Decision document DD2018-122 - Determination of the safety of monsanto canada inc. cotton (Gossypium hirsutum) event MON 88702

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This Decision Document has been prepared to explain the regulatory decisions reached under Section 2.6 - Guidelines for the Assessment of Novel Feeds: Plant Sources, of Chapter 2 of the RG-1 Regulatory Guidance: Feed Registration Procedures and Labelling Standards, and based on the environmental criteria in Directive 94-08 - Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits.

The Canadian Food Inspection Agency (CFIA), specifically the Animal Feed Division of the Animal Health Directorate, with input from the Plant and Biotechnology Risk Assessment Unit of the Plant Health Science Directorate, CFIA, has evaluated information submitted by Monsanto Canada Inc. This information is in regard to the insect-protected cotton event MON 88702. CFIA has determined that feed derived from these modified plants does not present a significant risk to the environment, nor does it present livestock feed safety or nutrition concerns when compared to currently commercialized cotton varieties in Canada.

Taking into account this evaluation, use as livestock feed of cotton event MON 88702 is, therefore, authorized by the Animal Feed Division of the Animal Health Directorate as of August 27, 2018. Any cotton lines derived from cotton event MON 88702 may also be used as livestock feed, provided that

  1. no inter-specific crosses are performed
  2. the intended uses are similar
  3. it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to currently commercialized cotton and permitted to be used as livestock feed in Canada, in terms of their potential environmental impact and livestock feed safety and nutrition
  4. the novel genes are expressed at a level similar to that of the authorized line

Cotton event MON 88702 is subject to the same phytosanitary import requirements as the unmodified cotton varieties, and is required to meet the requirements of other Canadian legislation including, but not limited to, the Food and Drugs Act and the Pest Control Products Act.

Please note that the livestock feed safety of novel feeds is a critical step 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.

August 27, 2018

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

On this page

I. Brief identification of the modified plant

Designation of the Modified Plant: Cotton Event MON 88702, OECD Unique Identifier MON-887Ø2-4

Applicant: Monsanto Canada Inc

Plant Species: Cotton (Gossypium hirsutum)

Novel Traits: Resistance to hemipteran and thysanopteran insect pests

Trait Introduction Method: Agrobacterium-mediated transformation

Intended Use of the Modified Plant: Production of cotton for fibre, whole or crushed cottonseed and cottonseed meal (cake, grain, flakes, pellets) or roughage for livestock feed and cottonseed oil for human consumption. These materials will be grown outside Canada, in the usual production areas for cotton. Cottonseed and cottonseed meal will be imported into Canada for livestock feed use only.

II. Background information

Monsanto Canada Inc. has developed a cotton event that is resistant to feeding damage caused by targeted hemipteran (Lygus hesperus, Lygus lineolaris and Pseudoalomoscelis seriatus) and thysanopteran (Frankliniella spp.) insect pests.

Cotton event MON 88702 was developed by Monsanto Canada Inc. using recombinant deoxyribonucleic acid (rDNA) technology, resulting in the introduction of the Cry51Aa2.834_16 gene which encodes a modified Bt insecticidal Cry protein. The expressed Cry51Aa2.834_16 protein (hereinafter referred to as mCry51Aa2) is a pore-forming protein similar to Cry1Ac and Cry2Ab2 proteins expressed in the previously authorized events; cotton MON 15985, corn event MON 89034 and soybean event MON 87701.

Monsanto Canada Inc. has provided information on the identity of cotton event MON 88702, a detailed description of the transformation method and information on insert copy number and intactness, levels of protein expression in the plant and the role of the inserted sequences. The novel protein was identified and characterized. Information was provided for the evaluation of the potential toxicity of the novel protein to livestock and non-target organisms and potential allergenicity of the novel protein to humans and to livestock.

Cotton event MON 88702 was field tested at eight sites in the United States in 2015. An unmodified control cotton variety that shares the same genetic background as cotton event MON 88702 was included in the trials to act as a comparator. Four reference cotton varieties were also included in each site of the field trial to establish a typical cotton behavior reference range for phenotypic parameters.

Agronomic characteristics of cotton event MON 88702, such as early stand count, days to first flower, final stand count, plant height, total bolls, seed cotton yield, seed index, abiotic stressors response, arthropod damage, and disease damage, were compared to those of the unmodified control cotton variety and to the range established by the reference cotton varieties.

Nutritional components of cotton event MON 88702 seed, such as protein, fat, moisture, ash, fibre, amino acids, fatty acids, vitamin E, minerals and anti-nutrients were compared to those of the unmodified control cotton variety and to the range established by the reference cotton varieties.

The Animal Feed Division of the Animal Health Directorate, CFIA, with input from the Plant and Biotechnology Risk Assessment Unit of the Plant Health Science Directorate, CFIA, has reviewed the above information. The following assessment criteria, as described in Section 2.6 - Guidelines for the Assessment of Novel Feeds: Plant Sources, of Chapter 2 of the RG-1 Regulatory Guidance: Feed Registration Procedures and Labelling Standards and Directive 94-08 - Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits were used to determine the safety and efficacy as livestock feed and the environmental safety of this novel feed:

  • the potential impact of cotton event MON 88702 on livestock nutrition
  • the potential impact of cotton event MON 88702 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 potential for cotton event MON 88702 to become a weed of agriculture or be invasive of natural habitats
  • the potential for gene flow from cotton event MON 88702 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive
  • the potential for cotton event MON 88702 to become a plant pest
  • the potential impact of cotton event MON 88702 and its gene products on non-target organisms, including humans
  • the potential impact of cotton event MON 88702 on biodiversity

The Animal Feed Division has also considered whether feeds derived from cotton event MON 88702 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

III. Description of the novel traits

1. Development method

Cotton event MON 88702 was developed through Agrobacterium-mediated transformation of cells from cotton variety DP393 using a plasmid with two separate T-DNAs. The first T-DNA designated as T-DNA-I, contains the mCry51Aa2 gene and its associated regulatory elements. The second T-DNA, designated as T-DNA-II, contains the spectinomycin selectable marker gene aadA and other genetic elements. During transformation, both T-DNAs were inserted into the cotton genome. Then, traditional breeding, segregation, selection and screening were used to isolate those plants that contained the mCry51Aa2 gene (T-DNA-I) and did not contain the aadA gene (T-DNA-II). Cotton event MON 88702 was identified as a successful transformant based on molecular analyses and agronomic evaluations, and was thus chosen for further development.

2. Protection from hemipteran and thysanopteran 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), including Cry51Aa2. Cry proteins after being ingested by insects and bound to specific receptors on the insect cell membrane, form pores leading to cell disruption and insect death. The Cry51Aa2 protein was identified to be active against two hemipteran species of cotton pests, L. hesperus and L. lineolaris and it exerts a mode of action similar to other Cry proteins.

The naturally-occurring Cry51Aa2 protein was modified through amino acid sequence changes to improve its insecticidal potency against Lygus spp. The modifications to Cry51Aa2 resulted in the variant Cry51Aa2.834_16 (assigned as mCry51Aa2) and consisted of eight amino acid substitutions and a deletion of 3 amino acids in a single HYS motif. It was demonstrated that mCry51Aa2 with these sequence changes exerts an enhanced control of Lygus spp. compared to the wild-type Cry51Aa2 protein. Furthermore, activity spectrum data demonstrate activity of the mCry51Aa2 protein against hemipteran species Pseudoalomoscelis seriatus and thysanopteran species Frankliniella spp.

The mCry51Aa2 protein shares approximately 96% sequence identity to the wild type protein Cry51Aa2 found in B. thuringiensis. Both proteins, mCry51Aa2 and the native Cry51Aa2, belong to the aerolysin-like/ETX_MTX2 family of the β-pore forming proteins which have a well-known history of safe consumption by humans and animals.

To perform the safety assessment of the modified protein for livestock use, it was necessary to express the mCry51Aa2 protein in a B. thuringiensis expression system to obtain sufficient quantities of the protein. The equivalence between the cotton event MON 88702-produced and the Bt-produced mCry51Aa2 proteins was demonstrated by apparent molecular weight (SDS-PAGE), immunoreactivity, N-terminal sequencing, matrix assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF MS), tryptic mass fingerprint analysis, functional activity (insect bioassay) and glycosylation status. The results from these analyses demonstrated that the cotton event MON 88702-produced mCry51Aa2 protein and the Bt-produced mCry51Aa2 protein were equivalent. This equivalence allowed the use of the Bt-produced mCry51Aa2 protein in studies to evaluate the safety of cotton event MON 88702.

The potential allergenicity and toxicity of the mCry51Aa2 protein to livestock and non-target organisms were evaluated. The weight of evidence indicates that the mCry51Aa2 protein is unlikely to be allergenic and toxic, based on the following information. The source of the mCry51Aa2 gene, B. thuringiensis, is not commonly associated with allergenicity. A bioinformatics evaluation of the mCry51Aa2 protein amino acid sequence confirmed the lack of relevant similarities to known allergens. In vitro digestion studies demonstrated that, unlike many allergens, mCry51Aa2 is rapidly degraded by pepsin, is not heat stable and is expressed at low levels in cottonseed (91 – 170 µg/g dry weight). It was also demonstrated that the mCry51Aa2 protein is unlikely to be toxic to livestock and non-target organisms because it lacks a mode of action that is intrinsically toxic to livestock and non-target organisms and the bioinformatics evaluation revealed that the mCry51Aa2 protein amino acid sequence lacks relevant similarities to known toxins. Acute oral toxicology studies in mice demonstrated that mCry51Aa2 protein administered by oral gavage at a dose of 5000 mg/kg body weight does not cause adverse effects. The livestock exposure to the mCry51Aa2 protein is expected to be negligible as the mCry51Aa2 protein is expressed at low levels in the seed of cotton event MON 88702 and is rapidly degraded under conditions which simulate the mammalian digestive tract.

For a more detailed discussion of the potential allergenicity and toxicity of the mCry51Aa2 protein, see Section V, part 2. Potential Impact of Cotton Event MON 88702 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.

3. Stable integration into the plant genome

Characterization of the genetic modification in cotton event MON 88702 was conducted using a combination of next-generation sequencing (NGS), polymerase chain reaction (PCR) and bioinformatics. Molecular characterization of cotton event MON 88702 by NGS demonstrated that cotton event MON 88702 contains a single copy of T-DNA containing the mCry51Aa2 expression cassette inserted at a single locus with no detectable vector backbone sequences. Directed sequencing (locus-specific PCR, DNA sequencing and analyses) of cotton event MON 88702 which examined the T-DNA insert sequence, flanking genomic regions and insert-to-flank junctions confirmed that the sequence and genomic organization of T-DNA are as expected and no major DNA rearrangement occurred at the insertion site in cotton event MON 88702 upon DNA integration.

The generational stability analysis by NGS demonstrated that a single copy of the intended T-DNA insert in cotton event MON 88702 was maintained through five breeding generations. Segregation analysis demonstrated that the T-DNA insert in cotton event MON 88702 resides at a single locus within the cotton genome and is inherited according to Mendelian principles over multiple generations.

IV. Criteria for the environmental assessment

Lines derived from cotton event MON 88702 will not be grown in Canada. However, Canada imports cottonseed, as well as a wide range of other cotton products, that are used as human food, livestock feed or other industrial products.

1. Potential for cotton event MON 88702 to become a weed of agriculture or be invasive of natural habitats

Cotton (Gossypium hirsutum) is a member of the family Malvaceae. It is a perennial species cultivated as an annual and grown in the U.S., mostly in areas from Virginia southward and westward to California. Cotton is not grown in Canada as it is not adapted to environmental conditions found at these latitudes.

Cotton is not considered a weed in the regions where it is grown, nor is it invasive of unmanaged habitats in Canada. Cotton event MON 88702 has not been modified to have altered cold-tolerance, and information supplied by Monsanto Canada Inc. indicates that the reproductive and survival biology of cotton event MON 88702 is unchanged compared to its unmodified control.

CFIA has therefore concluded that cotton event MON 88702 is unlikely to become a weed of agriculture or invasive of natural habitats.

2. Potential for gene flow from cotton event MON 88702 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive

Cotton is predominately self-pollinated. Although cross-pollination may occur at low levels, particularly in the presence of pollinators such as honeybees, cotton has no wild relatives native to Canada. Wild relatives of commercial cotton, such as Gossypium barbadense and G. tomentosum, are found only in tropical and sub-tropical regions.

This information, together with the fact that the novel traits have no intended effects on cotton reproductive biology, led CFIA to conclude that gene flow from cotton event MON 88702 to wild relatives in Canada is not possible.

3. Altered plant pest potential of cotton event MON 88702

Cotton is not a plant pest in Canada, and the intended effect of the novel trait is unrelated to plant pest potential. In addition, agronomic characteristics of cotton event MON 88702 are similar to those described for currently commercialized cotton varieties.

CFIA has therefore determined that cotton event MON 88702 does not present a plant pest concern.

4. Potential impact of cotton event MON 88702 on non-target organisms

The mCry51Aa2 protein has a similar mode of action to Bt Cry proteins that have been assessed by CFIA and that have a history of safe use in Canada.

Detailed characterization of the mCry51Aa2 protein expressed in cotton event MON 88702 led to the conclusion that this protein does not display any characteristic of a potential allergen (see Section V, part 2. Potential Impact of Cotton Event MON 88702 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).

No adverse effects were observed when channel catfish were fed meal comprising approximately 20% seed from MON 88702 cotton event for 8 weeks.

The results of published studies (Bachman et al. 2017)Footnote 1 demonstrate selective and limited activity of the mCry51Aa2 protein within in three insect orders: Hemiptera, Thysanoptera, and Coleopteran. Additional feeding studies showed that continuous dietary exposure to the mCry51Aa2 protein did not affect indicator species tested from the orders Lepidoptera, Hymenoptera, Collembola, and Haplotaxida. Therefore the mCry51Aa2 protein expressed in cotton event MON 88702 is unlikely to have a direct or indirect effect on arthropods in Canada, with the exception of sensitive hemipteran, thysanopteran, and coleopteran species that may be fed on cotton.

Composition analyses showed that the levels of key nutrients and anti-nutrients in seed from cotton event MON 88702 are comparable to those in unmodified control cotton variety (Section V, part 1 Potential Impact of Cotton Event MON 88702 on Livestock Nutrition). Therefore, it is very unlikely that the introduction of the novel traits may have caused unintended changes to the composition of cotton event MON 88702 that would negatively impact organisms interacting with cotton event MON 88702.

Cotton event MON 88702 will not be grown in Canada. In the event that seed from cotton event MON 88702 was accidentally released into the environment, any resulting plants would not be expected to set seed. Therefore, exposure of non-target organisms to the mCry51Aa2 protein from cotton event MON 88702 is expected to be minimal to non-existent.

Based on the above, CFIA has determined that the use of cotton event MON 88702 will not result in altered impacts on interacting organisms, including humans, when compared to currently commercialized cotton varieties.

5. Potential impact of cotton event MON 88702 on biodiversity

No varieties of cotton, nor any wild relatives that can readily interbreed with cotton, can grow in the Canadian environment since cotton is not adapted to the environmental conditions encountered in Canadian agricultural environments. In addition, cotton event MON 88702 has no observed or expected modifications that would allow it to survive in the Canadian environment and, as a result, is not expected to enter or survive in managed or unmanaged ecosystems in Canada. Furthermore, there is no evidence to suggest that cotton event MON 88702 would cause negative impacts on interacting organisms.

CFIA has therefore concluded that cotton event MON 88702 does not present any adverse impacts on biodiversity in Canada.

V. Criteria for the livestock feed assessment

The Animal Feed Division considered the nutrient and anti-nutrient profiles of the cotton event MON 88702. It also took into consideration the safety of feed ingredients derived from it, including 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. Finally, the Animal Feed Division sought to determine whether feeds derived from cotton event MON 88702 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

1. Potential impact of cotton event MON 88702 on livestock nutrition

Nutritional and anti-nutrient composition

The nutritional equivalence of cotton event MON 88702 to the unmodified control cotton variety DP393 was determined from four replicates at each of five field sites in the United States during the 2015 growing season. Cottonseed samples were collected at maturity and subsequently were ginned and acid-delinted. Samples were analyzed for ash, protein, crude fat, carbohydrates (by calculation), acid detergent fibre (ADF), neutral detergent fibre (NDF), crude fibre, and total dietary fibre (TDF). Cotton seed samples were further analyzed for amino acids, fatty acids, vitamin E, minerals, and anti-nutrients (total gossypol, free gossypol, malvalic acid, sterculic acid and dihydrosterculic acid) as recommended by the OECD consensus document for new varieties of cotton (OECD, 2009 (PDF 328 kb)).

Composition data were analyzed statistically using a mixed model analysis of variance, and statistical differences between MON 88702 and the unmodified control cotton variety were identified and assessed (P<0.05). The biological relevance of any statistically significant difference among cotton varieties was assessed by comparing the mean values of MON 88702 component with the range of natural variation as reported in the literature and/or the ILSI Crop Composition Database (ILSI-CCDB).

No statistically significant differences were observed between cotton seed from cotton event MON 88702 and the unmodified control cotton variety for fat, ash, carbohydrates, crude fibre, ADF, NDF and TDF. Statistically significant difference was found between cotton seed from cotton event MON 88702 and the unmodified control cotton variety for protein. However, this difference was not biologically significant as the mean was found to be within the range of the values observed in the literature and/or the ILSI-CCDB.

Except for calcium, no statistically significant differences were observed between cotton seed from cotton event MON 88702 and the unmodified control cotton variety for phosphorus, iron, magnesium, potassium, copper, manganese, sodium and zinc. However, this difference was not biologically significant as mean was within the range of the values observed in the literature and/or the ILSI-CCDB.

No statistically significant differences were observed between cotton seed from cotton event MON 88702 and the unmodified control cotton variety for vitamin E. No statistically significant differences were observed between cotton event MON 88702 and the unmodified control cotton variety for amino acids. No statistically significant differences were observed between cotton event MON 88702 and the unmodified control cotton variety for anti-nutrients.

Statistically significant differences were observed between cotton seed from cotton event MON 88702 and the unmodified control cotton variety for lauric, myristic, palmitic, stearic, oleic, arachidic, and behenic acids. However, all means were within the range of the values observed in the literature and/or the ILSI-CCDB.

Channel catfish feeding study

A total of 600 Channel Catfish, Ictalurus punctatus, Kansas x Missouri x Lake Erie cross of similar size were weighed (as a group) 20 fish per aquarium into 30 aquaria. Aquaria were randomly allocated to six diet groups - five (5) replicates per diets formulated such that the cottonseed meal component of each diet was represented entirely by cottonseed meal from cotton event MON 88702, the unmodified control cotton variety, each of 4 different commercial cottonseed varieties. All diets were formulated to be isonitrogenous and contained 20% cottonseed meal, which is equivalent to, or greater than, levels typically used in commercial catfish diets. The diets were formulated to contain approximately 32% crude protein. Fish were fed once daily, at approximately the same time each day for eight (8) weeks.

There were no statistically significant differences (α = 0.05) in overall weight gain per fish, total diet consumption per fish, or diet conversion ratio among fish fed the reference, control and test diets containing 20% of cottonseed meal. Results of survival and growth monitoring during the study indicate that cottonseed meal from cotton event MON 88702 has no adverse effects on diet consumption, weight gain, diet conversion, survival, or behavior of channel catfish compared to meal from the unmodified control cottonseed meal.

Conclusion

It was concluded, based on the evidence provided by Monsanto Canada Inc. that the nutritional composition of cotton event MON 88702 is similar to that of the corresponding unmodified control cotton variety grown in the trials and to that reported for other cotton varieties in the published scientific literature and/or the ILSI-CCDB. In addition to this, cottonseed meal from cotton event MON 88702 is considered to be nutritionally equivalent to the cottonseed meal from the unmodified control cotton variety when fed to channel catfish. Therefore, feed ingredients derived from cotton event MON 88702 are considered to meet the present ingredient definitions for cotton.

2. Potential impact of cotton event MON 88702 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 insect protected cotton event MON 88702 produces a modified Cry51Aa2 protein (mCry51Aa2 protein) which protects against feeding damage caused by targeted hemipteran (Lygus hesperus, Lygus lineolaris and Pseudoalomoscelis seriatus) and thysanopteran (Frankliniella spp.) insect pests. The assessment of cotton event MON 88702 evaluated the impact of potential hazards of the mCry51Aa2 protein on the safety of feed ingredients derived from this event.

mCry51Aa2 protein

To obtain sufficient quantities of the mCry51Aa2 protein for the assessment of feed safety, mCry51Aa2 protein was purified from Bacillus thuringiensis cells. The cotton-produced and the Bt-produced mCry51Aa2 proteins were demonstrated to be equivalent by comparing molecular weight, immunoreactivity, functional activity, and glycosylation status. This allowed the Bt-produced mCry51Aa2 to be used in studies to confirm the safety of the mCry51Aa2 produced in cotton event MON 88702.

The potential allergenicity and toxicity of the mCry51Aa2 protein to livestock were evaluated. With respect to its potential allergenicity, no single experimental method yields decisive evidence, thus a weight of evidence approach was utilised, taking into account information obtained with various test methods. B. thuringiensis, the source of the gene encoding the mCry51Aa2 protein, is not known to produce allergens and a bioinformatics evaluation of the mCry51Aa2 protein amino acid sequence confirmed the lack of relevant similarities between the mCry51Aa2 protein and known allergens. mCry51Aa2 protein safety studies indicated that, unlike many allergens, this protein is rapidly degraded in simulated gastric fluid and is not heat stable. Finally, unlike many allergens, mCry51Aa2 protein was shown experimentally to be unglycosylated. The weight of evidence indicates that the mCry51Aa2 protein is unlikely to be allergenic.

In terms of its potential toxicity to livestock, the mCry51Aa2 protein lacks a mode of action to suggest that it is intrinsically toxic to livestock and a bioinformatics evaluation of the mCry51Aa2 protein amino acid sequence confirmed the lack of relevant similarities between the mCry51Aa2 protein and known toxins. In addition, acute mCry51Aa2 protein safety studies indicated that no adverse effects were observed when the mCry51Aa2 protein was ingested by mice at doses of approximately 5000 mg/kg bw. In addition, no signs of toxicity were observed in a catfish growth study when fish were fed diets containing 20% cottonseed meal from cotton event MON 88702 for 8 weeks. This information indicates that the mCry51Aa2 protein is unlikely to be toxic to livestock.

The livestock exposure to the mCry51Aa2 protein is expected to be negligible as the mCry51Aa2 protein is expressed at very low levels in cotton event MON 88702 and is rapidly degraded under conditions which simulate the mammalian digestive tract.

Conclusion

It was concluded, based on the evidence provided by Monsanto Canada Inc., that the novel mCry51Aa2 protein which protects against feeding damage caused by targeted hemipteran and thysanopteran insect pests, will not confer to cotton event MON 88702 any characteristic that would raise concerns regarding the safety of cotton event MON 88702. Feed ingredients derived from cotton event MON 88702 are considered to meet ingredient definitions for cotton present in Schedule IV of the Feeds Regulations.

VI. New information requirements

If at any time Monsanto Canada Inc. becomes aware of any new information regarding risk to the environment, livestock or human health that could result from the environmental release or livestock feed use of cotton event MON 88702 or lines derived from it, Monsanto Canada Inc. is required to immediately provide such information to CFIA. On the basis of such new information, CFIA will re-evaluate the potential impact of cotton event MON 88702 on the environment, livestock and human health and may re-evaluate its decision with respect to the livestock feed use and environmental release authorizations of cotton event MON 88702.

VII. Regulatory decision

Cotton event MON 88702 will not be grown in Canada nor can the seed overwinter; therefore, the release of the feed into the environment would result in neither intended nor unintended environmental effects.

Based on the review of the data and information submitted by Monsanto Canada Inc. and input from other relevant scientific sources, the Animal Feed Division has concluded that the novel mCry51Aa2 insecticidal Cry protein will not confer to cotton event MON 88702 any characteristic that would raise concerns regarding the safety or nutritional composition of cotton event MON 88702. Cottonseed and cottonseed meal are currently listed in Schedule IV of the Feeds Regulations and are, therefore, approved for use in livestock feeds in Canada. Cotton event MON 88702 has been found to be as safe and nutritious as currently and historically grown cotton varieties. Cotton event MON 88702 and its products are considered to meet present ingredient definitions and are approved for use as livestock feed ingredients in Canada.

Taking into account this evaluation, use as livestock feed of cotton event MON 88702 is, therefore, authorized by the Animal Feed Division of the Animal Health Directorate as of August 27, 2018. Any cotton lines derived from cotton event MON 88702 may also be used as livestock feed, provided that

  1. no inter-specific crosses are performed
  2. the intended uses are similar
  3. it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to currently commercialized cotton and permitted to be used as livestock feed in Canada, in terms of their potential environmental impact and livestock feed safety and nutrition
  4. the novel genes are expressed at a level similar to that of the authorized line

Cotton event MON 88702 is subject to the same phytosanitary import requirements as the unmodified cotton varieties, and is required to meet the requirements of other Canadian legislation including, but not limited to, the Food and Drugs Act and the Pest Control Products Act.

Please refer to Health Canada's Decisions on Novel Foods for a description of the food safety assessment of cotton event MON 88702.

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