Decision Document DD2016-115
Determination of the Safety of BASF Canada Inc.'s Rice (Oryza sativa L.) Event HPHI2 (Provisia™)

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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, has evaluated information submitted by BASF Canada Inc. This information concerns the herbicide tolerant rice event HPHI2. The CFIA has determined that feed derived from these modified plants does not present significant risk to the environment, nor does it present livestock feed safety or nutrition concerns when compared to currently commercialized rice varieties in Canada.

Taking into account these evaluations, use as livestock feed of rice event HPHI2 is therefore authorized by the Animal Feed Division of the Animal Health Directorate, respectively, as of April 05, 2016. Any rice lines derived from rice event HPHI2 may also be used as livestock feed, provided that:

  1. no inter-specific crosses are performed,
  2. the intended uses are similar, and
  3. it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to rice 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.

Additionally, with respect to its use as livestock feed, rice event HPHI2 must meet the restrictions specific to quizalofop-ethyltreated straw set out in the authorization.

Rice event HPHI2 is subject to the same phytosanitary import requirements as unmodified rice varieties. Rice event HPHI2 is required to meet the requirements of other jurisdictions, including but not limited to, the Food & 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 assessment of novel foods by Health Canada, have been addressed separately from this review.

April 05, 2016

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.

Table of Contents

I. Brief Identification of the Modified Plant

Designation of the Modified Plant: Rice event HPHI2

Applicant: BASF Canada Inc.

Plant Species: Rice (Oryza sativa L.)

Novel Traits: Tolerance to quizalofop-ethyl

Trait Introduction Method: Tissue culture mutagenesis and conventional breeding

Intended Use of the Modified Plant: Production of rice for livestock feed, human food and industrial uses. The new rice line will be used in the same manner as conventional rice as livestock feed. These materials will be grown outside Canada, in the usual production areas for rice. Rice grain, rice hulls, and rice bran with germ will be imported into Canada for livestock feed use only.

II. Background Information

BASF Canada Inc. has developed a rice event that is tolerant to quizalofop-ethyl herbicides. Rice event HPHI2 was developed by BASF Canada Inc. using tissue culture mutagenesis and conventional breeding to introduce a single nucleotide mutation in the OsACC2 gene and resulting in a single amino acid substitution, leading to the expression of the modified HPHI2 ACCase protein. The resultant amino acid substitution within the endogenous rice acetyl-CoA carboxylase (ACCase) enzyme prevents binding of specific Group 1 herbicides (e.g. quizalofop-ethyl) to the ACCase protein, and therefore confers tolerance to the herbicide.

BASF Canada Inc. has provided information on the identity of rice event HPHI2, a detailed description of the modification method and breeding history, levels of protein expression in the plant. The modified ACCase protein in rice event HPHI2 was identified and characterized. Information was provided for the evaluation of the potential toxicity and allergenicity of the modified ACCase protein to livestock and non-target organisms including humans. Information was also provided for the evaluation of herbicide residues in the feed commodities derived from the crop, following the intended herbicide application.

Rice event HPHI2 was field tested at five replicated sites in the United States (US) in 2013 growing season. An unmodified control rice variety, which shares the same genetic background as rice event HPHI2, was included in the trials to act as a comparator for rice event HPHI2. Four conventional rice varieties were also included in the field trials to establish ranges of comparative values that are representative of currently grown rice varieties.

Agronomic and phenotypic characteristics of rice event HPHI2, such as as stand count, seedling vigour, days to panicle initiation, days to heading, days to maturity, plant height, grain moisture, grain yield and grain, were compared to those of the unmodified control rice variety and to the range established by the reference rice varieties.

Nutritional components of rice event HPHI2 grain, such as protein, fat, moisture, ash, fibre, amino acids, fatty acids, vitamins, minerals and anti-nutrients were compared to those of the unmodified control rice variety and to the range established by the conventional rice varieties.

The Animal Feed Division (AFD) 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 rice event HPHI2 on livestock nutrition;
  • the potential impact of rice event HPHI2 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 rice event HPHI2 to become a weed of agriculture or to be invasive of natural habitats;
  • the potential for gene flow from rice event HPHI2 to sexually compatible plants whose hybrid offspring may become more weedy or more invasive;
  • the potential for rice event HPHI2 to become a plant pest;
  • the potential impact of rice event HPHI2 and its gene products on non-target organisms, including humans; and
  • the potential impact of rice event HPHI2 on biodiversity.

The AFD has also considered whether feeds derived from rice event HPHI2 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

III. Description of the Novel Trait

1. Development Method

Rice event HPHI2 was developed by BASF Canada Inc. using tissue culture mutagenesis and conventional breeding. During tissue culture, the calli from germinated rice seeds of variety Indica-1 were selected for tolerance to cycloxydim herbicides. The cycloxydim-resistant calli were regenerated to produce whole plants. For development of rice event HPHI2, the cycloxydim-resistant plants were further selected for tolerance to quizalofop-ethyl herbicide and agronomic performance equivalent to the unmodified control rice variety. Rice event HPHI2 was identified as a successful mutant based on molecular analyses, herbicide efficacy and agronomic evaluations, and chosen for further development.

2. Tolerance to Quizalofop-ethyl

Quizalofop-ethyl is Group1 herbicide that inhibits ACCase protein. ACCase proteins are endogenously present in plants including rice and catalyze the carboxylation of acetyl-CoA to produce malonyl-CoA in de novo fatty acid and flavonoid synthesis. Quizalofop-ethyl herbicides bind to ACCase proteins and blocks fatty acid synthesis causing loss of membrane integrity, metabolite leakage and eventually plant death. In rice, ACCase proteins are present in two forms, a cytosolic form (OsACC1) that is resistant to herbicides and a plastidic form (OsACC2) that is susceptible to herbicides. The single nucleotide mutation in the OsACC2 gene in rice event HPHI2 reduces the ability of Group 1 herbicides to bind to the active site of the ACCase protein, which confers commercial-level tolerance to quizalofop-ethyl herbicides.

In rice event HPHI2, the single nucleotide mutation in OsACC2 gene resulted in single amino acid substitution and expression of the modified HPHI2 ACCase protein. Polymerase chain reaction (PCR) amplification and sequencing of the OsACC2 coding region in herbicide-tolerant rice HPHI2 confirmed the presence of expected single nucleotide mutation of the OsACC2 gene in rice event HPHI2 compared to the unmodified control rice variety. The same amino acid substitution in ACCase protein is also present in BASF Canada Inc.'s sethoxydim-tolerant corn event DK404SR (DD1996-13) previously approved for unconfined release and livestock feed use in Canada by CFIA.

Equivalency was demonstrated between ACCase protein produced in rice event HPHI2 and the unmodified control rice variety by comparing their molecular weights, immunoreactivity, structure and functional activity using quantitative western blots, liquid chromatography-tandem mass spectrometry (LC-MS/MS) and ELISA. Based on results the protein was found to be equivalent and demonstrated the herbicide-tolerant trait.

ACCase protein expression in rice event HPHI2 varies with the physiological status of plant that is typical for constitutively-expressed plant proteins. Samples of rice event HPHI2 tissues were collected from unsprayed plants and plants sprayed with quizalofop-ethyl herbicide. The average ACCase protein expression levels in micrograms of protein per gram of dry weight tissue (μg/g dwt) evaluated by quantitative western blot, were as follows: 207 μg/g dwt in leaf/stem at beginning of tillering, 174 μg/g dwt in leaf/stem at mid-tillering, 21.0 μg/g dwt in flowers and 4.0 μg/g dwt in seed and below detectable limits in roots. The ACCase protein concentrations observed in rice event HPHI2 tissues were comparable for both unsprayed and herbicide-treated plants and were equivalent to unmodified control rice variety.

The potential allergenicity and toxicity of the modified HPHI2 ACCase protein to livestock were evaluated. The modified HPHI2 ACCase protein lacks a mode of action to suggest that it is intrinsically toxic to livestock. Furthermore, the source of the OsACC2 gene, rice (Oryza sativa L.), is not known to produce allergens. A bioinformatics evaluation of the amino acid sequences of modified HPHI2 ACCase protein confirmed the lack of relevant similarities between this protein and known allergens or toxins. Moreover, this protein is rapidly degraded in simulated gastric and intestinal fluid and is heat labile, thus reducing the potential livestock exposure. The weight-of-evidence approach taken indicates that the modified HPHI2 ACCase protein is unlikely to be allergenic or toxin.

For a more detailed discussion of the potential allergenicity and toxicity of the modified HPHI2 ACCase protein, see Section V, part 2: Potential Impact of Rice event HPHI2 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 Expression

The single nucleotide mutation in OsACC2 gene resulting in HPHI2 ACCase amino acid substitution and hence herbicide-tolerance trait to quizalofop-ethyl herbicides in rice event HPHI2 were shown to be inherited according to Mendelian principles across multiple generations. The inheritance and stable expression of the herbicide-tolerance trait was verified by genotypic and phenotypic assays over three generations. The Single Nucleotide Polymorphism (SNP) assay based on quantitative polymerase chain reaction (qPCR) confirmed the presence of single mutated OsACC2 gene on one chromosome in the rice genome that is inherited according to Mendelian principles and also detected the single nucleotide change in OsACC2 gene. Moreover, phytotoxicity ratings of rice event HPHI2 treated with quizalofop-ethyl herbicides demonstrated consistent herbicide tolerance over multiple generations.

IV. Criteria for the Environmental Assessment

Lines derived from rice event HPHI2 will not be grown in Canada and will only be imported as human food or livestock feed. The majority of rice imported to Canada does not have an intact hull, which results in the seed being incapable of germination and growth. Due to the unfavourable climatic conditions for rice in Canada, it is unlikely that grain from rice event HPHI2 would be capable of persisting in the Canadian environment

1. Potential for Rice Event HPHI2 to Become a Weed of Agriculture or be Invasive of Natural Habitats

The centre of origin of rice (Oryza sativa L.) is considered to be in the subtropics of Southeast Asia. Rice is not grown in Canada and is not adapted to the environmental conditions encountered in Canadian agricultural environments.

The CFIA evaluated data submitted by BASF Canada Inc. on the reproductive biology and life history traits of rice event HPHI2. The phenotypic and agronomic traits, such as stand count, seedling vigour, days to panicle initiation, days to heading, days to maturity, plant height, grain moisture, grain yield and grain, were determined to be equivalent to the unmodified rice control variety and within the normal range of expression of the traits currently displayed by conventional rice varieties.

No competitive advantage was conferred to these plants, other than that conferred by tolerance to quizalofop-ethyl herbicides. Tolerance to quizalofop-ethyl herbicides will not, in itself, render rice weedy or invasive of natural habitats since none of the reproductive and growth characteristics were modified.

Rice event HPHI2 is not intended for cultivation in Canada and the novel trait has no intended effects on weediness or invasiveness. The CFIA has therefore concluded that rice event HPHI2 has no altered weediness or invasiveness potential in Canada.

2. Potential for Gene Flow from Rice Event HPHI2 to Sexually Compatible Plants Whose Hybrid Offspring May Become More Weedy or More Invasive

Species sexually compatible with rice do not occur in Canada. The wild "rice" which occurs in Canada (Zizania aquatica L.) belongs to a species that is not sexually compatible with domesticated rice (Oryza sativa L.). Rice event HPHI2 will not be cultivated in Canada and if released, would not persist.

This information, together with the fact that the novel trait has no intended effects on rice reproductive biology, led the CFIA to conclude that gene flow form rice event HPHI2 to sexually compatible species in Canada is not possible.

3. Potential for Rice Event HPHI2 to Become a Plant Pest

Rice 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 rice event HPHI2 are similar to those described for currently commercialized rice varieties.

The CFIA has therefore determined that rice event HPHI2 does not present a plant pest concern.

4. Potential Impact of Rice Event HPHI2 and Its Gene Products on Non-Target Organisms, Including Humans

The quizalofop-ethyl tolerance trait introduced into rice event HPHI2 is unrelated to a potential impact on non-target organisms. In addition, the ACCase protein is commonly found in plant and microbial-based foods that have a history of safe consumption by humans and animals. The amino acid substitution in the ACCase protein that is present in rice event HPHI2 is the same as the one present in BASF Canada Inc.'s corn event DK404SR (DD1996-13) that has been previously authorized for unconfined environmental release in Canada.

Detailed characterization of the ACCase protein expressed in rice event HPHI2 led to the conclusion that this protein does not display any characteristic of a potential toxin or allergen (see Section III: Description of the Novel Trait). Therefore, no negative impacts resulting from exposure of organisms to the ACCase protein expressed in rice event HPHI2 is expected.

Composition analyses showed that the levels of key nutrients and anti-nutrients in grain from rice event HPHI2 is comparable to those in conventional rice varieties (see Section V, part 1: Potential Impact of Rice event HPHI2 on Livestock Nutrition). Therefore, it is very unlikely that the introduction of the novel trait may have caused unintended changes to the composition of rice event HPHI2 that would negatively impact organisms interacting with rice event HPHI2.

Rice event HPHI2 will not be grown in Canada. In the event that grain from rice event HPHI2 is accidentally released into the environment, it is unlikely that it would be capable of germination and growth. Therefore, exposure of non-target organisms to ACCase protein from rice event HPHI2 is expected to be minimal to non-existent.

Based on the above, the CFIA has determined that rice event HPHI2 will not result in altered impacts on interacting organisms, including humans, when compared to currently grown rice varieties.

5. Potential Impact of Rice Event HPHI2 on Biodiversity

No varieties of rice, nor any sexually compatible species that can readily interbreed with rice, can grow in the Canadian environment since rice is not adapted to the environmental conditions encountered in Canadian agricultural environments. In addition, rice event HPHI2 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 rice event HPHI2 would cause negative impacts on interacting organisms.

The CFIA has therefore concluded that rice event HPHI2 does not present any adverse impacts on biodiversity in Canada.

V. Criteria for the Livestock Feed Assessment

The AFD considered nutrient and anti-nutrient profiles; the safety of feed ingredients derived from rice event HPHI2, 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; and whether feeds derived from rice event HPHI2 meet the definitions and requirements of feeds as listed in Schedule IV of the Feeds Regulations.

1. Potential Impact of Rice event HPHI2 on Livestock Nutrition

Nutrient and anti-nutrient composition

The nutritional equivalence of rice event HPHI2 (treated with quizalofop-ethyl herbicide) to its unmodified control rice varietyand four other conventional control ricevarieties (treated with quizalofop-ethyl herbicide) was assessed from five replicated field sites in the US during the 2013 growing season. The field trials were conducted in a randomized complete design with four plots per each rice line, at each site. Compositional analyses in the paddy rice samples included proximate (ash, crude fat, protein, moisture, calculated carbohydrates), neutral detergent fiber (NDF), acid detergent fiber (ADF), total dietary fiber (TDF), amino acids, fatty acids, minerals (calcium, copper, iron, magnesium, manganese, phosphorus, potassium, sodium, zinc), vitamins (folic acid, niacin, pantothenic acid, pyridoxine, riboflavin, thiamine, alpha-tocopherol, biotin), phytic acid, lectins, and trypsin inhibitors using published and approved analytical methods and procedures. Analysis of variance was used for statistical examination of the compositional data and comparison of means was conducted at (P<0.05). Statistically significant differences observed between rice event HPHI2 and the unmodified control rice variety were assessed within the range of the conventional control rice varieties included in the trials and those published in the literature (OECD, 2016).

There were no statistically significant differences in protein, crude fat, ash, carbohydrates, NDF, ADF, and TDF content between rice event HPHI2 (quizalofop-ethyl herbicide) and the unmodified control rice variety for the combined-site analysis. Except for one location, there were no statistically significant differences in ash content between rice event HPHI2 and the unmodified control rice variety at the individual sites. All means were within the range of the conventional control rice varieties and/or published literature (OECD, 2016).

No statistically significant differences were detected in amino acid content of rice event HPHI2 (quizalofop-ethyl herbicide) and the unmodified control rice variety at each site and for the combined- site analysis. Small, but statistically significant differences in the content of individual amino acids were observed between rice event HPHI2 (treated with quizalofop-ethyl herbicide) and some of the conventional control rice varieties (at some locations, but these observations were not consistent across the locations.

Except for one field site, there were no statistically significant differences observed for the different fatty acids in grain of rice event HPHI2 (quizalofop-ethyl herbicide applications) and grain obtained from the unmodified control rice variety across the combined locations. At the one location, there was a statistically significantly lower level of oleic acid in rice event HPHI2 (treated with quizalofop-ethyl herbicide) than the unmodified control rice variety, and a significantly lower linoleic acid in rice event HPHI2 (treated quizalofop-ethyl herbicide) than the unmodified control rice variety. The mean values were however within the values reported in the published literature and these observations were not consistent across locations. Small, but statistically significant differences in the content of specific fatty acids were observed between rice event HPHI2 and the conventional control rice varieties but the differences were not considered to be biologically relevant.

There were no statistically significant differences in vitamin composition between rice event HPHI2 (treated with quizalofop-ethyl herbicide) and unmodified control rice variety across the locations. The level of folic acid in the unmodified control rice variety was statistically significantly higher than in rice event HPHI2 (quizalofop-ethyl herbicide herbicide), at one location and statistically significantly higher than rice event HPHI2 (treated with quizalofop-ethyl herbicide) at another location. Levels of pantothenic acid in the unmodified control rice variety at one site, was statistically significantly higher than in rice event HPHI2 (treated with quizalofop-ethyl herbicide), while the levels of thiamine and riboflavin in the unmodified control rice variety were statistically significantly lower than levels in rice event HPHI2 treated with quizalofop-ethyl herbicide at another location. However, the mean values were all with the range of the conventional control rice varieties and the differences were not considered significant from a biological perspective.

Except for copper, there were no statistically significant differences in mineral composition between rice event HPHI2 (treated with quizalofop-ethyl herbicide) and the unmodified control rice variety across the locations. Copper levels were statistically significantly higher in the unmodified control rice variety than in rice event HPHI2 (treated with quizalofop-ethyl). However, the level of copper was within the published literature values (OECD, 2016) and this trend was not observed at the five individual locations. Statistically significant differences were observed between rice event HPHI2 (treated with quizalofop-ethyl) and the unmodified control rice variety for iron, potassium, magnesium, phosphorus at one or two locations. However the mean values were all with the range of the conventional control rice varieties and the differences were not considered significant from a biological perspective.

For the combined site analysis, there was no significant difference in the level of phytic acid between rice event HPHI2 (treated with quizalofop-ethyl herbicide) and the unmodified control rice variety. A significant difference was observed at one location between rice event HPHI2 rice (treated with quizalofop-ethyl) and control variety, however the mean value was within range of the conventional control rice varieties and/or published literature values. The anti-nutrients; lectin and trypsin inhibitor were not analysed as majority of the values were below the levels of analytical detection.

Conclusion

It was concluded based on the evidence provided by BASF Canada Inc. that the nutritional composition of rice event HPHI2 is similar to that of the conventional control rice varieties and to that reported in the published scientific literature.

2. Potential Impact of Rice event HPHI2 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

Rice event HPHI2 is tolerant to quizalofop-ethyl herbicides due to production of the modified HPHI2 ACCase protein. A weight-of-evidence approach was used to assess the impacts of rice event HPHI2 on the following potential hazards relative to the safety of feed ingredients derived from this event:

  • The presence of the modified HPHI2 ACCase protein
  • The chemical pesticide residue profile

Modified HPHI2 ACCase protein

The ACCase protein expression levels in rice event HPHI2 tissues, including leaf/stem, flowers and seeds were comparable for both unsprayed and herbicide-treated plants and were equivalent to unmodified control rice variety. The potential allergenicity and toxicity of the modified HPHI2 ACCase 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 taken, taking into account information obtained with various test methods. The source of the OsACC2 gene in rice (Oryza sativa L.), is not known to produce allergens and a bioinformatics evaluation of the amino acid sequences of modified HPHI2 ACCase protein confirmed the lack of relevant similarities between this protein and known allergens. Unlike many allergens, this protein is rapidly degraded in simulated gastric and intestinal fluid. The protein is also heat labile.The weight of evidence thus indicates that the modified HPHI2 ACCase protein is unlikely to be allergenic.

In terms of the potential toxicity to livestock, the modified HPHI2 ACCase protein lacks a mode of action to suggest that it is intrinsically toxic to livestock and a bioinformatics evaluation of its protein amino acid sequences confirmed the lack of relevant similarities between the modified HPHI2 ACCase protein and known toxins. This information indicates that the modified HPHI2 ACCase protein is unlikely to be toxic to livestock.

The livestock exposure to the modified HPHI2 ACCase protein is expected to be negligible as this protein is expressed at very low levels in rice event HPHI2 grain and are rapidly degraded under conditions which simulate the mammalian digestive tract.

Chemical pesticide residue profile

The herbicide residues and metabolites in feed commodities from rice event HPHI2, following application of herbicides, were also evaluated as part of the feed safety assessment.

It was determined that the potential maximum quizalofop-ethyl residues in rice grain are below the default values of the maximum residue level (MRL) as set by the Health Canada's Pest Management Regulatory Agency (PMRA).

No authorization for straw produced from rice event HPHI2 treated with quizalofop-ethyl can be granted at this time, as there were not sufficient data available to support the inclusion of quizalofop-ethyl treated straw as feed.

Only feed ingredient(s) from rice grain, derived from the combination of quizalofop-ethyl and rice event HPHI2 commodities, may be manufactured or sold in Canada, or imported into Canada. This restriction will remain until a full authorization for quizalofop-ethyl application on quizalofop-ethyl tolerant rice (e.g., rice event HPHI2) has been granted by the PMRA.

Conclusion

Based on the evidence provided by BASF Canada Inc., it was concluded that the novel HPHI2 ACCase protein-based herbicide tolerance trait will not confer to rice event HPHI2 grain any characteristic that would raise concerns regarding the safety of rice event HPHI2. Feed ingredient(s) from rice event HPHI2 grain are considered to meet present ingredient definitions for rice in the Feeds Regulations and as such are approved for use as livestock feed in Canada.

No authorization for forage or hay or straw or stover produced from rice event HPHI2 treated with quizalofop-ethyl can be granted at this time, as there were not sufficient data available to support the inclusion of quizalofop-ethyl treated forage, hay, straw and stover as feed. This restriction will remain until a full authorization for quizalofop-ethyl application on quizalofop-ethyl tolerant rice (e.g., rice event HPHI2) has been granted by the PMRA.

VI. New Information Requirements

If at any time, BASF Canada 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 rice event HPHI2 or lines derived from it, BASF Canada 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 rice event HPHI2 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 rice event HPHI2.

VII. Regulatory Decision

Rice event HPHI2 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 BASF Canada Inc. and input from other relevant scientific sources, the AFD of the Animal Health Directorate, CFIA, has concluded that the novel HPHI2 ACCase protein-based herbicide tolerance trait will not confer to rice event HPHI2 any characteristic that would raise concerns regarding the safety or nutrition of rice event HPHI2. Livestock feeds derived from rice are currently listed in IV of the Feeds Regulations. Rice event HPHI2 has been found to be as safe as and as nutritious as currently and historically grown rice varieties. Rice event HPHI2 and its products are considered to meet present ingredient definitions.

Taking into account these evaluations, use as livestock feed of rice event HPHI2 is therefore authorized by the Animal Feed Division of the Animal Health Directorate, respectively, as of April 05, 2016. Any rice lines derived from rice event HPHI2 may also be used as livestock feed, provided that:

  1. no inter-specific crosses are performed,
  2. the intended uses are similar, and
  3. it is known based on characterization that these plants do not display any additional novel traits and are substantially equivalent to rice 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.

Additionally, with respect to its use as livestock feed, rice event HPHI2 must meet the restrictions specific to quizalofop-ethyltreated straw set out in the authorization.

Rice event HPHI2 is subject to the same phytosanitary import requirements as unmodified rice varieties. Rice event HPHI2 is required to meet the requirements of other jurisdictions, including but not limited to, the Food & 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 rice event HPHI2.

Date modified: