DD2010-80: Determination of the Safety of BASF Canada Inc.'s Sunflower Line CLHA-PLUS and CL Sunflower Hybrid H4

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This Decision Document has been prepared to explain the regulatory decision reached under Dir94-08 Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits and its companion document BIO2005-01 The Biology of Helianthus annuus L. (Sunflower) and Chapter 2.6 of the Regulatory Guidance: Feed Registration Procedures and Labelling Standards, entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources".

The Canadian Food Inspection Agency (CFIA) has evaluated information submitted by BASF Canada Inc. in regard to the imidazolinone herbicide tolerant sunflower line CLHA-PLUS and CL sunflower hybrid H4. The CFIA has determined that these plants with novel traits (PNTs) do not present altered environmental risk nor, as novel feeds, do they present livestock feed safety concerns when compared to currently commercialized sunflower varieties in Canada.

Taking into account these evaluations, unconfined release into the environment and use as livestock feed of line CLHA-PLUS, including lines derived from it as well as hybrids containing novel traits from CLHA-PLUS and line CL IMISUN (including CL sunflower hybrid H4) are therefore authorized by the Plant Biosafety Office of the Plant Health and Biosecurity Directorate and the Animal Feed Division of the Animal Health Directorate, as of June 4, 2010. Any sunflower lines or hybrids derived from line CLHA-PLUS may also be released into the environment and used as livestock feed, provided that (i) no inter-specific crosses are performed, (ii) the intended uses are similar, and (iii) it is known based on characterization, that these plants do not display any additional novel traits and are substantially equivalent to sunflowers currently grown in Canada, in terms of their potential environmental impact and livestock feed safety.

Sunflower line CLHA-PLUS and CL sunflower hybrid H4 are subject to the same phytosanitary import requirements as their unmodified counterparts.

Please note, that the livestock feed and environmental safety assessments of novel feeds and PNTs are critical steps in the potential commercialization of these plant types. Other requirements, such as the evaluation of food safety by Health Canada, have been addressed separately from this review.

Table of Contents

  1. Brief Identification of the Modified Plant
  2. Background Information
  3. Description of the Novel Trait
    1. Development Method
    2. Imidazolinone Tolerance
    3. Stable Expression
  4. Criteria for the Environmental Assessment
    1. Potential of sunflower hybrid H4 to Become a Weed of Agriculture or be Invasive of Natural Habitats
    2. Potential for Gene Flow from CL sunflower hybrid H4 to Wild Relatives Whose Hybrid Offspring May Become More Weedy or More Invasive
    3. Altered Plant Pest Potential of CL sunflower hybrid H4
    4. Potential Impact of CL sunflower hybrid H4 on Non-Target Organisms
    5. Potential Impact of CL sunflower hybrid H4 on Biodiversity
  5. Criteria for the Livestock Feed Assessment
    1. Potential Impact of CL sunflower hybrid H4 on Livestock Nutrition
    2. Potential Impact of CL sunflower hybrid H4 on Livestock and Workers/Bystanders
  6. New Information Requirements
  7. Regulatory Decision

I. Brief Identification of the Modified Plant

Designation of the Modified Plant: CL sunflower hybrid H4 and parental line CLHA-PLUS
Applicant: BASF Canada Inc.
Plant Species: Sunflower (Helianthus annuus L.)
Novel Traits: Tolerance to imidazolinone herbicides
Trait Introduction Method: Chemically induced seed mutagenesis and conventional crossbreeding
Proposed Use of the Modified Plant: Production of H. annuus for human food and livestock feed.

II. Background Information

BASF Canada Inc. has developed a sunflower hybrid tolerant to imidazolinone herbicides. This sunflower hybrid, designated CL sunflower hybrid H4, was developed to allow in-crop applications of imidazolinone herbicides at normal field application rates. This will allow expanded use of post-emergent applications of imidazolinone herbicides in sunflower crops.

The CL sunflower hybrid H4 was developed by conventionally breeding a previously approved imidazolinone-tolerant sunflower line (Clearfield™ Oilseed Sunflower hybrid X81359, also referred to as the CL IMISUN event; DD2005-50) with a new imidazolinone-tolerant line (CLHA-PLUS) in which the imidazolinone tolerance trait was introduced by mutagenesis. The herbicide tolerance trait in CLHA-PLUS is conferred by a single point mutation in the acetohydroxyacid synthase (AHAS) gene such that this enzyme is no longer affected by imidazolinone herbicides.

BASF Canada Inc. intends to commercialize CL sunflower hybrid H4, as well as sunflower lines with only the CLHA-PLUS event. The CFIA has determined that BASF Canada Inc.'s information regarding CL sunflower hybrid H4 is also relevant to the determination of environmental safety and feed safety of the parental CLHA-PLUS line. This determination is based on the CFIA's familiarity with the evaluation of PNTs and novel feeds with one or more modified AHAS genes in at least 9 different plant species, the nature of the two different mutations and their products, a safe history of cultivation in Canada of other products with single or dual mutations conferring imidazolinone herbicide tolerance, and that no environmental and feed safety concerns were identified with the CL sunflower hybrid H4, which includes the CLHA-PLUS mutation.

BASF Canada Inc. has provided data on the identity of CL sunflower hybrid H4 and event CLHA-PLUS, a detailed description of the modification method and breeding history, information on the modified gene, the resulting protein and its mode of action and the stability of trait expression.

CL sunflower hybrid H4 was field tested at three locations in the US in 2007, in regions representative of Canadian sunflower growing regions. Agronomic characteristics and nutritional components were compared with the unmodified parental control hybrid H7 and two other unmodified sunflower varieties. Agronomic characteristics included germination (including dormancy), seedling emergence, seedling vigor, days to flower, days to maturity, plant height, and yield. Responses to biotic and abiotic stress tolerances were also observed. Nutritional components included proximates, fiber composition, amino acids, fatty acids, minerals, vitamins, and anti-nutrients

The Plant and Biotechnology Risk Assessment (PBRA) Unit of the Plant Health Science Directorate, CFIA, has reviewed the above information, in light of the assessment criteria for determining environmental safety of PNTs, as described in the Directive 94-08 (Dir94-08), entitled "Assessment Criteria for Determining Environmental Safety of Plants With Novel Traits". The PBRA Unit has considered:

  • potential of CL sunflower hybrid H4 and sunflower event CLHA-PLUS to become a weed of agriculture or to be invasive of natural habitats;
  • potential for gene-flow from CL sunflower hybrid H4 and sunflower event CLHA-PLUS to wild relatives whose hybrid offspring may become more weedy or more invasive;
  • potential for CL sunflower hybrid H4 and sunflower event CLHA-PLUS to become a plant pest;
  • potential impact of CL sunflower hybrid H4 and sunflower event CLHA-PLUS or its gene products on non-target species, including humans; and
  • potential impact of CL sunflower hybrid H4 and sunflower event CLHA-PLUS on biodiversity

The Animal Feed Division, CFIA, has also reviewed the above information with respect to the assessment criteria for determining the safety and efficacy of livestock feed, as described in Directive 95-03 (Dir95-03), entitled "Guidelines for the Assessment of Novel Feeds: Plant Sources". The Feed Section has considered:

  • potential impact of CL sunflower hybrid H4 and sunflower event CLHA-PLUS on livestock nutrition; and
  • potential impact of CL sunflower hybrid H4 and sunflower event CLHA-PLUS on livestock and workers/bystanders.

BASF Canada Inc. has provided the CFIA with a method for the detection and identification of sunflower products containing CL sunflower hybrid H4 and sunflower event CLHA-PLUS.

III. Description of the Novel Trait

1. Development Method

The CL sunflower hybrid H4 was developed by conventional breeding between a CL IMISUN breeding line (described in DD2005-50) and a CLHA-PLUS breeding line. Sunflower event CLHA-PLUS was developed by subjecting seeds of the sunflower line BTK47 to the mutagenic agent ethyl methanesulfonate (EMS). The plants derived from mutagenized seeds were treated with imidazolinone herbicides to identify imidazolinone tolerant events. After greenhouse and field evaluations of several mutant lines and generations for preferred characteristics, the CLHA-PLUS sunflower mutant was selected for further breeding.

2. Imidazolinone Tolerance

Imidazolinone herbicides are active against the enzyme acetohydroxyacid synthase (AHAS), also known as acetolactate synthase (ALS).

AHAS is an enzyme found in bacteria, certain other micro-organisms and plants. This enzyme catalyses the first step in the biosynthesis of the essential branched chain amino acids isoleucine, leucine and valine. Herbicide-induced AHAS inhibition results in a lethal decrease in protein synthesis. Unmodified sunflowers are not tolerant to imidazolinone herbicides.

BASF Canada Inc. provided data that demonstrated that CL sunflower hybrid H4 contains two distinct mutations, each in different AHAS alleles, that confer imidazolinone tolerance. One of the mutations is from a previously authorized imidazolinone tolerant sunflower (Clearfield™ Oilseed Sunflower hybrid X81359, also known as the CL IMISUN trait). The other mutation is from sunflower event CLHA-PLUS, which possesses a different mutation than that found in sunflower hybrid X81359. The single amino acid substitution in the AHAS gene of sunflower event CLHA-PLUS is sufficient to alter the binding site such that imidazolinone herbicides no longer bind to the AHAS enzyme, resulting in the herbicide tolerant phenotype for both CLHA-PLUS and the CL sunflower hybrid H4.

The CLHA-PLUS imidazolinone tolerance trait is under the control of the native AHAS promoter and is believed to be constitutively expressed. Sequence information for the modification in the AHAS gene was submitted.

The imidazolinone tolerance of the modified AHAS enzymes from CL sunflower H4 was demonstrated in vitro by comparison of the activity of the AHAS enzyme extracted from CL sunflower hybrid H4 plants to that of imidazolinone-susceptible sunflower plants in presence of imidazolinone herbicides.

The single amino acid change in sunflower event CLHA-PLUS has previously been approved in BASF Canada Inc.'s Clearfield™ rice (varieties IMINTA 1 and 4) and Clearfield™ bread wheat (variety BW7). AHAS proteins are not known toxins or allergens. Since the amino acid sequence of the mutated AHAS of sunflower event CLHA-PLUS differs by one amino acid from that of unmodified sunflower, no changes in allergenic or toxicological properties are anticipated for sunflower event CLHA-PLUS or CL sunflower hybrid H4. Bioinformatic analysis confirmed the lack of homology between the amino acid sequence of sunflower event CLHA-PLUS AHAS protein and that of known or putative allergens or toxins.

3. Stable Expression

The introduced mutation in sunflower event CLHA-PLUS is inherited as a partially dominant trait conferred by a single nuclear gene. Studies confirmed the Mendelian inheritance of the mutation and stable expression of the herbicide tolerance trait in event CLHA-PLUS across breeding generations. The two mutations were stably inherited in breeding lines leading to CL sunflower hybrid H4 as well. The mutation present in the CLHA-PLUS AHAS enzyme is therefore stable across generations.

IV. Criteria for the Environmental Assessment

1. Potential of sunflower hybrid H4 to Become a Weed of Agriculture or be Invasive of Natural Habitats

Sunflower production in Canada occurs in southern Manitoba, Saskatchewan and Alberta, with a very small amount of production in Ontario. Cultivated sunflower does not have a high potential for weediness. Sunflower plants can grow as volunteers in a cultivated field following a sunflower crop and are usually eliminated via cultivation or the use of herbicides. In the recent provincial weed surveys conducted in Manitoba (2002) and Saskatchewan (2003), volunteer sunflower was ranked the 66th and 85th most abundant weed, respectively, and the Prairie Weed Survey Report 2005 ranked "Sunflower species" (Helianthus sp.) 95th out of 148 species in terms of relative abundance.

According to the information provided by BASF Canada Inc., no competitive advantage was conferred to CL sunflower hybrid H4 other than that conferred by tolerance to imidazolinone herbicides. CL sunflower hybrid H4 was tested at three locations in 2007 in the United States in areas representative of Canada's sunflower growing regions. Agronomic characteristics were evaluated that encompass a broad range of characteristics indicative of the entire life cycle of the sunflower plant. They included germination (including dormancy), seedling emergence, seedling vigour, days to flower, days to maturity, plant height, and yield. The results showed no significant differences between CL sunflower hybrid H4 and the unmodified counterpart, and support a conclusion of phenotypic equivalence to currently commercialized sunflower varieties. It is therefore not expected that CL sunflower hybrid H4 would possess traits that would render it invasive of natural habitats since none of the reproductive or growth characteristics were modified.

Imidazolinone tolerance in itself will not cause CL sunflower hybrid H4 to become more weedy or invasive in managed habitats than non-modified H. annuus. Imidazolinone-tolerant sunflower volunteers will not be controlled in subsequent crops if a Group 2 herbicide is used as the sole weed control tool. However, control of imidazolinone tolerant sunflower as a volunteer weed can readily be achieved by the use of herbicides with other modes of action (i.e. non-Group 2 herbicides) or by mechanical means. BASF Canada Inc. has provided the CFIA with a stewardship plan that describes appropriate strategies that will allow the management of CL sunflower hybrid H4 volunteers (see Appendix 1).

The above considerations have led the CFIA to conclude that CL sunflower hybrid H4 and its parental line CLHA-PLUS will not become weedier or more invasive than currently commercialized sunflower varieties.

2. Potential for Gene Flow from CL sunflower hybrid H4 to Wild Relatives Whose Hybrid Offspring May Become More Weedy or More Invasive

Canada is a centre of biodiversity for sunflower germplasm. Wild Helianthus annuus L. is a native of North America, and Helianthus species are distributed widely across the Central Plains of Canada.

The wild H. annuus is a common roadside weed in the southern parts of the prairies, particularly in Manitoba. The cultivated and wild H. annuus have many opportunities for hybridization as they often grow in close proximity. These populations overlap in flowering time and are visited by the same pollinators. Genetic cultivar markers are readily found in wild populations of H. annuus indicating no strong barrier to the introgression of domesticated germplasm into wild populations. H. petiolaris, another annual species that occurs in pockets in Canada, has also been known to hybridize with H. annuus.

Several perennial species of genus Helianthus occur in Canada. The most conspicuous is H. maximiliani which flowers on the roadside in late summer and fall. H. giganteus occurs in pockets and H. tuberosus (Jerusalem artichoke) is found primarily on riverbanks. hybridization with these perennial species occurs very rarely in nature and artificial methods are generally required to cross H. annuus with these perennial species.

Gene flow from CL sunflower hybrid H4 to wild H. annuus and H. petiolaris in Canada will occur, but it is not expected to result in increased invasiveness of the offspring. The imidazolinone tolerance trait is not associated with enhanced weediness or competitiveness in the absence of the herbicide. The occurrence of imidazolinone tolerant wild sunflowers in agricultural fields will not cause greater weed management issues in comparison to wildtype wild sunflowers. Imidazolinone herbicides are not widely used to control these weeds, and imidazolinone-tolerant wild sunflowers will still be easily controlled with herbicides with other modes of action (non-Group 2 herbicides) or cultivation. Imidazolinone herbicides are not used outside of managed ecosystems and thus any wild H. annua or H. petiolaris with the imidazolinone-tolerance trait will not have a competitive advantage over these species without the trait.

Any new authorization of a PNT must take into account the spectrum of PNTs that have already been approved for unconfined environmental release in Canada. Since there are no barriers to outcrossing within different varieties of cultivated H. annuus and wild H. annua or H. petiolaris, there is the possibility that novel trait of a previously authorized plant could become combined in volunteer sunflowers or in individuals in wild populations. Two sunflower PNTs have been previously authorized for unconfined environmental release in Canada. In CL sunflower hybrid H4, BASF Canada Inc. has provided information to describe the environmental interactions between novel traits of a previously authorized hybrid  X81359 and CLHA-PLUS. The combination of traits did not result in increased weediness or invasiveness of the hybrid in comparison to unmodified sunflower. Based on familiarity with the other previously authorized trait (SU7), it is also unlikely that there will be increased weediness or invasiveness as a result of gene flow with CL sunflower hybrid H4.

BASF Canada Inc. has provided the CFIA with a stewardship plan that describes appropriate strategies that will allow the deployment of cultivated sunflower lines expressing imidazolinone tolerance while minimizing volunteers and outcrossing to wild sunflowers (see Appendix 1). This stewardship plan also describes management strategies for the control of these plants should they appear in an agronomic situation. Additionally, the stewardship plans that have been provided by BASF Canada Inc. provide strategies for the management of volunteers or individuals in wild populations with both of the imidazolinone- and sulfonylurea-tolerance traits. These plants will still be controlled by non-Group 2 herbicides and by non-chemical methods of control that control H. annuus.

3. Altered Plant Pest Potential of CL sunflower hybrid H4

H. annuus is not a plant pest in Canada and the imidazolinone tolerance traits in CL sunflower hybrid H4 are not expected to alter its plant pest potential. Many crop plants with mutations in the AHAS gene are cultivated in Canada and no instances of altered plant pest potential have ever been associated with these mutations. Furthermore, BASF Canada Inc. observed the severity of an insect pest (the sunflower midge, Contarinia schulzi) and three pathogens (downy mildew (Plasmopara halstedii), rust (Puccinia helianthi), and sclerotinia (Sclerotinia sclerotiorum))in the agronomic field trials and identified no statistical or biological differences between CL sunflower hybrid H4 and its unmodified counterparts.

The CFIA has therefore determined that CL sunflower hybrid H4 and its parental line CLHA-PLUS do not present any concerns with respect to altered plant pest potential.

4. Potential Impact of CL sunflower hybrid H4 on Non-Target Organisms

The AHAS enzyme is not a known toxin or allergen and is commonly found in a wide variety of plants and micro-organisms with a history of safe use. It does not exhibit properties typical of protein allergens or toxins (e.g. it is not resistant to digestive degradation or heat treatment) and the protein lacks homology with any known toxins or allergens.

BASF Canada Inc. has provided information to demonstrate that the two amino acid substitutions found in the CL sunflower hybrid H4 AHAS enzyme do not change the nontoxic and nonallergenic properties of the plants' AHAS protein. The functional activity of the protein is unaltered as well, and results of the compositional analysis of CL sunflower hybrid H4 demonstrated that seed from this hybrid is as safe and nutritious as unmodified sunflower seed.

Therefore, no negative interactions with non-target symbiotic or consumer organisms are anticipated. The CFIA has therefore determined that the unconfined release of CL sunflower hybrid H4 or its parental line CLHA-PLUS will not result in altered impacts on non-target organisms, including humans, compared to current commercial sunflower hybrids.

5. Potential Impact of CL sunflower hybrid H4 on Biodiversity

CL sunflower hybrid H4 has no novel phenotypic characteristics which would extend its use beyond the current geographic range of sunflower production in Canada. Imidazolinone tolerance will not alter the ability of CL sunflower hybrid H4 to persist in the Canadian environment. In addition, CL sunflower hybrid H4 is not different from conventional sunflower in terms of safety to non-target organisms, weediness or plant pest potential.

The ability of CL sunflower hybrid H4 to outcross is not expected to be altered either. The herbicide tolerance trait could be linked to other domestic traits that could make the offspring of any hybrids less ‘fit', which could then be increased in the population by selection with imidazolinone herbicides. However, imidazolinone herbicides are not used to control Helianthus species in unmanaged ecosystems, therefore, the genetic diversity of wild Helianthus species is not likely to change as any linked traits will not be selected. In managed ecosystems, the imidazolinone trait (and any linked traits) may be selected by imidazolinone herbicide use, but any hybrid offspring will be controlled by other weed management techniques.

The CFIA has therefore concluded that the impact on biodiversity of CL sunflower hybrid H4 and its parental line CLHA-PLUS is equivalent to that of currently commercialized sunflower varieties.

V. Criteria for the Livestock Feed Assessment

1. Potential Impact of CL sunflower hybrid H4 on Livestock Nutrition

Nutritional Composition:
The compositional equivalence of CL sunflower hybrid H4 to its parental control (hybrid H7) and two conventional sunflower varieties was assessed from three field trials in the US, during the 2007 growing season. Grain samples were collected from replicated plots and analysed for protein, crude fat, crude fibre, ash, acid detergent fibre (ADF), neutral detergent fibre (NDF), total dietary fibre (TDF), amino acids, fatty acids, minerals and vitamins. No statistically significant differences were observed between CL sunflower hybrid H4 and the parental control for protein, crude fat, crude fibre, ash, ADF, NDF and TDF. All means were within literature ranges. No statistically significant differences were observed between CL sunflower hybrid H4 and the parental control for branched-chain amino acids (valine, isoleucine and leucine), lysine, methionine, cystine and threonine. All means were within the range of literature values. Apart from stearic acid, there were no statistically significant differences between CL hybrid H4 and the parental control for myristic, pentadecanoic, palmitic, palmitoleic, oleic, linoleic, linolenic, arachidic, gadoleic, behenic, erucic and nervonic acids. All means were within the range for commercial sunflower varieties. No statistically significant differences were observed between CL sunflower hybrid H4 and the parental control for all minerals analysed. There were statistically significant differences between CL sunflower hybrid H4 and the conventional sunflower hybrids for phosphorus, magnesium and potassium, however the means were within literature ranges. No statistically significant differences were observed between CL sunflower hybrid H4 and the parental control for vitamin B1, niacin, pantothenic acid, vitamin B6, vitamin B2, and folic acid. Statistically significant differences were observed between CL sunflower hybrid H4 and the parental control for vitamin E, however the means were within commercial sunflower ranges.

Anti-nutritional factors:
Phytic acid was analysed in grain samples from CL sunflower hybrid H4 and compared to the parental control and two other conventional sunflower varieties. There were no statistically significant differences between the CL sunflower hybrid H4 and the parental control for phytic acid.  No statistically significant differences were observed between CL sunflower hybrid H4 and the two conventional sunflower varieties. All means were within literature ranges.

The evidence provided by BASF Canada Inc. supports the conclusion that the nutritional composition of CL sunflower hybrid H4 is substantially equivalent to conventional sunflower varieties.

2. Potential Impact of CL sunflower hybrid H4 on Livestock and Workers/Bystanders

The AHAS enzyme is found in a wide variety of plants and micro-organisms. AHAS is not a known toxin or allergen and the single base pair change in the AHAS enzyme found in CLHA-PLUS sunflower line would not be expected to change this.  AHAS from CL sunflower hybrid H4 is feedback inhibited by valine and leucine as is the unmodified AHAS, it is present in small amounts in the feed, it is heat labile and it is rapidly degraded under conditions in the gastrointestinal tract. The activity of AHAS in seed of CL sunflower hybrid H4 is similar to that of its parental control comparator sunflower. Lower levels of AHAS were detected in leaf tissue of the CL sunflower hybrid H4 than that of its parental control, however, no statistically significant differences in levels of the branched-chain amino acids valine, isoleucine and leucine were observed between CL sunflower hybrid H4 and the comparator, suggesting that the difference in AHAS activity leaf tissue is not biologically significant. Based on the information provided by BASF Canada Inc., the modified AHAS is unlikely to be a novel toxin or allergen.

The evidence provided by BASF Canada Inc. supports the conclusion that the potential impact on livestock and workers/by-standers of the CLHA-PLUS sunflower line and CL sunflower hybrid H4 is equivalent to that of currently commercialized sunflower lines.

VI. New Information Requirements

If at any time, BASF Canada Inc. becomes aware of any information regarding risk to the environment, including risk to human or animal health, which could result from release of CL sunflower hybrid H4 in Canada or elsewhere, BASF Canada Inc. will immediately provide such information to the CFIA. On the basis of such new information, the CFIA will re-evaluate the potential impact of CL sunflower hybrid H4 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 CL sunflower hybrid H4.

VII. Regulatory Decision

Based on the review of the data and information submitted by BASF Canada Inc., and through comparisons of CL sunflower hybrid H4 with unmodified sunflower counterparts, the Plant and Biotechnology Risk Assessment Unit of the Science Strategies Division, CFIA, has concluded that the novel AHAS gene and trait do not confer to sunflowers any characteristic that would result in unintended environmental effects following unconfined release.

Based on the review of submitted data and information by BASF Canada Inc., including comparisons of CL sunflower hybrid H4 with its unmodified sunflower counterparts, the Animal Feed Division of the Animal Health Directorate, CFIA has concluded that the novel AHAS gene and trait will not confer to sunflowers any characteristic that would raise any concerns regarding the safety or nutritional composition of sunflowers. Sunflower seed meal and hulls are currently listed in Schedule IV of the Feeds Regulations and are, therefore approved for use in livestock feeds in Canada. CL sunflower hybrid H4 has been found to be as safe as and as nutritious as traditional sunflower varieties. CL sunflower hybrid H4 and its products are considered to meet present ingredient definitions and are approved for use as livestock feed ingredients in Canada.

Unconfined release into the environment and use as livestock feed of line CLHA-PLUS including lines derived from it, as well as hybrids containing novel traits from CLHA-PLUS and line CL IMISUN (including CL sunflower hybrid H4), are therefore authorized by the Plant Biosafety Office of the Plant Health and Biosecurity Directorate and the Animal Feed Division of the Animal Health Directorate as of June 4, 2010. Any sunflower lines or hybrids derived from line CLHA-PLUS 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, and it is known based on characterization, that these plants do not display any additional novel traits and are substantially equivalent to currently grown sunflower varieties in Canada, in terms of their potential environmental impact and livestock feed safety.

Sunflower line CLHA-PLUS and CL sunflower hybrid H4 are subject to the same phytosanitary import requirements as their unmodified counterparts.

Please refer to Health Canada's Decisions on Novel Foods for a description of the food safety assessment of CL sunflower hybrid H4.

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