DD2010-81: Determination of the Safety of Monsanto Canada Inc.'s Soybean (Glycine max (L.) Merr.) Event MON 87701

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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 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) has evaluated information submitted by Monsanto Canada Inc. in regard to insect resistant soybean event MON 87701.

This plant with a novel trait (PNT) was assessed by the Plant and Biotechnology Risk Assessment Unit (PBRA) of the CFIA for its environmental risk, including human health, having regard to weediness potential, gene flow, plant pest potential, impact on non target organisms and impact on biodiversity. Taking into account the intended use of this product, which does not include cultivation in Canada, the risk from incidental release of event MON 87701 into the environment was determined to be minimal.

The Animal Feed Division of the CFIA has determined that insect resistant soybean event MON 87701 does not present livestock feed safety concerns when compared to currently commercialized soybean varieties.

Taking into account the conclusion of the risk assessment and recognizing that incidental release into the environment could occur when this PNT is used as intended, unconfined releaseFootnote1 into the environmentFootnote2 of soybean event MON 87701 and of any lines derived from it is therefore authorized by the Plant Biosafety Office of the Plant Health and Biosecurity Directorate as of October 15, 2010 on a condition that no sale of seed takes place in Canada. This condition is being applied to ensure that the PNT is used as intended.

Taking into account livestock feed evaluation, use as livestock feed of soybean event MON 87701 and of any lines derived from it is authorized by the Animal Feed Division of the Animal Health Directorate.

Authorizations of the soybean lines derived from the event MON 87701 are conditional on the following: (i) no inter-specific crosses are performed, (ii) the intended use(s) are similar, (iii) it is known, following thorough characterization, that these plants do not display any additional novel traits and are substantially equivalent to MON 87701 in terms of their specific use and safety for the environment, including human health, as well as livestock safety and (iv) the novel gene is expressed at a level similar to that of the authorized line.

Soybean event MON 87701 is subject to the same phytosanitary import requirements as its unmodified counterparts.

Please note, that the assessment of livestock feed and environmental safety 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.

Table of Contents

  1. Brief Identification of the Modified Plant
  2. Background Information
  3. Description of the Novel Trait
    1. Development Method
    2. Resistance to Lepidopteran Pests of Soybean
    3. Stable Integration into the Plant Genome
  4. Criteria for the Environmental Assessment
    1. Potential of Soybean Event MON 87701 to become a Weed of Agriculture or be Invasive of Natural Habitats
    2. Potential for Gene Flow from Soybean Event MON 87701 to Wild Relatives whose Hybrid Offspring May Become More Weedy or More Invasive
    3. Altered Plant Pest Potential of Soybean Event MON 87701
    4. Potential Impact of Soybean Event MON 87701 on Non-Target Organisms
    5. Potential Impact of Soybean Event MON 87701 on Biodiversity
  5. Criteria for the Livestock Feed Assessment
    1. Potential Impact of Soybean Event MON 87701 on Livestock Nutrition
    2. Potential Impact of Soybean Event MON 87701 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 87701, OECD Unique Identifier MON-87701-2
Applicant: Monsanto Canada Inc.
Plant Species: Soybean (Glycine max (L.) Merr.)
Novel Traits: Resistance to lepidopteran pests of soybean including velvetbean caterpillar (Anticarsia gemmatalis) and soybean looper (Pseudoplusia includens)
Trait Introduction Method: Agrobacterium-mediated transformation
Intended Use of the Modified Plant: Human consumption and livestock feed use. MON 87701 is not intended for cultivation in Canada.

II. Background Information

Monsanto Canada Inc. has developed, through the use of recombinant DNA techniques, a soybean that is resistant to certain lepidopteran pests of soybean, including velvetbean caterpillar (Anticarsia gemmatalis) and soybean looper (Pseudoplusia includens). The soybean event, designated as MON 87701, was developed to provide a method to control yield losses from insect feeding damage caused by these and other lepidopteran insect pests. MON 87701 was developed for cultivation primarily in South America, where lepidopteran pests of soybean are controlled with insecticide applications.

Only one lepidopteran pest species is associated with soybean in Canada (green clover worm, Hypena scabra, also referred to as Plathypena scabra). This insect is found in most Canadian soybean fields but only rarely at population densities that cause economic damage. Since lepidopteran pest pressure is not high in Canadian soybean fields, Monsanto has no plans to cultivate MON 87701 in Canada at this time and is not breeding this trait into Canadian-adapted germplasm.

Soybean event MON 87701 was developed using recombinant DNA technology, resulting in the introduction of the cry1Ac gene from Bacillus thuringiensis subsp. kurstaki. The cry1Ac gene encodes an insecticidal protein that provides resistance to certain lepidopteran pests. Along with the cry1Ac gene cassette, a second T-DNA was independently introduced containing the cp4 epsps gene from Agrobacterium sp. strain CP4, encoding the CP4 EPSPS protein that confers tolerance to glyphosate. This second T-DNA was used as a selectable marker and following transformation was eliminated through segregation and selection and is not present in MON 87701.

Monsanto Canada has provided data on the identity of soybean event MON 87701, 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 were provided for the evaluation of the potential toxicity and allergenicity of the novel protein to humans and to livestock.

Soybean event MON 87701 was field tested at 16 locations in the United States in the 2007 growing season. This germplasm, which has been developed for cultivation primarily in South America, is not suitable for cultivation in the soybean-growing regions of Canada as it would not reach maturity due to the environment. Consequently, studies were not conducted in a Canadian or similar environment. A risk assessment was conducted taking into account that the seed of soybean event MON 87701 will not be authorized for sale in Canada.

Agronomic characteristics of soybean event MON 87701 such as seed germination and seed dormancy, seedling vigour, days to 50% flowering, susceptibilities to various soybean pests and pathogens, and seed production were compared to those of unmodified soybean counterparts.

Nutritional components of soybean event MON 87701, such as protein, fat, carbohydrates, fibre, ash, moisture, amino acids, fatty acids, vitamins, and anti-nutrients were compared with those of unmodified soybean counterparts.

The Plant and Biotechnology Risk Assessment (PBRA) Unit of the Science Strategies Division, 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 87701 to become a weed of agriculture or be invasive of natural habitats;
  • potential for gene flow from soybean event MON 87701 to wild relatives whose hybrid offspring may become more weedy or more invasive;
  • potential for soybean event MON 87701 to become a plant pest;
  • potential impact of soybean event MON 87701 or its gene products on non-target species, including humans;
  • potential impact of soybean event MON 87701 on biodiversity; and
  • potential for development of insect resistance to soybean event MON 87701.

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 87701 on livestock nutrition; and
  • potential impact of soybean event MON 87701 on livestock and workers/bystanders.

Monsanto Canada has provided the CFIA with a method for the detection and identification of soybean containing the soybean event MON 87701.

III. Description of the Novel Trait

1. Development Method

Soybean event MON 87701 was developed through Agrobacterium-mediated transformation of soybean meristem tissue from the soybean variety A5547 using a plasmid with two separate T-DNAs. The first T-DNA, designated as T-DNA I, contains the cry1Ac gene and its regulatory elements. The second T-DNA, designated as T-DNA II, contains the selectable marker gene cp4 epsps, which confers glyphosate tolerance, and its regulatory elements. Following cultivation with Agrobacterium, meristems were transferred to a selection medium containing spectinomycin and chloramphenicol to inhibit the growth of Agrobacterium and glyphosate to inhibit the growth of untransformed cells. During subsequent breeding, the unlinked insertions of T-DNA I and T-DNA II were segregated. The plants containing only the cry1Ac gene were selected using molecular analysis while the plants containing the cp4 epsps gene were eliminated from subsequent breeding. Event MON 87701 was identified as a successful transformant and was chosen for further development.

2. Resistance to Lepidopteran Pests of Soybean

Bacillus thuringiensis is a common gram-positive soil-borne bacterium. In the spore-forming stage, it produces several insecticidal protein crystals, including the δ-endotoxin Cry1Ac, which is active against certain lepidopteran insects such as velvetbean caterpillar and soybean looper. The protein is insecticidal to susceptible lepidopterans after cleavage by proteases in the insect's gut, forming a protease-resistant active fragment (core toxin) that is the bio-active form of the protein. Insecticidal activity is believed to depend on the binding of the active fragment to specific receptors present in susceptible insects on midgut epithelial cells, forming pores which disrupt osmotic balance and eventually result in cell lysis and insect death.

The Cry1Ac protein in soybean event MON 87701 was modified through the addition of a chloroplast transit peptide coding sequence to the N-terminus of the protein. Following translocation into chloroplasts, the chloroplast transit peptide is cleaved. Based on N-terminal sequencing of the Cry1Ac from soybean event MON 87701, four amino acids from the chloroplast transit peptide are not cleaved following translocation into the chloroplast. The presence of these additional four amino acids is not expected to have any impact on protein activity or toxicity to target insects, since the N-terminus is cleaved in the insect's gut. With the exception of these four additional amino acids at the N-terminus of Cry1Ac, the protein is 100% identical to Cry1Ac in Bollgard® cotton, which has been authorized by the CFIA for livestock feed use, and more than 99% identical to Cry1Ac from B. thuringiensis subsp. kurstaki.

Cry1Ac expression in soybean event MON 87701 is driven by a promoter which confers expression in above-ground portions of the plant. Tissue samples were collected at various growth stages from five field trial sites in the United States. Levels of Cry1Ac protein were evaluated by enzyme-linked immunosorbent assays. Average Cry1Ac levels across all stages and all sites expressed in micro-grams Cry1Ac protein per gram dry weight tissue (µg/g dwt), ranged from 220-340 µg/g dwt in leaves. Average Cry1Ac concentrations were 34 µg/g dwt in forage and 4.7 µg/g dwt in harvested seed. No Cry1Ac protein was detected in roots of soybean event MON 87701. Due to limited quantities of pollen/anther, the levels of Cry1Ac could only be evaluated on a fresh weight basis. Average Cry1Ac concentration was 2.3 µg/g dwt in pollen/anther.

The Cry1Ac protein in soybean event MON 87701 was purified from seed and characterized. The identity of the purified protein was confirmed by western immunoblot analysis, tryptic peptide mass mapping, N-terminal sequence analysis and insecticidal activity.

The levels of Cry1Ac protein in soybean event MON 87701 tissues were too low to extract sufficient amounts for evaluation of environmental and feed safety. To obtain sufficient quantities of Cry1Ac for safety studies, it was necessary to express the cry1Ac gene in an E. coli production system. The equivalency of the plant-produced protein to the E. coli-produced protein was evaluated by comparing their molecular weight, immunological reactivity, N-terminal sequence, insecticidal activity and glycosylation status. Based on the results, the Cry1Ac protein from soybean event MON 87701 was found to be equivalent to its E. coli-produced counterpart.

The potential mammalian toxicity and allergenicity of the Cry1Ac protein was evaluated. The Cry1Ac protein has been used in microbial pesticides for more than 45 years and a highly similar protein is expressed in the commercially available Bollgard cotton and therefore the Cry1Ac protein has a history of safe use. The Cry1Ac protein lacks sequence similarity to known allergens and toxins that have adverse effects on mammals. No adverse effects were observed when Cry1Ac was ingested by mice at doses of approximately 1460 mg/kg body weight for males and 1290 mg/kg body weight for females in acute oral toxicity studies. In vitro digestive fate studies have shown that Cry1Ac is rapidly degraded in simulated gastric fluid, unlike protein allergens which are normally resistant to digestion. A small transiently stable Cry1Ac protein fragment was observed but this was quickly degraded during short exposure to simulated intestinal fluid. The Cry1Ac protein expressed in soybean event MON 87701 is not glycosylated, unlike many known allergens, providing additional evidence that the Cry1Ac protein does not have the properties of known allergens. Therefore, based on the weight-of-evidence, the Cry1Ac protein expressed in soybean event MON 87701 is unlikely to be toxic or allergenic to mammals.

3. Stable Integration into the Plant Genome

Molecular characterization by Southern blot analysis demonstrated that soybean event MON 87701 contains one intact copy of the cry1Ac gene cassette inserted at a single site in the soybean genome. No additional elements, including intact or partial DNA fragments of the cry1Ac cassette, T-DNA II sequences or backbone sequences from the plasmid vector, linked or unlinked to the intact insert, were detected in soybean event MON 87701. Sequencing of the introduced DNA and the flanking genomic DNA confirmed the organization of the genetic elements and revealed that the right and left borders of the insert were truncated and there was a 32 bp deletion and a 14 bp insertion 5' to the insertion site in the flanking genomic DNA. The truncations, deletion, and insertion had no effect on the functionality of the DNA insert or the plant and such phenomena have been previously observed with Agrobacterium transformation.

The stability of the insert within soybean event MON 87701 was verified by Southern blot analysis over five generations. Analysis of the inheritance pattern of the cry1Ac gene across three segregating generations of soybean event MON 87701 confirmed the stability of the inserted DNA. 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 Soybean Event MON 87701 to Become a Weed of Agriculture or be Invasive of Natural Habitats

The biology of soybean, described in the CFIA Biology Document BIO1996-10, indicates that unmodified plants of this species are not invasive of unmanaged habitats in Canada. Soybean is not weedy due to the lack of seed dormancy and the poor competitive ability of seedlings. The information supplied by Monsanto Canada Inc. showed soybean event MON 87701 to be similar to unmodified soybean in this respect.

The expression of the Cry1Ac protein was demonstrated not to render soybean weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified. Soybean event MON 87701 was tested in 16 locations in the United States in the 2007 growing season. The following agronomic characteristics were evaluated: seed germination, dormancy, early plant stand, final plant stand, seedling vigour, plant height, pod shattering, degree of lodging, days to 50% flowering, seed size (weight of one hundred seeds), seed test weight, growth stage, flower colour, plant pubescence and grain yield. The agronomic characteristic data showed no biologically meaningful differences between MON 87701 soybean and unmodified soybean counterparts. Viable hard seeds, defined as seeds that did not imbibe water, were detected in soybean event MON 87701 as well as in unmodified soybeans at less than 1% total seed (viable hard seed is associated with seed dormancy).

The susceptibility of soybean event MON 87701 to various soybean pests and pathogens was evaluated. No competitive advantage was conferred to soybean event MON 87701 by expression of the Cry1Ac protein, other than that conferred by resistance to certain lepidopteran pests of soybean. Feeding damage by lepidopteran pests is not known to be a major factor restricting the establishment or distribution of soybean in Canada.

Soybean event MON 87701 is not intended to be cultivated in Canada and seed will not be authorized for sale to ensure its intended use. Therefore, environmental exposure to MON 87701 plants will be minimal.

Based on the above information, the CFIA has concluded that soybean event MON 87701 is unlikely to become a weed of agriculture or invasive of natural habitats as a result of incidental environmental release.

2. Potential for Gene Flow from Soybean Event MON 87701 to Wild Relatives Whose Hybrid Offspring May Become More Weedy or More Invasive

Soybeans exhibit a high percentage of self-fertilization. Cross pollination is usually less than one percent, especially when plants are more than 1 metre apart, and pollen flow from cultivated soybeans to other soybeans or to related species is minimal.

Natural hybridization between cultivated soybean and the wild annual species Glycine soja has been documented. G. soja is occasionally cultivated in research plots in North America, but is not naturalized here and there are no reports of its escape from such plots to unmanaged habitats. The novel trait in MON 87701 would not confer a fitness advantage in the absence of lepidopteran pests in the event that a natural hybrid occurred between MON 87701 soybean and G. soja. No other sexually compatible species are present in North America.

Monsanto Canada Inc. provided information regarding floral development in MON 87701 soybean, including days to 50% flowering and pollen characteristics. No significant differences in time to 50% flowering, pollen viability or pollen diameter were detected between MON 87701 soybean and the unmodified control variety, nor was any difference in pollen morphology observed. This indicates that the reproductive characteristics of soybean event MON 87701 are unaltered with respect to those of unmodified soybean.

Soybean event MON 87701 is not intended to be cultivated in Canada and seed will not be authorized for sale to ensure its intended use. Therefore, environmental exposure to MON 87701 plants will be minimal.

Based on the above information, the CFIA has concluded that the potential for gene transfer from soybean event MON 87701 to soybean relatives in managed ecosystems is negligible, and that there is no potential for gene transfer to related wild species in Canada as a result of incidental environmental release.

3. Altered Plant Pest Potential of Soybean Event MON 87701

Soybean is not considered a plant pest in Canada. The expression of the Cry1Ac protein in soybean event MON 87701 is not expected to have effects on susceptibility to any soybean pathogens or pests with the exception of the intended resistance to certain lepidopteran pests. Ecological evaluations of soybean event MON 87701 did not show any biologically meaningful increase or decrease in susceptibility to any insect or disease stressor, with the exception of the intended resistance to some lepidopteran pests (green clover worms, soybean loopers, velvetbean caterpillars), compared to unmodified soybeans grown at the same locations. These stressors included twenty pest insects and nineteen diseases.

Cultivation of MON 87701 would require implementation of a management plan designed to delay development of resistance to the insecticidal protein by its target pests. Since soybean event MON 87701 is not intended to be cultivated in Canada, an insect resistance management plan specific to this product is not required.

Soybean event MON 87701 is not intended to be cultivated in Canada and seed will not be authorized for sale to ensure its intended use. Therefore, environmental exposure to MON 87701 plants will be minimal.

Based on the above information, the CFIA has concluded that that soybean event MON 87701 would not be expected to display altered plant pest potential as a result of incidental environmental release.

4. Potential Impact of Soybean Event MON 87701 on Non-Target Organisms

With the exception of the four added amino acids from the chloroplast transit peptide, the Cry1Ac protein expressed in MON 87701 shares >99% amino acid identity with Cry1Ac from B. thuringiensis subsp. kurstaki and 100% amino acid sequence identity with the Cry1Ac protein present in Bollgard cotton. The safety of the Cry1Ac protein in Bollgard cotton to non-target organisms, including humans, has been previously established (see DD96-14).

Monsanto Canada Inc. submitted an evaluation of the potential toxicity of Cry1Ac to selected non-target organisms. The detailed hazard assessment included toxicity testing against one mammalian species (mouse), an avian species (bobwhite quail), soil decomposers, including two species of Collembola (Folsomia candida and Xenylla grisea) and an earthworm (Eisenia fetida), and four beneficial insect species, including larval and adult honeybees (Apis mellifera), a parasitic wasp (Pediobius foveolatus), a ladybird beetle (Coleomegilla maculata) and a minute pirate bug (Orius albidipennis). Exposure information was developed to determine the maximum expected exposure concentration for the Cry1Ac protein produced in MON 87701. Margins of exposure for the non-target organisms were calculated based on the ratio of no observed effect concentrations to the maximum expected exposure concentrations. The calculated margins of exposure were at least ≥15 fold of the potential maximum exposure levels for all non-target organisms listed above. Therefore, as with other Cry proteins, the Cry1Ac protein present in MON 87701 is not likely to produce adverse effects to non-target organisms at field exposure levels. This conclusion is in agreement with prior published literature which reported no adverse effects on non-target organisms from insect-protected crops that produce Cry1 proteins.

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 root nodules. Soybean event MON 87701 was compared to an unmodified control with respect to nitrogen fixation and nodulation. In addition, reference ranges were established for six commercially available soybean varieties. Nodule number and dry weight, shoot dry weight, root dry weight, shoot total nitrogen in percentage and shoot total nitrogen in grams were observed in a greenhouse study. No biologically meaningful differences between soybean event MON 87701 and the unmodified control were observed for any of these characteristics, indicating that B. japonicum and nitrogen fixation are not affected by the lepidopteran resistance trait.

Soybean event MON 87701 is not intended to be cultivated in Canada and seed will not be authorized for sale to ensure its intended use. Therefore, environmental exposure to MON 87701 plants will be minimal.

Based on the above information, the CFIA has concluded that that soybean event MON 87701 will not result in altered impacts on non-target organisms, including humans as a result of incidental environmental release.

5. Potential Impact of Soybean Event MON 87701 on Biodiversity

Soybean event MON 87701 does not contain any novel phenotypic characteristics that would extend its production past the current geographical range of soybean production in Canada. There would be no transfer of the insect resistance trait to plants in unmanaged environments as soybean's only sexually compatible wild relative in Canada (G. soja) does not occur in unmanaged habitats, and the possibility of soybean outcrossing to G. soja is very low.

MON 87701 soybean does not pose a risk to interacting non-target organisms. In addition, Monsanto Canada Inc. provided data showing that the introduction of the resistance to lepidopteran pests trait does not alter the symbiotic relationship between the bacterium Bradyrhyzobium japonicum and MON 87701 soybean compared to conventional soybean.

Soybean event MON 87701 is not intended to be cultivated in Canada and seed will not be authorized for sale to ensure its intended use. Therefore, environmental exposure to MON 87701 plants will be minimal.

Based on the above information, the CFIA has concluded that the potential impact on biodiversity would be minimal as a result of incidental environmental release.

V. Criteria for the Livestock Assessment

1. Potential Impact of Soybean Event MON 87701 on Livestock Nutrition

Nutritional Composition

The compositional equivalence of MON 87701 soybean to its isogenic control A5547 was assessed from five replicated sites in the US during the 2007 growing season. Forage and seed samples were analysed for proximate, acid detergent fibre (ADF), neutral detergent fibre (NDF), amino acids, fatty acids, vitamin E and isoflavones (diadzein, genistein and glycitein). No statistically significant differences were observed between MON 87701 and A5547 forage for ash, total fat, protein, ADF and NDF. Statistically significant differences between test and control soybean seed were observed for protein; however, both means were within the conventional range and literature values. Statistically significant differences were observed between MON 87701 and A5547 seed for alanine, glycine, histidine, isoleucine, leucine, lysine, serine, threonine and valine. However, the means were within the range for conventional soybeans and literature values. Except for behenic acid, no statistically significant differences were observed between MON 87701 and A5547 for all fatty acids measured. The levels of vitamin E and diadzein in MON 87701 were statistically significantly higher than those of the control, but the mean values were within the range for the commercial varieties and/or literature values. No significant differences were shown between test and control for genistein and glycitein isoflavones. Statistically significant differences were observed between test and control soybean meal for ash, ADF, arginine, histidine, phenylalanine and tryptophan; however, all mean values were within the range of conventional soybean varieties. Statistically significant differences were found between MON 87701 and control soy oil for eicosenoic acid, behenic acid and vitamin E. No differences were observed between test and control soybean protein isolates and lecithin. All means were within the range of conventional soybean varieties.

Anti-nutrients

Phytic acid, trypsin inhibitor, lectin, raffinose and stachyose were analysed in MON 87701 soybean seed and compared to A5547 control. Except for trypsin inhibitor, there were no statistically significant differences between MON 87701 and the control soybean for lectin, phytic acid, raffinose and stachyose. Trypsin inhibitor was statistically significantly lower in MON 87701 than A5547 control; however, all means were within the range of commercial soybean varieties.

Broiler Performance

900 broiler birds were randomly distributed to 90 pens to examine the performance of birds fed MON 87701 soybean meal diets compared to A5547 control and other conventional varieties, for 42 days. No statistically significant differences were observed between birds on MON 87701 and other control diets for average daily gain, feed intake, feed:gain, except for adjusted feed: gain which was significantly lower in birds on MON 87701 soybean meal than the control. However, no statistically significant differences were observed between MON 87701 and the combined population of control and conventional soybean meal varieties for this parameter. No statistically significant differences were observed between MON 87701 and A5547 control for carcass characteristics of the birds. Fat, moisture and protein content of skinless breast and thigh meat samples collected during bird processing showed no significant differences among dietary treatments. Overall, there were no major differences in the performance and health of birds fed diets containing soybean meal from MON 87701 when compared to birds on diets of the control or conventional soybean varieties.

Conclusion

The evidence provided by Monsanto supports the conclusion that the nutritional composition of MON 87701 soybean is substantially equivalent to conventional soybean varieties.

2. Potential Impact of Soybean Event MON 87701 on Livestock and Workers/By-standers

The expressed protein Cry1Ac is not a known toxin or allergen. The Cry1Ac protein in MON 87701 does not have homology with any known allergens or toxins. The Cry1Ac protein is also heat labile and rapidly degraded under conditions similar to those encountered in the gastrointestinal tract. This information suggests that the Cry1Ac protein is unlikely to be a novel toxin or allergen.

No adverse effects from the Cry1Ac protein were observed in acute oral toxicity studies in male and female mice using approximately 162 times as the highest predicted livestock dose level per kg body weight. No adverse effects on nutrition or health were observed in a broiler feeding trial comparing MON 87701 soy grain to several conventional varieties of soy grain in the diet.

The evidence provided by Monsanto indicates that there is no potential impact of MON 87701 on livestock and workers/bystanders when compared to commercialized soy 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 87701 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 87701 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 87701.

VII. Regulatory Decision

Based on the review of the data and information submitted by Monsanto Canada, and through comparisons of soybean event MON 87701 with unmodified soybean counterparts, the Plant and Biotechnology Risk Assessment Unit of the Science Strategies Division, CFIA, has concluded that the novel cry1Ac gene and trait do not confer to soybean MON 87701 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 87701 with its unmodified soybean counterparts, the Animal Feed Division of the Animal Health Directorate, CFIA has concluded that the novel cry1Ac gene and trait will not confer to soybean MON 87701 any characteristic that would raise any concerns regarding the safety or nutritional composition of soybean MON 87701. Grain soybean, its byproducts and soybean oil are currently listed in Schedule IV of the Feeds Regulations and are, therefore approved for use in livestock feeds in Canada. Soybean event MON 87701 has been found to be as safe as and as nutritious as traditional soybean varieties. Soybean event MON 87701 and its products are considered to meet present ingredient definitions and are approved for use as livestock feed ingredients in Canada.

Taking into account the conclusion of the risk assessment and recognizing that incidental release into the environment could occur when this PNT is used as intended, unconfined releaseFootnote1 into the environmentFootnote2 of soybean event MON 87701 and of any lines derived from it is therefore authorized by the Plant Biosafety Office of the Plant Health and Biosecurity Directorate as of October 15, 2010 on a condition that no sale of seed takes place in Canada. This condition is being applied to ensure that the PNT is used as intended.

Taking into account livestock feed evaluation, use as livestock feed of soybean event MON 87701 and of any lines derived from it is authorized by the Animal Feed Division of the Animal Health Directorate.

Authorizations of the soybean lines derived from the event MON 87701 are conditional on the following: (i) no inter-specific crosses are performed, (ii) the intended use(s) are similar, (iii) it is known, following thorough characterization, that these plants do not display any additional novel traits and are substantially equivalent to MON 87701 in terms of their specific use and safety for the environment, including human health, as well as livestock safety and (iv) the novel gene is expressed at a level similar to that of the authorized line.

Soybean event MON 87701 is subject to the same phytosanitary import requirements as its unmodified counterparts.

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