DD2006-61: Determination of the Safety of Monsanto Canada Inc.'s Corn (Zea mays L.) Event LY038

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Issued: 2006-07

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 Dir94-11, "The Biology of Zea mays L. (Corn/Maize)", and Directive 95-03 (Dir95-03), entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources".

The Canadian Food Inspection Agency (CFIA), specifically the Plant Biosafety Office (PBO) of the Plant Products Directorate and the Feed Section of the Animal Health and Production Division has evaluated information submitted by Monsanto Canada Inc. This information is in regard to the elevated levels of free lysine predominately in the germ of corn event LY038. 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 maize varieties in Canada.

Unconfined release into the environment and use as livestock feed of the corn event LY038 is therefore authorized as of July 21, 2006. Any other corn lines and intraspecific hybrids resulting from the same transformation events and all their descendants, may also be released into the environment and used as livestock feed, provided that (i) no inter-specific crosses are performed, (ii) the intended use is similar, (iii) based on characterization, these plants do not display any additional novel traits and are substantially equivalent, in terms of their specific use and safety for the environment and for human and animal health, to plants currently being cultivated.

The corn event LY038 is subject to the same phytosanitary import requirements as its unmodified counterpart.

Please note, that the 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

I. Brief Identification of the Modified Plant

II. Background Information

III. Description of the Novel Trait

  1. Increased Lysine in Corn event LY038
  2. Development Method
  3. Stable Integration into the Plant Genome

IV. Criteria for the Environmental Assessment

  1. Potential of corn event LY038 to Become a Weed of Agriculture or be Invasive of Natural Habitats
  2. Potential for Gene Flow to Wild Relatives Whose Hybrid Offspring May Become More Weedy or More Invasive
  3. Altered Plant Pest Potential
  4. Potential Impact on Non-Target Organisms
  5. Potential Impact on Biodiversity

V. Criteria for the Livestock Feed Assessment

  1. Potential Impact of corn event LY038 on Livestock Nutrition
  2. Potential Impact of corn event LY038 on Livestock and Workers/Bystanders

VI. New Information Requirements

VII. Regulatory Decision

I. Brief Identification of the Modified Plant

Designation(s) of the Modified Plant: Corn Event LY038, OECD identifier REN-00038-3

Applicant: Monsanto Canada, Inc. on behalf of Renessen LLC a joint venture between Monsanto Company and Cargill Inc.

Plant Species: Corn (Zea mays L.)

Novel Traits: Increased level of free lysine predominately in the germ portion of corn grain for animal feed applications

Trait Introduction Method: A particle acceleration methodology (biolistic method)

Proposed Use of the Modified Plant: Commercial production of Z. mays for seed and forage for livestock feed. These plants are not intended for cultivation in Canada.

II. Background Information

Monsanto Canada Inc. in collaboration with Renessen LLC developed, through the use of recombinant DNA techniques, a corn with elevated levels of free lysine in grain. Poultry and swine diets based on corn and soybean are characteristically deficient in lysine and require the addition of supplemental lysine for optimal animal growth and production. The corn event, designated as LY038, was developed to provide an alternative to direct addition of supplemental lysine to poultry and swine diets by increasing the amount of free lysine in the corn component of feed (i.e., grain).

Corn event LY038 was developed using recombinant DNA technology, resulting in the introduction of the bacterial gene cordapA from Corynebacterium glutamicum. This gene encodes the lysine-insensitive dihydrodipicolinate synthase (cDHDPS) enzyme. Dihydrodipicolinate synthase (DHDPS) is a regulatory enzyme in the lysine biosynthetic pathway and is the first and major rate-limiting enzyme for lysine biosynthesis in plants and bacteria. As the first committed enzyme in lysine biosynthesis, DHDPS is highly susceptible to lysine feedback inhibition, particularly DHDPS isolated from plants. Since the cDHDPS enzyme is less sensitive to lysine feedback inhibition, its expression in corn LY038 is expected to result in the elevated levels of free lysine in the plant when compared to conventional corn. The transcription of cordapA is under the control of the corn promoter globulin 1 (Glb1) which directs cDHDPS expression predominantly in the germ, resulting in accumulation of free lysine in this portion of the grain.

Monsanto Canada Inc. has provided data on the identity of the corn event LY038, 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. Each novel protein was identified, the mode of action described, characterized and compared to the original donor bacterial proteins. 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.

Corn event LY038 has been field tested in the United States and the data for trial years 2002 and 2003 was submitted.

Agronomic characteristics of corn hybrids derived from corn event LY038 such as seed dormancy, vegetative vigour, early stand establishment, time to maturity, flowering period, susceptibilities to various corn pests and pathogens, and seed production were compared to those of unmodified corn counterparts.

Nutritional components of corn event LY038, such as proximates, amino acids and fatty acids were compared with those of unmodified corn counterparts.

The Plant Biosafety Office (PBO) of the Plant Products 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 PBO has considered:

  • potential of corn event LY038 to become a weed of agriculture or be invasive of natural habitats,
  • potential for gene flow to wild relatives whose hybrid offspring may become more weedy or more invasive,
  • potential for corn event LY038 to become a plant pest,
  • potential impact of corn event LY038 or its' gene products on non-target species, including humans, and
  • potential impact on biodiversity.

The Feed Section of the Animal Health and Production Division, 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:

  • potential impact of corn event LY038 on livestock nutrition
  • potential impact of corn event LY038 on livestock and workers/bystanders

Monsanto Canada Inc. has provided the CFIA with a method for the detection and identification of corn containing the event LY038.

III. Description of the Novel Trait

1. Increased Lysine in Corn event LY038

cDHDPS and Cornybacterium glutamicum

The DHDPS protein is a member of the lyase subfamily of pyruvate-dependent class I aldolases found in a wide range of organisms including bacteria, rodents and humans. The DHDPS enzyme mediates a critical rate-limiting step in the lysine biosynthesis pathway that in corn is controlled by lysine feedback inhibition. The enzyme catalyses the condensation of L-aspartate-4-semialdehyde and pyruvate to form 2,3-dihydrodipicolinate that is converted to lysine through a series of subsequent enzymatic reactions. In contrast to the native corn DHDPS the variant of this enzyme, from Cornybacterium glutamicum (cDHDPS), is less sensitive to lysine feedback inhibition. Since the cDHDPS enzyme is less sensitive to lysine feedback inhibition, its expression in corn event LY038 is expected to result in the elevated levels of free lysine in the plant when compared to conventional corn. The transcription of cordapA is under the control of the corn promoter globulin 1 (Glb1), which directs cDHDPS expression predominantly in the germ resulting in accumulation of free lysine in this portion of the grain.

Cornybacterium glutamicum is a common soil bacterium that is widespread in the environment; therefore, animals and humans are regularly exposed without adverse consequences to this organism and its components, such as the cDHDPS protein. The supplemental lysine that is most commonly provided for supplementing maize-soybean based animal diets is from commercially available lysine sources in the form of lysine monohydrochloride or lysine sulphate which are produced via fermentation by Cornybacterium glutamicum or Brevibacterium lactofermentum. In addition, DHDPS proteins functionally related to the cDHDPS protein found in corn event LY038 are present in plants and microbes that make lysine, many of which are consumed as feed and/or food. Consistent with the fact that all of these DHDPS proteins, including cDHDPS, catalyze the first enzymatic step in lysine biosynthesis in a wide range of organisms it was expected that an algorithm identified (i) high amino acid homology (27-37%) along the entire length of the protein, and (ii) high sequence similarity (36-47%), between cDHDPS and DHDPS proteins from other species.

Expression levels of cDHDPS in corn event LY038

The cordapA gene expressed in corn event LY038 is linked to the Glb1 promoter which directs the cDHDPS expression predominantly in the germ. Samples of grain, forage, whole plant (V2-V4), forage root, root (V2-V4) and pollen tissues were collected from five representative US field trial sites. The average protein expression in the different plant tissues, in micro-grams of protein per gram of dry weight tissue, as evaluated by an ELISA test, is as follows:

Results confirm transcription of the cordapA gene
Tissue Type cDHDPS Mean Protein Level µg/g dwt
Grain 26
Forage 0.94
Whole Plant (V2-V4) 0.081
Forage Root 0.069
Root (V2-V4) 1.5
Pollen 0.78

These results confirm transcription of the cordapA gene expressing the cDHDPS protein and that cDHDPS expression is predominantly in grain tissue.

2. Development Method

Lysine corn LY038 was generated through application of techniques of modern biotechnology by integrating the cordapA coding sequence as well as an nptII cassette encoding resistance to the antibiotic paromomycin into the corn inbred line H99 via biolistic transformation. The antibiotic resistance marker was used to facilitate selection of plants carrying both the cordapA and nptII coding sequences. The nptII cassette was flanked by loxP sites that allowed the nptII cassette to be excised by Cre recombinase when plants regenerated from transformation were crossed with corn plants expressing the cre gene. The cre gene was segregated out by conventional breeding to produce corn event LY038 from which the nptII gene was eliminated. Southern blot analysis confirmed the absence of the nptII gene as well as the plasmid containing the gene encoding the cre recombinase.

3. Stable Integration into the Plant Genome

Molecular characterization by Southern blot analysis demonstrated that corn event LY038 contains one intact copy of the cordapA gene cassette inserted at a single site in the maize genome. PCR analyses confirmed the organization of the genetic elements. No additional elements, including intact or partial DNA fragments of the nptII cassette or backbone sequence, from the plasmid vector, linked or unlinked to the intact gene cassette, were detected in corn event LY038. Also, no intact or partial DNA fragments of the cre cassette, or backbone sequence from the plasmid vector used to generate cre-expressing plants, were detected in corn event LY038. The presence of the cordapA gene cassette and absence of both the cre and nptII gene cassettes in LY038 was further confirmed by Southern blot generational stability analyses over multiple generations representing each branch point of the LY038 breeding tree. Therefore, no gene products from the cre and nptII coding sequences are expected to be present in LY038. Based on the detailed molecular characterization, LY038 contains only one newly inserted coding sequence, cordapA, that encodes the cDHDPS enzyme from Corynebacterium glutamicum.

IV. Criteria for the Environmental Assessment

1. Potential of corn event LY038 to Become a Weed of Agriculture or be Invasive of Natural Habitats

The biology of corn, described in the CFIA Biology Document BIO1994-11, shows that unmodified plants of this species are not invasive of unmanaged habitats in Canada. Corn does not possess the potential to become weedy due to the lack of seed dormancy, the non-shattering nature of corn cobs, and the poor competitive ability of seedlings. According to the information provided by Monsanto Canada Inc., corn event LY038 and derived hybrids were determined to be similar to their counterparts in this respect.

Corn event LY038 was tested in 17 locations in two consecutive years in the USA which provided a range of environmental and agronomic conditions representative of major corn growing regions where commercial production of corn event LY038 is intended. A total of 14 phenotypic characteristics were evaluated in 2002 and 2003: seedling vigor, early stand count, days to 50% pollen shed, days to 50% silking, ear height, plant height, stay green, final stand count, dropped ears, stalk lodging, root lodging, grain test weight, grain moisture and yield. Data generated from these studies represent observations that are typically recorded by plant breeders and agronomists to evaluate the qualities of maize over a broad range of environmental conditions and agronomic practices that corn event LY038 likely would encounter. The measured characteristics provide crop biology data useful in establishing a basis to assess phenotypic equivalence and familiarity of corn event LY038 compared to conventional maize in the context of ecological risk assessment. Detected differences were considered alone, in consideration of other observed differences, and for trends across locations. The phenotypic characteristic data showed no biologically meaningful differences between corn event LY038 and the negative segregant control, or a selection of conventional reference maize hybrids, and support a conclusion of phenotypic equivalence as it relates to familiarity and a lack of increased weed potential. Likewise, assessment of the phenotypic data detected no biologically significant differences between corn event LY038 and negative segregant control, indicative of a selective advantage that would result in increased weed potential for corn event LY038 or other plants if the trait were transferred to a sexually compatible species.

Plant height tended to be greater in corn event LY038 than in the negative segregant control, although the height of both was within the range of values seen in reference hybrids grown in the same locations. Seedlings of corn event LY038 were consistently and significantly less vigorous than the negative segregant control in two years of agronomic testing, although the values for both were each within the range of values seen in reference hybrids grown in the same locations. No increase or decrease outside of the reference range was observed in any insect, disease, or abiotic stressor in corn event LY038 (abiotic stressors include chemical stress, chlorosis, cold, compaction, crusting, drought, flood, heat, leaf curl, poor emergence, wind, and wrapped whorl; biotic stressors are listed under section IV-3. altered plant pest potential). No significant differences in percent viable pollen or average pollen diameter were detected between corn event LY038 and the negative segregant control corn line.

The seed dormancy and germination of corn event LY038 was compared with its' negative segregant control. No significant differences were detected in percent normal germinated seed, percent viable hard seed, percent dead seed, and percent viable firm swollen seed. Additionally, no viable hard seeds were detected in corn event LY038 (viable hard seed is associated with seed dormancy).

In some locations, approximately 4 to 7% of the corn event LY038 crop was comprised of plants with a white leaf phenotype (described as completely white plants). The white leaf phenotype is only transiently expressed from germination up to the second leaf stage, and only under certain planting conditions.

The white leaf phenotype observed in a small percentage of the plants was determined to be associated with the LY038 trait of increased lysine in the seed. The literature has shown that similar altered phenotypes (which include but are not limited to decreased chlorophyll content, loss of apical dominance, and degeneration of floral organs) have been observed in other plant species that accumulate high levels of lysine. The effects of the white leaf characteristic did not result in significant changes in other growth and development characteristics on a whole-plot basis and it would not contribute to increased pest potential. On the basis of these data, the CFIA concluded that the corn event LY038 has no increased weediness or invasiveness potential compared to currently commercialized corn hybrids.

2. Potential for Gene Flow to Wild Relatives Whose Hybrid Offspring May Become More Weedy or More Invasive

There are no wild relatives of corn reported in Canada. One distant relative (Tripsacum dactyloides) is found in the north-eastern United States of America, but hybridization of this species with corn is difficult and only accomplished with significant human intervention. The CFIA therefore concludes that gene flow from corn event LY038 to wild relatives of corn is not possible in Canada.

3. Altered Plant Pest Potential

The novel trait (increased lysine) is unrelated to plant pest potential, and corn is not considered a plant pest in Canada. Ecological evaluations did not show any increase or decrease in any insect or disease stressor that was outside of the reference range generated from selected cultivars grown at the same locations when compared to corn event LY038. These stressors included: black cutworm, flea beetle, anthracnose, ear rot, fusarium, leaf spot, corn dwarf mosaic virus, northern corn leaf blight, seedling blight, southern corn leaf blight, and stalk rot.

The CFIA has, therefore, determined that the corn event LY038 does not display any altered pest potential.

4. Potential Impact on Non-Target Organisms

Neither the introduced trait nor the sources of the introduced trait would be expected to have any impact on non-target organisms. Naturally-occurring lysine is constitutively expressed in corn. The cDHDPS lysine-insensitive enzyme (cordapA) was isolated from a common soil bacterium (Corynebacterium glutamicum) which has no known capacity to cause disease in humans or animals, and has historically been used to ferment L-lysine for use as an additive in animal feed. The Glb1 promoter that directs the expression of the gene is a native corn promoter, and it targets the expression of lysine to the germ in the seed.

Based on the above, the information cited below in Section V. Criteria for the Livestock Feed Safety Assessment, and the agronomic properties of corn event LY038, the CFIA has determined that the unconfined release of corn event LY038 will not result in altered impacts on interacting organisms, including humans, compared to current commercial corn hybrids.

5. Potential Impact on Biodiversity

Corn event LY038 has no novel phenotypic characteristics that would extend its range beyond the current geographic range of corn production in Canada. Since corn has no wild relatives with which it can outcross in Canada, there will be no transfer of novel traits to unmanaged environments.

The CFIA has therefore concluded that the potential impact on biodiversity of corn event LY038 is equivalent to that of currently commercialized corn hybrids.

V. Criteria for the Livestock Feed Assessment

1. Potential Impact of corn event LY038 on Livestock Nutrition

Nutritional Composition:

Compositional equivalence of corn event LY038 to the negative segregant control and 20 commercial corn varieties was assessed from five replicated sites in the US in the 2002 growing season. Forage and grain samples were analyzed for proximate, fibre, amino acids, fatty acids, minerals, vitamins and secondary metabolites. With the exception of phosphorus, all forage nutrients were not statistically significantly different between corn event LY038 and negative segregant control. Specifically, the intended change in total and free lysine in corn event LY038 grain was statistically significantly different from the negative segregant control at all sites. The range of lysine content in corn event LY038 was outside the tolerance interval of the reference corn varieties, but was within the literature range reported for field corn.

Statistically significant differences were observed between corn event LY038 and the control for glutamic acid, histidine, isoleucine, and phenylalanine (% total aa), alanine, aspartic acid, cysteine, glutamic acid, leucine, methionine, phenylamine, serine and valine (%DW). These amino acids were within the range of commercial corn varieties. Statistically significant differences were observed between corn event LY038 and the negative segregant control for CP, NDF, TDF, Ca, Mn, Cu, Zn, folic acid, Vitamin E, oleic, linoleic, linolenic, arachidic and eicosenoic acid. No consistent difference was observed within sites for these nutrients, which were also within the range of commercial corn varieties and literature values.

Lysine-related catabolites, L-pipecolic acid, saccharopine and - aminoadipic acid in corn event LY038 grain were statistically significantly higher than negative segregant control at all sites. L-pepecolic acid in corn event LY038 was within the tolerance interval of the commercial corn varieties, while saccharopine and a-aminoadipic acid were outside the tolerance interval. Monsanto Canada Inc. provided scientific evidence to support the safety of the high levels of saccharopine and a-aminoadipic acid in corn event LY038 grain. They noted that both catabolites are intermediary metabolites of normal endogenous lysine catabolism in plants and animals and are rapidly degraded in the animal's liver ultimately entering the tricarboxylic acid cycle as acetoacetyl-CoA. The applicants also calculated the levels of these catabolites from a broiler study to show that the amounts consumed by birds on corn event LY038 diets were degraded, with no negative effects on bird performance or health.

Anti-Nutrients

According to OECD, "in considering the anti-nutrients and natural toxins in maize, only phytic acid is significant to the animal feed" (OECD, 2002). Levels of anti-nutrients (phytic acid and raffinose) and secondary metabolites (ferulic acid and p-coumaric acid) were measured in grain of LY038 and compared to conventional maize. No statistically significant differences were observed. Therefore, it is concluded that the levels of these antinutrients and secondary metabolites in corn event LY038 are comparable to those found in conventional maize.

Bioefficacy

1400 male broilers were used in a 42-day broiler study to establish the bioefficacy and safety of corn event LY038 grain. Starter and finisher diets with corn event LY038 grain were compared to LY038 (-) and five commercial reference corn varieties (with or without supplemental lysine). 14 treatment diets were randomly assigned to 140 pens (10 pens/treatment) with 10 birds per pen in a randomized complete block design. Diet formulations targeted similar lysine content in corn event LY038 diets and treatments with supplemental lysine. Broilers on corn event LY038 diets had statistically significantly higher intakes, weight gains and gain:feed than birds on the negative segregant control and reference corn diets with no supplemental lysine. No statistically significant differences in intakes, weight gains and gain:feed were observed between birds on corn event LY038 diets and birds on LY038 (-) and the commercial corn diets with supplemental lysine. Carcass characteristics and meat composition of broilers on corn event LY038 diets were similar to dietary treatments with supplemental lysine. Statistically significant improvement in carcass characteristics and meat composition was observed in broilers on corn event LY038 diets when compared to those on diets without supplemental lysine. Chick mortality throughout the trial was low and not related to dietary treatments. No mortality was reported on birds on corn event LY038 diets during the 42 day trial. No unintended effects occurred when broilers were fed diets formulated with corn event LY038 grain.

The evidence provided by Monsanto Canada Inc. supports the conclusion that the nutritional composition of corn event LY038 corn is equivalent to conventional corn except for the intended increase in lysine and the associate increase in the levels of the lysine-related catabolites, saccharopine and a-aminoadipic acid. No detrimental effect of these catabolites was seen on the performance and health of broilers on diets containing corn event LY038 grain. The bioefficacy of corn event LY038 grain was similar to corn grain with supplemental lysine.

2. Potential Impact of corn event LY038 on Livestock and Workers/Bystanders

Corn is not known for the production of endogenous allergens and the transformation event which produced LY038 would not be expected to induce their synthesis.

Due to the low levels of the cDHDPS protein expressed in corn event LY038 it was necessary to express the cordapA gene in an E. coli production system in order to obtain sufficient quantities of the test article for conducting some safety studies (e.g., acute oral mouse toxicity study and simulated gastric fluid digestion study). The bacterial-produced protein was compared to the plant-produced protein and shown to be of similar molecular weight, immunological reactivity and, to have similar functional activity as the plant produced protein. Matrix assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) and N-terminal sequencing demonstrated amino acid sequence equivalency of the plant and bacterial produced proteins. Based on the results, both proteins were found to be physicochemically and functionally equivalent.

Proteins in the lyase subfamily, such as cDHDPS, are present in many foods with a long history of safe use in Canada, and, therefore, would not be expected to be toxic or allergenic. Unlike known food allergens, cDHDPS is heat sensitive and susceptible to digestion. Data demonstrated rapid degradation of the E. coli-produced cDHDPS protein in simulated gastric fluid. Greater than 96% of the cDHDPS protein was degraded within 30 seconds. Unlike many known allergens, the cDHDPS protein is not glycosylated, and is present at low levels.

Using a database assembled from the public domain databases such as SwissProt, GenBank, EMBL, NRL3D, bioinformatic analyses revealed no biologically relevant structural or immunological similarities of the cDHDPS protein sequence to known allergens, toxins or pharmacologically active proteins. Furthermore, no short (eight amino acids) polypeptide matches were shared between the cDHDPS protein sequence and known protein allergens. These analyses establish the lack of both structurally and immunologically relevant similarities between allergens and the cDHDPS protein sequence. Also, a mouse acute oral toxicity study using bacterially expressed cDHDPS protein indicated there were no adverse effects at 780 mg/kg body weight.

The cDHDPS protein shares no significant homology with known toxins or allergens, it is present in small amounts in the feed, and it is rapidly degraded under the conditions present in the gastrointestinal tract. An acute oral toxicity study performed in mice using bacterially expressed cDHDPS protein indicated there were no adverse effects at 780 mg/kg body weight. From the information provided by Monsanto Canada Inc., the cDHDPS protein is unlikely to be a novel toxin or allergen. The cDHDPS protein has a history of safe use, as it is found in other livestock feed ingredients, without evidence of toxicological effects or allergenicity.

Based on the predicted exposure levels and the results of the above tests, no significant risk to livestock and workers/by-standers is expected from exposure to the cDHDPS protein.

VI. New Information Requirements

Where, at any time after providing notification of the proposed unconfined release or receiving authorization for the unconfined release of Lysine maize event LY038, Monsanto Canada Inc. becomes aware of any new information regarding the environmental safety or animal or human health safety of Lysine maize LY038 that could result from the release, Monsanto Canada Inc. must immediately provide the CFIA with the new information. On the basis of such new information, the CFIA will re-evaluate the potential risk to environmental, animal or human health that could result from release of lysine maize LY038 and will re-evaluate its decision with respect to the livestock feed use and environmental release authorizations of Lysine maize LY038. The CFIA may maintain, change, or remove existing conditions respecting the release; impose additional conditions; or refuse or cancel the authorization and require the applicant to stop the release and take any appropriate action necessary to eliminate from, or minimize the risk to, the environment.

VII. Regulatory Decision

Based on the review of the data and information submitted by Monsanto Canada, Inc., and through comparisons of corn event LY038 with unmodified corn counterparts, the Plant Biosafety Office, of the Plant Products Directorate, CFIA, has concluded that the novel gene and its corresponding trait does not confer to these plants any characteristic that would result in unintended environmental effects following unconfined release.

Based on the review of submitted data and information by Monsanto Canada Inc., including comparisons of corn event LY038 with it's unmodified corn counterparts, the Feed Section of the Animal Health and Production Division has concluded that the introduced gene and it's corresponding trait will not confer to corn event LY038 any characteristic that would raise any concerns regarding the safety or nutritional composition of corn event LY038. Grain corn, its byproducts and corn oil are currently listed in Schedule IV of the Feeds Regulations and are, therefore, approved for use in livestock feeds in Canada. Corn event LY038 has been assessed and found to be as safe as and as nutritious as traditional corn varieties. Corn event LY038 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 corn event LY038 is therefore authorized as of July 21, 2006. Any other corn hybrids and intra-specific hybrids resulting from the same transformation event and all their descendants, may also be released into the environment and used as livestock feed, provided no inter-specific crosses are performed, provided the intended use is similar, provided it is known following thorough characterization that these plants do not display any additional novel traits and are substantially equivalent to currently grown corn, in terms of their potential environmental impact and livestock feed safety and efficacy.

Corn event LY038 is subject to the same phytosanitary 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 corn event LY038. 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-eng.php

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