DD2009-77: Determination of the Safety of Pioneer Hi-Bred Production Ltd.'s Soybean (Glycine max (L.) Merr.) Event 356043

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Issued: 2009-08

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 Directive 95-03 (Dir95-03), entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources".

The Canadian Food Inspection Agency (CFIA) has evaluated information submitted by Pioneer Hi-Bred Production Ltd. This information is in regard to the herbicide resistant soybean event 356043. The CFIA has determined that this plant with novel traits (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 356043 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 August 26, 2009. Any soybean lines derived from soybean event 356043 may also be released into the environment and used as livestock feed, provided that (i) no inter-specific crosses are performed, (ii) the intended uses are similar, (iii) 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 (iv) the novel genes are expressed at a level similar to that of the authorized line.

Soybean event 356043 is subject to the same phytosanitary import requirements as its unmodified counterpart.

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.

Table of Contents

  1. Brief Identification of the Modified Plant
  2. Background Information
  3. Description of the Novel Trait
    1. Tolerance to Glyphosate and ALS-Inhibiting Herbicides
    2. Development Method
    3. Stable Integration into the Plant Genome
  4. Criteria for the Environmental Assessment
    1. Potential of Soybean Event 356043 to Become a Weed of Agriculture or be Invasive of Natural Habitats
    2. Potential for Gene Flow from Soybean Event 356043 to Wild Relatives Whose Hybrid Offspring May Become More Weedy or More Invasive
    3. Altered Plant Pest Potential of Soybean Event 356043
    4. Potential Impact of Soybean Event 356043 on Non-Target Organisms
    5. Potential Impact of Soybean Event 356043 on Biodiversity
  5. Criteria for the Livestock Feed Assessment
    1. Potential Impact of Soybean Event 356043 on Livestock Nutrition
    2. Potential Impact of Soybean Event 356043 on Livestock and Workers/Bystanders
  6. New Information Requirements
  7. Regulatory Decision

Annex: Guidance on Sustainable Weed Management with Herbicide Tolerant Crops

I. Brief Identification of the Modified Plant

Designation of the Modified Plant: Soybean event 356043, OECD Unique Identifier DP-356Ø43-5
Applicant: Pioneer Hi-Bred Production Ltd.
Plant Species: Soybean (Glycine max (L.) Merr.)
Novel Traits: Tolerance to glyphosate herbicide and tolerance to ALS-inhibiting herbicides
Trait Introduction Method: Microprojectile bombardment (gene gun) mediated transformation
Proposed Use of the Modified Plant: Commercial production of soybean grain for human consumption and for livestock feed. These plants are not intended to be grown outside the normal cultivation area for soybeans in Canada

II. Background Information

Soybean event 356043 was developed by Pioneer Hi-Bred Production Ltd. using recombinant DNA technology, resulting in the introduction of the gat4601 and the gm-hra genes. The gat4601 gene encodes a glyphosate N-acetyltransferase (GAT) enzyme derived from Bacillus licheniformis enzymes, which metabolises the herbicide glyphosate, conferring resistance to the plant. The gm-hra gene encodes a modified ALS enzyme that confers resistance to ALS-inhibiting herbicides.

Pioneer Hi-Bred Production Ltd. has provided data on the identity of soybean event 356043, 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 proteins were identified and characterized. Data was provided for the evaluation of the potential toxicity of the novel proteins to livestock and non-target organisms and potential allergenicity of the novel proteins to humans and to livestock.

Soybean event 356043 has been field tested in the United States and Canada and the data for trial year 2005 were submitted. The Canadian locations, Thorndale, ON and Branchton, ON were representative of soybean growing regions in Canada.

Agronomic characteristics of soybean event 356043 such as seed dormancy, vegetative vigour, time to maturity, flowering period, susceptibilities to various soybean pests and pathogens, and seed production were compared to those of unmodified soybean counterparts.

Nutritional components of soybean event 356043, such as proximates, amino acids and fatty acids were compared with those of unmodified soybean counterparts.

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

The PBRA Unit has considered:

  • the potential of soybean event 356043 to become a weed of agriculture or be invasive of natural habitats;
  • the potential for gene flow from soybean event 356043 to wild relatives whose hybrid offspring may become more weedy or more invasive;
  • the potential for soybean event 356043 to become a plant pest;
  • the potential impact of soybean event 356043 or its gene products on non-target species, including humans; and
  • the potential impact of soybean event 356043 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 Directive 95-03 (Dir95-03), entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources". The Feed Section has considered:

  • the potential impact of soybean event 356043 on livestock nutrition; and
  • the potential impact of soybean event 356043 on livestock and workers/bystanders

Pioneer Hi-Bred Production Ltd. has provided the CFIA with a method for the detection and identification of soybean containing the soybean event 356043.

III. Description of the Novel Traits

1. Tolerance to Glyphosate and ALS-Inhibiting Herbicides

Glyphosate blocks the shikimic acid pathway required for biosynthesis of the aromatic amino acids phenylalanine, tyrosine, and tryptophan in plants, leading to growth suppression or death of the plants. The gat4601 gene encodes an enzyme, derived from three B. licheniformis N-acetyltransferase enzymes, which inactivates glyphosate by N-acetylation. The sequence of this enzyme is 84% homologous to the sequences that were used to create it. The gat4601 gene introduced into soybeans during the transformation process to develop event 356043, imparts field level tolerance to glyphosate.

Acetolactate synthase (ALS), also known as acetohydroxyacid synthase (AHAS), is a key enzyme in the synthesis of the essential branched-chain amino acids isoleucine, leucine, and valine. ALS-inhibiting herbicides disrupt synthesis of isoleucine, leucine, and valine in plants, leading to growth suppression or death of the plant. The gm-hra gene encodes a soybean ALS enzyme that contains two specific amino acid differences from the wild type enzyme, rendering it resistant to all classes of ALS-inhibiting herbicides. The gm-hra gene, which was introduced into soybeans during the transformation process to develop event 356043, imparts field level tolerance to ALS-inhibiting herbicides.

Both GAT4601 and GM-HRA expression in soybean event 356043 are driven by constitutive promoters. Samples of soybean tissues were collected from plants at various growth stages from six field trial sites across Canada and the United States. Average GAT4601 and GM-HRA protein expression across all plant stages was evaluated by enzyme-linked immunosorbent assay. The levels of GAT4601, expressed in micro-grams protein per gram dry weight tissue (µg/g dwt), observed were as follows: 1.6 µg/g dwt in forage 1.6 µg/g dwt in root, and 0.24 µg/g dwt in grain. The levels of GM-HRA observed were as follows: 27 µg/g dwt in forage 3.3 µg/g dwt in root, and 0.91 µg/g dwt in grain.

The GAT4601 and GM-HRA proteins were purified from the grain of soybean event 356043 and characterized. The identities of the purified proteins were confirmed by Western immunoblot analysis, tryptic peptide mass mapping, and N-terminal characterization.

The concentrations of GAT4601 and GM-HRA proteins in soybean event 356043 tissues were too low to extract sufficient amounts for evaluation of environmental and feed safety. To obtain sufficient quantities of the proteins for safety studies, it was necessary to express the gat4601 and gm-hra genes in an E. coli production system. The equivalency of the plant-produced GAT4601 and GM-HRA proteins to the E. coli - produced proteins was evaluated by comparing their molecular weights, immunological reactivity, tryptic peptide mass map and glycosylation status. Based on the results, the GAT4601 and GM-HRA proteins produced in soybean event 356043 were found to be equivalent to their E. coli-produced counterparts.

The potential mammalian toxicity and allergenicity of the GAT4601 and GM-HRA proteins was evaluated. These proteins lack sequence similarity to known allergens and protein toxins which have adverse effects to mammals. No adverse effects were observed when the GAT4601 or GM-HRA proteins were ingested by mice at a dose of approximately 1900-2000 mg/kg body weight and 436-582 mg/kg body weight, respectively in acute oral toxicity studies. In vitro digestive fate studies have shown that GAT4601 and GM-HRA are rapidly degraded in simulated gastric fluid, unlike protein allergens which are normally resistant to digestion. The GAT4601 and GM-HRA proteins expressed in soybean event 356053 are not glycosylated, unlike many known allergens, providing additional evidence that these proteins do not have the properties of known allergens.

2. Development Method

Soybean event 356043 was developed through microprojectile bombardment of secondary somatic soybean embryos with a DNA fragment containing only the gat4601 and gm-hra genes and their regulatory elements. Soybean event 356043 was selected on the basis of tolerance to chlorsulfuron, an ALS-inhibiting herbicide, and the presence of gat4601 and gm-hra genes in the transformant was confirmed.

3. Stable Integration into the Plant Genome

Molecular characterization by Southern blot analysis demonstrated that soybean event 356043 contains one copy of gat4601 and gm-hra gene cassettes inserted at a single site in the soybean genome. No additional elements, including intact or partial DNA fragments of the gat4601 and gm-hra gene cassettes or backbone sequences from the plasmid vector, linked or unlinked to the intact insert, were detected in soybean event 356043.

The stability of the inserted DNA was demonstrated by Southern blot analysis across three generations in the breeding history of soybean event 356043. Analysis of the inheritance pattern of the gat4601 and gm-hra genes and the GAT4601 and GM-HRA proteins across five generations of soybean event 356043 confirmed the stability of the inserted DNA and the stability of GAT4601 and GM-HRA protein expression. The results of the analysis are consistent with the finding of a single site of insertion that segregates according to the Mendelian laws of genetics.

IV. Criteria for the Environmental Assessment

1. Potential of Soybean Event 356043 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 Pioneer Hi-Bred Production Ltd., soybean event 356043 was determined not to be significantly different from their conventional counterparts in this respect.

The PBRA evaluated data submitted by Pioneer Hi-Bred Production Ltd. on the reproductive biology and life history traits of soybean event 356043. This event was field-tested in four locations in the US and in two locations in Canada. The US locations share similar environmental and agronomic conditions to southwestern Ontario and all locations were considered to be representative of major Canadian soybean regions. During the field trials, several phenotypic characteristics were evaluated: early population, seedling vigour, days to maturity, plant height, lodging, pod shattering, final population and yield. The statistical analysis of these observations showed no biologically meaningful differences between soybean event 356043 and the unmodified isoline 'Jack', and support a conclusion of phenotypic equivalence to currently commercialized soybean lines.

The seed dormancy and germination of soybean event 356043 were compared with the unmodified control variety isoline Jack. No significant differences were detected in percent germinated seed, percent dead seed and percent viable firm, swollen seed and viable hard seed. Viable hard seed was not observed in seed germination and seed viability tests of soybean event 356043.

Data on the susceptibility to a range of insect pest and disease, and response to abiotic stressors were also recorded at each of the field trial sites. No increase or decrease outside of the reference range was observed in any insect, disease, or abiotic stressor in soybean event 356043.

The introduction of the gat4601 and gm-hra gene cassette did not make soybean event 356043 weedy or invasive of natural habitats since none of the soybean's reproductive or growth characteristics were modified, and soybean event 356043's tolerance to abiotic and biotic stresses was unchanged as well. No competitive advantage was conferred to soybean event 356043, other than that conferred by tolerance to glyphosate and acetolactate synthase (ALS) herbicides.

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. This requires the management of this technology as a part of an integrated approach which may include currently available weed control products with alternate modes of action.

Pioneer Hi-Bred Production Ltd. has submitted a herbicide tolerance stewardship plan to the CFIA which was evaluated by PBRA. 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 these traits. In addition, the stewardship plan contains strategies for communication to growers and an efficient mechanism allowing growers to report problems to Pioneer Hi-Bred Production Ltd. Pioneer Hi-Bred Production Ltd. will make this stewardship plan readily available to growers to promote careful management practices for soybean event 356043.

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 356043 has no altered weed or invasiveness potential compared to currently commercialized soybean varieties.

2. Potential for Gene Flow from Soybean Event 356043 to Wild Relatives Whose Hybrid Offspring May Become More Weedy or 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 minimal potential for gene flow from soybean event 356043 to related species in Canada.

3. Altered Plant Pest Potential of Soybean Event 356043

Soybean is not considered a plant pest in Canada. The novel traits are unrelated to plant pest potential. Ecological evaluations of soybean event 356043 did not show any increase or decrease in susceptibility to any insect or disease stressor compared to lines sharing identical genetic background and commercial soybean varieties grown at the same locations. These stressors included eight pest insects and five diseases.

Despite tolerance to glyphosate and ALS-inhibing herbicides, soybean event 356043 volunteers can still be managed by growers using alternative herbicides with different modes of action, or cultivation practices which do not involve the use of these herbicides.

The PBRA therefore concludes that soybean event 356043 does not display any altered pest potential compared to currently commercialized soybean varieties.

4. Potential Impact of Soybean Event 356043 on Non-Target Organisms

The detailed characterizations of the novel genes and resulting enzymes (as briefly summarized in Part III: Description of the Novel Traits) has led to the conclusion that the the novel proteins are not toxic or allergenic and do not result in altered toxic or allergenic properties of soybean. The reproductive biology and life history traits of soybean event 356043 are not altered as a result of the expression of these two traits and the interaction of soybean event 356043 with other organisms is therefore not expected to be altered either.

The PBRA has therefore determined that the unconfined release of soybean event 356043 will not result in altered impacts on non-target organisms, including humans, compared to currently available Canadian soybean varieties.

5. Potential Impact of Soybean Event 356043 on Biodiversity

Soybean event 356043 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 outcrossing to G. soja is very low. Additionally, the novel traits will not confer a fitness advantage to G. soja in the absence of either or both of the associated herbicide groups (which are not used in unmanaged habitats). The novel traits are unlikely to have an impact on plant pest potential or non- target organisms. It is therefore unlikely that soybean event 356043 will have any direct effects on biodiversity, in comparison to the effects that would be expected from the cultivation of currently grown Canadian soybean varieties.

Soybean event 356043 has tolerance to broad spectrum herbicides such as glyphosate and the ALS-inhibiting herbicides. The use of these herbicides in cropping systems has the intended effect of reducing local weed populations within agroecosystems. 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 356043, or the cultivation of soybean. It is therefore unlikely that soybean event 356043 will have any indirect effects on biodiversity, in comparison to the effects that would be expected from the cultivation of currently cultivated Canadian soybean varieties.

The CFIA has therefore concluded that the potential impact on biodiversity of soybean event 356043 is unlikely to be different from that of currently cultivated Canadian soybean varieties.

V. Criteria for the Livestock Feed Assessment

1. Potential Impact of soybean event 356043 on Livestock Nutrition

Nutritional Composition:

The compositional equivalence of soybean event 356043 to its non transgenic, isoline control (Jack) was determined from replicated trials at four sites in the US and two sites in Canada. Forage and grain samples were collected at each site and analysed for proximate, acid detergent fibre (ADF) and neutral detergent fibre (NDF). Grain samples were also analysed for fatty acids, amino acids, free and acetylated amino acids, minerals, vitamins, oligosaccharides and isoflavones. There were no statistically significant differences between soybean event 356043 and the control for protein, fat, crude fibre, ash, ADF and NDF in forage and grain samples. Statistically significant differences were observed between soybean event 356043 and the control for myristic, palmitic, heptadecanoic (C17:0), heptadecenoic (C17:1), oleic, linoleic and linolenic acids. All means were with the tolerance interval of commercial varieties and/or literature values except for heptadecanoic and heptadecenoic acids. Pioneer Hi-Bred Production Ltd. asserted that the terminal metabolic substrate (propionyl-CoA) in odd chain fatty acids enters into the Krebs cycle and is further metabolized to succinyl-CoA. Therefore the higher levels of C17:0 and C17:1 presents no risk to livestock. There were no statistically significant differences between the transgenic and control soybean for all total and free amino acids measured.

The levels of N-acetylglutamate and N-acetylaspartate were statistically significantly elevated in soybean event 356043 grain compared to that of the control and were outside the tolerance interval and/or literature values. Statistically significant differences were also observed between test and control soybeans for N-acetylserine and N-acetylthreonine, however, the mean levels in soybean event 356043 were within the ranges of the control. The applicant provided evidence to show that due to the rapid rate of deacetylation of N-acetylglutamate and N-acetylaspartate into free glutamate and aspartate during metabolism as well as the low animal exposure, the increased concentration of N-acetylglutamate and N-acetylaspartate in soybean event 356043 poses no risk. Furthermore no negative effects on performance or health were observed in birds consuming soybean event 356043 diets.

No statistically significant differences were observed between soybean event 356043 and the control soybean for all minerals, except for magnesium, which was within the range of literature values. No statistically significant differences were observed between soybean event 356043 and the control soybean for Vitamins B1, B2, folic acid and tocopherols. There were no statistically significant difference between the transgenic soybean and control soybean for genistin, malonylgenistin, genistein, daidzin, daidzein, glycitin and malonylglycitin. Malonyldaidzin was statistically significantly higher in transgenic than control, but the means were within the tolerance interval for commercial varieties.

Anti-nutrients:

Phytic acid, trypsin inhibitor, lectins, stachyose and raffinose were analysed in soybean event 356043 grain and compared to (Jack) control. No statistically significant differences were observed between soybean event 356043 and the control soybean for stachyose, raffinose, lectins and phytic acid. Trypsin inhibitor in soybean event 356043 was significantly lower than the control, however the means were within the range of the tolerance interval and literature values.

Broiler Study

To assess the wholesomeness of soybean event 356043 for use in animal feed, a 42- day broiler study was conducted. Soybean event 356043 diets were evaluated by comparing growth, organ and carcass yield of broiler chicken fed processed fractions (meal, hull and oil), to those from isoline control (Jack) and three commercial reference varieties. There were 10 broilers per pen (50% male and 50% female) with 12 pens per treatment. 1 20 Ross x Cobb broilers were fed in 3 phases, starter (0-21d), grower (22-35d) and finisher (36- 42d) with the meal include at 30%, 26% and 21.5% of the diet, respectively. Mortality and complete necropsy examinations were performed. No statistically significant differences were observed in mortality, weight gain, feed efficiency organ and carcass yield variables between broiler consuming diets containing soybean event 356043 and control soybeans. All means were within the tolerance interval calculated for the study.

The evidence provided by Pioneer Hi-Bred Production Ltd. supports the conclusion that the nutritional composition of soybean event 356043 is substantially equivalent to that of conventional soybean varieties with its associated elevated levels of heptadecanoic (C17:0) and heptadecenoic (C17:1) acids, N-acetylglutamate and N-acetylaspartate. No detrimental effects of these analytes were seen on the health, growth and carcass performance of broilers consuming diets containing soybean event 356043.

2. Potential Impact of Soybean event 356043 on Livestock and Workers/Bystanders

The gm-hra gene encodes a modified ALS enzyme that was altered by site-directed mutagenesis to contain two amino acid differences from the wild type ALS enzyme. ALS enzymes are found in a wide variety of plants and micro-organisms. ALS enzymes are not known toxins or allergens and the two amino changes are not expected to alter this. The modified ALS enzyme does not have homology with any known allergens or toxins. It was also heat labile and rapidly degraded under conditions similar to those encountered in the gastrointestinal tract. The amino acid sequence of the GM-HRA protein found in soybean event 356043 is identical to that of the GM-HRA protein in Pioneer Hi-Bred Productions Ltd.'s soybean event 305423 previously approved in Canada. This information suggests that the modified ALS is unlikely to be a novel toxin or allergen.

The GAT4601 protein was derived from three B. licheniformis N-acetyltransferase enzymes, and is 84% homologous to these sequences. B. licheniformis is not pathogenic and has been used as a source of industrial enzymes for many years without reports of adverse effects to human health or the environment. The GAT4601 enzyme did not have homology with any known allergens or toxins. It was also heat labile and rapidly degraded under conditions similar to those encountered in the gastrointestinal tract. This information suggests that GAT4601 is unlikely to be a novel toxin or allergen.

No adverse effects from the GM-HRA and GAT4601 proteins were observed in acute oral toxicity studies in mice using approximately 130 times and 7900 times, respectively, 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 soybean event 356043 grain to a conventional variety of soybean grain in the diet.

An assessment was also completed on N-acetyl glyphosate and other minor metabolites formed due to the activity of the GAT4601 protein on glyphosate. N-acetyl glyphosate was found in all of the tissues of the soybean event 356043 that are consumed by livestock (hay, forage, and grain) following application of glyphosate. No adverse effects from N-acetyl glyphosate were observed in a 90-day oral toxicity study in rats using approximately 76 times the highest predicted livestock dose level per kg body weight. N-acetyl glyphosate and other minor metabolites do not show any evidence of significant toxicological effects in the data considered. N-acetyl glyphosate and other minor metabolites are rapidly excreted and no tissue residues of concern are expected in livestock or products from food animals.

The evidence provided by Pioneer Hi-Bred Production Ltd. indicates there is no potential impact of soybean event 356043 on livestock and workers/by-standers when compared to commercialized soybean lines.

VI. New Information Requirements

If at any time, Pioneer Hi-Bred Production Ltd. 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 356043 materials in Canada or elsewhere, Pioneer Hi-Bred Production Ltd. 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 356043 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 356043.

VII. Regulatory Decision

Based on the review of the data and information submitted by Pioneer Hi-Bred Production Ltd., and through comparisons of soybean event 356043 with unmodified soybean counterparts, the Plant and Biotechnology Risk Assessment Unit of the Science Strategies Division, CFIA, has concluded that soybean event 356043 is substantially equivalent to commercially cultivated soybean lines. The novel genes and their corresponding traits in soybean event 356043 do not alter or confer any characteristic that would result in unintended environmental effects following unconfined release. Pioneer Hi-Bred Production Ltd. has provided a stewardship plan to address any concerns associated with the use of glyphosate or acetolactate synthase-inhibiting herbicides in soybean event 356043 production.

Based on the review of submitted data and information by Pioneer Hi-Bred Production Ltd., including comparisons of soybean event 356043 with it's unmodified soybean counterparts, the Animal Feed Division has concluded that the introduced genes and their corresponding traits will not confer to soybean event 356043 any characteristic that would raise any concerns regarding the safety or nutritional composition of soybean event 356043. 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 356043 has been assessed and found to be as safe as and as nutritious as traditional soybean varieties. Soybean event 356043 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 356043 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 August 26, 2009. Any soybean lines derived from soybean event 356043 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 soybean varieties in Canada, in terms of their potential environmental impact and livestock feed safety, the novel genes are expressed at levels similar to that of the authorized line.

Soybean event 356043 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 food safety assessment of soybean event 356043. The food safety decisions are available at the following Health Canada web site:
http://www.hc-sc.gc.ca/fn-an/gmf-agm/appro/index_e.html

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