Decision Document DD2011-86 Determination of the Safety of Monsanto Canada Inc.'s Soybean (Glycine max (L.) Merr.) Event MON 87705

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September 21, 2011

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 BIO1996-10, "The Biology of Glycine max (L.) Merr. (Soybean)", 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 modified fatty acid profile soybean event MON 87705. 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 soybean varieties in Canada.

Taking into account these evaluations, unconfined release into the environment and use as livestock feed of soybean event MON 87705 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 September 21, 2011. Any soybean lines derived from soybean event MON 87705 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 soybean 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.

Soybean event MON 87705 is subject to the same phytosanitary import requirements as its unmodified counterparts.

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
Telephone: 613-225-2342
Animal Feed Division
Animal Health Directorate
59 Camelot Drive
Ottawa ON  K1A 0Y9
Telephone: 613-225-2342

Table of Contents

  1. Brief Identification of the Modified Plant
  2. Background Information
  3. Description of the Novel Trait
    1. Modified Fatty Acid Profile
    2. Tolerance to Glyphosate
    3. Development Method
    4. Stable Integration into the Plant Genome
  4. Criteria for the Environmental Assessment
    1. Potential of Soybean Event MON 87705 to Become a Weed of Agriculture or be Invasive of Natural Habitats
    2. Potential for Gene Flow from Soybean Event MON 87705 to Wild Relatives whose Hybrid Offspring May Become More Weedy of More Invasive
    3. Altered Plant Pest Potential of Soybean Event MON 87705
    4. Potential Impact of Soybean Event MON 87705 on Non-Target Organisms
    5. Potential Impact of Soybean Event 87705 on Biodiversity
  5. Criteria for the Livestock Feed Assessment
    1. Potential Impact of Soybean Event MON 87705 on Livestock Nutrition
    2. Potential Impact of Soybean Event MON 87705 on Livestock and Workers/Bystanders
  6. New Information Requirements
  7. Regulatory Decision

I. Brief Identification of the Modified Plant

Designation of the Modified Plant: Soybean event MON 87705, OECD Unique Identifier MON-877Ø5-6
Applicant: Monsanto Canada Inc.
Plant Species: Soybean (Glycine max (L.) Merr.)
Novel Traits: Modified fatty acid profile (increased levels of oleic acid and reduced levels of polyunsaturated and saturated fatty acids); tolerance to glyphosate-based herbicides
Trait Introduction Method: Agrobacterium-mediated transformation
Intended Use of the Modified Plant: Human consumption and livestock feed use. Soybean event MON 87705 is not intended to be grown outside the normal production area for soybean in Canada.

II. Background Information

Monsanto Canada Inc. has developed, through the use of recombinant DNA techniques, a soybean with a modified fatty acid profile and tolerance to glyphosate-based herbicides. The soybean event, designated as MON 87705, was developed to provide increased levels of monounsaturated 18:1 oleic acid and reduced levels of polyunsaturated and saturated fatty acids in soybean oil. The oil from soybean event MON 87705 is expected to provide higher oxidative stability than commodity soybean oil.

Soybean event MON 87705 was produced by Agrobacterium-mediated transformation of soybean with two transfer DNAs (T-DNA I and T-DNA II) designed to suppress endogenous FAD2 and FATB genes, which encode two key enzymes in the soybean fatty acid biosynthetic pathway. T-DNA I contains sense segments of the FAD2-1A intron and FATB1-A 5' untranslated region. T-DNA II contains antisense segments of the FAD2-1A intron and FATB1-A 5' untranslated region. T-DNA I also contains a cp4 epsps expression cassette, encoding the 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein from Agrobacterium sp. strain CP4, known as CP4 EPSPS, which confers tolerance to glyphosate. During plant transformation, the cointegration of the T-DNAs creates an insert containing a single cp4 epsps expression cassette and a single FAD2-1A/FATB1-A suppression cassette that results in suppression of the endogenous soybean FAD2 and FATB genes.

Monsanto Canada Inc. has conducted a wide variety of studies to determine the safety of soybean event MON 87705, including a detailed description of the transformation method and the role of the inserted genes, gene segments and regulatory sequences, as well as data and information on the insertion site and gene copy number. An RNA expression analysis for the FAD2-1A and FATB1-A genes was provided, and the CP4 EPSPS protein was identified and characterized. Data was provided on the equivalence of CP4 EPSPS to a bacterially expressed counterpart, and protein expression levels of CP4 EPSPS. Data was also provided for the evaluation of the potential toxicity and allergenicity of CP4 EPSPS to humans and to livestock.

Soybean event MON 87705 was field tested for CP4 EPSPS protein expression levels, fatty acid profile, agronomic analysis and compositional analysis in Chile and the United States (US) during the 2007 and 2008 growing seasons. Soybean event MON 87705 was compared to an unmodified control, A3525, a conventional soybean variety that has a genetic background similar to that of soybean event MON 87705 but does not contain the FAD2-1A/FATB1-A suppression cassette or cp4 epsps gene cassette. These field sites were representative of soybean producing regions suitable for commercial soybean production. Some of the US locations share similar environmental and agronomic conditions to south western Ontario and were considered to be representative of major Canadian soybean growing regions.

Agronomic characteristics of soybean event MON 87705 such as seed germination and seed dormancy, early stand count, seedling vigour, days to 50% flowering, plant height, lodging, final stand count, susceptibilities to various soybean pests and pathogens, and yield were compared to those of the unmodified control.

Nutritional components of soybean event MON 87705, such as protein, fat, carbohydrates, fibre, ash, moisture, amino acids, fatty acids, vitamins, and anti-nutrients were compared with those of the unmodified control.

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 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 soybean event MON 87705 to become a weed of agriculture or be invasive of natural habitats;
  • potential for gene flow from soybean event MON 87705 to wild relatives whose hybrid offspring may become more weedy or more invasive;
  • potential for soybean event MON 87705 to become a plant pest;
  • potential impact of soybean event MON 87705 or its gene products on non-target species, including humans; and
  • potential impact of soybean event MON 87705 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 the:

  • potential impact of soybean event MON 87705 on livestock nutrition; and
  • potential impact of soybean event MON 87705 on livestock and workers/bystanders.

Monsanto Canada Inc. has provided the CFIA with a method for the detection and identification of soybean containing the soybean event MON 87705.

III. Description of the Novel Trait

1. Modified Fatty Acid Profile

Soybean oil is one of the most versatile and plentiful vegetable oils available to food manufacturers. However, given its high proportion of polyunsaturated fatty acids, commodity soybean oil requires hydrogenation to improve its stability for use in many foods. A major food use for soybean is as purified oil for use in margarines, shortenings, cooking, and salad oils. Plant oils such as canola and olive oil are relatively high in monounsaturated 18:1 oleic acid and low in polyunsaturated fatty acids providing stability advantages over commodity soybean oil. Soybean event MON 87705 was developed to have an unsaturated fatty acid profile similar to other widely consumed vegetable oils including olive oil and canola oil, while having less than half the levels of saturated fatty acids of commodity soybean oil. Soybean event MON 87705 contains the same five major fatty acids that are found in conventional soybean: 16:0 palmitic and 18:0 stearic (saturated); 18:1 oleic (monounsaturated); and 18:2 linoleic and 18:3 linolenic acids (polyunsaturated), but in different proportions such that there are increased levels of monounsaturated 18:1 oleic acid and reduced levels of the polyunsaturated fatty acids. This is expected to provide higher oxidative stability than commodity soybean oil and enable formulation of foods with lower saturated fat content.

Soybean event MON 87705 was developed to selectively down-regulate two key enzymes in the soybean seed fatty acid biosynthetic pathway, FATB and FAD2. FATB enzymes are acyl-acyl carrier protein (acyl-ACP) thioesterases that are located in the chloroplast where they hydrolyze saturated fatty acids from the acyl-ACP-fatty acid moiety. The RNA-based suppression of FATB results in a decrease in transport of saturated fatty acids out of the plastid, thereby increasing their availability for desaturation to 18:1 oleic acid. As a result, suppression of FATB leads to decreases in the levels of saturated fatty acids and increases in the levels of 18:1 oleic acid in the plastids that are then delivered to the oil body or to the endoplasmic reticulum for further desaturation.

FAD2 enzymes are delta-12 desaturases that desaturate 18:1 oleic acid to 18:2 linoleic acid. The RNA-based suppression of FAD2 results in reduced desaturation of 18:1 oleic acid to 18:2 linoleic acid, which leads to an increase in the levels of 18:1 oleic acid and a decrease in the levels of 18:2 linoleic acid.

The FAD2-1A/FATB1-A suppression cassette does not code for a functional protein, therefore it does not produce a novel protein.

2. Tolerance to Glyphosate

A gene derived from the Agrobacterium sp. strain CP4 (cp4 epsps) which imparts field level tolerance to glyphosate, the active ingredient in Roundup® brand herbicides, was also introduced into soybean event MON 87705. 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 EPSPS enzyme into the chloroplast, the site of amino acid biosynthesis.

EPSPS is an enzyme involved in the shikimic acid metabolic pathway which is essential for the production of the aromatic amino acids. The native soybean EPSPS enzyme is sensitive to glyphosate. The herbicide disrupts the shikimic acid pathway, leading to growth suppression or death of the plant. The CP4 EPSPS version of this enzyme expressed in soybean event MON 87705 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 soybean EPSPS.

The CP4 EPSPS protein produced in soybean event MON 87705 is the same as the CP4 EPSPS protein produced in other Roundup Ready® crops which have already been approved for unconfined release and animal feed uses in Canada, including soybean events GTS 40-3-2 and MON 89788 and Roundup Ready 2 corn (NK603).

The CP4 EPSPS protein has been subject previously to a number of safety assessment studies. 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. The equivalency of the soybean event MON 87705-produced CP4 EPSPS protein to the E. coli-produced CP4 EPSPS was evaluated by comparing their molecular weights, immunoreactivity, glycosylation status, N-terminal sequence analysis, MALDI-TOF mass spectrometry and functional activity. Based on the results, the proteins were found to be equivalent.

Demonstration of protein equivalence between E. coli- and soybean event MON 87705-produced CP4 EPSPS proteins allows utilization of the existing data to confirm the safety of the CP4 EPSPS protein in soybean event MON 87705. Previous assessments have shown that the CP4 EPSPS protein did not cause any adverse effects in mice at a level of 572 mg/kg body weight, and that the CP4 EPSPS protein, unlike many allergens, is readily degraded in simulated mammalian gastric and intestinal fluids. CP4 EPSPS protein expressed in soybean event MON 87705 is structurally and functionally similar to EPSPS enzymes present in many foods with a long history of safe use in Canada, and therefore would not be expected to be toxic or allergenic. In addition, Monsanto Canada Inc. provided an updated bioinformatic 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.

The cp4 epsps gene expressed in soybean event MON 87705 is linked to a constitutive promoter. Samples of soybean tissues were collected at various growth stages from five representative field trial sites in Chile. 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: 120-530 µg/g dwt in leaf, 120 µg/g dwt in root, 77µg/g dwt in forage and 110 µg/g dwt in mature seed.

3. Development Method

Soybean event MON 87705 was produced by Agrobacterium-mediated transformation of soybean with the binary vector PV-GMPQ/HT4404 that contains two transfer DNAs (T-DNA I and T-DNA II) to suppress endogenous FAD2 and FATB genes which encode two key enzymes in the soybean fatty acid biosynthetic pathway. T-DNA I contains the sense segments of the FAD2-1A intron and FATB1-A 5' untranslated region. T-DNA II contains the antisense segments of the FAD2-1A intron and FATB1-A 5' untranslated region. In soybean event MON 87705, T-DNA I and T-DNA II are inserted tandem to one another such that an inverted repeat of the FAD2-1A and FATB1-A gene segments is formed, creating the FAD2-1A/FATB1-A suppression cassette. T-DNA I also contains a cp4 epsps expression cassette, which encodes the CP4 EPSPS protein. Transformants were selected based on tolerance to glyphosate. Soybean event MON 87705 was identified as a successful transformant and was chosen for further development.

4. Stable Integration into the Plant Genome

Molecular characterization demonstrated that soybean event MON 87705 contains one copy of each T-DNA inserted at the same locus. The absence of backbone sequence from the plasmid PV-GMPQ/HT4404 in soybean event MON 87705 was confirmed by Southern blot analysis. Sequencing of the inserted DNA confirmed the organization and sequence of the cointegrated inserts, and demonstrated that the genomic DNA sequences flanking the 5' and 3' ends of the insert are native to the soybean genome. The stability of the insert was demonstrated by Southern blot analysis over four generations. Stable expression of the CP4 EPSPS protein across four generations was also demonstrated by western blot analysis. Results from segregation analysis showed heritability and stability of the insert 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 Soybean Event MON 87705 to become a Weed of Agriculture or be Invasive of Natural Habitats

The biology of soybean, as described in the CFIA Biology Document BIO1996-10, "The Biology of Glycine max (L.) Merr. (Soybean)", is such that unmodified plants of this species are not invasive of unmanaged habitats in Canada. Soybean does not possess an intrinsic potential to become weedy in Canada due to traits such as the lack of seed dormancy and the poor competitive ability of seedlings. According to the information provided by Monsanto Canada Inc., soybean event MON 87705 was determined not to be significantly different from the unmodified control in this respect.

The PBRA evaluated data submitted by Monsanto Canada Inc. on the reproductive biology and life history traits of soybean event MON 87705. This event was field tested in the US in 17 locations in the 2007 growing season and in four locations in the 2008 growing season. The unmodified control and a range of conventional soybean varieties were also grown in the field trials. Some of the US locations share similar environmental and agronomic conditions to southwestern Ontario and were considered to be representative of major Canadian soybean growing regions. During the field trials, several phenotypic characteristics were evaluated; early stand count, seedling vigour, days to 50% flowering, plant height, lodging, pod shattering, final stand count, seed moisture, 100 seed weight, seed test weight, and yield. For the majority of agronomic traits, no statistically significant differences between soybean event MON 87705 and the unmodified control were observed. Although instances of statistically significant differences were observed between soybean event MON 87705 and the unmodified control for some traits, there were few consistent trends in the data across locations or years that would indicate that any differences that could be associated with weediness were due to the genetic modification. There was indication of a trend occurring in which soybean event MON 87705 had a lower 100 seed weight than that of the unmodified control. However, the values for soybean event MON 87705 were within the range of conventional soybean varieties grown in the same field trials. Therefore, the statistical analysis of these observations showed no biologically significant differences between soybean event MON 87705 and the unmodified control, and supports a conclusion of phenotypic equivalence to conventional soybean varieties.

Monsanto Canada Inc. provided information on the dormancy and germination of soybean event MON 87705 seed under several different temperature regimes. No biologically significant differences were detected with respect to percentages of dead seed, normal germinated seed, abnormal germinated seed, total germinated seed, viable firm swollen seed, and viable hard seed.

Volunteer potential was assessed at three locations in the US. Soybean event MON 87705 seeds were seeded in the fall of 2007. No volunteers were detected the following spring.

The susceptibility of soybean event MON 87705 to various abiotic stressors and soybean pests and pathogens was evaluated in the field at the same locations as the phenotypic characteristic studies. The stressors observed included: chloride toxicity, cold stress, drought, flood, frost, hail, heat stress, moisture stress, nutrient deficiency, soil compaction, sun scald, wet soil, wind, Alternaria (leaf spot), anthracnose, Asian rust, bacterial blight, brown stem rot, charcoal rot, downy mildew, frogeye leaf spot, Phythium, Rhizoctonia, Septoria, suddern death, soybean mosaic virus, white mold, soybean rust, armyworms, aphids, bean leaf beetles, corn rootworm adults, fall armyworms, flea beetles, grasshoppers, green cloverworms, Japanese beetles, leaf hoppers, leafrollers, Mexican bean beetles, soybean loopers, spider mites, stink bugs, thistle caterpillars, thrips, whiteflies, wireworms, and yellow wooly bear caterpillars. No qualitative differences were observed for 744 of 749 observations between soybean event MON 87705 and the unmodified control. For the five observations where qualitative differences were observed (bacterial blight (three different observations at the same location), aphids, and leafhoppers), there was no trend observed across locations. All the values were within the range for conventional soybean varieties grown in the same field trials and therefore these differences were not biologically significant.

The introduction of the FAD2-1A/FATB1-A and the cp4 epsps cassettes did not make soybean event MON 87705 weedy or invasive of natural habitats since none of the soybean's reproductive or growth characteristics were modified, and soybean event MON 87705's tolerance to abiotic and biotic stresses was unchanged as well. No competitive advantage was conferred to soybean event MON 87705, other than that conferred by tolerance to glyphosate herbicide.

A longer term consideration is the potential development of crop volunteers with a combination of herbicide tolerances. Similarly, the use of several crop species in rotation which all rely on tolerance to the same herbicide can lead to the development of significant selection pressure and the potential development of herbicide resistant weeds. These issues require the management of the technology as part of an integrated approach which may include currently available weed control products with alternate modes of action.

Monsanto Canada Inc. has submitted a herbicide tolerance stewardship plan to the CFIA which was evaluated by PBRA. The stewardship plan contains measures to address the concerns mentioned above, as well as appropriate strategies that will allow for the environmentally safe and sustainable deployment of these traits. In addition, the stewardship plan contains strategies for communication to growers and an efficient mechanism allowing growers to report problems to Monsanto Canada Inc. will make this stewardship plan readily available to growers to promote careful management practices for soybean event MON 87705.

This information, together with the fact that the novel traits have no intended effects on soybean weediness or invasiveness, led the PBRA to conclude that soybean event MON 87705 has no altered weed or invasiveness potential compared to conventional soybean varieties currently grown in Canada.

2. Potential for Gene Flow from Soybean Event MON 87705 to Wild Relatives whose Hybrid Offspring May Become More Weedy of More Invasive

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

This information, together with the fact that the novel traits have no intended effects on soybean reproductive biology, led the PBRA to conclude that there is minmal potential for gene flow from soybean event MON 87705 to related species in Canada.

3. Altered Plant Pest Potential of Soybean Event MON 87705

Soybean is not considered a plant pest in Canada. The novel traits are unrelated to plant pest potential. Ecological evaluations of soybean event MON 87705 did not show any increase or decrease in susceptibility to any insect or disease stressor compared to an unmodified control with a similar genetic background and a range of conventional soybean varieties grown at the same locations. These stressors included 15 diseases and 20 pest insects.

The PBRA therefore concludes that soybean event MON 87705 does not display any altered pest potential compared to conventional soybean varieties currently grown in Canada.

4. Potential Impact of Soybean Event MON 87705 on Non-Target Organisms

The modified oil profile in soybean event MON 87705 seeds results from the expression of double stranded RNAs derived from fragments of the endogenous soybean FATB and FAD2 genes. It is very unlikely that a protein be produced from the FAD2-1A/FATB1-A suppression cassette. In addition, a bioinformatic analysis of all putative polypeptides encoded by the DNA insert and the 5' and 3' insert junctions showed that none of these putative polypetides shared relevant structural similarity to known allergens, toxins or other biologically active proteins.

Double stranded RNA is commonly found in plants and animals, for naturally occurring endogenous gene suppression. Double stranded RNA has a history of safe consumption by mammals and birds. Though ingestion of plant tissues expressing double stranded RNA derived from insect genes can silence these genes in insects, it is very unlikely that the soybean FATB1-A and FAD2-1A gene fragments introduced into soybean event MON 87705 mediate disruption of gene expression in insects or other organisms consuming soybean event MON 87705 tissues or indirectly exposed to soybean event MON 87705 tissues via their preys.

Therefore, no negative impacts on non-target organisms are anticipated from the expression of the FAD2-1A/FATB1-A suppression cassette.

The only novel protein expressed in soybean event MON 87705 is the CP4 EPSPS protein. The environmental safety of the CP4 EPSPS protein has previously been established. In addition, Monsanto Canada Inc. provided an updated bioinformatic 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. The CP4 EPSPS protein expressed in MON 87705 soybean is equivalent to the CP4 EPSPS proteins present in other Roundup Ready crops including soybean, corn, cotton, sugar beet and canola, which have a history of safe use. Therefore, no negative impacts resulting from exposure of organisms to CP4 EPSPS protein expressed in soybean event MON 87705 are expected.

Soybean event MON 87705 seed contains increased levels of oleic acid and lower levels of linoleic, stearic and palmitic acids compared to conventional soybean seed. These fatty acids are widely prevalent in the environment and have a history of environmental safety. In addition, soybean event MON 87705 seed contains similar levels of other fatty acids compared to conventional soybean seed. Therefore, the modified fatty acid profile of soybean event MON 87705 grain is not expected to be detrimental to organisms interacting with soybean.

Composition analysis showed that, except for the intended fatty acid changes, the levels of key nutrients and anti-nutrients in soybean event MON 87705 grain and forage are comparable to those in conventional soybean varieties. An IgE antibody binding analysis using the sera from 13 clinically documented, soybean-allergic patients showed that soybean event MON 87705 seed does not contain increased levels of endogenous allergens compared to conventional soybean seed.

Ecological evaluations of soybean event MON 87705 did not show any increase in resistance to insects or pathogens compared to conventional soybean varieties.

Ecological evaluations showed that the abundance of beneficial arthropods in soybean event MON 87705 plots was equivalent to that in the plots of conventional soybean varieties grown at the same locations. The beneficial organisms assessed included big-eyed bugs, carabid beetles, lacewings, ladybird beetles, micro-parasitic wasps (parasitoids), Nabis spp., Orius spp., spiders, spined solider bugs, and syrphid larvaes.

Soybeans interact with a plant-associated nitrogen-fixing bacterium (Bradyrhizobium japonicum), which results in the fixation of atmospheric nitrogen to a plant-available form inside the root nodules. No significant differences were detected between soybean event MON 87705 and the unmodified control for nodule number, nodule dry weight, shoot dry weight, root dry weight, shoot total nitrogen in percentage, and shoot total nitrogen in grams. This indicates that B. japonicum and nitrogen fixation are not affected by the altered fatty acid profile or the herbicide tolerance trait.

The PBRA has therefore determined that the unconfined release of soybean event MON 87705 will not result in altered impacts on non-target organisms, including humans, compared to conventional soybean varieties currently grown in Canada.

5. Potential Impact of Soybean Event 87705 on Biodiversity

Soybean event MON 87705 expresses no novel phenotypic characteristics that would extend its range beyond the current geographic range of soybean production in Canada. Soybean's only sexually compatible wild relative in Canada (G. soja) does not occur in unmanaged habitats, and the possibility of soybean out crossing to G. soja is very low. The novel traits are unlikely to have an impact on plant pest potential or non-target organisms. It is therefore unlikely that soybean event MON 87705 will have any direct effects on biodiversity, in comparison to the effects that would be expected from the cultivation of conventional soybean varieties.

Soybean event MON 87705 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 agroeco systems. 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, soybean event MON 87705, or the cultivation of soybean. It is therefore unlikely that soybean event MON 87705 will have any indirect effects on biodiversity, in comparison to the effects that would be expected from cultivation of conventional soybean varieties.

The CFIA has therefore concluded that the potential impact on biodiversity of soybean event MON 87705 is unlikely to be different from that of conventional soybean varieties currently grown in Canada.

V. Criteria for the Livestock Assessment

1. Potential Impact of Soybean Event MON 87705 on Livestock Nutrition

Nutrient and Anti-nutrient Composition

The nutritional equivalence of soybean event MON 87705 to the unmodified control was determined from data of replicated field sites in Chile and the US during the 2007 and 2008 growing seasons. At each field site soybean event MON 87705, the unmodified control and 20 conventional soybean varieties were planted. Forage and seed samples were collected and analysed for proximate and fibre and seed samples were further analysed for amino acids, fatty acids, vitamin E, isoflavones (diadzein, genistein and glycitein) and anti-nutrients (lectin, phytic acid, trypsin inhibitor, raffinose and stachyose). In separate US trials conducted with soybean event MON 87705, the unmodified control and 12 conventional soybean varieties, seed samples were processed and analysed for proximate and fibre, amino acids, trypsin inhibitor, phytic acids (meal), fatty acids, vitamin E (refined oil) amino acids and moisture (protein isolates) and phophatides (crude lecithin). No statistically significant differences were observed between soybean event MON 87705 and the unmodified control forage for proximates, acid detergent fibre (ADF) and neutral detergent fibre (NDF). In the Chilean trial, ash in forage was significantly higher in soybean event MON 87705 than in the unmodified control, but the means were within the range of the conventional soybean varieties. Protein (US), fat, arginine lysine, aspartic acid, cystine, leucine, proline, serine methionine and threonine values in seed (US or Chile) were significantly different in soybean event MON 87705 compared to the unmodified control; however all means were within the range of the conventional soybean varieties and literature values.

Soybean event MON 87705 was developed to have lower levels of saturated fatty acids (16:0 palmitic acid and 18:0 stearic acid) and higher levels of 18:1 oleic acid, with an associated decrease in 18:2 linoleic acid). As intended, soybean event MON 87705 seed had significantly lower palmitic (2.3% vs 10.8%) and stearic acid levels (3.3% vs 4.5% ), higher oleic acid levels (76% vs 23%) and lower linoleic acid levels (10% vs 53%) compared to the control. Differences in these four fatty acids were consistently observed at each of the individual sites in both trials. Stearic acid in soybean event MON 87705 seed, however, was with the range of conventional soybean varieties, while the other three fatty acids, were outside the range of the conventional soybean varieties. As expected, 18:0 linolenic acid was significantly lower in soybean event MON 87705 compared to the unmodified control seed, but the mean was within the range of the conventional soybean varieties. Arachidic and behenic acids were significantly lower in soybean event MON 87705 compared to the unmodified control while eicosenoic acid was higher in soybean event MON 87705 than in the unmodified control seed; however all mean values were within the range of conventional soybean varieties and/or literature values. No statistically significant differences were found between soybean event MON 87705 and the unmodified control for vitamin E, glycitein, diadzein genistein, lectin (Chile), phytic acid, raffinose, stachyose and trypsin inhibitor. With regards to co-products, statistically significant differences were observed between soybean event MON 87705 and the unmodified control soybean meal for NDF, alanine, glycine, isoleucine, lysine and valine but the means were within the range of the conventional soybean varieties and/or literature values. In soybean event MON 87705 oil, the levels of palmitic, stearic, oleic and linoleic acids were comparable to the levels and the trend observed in the seed. No statistically significant differences were observed between soybean event MON 87705 and the unmodified control for the amino acids in the protein isolate fraction. All phosphatides in crude lecithin were similar for soybean event MON 87705 and the unmodified control.

Broiler Performance

Eight hundred Cobb x Cobb birds were to assigned to 10 pens to examine the health and performance effects of feeding soybean event MON 87705 meal, compared to meal from the unmodified control and six conventional soybean varieties for 42 days. Bird mortality was random (1-3%) with no relation to dietary treatment. Bird performance over the 42 day trial showed no difference between birds fed on meal from soybean event MON 87705, the unmodified control and conventional soybean varieties. No statistically significant differences were observed between soybean event MON 87705, the unmodified control and conventional soybean variety diets for average daily gain, feed intake and feed gain of the broilers. Carcass yields and meat nutrient analysis were not different for broilers fed soybean event MON 87705 compared to those fed the unmodified control soybean meal. No unexpected effects were observed when broilers were fed diets from soybean event MON 87705 meal.

Conclusion

The evidence provided by Monsanto supports the conclusion that except for intended changes in fatty acid levels in soybean event MON 87705 (i.e. increased levels of oleic acid and lowered levels of palmitic, stearic and linoleic acids), the nutritional composition of soybean event MON 87705 is within the range of conventional soybean varieties. No detrimental effects were shown on the performance and health of broilers on diets containing soybean event MON 87705 meal.

2. Potential Impact of Soybean Event MON 87705 on Livestock and Workers/Bystanders

Soybean event MON 87705 is a soybean plant that has two novel traits. One is the production of CP4 EPSPS, which confers tolerance to the herbicide glyphosate. The other is a modified fatty acid profile with higher levels of oleic acid as a result of the silencing of the FATB and FAD2 genes.

The expressed protein CP4 EPSPS is not a known toxin or allergen. The CP4 EPSPS in soybean event MON 87705 did not show similarity to any known allergens or toxins. The CP4 EPSPS is also heat labile and rapidly degraded under conditions similar to those encountered in the gastrointestinal tract. This information suggests that the CP4 EPSPS protein is unlikely to be a novel toxin or allergen. CP4 EPSPS has history of safe use, having been approved in prior events.

The maximum exposure levels of CP4 EPSPS are roughly 40 times lower than the highest tested no effects level of 475 mg/kg-bw (oral gavage, mouse). No adverse effects on nutrition or health were observed in a broiler feeding trial comparing soybean event MON 87705 grain to several conventional soybean varieties in the diet.

The high oleic fatty acid profile was not expected to have any toxicological effects on either livestock or humans consuming products derived from livestock.

The evidence provided by Monsanto Inc. indicates there is no potential impact of soybean event MON 87705 on livestock and workers/bystanders when compared to conventional soybean lines.

VI. New Information Requirements

If at any time, Monsanto Canada becomes aware of any information regarding risk to the environment, including risk to human or animal health, which could result from release of soybean event MON 87705 in Canada or elsewhere, Monsanto Canada will immediately provide such information to the CFIA. On the basis of such new information, the CFIA will re-evaluate the potential impact of soybean event MON 87705 on the environment, livestock and human health, and may re-evaluate its decision with respect to the livestock feed use and environmental release authorizations of soybean event MON 87705.

VII. Regulatory Decision

Based on the review of the data and information submitted by Monsanto Canada, and through comparisons of soybean event MON 87705 with unmodified soybean counterparts, the Plant and Biotechnology Risk Assessment Unit of the Science Strategies Division, CFIA, has concluded the novel genes and their corresponding traits do not confer to soybean event MON 87705 any characteristic that would result in unintended environmental effects following unconfined release.

Based on the review of submitted data and information by Monsanto Canada, including comparisons of soybean event MON 87705 with its unmodified soybean counterparts, the Animal Feed Division of the Animal Health Directorate, CFIA has concluded that the novel genes and their corresponding traits will not confer to soybean event MON 87705 any characteristic that would raise any concerns regarding the safety or nutritional composition of soybean event MON 87705. Grain soybean, its byproducts and soybean oil are currently listed in Section IV of the Feeds Regulations and are, therefore approved for use in livestock feeds in Canada. Soybean event MON 87705 has been found to be as safe as and as nutritious as traditional soybean varieties. Soybean event MON 87705 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 soybean event MON 87705 is therefore authorized by Plant Biosafety Office of the Plant Health and Biosecurity Directorate and the Animal Feed Division of the Animal Health Directorate as of September 21, 2011. Any soybean lines derived from soybean event MON 87705 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, and it is known based on characterization, that these plants do not display any additional novel traits and are substantially equivalent to currently grown soybean varieties in Canada, in terms of their potential environmental impact and livestock feed safety.

Soybean event MON 87705 is subject to the same phytosanitary import requirements as its unmodified counterpart.

Please refer to Health Canada's Decisions on Novel Foods for a description of the safety assessment for soybean MON 87705, as it pertains to foods for human consumption.

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