<p style="text-align: justify;"><b>Dietary Exposure</b></p>

<p style="text-align: justify;">The modification to the AHAS enzyme in RH44 will not result in any change in the consumption pattern of lentil. The availability of many lentil varieties for cultivation, the diversity of lentil varieties in phenotypic traits, and the normal variation in lentil composition due to differences in growing conditions, all result in a wide variation in the composition of conventional lentil. Thus, the cultivation of RH44 would not be expected to change the dietary exposure to humans, any more than do commercially available lentil cultivars.</p>

<p style="text-align: justify;"><b>Nutritional and Compositional Data</b></p>

<p style="text-align: justify;">Nutritional components of line RH44 were measured analytically and compared to those of unmodified commercial lentil cultivars. These components included proximates (crude protein, crude fat, crude fibre, ash, moisture), amino acids, fatty acids, vitamins (thiamine, niacin, pantothenic acid, B6), and minerals (magnesium, zinc, iron, phosphorus). The levels of these nutrients in RH44 lentil were within the range observed for currently registered commercial cultivars in Canada. The levels of the antinutritional factors phytic acid and trypsin inhibitor for RH44 were also within the range observed in these commercial cultivars.</p>

<p style="text-align: justify;">Certain components were not included in the compositional analysis of RH44 lentil. These were folacin, riboflavin, vitamin C, copper, potassium and manganese, and lectin. The developer of RH44 provided a rationale to the reviewing regulatory agencies stating that since the overall composition, physiology and phenological characteristics of RH44 were not significantly changed, there was no indication that the levels of these other nutritional components and antinutrients would be outside of the acceptable range for conventional lentil cultivars. The lentil line RH44 is also not intended as a stand-alone cultivar, but rather as genetic stock (and source of the imidazolinone-tolerance trait) for lentil cultivar improvement.</p>

<p style="text-align: justify;">The results of these compositional analyses, and the submitted rationale, led to the conclusion that the lentil line RH44, and any progeny containing its imidazolinone-tolerance trait, would not be nutritionally or compositionally different than conventional commercial lentil cultivars.</p>

<p style="text-align: justify;"><b>Toxicity and Allergenicity</b></p>

<p style="text-align: justify;">The potential for toxicity and allergenicity of RH44 was investigated by examining the amino acid sequence homology and the characteristics of the altered AHAS protein. The unmodified form of AHAS is heat sensitive and susceptible to trypsin degradation. The AHAS from RH44 demonstrated no enzyme activity after 1 min of heating at 100&ordm;C. The modified AHAS was also completely degraded after 30 minutes of treatment with trypsin, to simulate gastric digestibilitiy. The unmodified form of AHAS demonstrated no amino acid similarity to known toxins or allergens. The amino acid sequence of the mutated AHAS differs by only one amino acid compared to unmodified rice.</p>

<p style="text-align: justify;">The potential for increased allergenicity of the seed from RH44 was investigated, specifically with regard to endogenous lentil allergens that induce an IgE reaction in susceptible humans. The data submitted showed that protein banding patterns and IgE activity from sera obtained from lentil allergic persons were similar among RH44 lentil and the conventional lentil cultivars.</p>

<p style="text-align: justify;">The results of the amino acid sequence homology investigations, heat sensitivity and digestibility studies, and immunological assays led to the conclusion that the lentil line RH44 did not demonstrate any potential for toxicity and novel allergenicity, or any altered endogenous allergenicity, compared to conventional lentil culivars.</p>
