Decision Document 2012-90: Determination of the Safety of Monsanto Canada Inc. Canola (Brassica napus) Event MON 88302

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This Decision Document has been prepared to explain the regulatory decision reached under Directive 94-08 (Dir 94-08) - Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits, its companion biology document BIO1994-09 - The Biology of Brassica napus L. (Canola/Rapeseed), and Chapter 2.6 of the Regulatory Guidance: Feed Registration Procedures and Labelling Standards - 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 canola event MON 88302. 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 canola varieties in Canada.

Taking into account these evaluations, unconfined release into the environment and use as livestock feed of canola event MON 88302 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 canola lines derived from canola event MON 88302 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 canola 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.

Canola event MON 88302 is subject to the same phytosanitary import requirements as its unmodified counterparts. Canola event MON 88302 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
613-773-2342
Animal Feed Division
Animal Health Directorate
59 Camelot Drive
Ottawa ON K1A 0Y9
613-773-2342

Table of Contents

  1. Brief Identification of the Modified Plant
  2. Background Information
  3. Description of the Novel Traits
    1. Development Method
    2. Tolerance to Glyphosate
    3. Stable Integration into the Plant Genome
  4. Criteria for the Environmental Assessment
    1. Potential of Canola Event MON 88302 to Become a Weed of Agriculture or be Invasive of Natural Habitats
    2. Potential for Gene Flow from Canola Event MON 88302 to Sexually Compatible Plants Whose Hybrid Offspring May Become More Weedy or More Invasive
    3. Altered Plant Pest Potential of Canola Event MON 88302
    4. Potential Impact of Canola Event MON 88302 on Non-Target Organisms
    5. Potential Impact of Canola Event MON 88302 on Biodiversity
  5. Criteria for the Livestock Feed Assessment
    1. Potential Impact of Canola Event MON 88302 on Livestock Nutrition
    2. Potential Impact of Canola Event MON 88302 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 Canola event MON 88302, OECD Unique Identifier MON-883Ø2-9
Applicant Monsanto Canada Inc.
Plant Species Canola (Brassica napus L.)
Novel Traits Tolerance to glyphosate herbicide with enhanced expression in male reproductive tissues
Trait Introduction Method Agrobacterium-mediated transformation
Intended Use of the Modified Plant Production of canola quality B. napus for livestock feed and human food. These plants are not intended to be grown outside the normal production area for canola in Canada.

II. Background Information

Canola event MON 88302 was developed by Monsanto Company using recombinant DNA technology, resulting in the introduction of the cp4 epsps gene. The cp4 epsps gene, derived from Agrobacterium sp. strain CP4,encodes a 5-enolpyruvoyl-shikimate-3-phosphate synthetase (EPSPS) protein. The cp4 epsps gene expression in MON 88302 is enhanced in male reproductive tissues due to the presence of enhancer sequences in the gene promoter region. This enhanced expression confers increased tolerance to glyphosate-based herbicides in these tissues, which permits greater flexibility in the application of glyphosate herbicide.

Monsanto Canada Inc. has provided data on the identity of canola event MON 88302, 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 genes 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.

Canola event MON 88302 has been field tested at 17 sites located within the major canola producing regions of the United States and Canada in 2009. The Canadian locations were representative of canola growing regions in Canada.

Agronomic characteristics of canola event MON 88302, such as early stand count, seedling vigour, days to first flowering, seed maturity, lodging, plant height, pod shattering (visual rating and quantitative), seed moisture, seed quality and yield, were compared to those of the unmodified control.

Nutritional components of canola event MON 88302, such as proximates, acid detergent fibre, neutral detergent fibre, total detergent fibre, amino acids, fatty acids, minerals, vitamin E, and anti-nutrients 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) - Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits. The PBRA Unit has considered:

  • the potential of canola event MON 88302 to become a weed of agriculture or be invasive of natural habitats;
  • the potential for gene flow from canola event MON 88302 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive;
  • the potential for canola event MON 88302 to become a plant pest;
  • the potential impact of canola event MON 88302 or the gene products on non-target species, including humans; and
  • the potential impact of canola event MON 88302 on biodiversity.

The Animal Feed Division (AFD) 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 - Guidelines for the Assessment of Novel Feeds: Plant Sources.

The AFD 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 canola event MON 88302 for their intended purpose; including:

  • potential impact of canola event MON 88302 on livestock nutrition and
  • potential impact of canola event MON 88302 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 canola event MON 88302 meet the definitions and requirements 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 canola event MON 88302.

III. Description of the novel trait

1. Development Method

Canola event MON 88302 was developed through Agrobacterium-mediated transformation of immature canola embryos. Transformants were selected for glyphosate tolerance and the resulting plants were screened for the presence of the cp4 epsps expression cassette and absence of plasmid vector backbone. According to the developer, canola event MON 88302 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 canola event MON 88302. 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 canola event MON 88302 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 canola EPSPS.

The CP4 EPSPS protein produced in canola event MON 88302 is the same as the CP4 EPSPS protein produced in other 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 (DD1995-02), sugar beet (DD2005-54) and cotton (DD2005-56).

Canola event MON 88302 contains enhancer sequences in the cp4 epsps gene promoter region. The purpose of these enhancer sequences is to enhance cp4 epsps gene expression in male reproductive tissues of canola event MON 88302, compared to previous glyphosate-tolerant crops. Samples of canola tissues were collected at various growth stages from six field sites in the US and Canada, which were representative of canola producing regions suitable for commercial production. Average CP4 EPSPS protein expression levels in micro-grams protein per gram dry weight tissue (µg/g dwt) evaluated by enzyme-linked immunosorbent assay are as follows: 180-230 µg/g dwt in overseason leaf, 38-82 µg/g dwt in root, 170 µg/g dwt in forage and 27 µg/g dwt in mature seed.

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 an E. coli production system. Equivalency was demonstrated between canola event MON 88302-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 canola event MON 88302. The equivalency of the canola event MON 88302-produced CP4 EPSPS protein to E. coli-produced CP4 EPSPS used in previous safety studies was evaluated by comparing their molecular weights, immunoreactivity, glycosylation status, amino-terminal sequences, matrix-assisted laser desorption/ionization (MALDI) time-of-flight (TOF) mass spectrometry profiles and functional activity.

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 canola event MON 88302, 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 canola event MON 88302 is unlikely to be toxic or allergenic to mammals.

3. Stable Integration into the Plant Genome

Molecular characterization by Southern blot analysis demonstrated that canola event MON 88302 contains one intact copy of the cp4 epsps gene cassette at a single site in the canola 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 canola event MON 88302. 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 insert was demonstrated by Southern blot analysis over five generations. Stable expression of the CP4 EPSPS protein across five generations was also demonstrated by western blot analysis. Results from segregation analysis showed heritability and stability of the insert was as expected across multiple generations, which corroborates the molecular insert stability analysis and establishes the genetic behaviour of the DNA insert as a single chromosomal locus segregating according to the Mendelian laws of genetics.

IV. Criteria for the Environmental Assessment

1. Potential of Canola Event MON 88302 to Become a Weed of Agriculture or be Invasive of Natural Habitats

Canola possesses some of the characteristics that are common to weeds and invasive plants. It is an annual crop that may persist in unmanaged ecosystems without human intervention. There have been reports of B. napus becoming a weed of agriculture in North America and other parts of the world, however it has not become an abundant or problematic weed in Canada, despite being cultivated in Canada for many years. B. napus plants can grow as volunteers in cultivated fields in the seasons following a B. napus crop, but they are usually eliminated by soil cultivation or the use of herbicides. According to the information provided by Monsanto Canada Inc., canola event MON 88302 was determined not to be significantly different from the unmodified control in this respect.

The CFIA evaluated data submitted by Monsanto Canada Inc. on the reproductive biology and life history traits of canola event MON 88302. This event was field tested in the United States (US) at eight locations and in Canada at nine locations in the 2009 growing season. During the field trials, several phenotypic characteristics were evaluated including early stand count, seedling vigour, days to first flowering, seed maturity, lodging, plant height, pod shattering (visual rating and quantitative), seed moisture, seed quality and yield. For the majority of agronomic traits, no statistically significant differences between canola event MON 88302 and the unmodified control were observed. Although instances of statistically significant differences were observed between canola event MON 88302 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 the differences were due to the genetic modification. There was indication of a trend occurring in which canola event MON 88302 had higher seed moisture and reached days to first flowering later than that of the unmodified control. However, the values for canola event MON 88302 were within the reference range established for conventional canola varieties grown in the same field trials and did not impact final yield. Therefore, the statistical analysis of these observations showed no biologically meaningful differences between canola event MON 88302 and the unmodified control, and supports a conclusion of phenotypic equivalence to currently grown canola varieties.

Monsanto Canada Inc. provided information on the dormancy and germination of canola event MON 88302 seed under several different temperature regimes. No biologically significant differences were detected with respect to percentages of normal germinated seed, abnormal germinated seed, total germinated seed, dead seed, viable non-dormant seed and dormant seed.

The susceptibility of canola event MON 88302 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, hail, heat stress, nutrient deficiency, soil compaction, sun scald, wet soil and wind. No qualitative differences were observed for 130 out of 131 observations between canola event MON 88302 and the unmodified control. A single qualitative difference was observed for frost damage. However, the observed damage rating for canola event MON 88302 was within the range of reference cultivars and there was no trend observed across observations or sites. Thus, this single qualitative difference is unlikely to be biologically meaningful.

The susceptibility of canola event MON 88302 to various canola pests and pathogens was evaluated in the field at the same locations as the agronomic characteristic studies (further detail provided below in Section 3: Altered Plant Pest Potential of Canola Event MON 88302). No trend in increase or decrease of susceptibility was observed in canola event MON 88302 compared to the unmodified control.

The introduction the cp4 epsps expression cassette did not make canola event MON 88302 weedy or invasive of natural habitats since none of the canola's reproductive or growth characteristics were modified, and the tolerance of canola event MON 88302 to abiotic and biotic stresses was unchanged as well. No competitive advantage was conferred to canola event MON 88302, 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 regularly update this stewardship plan and make it readily available to growers to promote careful management practices for canola event MON 88302.

This information, together with the fact that the novel trait has no intended effects on canola weediness or invasiveness, led the CFIA to conclude that canola event MON 88302 has no altered weed or invasiveness potential compared to conventional canola varieties.

2. Potential for Gene Flow from Canola Event MON 88302 to Sexually Compatible Plants Whose Hybrid Offspring May Become More Weedy of More Invasive

Successful interspecific and intergeneric crosses between B. napus and some related species have been reported in the scientific literature [see biology document BIO1994-09 - The Biology of Brassica napus L. (Canola/Rapeseed) for more information]. However, many of these crosses have required extensive human intervention and the rates of natural hybridization between B. napus and weedy relatives resulting in fertile offspring appear to be very low. Sinapis arvensis is considered the worst of the weedy relatives of B. napus in Western Canada. Hybrids between these species can be produced under field conditions, however at very low frequency. Additionally, backcrossing of the hybrids to S. arvensis failed to produce viable progeny. Therefore, the likelihood of introgression of traits from B. napus to S. arvensis appears to be very low. Raphanus raphanistrum, another economically damaging weed, has been shown to hybridize with B. napus at low frequency. However, introgression has never been demonstrated and can be considered unlikely. In crosses with other wild related species (e.g., Erucastrum gallicum), no viable hybrid seed was produced.

Stable gene transfer from B. napus is most likely within Brassica crops such as B. juncea and B. rapa. Any hybrids resulting from outcrossing between B. rapa and canola event MON 88302 could be controlled by herbicides other than glyphosate or by cultivation. Any unintended presence of glyphosate tolerance in non-glyphosate tolerant varieties of B. napus can be controlled by standard crop management practices.

If glyphosate-tolerant individuals arose through interspecific or intergeneric hybridization, the novel trait would confer no competitive advantage to these plants unless challenged by glyphosate. This would only occur in managed ecosystems where glyphosate is used for weed control. Should glyphosate-tolerant, individuals arise, glyphosate-tolerant canola event MON 88302 could be controlled using mechanical means or herbicides other than glyphosate. Hybrids, if they develop, could potentially result in the loss of glyphosate as a tool to control these species. This, however, can be mitigated by the use of sound crop management practices.

This information led the CFIA to conclude that gene flow from canola event MON 88302 to related species in Canada is possible but would not result in increased weediness or invasiveness of the resulting progeny.

3. Altered Plant Pest Potential of Canola Event MON 88302

Canola is not considered a plant pest in Canada and the novel traits are unrelated to plant pest potential.

The susceptibility of canola event MON 88302 to various canola pests and pathogens was evaluated in the field at the same locations as the agronomic characteristic studies. The stressors observed included alfalfa loopers, aphids, bertha armyworms, blister beetles, cabbage worms, cutworms, diamond back moth larvae, flea beetles, grasshoppers, lygus bugs, red turnip beetles, cabbage seedpod weevils, wireworms, Alternaria, aster yellow, bacterial leaf spot, black leg, Cercospora leaf spot, clubroot, downy mildew, Fusarium wilt, Phytophtora, powdery mildew, root rot, Sclerotinia, seedling blight, seedling disease complex, white mold and white rust. Ecological evaluations of canola event MON 88302 did not show any increase or decrease in susceptibility to disease stressors compared to an unmodified line with a similar genetic background and commercial canola varieties grown at the same locations for any of the 141 observations. Furthermore, no qualitative differences were observed between canola event MON 88302 and the unmodified control for any of the 165 observations for plant damage caused by arthropods.

Monsanto Canada Inc. has quantitatively assessed the flea beetle and seedpod weevil damage in the field at the same locations as the phenotypic characteristic studies, but at four sites only. Although a single difference was detected out of nine observations between canola event MON 88302 and the unmodified control for flea beetle damage in the individual-site analysis, there was no trend observed across observations or sites and is unlikely to be biologically meaningful.

The CFIA therefore concludes that canola event MON 88302 does not display any altered plant pest potential compared to conventional canola varieties.

4. Potential Impact of Canola Event MON 88302 on Non-Target Organisms

The glyphosate tolerance trait introduced into canola event MON 88302 is unrelated to potential impact on non-target organisms. The CP4 EPSPS protein expressed in canola event MON 88302 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 canola event MON 88302 are expected.

Composition analyses showed that the levels of key nutrients, anti-nutrients and endogenous toxicants in canola event MON 88302 grain are comparable to those in conventional canola varieties. Therefore, it is very unlikely that the genetic transformation may have caused unintended changes to the composition of canola event MON 88302 tissues that would negatively impact organisms interacting with canola event MON 88302.

Ecological evaluations confirmed that the abundance of pest and beneficial arthropods in canola event MON 88302 plots was similar to that in conventional canola grown at the same locations. A total of 51 observations were made between canola event MON 88302 and the unmodified control, including 36 arthropod pest observations and 15 beneficial arthropod observations. No statistically significant differences were observed between canola event MON 88302 and the unmodified control for the abundance of the following pest and beneficial arthropods: aphids, bertha armyworms, diamond back moth larvae, flea beetles, lygus bug, thrips, chironomid midges, lacewings, ladybird beetles, micro-parasitic hymenoptera, macro-parasitic hymenoptera, Orius sp., spiders and sphecid wasps. Therefore, ecological evaluations of canola event MON 88302 did not show any increase in resistance to pest insects or pathogens compared to commercial canola varieties (see further detail provided above in Section 3: Altered Plant Pest Potential of Canola Event MON 88302).

Collectively, these information elements indicate that the interactions between canola event MON 88302 and the populations of animals and microorganisms interacting with canola, including beneficial arthropods, will be similar compared to conventional canola.

The CFIA has therefore determined that the unconfined release of canola event MON 88302 will not result in altered impacts on non-target organisms, including humans, compared to canola varieties currently grown in Canada.

5. Potential Impact of Canola Event MON 88302 on Biodiversity

Canola event MON 88302 is safe to non-target organisms and does not present altered weediness, invasiveness or plant pest potential. The novel trait is not expected to expand the range of cultivation of B. napus in Canada. No changes in current agronomic practices for B. napus are expected, with the exception of the use of glyphosate for weed control. Monsanto Canada Inc.'s herbicide tolerance stewardship plan for canola event MON 88302 contains recommendations for delaying the development of glyphosate resistance in weeds.

The introduction of glyphosate-tolerant B. napus is not likely to affect typical crop rotation practices.

The CFIA has concluded that the novel gene and its corresponding trait does not confer to canola event MON 88302 any characteristic that would result in unintended environmental effects following unconfined release. The CFIA has therefore concluded that the potential impact on biodiversity of canola event MON 88302 is unlikely to be different from that of canola varieties currently grown in Canada.

V. Criteria for the Livestock Feed Assessment

The AFD considered nutrient and anti-nutrient profiles; the safety of feed ingredients derived from canola event MON 88302, 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 canola event MON 88302 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

1. Potential Impact of canola event MON 88302 on Livestock Nutrition

Nutrient and anti-nutrient composition:

The nutritional equivalence of canola event MON 88302 (glyphosate- treated and untreated) to an unmodified control canola (Ebony) and seven conventional canola varieties was determined from replicated field sites in the US (two sites) and Canada (three sites), during the 2009 growing season. Canola seed samples were collected and analyzed for proximates (protein, crude fat, ash, moisture), acid detergent fibre (ADF), neutral detergent fibre (NDF), total detergent fibre (TDF), amino acids, fatty acids, minerals, vitamin E, and anti-nutrients (phytic acid, sinapine and glucosinolates). No statistically significant differences were observed between canola event MON 88302 and the unmodified control canola for proximates, ADF and NDF. All means of canola event MON 88302 for these components were within the natural variation of the conventional canola varieties. Statistically significant differences were observed between canola event MON 88302 (glyphosate-treated only) and the unmodified control canola for TDF, however the mean value for the canola event MON 88302 seed was within the 99% tolerance intervals for the population of conventional canola varieties and literature values. In the combined-site analysis, no statistically significant differences were observed between canola event MON 88302 and the unmodified control for all amino acids and vitamin E analyzed. Calcium was significantly higher in canola event MON 88302 (untreated) compared to the unmodified control, but the mean was within the range of the conventional canola varieties. All other minerals analyzed were similar between the canola event MON 88302 and the unmodified control. Statistically significant differences were observed between canola event MON 88302 and the unmodified control for palmitoleic acid (C16:1) (glyphosate- treated only), stearic acid (C18:0), oleic acid (C18:1), linoleic acid (C18:2), linolenic acid (C18:3), arachidic acid (C20:0), eicosenoic (C20:1) (untreated only) and behenic acid (C22:0). Mean values of these components were within the 99% tolerance intervals for the population of conventional canola varieties and also within published literature ranges. The alkyl-glucosinolate content of canola event MON 88302 (glyphosate-treated only) was significantly lower than the unmodified control. The mean values were within the 99% tolerance intervals for the population of conventional varieties and the range of published literature values. There were no significant differences observed in the anti-nutrients (phytic acid, sinapine, and total glucosinolates) measured, when seeds from glyphosate-treated canola event MON 88302 were compared to seeds from the unmodified control. Phytic acid was significantly lower in canola event MON 88302 (untreated) than the unmodified control, however the means were within the range of conventional canola varieties and published literature values.

Conclusion:

The evidence provided by Monsanto Canada Inc. supports the conclusion that the nutritional composition of canola event MON 88302 (glyphosate-treated or untreated) is compositionally equivalent to conventional canola varieties.

2. Potential Impact of canola event MON 88302 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

Canola event MON 88302 is tolerant to glyphosate as a result of insertion of genes encoding the CP4 EPSPS protein. The assessment of canola event MON 88302 evaluated the impact of the following potential hazard 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 canola event MON 88302.

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 body weight. 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.

Conclusions

Feed ingredients derived from canola event MON 88302 are considered to meet present ingredient definitions for canola 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 canola event MON 88302 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 canola event MON 88302 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 canola event MON 88302.

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 canola event MON 88302 does not present altered environmental risk when compared to currently commercialized canola varieties in Canada.

Based on the review of submitted data and information by Monsanto Canada Inc., including comparisons of canola event MON 88302 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 canola event MON 88302 any characteristic that would raise any concerns regarding the safety or nutritional composition of canola event MON 88302. Oil and meal prepared from canola-quality B. napus are currently listed in Schedule IV of the Feeds Regulations and are, therefore, approved for use in livestock feeds in Canada. Canola event MON 88302 has been assessed and found to be as safe and nutritious as traditional canola-quality B. napus varieties. Canola event MON 88302 and its products are considered to meet the 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 canola event MON 88302 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 canola lines derived from canola event MON 88302 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 canola 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.

Canola event MON 88302 is subject to the same phytosanitary import requirements as its unmodified counterparts. Canola event MON 88302 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 Canola event MON 88302.

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