Decision document DD2021-135: Determination of the safety of Bayer CropScience Inc.'s corn (Zea mays L.) Event MON 95379

Authorized as of September 23, 2021

The Canadian Food Inspection Agency (CFIA) has evaluated information submitted by Bayer CropScience Inc. concerning insect-resistant corn event MON 95379. The CFIA has determined that corn event MON 95379 does not present altered environmental risk or livestock feed risk when compared to corn varieties currently grown and permitted to be used in Canada. Corn event MON 95379 is therefore authorized for unconfined release and livestock feed as of September 23, 2021, subject to the provisions outlined in this decision document.

This bulletin was created by the CFIA. For further information, please contact the Plant Biosafety Office or the Animal Feed Program by visiting the contact page.

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1. Brief identification of the modified plant

Designation of the modified plant: Corn Event MON 95379, OECD Unique Identifier MON-95379-1

Applicant: Bayer CropScience Inc.

Plant species: Corn, Zea mays L.

Novel trait: Resistance to lepidopteran insect pests

Trait introduction method: Agrobacterium-mediated transformation

Intended use of the modified plant: Human consumption and livestock feed use.

Intended area of cultivation: Corn event MON 95379 is not intended for cultivation in Canada.

2. Background information

Bayer CropScience Inc. has developed a corn event that is resistant to feeding damage caused by targeted lepidopteran fall armyworm (Spodopera frugiperda) and corn earworm (Helicoverpa zea) insect pests.
Corn event MON 95379 was developed by Bayer CropScience Inc. using recombinant deoxyribonucleic acid (rDNA) technology, resulting in the introduction of the cry1B.868 and cry1Da_7 genes. These genes encode modified Bacillus thuringiensis (Bt) insecticidal Cry proteins. Like other Cry proteins expressed in previously authorized corn events (such as MON 87411, MON 88017, or MON 89034), the Cry1B.868 and Cry1Da_7 proteins bind to specific midgut epithelial cell receptors of susceptible insects, and induce pore formation which disrupts osmotic balance, resulting in cell lysis and insect death.

Bayer CropScience Inc. has provided:

  • information on the identity of corn event MON 95379
  • a detailed description of the introduced genetic elements and proteins encoded by these genetic elements
  • information about how corn event MON 95379 compares to other corn varieties in terms of its environmental safety
  • information about how corn event MON 95379 compares to other corn varieties in terms of its nutrition and safety as an animal feed

The CFIA has reviewed the above information, in light of the assessment criteria for determining environmental safety of plants with novel traits, as described in Directive 94-08 (Dir94-08) Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits. The CFIA has considered:

  • the potential for corn event MON 95379 to become a weed of agriculture or be invasive of natural habitats
  • the potential for gene flow from corn event MON 95379 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive
  • the potential for corn event MON 95379 to become a plant pest
  • the potential impact of corn event MON 95379 and its gene products on non-target organisms, including humans
  • the potential impact of corn event MON 95379 on biodiversity

The CFIA has also reviewed the above information with respect to the Guidelines for the Assessment of Novel Feeds: Plant Sources.

The CFIA has considered both intended and unintended effects and similarities and differences between corn event MON 95379 and unmodified control corn relative to the safety and efficacy of feed ingredients derived from corn event MON 95379 for their intended purpose, including:

  • the potential impact of corn event MON 95379 on livestock nutrition
  • the potential impact of corn event MON 95379 on animal health and human safety as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed

The CFIA has also considered whether feeds derived from corn event MON 95379 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

3. Description of the novel traits

3.1 Development method

Corn event MON 95379 was developed using recombinant deoxyribonucleic acid (rDNA) technology, resulting in the introduction of the cp4 epsps, cry1B.868 and cry1Da_7 genes into corn inbred line LH244 via Agrobacterium-mediated transformation. The cp4 epsps gene, derived from Agrobacterium sp. strain CP4, encodes a 5-enolpyruvoyl-shikimate-3-phosphate synthetase (EPSPS) protein, which imparts tolerance to glyphosate. The herbicide tolerance trait was used as a marker to facilitate the selection of plants carrying the complete transfer DNA (T-DNA) sequence.

The cp4 epsps gene was flanked by loxP sites that allowed the cp4 epsps cassette to be excised by the 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 MON 95379, from which the cp4 epsps gene was eliminated. Whole genome sequencing analysis confirmed the absence of the cp4 epsps gene as well as the plasmid containing the gene encoding the Cre recombinase.

3.2 Protection from lepidopteran insect pests

Bacillus thuringiensis is a common gram-positive soil-borne bacterium. B. thuringiensis strains produce a variety of insecticidal proteins such as crystal (Cry) and cytolytic (Cyt) toxins (δ-endotoxins). Cry proteins, after being ingested by insects and bound to specific receptors on the membrane of insect midgut cells, form pores leading to cell disruption and insect death. The history of use and available literature indicate that B. thuringiensis Cry proteins are active only against specific insect groups or nematodes, and are not toxic to other organisms including humans and other vertebrates. The Cry1B.868 and Cry1Da_7 proteins are active against 2 lepidopteran species that are pests of corn, S. frugiperda and H. zea, and exert a mode of action similar to other Cry proteins.

The Cry1B.868 protein was designed using a domain exchange strategy from naturally occurring Cry proteins to achieve high levels of activity against the target pests. Domain I and II from Cry1Be, Domain III from Cry1Ca, and C-terminal domain from Cry1Ab were used to produce Cry1B.868. By exchanging Domain III, Cry1B.868 has been engineered to have an enhanced specificity for S. frugiperda relative to Cry1Be.

The expression of the gene encoding the Cry1B.868 protein in corn event MON 95379 is driven by a constitutive promoter. Samples of corn tissues were collected from plants from 5 field trials in the USA. The average Cry1B.868 protein expression in micrograms protein per gram dry weight tissue ( μg/g dwt), as evaluated by enzyme-linked immunosorbent assays (ELISA), was as follows: 120 to 760 µg/g dwt in leaves, 67 to 210 µg/g dwt in roots, 50 to 170 µg/g dwt in forage, 6.7 to 76 µg/g dwt in forage root, 53 to 86 µg/g dwt in silk, 7.8 to 77 µg/g dwt in grain and 73 to 110 µg/g dwt in pollen.

The naturally occurring Cry1Da protein was modified through amino acid sequence changes to improve its insecticidal potency against H. zea while maintaining potency against S. frugiperda. The modifications to Cry1Da resulted in the variant Cry1Da_7 and consisted of the addition of an alanine at position 2, and 3 amino acid substitutions in Domain II (serine 282 to valine, tyrosine 316 to serine, and isoleucine 368 to proline). It was demonstrated that Cry1Da_7, with these sequence changes, exerts enhanced control of H. zea compared to the wild-type protein.

The expression of the Cry1Da_7 protein in corn event MON 95379 is driven by a constitutive promoter. Samples of corn tissues were collected from plants from 5 field trials in the USA. The average Cry1Da_7 protein expression, as evaluated by ELISA, was as follows: 29 to 140 µg/g dwt in leaves, 26 to 72 µg/g dwt in roots, 13 to 50 µg/g dwt in forage, 5.2 to 15 µg/g dwt in forage root, 5.8 to 12 µg/g dwt in silk, 0.13 to 0.64 µg/g dwt in grain and less than the limit of detection (LOD) in pollen.

To perform the safety assessment of the modified proteins for livestock use and environmental safety, it was necessary to express the Cry1B.868 and Cry1Da_7 proteins in a B. thuringiensis expression system to obtain sufficient quantities of the proteins. The equivalence between the Cry1B.868 and Cry1Da_7 proteins produced in corn event MON 95379 and the Cry1B.868 and Cry1Da_7 proteins produced in the Bt expression system was evaluated by comparing their apparent molecular weights (SDS-PAGE), immunoreactivity, N-terminal sequences, tryptic mass fingerprints, functional activities (insect bioassay) and glycosylation status. The results from these analyses demonstrated that the Cry1B.868 and Cry1Da_7 proteins expressed in the Bt expression system were equivalent to those expressed in corn event MON 95379. This equivalence allowed the use of the Bt-produced Cry1B.868 and Cry1Da_7 proteins in studies to evaluate the safety of corn event MON 95379.

The potential allergenicity and toxicity of the Cry1B.868 and Cry1Da_7 proteins to mammals were evaluated. The weight of evidence indicates that the Cry1B.868 and Cry1Da_7 proteins are unlikely to be allergenic, based on the following information. The source of the Cry1B.868 and Cry1Da_7 genes, B. thuringiensis, is not commonly associated with allergenicity. A bioinformatics evaluation of the Cry1B.868 and Cry1Da_7 proteins amino acid sequences confirmed the lack of relevant similarities to known allergens. In vitro digestion studies demonstrated that, unlike many allergens,Cry1B.868 and Cry1Da_7 proteins are rapidly degraded by pepsin, and are not heat stable.

It was also demonstrated that the Cry1B.868 and Cry1Da_7 proteins are unlikely to be toxic to mammals because Cry proteins bind to specific receptors present on insect midgut cells but not in other organisms, therefore it lacks a mode of action that is intrinsically toxic to mammals. Further, the bioinformatics evaluation revealed that the amino acid sequences of the Cry1B.868 and Cry1Da_7 proteins lack relevant similarities to known mammalian toxins. Acute oral toxicology studies in mice demonstrated that Cry1B.868 and Cry1Da_7 proteins administered by oral gavage at a dose of 5000 mg/kg body weight does not cause adverse effects.

For a more detailed discussion of the potential allergenicity and toxicity of the Cry1B.868 and Cry1Da_7 proteins, see Section 5.2.

 

3.3 Stable integration into the plant genome

Characterization of the genetic modification in corn event MON 95379 was conducted using a combination of whole genome sequencing, polymerase chain reaction (PCR) and bioinformatics. This molecular characterization demonstrated that corn event MON 95379 contains a single copy of T-DNA containing the cry1B.868 and cry1Da_7 expression cassettes, inserted at a single locus with no detectable vector backbone sequences. Whole genome sequencing analysis confirmed the absence of the cp4 epsps gene as well as the plasmid containing the gene encoding the Cre recombinase used during MON 95379 development. Directed sequencing (locus-specific PCR, DNA sequencing and analyses) of corn event MON 95379 examined the T-DNA insert sequence, flanking genomic regions and insert-to-flank junctions. These analyses confirmed that the sequence and genomic organization of T-DNA are as expected and no major DNA rearrangement occurred at the insertion site in corn event MON 95379 upon DNA integration.

The stability of the single copy T-DNA insert was verified by whole genome sequencing across 5 generations in the breeding history of corn event MON 95379. The inheritance pattern of the insert was evaluated by PCR analysis across 3 segregating generations of corn event MON 95379. The combined analysis showed that the insert is stably inherited and segregates according to the Mendelian rules of inheritance for a single genetic locus.

4. Criteria for the environmental assessment

The CFIA used information on the biology of corn and conclusions from previous assessments of plants resistant to lepidopteran pests to inform the environmental assessment of corn event MON 95379, as described in the following sections.

4.1. Potential for corn event MON 95379 to become a weed of agriculture or be invasive of natural habitats

The CFIA biology document BIO2020-01 – The biology of Zea mays(L.) (Corn) indicates that unmodified corn is 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.
Since 1995, the CFIA has reviewed data from agronomic field trials conducted on Bt corn events expressing various Bt proteins. The results from these trials have consistently shown that Bt corn events do not display increased weediness potential compared to conventional corn.
Accordingly, no occurrence of Bt corn becoming weedy has been reported after over 20 years of Bt corn cultivation in Canada and elsewhere. The observations are consistent with the fact that production of Bt proteins is unrelated to increased weediness or invasiveness potential in corn. Similarly, it is anticipated that corn event MON 95379 will not display any increased weediness compared to conventional corn.
Based on the above information, the CFIA has concluded that corn event MON 95379 is unlikely to become a weed of agriculture or invasive of natural habitats in Canada.

4.2. Potential for gene flow from corn event MON 95379 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive

There are no sexually compatible species in Canada that can hybridize with corn (see Biology Document BIO2020-01 - The biology of Zea mays L. (maize) for more information). The novel trait (resistance to lepidopteran insects) introduced into corn event MON 95379 is not expected to change corn reproductive biology.
Based on the above information, the CFIA has concluded that there is no potential for gene transfer from corn event MON 95379 to sexually compatible species in Canada.

4.3. Potential for corn event MON 95379 to become a plant pest

The potential for corn event MON 95379 to harbour new or increased populations of pathogens or pests was evaluated. The Cry1Da_7 and Cry1B.868 proteins expressed in corn event MON 95379 are not intended or expected to alter the response of corn to pests or pathogens, with the exception of the target lepidopteran species.
As indicated in Section 4.1, the CFIA has previously assessed data from agronomic field trials conducted on Bt corn events expressing various Bt proteins. The results from these trials have consistently shown no altered susceptibility of Bt corn to pathogens and pests, with the exception of the insect species targeted by the Bt protein, compared to conventional corn. Similarly, it is anticipated that corn event MON 95379 will not display any unintended altered susceptibility to pathogens and pests compared to conventional corn.
Corn event MON 95379 is not intended for cultivation in Canada. Therefore, the potential for lepidopteran pests to evolve resistance to the Cry1Da_7 or Cry1B.868 protein expressed in corn event MON 95379 is negligible in Canada.

Based on the above information, the CFIA has concluded that corn event MON 95379 is not expected to display altered plant pest potential as a result of incidental environmental release.

4.4. Potential impact of corn event MON 95379 and its gene products on non-target organisms, including humans

The Cry1Da_7 and Cry1B.868 proteins have a similar mode of action to Bt Cry proteins that have been assessed by the CFIA and that have a history of safe use in Canada.
According to information provided by Bayer CropScience Inc., the activity spectrum of the Cry1Da_7 and Cry1B.868 proteins expressed in corn event MON 95379 is limited to lepidopteran species. To evaluate specificity, laboratory bioassays using the Cry1Da_7 and Cry1B.868 proteins were performed using a variety of insect species.
Species tested included:
4 lepidopteran species

  • fall armyworm (Spodoptera frugiperda)
  • corn earworm (Helicoverpa zea)
  • European corn borer (Ostrinia nubilalis)
  • monarch butterfly (Danaus plexippus)

4 coleopteran species

  • western corn rootworm (Diabrotica virgifera virgifera)
  • southern corn rootworm (Diabrotica undecimpunctata howardi)
  • Colorado potato beetle (Leptinotarsa decimlineata)
  • Mexican bean beetle (Epilachna varivestis)

2 hemipteran species

  • western tarnished plant bug (Lygus hesperus)
  • neotropical brown stink bug (Euschistus heros)

No impacts on survival, growth, or development of the coleopteran or hemipteran species were noted when fed conservative doses relevant to the exposure of the insect in the field (that is, above the 95th percentile values of Cry1Da_7 or Cry1B.868 protein expression in MON 95379 tissues deemed most relevant to the exposure by the insect species over multi-day periods). All 4 lepidopteran species tested were susceptible to the Cry1Da_7 and Cry1B.868 proteins. Second, laboratory bioassays were performed to evaluate the potential effects of the Cry1Da_7 and Cry1B.868 proteins against a honeybee (Apis mellifera), springtail (Folsomia candida), and earthworm (Eisenia andrei). No adverse effects of the Cry1Da_7 and Cry1B.868 proteins were observed on the non-target organisms tested.

Detailed characterization of the Cry1Da_7 and Cry1B.868 proteins expressed in corn event MON 95379 led to the conclusion that it does not display any characteristic of a potential allergen or mammalian toxin (see Section 5.2).

Corn event MON 95379 is not intended to be cultivated in Canada, and seed is not authorized for intentional release to ensure this intended use. If seed from corn event MON 95379 was accidentally released into the environment, any resulting plants would not be invasive of unmanaged habitats in Canada. Therefore, environmental exposure of non-target organisms to corn event MON 95379 plants will be minimal to non-existent.

Based on the above, the CFIA has determined that, compared to current commercial corn varieties, the incidental release of corn event MON 95379 will not result in altered impacts on non-target organisms, including humans.

4.5. Potential impact of corn event MON 95379 on biodiversity

Corn event MON 95379 expresses no novel phenotypic characteristics that would extend its geographic range beyond the current 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 the novel traits to other species in unmanaged environments. As summarized above, corn event MON 95379 does not possess increased weediness or invasiveness compared to conventional corn. Corn event MON 95379 is not intended to be cultivated in Canada. Therefore, environmental exposure to corn event MON 95379 plants will be minimal and the incidental release of corn event MON 95379 would not pose a risk to non-target organisms or increase plant pest potential.

It is therefore unlikely that the incidental release of corn event MON 95379 would have any direct effects on biodiversity, in comparison to the effects that would be expected from the cultivation of the corn varieties that are currently grown in Canada.

Based on the above information, the CFIA has concluded that the potential impact on biodiversity of corn event MON 95379 would be minimal as a result of incidental environmental release.

4.6. Potential for development of insect resistance to corn event MON 95379

The CFIA requires that an insect resistance management (IRM) plan be implemented during cultivation of plants expressing novel insect resistance, to minimize the likelihood of development of resistance in populations of the target insect. Since corn event MON 95379 is not intended to be cultivated in Canada, an insect resistance management plan specific to this product is not required at this time.

5. Criteria for the livestock feed assessment

The CFIA considered the safety and efficacy of feed ingredients derived from MON 95379 corn including nutrient and anti-nutrient profiles; the presence of gene products, residues, and metabolites, in terms of animal health and human safety as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed; and whether feeds derived from MON 95379 corn meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

5.1 Nutrient and anti-nutrient composition

The nutritional equivalence of corn event MON 95379 to an unmodified control corn variety (LH244+HCL617) was determined from five replicated field sites in the US, during the 2018 growing season. Corn event MON 95379 and the unmodified control corn variety were planted in a randomized complete block design with four replicates at each of the five field sites. Forage and grain samples were collected and analyzed for proximate (protein, crude fat, ash, moisture), carbohydrates by calculation, fibers (acid detergent fiber (ADF) and neutral detergent fiber (NDF)) and minerals (calcium and phosphorus). Grain samples were further analyzed for total dietary fiber (TDF), amino acids, fatty acids, minerals, vitamins, anti-nutrients (phytic acid and raffinose) and secondary metabolites (ferulic acid, furfural and p-coumaric acid). Components analyzed were selected based on recommendations for corn as specified by the Organization for Economic Co-operation and Development (OECD, 2002). Compositional data was statistically analyzed using a mixed model analysis of variance, and statistical differences among treatments were identified and assessed (P < 0.05). The biological relevance of any significant difference among the corn varieties was assessed by determining the magnitude of difference between corn event MON 95379 and the unmodified control corn variety; assessment of the differences in the natural variation within the unmodified control corn variety across the multiple sites and lastly, the natural variation within corn obtained from the published scientific literature values and ILSI Crop composition database (ILSI-CCDB).

No statistically significant differences were observed between corn event MON 95379 forage and the unmodified control corn variety for proximate, ADF, NDF, calcium and phosphorus. All means of corn event MON 95379 were within the natural variation of the unmodified control corn variety and conventional corn varieties from the published scientific literature values and ILSI-CCDB. Except for protein and carbohydrates, all proximate and fibres in corn event MON 95379 grain were not statistically significantly different from unmodified control corn variety. Corn event MON 95379 protein and carbohydrates values were within the natural variability defined by the range of values observed in the literature and/or the ILSI-CCDB values and therefore the differences were not considered biologically relevant. Statistically significant differences between corn event MON 95379 and the unmodified control corn variety were observed for alanine, glutamic acid, isoleucine, leucine, methionine, phenylalanine, serine, threonine and valine, however all means were within the natural variation of the unmodified control corn variety and conventional corn varieties from the published scientific literature values and ILSI-CCDB. No statistically significant differences between corn event MON 95379 and the unmodified control corn variety were observed for palmitic acid, palmitoleic acid, stearic acid, oleic acid, linoleic acid, arachidic acid, eicosenoic acid and behenic acid. A statistically significant difference between corn event MON 95379 and the unmodified control variety was observed for linolenic acid, however the means in corn event MON 95379 were within the natural variation expected of conventional corn varieties. Statistically significant differences between MON 95379 and the unmodified control corn variety were observed for copper, iron, manganese, phosphorus and zinc, however the means were within the natural variation in conventional corn varieties and the differences were therefore not considered biological. No statistically significant differences were observed between corn event MON 95379 and the unmodified control corn variety for six vitamin components (vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9 and vitamin E). A statistically significant difference between corn event MON 95379 and the unmodified control corn variety was observed for vitamin A, but means were within the natural variation expected for conventional corn. No statistically significant differences were observed between corn event MON 95379 and the unmodified control corn variety for the anti-nutrients and secondary metabolites analyzed (phytic acid, raffinose, ferulic acid and p-coumaric acid). Furfural levels were below the limit of quantification for both corn event MON 95379 and the unmodified control corn variety.

Conclusion

The evidence provided by Bayer CropScience Inc. supports the conclusion that the nutritional composition of corn event MON 95379 is similar to that of the unmodified control corn variety and to other conventional corn varieties. Feed ingredients derived from corn event MON 95379 are considered to meet the present ingredient definitions for corn in Schedule IV of the Feeds Regulations and therefore no new ingredient definitions were created.

5.2 Potential impact of corn event MON 95379 on animal health and human safety as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed

Corn event MON 95379 is resistant to lepidopteran and corn earworm insect pests as a result of the activity of Cry1B.868 and Cry1Da_7 proteins. The assessment of corn event MON 95379 evaluated the impact of the following potential hazards relative to the safety of feed ingredients derived from this event:

  • the potential allergenicity and toxicity of modified Cry1B.868 protein
  • the potential allergenicity and toxicity of modified Cry1Da_7 protein

Cry1B.868 protein

Expression of Cry1B.868 protein in corn event MON 95379 was low and insufficient for use in safety evaluations. Recombinant Cry1B.868 protein was produced in B. thuringiensis using expression vectors with Cry1B.868 coding sequences that matched those of the Cry1B.868 produced by corn event MON 95379. The equivalence of the proteins was confirmed with:

  • N-terminal sequence analysis
  • liquid chromatography-mass spectrometry analysis
  • western blot analysis for immunoreactivity
  • SDS-PAGE analysis for molecular weight
  • glycosylation test, and
  • insect bioassay data

The potential allergenicity of the Cry1B.868 protein to livestock and feed handlers was evaluated. With respect to its potential allergenicity, no single experimental method yields decisive evidence, thus a weight of evidence approach was taken, taking into account information obtained with various test methods. A bioinformatics evaluation of the Cry1B.868 protein amino acid sequence confirmed the lack of relevant similarities between the Cry1B.868 protein and known allergens. Previously used Cry proteins have also shown no allergenic properties. Cry1B.868 was degraded by simulated gastric and intestinal fluid within 0.5 and 5 minutes, respectively. The weight of evidence indicates that the Cry1B.868 protein is unlikely to pose an allergenic safety concerns.

While the Cry1B.868 protein exhibits insecticidal activity to lepidopteran pests, it lacks a mode of action to suggest that it is intrinsically toxic to livestock or humans. Furthermore, bioinformatics evaluation of the Cry1B.868 protein amino acid sequences confirmed the lack of relevant similarities between the Cry1B.868 protein and known livestock or human toxins. This information indicates that the Cry1B.868 protein is unlikely to pose a toxicological safety concerns.

In a scenario with no digestion, the maximum livestock exposure to the Cry1B.868 protein is expected to be less than 5 ppm in all classes of livestock. However, it is unlikely that the animals would be exposed to this level of protein as the Cry1B.868 protein is rapidly degraded in the digestive tract.

Cry1Da_7 protein

Expression of Cry1Da_7 protein in corn event MON 95379 was low and insufficient for use in safety evaluations. Recombinant Cry1Da_7 protein was produced in B. thuringiensis using expression vectors with Cry1Da_7 coding sequences that matched those of the Cry1Da_7 produced by corn event MON 95379. The equivalence of the proteins was confirmed with:

  • N-terminal sequence analysis
  • liquid chromatography-mass spectrometry analysis
  • western blot analysis for immunoreactivity
  • SDS-PAGE analysis for molecular weight
  • glycosylation test, and
  • insect bioassay data

The potential allergenicity of the Cry1Da_7 protein to livestock and feed handlers was evaluated. With respect to its potential allergenicity, no single experimental method yields decisive evidence, thus a weight of evidence approach was taken, taking into account information obtained with various test methods. A bioinformatics evaluation of the Cry1Da_7 protein amino acid sequence confirmed the lack of relevant similarities between the Cry1Da_7 protein and known allergens. Previously used Cry proteins have also shown no allergenic properties. Cry1Da_7 was degraded by simulated gastric and intestinal fluid within 0.5 and 5 minutes, respectively. The weight of evidence indicates that the Cry1Da_7 protein is unlikely to be allergenic.

While the Cry1Da_7 protein is exhibits insecticidal activity to lepidopteran pests it lacks a mode of action to suggest that it is intrinsically toxic to livestock or humans. Furthermore, bioinformatics evaluation of the Cry1Da_7 protein amino acid sequences confirmed the lack of relevant similarities between the Cry1Da_7 protein and known livestock or human toxins. An acute study in mice did not show signs of toxicity at up to 5000 mg Cry1Da_7/kg body weight. This information indicates that the Cry1Da_7 protein is unlikely to pose a toxicological safety concerns.

In a scenario with no digestion, the maximum livestock exposure to the Cry1Da_7 protein is expected to be less than 1 ppm in all classes of livestock. However, it is unlikely that the animals would be exposed to this level of protein as the Cry1Da_7 protein is rapidly degraded in the digestive tract.

Conclusion

It was concluded, based on the evidence provided by Bayer CropScience Inc., that the Cry1B.868 and Cry1Da_7 proteins which provide resistance to lepidopteran pests will not confer to the corn event MON 95379 any characteristic that would raise concerns regarding the safety of corn event MON 95379. Feed ingredients derived from corn event MON 95379 are considered to meet present ingredient definitions for corn in the Feeds Regulations and as such are approved for use as livestock feed in Canada.

6. New information requirements

If at any time, Bayer CropScience Inc. becomes aware of any new information regarding risk to the environment, livestock or human health, which could result from the unconfined environmental release or livestock feed use of corn event MON 95379 or lines derived from it, Bayer CropScience Inc. is required to immediately provide such information to the CFIA. On the basis of such new information, the CFIA will re-evaluate the potential impact of corn event MON 95379 on the environment, livestock and human health and may re-evaluate its decision with respect to the livestock feed use and unconfined environmental release authorizations of corn event MON 95379.

7. Regulatory decision

Environmental release

Based on the review of the data and information submitted by Bayer CropScience Inc., the intended use, and input from other relevant scientific sources, the CFIA has concluded that the unconfined environmental release of corn event MON 95379 does not present altered environmental risk when compared to corn varieties that are currently grown in Canada.

Taking into account the conclusion of the environmental risk assessment and recognizing that incidental release into the environment could occur when this PNT is used as intended, which does not include cultivation in Canada, unconfined release into the environment of corn event MON 95379 and any lines derived from it is therefore authorized by the CFIA as of September 23, 2021 on a condition that no intentional release takes place in Canada.

Livestock feed use

Based on the review of the data and information submitted by Bayer CropScience Inc. and input from other relevant scientific sources, the CFIA has concluded that the novel Bt protein-based insect resistance trait will not confer to corn event MON 95379 any characteristic that would raise concerns regarding the safety or nutrition of corn event MON 95379. Grain corn, its by-products and corn oil are currently listed in Schedule IV of the Feeds Regulations and are, therefore authorized for use in livestock feeds in Canada. Corn event MON 95379 has been found to be as safe as and as nutritious as currently and historically grown corn varieties. Corn event MON 95379 grain and its products are considered to meet present ingredient definitions.

Taking into account livestock feed assessment, use as livestock feed of corn event MON 95379 and of any lines derived from it is authorized by the CFIA as of September 23, 2021.

Lines derived from the authorized line

Authorizations of the corn lines derived from corn event MON 95379 are conditional on the following:

  • 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 Zea mays varieties that are currently grown and permitted to be used as livestock feed in Canada, in terms of their potential environmental impact and livestock feed safety and nutrition
  • the novel genes are expressed at a level similar to that of the authorized event
  • data used to establish the substantial equivalence of lines derived from corn event MON 95379 be made available to the CFIA upon request, and
  • no intentional release of seed takes place in Canada

Other regulatory requirements

Corn event MON 95379 is subject to the same phytosanitary import requirements as unmodified corn varieties. Corn event MON 95379 is required to meet the requirements of other Canadian legislation, including but not limited to, the requirements set out in the Food and Drugs Act and the Pest Control Products Act.
Other requirements, such as the assessment of novel foods by Health Canada, have been addressed separately from this review. Please refer to Health Canada's Decisions on Novel Foods for a description of the food safety assessment of corn event MON 95379.

8. Contact us

For more information on this decision, please contact the CFIA's Plant Biosafety Office at PBO@inspection.gc.ca or Animal Feed Program at cfia.afp-paa.acia@inspection.gc.ca.

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