DD2008-75: Determination of the Safety of Monsanto Canada Inc.'s Enhanced Stearate Soybean
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This Decision Document has been prepared to explain the regulatory decision reached under Directive 95-03, entitled Guidelines for the Assessment of Novel Feeds: Plant Sources.
The Canadian Food Inspection Agency (CFIA), specifically the Animal Feed Division of the Animal Health Directorate, has evaluated information submitted by Monsanto Canada Inc. regarding Enhanced Stearate Soybean, which has elevated stearic acid content. The CFIA has determined that this novel feed does not present livestock feed safety concerns when compared to currently commercialized soybean varieties in Canada.
Taking into account this evaluation, use as livestock feed of Enhanced Stearate Soybean is therefore authorized by the Animal Feed Division of the Animal Health Directorate as of July 30th, 2008. Any soybean lines derived from Enhanced Stearate Soybean may also be used as livestock feed, provided that (i) no inter-specific crosses are performed, (ii) the intended uses are similar and (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 varieties in Canada, in terms of their potential environmental impact and livestock feed safety.
Enhanced Stearate Soybean is subject to the same phytosanitary import requirements as its unmodified counterpart.
Table of Contents
- Brief Identification of the Modified Plant
- Background Information
- Description of the Novel Traits
- Enhanced Stearic Acid Content
- Development Method
- Stable Expression
- Criteria for the Environmental Assessment
- Criteria for the Livestock Feed Assessment
- Potential Impact of Enhanced Stearate Soybean on Livestock Nutrition
- Potential Impact of Enhanced Stearate Soybean on Livestock Workers and Bystanders
- New Information Requirements
- Regulatory Decision
I. Brief Identification of the Modified Plant
Designation of the Modified Plant: Enhanced Stearate Soybean
Applicant: Monsanto Canada Inc.
Plant Species: Soybean (Glycine max (L.) Merr)
Novel Traits: Enhanced stearic acid content
Trait Introduction Method: Conventional breeding
Proposed Use of the Modified Plant: Commercial production of soybeans in an identity preserved system for human consumption. These plants are not intended to be grown outside the normal cultivation area for soybeans in Canada.
II. Background Information
Monsanto Company has developed a soybean line, designated as Enhanced Stearate Soybean, which has enhanced stearic acid content. This trait is intended to increase the melting point of the soybean oil, permitting it to exist as a semi-solid at room temperature which would allow it to be used as an alternative to partially hydrogenated oils in baked goods, etc., thus reducing the need for hydrogenation of Enhanced Stearate Soybean oil.
Enhanced Stearate Soybean was generated by crossing a high stearate soybean line with a low linolenic acid soybean line to produce the Enhanced Stearate Soybean line HS-2.
Monsanto has provided data on the identity of Enhanced Stearate Soybean, a detailed description of the development method and breeding history as well as information about the genes involved in the enhanced stearic acid and reduced linolenic acid traits and the stability of the expression of these traits.
Enhanced Stearate Soybean has been field tested in the United States. Compositional data for the trial years 2005 and 2006 were submitted along with agronomic data from 2005. Some of the locations (Arkansas, Illinois, Indiana, Maryland, and North Carolina) of these trials share similar environmental and agronomic conditions to soybean production areas in Southwestern Ontario and were considered representative of major Canadian soybean growing regions.
Agronomic characteristics of Enhanced Stearate Soybean, such as plant height, lodging, maturity, grain yield, and seed germination, were provided and were shown to be similar to commercial soybean lines.
Nutritional components of Enhanced Stearate Soybean, such as proximates, amino acids and fatty acids were compared with those of commercial reference varieties.
The Plant Biosafety Office of the Plant Production Directorate, CFIA, with advice from the Plant and Biotechnology Risk Assessment (PBRA) Unit of the Science Strategies Division, CFIA, has reviewed information provided by Monsanto Canada Inc. and agrees with Monsanto Canada Inc.'s determination, based on this information, that Enhanced Stearate Soybean is not a Plant with a Novel Trait (PNT) and therefore does not require an assessment of environmental safety.
The Animal Feed Division of the Animal Health Directorate, CFIA, has reviewed the submitted data to determine the safety and efficacy of Enhanced Stearate Soybean and its derivatives as a livestock feed, as described in Directive 95-03, entitled Guidelines for the Assessment of Novel Feeds: Plant Sources. The Animal Feed Division has considered:
- potential impact of Enhanced Stearate Soybean on livestock nutrition; and
- potential impact of Enhanced Stearate Soybean on livestock workers and bystanders.
Monsanto Canada Inc. has provided the CFIA with a method for the detection and identification of Enhanced Stearate Soybean.
III. Description of the Novel Traits
1. Enhanced Stearic Acid Content
Soybean oil is commonly used in salad dressings and shortening and as oil for baking and frying. Soybean oil contains high levels of the polyunsaturated linoleic (C18:2) and linolenic (C18:3) fatty acids and the monounsaturated oleic (C18:1) fatty acid, and moderate amounts of the saturated palmitic (C16:0) and stearic (C18:0) fatty acids. This fatty acid profile results in an oil that is liquid at room temperature and highly susceptible to oxidation, resulting in off-flavours. Soybean oil is frequently hydrogenated to make it suitable for inclusion in products requiring a solid physical state or a long shelf-life. Hydrogenation of soybean oil, however, promotes formation of trans fats which are thought to have negative health effects.
The fatty acid profile of Enhanced Stearate Soybean contains significantly higher levels of stearic acid than conventional soybeans (16 to 24% versus 4%). There is some evidence to suggest that not all saturated fatty acids have the same physiological effect. Most of the research that has been done indicates that stearic acid may have a neutral effect on cholesterol levels in comparison to other individual saturated fatty acids and carbohydrates. Enhanced Stearate Soybean possesses reduced levels of the polyunsaturated fatty acid linolenic acid (< 4% versus 8%). The reduced linolenic levels reflect the breeding background of Enhanced Stearate Soybean, which includes a soybean line that was selected for reduced linolenic content as a means of increasing the stability of oil derived from these soybeans. Enhanced Stearate Soybean also possesses slightly increased levels of the saturated fatty acids arachidic (1.7% versus 0.2 to 0.5%) and behenic acids (1% versus 0.3 to 0.6%) compared to conventional soybeans.
2. Development Method
Enhanced Stearate Soybean was generated by crossing a high stearate soybean line with a low linolenic acid soybean line to produce the Enhanced Stearate Soybean line HS-2. Enhanced stearate soybean lines were selected on the basis of high stearate content, as evaluated by fatty acid profile and presence of a DNA marker associated with high stearate levels, and good agronomic characteristics.
3. Stable Expression
Chi square analysis demonstrated that the DNA marker associated with the high stearate trait fit the expected segregation ratio normally exhibited by single recessive genes with Mendelian inheritance patterns within the F2 generation of a cross between the HS-2 line and a commercial cultivar. High stearate expression was stable in several soybean lines derived from HS-2, as demonstrated by consistent production of 16 to 24% stearic acid as a proportion of total fatty acids in these lines.
IV. Criteria for the Environmental Assessment
The Plant Biosafety Office of the Plant Production Directorate, CFIA, with advice from the Plant and Biotechnology Risk Assessment (PBRA) Unit of the Science Strategies Division, CFIA, has reviewed information provided by Monsanto Canada Inc. and agrees with Monsanto Canada Inc.'s determination, based on this information, that Enhanced Stearate Soybean is not a PNT and therefore does not require an assessment of environmental safety.
V. Criteria for the Livestock Feed Assessment
1. Potential Impact of Enhanced Stearate Soybean on Livestock Nutrition
The compositional equivalence of Enhanced Stearate Soybean to commercial soybean varieties was demonstrated using data from several field sites in the US during the 2005 and 2006 growing seasons. Seed samples were analyzed for proximate, acid detergent fibre (ADF), neutral detergent fibre (NDF), fatty acids, amino acids, vitamin E and isoflavones (diadzein, genistein and glycitein). Compositional analyses of defatted toasted meal and refined bleached oil derived from Enhanced Stearate Soybeans were also characterized for both years.
The means of crude protein, fat, ash, ADF, NDF in Enhanced Stearate Soybean seed were within the range of the commercial soybean, literature and/or International Life Sciences Institute (ILSI) database for soybeans. As intended, the mean stearic acid (C18:0) in Enhanced Stearate Soybean seed was about 16-24% versus 4% for conventional varieties, literature and ILSI data base values. Arachidic (C20:0) and behenic (C22:0) acids were also above the range of the commercial varieties, literature and ILSI data base for soybeans. For both years, palmitic (C16:0) and linolenic (C18:3) acids means were below the commercial varieties and literature values but linolenic was within the ILSI database. For 2005 data, linoleic (C18:2) and eicosenoic (C20:1) acids in Enhanced Stearate Soybean had mean values below the range values of the commercial varieties, literature and ILSI database, while oleic (C18:1) in 2006, was below the commercial range but was within the literature and ILSI database. Amino acids and vitamin E measured in Enhanced Stearate Soybean were within the range of the commercial reference soybean, literature values and/or ILSI database. The ranges for diadzein, genistein and glycitein in Enhanced Stearate Soybean were outside the range of the commercial varieties but were within the range of the literature and/or ILSI database.
In Enhanced Stearate Soybean meal, proximate, fibres, amino acids and Vitamin E were within literature values for both years, except for alanine, cystine, histidine, isoleucine, tryptophan, valine which were below the literature range in 2006. This was considered not to be biologically relevant. In Enhanced Stearate Soybean oil, as intended, stearic acid was about 4 times above the range of literature values. The means of palmitic, palmitoleic, heptadecanoic, oleic, linoleic, linolenic, eicosenoic acids were within the range of literature values. Arachidic and behenic acids were above the range of literature values.
Phytic acid, raffinose, stachyose, trypsin inhibitor and lectin in Enhanced Stearate Soybean seed were compared to conventional soybean varieties, literature values and ILSI database for soybeans. All anti-nutrients were within the range of the commercial varieties, literature and/or ILSI database. Phytic acid and trypsin inhibitor were also measured in the meal and were within literature ranges for both years.
The evidence provided by Monsanto supports the conclusion that the nutritional composition of Enhanced stearate soybean is substantially equivalent to conventional soybean except for the increase in stearic (C18:0), arachidic (C20:0) and behenic acids (C22:0) in the oil, as expected based on selection for enhanced stearic acid content trait.
2. Potential Impact of Enhanced Stearate Soybean on Livestock Workers and Bystanders
Enhanced Stearate Soybean was not modified to express a new protein, or a modified form of an endogenous protein, but rather selected for increased expression of stearic acid and reduce expression of linolenic acid. Selection for these traits is not expected to result in the expression of a novel allergen or toxin based on the characterization data provided (nutritional composition and agronomic data), it is unlikely that the enhanced stearic acid and reduced linolenic acid traits have had any unintended effects on the modified plant including altering expression of endogenous toxins and allergens.
The evidence provided by Monsanto Canada Inc. supports the conclusion that Enhanced Stearate Soybean will not result in altered impacts on livestock and workers/by-standers compared to current commercial soybean lines.
VI. New Information Requirements
If at any time Monsanto Canada Inc. becomes aware of any information regarding risk to the environment, including risk to human or animal health, which could result from the release of Enhanced Stearate Soybean materials in Canada or elsewhere, Monsanto Canada Inc. will immediately provide such information to the CFIA. On the basis of such new information, the CFIA will re-evaluate the potential impact of Enhanced Stearate Soybean 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 Enhanced Stearate Soybean.
VII. Regulatory Decision
Based on the review of submitted data and information by Monsanto Canada Inc., including comparisons of Enhanced Stearate Soybean with its unmodified soybean counterparts, the Animal Feed Division of the Animal Health Directorate has concluded that Enhanced Stearate Soybeans do not confer any characteristic that would raise any concerns regarding the feed safety of Enhanced Stearate Soybean. Soybean and several of its byproducts are currently listed in Schedule IV of the Feeds Regulations and are, therefore, approved for use in livestock feeds in Canada. Enhanced Stearate Soybean has been assessed and found to be as safe as and as nutritious as traditional soybean varieties. Enhanced Stearate Soybean and its products are considered to meet present ingredient definitions and are approved for use as livestock feed ingredients in Canada.
Taking into account this evaluation, livestock feed use of Enhanced Stearate Soybean is therefore authorized by the Animal Feed Division of the Animal Health Directorate as of July 30th, 2008. Any soybean lines derived from Enhanced Stearate Soybean may also be used as livestock feed, provided no inter-specific crosses are performed, provided the intended uses are similar, and provided 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.
Enhanced Stearate Soybean is subject to the same phyto-sanitary import requirements as its unmodified counterparts.
Please refer to Health Canada's Decisions on Novel Foods for a description of the food safety assessment of Enhanced Stearate Soybean.
This bulletin is published by the Animal Feed Division. For further information, please contact the Animal Feed Division at:
Animal Feed Division
Animal Health Directorate
59 Camelot Drive
Ottawa, Ontario, K1A 0Y9
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