with Agrobacterium, the immature embryos were placed in a selection medium containing glyphosate to select for positive transformed cells, as well as carbenicillin disodium salt to limit the growth of Agrobacterium. Event MON 87427 was selected as the lead event based on superior phenotypic characteristics and its comprehensive molecular profile.

2. Tolerance to Glyphosate

The herbicide glyphosate targets the 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) enzyme in plants, which is part of the shikimic acid pathway essential for the production of the aromatic amino acids, leading to growth suppression or death of the plant. A gene derived from the Agrobacterium sp. strain CP4 (cp4 epsps), which imparts field level tolerance to glyphosate, was introduced into corn event MON 87427. A plant-derived coding sequence expressing a chloroplast transit peptide was fused to the cp4 epsps coding sequence. This peptide facilitates the import of the newly translated CP4 EPSPS enzyme into the chloroplast, the site of amino acid biosynthesis. The CP4 EPSPS version of this enzyme expressed in corn event MON 87427 confers glyphosate tolerance since it continues to catalyze the production of aromatic amino acids in the presence of glyphosate due to a reduction in the binding of glyphosate to the CP4 EPSPS in comparison to the native corn EPSPS.

The CP4 EPSPS protein in corn event MON 87427 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 protein produced in glyphosate-tolerant crops which have already been authorized for unconfined release or animal feed uses in Canada, including soybean (DD1995-05 and DD2007-67), corn (DD2002-35), canola (DD95-02), sugar beet (DD2005-54) and cotton (DD2005-56).

cp4 epsps gene expressed in corn event MON 87427 is linked to a promoter and intron combination which drives lower expression in male reproductive tissues (pollen microspore and tapetum cells). Samples of corn tissues were collected at various growth stages from three representative US field trial sites. Either the range of the average or the average CP4 EPSPS protein expression in micro-grams protein per gram dry weight tissue (µg/g dwt) as evaluated by enzyme-linked immunosorbent assay are as follows: 290-680 µg/g dwt in over season leaf (various growth stages), 4.2 µg/g dwt in grain, 0.87 µg/g dwt in pollen at pollination, 100 µg/g dwt in silk during pollination, 120 µg/g dwt in forage, 43 µg/g dwt in stover, 72-140 µg/g dwt in root (various growth stages) 240-500 µg/g dwt in over season whole plant (various growth stages).

To obtain sufficient quantities of CP4 EPSPS protein for evaluation 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 87427-produced CP4 EPSPS protein and a microbial-produced CP4 EPSPS protein that had been used in studies previously submitted for authorized Monsanto glyphosate-tolerant crops. These studies were accepted to support the safety of corn event MON 87427. The equivalency of the corn event MON 87427-produced CP4 EPSPS protein to the microbial produced CP4 EPSPS was evaluated by comparing their molecular weights, immunoreactivities, glycosylation status and functional activities.

Monsanto Canada Inc. provided a bioinformatics evaluation of the CP4 EPSPS protein, which confirmed the lack of relevant similarities between the CP4 EPSPS protein sequence and sequences of known allergens and toxins. Many allergens have been reported to be expressed at high levels in plants and resistant to digestive enzymes. The CP4 EPSPS protein was expressed at low levels in corn event MON 87427, and the microbial CP4 EPSPS safety studies provided for previous submissions for crops containing the CP4 EPSPS protein indicated that the CP4 EPSPS protein is readily degraded in simulated mammalian gastric and intestinal fluids. The previous studies also indicated that the CP4 EPSPS protein did not cause any adverse effects in mice at a level of 572 mg/kg body weight. Therefore, based on the weight of evidence, the CP4 EPSPS protein expressed in corn event MON 87427 is unlikely to be toxic or allergenic to mammals.

3. Stable Integration into the Plant Genome

Molecular characterization by Southern blot analysis demonstrated that corn event MON 87427 contains one intact copy of the cp4 epsps gene cassette at a single site in the corn genome. No additional elements, including intact or partial DNA fragments of the cp4 epsps gene cassette or backbone sequences from the vector, linked or unlinked to the intact insert, were detected in corn event MON 87427. DNA sequence analysis confirmed that the insertion event resulted in small insertions and deletions of genomic DNA, however no new open reading frames were created. These insertional effects are not uncommon in transformation events, and 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.

The stability of the inserted DNA in corn event MON 87427 was demonstrated by Southern blot analysis across five breeding generations. Analysis of the inheritance pattern of the cp4 epsps gene and the glyphosate tolerance phenotype within multiple segregating generations of corn event MON 87427 confirmed the stability of the inserted DNA and the stability of CP4 EPSPS protein expression. The results of the analysis are consistent with the finding of a single site of insertion that segregates according to the Mendelian laws of genetics.

IV. Criteria for the Environmental Assessment

1. Potential of Corn Event MON 87427 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. Monsanto Canada Inc. provided data on phenotypic and agronomic traits to establish that corn event MON 87427 is not weedier or more invasive than commercially available Canadian corn hybrids.

The CFIA evaluated data submitted by Monsanto Canada Inc. on the reproductive biology and life history traits of corn event MON 87427. This event was field tested in the US at 16 trial locations in the 2008 growing season. Some of the locations (Michigan, Wisconsin and Iowa) of these trials share similar environmental and agronomic conditions to corn production areas in Southern Ontario and Quebec and were considered representative of major Canadian corn growing regions, of which this product may be intended for cultivation. During the field trials, corn event MON 87427 was compared to an unmodified control that had a similar genetic background but without the novel trait. Commercially available hybrids were also grown in these trials to provide a reference range for typical corn behaviour. 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 seedling vigour, early stand count, days to 50% pollen shed, days to 50% silking, stay green, ear height, dropped ears, stalk lodge plants, root lodge plants, final stand count, grain moisture, test weight and yield. Although instances of statistically significant differences were detected between corn event MON 87427 and the unmodified control for some traits in the individual-site analyses, there were few consistent trends in the data across locations that would indicate that any of these differences were due to genetic modification. A single trait, seedling vigour, indicated that there was a trend of poorer vigour occurring in corn event MON 87427 that was not occurring in the unmodified control, but the values were within the reference range established as typical corn behaviour in the same field trials and therefore not biologically meaningful.

Monsanto Canada Inc. provided information on the dormancy and germination of corn event MON 87427 seed under seven different temperature regimes. During the trials, seed germination characteristics were evaluated including percent germinated seed (normal and/or abnormal), percent hard seed (viable and non-viable), percent dead seed and percent firm swollen seed (viable and non-viable). Although instances of statistically significant differences were observed between corn event MON 87427 and the unmodified control for percent germinated seed, percent viable swollen seed and percent dead seed, these differences were not consistently detected across temperature regimes and the values were within the range of reference established for conventional corn varieties.

Monsanto Canada Inc. provided information on the pollen viability and morphology of corn event MON 87427. During the trials, pollen characteristics were evaluated including viability, diameter and general morphology. No statistically significant differences were detected between corn event MON 87427 and the unmodified control for pollen diameter. Furthermore, no visual differences were observed in general pollen morphology between corn event MON 87427 and the unmodified control. Although instances of significant differences were observed for percent pollen viability, the differences were small in magnitude and not therefore not considered to be biologically meaningful.

Volunteer potential was assessed at two locations in the US. Corn event MON 87427 seeds were seeded in the fall of 2008. A small number of volunteer plants were detected at both sites in the following spring, however there was no statistically significant difference between corn event MON 87427 and the unmodified control.

The susceptibility of corn event MON 87427 to various abiotic stressors was evaluated in the field at the same locations as the phenotypic characteristic studies. The stressors observed included cold stress, drought, flood, frost, hail, heat stress, mineral toxicity, nitrogen deficiency, nutrient deficiency, soil compaction, wet soil and wind. No qualitative differences were observed for any of the 172 observations between corn event MON 87427 and the unmodified control.

The susceptibility of corn event MON 87427 to various corn pests and pathogens was evaluated in the field at the same locations as the agronomic characteristics studies (further detail provided below in Section 3: Altered Plant Pest Potential of Corn Event MON 87427). No trend in increase or decrease of susceptibility was observed in corn event MON 87427 compared to the unmodified control.

The introduction of the cp4 epsps expression cassette did not make corn event MON 87427 weedy or invasive of natural habitats since none of the corn's reproductive or growth characteristics were modified, and the tolerance of corn event MON 87427 to abiotic and biotic stresses was unchanged as well. No competitive advantage was conferred to corn event MON 87427, other than that conferred by tolerance to glyphosate herbicide.

The CFIA considered the changes in usual agronomic practices that may arise from volunteer plants with novel herbicide tolerances. Similarly, the CFIA considered the potential that continued application of the same herbicide in subsequent rotations may lead to increased selection pressure for herbicide resistant weed populations. In order to address these issues, a herbicide stewardship plan which includes integrated pest 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.

Monsanto Canada Inc. has submitted a herbicide tolerance stewardship plan which was evaluated by the CFIA. The stewardship plan contains recommendations to address these concerns, as well as appropriate strategies that will allow for the environmentally safe and sustainable deployment of this trait. In addition, the stewardship plan contains strategies for communication to growers and an efficient mechanism allowing growers to report problems to Monsanto Canada Inc. Monsanto Canada Inc. will make this stewardship plan readily available to growers to promote careful management practices for corn event MON 87427.

This information, together with the fact that the novel trait has no intended effects on corn weediness or invasiveness, led the CFIA to conclude that corn event MON 87427 has no altered weed or invasiveness potential compared to conventional corn varieties currently grown in Canada.

2. Potential for Gene Flow from Corn Event MON 87427 to Sexually Compatible Plants Whose Hybrid Offspring May Become More Weedy of More Invasive

The biology of corn, as described in the CFIA biology document BIO1994-11, indicates that there are no wild relatives in Canada that can hybridize with corn. The glyphosate tolerance trait is unrelated to sexual compatibility and the information submitted by Monsanto Canada Inc. on corn event MON 87427 indicates that it behaves similarly to commercially available corn in terms of reproduction.

The CFIA has therefore concluded that gene flow from corn event MON 87427 to wild relatives is not possible in Canada.

3. Altered Plant Pest Potential of Corn Event MON 87427

Corn is not considered a plant pest in Canada. The expression of the CP4 EPSPS protein in corn event MON 87427 is not expected to have effects on susceptibility to corn pests or pathogens.

The susceptibility of corn event MON 87427 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, armyworm, bill bug, black cutworm, chinch bug, corn earworm, corn rootworm beetle, cutworm, European corn borer, fall armyworm, flea beetle, grasshopper, Japanese beetle, seedcorn beetle, southern corn leaf beetle, southern corn borer, spider mite, stalk borer, stink bug, thrips, white grub, wireworm, anthracnose, bacterial leaf spot, black sooty mold, brown spot, ear rot, eyespot, Fusarium, grey leaf spot, kernel red streak, leaf blight, maize dwarf mosaic virus, northern corn leaf blight, purple corn syndrome, Pythium, Rhizoctonia, root rot, rust, seedling blight, seedling rot, smut, southern leaf blight, stalk rot and Stewart's wilt. Ecological evaluations of corn event MON 87427 did not show any increase or decrease in susceptibility to disease stressors compared to an unmodified line with similar genetic background and commercial corn varieties grown at the same locations for any of the 210 observations. Furthermore, no qualitative differences were observed between corn event MON 87427 and the unmodified control for any of the 167 observations for plant damage caused by arthropods.

Monsanto Canada Inc. has quantitatively assessed the corn earworm and European corn borer damage in the field at the same locations as the phenotypic characteristic studies, but at four sites only. Although instances of significant differences were detected between corn event MON 87427 and the unmodified control for corn earworm and European corn borer damage in the individual-site analyses, there was no trend observed across observations or sites and is unlikely to be biologically meaningful.

The CFIA therefore concludes that corn event MON 87427 does not display any altered pest potential compared to corn varieties currently grown in Canada.

4. Potential Impact of Corn Event MON 87427 on Non-Target Organisms

The glyphosate herbicide tolerance trait introduced into corn event MON 87427 is unrelated to potential impact on non-target organisms. The CP4 EPSPS protein expressed in corn event MON 87427 is identical to the CP4 EPSPS protein produced in other glyphosate-tolerant crops that have been reviewed and authorized in Canada and have a history of safe use, including the glyphosate-tolerant products previously mentioned. As the environmental safety of the CP4 EPSPS protein has previously been established, no negative impacts resulting from exposure of organisms to the CP4 EPSPS protein expressed in corn event MON 87427 are expected.

Composition analyses showed that the levels of key nutrients, anti-nutrients and secondary metabolites in corn event MON 87427 grain and forage are comparable to those in conventional corn varieties. Therefore, it is very unlikely that the genetic transformation may have caused unintended changes to the composition of corn event MON 87427 tissues that would negatively impact organisms interacting with corn event MON 87427.

Ecological evaluations confirmed that the abundance of pest and beneficial arthropods in corn event MON 87427 plots was similar to that in conventional corn grown at the same locations. The pest and beneficial arthropods assessed included aphids, corn earworm, corn flea beetle, delphacid planthopper, grasshopper, leafhopper, northern corn rootworm, sap beetle, southern corn rootworm, western corn rootworm, Aranea, big-eyed bug, brown lacewing, green lacewing, ladybird beetle, macro-parasitic Hymenoptera, micro-parasitic Hymenoptera, Nabis spp. and Orius spp. A total of 203 observations were made between corn event MON 87427 and the unmodified control, including 98 observations of arthropod pests and 105 observations of beneficial arthropods. Although four significant differences were detected out of 98 observations for pest arthropod abundance involving corn flea beetle, grasshoppers and leafhoppers, these differences were small in magnitude, not indicative of a consistent trend associated with the trait and not biologically meaningful. Furthermore, a total of eight differences were detected out of 105 observations for beneficial arthropods involving Aranae, ladybird beetles, macro-parasitic Hymenoptera, Nabis spp. and Orius spp. The differences detected were all within the range of referance cultivars, except for ladybird beetles, Nabis spp. and macro-parasitic Hymenoptera; however the differences detected for ladybird beetles and Nabis spp. were not indicative of a trend response across observation times or across sites and the differences detected for macro-parasitic Hymenoptera were not observed at other sites. The results support that the detected differences in beneficial and pest arthropod abundance showed no indication of a trend response associated with the trait and are not biologically meaningful. Therefore, ecological evaluations of corn event MON 87427 did not show any increase in resistance to pest insects or pathogens compared to commercial corn varieties (further detail provided above in Section 3: Altered Plant Pest Potential of Corn Event MON 87427).

Collectively, these information elements indicate that the interactions between corn event MON 87427 and the populations of animals and microorganisms interacting with corn, including beneficial arthropods, will be similar compared to conventional corn.

The CFIA has therefore determined that the unconfined release of corn event MON 87427 will not result in altered impacts on non-target organisms, including humans, compared to corn varieties currently grown in Canada.

5. Potential Impact of Corn Event MON 87427 on Biodiversity

Corn event MON 87427 expresses no novel phenotypic characteristics that would extend its range beyond the current geographic range of corn production in Canada. Since corn has no wild relatives with which it can outcross in Canada, there will be no transfer of the novel trait to other species in unmanaged environments. The novel trait is unlikely to have an impact on plant pest potential or non-target organisms. It is therefore unlikely that corn event MON 87427 will have any direct effects on biodiversity, in comparison to the effects that would be expected from the cultivation of currently grown Canadian corn hybrids.

Corn event MON 87427 has tolerance to the broad spectrum herbicide glyphosate. 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 87427, or the cultivation of corn. It is therefore unlikely that corn event MON 87427 will have any indirect effects on biodiversity, in comparison to the effects that would be expected from cultivation of currently cultivated corn varieties.

The CFIA has concluded that the novel gene and its corresponding trait do not confer to corn event MON 87427 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 87427 is unlikely to be different from that of corn varieties currently grown in Canada.

V. Criteria for the Livestock Feed Assessment

The Animal Feed Division considered nutrient and anti-nutrient profiles; the safety of feed ingredients derived from corn event MON 87427, including the presence of gene products, residues, and metabolites in terms of animal health and human safety as they relate 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 MON 87427 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

1. Potential Impact of Corn event MON 87427 on Livestock Nutrition

Nutrient and anti-nutrient composition

The nutritional equivalence of corn event MON 87427 (glyphosate-treated) to an unmodified control corn (LH198 x LH287) and 12 conventional corn varieties was determined from replicated field sites in the US during the 2008 growing season. Forage and grain samples were collected and analyzed for proximates (protein, crude fat, ash, moisture), acid detergent fibre (ADF) and neutral detergent fibre (NDF), calcium and phosphorus. Grain samples were further analyzed for amino acids, fatty acids, minerals, vitamins, anti-nutrients (phytic acid and raffinose) and secondary metabolites (ferulic acid, furfural and p-coumaric acid). No statistically significant differences were observed between corn event MON 87427 forage and that of the unmodified control for proximates, ADF, NDF, calcium and phosphorus. All means of the corn event MON 87427 forage analytes were within the natural variation of the conventional corn varieties. Statistically significant differences were observed between corn event MON 87427 and unmodified control corn for total fat; however, the mean value was within the 99% tolerance intervals for the population of conventional corn varieties and published literature values. In the combined-site analysis of the grain, no statistically significant differences were observed between corn event MON 87427 and the unmodified control for amino acids, minerals and vitamins analyzed. Statistically significant differences were observed between corn event MON 87427 grain and the unmodified control for palmitic acid (C16:0), stearic acid (C18:0), oleic acid (C18:1), linoleic acid (C18:2) and arachidic acid (C20:0). Mean values for these components were within the 99% tolerance intervals for the population of conventional corn varieties. The phytic acid content of corn event MON 87427 grain was significantly lower than the unmodified control, but the mean values were within the 99% tolerance intervals for the population of conventional corn varieties. There were no statistically significant differences observed for the secondary metabolites (ferulic acid and p-coumaric acid), when corn event MON 87427 was compared to the unmodified control. Furfural levels were below the limit of quantification for both corn event MON 87427 and unmodified control corn grain.

Conclusion

The evidence provided by Monsanto Canada Inc. supports the conclusion that the nutritional composition of corn event MON 87427 is comparable to conventional corn varieties.

2. Potential Impact of Corn event MON 87427 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

Corn event MON 87427 is tolerant to glyphosate as a result of insertion of gene encoding the CP4 EPSPS protein. The assessment of corn event MON 87427 evaluated the impact of the following potential hazards relative to the safety of feed ingredients derived from this event:

  • The presence of the novel CP4 EPSPS protein

Novel CP4 EPSPS protein

The CP4 EPSPS protein shares no significant biologically relevant sequence homology with any known toxins or allergens and lacks a mode of action that suggests that it is intrinsically toxic. The CP4 EPSPS protein was previously assessed in other glyphosate-tolerant crops which have already been authorized for unconfined release or animal feed uses in Canada, and it has been determined, based on the established equivalence, that the prior protein safety data may be used to support the safety of the CP4 EPSPS from corn event MON 87427.

These studies indicated that CP4 EPSPS protein is heat labile and rapidly degraded under conditions similar to those encountered in the gastrointestinal tract. No signs of toxicity were demonstrated in the original single-dose oral toxicity studies in mice using purified CP4 EPSPS protein from an E. coli at doses up to 572 mg/kg-bw. These factors support the lack of intrinsic toxicity or allergenicity of the CP4 EPSPS protein. Furthermore, the CP4 EPSPS protein has history of safe use, having been approved in prior events, and is found throughout the food chain.

Conclusion

Feed ingredients derived from corn event MON 87427 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 information regarding risk to the environment, including risk to human or animal health, which could result from release of corn event MON 87427 in Canada or elsewhere, Monsanto Canada Inc. will 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 87427 on the environment, livestock and human health, and may re-evaluate its decision with respect to the livestock feed use and environmental release authorization of corn event MON 87427.

VII. Regulatory Decision

Based on the review of the data and information submitted by Monsanto Canada Inc. and other relevant information, the CFIA has determined that corn event MON 87427 does not present altered environmental risk when compared to currently commercialized corn varieties in Canada.

Based on the review of submitted data and information by Monsanto Canada Inc. including comparisons of corn event MON 87427 with the unmodified control, the Animal Feed Division of the Animal Health Directorate, CFIA, has concluded that the novel gene and its corresponding traits will not confer to corn event MON 87427 any characteristic that would raise any concerns regarding the safety or nutritional composition of corn event MON 87427. Grain corn, its byproducts and corn oil are currently listed in Schedule IV of the Feeds Regulations and are, therefore, approved for use in livestock feeds in Canada. Corn event MON 87427 has been assessed and found to be as safe as and as nutritious as traditional corn varieties. Corn event MON 87427 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 87427 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 June 8, 2012. Any corn lines derived from corn event MON 87427 may also be released into the environment and used as livestock feed, provided that no inter-specific crosses are performed, the intended uses are similar, it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to currently grown corn in Canada, in terms of their potential environmental impact and livestock feed safety, and the novel gene is expressed at a level similar to that of the authorized line.

Corn event MON 87427 is subject to the same phytosanitary import requirements as its unmodified counterparts. Corn event MON 87427 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 corn event MON 87427. The food safety decisions are available at the Health Canada web site.

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