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DD2002-40: Determination of the Safety of BASF's Imazethapyr Tolerant (CLEARFIELD) Rice

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Issued: 2002-02

This Decision Document has been prepared to explain the regulatory decision reached under the guidelines Dir95-03 "Guidelines for the Assessment of Livestock Feed from Plants with Novel Traits" and Dir94-08 "Assessment Criteria for Determining Environmental Safety of Plants with Novel Traits".

The Canadian Food Inspection Agency (CFIA), specifically the Animal Feed Division of the CFIA, with advice from the Plant Biosafety Office of the CFIA has evaluated information submitted by BASF regarding the Imazethapyr tolerant CLEARFIELD™ rice lines CL121, CL141 and CFX51. CFIA has determined that feed derived from these plant with novel traits does not present a concern to environmental or livestock feed safety, when compared to currently commercialized rice varieties in Canada.

Livestock feed use of the CLEARFIELD™ rice lines CL121, CL141 and CFX51 is therefore authorized as of February 5, 2002. Lines CL121, CL141 and CFX51 and any rice lines derived from them may be imported and/or released, provided no inter-specific crosses are performed, provided the intended use is similar and provided it is known following thorough characterization that these plants do not display any additional novel traits and are substantially equivalent to currently commercialized rice, in terms of their potential environmental impact and livestock feed safety.

The CLEARFIELD™ rice lines are subject to the same phytosanitary import requirements as their unmodified counterparts.

Table of Contents

I. Brief Identification of Plant with Novel Traits (PNT)

II. Background Information

III. Description and Assessment of the Novel Trait

  1. Imazethapyr Tolerance
  2. Development Method
  3. Stable Expression

IV. Criteria for Safety Assessment

  1. Potential of lines CL121, CL141 and CFX51 to Become Weeds of Agriculture or Invasive of Natural Habitats
  2. Potential for Gene Flow to from lines CL121, CL141 and CFX51 to Wild Relatives
    Whose Offspring May Become More Weedy or More Invasive
  3. Altered Plant Pest Potential of lines CL212, CL141 and CFX51
  4. Potential Impact on Non-Target Organisms of lines CL121, CL141 and CFX51
  5. Potential Impact on Biodiversity of lines CL121, CL141 and CFX51

V. Nutritional Criteria Assessment as Livestock Feed

  1. Anti-Nutritional Factors
  2. Nutritional Composition

VI. New Information Requirements

VII. Regulatory Decision

I. Brief Identification of Plant with Novel Traits (PNT)

Designation(s) of the PNT: CLEARFIELD™ rice lines CL121, CL141 and CFX51

Applicant: BASF

Species: Rice (Oryza sativa)

Novel Traits: Tolerance to imazethapyr, an imidazolinone herbicide

Trait introduction method: Chemically induced seed mutagenesis

Intended use of the PNT: Production of rice for livestock feed, human food and industrial uses. These materials will be grown outside of Canada, in the usual production areas for rice.

II. Background Information

BASF has developed three rice lines tolerant to imazethapyr, an imidazolinone herbicides. These rice lines, referred to as CLEARFIELD™ rice (lines CL121, CL141 and CFX51 all of which were derived from crosses with the 93AS3510 mutant), were developed to provide an alternative strategy for weed control.

The development of the CLEARFIELD™ rice was accomplished using chemically induced seed mutagenesis. The herbicide tolerance results from a single point mutation modification of the acetohydroxyacid synthase (AHAS) gene such that this enzyme, the target of imidazolinone herbicides, is no longer affected by imazethapyr.

93AS3510 was field tested in the United States in 2000.

BASF has provided data on the identity of CLEARFIELD™ rice lines, 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. Relevant scientific publications were also supplied.

Agronomic characteristics of rice lines CL121, CL141 and CFX51 derived from 93AS3510 such as grain yield, days to 50% head, plant height and milling were compared to those of unmodified rice counterparts.

Nutritional components of rice lines CL121, CL141 and CFX51 derived from 93AS3510 such as proximates, amino acids and fatty acids were compared with unmodified rice counterparts. Anti-nutritional factors were also determined.

The Animal Feed Division of the Animal Health Directorate, CFIA, with input from the Plant Biosafety Office of the Plant Health and Biosecurity Directorate, CFIA, has reviewed the above information. The following assessment criteria as described in regulatory directives Dir95-03 and Dir94-08 were used to determine the suitability as livestock feed and the environmental safety of feed from these plant with novel traits:

III. Description and Assessment of the Novel Trait

1. Imazethapyr Tolerance

2. Development Method

3. Stable Expression

IV. Criteria for Safety Assessment

Note: Rice lines CL121, CL141 and CFX51 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 unfavorable climatic conditions for rice in Canada, it is unlikely that grain from rice lines CL121, CL141 and CFX51 would be capable of persisting in the Canadian environment.

1. Potential of lines CL121, CL141 and CFX51 to Become Weeds of Agriculture or Invasive of Natural Habitats

Rice lines CL121, CL141 and CFX51 are not intended for cultivation in Canada and the novel traits have no intended effects on weediness or invasiveness. The CFIA has therefore concluded that these rice lines have no altered weed or invasiveness potential in Canada when compared to conventional rice varieties.

2. Potential for Gene Flow from lines CL121, CL141 and CFX51 to Wild Relatives Whose Offspring May Become More Weedy or More Invasive

The CFIA has therefore determined that gene flow to sexually compatible species in Canada is not possible.

3. Altered Plant Pest Potential of lines CL121, CL141 and CFX51

The CFIA has therefore determined that rice lines CL121, CL141 and CFX51 do not present a plant pest concern.

4. Potential Impact on Non-Target Organisms of lines CL121, CL141 and CFX51

Based on the above, the CFIA has determined that rice lines CL121, CL141 and CFX51 will not result in altered impacts on non-target organisms, including humans, compared to current rice varieties.

5. Potential Impact on Biodiversity of lines CL121, CL141 and CFX51

The CFIA has therefore concluded that the potential impact on biodiversity of rice lines CL121, CL141 and CFX51 does not present any adverse impacts on biodiversity in Canada.

V. Nutritional Assessment Criteria as Livestock Feed

The nutritional assessment was based on nutrient and anti-nutrient composition of rice grain from the three lines derived from 93AS3510, compared with five representative commercial lines (Cocodrie, Cypress, Drew, Wells, Bengal) grown in three locations in the rice growing area of the United States.

1. Anti-Nutritional Factors

2. Nutritional Composition

VI. New Information Requirements

If at any time, BASF becomes aware of any information regarding risk to the environment, including risk to human or animal health that could result from release of these materials in Canada, or elsewhere BASF will immediately provide such information to CFIA. On the basis of such new information, CFIA will re-evaluate the potential impact of the proposed use, and will re-evaluate its decision with respect to the livestock feed use authorization of these rice lines.

VII. Regulatory Decision

Based on the review of data and information submitted by BASF, including comparisons of rice hybrids derived from 93AS3510 with unmodified rice counterparts, the Animal Feed Division of the Animal Health and Production Division, CFIA, has concluded that the modified gene and its corresponding novel trait will not confer to these plants any characteristic that would raise any concerns regarding the safety or nutritional composition of CLEARFIELD™ rice lines CL121, CL141 and CFX51. Rice grain, groats, hulls, bran and rice bran oil are currently listed in Schedule IV of the Feeds Regulations and are, therefore approved for use in livestock feeds in Canada. Rice lines CL121, CL141 and CFX51 derived from 93AS3510 have been assessed and found to be substantially equivalent to traditional rice varieties, with respect to safety and nutritional quality. CL121, CL141 and CFX51 and their products are considered to meet the present ingredient definitions and are approved for use as livestock feed ingredients in Canada. None of the rice lines will be grown in Canada nor can the seed overwinter, therefore the release of the feed into the environment would result in no intended or unintended environmental effects.

Livestock feed use of the CLEARFIELD™ rice lines CL121, CL141 and CFX51 derived from 93AS3510 is therefore authorized as of February 5, 2002. CL121, CL141 and CFX51 and any other rice lines derived from them may be imported and/or released, provided no inter-specific crosses are performed, provided the intended use is similar, and provided it is known, following thorough characterization that these plants do not display any additional novel traits and are substantially equivalent to currently grown rice, in terms of their livestock feed safety and environmental impact.

The CLEARFIELD™ rice lines 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 CLEARFIELD™ rice lines.

This bulletin is published by the Animal Health Directorate. For further information, please contact the Animal Feed Division at:

Animal Feed Division
Animal Health Directorate
59 Camelot Drive
Ottawa ON K1A 0Y9
Tel.: 613-225-2342

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