Decision document DD2024-146 Determination of the Safety of Bayer Crop Science Inc.'s Corn (Zea mays L.) Event MON 94804

Authorized as of February 20, 2024

The Canadian Food Inspection Agency (CFIA) has evaluated information submitted by Bayer Crop Science Inc. concerning corn event MON 94804, which displays reduced plant height. CFIA has determined that corn event MON 94804 does not present an altered environmental or livestock feed risk when compared to corn varieties currently grown and permitted to be used in Canada. Corn event MON 94804 is therefore authorized for these uses as of February 20, 2024, subject to the provisions outlined in this decision document.

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

1. Brief identification of the modified plant

Designation of the modified plant: Corn event MON 94804, OECD Unique Identifier MON-948Ø4-4

Applicant: Bayer Crop Science Inc.

Plant species: Corn, Zea mays L.

Novel trait: Reduced plant height

Trait introduction method: Agrobacterium-mediated transformation

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

Intended area of cultivation: Corn event MON 94804 is intended to be grown within the normal production area for corn in Canada

2. Background information

Bayer Crop Science Inc. has developed a corn event with reduced plant height (also referred to as short stature corn). Corn event MON 94804 was developed using recombinant deoxyribonucleic acid (rDNA) technology, resulting in the introduction of an inverted repeat sequence designed to reduce the expression of gibberellic acid 20 oxidase (GA20ox) genes that are present in corn.

Bayer Crop Science Inc. provided information on the identity of corn event MON 94804, and a detailed description of the introduced DNA sequences and their effects on suppressing expression of the GA20ox genes. Bayer Crop Science Inc. also provided information about how corn event MON 94804 compares to other corn varieties in terms of its agronomic characteristics and environmental safety, and 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 (Dir 94-08) - Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits. The CFIA has considered:

the potential for corn event MON 94804 to become a weed of agriculture or to be invasive of natural habitats
the potential for gene flow from corn event MON 94804 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive
the potential for corn event MON 94804 to become a plant pest
the potential impact of corn event MON 94804 and its gene products on non-target organisms, including humans
the potential impact of corn event MON 94804 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 94804 and unmodified corn varieties relative to the safety and efficacy of feed ingredients derived from corn event MON 94804 for their intended purpose, including:

the potential impact of corn event MON 94804 on livestock nutrition
the potential impact of corn event MON 94804 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 94804 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 94804 was developed using Agrobacterium-mediated transformation of corn line HCL301, using a plasmid with a T-DNA that contains:

a suppression cassette expressing an inverted repeat sequence designed to target endogenous corn GA20ox genes, and
a cp4 epsps gene.

The cp4 epsps gene was derived from Agrobacterium sp. strain CP4 and encodes a 5-enolpyruvoyl-shikimate-3-phosphate synthetase (EPSPS) protein, which makes the corn tolerant to the herbicide glyphosate. The glyphosate tolerance trait was used as a selectable marker to facilitate the selection of transformed plants but was removed through the development process. The cp4 epsps gene was flanked by loxP sites that allowed the cp4 epsps cassette to be excised by Cre recombinase when plants regenerated from the transformation were crossed with corn plants expressing the Cre gene. The Cre gene was segregated out using conventional breeding to produce corn event MON 94804, from which the cp4 epsps and Cre genes were eliminated. Corn event MON 94804 was selected for further development based on its molecular and phenotypic characteristics.

3.2. Reduced plant height

Corn event MON 94804 contains an inverted repeat sequence designed to target 2 endogenous genes. Expression of the inverted repeat sequence results in the formation of a micro-ribonucleic acid (miRNA) transcript which targets the GA20ox3 and GA20ox5 genes in corn. The sequence of the transcript contains the inverted repeat sequence derived from corn with intervening sequences from rice (Oryza sativa) for the sequence backbone.The initial miRNA transcript is processed by the corn's cellular machinery into short miRNAs, which result in reduced production of the corn GA20ox3 and GA20ox5 proteins through a process known as RNA interference (RNAi).

Gibberellin is a plant hormone that influences multiple aspects of plant growth and development, including plant height. GA20ox proteins catalyze a key step in the gibberellin biosynthesis pathway. In conventional corn, GA20ox3 and GA20ox5 are expressed at relatively higher levels in vegetative tissues compared to reproductive tissues. Expression of the GA20ox miRNA transcripts reduces gibberellin levels in the corn stalk, resulting in reduced internode length and plant height in corn event MON 94804.

The expression of the GA20ox miRNA transcripts in corn event MON 94804 is regulated by a promoter that drives expression primarily in vegetative tissues. Tissue samples of corn event MON 94804 were collected from plants grown in a greenhouse. The presence or absence of the miRNA transcripts was determined by northern blot. Since miRNA is processed in multiple steps, 2 types of northern blot were performed. The first type of northern blot was used to identify expression of the full-length transcript or a semi-processed, intermediate transcript. A second type of northern blot was used to identify expression of fully processed, short miRNA transcript. Limits of detection were 0.25, 0.5, or 1 picogram miRNA (pg) per 1 microgram (μg) total RNA, depending on the plant tissue and type of northern blot. The results of the northern blots are as follows:

Tissue	Full length transcript	Intermediate transcript	Short miRNA transcript
Leaf	Present	Not detected (<0.5 pg/ μg)	Present
Root	Present	Not detected (<0.5 pg/ μg)	Present
Stalk	Present	Not detected (<1 pg/ μg)	Present
Forage	Present	Not detected (<0.5 pg/ μg)	Present
Pollen	Not detected (<0.5 pg/ μg)	Not detected (<0.5 pg/ μg)	Not detected (<0.25 pg/ μg)
Grain	Not detected (<0.5 pg/ μg)	Not detected (<0.5 pg/ μg)	Present

The potential toxicity and allergenicity of the GA20ox miRNA transcripts was evaluated. The weight of evidence indicates that the GA20ox miRNA transcripts are unlikely to be allergenic or toxic to livestock and non-target organisms because:

expression of the GA20ox inverted repeat sequence results in the production of miRNA but does not result in the expression of proteins
Therefore, there is no risk of new protein toxins or allergens being introduced into corn event MON 94804 from the introduced inverted repeat sequence
miRNAs, such as those expressed in corn event MON 94804, are present in all plants and animals where they play central roles in gene regulation, without any report of toxicity or allergenicity to organisms ingesting them
there are multiple barriers to uptake and cross-kingdom activity of miRNA from plants into animals
animals do not have gibberellin biosynthetic pathways or GA20ox genes
a bioinformatics evaluation compared the GA20ox inverted repeat sequence to transcriptomes from 24 species of livestock and non-target organisms, including humans Based on these results, the GA20ox inverted repeat sequence is not expected to impact gene expression in livestock or non-target organisms

For a more detailed discussion of the potential allergenicity and toxicity of the GA20ox miRNAs, see section 5.

3.3. Stable integration into the plant genome

Molecular characterization by junction sequence analysis and directed sequencing demonstrated that corn event MON 94804 contains 1 copy of the GA20ox inverted repeat sequence, along with the associated regulatory elements. Whole genome sequencing analysis confirmed the absence of the cp4 epsps gene as well as the plasmid containing the Cre gene used during corn event MON 94804 development. No additional elements, including intact or partial T-DNA fragments or backbone sequences, linked or unlinked to the insert, were detected in corn event MON 94804.

The stability of the inserted DNA was demonstrated by whole genome sequencing with junction sequence analysis across 5 generations in the breeding history of corn event MON 94804. The inheritance pattern of the insert was evaluated by real-time polymerase chain reaction across 3 segregating generations of corn event MON 94804. 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

4.1. Potential for corn event MON 94804 to become a weed of agriculture or be invasive of natural habitats

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. For more information on the biology of corn see Biology Document BIO2020-01 - The biology of Zea mays L. (maize). According to the information provided by Bayer Crop Science Inc., corn event MON 94804 was determined not to be significantly different from unmodified corn in this respect.

The CFIA evaluated data submitted by Bayer Crop Science Inc. on the phenotypic and agronomic traits of corn event MON 94804. This event was field tested in the U.S. at 8 sites in the 2020 growing season. The U.S. locations share similar environmental and agronomic conditions to corn production areas in Southern Ontario, Quebec, and Manitoba and were considered representative of the major Canadian corn growing regions. During the field trials, corn event MON 94804 was compared to an unmodified control corn hybrid with a similar genetic background. Reference corn hybrids were also included in these trials to establish ranges of comparative values that are representative of currently grown corn varieties. Phenotypic and agronomic traits were evaluated, covering a broad range of characteristics that encompass the entire life cycle of the corn plant. The traits included early stand count, days to flowering, ear height, plant height, days to maturity, lodging, seed loss, final stand count, moisture, seed weight, and yield. The mean values for corn event MON 94804 were statistically lower for plant height and ear height and these values were outside of the range established for the reference corn hybrids. These observations are consistent with the short stature trait introduced in corn event MON 94804. These intended differences are not expected to make corn event MON 94804 more weedy or more invasive than conventional corn. Additionally, statistically significant differences were observed between corn event MON 94804 and the unmodified control corn hybrid in the individual-site analyses for days to flowering, days to maturity, lodging, moisture, seed weight, final stand count, ear height and plant height. The values for corn event MON 94804 were within the range established for the reference corn hybrids grown in the same field trials. Combined-site analyses comparing corn event MON 94804 to the unmodified control corn hybrid showed corn event MON 94804 had higher values for days to flowering and moisture, and a lower value for seed loss. The values for corn event MON 94804 were within the range established for the reference corn hybrids. Therefore, these differences are not expected to be biologically meaningful.

Bayer Crop Science Inc. provided information on the dormancy and germination of corn event MON 94804 under 2 different temperature regimes. Seed germination characteristics were evaluated, including percent germinated seed (normal and/or abnormal), percent hard seed, percent dead seed, and percent firm swollen seed. Corn event MON 94804was compared to an unmodified control corn hybrid with a similar genetic background. To provide a range of comparative values for each germination characteristic, 4 reference corn hybrids were also included. No statistically significant differences were detected between corn event MON 94804 and the unmodified control corn hybrid for any of the germination characteristics at either temperature regime. Therefore, the introduction of the novel trait did not impact the germination of the corn seed and did not confer dormancy to the corn seed.

The response of corn event MON 94804 to abiotic stressors was evaluated in the field at the same locations as the agronomic characteristic studies. The stressors observed included:

drought
excessive rain
hail
high temperatures
high winds
nutrient deficiency
soil compaction
sun scald

No increased or decreased susceptibility to these abiotic stressors was observed in corn event MON 94804 compared to the unmodified control corn hybrid, with the exception of plant response to high winds. Wind damage was less severe in corn event MON 94804 compared to the unmodified control corn hybrid at 1 site; however, there was not a consistent trend across locations and the ratings were within the range established for the reference corn hybrids. Improved tolerance to wind may be attributed to the reduced plant height of corn event MON 94804 and is not expected to meaningfully change the weediness or invasiveness of corn event MON 94804.

The susceptibility of corn event MON 94804 to corn pests and pathogens was evaluated in the field at the same locations as the agronomic characteristic studies (see section 4.3). No trend of increased or decreased susceptibility to pests or pathogens was observed in corn event MON 94804 compared to the unmodified corn variety.

The novel trait was not expected to meaningfully change the weediness or invasiveness of corn event MON 94804. Field observations confirmed that no competitive advantage was conferred by the reduced plant height trait, with the exception of improved tolerance to wind under high wind conditions. Although it can have a significant impact on yield, tolerance to wind is not considered to be a major factor restricting the establishment or distribution of corn in Canada.

The CFIA has therefore concluded that corn event MON 94804 has no altered weediness or invasiveness potential in Canada compared to currently grown corn varieties.

4.2. Potential for gene flow from corn event MON 94804 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 reduced plant height trait is unrelated to sexual compatibility and the information submitted by Bayer Crop Science Inc. on corn event MON 94804 indicated that it behaves similarly to currently grown corn varieties in terms of reproduction.

The CFIA has therefore concluded that gene flow from corn event MON 94804 to sexually compatible relatives is not possible in Canada.

4.3. Potential for corn event MON 94804 to become a plant pest

The potential for corn event MON 94804 to harbour new or increased populations of pathogens or pests was evaluated. Corn is not considered to be a plant pest in Canada. However, considering the proposed role of gibberellin^{Footnote 1} in plant-pathogen and plant-pest interactions, Bayer Crop Science Inc. submitted studies to examine the response of corn event MON 94804 to plant pathogens and pests.

The susceptibility of corn event MON 94804 to corn pests and pathogens was evaluated in the field at the same locations as the agronomic characteristic studies.

The pests observed included:

aphids
armyworms
billbugs
black cutworm
corn earworm
corn flea beetles
European corn borer
fall armyworms
grape colaspis
grasshoppers
Japanese beetles
leafhoppers
rootworms
sap beetles
slugs
spider mites
thrips
western bean cutworm

The pathogens observed include:

anthracnose
bacterial stalk rot
common maize rust
common maize smut
corn stunt
eyespot
Goss's bacterial wilt
grey leaf spot
maize dwarf mosaic virus
northern leaf blight
northern leaf spot
physoderma brown spot
southern maize rust
Stewart's wilt
tar spot
wheat streak mosaic virus

A single difference was observed: symptoms from common maize rust were less severe for corn event MON 94804 compared to the unmodified control corn hybrid at 1 site. However, the ratings for corn event MON 94804 were within the range established for the reference corn hybrids and there was no consistent trend in the response of corn event MON 94804 to common maize rust at different observation times or across sites. Therefore, this difference is not considered biologically relevant.

The CFIA has therefore concluded that corn event MON 94804 does not display altered plant pest potential compared to currently grown corn varieties.

4.4. Potential impact of corn event MON 94804 and its gene products on non-target organisms, including humans

The CFIA evaluated the potential impacts of the novel reduced plant height trait in corn event MON 94804, as well as the GA20ox miRNAs which confer the novel trait, on non-target organisms.

Reduced height of the corn plant is not intended or expected to impact non-target organisms interacting with corn, including humans.

The CFIA concluded that the GA20ox miRNAs expressed in corn event MON 94804 are unlikely to cause adverse impacts to non-target organisms on the basis of:

miRNAs, such as those expressed in corn event MON 94804, are present in all plants and animals and are not associated to potential allergenicity or toxicity (see section 5.2)
the GA20ox miRNAs were not detected in corn event MON 94804 pollen, therefore organisms interacting with corn through pollen, such as pollinators or monarch butterfly (Danaus plexippus) larvae, are not expected to be exposed to these miRNAs
there are multiple barriers to uptake and cross-kingdom activity of miRNA from plants into animals
animals do not have gibberellin biosynthetic pathways or GA20ox genes
a bioinformatics evaluation of 12 invertebrate species, 6 mammals, 2 fish, 3 birds, and humans found limited sequence homology between the GA20ox miRNAs and sequences in the non-target species tested

Field evaluations of corn event MON 94804 did not show any increased resistance to arthropod pests or pathogens compared to the unmodified control corn (see section 4.3).

Based on the above, the CFIA has determined that the unconfined release of corn event MON 94804 in Canada will not result in altered impacts on non-target organisms, including humans, when compared to corn varieties that are currently grown in Canada.

4.5. Potential impact of corn event MON 94804 on biodiversity

Corn event MON 94804 expresses no novel phenotypic characteristics that would extend its range beyond the current geographic range of corn production in Canada. Since corn has no sexually compatible relatives with which it can outcross in Canada, there will be no transfer of the novel trait to other species in unmanaged environments. Corn event MON 94804 is unlikely to cause adverse effects on non-target organisms and does not display increased weediness, invasiveness, or plant pest potential. It is therefore unlikely that corn event MON 94804 would have any direct effects on biodiversity, in comparison to the effects that would be expected from the cultivation of corn varieties currently grown in Canada.

The cultivation of corn event MON 94804 may change some of the current corn agronomic and management practices. Notably, corn event MON 94804 is expected to enable extended in-season field access for farm machinery. Extended in-season field access may result in some aerial applications of chemicals used in agriculture (including pesticides and fertilizers) being replaced with ground applications during cultivation of corn event MON 94804 compared to corn varieties that are currently grown in Canada. No significant changes to application timing or rate of chemical applications are expected for corn event MON 94804. The shift to ground applications of agrochemicals is not expected to have increased adverse environmental impacts or have any increased direct effects on biodiversity.

The CFIA has therefore concluded that the potential impact on biodiversity of corn event MON 94804 is unlikely to be different from that of the corn varieties that are currently grown in Canada.

5. Criteria for the livestock feed assessment

The CFIA considered the safety and efficacy of feed ingredients derived from corn event MON 94804, 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 corn event MON 94804 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

5.1 Potential impact of corn event MON 94804 on livestock nutrition

A field trial comparing corn event MON 94804 and a conventional control with similar genetic background (HCL301+HCL617) was conducted during the 2020 growing season at 5 field sites in the United States representative of commercial growing conditions (Iowa, Illinois, Indiana, Nebraska and Ohio). The trial was conducted using a randomized complete block design with 4 replicate blocks at each site. Each block contained corn event MON 94804 and the conventional control.

Corn grain harvested from corn event MON 94804 and the control was analyzed for proximates, amino acids, fatty acids, carbohydrates, fiber, minerals and vitamins. Forage harvested from MON 94804 and the control was analyzed for proximates, carbohydrates, fiber, minerals, anti-nutrients and secondary metabolites. Compositional data from corn event MON 94804 and the control were statistically analyzed using a mixed model analysis of variance. The biological relevance of statistically significant (P<0.05) differences between corn event MON 94804 and the control was assessed within the range of the published scientific literature.

For the majority of analytes tested, corn event MON 94804 was not significantly different from the conventional control, and test means fell within the normal range of conventional maize as reported in the literature. For corn grain, significant (P<0.05) differences were observed between corn event MON 94804 and the conventional control for 4 components (18:0 stearic acid, total dietary fiber (TDF), calcium and ferulic acid). In forage, 5 components showed significant (P<0.05) differences (protein, carbohydrates by calculation, acid detergent fiber (ADF), neutral detergent fiber (NDF) and ash).

The biological relevance of these differences was assessed in comparison to the natural variation in corn from the published literature. For all components, the mean values were within the range of natural variability reported in the literature and are therefore not considered biologically relevant. The observed differences in nutrient composition would have little impact on the total diet in normal livestock feeding practices, and little impact on the composition of co-products.

Based on the data provided by Bayer Crop Science Inc., the nutritional composition of short stature corn event MON 94804 is similar to that of conventional corn varieties. Grain, grain by-products and forage derived from MON 94804 are considered to meet present ingredient definitions in Schedule IV of the Feeds Regulations.

5.2 Potential impact of the corn event MON 94804 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

A weight-of-evidence approach was used to evaluate the risk to livestock consuming feed ingredients derived from corn event MON 94804; to humans consuming foods of animal origin derived from those livestock; and to workers/bystanders exposed to the feed ingredients from this corn event.

Novel GA20ox suppression cassette and resulting miRNA

The potential allergenicity and toxicity of the GA20ox inverted repeat and the derived miRNA were evaluated. With respect to its potential allergenicity, the host organism, corn, is not considered to be a commonly allergenic crop. The sources of the DNA sequences for the GA20ox suppression cassette, corn and rice, are not commonly associated with allergenicity. A bioinformatics evaluation of the T-DNA, the putative insert-to-flank junction peptides, and the mature GA20ox miRNA sequence in corn event MON 94804 confirmed the lack of relevant similarities to known allergens. Exposure to the GA20ox miRNA is expected to be negligible as the miRNA is expressed at very low levels in corn event MON 94804 and would be rapidly degraded in biological matrices and in the environment. The weight of evidence thus indicates that the GA20ox suppression cassette and resulting miRNA are unlikely to be allergenic.

In terms of the potential toxicity, the GA20ox miRNA lacks a mode of action to suggest that it is intrinsically toxic. The sources of the GA20ox suppression cassette, corn and rice, are not commonly associated with toxicity. A bioinformatics evaluation of the T-DNA, the putative insert-to-Flank-Junction peptides, and the mature GA20ox miRNA sequence in corn event MON 94804 confirmed the lack of relevant similarities to known toxins. Exposure to the GA20ox miRNA is expected to be negligible as the miRNA is expressed at very low levels in corn event MON 94804 and would be rapidly degraded in biological matrices and in the environment. The weight of evidence thus indicates that the GA20ox suppression cassette and resulting miRNA are unlikely to be toxic.

It is highly unlikely that the inserted GA20ox suppression cassette DNA sequences and resulting miRNA would yield translation products (proteins) in MON 94804 corn due to the suppression (down-regulation) of the targeted genes GA20ox3 and GA20ox5 by the endogenous RNAi machinery. Therefore, corn event MON 94804 is unlikely to pose encoded protein-related risk (pathogenic, toxic, allergenic or other adverse effects) to human and animal health compared to unmodified corn.

Therefore, the GA20ox suppression cassette and resulting GA20ox miRNA in the corn event MON 94804 are unlikely to pose a risk to livestock, humans and workers/bystanders.

Conclusions

It was concluded, based on the evidence provided by Bayer Crop Science Inc., that the novel RNAi-based GA20ox3 and GA20ox5 suppression trait will not confer to corn event MON 94804 any characteristic that would raise concerns regarding the safety of corn event MON 94804. Thus, corn event MON 94804 is unlikely to pose a risk to livestock consuming feed ingredients derived from corn event MON 94804, to humans consuming foods of animal origin derived from those livestock, and to workers/bystanders exposed to the feed ingredients from this event.

6. New information requirements

If at any time, Bayer Crop Science 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 94804 or lines derived therefrom, Bayer Crop Science 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 94804 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 94804.

7. Regulatory decision

Environmental release

Based on the review of the data and information submitted by Bayer Crop Science Inc. and input from other relevant scientific sources, the CFIA has concluded that the unconfined environmental release of corn event MON 94804 does not present altered environmental risk when compared to corn varieties that are currently grown in Canada.

Unconfined release into the environment of corn event MON 94804 is therefore authorized by the CFIA as of February 20, 2024.

Livestock feed use

Based on the review of the data and information submitted by Bayer Crop Science Inc. and input from other relevant scientific sources, the CFIA has concluded that the novel trait will not confer any characteristic that would raise concerns regarding the safety or nutrition of corn event MON 94804. Livestock feeds derived from corn are currently listed in Schedule IV of the Feeds Regulations and are, therefore, approved for use in livestock feeds in Canada. Corn event MON 94804 has been found to be as safe as, and as nutritious as, currently and historically grown corn varieties. Corn event MON 94804 and its products are considered to meet present ingredient definitions and are approved for use as livestock feed ingredients in Canada.

Use as livestock feed of corn event MON 94804 is therefore authorized by the CFIA as of February 20, 2024.

Lines derived from the authorized line

Any corn lines derived from corn event MON 94804 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 corn 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 introduced miRNAs expressed at a level similar to that of the authorized line

Other regulatory requirements

Corn event MON 94804 is subject to the same phytosanitary import requirements as unmodified corn varieties. Corn event MON 94804 is required to meet the requirements of other jurisdictions, including but not limited to, 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 94804.

8. Contact us

For more information on this decision, please contact the CFIA's Plant Biosafety Office or Animal Feed Program.

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