INSERT INTO `gmcropdatabase_events_esafeties` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(61, 88, '<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Wheat (<i>Triticum aestivum</i>) is primarily a self-pollinating plant. Gene transfer can occur by wind-mediated pollination to other <i>T. aestivum</i> plants; however, outcrossing rates are usually low (The potential for introgression of the novel trait into weedy relatives of wheat in Canada and the United States is also very low. Two species closely related to wheat are <i>Aegilops cylindria</i> Host (jointed goat grass) and <i>Agropyron repens</i> (L.) Beauv. (quackgrass). Both of these are introduced species, native to Eurasia, and are considered weedy and invasive in Canada and the United States. Jointed goatgrass is an annual, found in most of the United States, but not in Canada. It is considered a noxious weed in British Columbia due to the proximity of populations in Washington, Idaho and Montana, but is also found in other states contiguous to Canada, <i>i.e.</i>, North Dakota, Michigan, Ohio and New York. It would not be expected to become established in Canada except in southwestern British Columbia and southwestern Ontario (Darbyshire, 2003). Hybridization of jointed goatgrass with wheat can occur under field conditions and has been reported in wheat fields in Oregon. The hybridization was successful to the first backgross generation with jointed goat grass as the female plant. This has raised concerns of possible introgression of wheat into jointed goatgrass populations (Morrison et al., 2002). Quackgrass is a perennial species found extensively in Canada and the United States. Reports of hybridization between wheat and quackgrass have been reported; however, these have not been successfully reproduced by manual pollination (CFIA, 1999). Due to the doubtful nature of any hybridization between wheat and quackgrass, gene introgression into quackgrass populations is not expected to occur.</p>\n\n<p style="text-align: justify;"><b>Weediness potential</b></p>\n\n<p style="text-align: justify;">Cultivated wheat is not considered a weed of agriculture. Wheat plants can volunteer in fields following a wheat crop but these can be controlled by cultivation or herbicides. No competitive advantage was conferred to Teal 11A, other than resistance to two imidazolinone herbicides. Results from agronomic performance field trials and compositional data show that the physiology of Teal 11A was not affected by the mutation of the AHAS gene. Teal 11A is not expected to become weedy or invasive of natural habitats since neither vegetative growth or reproductive characteristics were altered. Wheat volunteers expressing the modified AHAS gene are therefore not expected to become weedier than conventional wheat volunteers. These volunteers could be managed with conventional weed control practices, including herbicides other than imidazolinones.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Effects</b></p>\n\n<p style="text-align: justify;">The characterization of the modified AHAS gene containing a single base pair change, and the resulting modified enzyme led to the conclusion that the expression of the modified does not result in altered toxic or allergenic properties. The modified AHAS enzyme was found to be substantially equivalent to AHAS in nonmodified plants. The AHAS enzyme is not a known toxin, does not confer resistance to agricultural pests, and is naturally present in plans and micro-organisms. It is similar to conventional wheat in terms of vegetative growth and seed production. Based on this information, Teal 11A would not result in altered impacts on non-target organisms, compared to conventional wheat varieties.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">Teal 11A does not possess novel phenotypic characteristics that would extend its cultivation beyond the current geographic range of spring wheat. Neither does it possess characteristics that would allow it to grow and compete under soil and climatic conditions for which it is not adapted. The herbicide-tolerant trait, in itself, will not confer to any potential hybrids any competitive advantage other than tolerance to imidazolinone herbicides. Teal 11A has also been found safe to non-target organisms and does not display altered plant pest potential since agronomic and biological characteristics were within the range of conventional wheat varieties.</p>\n', NULL, '2013-08-29 23:59:40'),
(62, 90, '<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Wheat (<i>Triticum aestivum</i>) is primarily a self-pollinating plant. Gene transfer can occur by wind-mediated pollination to other <i>T. aestivum</i> plants; however, outcrossing rates are usually low (The potential for introgression of the novel trait into weedy relatives of wheat in Canada and the United States is also very low. Two species closely related to wheat are <i>Aegilops cylindria</i> Host (jointed goat grass) and <i>Agropyron repens</i> (L.) Beauv. (quackgrass). Both of these are introduced species, native to Eurasia, and are considered weedy and invasive in Canada and the United States. Jointed goatgrass is an annual, found in most of the United States, but not in Canada. It is considered a noxious weed in British Columbia due to the proximity of populations in Washington, Idaho and Montana, but is also found in other states contiguous to Canada, <i>i.e.</i>, North Dakota, Michigan, Ohio and New York. It would not be expected to become established in Canada except in southwestern British Columbia and southwestern Ontario (Darbyshire, 2003). Hybridization of jointed goatgrass with wheat can occur under field conditions and has been reported in wheat fields in Oregon. The hybridization was successful to the first backgross generation with jointed goat grass as the female plant. This has raised concerns of possible introgression of wheat into jointed goatgrass populations (Morrison et al., 2002). Quackgrass is a perennial species found extensively in Canada and the United States. Reports of hybridization between wheat and quackgrass have been reported; however, these have not been successfully reproduced by manual pollination (CFIA, 1999). Due to the doubtful nature of any hybridization between wheat and quackgrass, gene introgression into quackgrass populations is not expected to occur.</p>\n\n<p style="text-align: justify;"><b>Weediness potential</b></p>\n\n<p style="text-align: justify;">Cultivated wheat is not considered a weed of agriculture. Wheat plants can volunteer in fields following a wheat crop but these can be controlled by cultivation or herbicides. No competitive advantage was conferred to AP205CL, other than resistance to two imidazolinone herbicides. Results from agronomic performance field trials and compositional data show that the physiology of AP205CL was not affected by the mutation of the AHAS gene. AP205CL is not expected to become weedy or invasive of natural habitats since neither vegetative growth or reproductive characteristics were altered. Wheat volunteers expressing the modified AHAS gene are therefore not expected to become weedier than conventional wheat volunteers. These will not be controlled by imidazolinone herbicides, thereby providing less flexibility in herbicide use.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Effects</b></p>\n\n<p style="text-align: justify;">The characterization of the modified AHAS gene containing a single base pair change, and the resulting modified enzyme led to the conclusion that the expression of the modified does not result in altered toxic or allergenic properties. The modified AHAS enzyme was found to be substantially equivalent to AHAS in nonmodified plants. The AHAS enzyme is not a known toxin, does not confer resistance to agricultural pests, and is naturally present in plans and micro-organisms. It is similar to conventional wheat in terms of vegetative growth and seed production. Based on this information, AP205CL would not result in altered impacts on non-target organisms, compared to conventional wheat varieties.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">AP205CL does not possess novel phenotypic characteristics that would extend its cultivation beyond the current geographic range of spring wheat. Neither does it possess characteristics that would allow it to grow and compete under soil and climatic conditions for which it is not adapted. The herbicide-tolerant trait, in itself, will not confer to any potential hybrids any competitive advantage other than tolerance to imidazolinone herbicides. AP205CL has also been found safe to non-target organisms and does not display altered plant pest potential since agronomic and biological characteristics were within the range of conventional wheat varieties.</p>\n', NULL, '2013-08-30 00:02:53'),
(63, 93, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">The cotton line 3006-210-23 was field tested in the United States from 1999 to 2002, and in Puerto Rico in 2000-01 at a total of 57 location-years. These trials were conducted to evaluate agronomic performance and crop quality, and to determine the plant pest risk potential of 3006-210-23. Comparisons were made between the modified line and one of its parental lines, PSC355. While small but significant differences were observed in some of the vegetative growth parameters, these were within the observed range of commercial cultivars. Also observed were small but significant differences in some reproductive parameters (<i>e.g.</i>, percent retention of bolls) and fibre quality. These slight differences would not be expected to confer weediness characteristics to line 3006-210-23. The susceptibility of line 3006-210-23 to cotton diseases, such as seed rot, <i>Fusarium</i> and <i>Verticilium</i> wilts, and boll rot, was evaluated and determined similar to that of the parental line PSC355. Results from these field trials demonstrate that the growth, agronomic performance and disease susceptibility of line 3006-210-23 is similar to that of conventional cotton. This cotton line is therefore not expected to become a plant pest risk, neither in terms of weediness, nor in becoming a more suitable host for plant diseases.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Cotton (<i>G. hirsutum</i>) is mainly a self-pollinating plant, but pollen is also routinely transferred by insects, particularly bumblebees and honey bees. The pollen is heavy and sticky and the range of natural crossing is limited. Outcrossing rates of up to 28% to other cotton cultivars grown directly adjacent to the pollen source have been observed under field conditions when sufficient insect pollinators have been present. The rate of outcrossing declines rapidly with increased distance from the pollen source. Results of outcrossing research trials in the United States have shown that pollen movement decreases rapidly at 12 metres from the pollen source. Nevertheless, certified seed cotton growers in the United States must maintain an isolation distance of 202 metres between fields. If the cotton line 3006-210-23 were to be grown in proximity with other cotton cultivars, and sufficient insect pollinators were present and active, the <i>cry</i>1Ac gene could possibly introgress into these cultivars. In the event of the formation of hybrids, there would no competitive advantage conferred on any hybrid progeny in the absence of infestations by Lepidopteran insect species.<br />\nIn the United States, species genetically compatible with 3006-210-23 cotton include <i>G. hirsutum</i> (wild or under cultivation), <i>G. barbadense</i> (cultivated Pima cotton), and <i>G. tomentosum</i>. Outcrossing from <i>G. hirsutum</i> to <i>G. barbadense</i> is possible under suitable conditions, such as the presence of pollinators. <i>G. thurberi</i> is another wild species found in the United States, but it is genetically incompatible with <i>G. hirsutum</i>. While <i>G. hirsutum</i> and <i>G. tomentosum</i> are genetically compatible (both possess the AADD genome), the possibility of gene transfer is unlikely due to the non-synchronous flowering periods (day for <i>G. hirsutum</i> and night for <i>G. tomentosum</i>), and lack of common pollinators. Populations of wild <i>Gossypium species</i> occur in southern Florida (<i>G. hirsutum</i>), Hawaii (<i>G. tomentosum</i>), Puerto Rico and the U.S. Virgin Islands. In other cotton growing areas of the world, species that could intercross with <i>G. hirsutum</i> include <i>G. mustelinum</i> in Brazil, and <i>G. lanceolatum</i> in Mexico.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Cultivated <i>Gossypium hirsutum</i> is not typically considered a weed species in the United States or other countries, but it is listed as a potential weed in southern Florida. Although the cotton plant is cultivated as an annual crop, it behaves as a perennial plant in undisturbed environments and suitable climatic conditions. Cotton does not tolerate cold conditions thereby limiting its overwintering potential to southern Florida, Hawaii, and Puerto Rico.</p>\n\n<p style="text-align: justify;">No competitive advantage was conferred to the cotton line 3006-210-23 other than the production of the insecticidal protein Cry1Ac. The levels of expression of the PAT protein in this cotton line do not confer tolerance to herbicidal applications of glufosinate ammonium. The purpose of introducing the <i>pat</i> gene was to provide a mechanism for selection of transformants. The cotton line 3006-210-23 was not expected to become weedy or invasive of natural habitats since none of the reproductive or growth characteristics of this line were substantially modified. While there were observed significant differences in some vegetative growth characteristics (number of vegetative branches and vegetative bolts) and reproductive parameters (percent retention of bolls), these were within the ranges observed in conventional cotton varieties. Seed dormancy, germination, and seedling establishment, were not significantly altered in 3006-210-23, compared to the parental line. The reproductive potential, in terms of number of seeds per boll, was also not significantly different in this cotton line.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The impact of 3006-210-23 cotton on non-target organisms was investigated. Ecological toxicity studies were conducted with representative terrestrial and aquatic species that could be inadvertently affected by Cry1Ac. Non-target organisms included insects other than lepidopterans (<i>e.g.</i>, honeybees, ladybird beetles, green lacewings, parasitic wasps), soil arthropods (collembola, earthworms), and representative terrestrial and aquatic species such as mice, bobwhite quail, rainbow trout and <i>Daphnia magna</i>. Toxicological effects were determined from feeding studies. The bobwhite quail and rainbow trout were fed Cry1Ac as expressed in cottonseed meal. The remaining studies were conducted with the full-length chimeric Cry1Ac from a microbial source (<i>Pseudomonas fluorescens</i>). Data were provided to substantiate the equivalency between the plant and microbial Cry1Ac, in terms of biochemistry and bioactivity. Results of these feeding studies showed no observable adverse effects of that could be attributed to the Cry1Ac protein.</p>\n\n<p style="text-align: justify;">Cry1Ac protein in cotton line 3006-210-23 was shown to be efficacious against the target lepidopteran pests. Insecticidal effects on non-target lepidopterans, such as the monarch butterfly, although not directly assessed in the field, were not expected given the low expression of the Cry1Ac protein in the pollen. Based on the results from dietary studies of monarch butterfly larvae with Cry1Ac protein, the estimated concentration of Cry1Ac necessary for a 50% reduction in larval growth is 10 times the concentration in pollen from line 3006-210-23. This, combined with the low volume of pollen produced, would result in very little risk to non-target lepidopterans, such as the monarch butterfly. While cotton is mostly self-pollinated, any cross-pollination would be achieved by non-lepidopteran insects, such as bees, which are unaffected by Cry proteins.</p>\n\n<p style="text-align: justify;">Based on this information, it was concluded that, compared to conventional cotton varieties, the cultivation of line 3006-210-23 would pose no greater risk to interacting organisms, with the exception of specific lepidopteran insect pests of cotton.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">The cotton line 3006-210-23 did not exhibit any novel phenotypic characteristics that would increase its survival in either unmanaged habitats, or in areas outside of the current geographical range of cotton production. Since the potential of gene transfer to wild relatives in the United States is quite minimal, the risk of transferring the insect resistance trait to species in unmanaged habitats is insignificant. In countries (<i>e.g.</i>, Brazil, Mexico) where hybrids could form with wild relatives of cotton, the introgression of the insect resistance trait into these wild species would confer no other advantage than increased resistance to attack by certain Lepidopteran insects.</p>\n\n<p style="text-align: justify;"><b>Other Considerations</b></p>\n\n<p style="text-align: justify;">In order to prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial spray formulations of these same toxins, regulatory authorities in the United States have required developers to implement specific Insect Resistant Management (IRM) Programs. These programs are mandatory for all transgenic <i>Bt</i>-expressing plants, including 3006-210-23 maize, and require that growers plant a certain percentage of their acreage to non-transgenic varieties in order to reduce the potential for selecting <i>Bt</i>-resistant insect populations. Details on the specific design and requirements of individual IRM programs are published by the relevant regulatory authority.</p>\n', NULL, '2013-08-30 00:07:52'),
(64, 92, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">The cotton line 281-24-236 was field tested in the United States from 2000 to 2002, and in Puerto Rico in 2000-01 for a total of 63 location-years. These trials were conducted to evaluate agronomic performance and crop quality, and to determine the plant pest risk potential of 281-24-236. Comparisons were made between the modified line and one of its parental lines, PSC355. While there were small but significant differences in vegetative growth parameters, these were within the observed range of commercial cultivars. Also observed were small but significant differences in some reproductive parameters (<i>e.g.</i>, percent retention of bolls) and fibre quality. These slight differences would not be expected to confer weediness characteristics to line 281-24-236. The susceptibility of line 281-24-236 to cotton diseases, such as seed rot, <i>Fusarium</i> and <i>Verticilium</i> wilts, and boll rot, was evaluated and determined similar to that of the parental line PSC355. Results from these field trials demonstrate that the growth, agronomic performance and disease susceptibility of line 281-24-236 is similar to that of conventional cotton. This cotton line is therefore not expected to become a plant pest risk, neither in terms of weediness, nor in becoming a more suitable host for plant diseases.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Cotton (<i>G. hirsutum</i>) is mainly a self-pollinating plant, but pollen is also routinely transferred by insects, particularly bumblebees and honey bees. The pollen is heavy and sticky and the range of natural crossing is limited. Outcrossing rates of up to 28% to other cotton cultivars grown directly adjacent to the pollen source have been observed under field conditions when sufficient insect pollinators have been present. The rate of outcrossing declines rapidly with increased distance from the pollen source. Results of outcrossing research trials in the United States have shown that pollen movement decreases rapidly at 12 metres from the pollen source. Nevertheless, certified seed cotton growers in the United States must maintain an isolation distance of 202 metres between fields. If the cotton line 281-24-236 were to be grown in proximity with other cotton cultivars, and sufficient insect pollinators were present and active, the cry1F gene could possibly introgress into these cultivars. In the event of the formation of hybrids, there would no competitive advantage conferred on any hybrid progeny in the absence of infestations by Lepidopteran insect species.<br />\nIn the United States, species genetically compatible with 281-24-236 cotton include <i>G. hirsutum</i> (wild or under cultivation), <i>G. barbadense</i> (cultivated Pima cotton), and <i>G. tomentosum</i>. Outcrossing from <i>G. hirsutum</i> to <i>G. barbadense</i> is possible under suitable conditions, such as the presence of pollinators. <i>G. thurberi</i> is another wild species found in the United States, but it is genetically incompatible with <i>G. hirsutum</i>. While <i>G. hirsutum</i> and <i>G. tomentosum</i> are genetically compatible (both possess the AADD genome), the possibility of gene transfer is unlikely due to the non-synchronous flowering periods (day for <i>G. hirsutum</i> and night for <i>G. tomentosum</i>), and lack of common pollinators. Populations of wild <i>Gossypium</i> species occur in southern Florida (<i>G. hirsutum</i>), Hawaii (<i>G. tomentosum</i>), Puerto Rico and the U.S. Virgin Islands. In other cotton growing areas of the world, species that could intercross with <i>G. hirsutum</i> include <i>G. mustelinum</i> in Brazil, and <i>G. lanceolatum</i> in Mexico.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Cultivated <i>Gossypium hirsutum</i> is not typically considered a weed species in the United States or other countries, but it is listed as a potential weed in southern Florida. Although the cotton plant is cultivated as an annual crop, it behaves as a perennial plant in undisturbed environments and suitable climatic conditions. Cotton does not tolerate cold conditions thereby limiting its overwintering potential to southern Florida, Hawaii, and Puerto Rico.</p>\n\n<p style="text-align: justify;">No competitive advantage was conferred to the cotton line 281-24-236 other than the production of the insecticidal protein Cry1F. The levels of expression of the PAT protein in this cotton line do not confer tolerance to herbicidal applications of glufosinate ammonium. The purpose of introducing the <i>pat</i> gene was to provide a mechanism for selection of transformants. The cotton line 281-24-236 was not expected to become weedy or invasive of natural habitats since none of the reproductive or growth characteristics of this line were substantially modified. While there were observed significant differences in some vegetative growth characteristics (number of vegetative branches and vegetative bolts) and reproductive parameters (percent retention of bolls), these were within the ranges observed in conventional cotton varieties. Seed dormancy, germination, and seedling establishment, were not significantly altered in 281-24-236, compared to the parental line. The reproductive potential, in terms of number of seeds per boll, was also not significantly different in this cotton line.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The impact of 281-24-236 cotton on non-target organisms was investigated. Ecological toxicity studies were conducted with representative terrestrial and aquatic species that could be inadvertently affected by Cry1F. Non-target organisms included insects other than lepidopterans (<i>e.g.</i>, honeybees, ladybird beetles, green lacewings, parasitic wasps), soil arthropods (collembola, earthworms), and representative terrestrial and aquatic species such as mice, bobwhite quail, rainbow trout and <i>Daphnia magna</i>. Toxicological effects were determined from feeding studies. The bobwhite quail and rainbow trout were fed Cry1F as expressed in cottonseed meal. The remaining studies were conducted with the full-length chimeric Cry1F from a microbial source (<i>Pseudomonas fluorescens</i>). Data were provided to substantiate the equivalency between the plant and microbial Cry1F, in terms of biochemistry and bioactivity. Results of these feeding studies showed no observable adverse effects of that could be attributed to the Cry1F protein.</p>\n\n<p style="text-align: justify;">Cry1F protein in cotton line 281-24-236 was shown to be efficacious against the target lepidopteran pests. Insecticidal effects on non-target lepidopterans, such as the monarch butterfly, although not directly assessed in the field, were not expected given the very low expression of the Cry protein in the pollen. Based on the results from dietary studies of monarch butterfly larvae with Cry1F protein, the estimated concentration of Cry1F necessary for a 50% reduction in larval growth is 450,000 times the concentration in pollen from line 281-24-236. This, combined with the low volume of pollen produced, would result in very little risk to non-target lepidopterans, such as the monarch butterfly. While cotton is mostly self-pollinated, any cross-pollination would be achieved by non-lepidopteran insects, such as bees, which are unaffected by Cry proteins.</p>\n\n<p style="text-align: justify;">Based on this information, it was concluded that, compared to conventional cotton varieties, the cultivation of line 281-24-236 would pose no greater risk to interacting organisms, with the exception of specific lepidopteran insect pests of cotton.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">The cotton line 281-24-236 did not exhibit any novel phenotypic characteristics that would increase its survival in either unmanaged habitats, or in areas outside of the current geographical range of cotton production. Since the potential of gene transfer to wild relatives in the United States is quite minimal, the risk of transferring the insect resistance trait to species in unmanaged habitats is insignificant. In countries (<i>e.g.</i>, Brazil, Mexico) where hybrids could form with wild relatives of cotton, the introgression of the insect resistance trait into these wild species would confer no other advantage than increased resistance to attack by certain Lepidopteran insects.</p>\n\n<p style="text-align: justify;"><b>Other Considerations</b></p>\n\n<p style="text-align: justify;">In order to prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial spray formulations of these same toxins, regulatory authorities in the United States have required developers to implement specific Insect Resistant Management (IRM) Programs. These programs are mandatory for all transgenic <i>Bt</i>-expressing plants, including 281-24-236 maize, and require that growers plant a certain percentage of their acreage to non-transgenic varieties in order to reduce the potential for selecting <i>Bt</i>-resistant insect populations. Details on the specific design and requirements of individual IRM programs are published by the relevant regulatory authority.</p>\n', NULL, '2013-08-30 00:06:06'),
(65, 94, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">H7-1 was field tested in the United States from 1998 to 2002, and in Europe (France and Germany) in 1998-99. In addition to evaluation in different environments, H7-1 was also evaluated in different genetic backgrounds that represented regionally adapted cultivars. Field trial evaluations included agronomic performance, disease and insect resistance, leaf morphology, seed germination and dormancy, bolting, flowering onset and seed harvest date. In most field trials, H7-1 was compared to a control that represented a nearly equivalent genotype. No significant differences were observed in any of these characteristics between H7-1 and the non-transgenic controls.</p>\n\n<p style="text-align: justify;">In only 6 out of 98 trials conducted in the United States were significant differences in disease and insect susceptibilities observed between H7-1 and the control and conventional cultivars. No differences were observed in the European trials. Some of these differences represented increased susceptibility, while others represented a decrease compared to the controls. Since there were no trends associated with these differences for H7-1, these were likely due to interactions between environment and genotype, rather than with the novel protein in H7-1.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Sugar beet is an outcrossing species, and is mainly wind pollinated. It is a biennial, developing a rosette of leaves and a large taproot in the first year, and bolting (<i>i.e.</i>, developing an inflorescence bearing stem) in the second year. Bolting is induced only after the plant has undergone vernalization at the end of the first season. In exceptional circumstances, bolting may be induced in the first year by low temperatures and longer daylength (<i>e.g.</i>, by growing a cultivar outside of its adapted area). Large amounts of pollen are produced during the reproductive phase; this pollen can be wind-borne over long distances.</p>\n\n<p style="text-align: justify;">The genus <i>Beta</i> is comprised of four sections: i) Beta, to which sugar beet belongs; ii) Corollinae; iii) Nanae; and iv) Procumbentes. All species within the Beta section (<i>B. vulgaris</i> ssp. <i>maritima</i>, <i>B. macrocarpa</i>) are sexually cross-compatible and produce fertile progeny. Hybrids between sugar beet and members of the other sections do not occur naturally, and cross-breeding with other members of the Chenopodiaceae is unlikely. Assuming proximity, synchronicity of flowering, and suitable conditions sugar beet may freely hybridize with the botanical varieties within the <i>vulgaris</i> subspecies.</p>\n\n<p style="text-align: justify;">Wild relatives that are sexually compatible with sugar beet exist in parts of Europe, Asia, and Central and South America. Hybrids resulting from crosses between cultivated sugar beets and <i>B. macrocarpa</i>, and those with <i>B. vulgaris</i> ssp. <i>maritima</i> have been reported in Europe. The potential therefore exists for introgression of the glyphosate tolerance trait from H7-1 into these wild relatives. In North America, concerns have been raised about potential outcrossing with populations of <i>B. macrocarpa</i> in the Imperial Valley of California. Studies have indicated the introgression of genes from commercial sugar beets, although other reports show that gene flow between these two populations is not likely due to non-synchronous flowering and the production of sterile F1 hybrids. Sugar beet plants have escaped from past commercial cultivation in the San Francisco Bay area and persist to this day. However, introgression of the glyphosate tolerance trait into these plants is highly unlikely as sugar beets are no longer in commercial production in that area.</p>\n\n<p style="text-align: justify;">As with conventional sugar beet cultivars, H7-1 plants are harvested prior to the initiation of the bolting phase. Since sugar beets are usually not allowed to bolt, except in fields or plots grown for seed production, there is little opportunity for uncontrolled pollen flow. Sugar beets grown for seed production are also spatially isolated from other sugar beet fields to minimize pollen flow. Since the cultivation practices for H7-1 sugar beet are identical to those for conventional sugar beet varieties, the potential for outcrossing would only exist when H7-1 is grown for seed production.</p>\n\n<p style="text-align: justify;">Glyphosate-tolerant hybrids resulting from the introgression of the transgene from H7-1 to commercial sugar beet cultivars, or compatible wild relatives, would possess no other competitive advantage than herbicide tolerance. This advantage would only be expressed in managed ecosystems, such as cultivated fields. Glyphosate-tolerant hybrids could be managed with conventional weed control practices, including herbicides other than glyphosate.<br />\n<br />\n<b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Sugar beet plants are not a serious weed, although sugar beets have escaped cultivation and their progeny have persisted in the environment for many years. Sugar beets may also volunteer in fields the year following cultivation. Volunteers may also arise from the presence of wild beet, the bolting of beet plants, the development of groundkeepers which arise initially form vegetative growth of beet crowns or tops left after harvest or the germination of seed (which may be dormant in soil for up to 10 years). Volunteer plants may be controlled by mechanical means or by the use of herbicides registered for use on sugar beet volunteers.</p>\n\n<p style="text-align: justify;">Field trials were conducted to address concerns that H7-1 sugar beet might become weedier, compared to conventional sugar beet cultivars. H7-1 and its control lines were evaluated for plant growth and reproductive characteristics related to persistence and competitiveness. Results from these trials revealed no significant differences between H7-1 and the control lines, for characteristics such as plant vigour, bolting, seedling emergence, seed germination, and seed dormancy. Based on these results, H7-1 is not expected to become weedier, nor is it expected to become invasive of natural habitats, compared to conventional sugar beet cultivars.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The herbicide-tolerance trait in H7-1 sugar beet is conferred by the novel protein CP4 EPSPS, an enzyme originally isolated from the soil bacterium <i>Agrobacterium</i> sp. strain CP4. The novel form of this enzyme is similar to that naturally found in plants, bacteria and fungi. The lack of toxicity of CP4 EPSPS has been substantiated in previous regulatory approvals of glyphosate-tolerant plants, and its high substrate specificity makes it unlikely to metabolize any other endogenous substances to produce toxic compounds. The cultivation of H7-1 sugar beet would therefore not be expected to result in deleterious effects on non-target and beneficial organisms that would be attributed to the novel protein. This was also supported by field trial observations that revealed no negative effects from the cultivation of H7-1 on honeybees and earthworms, compared to conventional sugar beet cultivars.</p>\n\n<p style="text-align: justify;">Results from field trials to evaluate disease and insect susceptibilities demonstrated generally that H7-1 was not more susceptible than conventional sugar beet cultivars. H7-1 would therefore not be expected to become a host for plant pathogens, or insect pest, any more than conventional sugar beet cultivars.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">H7-1 sugar beet did not exhibit any novel characteristics that would increase its weediness, or cause it to become an invasive species, compared to conventional sugar beet. The expression of the novel protein (CP4 EPSPS) in H7-1 has not been observed to negatively impact non-target or beneficial organisms. While the potential for gene transfer from H7-1 to cultivated sugar beet is possible, the transfer of the herbicide tolerance trait to wild relatives in the United States is insignificant. However, this is not the case in other areas, such as Europe, where wild relatives of sugar beet exist. The introgression of the glyphosate tolerance trait into wild relatives such as <i>B. vulgaris</i> ssp. <i>maritima</i> (sea beet) is therefore possible.</p>\n', NULL, '2013-08-30 00:09:35'),
(66, 78, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">TC-6275 was field tested at several locations, from 1999 to 2003, in the United States and Puerto Rico. These field tests were conducted to evaluate the agronomic performance of TC-6275 (in 2002 only), the efficacy of the insecticidal protein against the targeted lepidopteran pests, and susceptibility to plant diseases (<i>e.g. </i>, Northern Corn Leaf Blight, smut) and non-lepidopteran insect pests (<i>e.g. </i>, thrips, aphids, spider mites).</p>\n\n<p style="text-align: justify;">Agronomic parameters that were evaluated included seed germination, emergence vigour and stand density, plant height, accumulated growing degree days to 50% pollen shed and silking, percent stalk and root lodging, percent moisture at harvest, grain yield and bushel weight (grain density). Grain yield in TC-6275 was significantly higher, compared to the near-isogenic control hybrid, at locations where the infestations of ECB were higher. However, there were generally no statistically significant differences between TC-6275 and the control hybrid for most of the agronomic parameters. While there were some statistically significant differences observed for characteristics, such as emergence vigour, stand counts, and maturity, these were not consistent and could be attributed to the effect of location rather than genotype. Seed germination in TC-6275 was not significantly different than the control hybrid and was comparable to other maize hybrids.</p>\n\n<p style="text-align: justify;">Results of field monitoring for susceptibility to plant diseases and non-lepidopteran insect pests revealed no differences between TC-6275 and the control hybrid. Specifically, there were no observed differences in the severity of disease symptoms and, in non-lepidopteran insect damage.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Since pollen production and viability were unchanged by the genetic modification resulting in TC-6275, pollen dispersal by wind and outcropping frequency should be no different than for other maize varieties. Gene exchange between TC-6275 maize and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In the United States, where there are no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote. Feral species related to corn, as found within the United States, cannot be pollinated due to differences in chromosome number, phenology (periodicity or timing of events within an organism&rsquo;s life cycle as related to temperature and photoperiod, <i>e.g. </i>, flowering time) and habitat.<br />\nMaize (<i>Zea mays</i> ssp. <i>mays</i>) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>mexicana</i>) when in close proximity. These wild maize relatives are native to Central America and are not present in the United States, except for special plantings. <i>Tripsacum</i>, another genus related to <i>Zea</i>, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of <i>Tripsacum</i> have been reported in the continental United States: <i>T. dactyloides</i>, <i>T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (<i>i.e</i>., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some <i>Tripsacum</i> species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of <i>Tripsacum</i> species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b><br />\nNo competitive advantage was conferred to TC-6275 that would render maize weedy or invasive of natural habitats, since none of the reproductive or growth characteristics were modified. Cultivated maize is unlikely to establish in non-cropped habitats and there have been no reports of maize surviving as a weed. <i>Zea mays</i> is not invasive and is a weak competitor with very limited seed dispersal.</p>\n\n<p style="text-align: justify;">Volunteers can occur in fields, the year following cultivation, when maize is grown in rotation with other crops. Although maize volunteers are a minor weed problem, these can cause harvesting problems. TC-6275 maize volunteers will be tolerant to glufosinate ammonium, thereby compromising the use of this herbicide in glufosinate-tolerant crops (<i>e.g.</i>, glufosinate-tolerant soybeans). However, volunteer plants may be controlled by mechanical means or by the use of other herbicides registered for use on maize volunteers.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The history of use and literature suggest that bacterial <i>Bt</i> proteins are not toxic to humans, other vertebrates, and beneficial insects. The insecticidal active core of the <i>Bt</i> protein (Cry1F) expressed in TC-6275 was shown to be nearly equivalent to the bacterial protein, except for one amino acid substitution.</p>\n\n<p style="text-align: justify;">The impact of TC-6275 maize on non-lepidopteran pests, and on non-target organisms was investigated. In field trials conducted to evaluate the efficacy of TC-6275 against the targeted lepidopteran pests of maize, plots were also monitored for damage caused by non-lepidopteran pests, such as thrips, aphids and red spider mites. There were no observed differences between TC-6275 and the non-transgenic control line in the extent of damage caused by non-lepidopteran pests.</p>\n\n<p style="text-align: justify;">The Cry1F protein expressed in TC-6275 is similar to that expressed by the maize line <a href="dbase.php?action=ShowProd&amp;data=TC1507&amp;frmat=LONG"><b>TC1507</b></a>, which received regulatory approval for environmental release in the U.S. (2001), Canada (2002), and Japan (2002). This was substantiated by data, provided by Dow Agro Sciences, to demonstrate the equivalency in terms of biochemical properties and biological activity, of Cry1F in TC-6275 to that in TC1507. The following data and information on the effects of Cry1F on non-target organisms are those that were provided in support of the environmental safety of TC1507.</p>\n\n<p style="text-align: justify;">Maize inbreds and hybrids expressing the Cry1F protein were compared to their non-transformed counterpart for relative abundance of beneficial arthropods, including: lady beetles (<i>Cycloneda munda</i> and <i>Coleomegilla maculata</i>), predacious Carabids, brown lacewings (<i>Hemerobiidae</i>), green lacewings (<i>Chrysoperla plorabunda</i>), minute pirate bugs (<i>Orius insidiosus</i>), assassins bugs (<i>Reduviidae</i>), damsel bugs (Nabidae), Ichneumonid and Braconids (parasitic wasps), damselflies, dragonflies, and spiders. Visual counts showed no significant differences between the number of arthropods collected in the <i>Bt</i> maize plots and those cultivated to the non-transgenic isolines with two exceptions. There was a significantly greater number of lady beetles in the <i>Bt</i> maize plots (1.2 per test plant <i>vs</i> 0.6 per control plant), as well as significantly more <i>Orius</i> than in the non-transgenic control plots on two of the three sample dates. These field studies demonstrated that Cry1F had neither a direct, nor an indirect effect on beneficial arthropod populations.</p>\n\n<p style="text-align: justify;">Species representative of non-target and beneficial organisms in an agricultural environment were selected for acute dietary toxicity studies. The species were: honey bee larvae (<i>Apis melifera</i>), predatory ladybird beetle (<i>Hippodamia convergens</i>), green lacewing (<i>Chysoperla carnea</i>), parasitic Hymenoptera (<i>Nasonia vitripennis</i>), as well as the soil arthropod Collembola (<i>Folsomia candida</i>). Acute toxicity studies were also conducted with earthworms, the freshwater invertebrate <i>Daphnia magna</i>, Northern bobwhite quail, and mice. In all cases there were no observable adverse effects attributed to the Cry1F insecticidal protein.</p>\n\n<p style="text-align: justify;">An additional study was conducted on the effect of Cry1F on neonate monarch butterfly larvae when fed a 10000 ng/mL diet dose. First instar larval weight and mortality were recorded after seven days of feeding. Although there was some growth inhibition, there was no mortality to monarchs fed the 10000 ng/mL diet, the highest rate tested. Since pollen doses equivalent to 10000 ng/mL are not likely to occur on milkweed leaves in nature, it can be concluded that Cry1F will not pose a risk to monarchs.</p>\n\n<p style="text-align: justify;">The levels of Cry1F in TC-6275 pollen and grain were substantially lower than in TC1507 (83% less in pollen and 50% less in grain). Non-target organisms consuming TC-6275 pollen and grain would be exposed to considerably less Cry1F than from TC1507. However, soil exposure to Cry1F from TC-6275 was determined to be approximately 1.5-fold greater that from TC1507. The exposure to Cry1F in soil would nevertheless be minimal since the LC50 for Cry1F for Collembola and earthworms was at least 40-fold the estimated soil concentration from ploughed-under TC-6275 senescent plants.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">TC-6275 has no novel phenotypic characteristics that would extend its use beyond the current geographic range of maize production. Since the risk of outcrossing with wild relatives in the United States is remote, it was determined that risk of transferring genetic traits from TC-6275 maize to species in unmanaged environments was insignificant.</p>\n\n<p style="text-align: justify;"><b>Other Considerations</b></p>\n\n<p style="text-align: justify;">In order to prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial spray formulations of these same toxins, regulatory authorities in the United States have required developers to implement specific Insect Resistant Management (IRM) Programs. These programs are mandatory for all transgenic <i>Bt</i>-expressing plants, including TC-6275 maize, and require that growers plant a certain percentage of their acreage to non-transgenic varieties in order to reduce the potential for selecting <i>Bt</i>-resistant insect populations. Details on the specific design and requirements of individual IRM programs are published by the relevant regulatory authority.</p>\n', NULL, '2013-08-29 23:49:01');
INSERT INTO `gmcropdatabase_events_esafeties` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(67, 89, '<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Lentil (<i>L. culinaris</i>) is predominantly self-pollinating, with less than one percent cross-pollination (CFIA, 2003). As such, an isolation distance of only 3 metres is required for pedigreed seed production in Canada (Canadian Seed Growers Association, 2000). The potential for introgression of the herbicide tolerance trait into unmodified lentil plants is therefore negligible. Lentil can successfully hybridize with its wild progenitor <i>Lens orientalis</i>. This wild relative of lentil grows in the Near East, and from the western Mediterranean area to Ethiopia. Introgression of the herbicide tolerance trait from RH44 plants into <i>L. orientalis</i> is therefore possible in these regions. Neither <i>Lens orientalis</i>, nor any other wild relative of lentil grow in Canada.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Lentil does not exhibit characteristics that would render it either weedy or invasive of unmanaged habitats. While some lentil pods shatter at harvest, these seeds do not normally volunteer in any subsequent crop. In Canada, lentil seeds that germinate in the fall do not survive the winter. Those seeds that do germinate the following spring compete poorly with other crops and weeds. Unlike legumes species such as alfalfa or red clover, lentil seed does not exhibit dormancy characteristics such as hard seed. Since lentil seedlings grow slowly are not competitive, lentil could not establish itself successfully in unmanaged habitats. Lentil does not establish successfully in unmanaged habitats; the seedlings grow slowly and thus compete poorly with other plants.</p>\n\n<p style="text-align: justify;">Field trials were conducted to evaluate the agronomic performance of RH44 compared to conventional varieties. There were no significant differences in either seed yield, germination or days to maturity between RH44 and its unmodified comparators. These results indicated that since none of the growth and reproductive characteristics were unintentionally altered, RH44 would not be expected to become weedy or invasive.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Effects</b></p>\n\n<p style="text-align: justify;">The characterization of the modified AHAS gene containing a single base pair change, and the resulting modified enzyme led to the conclusion that the expression of the modified AHAS does not result in altered toxic or allergenic properties. The AHAS enzyme is not a known toxin, does not confer resistance to agricultural pests and is present in plants and micro-organisms with a history of safe use. Based on this information, it was determined that the RH44 lentil line will not result in altered impacts on non-target organisms, compared to conventional lentil cultivars.</p>\n\n<p style="text-align: justify;">The agronomic performance and disease and insect susceptibilities of RH44 were found to be in the range observed by conventional commercial lentil cultivars. RH44 lentil therefore does not display altered morphological or physiological characteristics that would alter its interaction with non-target organisms. Also, since RH44 did not exhibit any altered susceptibilities to either insect pests or plant diseases, it is not expected to display an altered plant pest potential.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">RH44 does not exhibit novel phenotypic characteristics that would extend its use beyond the current geographic range of lentil production. The insect and disease susceptibilities of RH44 were similar to those of conventional lentil cultivars. Furthermore, there does not exist the potential for outcrossing to wild lentil relatives in Canada. The impact of the cultivation of line RH44 in Canada would therefore be equivalent to that of conventional lentil cultivars.</p>\n\n<p style="text-align: justify;">The potential for outcrossing exists in areas of the world where wild relatives of lentil are indigenous. The cultivation of RH44 lentil in these areas, such as the Near East, the western Mediterrenean area, and Ethiopia, could result in the introgression of the imidazolinone-tolerance trait into these related species. The impact on biodiversity of these herbicide tolerant hybrids would be minimal outside of selection pressure from imidazolinone herbicides.</p>\n', NULL, '2013-08-30 00:01:09'),
(68, 86, '<p style="text-align: justify;">Only the meal and oil of X81359 hybrid sunflower will be imported into Canada since this hybrid is intended solely for use as human food and livestock feed. X81350 sunflower is not intended for cultivation in Canada. No environmental effects are therefore expected from the importation of X81359 sunflower into Canada.</p>\n', NULL, '2013-08-29 23:57:01'),
(69, 97, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">MON 88913 cotton was field tested at several locations in the United States and Puerto Rico from 2000 to 2003. Several of these trials were conducted to evaluate glyphosate tolerance under a range of environmental conditions. In 2002, fourteen trials were conducted to evaluate possible unintended effects from the transformation process and subsequent tissue culture. MON 88913 was evaluated for phenotypic characteristics relating to vegetative and reproductive growth and development, seed dormancy, germination and emergence, plant maturity, boll and seed yield, fibre quality, and plant interaction with diseases and insects. Comparisons were made between the MON 88913, a null segregant (non-trangenic counterpart) of this line [MON 88913 (-)] that did not contain the <i>cp4 epsps</i> genes, and conventional cotton varieties.</p>\n\n<p style="text-align: justify;">There were no significant differences among MON 88913 and its null counterpart for most of the measured growth and reproductive parameters, seed dormancy, germination and emergence, boll and seed yield, and fibre quality. The observed significant differences in these parameters were small, and were attributed to location rather than phenotype. Susceptibility to diseases and insects was qualitatively assessed during the field trials. Assessments were made for insects commonly found in cotton fields such as aphids, beet armyworm, cotton bollworm and thrips, and diseases such as boll rot, <i>Pythium</i> and <i>Verticillium</i>. Generally, there were no observed differences in susceptibilities to diseases and insects across locations and years. Results from these field trials demonstrate that the growth, agronomic performance, and disease and insect susceptibility of MON 88913 are similar to that of conventional cotton. MON 88913 is therefore not expected to become a plant pest risk, neither in terms of weediness, nor in becoming a more suitable host for plant diseases and insects.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Cotton (<i>G. hirsutum</i>) is mainly a self-pollinating plant, but pollen is also routinely transferred by insects, particularly bumblebees and honey bees. The pollen is heavy and sticky and the range of natural crossing is limited. Outcrossing rates of up to 28% to other cotton cultivars grown directly adjacent to the pollen source have been observed under field conditions when sufficient insect pollinators have been present. The rate of outcrossing declines rapidly with increased distance from the pollen source. Results of outcrossing research trials in the United States have shown that pollen movement decreases rapidly at 12 metres from the pollen source. Nevertheless, certified seed cotton growers in the United States must maintain an isolation distance of 202 metres between fields. If MON 88913 was to be grown in proximity with other cotton cultivars, and sufficient insect pollinators were present and active, the <i>cp4 epsps</i> genes could possibly introgress into these cultivars. In the event of the formation of hybrids, there would no competitive advantage conferred on any hybrid progeny in the absence of glyphosate applications.</p>\n\n<p style="text-align: justify;">In the United States, species genetically compatible cultivated cotton are <i>G. barbadense</i> (cultivated Pima cotton), and <i>G. tomentosum</i>. Outcrossing from <i>G. hirsutum</i> to <i>G. barbadense</i> is possible under suitable conditions, such as the presence of pollinators. <i>G. thurberi</i> is another wild species found in the United States, but it is genetically incompatible with <i>G. hirsutum</i>. <i>G. hirsutum</i> and <i>G. tomentosum</i> are genetically compatible (both possess the AADD genome); however, it is generally thought that gene transfer is unlikely due to the non-synchronous flowering periods (day for <i>G. hirsutum</i> and night for <i>G. tomentosum</i>), and lack of common pollinators. Preliminary results of research on <i>G. tomentosum</i> populations in Hawaii have shown that flowering occurs during the day and that bees and other hymenopterans were observed as pollinators. However, no evidence has yet been found in nature of crosses between cultivated cotton and <i>G. tomentosum</i>. Populations of wild <i>Gossypium</i> species occur in southern Florida (<i>G. hirsutum</i>), Hawaii (<i>G. tomentosum</i>), Puerto Rico and the U.S. Virgin Islands. In other cotton growing areas of the world, species that could intercross with <i>G. hirsutum</i> include <i>G. mustelinum</i> in Brazil, and <i>G. lanceolatum</i> in Mexico.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Cultivated <i>Gossypium hirsutum</i> is not typically considered a weed species in the United States or other countries, but it is listed as a potential weed in southern Florida. Although the cotton plant is cultivated as an annual crop, it behaves as a perennial plant in undisturbed environments and suitable climatic conditions. Cotton does not tolerate cold conditions thereby limiting its overwintering potential to southern Florida, Hawaii, and Puerto Rico.</p>\n\n<p style="text-align: justify;">Seed dormancy and germination are characteristics used to assess the weediness of plants. These characteristics were measured in MON 88913, its null counterpart and six conventional cotton cultivars. Generally, no significant differences were observed in the amount of hard seed, a seed dormancy characteristic, between MON 88913 and its null counterpart. There were some significant differences observed in seed germination, where MON 88913 displayed reduced germination compared to its counterpart. These differences were small, as were differences in the percentage of viable swollen seed, and were within the range displayed by conventional cultivars. Compared to its null counterpart and conventional cotton, MON 88913 is not expected to become weedy or invasive of natural habitats since the characteristics associated with weediness, such as seed dormancy, germination, as well as flowering, flower morphology, maturity and seed yield were not significantly altered compared to conventional cotton. No other competitive advantage was conferred to MON 88913, other than tolerance to glyphosate.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The impact of the novel CP4 EPSPS protein in MON 88913 on non-target organisms was not directly assessed. The results of studies on CP4 EPSPS in previously approved glyphosate tolerant crops were used to evaluate the impact of this novel protein in MON 88913. These studies evaluated the effect of CP4 EPSPS on pollinators, soil organisms, and beneficial arthropods. No toxic effects were reported in these studies. Furthermore, results from field trials with MON 88913 demonstrated similar susceptibilities to cotton diseases and insect pests, compared to conventional cotton. Levels of natural toxicants (gossypol, cyclopropenoid fatty acids and aflatoxins) were quantitatively determined and compared to the null counterparts and commercial varieties. Other than significant differences in the levels of two cyclopropenoid fatty acids at one location, the levels of these toxicants among MON 88913, the null counterpart, and conventional cotton were not significantly different.</p>\n\n<p style="text-align: justify;">Expression levels of CP4 EPSPS in MON 88913 were substantially higher than in previously approved glyphosate tolerant crops. Nevertheless, the results of previous environmental safety studies with CP4 EPSPS and field trials of MON 88913 do not indicate any increased risk to interacting organisms due to higher levels of this protein. Since the levels of natural toxicants were also not altered in MON 88913, the risk to interacting organisms is similar to conventional cotton.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">MON 88913 cotton did not exhibit any novel phenotypic characteristics that would increase its survival in either unmanaged habitats, or in areas outside of the current geographical range of cotton production. Since the potential of gene transfer to wild relatives in the United States is quite minimal, the risk of transferring the glyphosate tolerance trait to species in unmanaged habitats is insignificant. In countries (<i>e.g.</i>, Brazil, Mexico) where hybrids could form with wild relatives of cotton, the introgression of the glyphosate tolerance trait into these wild species would confer no advantage in the absence of glyphosate applications.</p>\n', NULL, '2013-08-30 00:17:39'),
(70, 109, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">Events J101 and J163 were field tested at several locations in the United States from1998 to 2004. These field trials were conducted to evaluate agronomic performance, disease and insect resistance, phenotypic equivalency, and for the multiplication of seed. Events J101 and J163 were compared to their non-transgenic counterpart which consisted of a population of null segregants obtained during the backcrossing of the transformed events into sets of nonmodified elite clones. No differences in disease and insect susceptibilities were observed between events J101 and J163 and the control population of null segregants. Phenotypic evaluations for events J101 and J163, including seed germination, seedling emergence, seedling vigour, vegetative vigour, dry matter yield, regrowth after cutting, and stand persistence were within the range of values observed for the control populations at each of the sites. Events J101 and J163 were generally equivalent to the control populations, indicating that the phenotype was not unintentionally altered by the genetic modification.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">The potential for introgression of the glyphosate-tolerance trait from events J101 and J163 into other alfalfa plants, or to wild or feral relatives of alfalfa, was investigated. Alfalfa is an outcrossing species and pollination is achieved by hymenopteran species, such as the leaf cutter bee (<i>Megachile rotundata</i>), honeybee (<i>Apis mellifera</i>), and bumble bee (<i>Bombus</i> spp.). Alfalfa outcrosses and hybridizes with members of the <i>M. sativa</i> complex (<i>M. sativa</i> subsp. <i>sativa</i> (cultivated alfalfa), subsp. <i>falcata</i>, subsp. <i>glutinosa</i>, subsp. <i>coerulea</i>, subsp. x <i>tunetana</i>, subsp. x <i>varia</i>, subsp. x <i>polychroa</i>, and subsp. x <i>hemicycla</i>). There have been reports of natural, but limited hybridization with <i>M. glomerata</i>; this species is indigenous to southern Europe and North Africa, and is not present in North America. <i>M. lupulina</i> (black medick) is an annual weed species indigenous to Europe and common in North America. Black medick does not hybridize with <i>M. sativa</i>.</p>\n\n<p style="text-align: justify;">Alfalfa is primarily cultivated for its herbage. Ideally, alfalfa herbage is harvested (<i>i.e.</i>, cut) at the first onset of flowering to optimize the nutritional quality and dry matter yield. Gene outflow is therefore negligible under this type of management. However, gene outflow is significant when alfalfa is grown for the production of seed, or when plants are inadvertently allowed to flower and mature (<i>e.g.</i>, in old pastures, or unharvested hay fields). Alfalfa grown for seed production is physically isolated from other alfalfa fields to ensure varietal purity, thus limiting gene flow. Isolation distances ranging from 200 to 300 m are required by seed certification agencies in the United States and Canada for the production of pedigreed seed.</p>\n\n<p style="text-align: justify;">The cultivation of glyphosate-tolerant alfalfa for seed production may therefore result in the development of glyphosate-tolerant hybrids with members of the <i>M. sativa</i> complex, and to a limited extent with <i>M. glomerata</i> in areas where this species is found. These hybrids will develop in areas where members of the<i>M. sativa</i> complex are indigenous (Europe, Asia, the Middle East and North Africa), as well as in North America where these species have become established and feral. Introgression of the trait into <i>M. glomerata</i> would occur only in areas where this species is indigenous. The glyphosate tolerance trait is not expected to provide a competitive advantage to hybrid plants unless these are growing in managed environments routinely subjected to glyphosate applications. Glyphosate-tolerant hybrids could be managed with conventional weed control practices, including herbicides other than glyphosate.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Alfalfa does not possess characteristics typical of serious weeds, such as vigorous vegetative growth and abundant seed production. It is, however, considered an agricultural weed in Canada (Darbyshire, 2003), and an invasive species by the Southern Weed Science Society (Southern Weed Science Society, 1998). Free-living populations are widespread, and found in environments such as old hay fields, pastures, roadsides, and ditches. Alfalfa can also volunteer in a succeeding crop, and seed can lay dormant in the soil for many years. Seed dormancy in conventional alfalfa is characterized by the amount of hard seed, <i>i.e.</i>, seeds with a relatively hard and impermeable seed coat. Alfalfa seed normally contains variable amounts of hard seed, which requires scarification before germination will occur.</p>\n\n<p style="text-align: justify;">Field trials of events J101 and J163 demonstrated that vegetative and reproductive growth, seed dormancy, germination and emergence and plant maturity were within the range observed for conventional alfalfa cultivars. The development of hard seed in events J101 and J163, and in the control population of null segregants was also investigated. The amount of hard seed in events J101 and J163 was significantly higher than in the conventional cultivars in one of the two years of the trials; however, these differences were attributed to the effect of environment rather than genotype. The results of these investigations led to the conclusion the alfalfa events J101 and J163 did not possess weediness characteristics, such as increased development of hard seed, compared to conventional alfalfa cultivars.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The glyphosate-tolerant trait in events J101 and J163 is conferred by the novel protein CP4 EPSPS, an enzyme originally isolated from the soil bacterium <i>Agrobacterium</i> sp. strain CP4. The novel form of this enzyme is similar to that naturally found in plants, bacteria and fungi. The lack of toxicity of CP4 EPSPS has been substantiated in previous regulatory approvals of glyphosate-tolerant plants, and its high substrate specificity makes it unlikely to metabolize any other endogenous substances to produce toxic compounds. The cultivation of glyphosate-tolerant alfalfa cultivars derived from events J101 and J163 would therefore not be expected to result in deleterious effects on non-target and beneficial organisms attributed to the novel protein. The results of studies on CP4 EPSPS in previously approved glyphosate-tolerant crops were therefore used to evaluate the impact of this novel protein in J101 and J163. These studies evaluated the effect of CP4 EPSPS on pollinators (<i>e.g</i>. bees), soil organisms (<i>e.g.</i>, earthworms), and beneficial arthropods. No toxic effects on these beneficial and non-target species were reported in the studies. Results from field trials with J101 and J163 also demonstrated similar susceptibilities to diseases and insect pests of alfalfa, compared to conventional alfalfa cultivars. Alfalfa cultivars expressing the glyphosate-tolerance trait would therefore not be expected to become new hosts for plant-pathogens, or insects pests, any more than conventional alfalfa cultivars.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b>:</p>\n\n<p style="text-align: justify;">Events J101 and J163 did not exhibit any novel phenotypic characteristics that would increase the survival of glyphosate-tolerant alfalfa in either unmanaged habitats, or in areas outside of the current geographical range of alfalfa production. However, the introgression of the glyphosate-tolerance trait into members of the M. sativa complex is possible when these are found growing in the vicinity of alfalfa populations containing either J101 or J163. This trait could also introgress into M. glomerata in areas where this species is endemic. The introgression of the glyphosate-tolerance trait into indigenous populations of the M. sativa complex, and M. glomerata, will not impart increased fitness, or weediness characteristics to these indigenous species, other than herbicide tolerance.</p>\n', NULL, '2013-08-30 00:22:39'),
(71, 110, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">Event COT102 was field tested at several locations in the United States, from 2000 to 2002, to evaluate agronomic performance, disease and insect resistance, and efficacy of the lepidopteran resistance trait in COT102 compared to its non-modified parental line Coker 312. Parameters measured included plant growth, morphology, reproductive traits, fibre yield and quality. At some of the locations, boll yield was significantly greater, and fibre quality significantly superior in COT102 compared to Coker 312. This was attributed to greater insect pressure at these locations; greater insect damage in Coker 312 compared to COT102 resulted in delayed maturity of the bolls, hence lower yield and decreased fibre quality. However, field trial results generally indicated that plant growth and morphology, agronomic performance and disease and non-lepidopteran susceptibility of COT102 was similar to that of its parental line. Differences that were observed were not consistent among locations, or among years, and were within the range of variability for conventional cotton cultivars. Since there were no biologically meaningful differences in disease and non-lepidopteran insect susceptibilities, and in vegetative and reproductive growth, COT102 is not expected to become a plant pest risk, neither in terms of weediness, nor in increased suspectibility to plant diseases and insects other than Lepidoptera.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Cotton (<i>G. hirsutum</i>) is mainly a self-pollinating plant, but pollen is also routinely transferred by insects, particularly bumblebees and honey bees. The pollen is heavy and sticky and the range of natural crossing is limited. Outcrossing rates of up to 28% to other cotton cultivars grown directly adjacent to the pollen source have been observed under field conditions when sufficient insect pollinators have been present. The rate of outcrossing declines rapidly with increased distance from the pollen source. Results of outcrossing research trials in the United States have shown that pollen movement decreases rapidly at 12 metres from the pollen source. Nevertheless, certified seed cotton growers in the United States must maintain an isolation distance of 202 metres between fields. If COT102 were to be grown in proximity with other cotton cultivars, and sufficient insect pollinators were present and active, the <i>vip3A(a)</i> gene could possibly introgress into these cultivars. In the event of the formation of hybrids, there would no competitive advantage conferred on any hybrid progeny in the absence of infestations by Lepidopteran insect species.</p>\n\n<p style="text-align: justify;">In the United States, species genetically compatible with COT102 cotton include <i>G. hirsutum</i> (wild or under cultivation), <i>G. barbadense</i> (cultivated Pima cotton), and <i>G. tomentosum</i>. Outcrossing from <i>G. hirsutum</i> to <i>G. barbadense</i> is possible under suitable conditions, such as the presence of pollinators. <i>G. thurberi</i> is another wild species found in the United States, but it is genetically incompatible with <i>G. hirsutum</i>. While <i>G. hirsutum</i> and <i>G. tomentosum</i> are genetically compatible (both possess the AADD genome), the possibility of gene transfer is unlikely due to the non-synchronous flowering periods (day for <i>G. hirsutum</i> and night for <i>G. tomentosum</i>), and lack of common pollinators. Populations of wild <i>Gossypium species</i> occur in southern Florida (<i>G. hirsutum</i>), Hawaii (<i>G. tomentosum</i>), Puerto Rico and the U.S. Virgin Islands. In other cotton growing areas of the world, species that could intercross with <i>G. hirsutum</i> include <i>G. mustelinum</i> in Brazil, and <i>G. lanceolatum</i> in Mexico.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Cultivated <i>Gossypium hirsutum</i> is not typically considered a weed species in the United States or other countries, but it is listed as a potential weed in southern Florida. Although cotton is cultivated as an annual crop, it behaves as a perennial in undisturbed environments and suitable climatic conditions. Cotton does not tolerate cold conditions thereby limiting its overwintering potential to southern Florida, Hawaii, and Puerto Rico.</p>\n\n<p style="text-align: justify;">No competitive advantage was conferred to COT102 other than the production of the insecticidal protein VIP3A, and it is not expected to become weedy or invasive of natural habitats since none of the reproductive or vegetative growth characteristics of this line were substantially modified. Differences in these characteristics that were observed were not consistent among locations, and were therefore due to environment, including variability in insect pressure among locations. Seed dormancy, germination, and seedling establishment, were not significantly altered in COT102, compared to the parental line Coker 312, and observed differences were within the range of variability for conventional cotton cultivars.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">Event COT102 cotton was developed to resist lepidopteran pests of cotton. Due to the insecticidal nature of the VIP3A protein, the impact of COT102 on non-target organisms, including non-target insect pests, was investigated. Ecological toxicity studies were conducted with representative terrestrial and aquatic species that could be inadvertently affected by the insecticidal protein VIP3A. Non-target organisms included insects other than lepidopterans (honeybees, ladybird beetles, and green lacewings), soil arthropods (Collembola, earthworms), and representative terrestrial and aquatic species such as mice, bobwhite quail, catfish and <i>Daphnia magna</i>.</p>\n\n<p style="text-align: justify;">Toxicological effects of were determined from acute feeding studies. Leaf tissue and cottonseed from COT102 were not used in these studies to avoid possible confounding effects of the natural toxicants of cotton (<i>e.g.</i>, gossypol). The organisms were fed VIP3A protein derived from either recombinant <i>E. coli</i>, or maize expressing the <i>vip3A(a)</i> gene. The VIP3A protein from both these sources was shown to be equivalent to that expressed by COT102 cotton, as demonstrated by similarity in molecular weight, immunoreactivity, results of mass spectral analysis of the peptides, and similarity in the rank-order of bioactivity against four species of VIP3A-sensitive lepidopteran larvae.</p>\n\n<p style="text-align: justify;">Most of the organisms in the acute feeding studies were fed, at the highest treatments, levels of VIP3A that were several times greater than the estimated environmental concentrations, based on the expression levels in COT102 tissues. No adverse effects were observed in any of the tested organisms at the highest treatment levels. For each of these organisms, the highest treatment levels represented the following exposure to VIP3A from COT102: Bobwhite quail, 21-fold the level in leaves, and &gt;1200-fold the level in cottonseed; honeybee larvae, &gt;77-fold the level in pollen; adult honeybees, &gt;8-fold the level in pollen; ladybird beetles and lacewings, &gt; 133-fold the level in pollen; Collembola and earthworm, &gt;2100- and 180-fold the estimated soil concentration, respectively.</p>\n\n<p style="text-align: justify;">Environmental concentrations of VIP3A from COT102 were not estimated for either <i>Daphnia magma</i> or catfish. Aquatic organisms would most likely be exposed to VIP3A protein from COT102 pollen drifting from nearby fields and depositing on the surface of the water. This represents a very minimal amount of exposure since cotton flowers are mostly self-pollinating, and the pollen is heavy, thereby minimizing dispersal by wind. No adverse effects were observed in either <i>Daphnia magna</i> or catfish when fed at the highest levels of the VIP3A protein.</p>\n\n<p style="text-align: justify;">The effect of VIP3A on mammals was investigated in an acute feeding study conducted with mice. VIP3A expressed in maize tissue was fed, by gavage, at 5000 mg/kg of body weight. VIP3A expressed in <i>E. coli</i> was also fed at 5050 mg/kg of body weight. No adverse effects were observed in the mice, fed either diet, during the 14 days of the acute feeding study. The digestibility of VIP3A in simulated gastric fluids was also investigated. The VIP3A protein expressed in E. coli was degraded, at time zero, to low molecular weight (&lt; 14,000) peptides, and no peptides were detectable after 2 min. The VIP3A protein is therefore rapidly digested in a mammalian gut environment.</p>\n\n<p style="text-align: justify;">VIP3A protein in COT102 cotton was shown to be insecticidal toward several lepidopteran pests of cotton, including cotton bollworm, tobacco budworm, pink bollworm, fall armyworm, beet armyworm, soybean looper, and cabbage looper. However, several lepidopteran pest species were not adversely affected by the protein, including the European Corn Borer (Ostrinia nubilalis), Fall webworm (<i>Hyphantria curea</i>) and Diamondback moth (<i>Plutella zylostella</i>).</p>\n\n<p style="text-align: justify;">The potential for exposure of non-target lepidopterans to the VIP3A protein was investigated. Insect sensitivity studies were conducted on the Monarch butterfly (<i>Danaus plexippus</i>) and demonstrated no adverse effects. The most likely route of exposure to non-target lepidopterans would be through the pollen. Cotton flowers are mostly self-pollinated and therefore very little pollen would be dispersed into the environment. Cotton pollen is also not readily dispersed by wind due to its mass and high moisture content. The exposure to VIP3A via cotton pollen would also be minimal due to the low levels of expression in the pollen.</p>\n\n<p style="text-align: justify;">Based on the results of the ecotoxicological studies, the VIP3A protein in COT102 poses a negligible risk to non-target organisms, including beneficial arthropod species. The cultivation of COT102 therefore poses no greater risk to interacting, non-target organisms, than conventional cotton cultivars.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">Event COT102 did not exhibit novel phenotypic characteristics that would increase its survival in either unmanaged habitats, or in areas outside of the current geographical range of cotton production. Since the potential of gene transfer to wild relatives in the United States is quite minimal, the risk of transferring the insect resistance trait to species in unmanaged habitats is insignificant. In countries (<i>e.g.</i>, Brazil, Mexico) where hybrids could form with wild relatives of cotton, the introgression of the insect resistance trait into these wild species would confer no other advantage than increased resistance to attack by certain Lepidopteran insects.</p>\n\n<p style="text-align: justify;"><b>Other Considerations</b></p>\n\n<p style="text-align: justify;">In order to prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial spray formulations of these same toxins, regulatory authorities in the United States have required developers to implement specific Insect Resistant Management (IRM) Programs. These programs are mandatory for all transgenic <i>Bt</i>-expressing plants, including COT102 cotton, and require that growers plant a certain percentage of their acreage to non-transgenic varieties in order to reduce the potential for selecting <i>Bt</i>-resistant insect populations. Details on the specific design and requirements of individual IRM programs are published by the relevant regulatory authority.</p>\n', NULL, '2013-08-30 00:24:32'),
(72, 122, '<p style="text-align: justify;"><b>Outcrossing:</b></p>\n\n<p style="text-align: justify;">Wheat (Triticum aestivum) is primarily a self-pollinating plant. Gene transfer can occur by wind-mediated pollination to other T. aestivum plants, however outcrossing rates are usually low (The potential for introgression of the novel trait into weedy relatives of wheat in Canada and the United States is also very low. Wild species closely related to T. aestivum in the continental United States and Canada are <i>Aegilops cylindria</i> Host (jointed goat grass) and <i>Agropyron repens</i> (L.) Beauv. (quackgrass). Both of these are introduced species, native to Eurasia, and are considered weedy and invasive in Canada and the United States. Jointed goat grass is an annual, found in most of the United States, but not in Canada. It is considered a noxious weed in British Columbia due to the proximity of populations in Washington, Idaho and Montana, but is also found in other states contiguous to Canada, <i>i.e.</i>, North Dakota, Michigan, Ohio and New York. It would not be expected to become established in Canada except in southwestern British Columbia and southwestern Ontario. Hybridization of jointed goat grass with wheat can occur under field conditions and has been reported in Oregon. The hybridization was successful to the first backgross generation with jointed goat grass as the female plant. This has raised concerns of possible introgression of wheat into jointed goat grass populations as introgression of an herbicide tolerant trait from wheat into jointed goatgrass would confer an additional advantage to this weedy species. Quackgrass is a perennial species found extensively in Canada and the United States. Reports of hybridization between wheat and quackgrass have been reported; however, these have not been successfully reproduced by manual pollination. Due to the doubtful nature of any hybridizations between wheat and quackgrass, gene introgression into quackgrass populations is not expected to occur.</p>\n\n<p style="text-align: justify;"><b>Weediness potential:</b></p>\n\n<p style="text-align: justify;">Cultivated wheat is not considered a weed of agriculture. Wheat plants can volunteer in fields following a wheat crop but these can be controlled by cultivation or herbicides. No competitive advantage was conferred to BW255-2 or BW238-3, other than resistance to imidazolinone herbicides. Results from agronomic performance field trials and compositional data show that the physiology of BW255-2 and BW238-3 was not affected by the mutation of the AHAS gene. BW255-2 and BW238-3 are not expected to become weedy or invasive of natural habitats since neither vegetative growth or reproductive characteristics were altered. Wheat volunteers expressing the modified AHAS gene are therefore not expected to become weedier than conventional wheat volunteers. These will not be controlled by imidazolinone herbicides, thereby providing less flexibility in herbicide use.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Effects:</b></p>\n\n<p style="text-align: justify;">The characterization of the modified AHAS gene containing a single base pair change, and the resulting modified enzyme, led to the conclusion that the expression of the modified enzyme does not result in altered toxic or allergenic properties. The modified AHAS enzyme was found to be substantially equivalent to AHAS in nonmodified plants. The AHAS enzyme is not a known toxin, does not confer resistance to agricultural pests, and is naturally present in plants and micro-organisms. It is similar to conventional wheat in terms of vegetative growth and seed production. Based on this information, BW255-2 and BW238-3 would not result in altered impacts on non-target organisms, compared to conventional wheat varieties.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity:</b></p>\n\n<p style="text-align: justify;">BW255-2 and BW238-3 do not possess novel phenotypic characteristics that would extend cultivation beyond the current geographic range of spring wheat. Neither do they possess characteristics that would allow them to grow and compete under soil and climatic conditions for which they are not adapted. The herbicide-tolerant trait, in itself, will not confer to any potential hybrids any competitive advantage other than tolerance to imidazolinone herbicides. BW255-2 and BW238-3 have also been found safe to non-target organisms and do not display altered plant pest potential since agronomic and biological characteristics were found to be within the range of conventional wheat varieties.</p>\n', NULL, '2013-08-30 00:41:06'),
(73, 123, '<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">There are no sexually compatible species for rice in Canada. The wild &ldquo;rice&rdquo; which does occur in Canada (<i>Zizania aquatica</i>) is not sexually compatible with domesticated rice, <i>Oryza sativa</i>. In addition, these herbicide-tolerant lines will not be cultivated in Canada and if released, would not persist in the environment.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Rice is not adapted to the environmental conditions encountered in Canada. The vegetative vigour, time to maturity, and seed production, for these herbicide-tolerant lines were within the normal range of these parameters as measured for other commercial rice varieties. In unmanaged ecosystems, the herbicide-tolerant trait will not confer a competitive advantage and will not, in itself, render rice more weedy or invasive of natural habitats.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">There are no anticipated changes in ecological toxicity that would adversely impact on other organisms within managed or unmanaged ecosystems.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">As these lines did not display altered weediness or plant pest potential, or potential to adversely impact non-target organisms, and will not be cultivated in Canada, there was no anticipated impact on biodiversity in Canada.</p>\n', NULL, '2013-08-30 00:42:29'),
(74, 111, '<p style="text-align: justify;"><b>Field Testing:</b></p>\n\n<p style="text-align: justify;">Numerous field trials were conducted in 2002 and 2003 in a variety of locations to evaluate LY038 corn. In each of these trials, LY038 was compared to a negative segregant (a sister line in which the <i>cordapA</i> transgene was not present) referred to as LY038(-) as well as several control and reference hybrids. Standard field trials included an evaluation of dormancy and germination, ecological evaluations (plant interactions with insect pests, disease, and abiotic stresses), phenotypic evaluations, and compositional changes. Data addressing the above categories were collected in order to assess possible effects from introduction of the <i>cordapA</i> gene and its associated regulatory sequences.</p>\n\n<p style="text-align: justify;">Dormancy and germination testing revealed no differences found between LY038 corn and the reference hybrids. There were slight qualitative differences between LY038 corn and the controls identified in the ecological evaluations, but all of the measurements were within the range of incidence observed for the reference hybrids. For the phenotypic evaluations, there were 14 phenotypic characteristics evaluated during field testing. While there were some small qualitative statistical differences found, such as decreased seedling vigor and a small increase in plant height; these varied between years and were all within the ranges observed for the reference corn hybrids. Analysis of phenotypic characteristics data showed no significant biological differences between the reference corn control populations and LY038 corn, or differences outside the range of conventional corn norms.</p>\n\n<p style="text-align: justify;">The only unusual observation was the appearance of a white-leaf phenotype in LY038 corn in some field test locations. The white-leaf phenotype occurs at germination and persists only to the V2 stage (when the second collar appears on the second leaf). A similar white-leaf or decreased chlorophyll content phenotype has been observed in other plant species that accumulate high concentrations of lysine. In some cases this trait is associated with a loss of apical dominance and other growth abnormalities, however no such characteristics were observed in the LY038 plants in these field tests.</p>\n\n<p style="text-align: justify;"><b>Outcrossing:</b></p>\n\n<p style="text-align: justify;">Since pollen production and viability were unchanged by the genetic modification resulting in LY038, pollen dispersal by wind and outcropping frequency should be no different than for other maize varieties. Gene exchange between LY038 maize and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In the United States, where there are no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote. Feral species in the United States related to corn cannot be pollinated due to differences in chromosome number, phenology (periodicity or timing of events within an organism&rsquo;s life cycle as related to climate, <i>e.g</i>., flowering time) and habitat.</p>\n\n<p style="text-align: justify;">Maize (<i>Zea mays</i> ssp. <i>mays</i>) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>mexicana</i>) when in close proximity. These wild maize relatives are native to Central America and are not present in the United States, except for special plantings. <i>Tripsacum</i>, another genus related to <i>Zea</i>, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of <i>Tripsacum</i> have been reported in the continental United States: <i>T. dactyloides</i>, <i>T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (i.e., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some <i>Tripsacum</i> species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of <i>Tripsacum</i> species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential:</b></p>\n\n<p style="text-align: justify;">No competitive advantage was conferred to LY038 that would render maize weedy or invasive of natural habitats, since none of the reproductive or growth characteristics were modified. Cultivated maize is unlikely to establish in non-cropped habitats and there have been no reports of maize surviving as a weed. <i>Zea mays</i> is not invasive and is a weak competitor with very limited seed dispersal. Volunteers can occur in fields, the year following cultivation, when maize is grown in rotation with other crops. Although maize volunteers are a minor weed problem, these can cause harvesting problems.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity:</b></p>\n\n<p style="text-align: justify;">LY038 has no novel phenotypic characteristics that would extend its use beyond the current geographic range of maize production. Since the risk of outcrossing with wild relatives in the United States is remote, it was determined that the risk of transferring genetic traits from LY038 maize to species in unmanaged environments was insignificant.</p>\n', NULL, '2013-08-30 00:26:27');
INSERT INTO `gmcropdatabase_events_esafeties` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(75, 125, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">Field trials were conducted at 17 locations during 2005 to thoroughly evaluate phenotypic, agronomic and ecological interactions of MON89788 and compare these to A3244, the conventional parental line, and other commercially available soybeans. These 17 locations provided a diverse range of environmental and agronomic conditions representative of the majority of commercial soybean production regions in the US. Plant growth stage was assessed several times during the growing season and observational data on the presence of various biotic and abiotic stresses, together with the response of the lines to these stresses was recorded.</p>\n\n<p style="text-align: justify;">A total of 11 different phenotypic characters was evaluated and the only significant difference detected in across-site analyses was a reduced height for MON89788 compared to A3244. The difference falls within the range of values observed for commercial soybean varieties. No differences were observed in susceptibility to pests and diseases, neither were there any differences observed in numbers of beneficial insects and spiders collected from the sites. Seed dormancy and germination characteristics were determined across a range of conditions with seed produced during the 2005 trials at three different locations.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Gene introgression from transformed soybean line MON89788 is considered as extremely unlikely as there are no relatives of cultivated soybean in the continental United States and soybean plants are almost completely self-pollinated. Furthermore, the reproductive characteristics such as pollen production and viability were unchanged by the genetic modification resulting in MON89788.</p>\n\n<p style="text-align: justify;">Cultivated soybean, <i>Glycine max</i>, naturally hybridizes with the wild annual species <i>G. soja</i>. However, <i>G. soja</i> is only found naturally occurring in China, Korea, Japan, Taiwan and the former USSR, and is not naturalized in North America, although it may possibly be grown in research plots. It was concluded that the potential for transfer of the glyphosate tolerance trait from the transgenic line to soybean relatives through gene flow was negligible in managed ecosystems, and that there was no potential for transfer to wild species in continental United States.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">No competitive advantage was conferred to MON89788, other than that conferred by resistance to glyphosate herbicide. The only phenotypic difference between MON89788 and the parental line was a slightly decreased plant height, which was within the range of commercial soybean was not expected to result in an increase in weediness potential. Resistance to glyphosate-containing herbicides will not, in itself, render soybean weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified. In the unlikely event of the formation of a herbicide tolerant hybrid, there would be no competitive advantage conferred on any hybrid progeny in the absence of sustained glyphosate use. The glyphosate-tolerant plant could easily be controlled by mechanical means or by using herbicides that are not based on glyphosate. Cultivated soybean does not exhibit any weedy characteristics in the United States, although related species are reported as weeds in Japan and China. It was concluded that soybean line MON89788 had no altered weed of invasiveness potential compared to commercial soybean varieties.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">Field observations of line MON89788 revealed no effects on pest or beneficial insects and spiders, suggesting that the levels of CP4 EPSPS in the transgenic plant tissues were not toxic to arthropods. The novel protein CP4 EPSPS did not result in altered toxicity or allergenicity properties as demonstrated from studies including the acute oral mouse gavage study, the digestive fate study, and the fact that homologous EPSPS proteins are ubiquitous in nature and common in plants, fungi and microbes. Furthermore, the high specificity of the enzyme for its substrates makes it unlikely that the introduced enzyme would metabolize endogenous substrates to produce compounds toxic to beneficial organisms. It was determined that the genetically modified soybean line MON89788 did not have a significant adverse impact on organisms beneficial to plants or agriculture, or on nontarget organisms, and was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">Analysis of available information indicates that MON 89788 exhibits no traits that would cause increased weediness, that its unconfined cultivation should not lead to increased weediness of other sexually compatible relatives (of which there are none in the United States), and it is likely to have no effect on non-target organisms common to the agricultural ecosystem or threatened or endangered species recognized by the U.S. Fish and Wildlife Service. Based on this analysis, there is no apparent potential for significant impact to biodiversity.</p>\n', NULL, '2013-08-30 00:44:18'),
(76, 113, '<p style="text-align: justify;"><b>Field Testing</b><br>\n<br>\nFiled trials were performed at a total of 32 locations in the United Stated during 2002 and 2003 with a number of different hybrids all containing the MIR604 event. As controls, non-transgenic segregants with the same genetic background were used at each site, as well as a range of conventional maize hybrids. For the majority of the traits assessed, there were no statistically significant differences and for the few traits where there was a significant difference, these differences were not consistent between sites over the two years of trials. The range of values for the agronomic characters, even when statistically significantly different from the controls, was within the range of values expected for maize hybrids and was thus not considered biologically significant.<br>\n<br>\nMIR604 hybrids and their non-segregant controls were exposed to various corn pathogens and susceptibility was measured revealing no significant differences in disease susceptibility. Insect efficacy trials were conducted in field plots that were infested with naturally occurring populations of corn rootworm, with populations enhanced by use of trap crops the preceding season, or artificially infested with rootworm eggs.<br>\n<br>\nThe outcome of these studies indicated that, except for reduced damage to roots caused by corn rootworm, the agronomic performance of MIR604-derived hybrids was similar, and for most traits, equivalent to their nontransformed near isogenic counterparts. In contrast to the similarity in most agronomic parameters, the yield performance of MIR604-derived hybrids in the presence of corn rootworm pressure was significantly increased relative to corn hybrids lacking this trait.<br>\n<br>\n<b>Outcrossing</b><br>\n<br>\nSince pollen production and viability were unchanged by the genetic modification resulting in MIR604, pollen dispersal by wind and outcrossing frequency should be no different than for other maize varieties. Gene exchange between MIR604 maize and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In the United States, where there are no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote. Feral species in the United States related to corn cannot be pollinated due to differences in chromosome number, phenology (periodicity or timing of events within an organism’s life cycle as related to climate, <i>e.g</i>., flowering time) and habitat.<br>\n<br>\nMaize (<i>Zea mays</i> ssp. <i>mays</i>) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>mexicana</i>) when in close proximity. These wild maize relatives are native to Central America and are not present in the United States, except for special plantings. <i>Tripsacum</i>, another genus related to <i>Zea</i>, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of <i>Tripsacum</i> have been reported in the continental United States: <i>T. dactyloides</i>, <i>T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (i.e., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some <i>Tripsacum</i> species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of <i>Tripsacum</i> species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.<br>\n<br>\n<b>Weediness Potential</b><br>\n<br>\nThe introduced traits in MIR604 are not expected to cause MIR604 maize to become a weed. No competitive advantage was conferred to MIR604 that would render maize weedy or invasive of natural habitats, since none of the reproductive or growth characteristics were modified and no significant differences in these traits were noted in the field trials. Cultivated maize is unlikely to establish in non-cropped habitats and there have been no reports of maize surviving as a weed. <i>Zea mays</i> is not invasive and is a weak competitor with very limited seed dispersal. Volunteers can occur in fields, the year following cultivation, when maize is grown in rotation with other crops. Although maize volunteers are a minor weed problem, these can cause harvesting problems.<br>\n<br>\n<b>Secondary and Non-Target Adverse Effects</b><br>\n<br>\nThree sources of data were used to evaluate the environmental safety of the modified Cry3A (mCry3A) <i>Bacillus thuringiensis</i>-related insect control protein expressed in MIR604. First, experimental data was used to establish how the spectrum of activity of mCry3A differs from native Cry3A. These data suggest that the toxicity of mCry3A differs from native Cry3A only in the intended increase in activity against certain pest species in the genus <i>Diabrotica</i> (Coleoptera: Chrysomelidae). Secondly, data on the spectrum of activity of native Cry3A was reviewed to provide evidence about the likely spectrum of activity (<i>i.e</i>., the hazard) of mCry3A. As the previous studies showed that mCry3A and native Cry3A differ only in the intended increase of activity of mCry3A to certain <i>Diabrotica</i> species, the toxicity of native Cry3A is a good predictor of the hazard of mCry3A to non-target organisms (NTOs).<br>\n<br>\nFrom the native Cry3A data it was predicted that mCry3A is unlikely to be hazardous except to certain species in 3 families of Coleoptera: the Chrysomelidae (leaf beetles, flea beetles and rootworms), the Curculionidae (weevils and snout beetles) and the Tenebrionidae (darkling beetles). The third source of data which was then used to test this hypothesis, was single-species laboratory studies exposing representative NTOs to concentrations of mCry3A in excess of the expected environmental concentrations of mCry3A resulting from the proposed cultivation of MIR604. Test species were chosen to represent taxa that might be exposed to mCry3A from tissues of MIR604, or taxa related to the western and northern corn rootworm. In addition, test species were selected to include functional groups found in agricultural fields and other habitats into which mCry3A might spread: birds, freshwater fish, predators and parasitoids of crop pests, soil invertebrates and pollinators.<br>\n<br>\n<b>Impact on Biodiversity</b><br>\n<br>\nAnalysis concluded that MIR604 maize exhibited no traits that would cause increased weediness and that cultivation would not lead to increased weediness of other maize or sexually compatible species, nor would cultivation be likely to harm non-target organisms. Based on this conclusion, there was no apparent potential for a significant impact on biodiversity.<br>\n </p>\n', NULL, '2013-08-29 16:02:42'),
(77, 96, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">Maize event MON88017 was field tested in Canada in 2003, and in the United States in 2001, 2002 and 2003. Agronomic characteristics of hybrids derived from MON88017 such as seed dormancy, vegetative vigour, early stand establishment, time to maturity, flowering period, susceptibilities to various pests and pathogens, and seed production were compared to those of unmodified counterparts. Nutritional components of MON88017, such as proximates, amino acids and fatty acids were compared with those of unmodified counterparts.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Pollen production and viability were unchanged by the genetic modification resulting in MON88017, therefore pollen dispersal by wind and outcrossing frequency should be no different than for other maize varieties. Gene exchange between MON88017 and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In the United States and Canada, where there are no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote. Feral species in the United States related to corn cannot be pollinated due to differences in chromosome number, phenology (periodicity or timing of events within an organism&rsquo;s life cycle as related to climate, <i>e.g</i>., flowering time) and habitat.</p>\n\n<p style="text-align: justify;">Maize (<i>Zea mays</i> ssp. <i>mays</i>) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>mexicana</i>) when in close proximity. These wild maize relatives are native to Central America and are not present in the United States, except for special plantings. <i>Tripsacum</i>, another genus related to <i>Zea</i>, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of <i>Tripsacum</i> have been reported in the continental United States: <i>T. dactyloides</i>, <i>T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (i.e., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some <i>Tripsacum</i> species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of <i>Tripsacum</i> species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">The history and biology of maize indicates that non-transgenic plants of this species are not invasive in unmanaged habitats. Maize does not possess the potential to become weedy due to traits such as lack of seed dormancy, the non-shattering nature of corn cobs, and the poor competitive ability of seedlings. The data generated from field trials shows that MON88017 and derived hybrids are similar to their counterparts in this respect. Data submitted by the developer on the reproductive and survival biology of hybrids derived from MON88017 determined that early stand establishment, flowering period, vegetative vigor, time to maturity and seed production were within the normal range of expression of these traits currently displayed by commercial hybrids. No competitive advantage was conferred to MON88017, other than that conferred by resistance to rootworm and tolerance to glyphosate herbicide. These traits were demonstrated not to render maize weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified. The above considerations lead to the conclusion that MON88017 has no altered weed or invasive potential compared to currently commercialized corn.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The agronomic characteristics of MON88017 hybrids were shown to be within the range of values displayed by currently commercialized maize hybrids, and indicate that the growing habit of maize will not be inadvertently altered by cultivation of MON88017. Field observations did not indicate modifications of disease and pest susceptibilities, other than to rootworm, which is not known to be a principal factor restricting the establishment or distribution of maize.<br />\nSome of the genetic elements introduced into MON88017 were derived from known plant pathogens, but in all cases the genes responsible for the pathogenic qualities of the pathogen were not introduced. Therefore, the introduction of genetic material for <i>Diabotica spp.</i> resistance and glyphosate tolerance would not be expected to result in MON88017 expressing novel pathogenic characteristics.</p>\n\n<p style="text-align: justify;">The history of use and literature suggest that the bacterial Cry3Bb1 toxins are not toxic to humans, other vertebrates, and non-coleopteran invertebrates. This protein is active only against specific coleopteran insects. Data from dietary toxicity and field studies on the effect of the Cry3Bb1 protein on non-target organisms supported the environmental safety assessment of corn event MON863. In all cases, MON863 corn was demonstrated to be safe to non-target organisms. Given that MON88017 Cry3Bb1 protein differs from the MON863 CryBb1 protein by a single amino-acid, that both proteins were demonstrated to be equivalent in terms of insecticidal activity against susceptible pest insects and that the levels of Cry3Bb1 expression in both lines are similar, MON88017 is expected to be safe to previously assayed non-target organisms. The Cry3Bb1 protein expressed in MON88017 was also demonstrated to be safe to mammals.</p>\n\n<p style="text-align: justify;">The impact of CP4 EPSPS protein on non-target organisms, including humans, has been thoroughly assessed in previous applications for environmental safety assessments of CP4 EPSPS-expressing crops. The CP4 EPSPS protein expressed in MON88017 tissues is the same or is &gt; 99% identical to CP4 EPSPS proteins produced in glyphosate-tolerant crops with a history of safe use. The environmental and feed safety of the CP4 EPSPS protein in corn has been previously established with, for example, the regulatory approval of NK603.</p>\n\n<p style="text-align: justify;">Non-transgenic maize is known to produce low levels of anti-nutrients such as raffinose and phytic acid, and the levels of these compounds in MON88017 were demonstrated to be equivalent to levels found in control lines. Therefore the genetic modification did not alter the expression of endogenous anti-nutritional factors.</p>\n\n<p style="text-align: justify;">Based on this data, it was determined that the unconfined release of MON88017 will not result in altered impacts when compared with currently commercialized corn on interacting organisms, including humans, with the exception of specific coleopteran pest species.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">MON88017 has no novel phenotypic characteristics which would extend its use beyond the current geographic range of maize production. Since maize does not out-cross to wild relatives in the united States or Canada, there will be no transfer of novel traits to unmanaged environments. In addition the novel traits were determined to pose minimal risks to non-target organisms.</p>\n\n<p style="text-align: justify;">MON88017 provides an alternative method to existing methods of control of rootworms, an important agricultural pest of maize. The control of agricultural pest species is a common practice that is not restricted to the environmental release of transgenic plants. Therefore, the reduction in local pest species as a result of the cultivation of MON88017 does not present a significant change from existing agricultural practices.</p>\n\n<p style="text-align: justify;">At present, the use of chemical insecticides to control rootworm is permitted, although crop rotation represents a major method of rootworm control ins some countries.</p>\n\n<p style="text-align: justify;">MON88017 also provides an alternative method of weed control in corn production. The use of broad spectrum herbicides has the intended effect of reducing local weed populations within agricultural fields and this may reduce local weed species biodiversity, and possibly other trophic levels which utilize these weed species. It must be noted, however, that reduction in weed biodiversity in agricultural fields is not unique to the use of transgenic plants, and is a common practice in virtually all modern agricultural systems. It was therefore concluded that MON88017 does not present a significantly altered impact on biodiversity in comparison to maize varieties currently being grown.</p>\n', NULL, '2013-08-30 00:16:03'),
(78, 95, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">Maize event DAS-59122-7 was field tested in the United States in 2001, 2002 and at 18 separate sites in 2003. Agronomic characteristics of hybrids derived from DAS-59122-7 such as seed dormancy, vegetative vigour, early stand establishment, time to maturity, flowering period, susceptibilities to various pests and pathogens, and seed production were compared to those of unmodified counterparts. Nutritional components of DAS-59122-7, such as proximates, amino acids and fatty acids were compared with those of unmodified counterparts.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Pollen production and viability were unchanged by the genetic modification resulting in DAS-59122-7, therefore pollen dispersal by wind and outcrossing frequency should be no different than for other maize varieties. Gene exchange between DAS-59122-7 and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In the United States and Canada, where there are no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote. Feral species in the United States related to corn cannot be pollinated due to differences in chromosome number, phenology (periodicity or timing of events within an organism&rsquo;s life cycle as related to climate, <i>e.g</i>., flowering time) and habitat.</p>\n\n<p style="text-align: justify;">Maize (<i>Zea mays</i> ssp. <i>mays</i>) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>mexicana</i>) when in close proximity. These wild maize relatives are native to Central America and are not present in the United States, except for special plantings. <i>Tripsacum</i>, another genus related to <i>Zea</i>, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of <i>Tripsacum</i> have been reported in the continental United States: <i>T. dactyloides</i>, <i>T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (i.e., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some <i>Tripsacum</i> species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of <i>Tripsacum</i> species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">The history and biology of maize indicates that non-transgenic plants of this species are not invasive in unmanaged habitats. Maize does not possess the potential to become weedy due to traits such as lack of seed dormancy, the non-shattering nature of corn cobs, and the poor competitive ability of seedlings. The data generated from field trials shows that DAS-59122-7 and derived hybrids are similar to their counterparts in this respect. Data submitted by the developer on the reproductive and survival biology of hybrids derived from DAS-59122-7 determined that early stand establishment, flowering period, vegetative vigor, time to maturity and seed production were within the normal range of expression of these traits currently displayed by commercial hybrids. No competitive advantage was conferred to DAS-59122-7, other than that conferred by resistance to rootworm and tolerance to glufosinate herbicide. These traits were demonstrated not to render maize weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified. The above considerations lead to the conclusion that DAS-59122-7 has no altered weed or invasive potential compared to currently commercialized corn.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The agronomic characteristics of DAS-59122-7 hybrids were shown to be within the range of values displayed by currently commercialized maize hybrids, and indicate that the growing habit of maize will not be inadvertently altered by cultivation of DAS-59122-7. Field observations did not indicate modifications of disease and pest susceptibilities, other than to rootworm, which is not known to be a principal factor restricting the establishment or distribution of maize.</p>\n\n<p style="text-align: justify;">Some of the genetic elements introduced into DAS-59122-7 were derived from known plant pathogens, but in all cases the genes responsible for the pathogenic qualities of the pathogen were not introduced. Therefore, the introduction of genetic material for <i>Diabotica spp.</i> resistance and glufosinate tolerance would not be expected to result in DAS-59122-7 expressing novel pathogenic characteristics.</p>\n\n<p style="text-align: justify;">The history of use and literature suggest that the bacterial Cry34Ab1 and Cry35Ab1 toxins are not toxic to humans, other vertebrates, and non-coleopteran invertebrates. This protein is active only against specific coleopteran insects and, as the specificity of the Cry34Ab1 and Cry35Ab1 protein insecticidal activity is dependent upon their binding to specific receptors present in the insect mid-gut, these insecticidal proteins are not expected to adversely affect other invertebrates or vertebrate organisms, including non-target birds, mammals and humans. Laboratory and field studies on representative species supported these expectations.</p>\n\n<p style="text-align: justify;">A series of diet bioassays was conducted with microbially-expressed Cry34Ab1 and Cry35Ab1 proteins to characterize the insecticidal specificity. Test species were: northern corn rootworm (<i>Diabrotica barberi</i>), western corn rootworm (<i>Diabrotica virgifera virgifera</i>), southern corn rootworm (<i>Diabrotica undecimpunctata howardi</i>), European corn borer (<i>Ostrinia nubilalis</i>), corn earworm (<i>Helicoverpa zea</i>), black cutworm (<i>Agrotis ipsilon</i>) and corn leaf aphid (<i>Rhopalosiphum maidis</i>). Only corn rootworm (<i>Diabrotica</i> spp.) experience high mortality when exposed to microbially-expressed Cry34 and Cry35 proteins.</p>\n\n<p style="text-align: justify;">Acute dietary toxicity studies were conducted in laboratory tests on the effect of the Cry34 and Cry35Ab1 proteins on non-target invertebrates, including honeybee larvae, green lacewing larvae, ladybird beetles (<i>Hippodamia convergens</i> and <i>Coleomegilla maculate</i>), parasitic wasp, ground beetle, daphnia, collembola, and earthworm. Data were also submitted on non-target vertebrates including mice and the rainbow trout. Cry34 and Cry35Ab1 proteins were demonstrated to be safe to these indicator species when ingested alone or in combination, at doses exceeding the levels of direct or indirect exposure to Cry34 and Cry35Ab1 proteins from corn 59122 tissues. Although growth inhibition was reported when <i>Coleomegilla maculate</i> larvae were fed Cry34Ab1 protein at about 10 times the field pollen value, no delay in development or weigh reduction were observed when larvae were fed a diet composed of 50% corn line 59122 pollen, which represents a conservative estimate of the potential exposure in the field. Therefore, no sub-lethal effects on <i>C. maculate</i> ladybird beetle are expected from exposure to event DAS-59122-7.</p>\n\n<p style="text-align: justify;">Field based observational studies were also performed on the stability and abundance of non-target arthropods communities and individual species where Cry34 and Cry35Ab1 expressing corn is grown. The species studied were representatives of various functional groups (predators, parasitoids, herbivores and detritivores) and were sampled using visual observations of corn plants, sticky traps, pitfall traps or litterbag traps. The studies did not reveal any negative impact on the abundance of these non-target organisms relative to the non-transgenic control hybrid. The Cry34 and Cry35Ab1 protein was shown to degrade readily in soil, indicating that it is unlikely to accumulate and persist in soil.</p>\n\n<p style="text-align: justify;">The herbicide tolerance trait of event DAS-59122-7 is conferred by expression of the phosphinothricin N-acetyltransferase (PAT) gene. The PAT protein has been studied extensively and has been found to be safe for non-target organisms, including human beings. This gene has been used in a number of other approved transgenic maize events, such as T25, BT11, DLL25 and DAS-06275-8.</p>\n\n<p style="text-align: justify;">Maize is not known for the production of significant levels of endogenous toxins and the transformation event that produced event DAS-59122-7 would not be expected to induce their synthesis. Maize is however, known to produce low levels of trypsin inhibitor and phytic acid and the levels of these compounds in DAS-59122-7 were found to be within the range of conventional corn lines. The genetic modification, therefore did not alter the expression of endogenous anti-nutrients.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">DAS-59122-7 has no novel phenotypic characteristics which would extend its use beyond the current geographic range of maize production. Since maize does not out-cross to wild relatives in the united States or Canada, there will be no transfer of novel traits to unmanaged environments. In addition the novel traits were determined to pose minimal risks to non-target organisms.</p>\n\n<p style="text-align: justify;">DAS-59122-7 provides an alternative method to existing methods of control of rootworms, an important agricultural pest of maize. The control of agricultural pest species is a common practice that is not restricted to the environmental release of transgenic plants. Therefore, the reduction in local pest species as a result of the cultivation of DAS-59122-7 does not present a significant change from existing agricultural practices. At present, the use of chemical insecticides to control rootworm is permitted, although crop rotation represents a major method of rootworm control in some countries.</p>\n\n<p style="text-align: justify;">DAS-59122-7 also provides an alternative method of weed control in maize production. The use of broad spectrum herbicides has the intended effect of reducing local weed populations within agricultural fields and this may reduce local weed species biodiversity, and possibly other trophic levels which utilize these weed species. It must be noted, however, that reduction in weed biodiversity in agricultural fields is not unique to the use of transgenic plants, and is a common practice in virtually all modern agricultural systems. It was therefore concluded that DAS-59122-7 does not present a significantly altered impact on biodiversity in comparison to maize varieties currently being grown.</p>\n', NULL, '2013-08-30 15:49:13'),
(79, 126, '<p style="text-align: justify;"><b>Field Testing:</b></p>\n\n<p style="text-align: justify;">BW7 has been field tested in multiple locations in the United States from 2002 to 2005. Data collected from replicated field trials demonstrated that BW7 did not differ significantly from the parental line in terms of vegetative vigour, time to maturity, seed production (yield), disease resistance, and tendency to weediness.</p>\n\n<p style="text-align: justify;"><b>Outcrossing:</b></p>\n\n<p style="text-align: justify;">Wheat (<i>Triticum aestivum</i>) is primarily a self-pollinating plant. Gene transfer can occur by wind-mediated pollination to other <i>T. aestivum</i> plants, however outcrossing rates are usually low (&lt;10%). Factors that influence the success of cross-pollination in wheat are: the synchronicity of flowering among the plants; population density; genotype; and the viability of the pollen, which is influenced by environmental conditions such as temperature, humidity and wind intensity. Under ideal conditions, outcrossing will occur to nearby plants, but not usually beyond 3 m from the source plant. However, given the variability of outcrossing rates and pollen spread among genotypes, an isolation distance of 30 m is required for certified seed production. Introgression of the herbicide tolerant trait of BW7 into unmodified wheat is therefore possible but rates of hybridization would be low. Any herbicide tolerant hybrids thus formed would not be expected to become weedy or invasive; the modified AHAS gene in BW7 does not confer any competitive advantage, other than tolerance to imidazolinone herbicides.</p>\n\n<p style="text-align: justify;">The potential for introgression of the novel trait into weedy relatives of wheat in Canada and the United States is also very low. Wild species closely related to <i>T. aestivum</i> in the continental United States and Canada are <i>Aegilops cylindria</i> Host (jointed goat grass) and <i>Agropyron repens</i> (L.) Beauv. (quackgrass). Both of these are introduced species, native to Eurasia, and are considered weedy and invasive in Canada and the United States. Jointed goat grass is an annual, found in most of the United States, but not in Canada. It is considered a noxious weed in British Columbia due to the proximity of populations in Washington, Idaho and Montana, but is also found in other states contiguous to Canada, <i>i.e.</i>, North Dakota, Michigan, Ohio and New York. It would not be expected to become established in Canada except in southwestern British Columbia and southwestern Ontario. Hybridization of jointed goat grass with wheat can occur under field conditions and has been reported in Oregon. The hybridization was successful to the first backcross generation with jointed goat grass as the female plant. This has raised concerns of possible introgression of wheat into jointed goat grass populations as introgression of an herbicide tolerant trait from wheat into jointed goatgrass would confer an additional advantage to this weedy species.</p>\n\n<p style="text-align: justify;">Quackgrass is a perennial species found extensively in Canada and the United States. Reports of hybridization between wheat and quackgrass have been reported; however, these have not been successfully reproduced by manual pollination. Due to the doubtful nature of any hybridizations between wheat and quackgrass, gene introgression into quackgrass populations is not expected to occur.</p>\n\n<p style="text-align: justify;"><b>Weediness potential:</b></p>\n\n<p style="text-align: justify;">Cultivated wheat is not considered a weed of agriculture. Wheat plants can volunteer in fields following a wheat crop but these can be controlled by cultivation or herbicides. No competitive advantage was conferred to BW7, other than resistance to imidazolinone herbicides. Results from agronomic performance field trials and compositional data show that the physiology of BW7 was not affected by the mutation of the AHAS gene. BW7 is not expected to become weedy or invasive of natural habitats since neither vegetative growth or reproductive characteristics were altered. Wheat volunteers expressing the modified AHAS gene are therefore not expected to become weedier than conventional wheat volunteers. These will not be controlled by imidazolinone herbicides, thereby providing less flexibility in herbicide use.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Effects:</b></p>\n\n<p style="text-align: justify;">The characterization of the modified AHAS gene identified a single base pair change resulting in a single amino acid change in the modified enzyme, leads to the conclusion that the expression of the modified enzyme does not result in altered toxic or allergenic properties. The modified AHAS enzyme was found to be substantially equivalent to AHAS in nonmodified plants. The AHAS enzyme is not a known toxin, does not confer resistance to agricultural pests, and is naturally present in plants and micro-organisms. It is similar to conventional wheat in terms of vegetative growth and seed production. Based on this information, BW7 would not result in altered impacts on non-target organisms, compared to conventional wheat varieties.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity:</b></p>\n\n<p style="text-align: justify;">BW7 does not possess novel phenotypic characteristics that would extend cultivation beyond the current geographic range of spring wheat. Neither does it possess characteristics that would allow it to grow and compete under soil and climatic conditions for which it is not adapted. The herbicide-tolerant trait, in itself, will not confer to any potential hybrids any competitive advantage other than tolerance to imidazolinone herbicides. BW7 has also been found safe to non-target organisms and does not display altered plant pest potential since agronomic and biological characteristics were found to be within the range of conventional wheat varieties.</p>\n', NULL, '2013-08-30 13:05:23'),
(80, 127, '<p style="text-align: justify;"><b>Field Testing:</b></p>\n\n<p style="text-align: justify;">Field trials were established in 1996-1997 in Poland, Spain and Romania with C5 shoots grafted onto non-transgenic rootstocks. These trials were maintained for efficacy testing of the transgenic lines and deliberately inoculated with PPV using infected grafts or interspersed with infected trees to test for resistance to aphid transmitted virus. Further field trials in the United States were approved in 1995 and included trees which were rooted from C5 clones as well as grafted material. Pollen movement from this trial has been monitored between blocks of transgenic and non-transgenic trees.</p>\n\n<p style="text-align: justify;"><b>Outcrossing:</b></p>\n\n<p style="text-align: justify;">Outcrossing is expected in <i>P. domestica</i> due to the high levels of self incompatibility shown in this species. Seeds collected from open pollinated field trials have all shown a 1:1 segregation pattern of transgenic to non-transgenic, indicating that C5 is not self-pollinating nor being pollinated by other transgenic lines. Non-transgenic control trees of the same parental material in the experimental blocks have not produced any transgenic progeny, confirming that this line is self-incompatible and the transformation process has not altered the compatibility status of the material.<br />\nSeeds collected from non-transgenic trees planted approximated 500 and 1000 meters from the transgenic plot were sampled over six years. Of 2,950 seeds tested, only two transgenic seeds were identified, from the 500 meter plot (outcrossing frequency was 2 in 850 seeds &ndash; 0.23%). It was considered that bees were the most likely vehicle of pollen movement. Further experiments with nine &lsquo;sentinel&rsquo; sites are being continuously monitored.</p>\n\n<p style="text-align: justify;">Gene flow between <i>P. domestica</i> and other <i>Prunus</i> species is unlikely as these species are nearly all diploid while <i>P. domestica</i> is hexaploid. Successful crosses have been made between <i>P. domestica</i> and other species, but most hybrids were sterile and the literature contains many references to the difficulty of interspecific hybridisation within <i>Prunus</i>.<br />\nIntrogression between wild and cultivated species is not documented, but is physically possible as escapes of cultivated varieties are frequently found in woods, pastures and abandoned orchards. However, intercrosses with truly wild species is unlikely as these species are extremely different in morphology as well as in adaptation.</p>\n\n<p style="text-align: justify;"><b>Weediness potential:</b></p>\n\n<p style="text-align: justify;"><i>P. domestica</i> is not described as a weedy species and none of the <i>Prunus</i> species that may be sexually compatible with <i>P. domestica</i> are described as weedy species. In addition, plum is not listed as a noxious weed by the United States Federal authorities or on other weed lists.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Effects:</b></p>\n\n<p style="text-align: justify;">The biology of the C5 plum trees with respect to their potential to affect non-target organisms such as beneficial insects (including pollinators such as bees), and biocontrol organisms was evaluated. The C5 plum does not express detectable coat protein from PPV, which eliminates concern of protein exposure to non-target organisms. Furthermore, even if C5 did express viral coat protein this would not increase the issue of potential impacts to non-target organisms as the PPV coat protein is not known to have any toxic properties. Plant viruses are ubiquitous in the environment and cause damage to fruits, leaves, seeds, flowers, stems, and roots of many important crop species. These viruses infect virtually every plant species and, under natural conditions, certain plant viruses are nearly always present on particular crop or weed hosts. Viral coat proteins are therefore routinely ingested by virtually all mammals when virus-infected fruits and vegetables are consumed. The small-interfering RNAs (siRNA) responsible for the PTGS resistance mechanism in C5 plum are also not of concern as nucleic acids are a normal part of every living organism and do not have toxic or allergenic properties.</p>\n\n<p style="text-align: justify;">The <i>nptII</i> and &szlig;-glucuronidase genes are commonly used marker genes found in soil inhabiting <i>E. coli</i> bacteria. These bacteria are not plant or human pathogens, and do not cause disease symptoms or the production of infectious agents in plants. In addition, these marker genes are not known to cause adverse effects to non-target organisms and both have been granted exemption from the requirement of a tolerance by EPA for use in or on all raw agricultural commodities</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity:</b></p>\n\n<p style="text-align: justify;">Analysis of available information indicates that C5 plum exhibits no traits that would cause increased weediness, that its unconfined cultivation should not lead to increased weediness of other cultivated plum or other sexually compatible relatives, and that it is unlikely to harm non-target organisms common to the agricultural ecosystem or threatened or endangered species. Based on this analysis, there is no apparent potential for significant impact to biodiversity.</p>\n\n<p style="text-align: justify;">Analysis of data on agronomic performance, disease and insect susceptibility, and compositional profiles of the plums indicate no significant differences between C5 plum and non-transgenic counterparts that would be expected to cause either a direct or indirect plant pest effect on any raw or processed plant commodity. Data supplied by the applicant, including results of 10 years of field tests in various environments, suggest that the C5 plum trees have not had observable or measurable impacts on the ecosystems in which they have been allowed to grow. Based upon available information, it was determined that there are no past, present, or reasonably foreseeable actions that would aggregate with effects of the proposed action to create significant cumulative impacts or significantly reduce the long-term productivity or sustainability of any of the resources (soil, water, ecosystem quality, biodiversity, etc.) associated with the ecosystem in which C5 plum is planted.</p>\n', NULL, '2013-08-30 00:48:39');
INSERT INTO `gmcropdatabase_events_esafeties` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(81, 131, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">Event 3272 maize hybrids were tested at 8 locations in 2003 and 17 locations in 2004 in the United States corn belt. A total of 26 agronomic traits were evaluated. These agronomic traits covered a broad range of characteristics that encompass the entire life cycle of the maize plant and included data assessing seedling emergence, vegetative vigour, basic morphology, growth habit, time to reproduction, susceptibility to European corn borer and gray leaf spot, and yield characteristics. Event 3272 is not expected to exhibit modified response to diseases and pest insects, compared to unmodified corn counterparts, as the expression of the AMY797E alpha-amylase and PMI phosphomannose isomerase is unrelated to plant pest potential. For the majority of agronomic traits, no statistically significant differences between Event 3272 hybrids and their non-transformed isogenic counterparts were observed.</p>\n\n<p style="text-align: justify;">Although instances of statistically significant differences between Event 3272 and control hybrids were observed for some traits, there were no consistent trends in the data across locations, hybrids or years, that would indicate that any of these differences were due to the genetic modification. Susceptibility to the European corn borer (ECB) could not be thoroughly evaluated due to very low ECB infestation levels. Similarly, susceptibility to Northern corn leaf blight, Southern corn leaf blight, and other diseases could not be evaluated due to a lack of naturally present disease inoculum. However, no change in response to pests or pathogens is anticipated from the expression of the AMY797E and PMI proteins in Event 3272. Furthermore, trial observations showed that susceptibility of Event 3272 hybrids to gray leaf spot disease is unchanged compared to control hybrids. The results showed no biologically meaningful differences between Event 3272 hybrids and their isogenic non-transgenic counterparts.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">The data included in the submission indicated that as pollen production and viability were unchanged by the genetic modification resulting in Event 3272, pollen dispersal by wind and outcropping frequency should be no different to other maize varieties. Gene exchange between Event 3272 and other cultivated maize varieties will be similar to that which occurs naturally between cultivated maize varieties at the present time. In the United States and Canada, where there are no plant species closely-related to maize in the wild, the risk of gene flow to other species appears remote.<br />\nMaize (<i>Zea mays</i> ssp. <i>mays</i>) freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>mexicana</i>) when in close proximity. These wild maize relatives are native to Central America and are not present in the United States or Canada, except for special plantings. <i>Tripsacum</i>, another genus related to <i>Zea</i>, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of <i>Tripsacum</i> have been reported in the continental United States: <i>T. dactyloides</i>, <i>T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (i.e., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some <i>Tripsacum</i> species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of <i>Tripsacum</i> species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Unmodified plants of <i>Zea mays</i> are not invasive of unmanaged habitats in the United States or Canada. Maize does not possess the potential to become weedy due to the lack of seed dormancy, the non-shattering nature of corn cobs and the poor competitive ability of seedlings. According to the information gained from the field trials, Event 3272 was determined to be similar to unmodified maize in this respect. No competitive advantage was conferred to Event 3272 by the expression of the AMY797E and PMI proteins. The introduction of these novel traits did not make Event 3272 maize weedy or invasive of natural habitats since none of the reproductive or growth characteristics were modified, and tolerance to disease was unchanged. It was concluded that Event 3272 has no increased weediness or invasiveness potential compared to currently commercialized corn varieties.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">The AMY797E protein is not homologous to known toxins. A single-dose oral toxicity study showed that the AMY797E protein is not toxic to the mouse at a dose of 1,511 mg/kg body weight. This dose represents about 2.1 times the worst-case daily dietary dose for rodents eating a diet comprising 100% kernels of maize Event 3272 in the field. Alpha-amylases of varying degrees of amino-acid homology with AMY797E protein occur widely in nature among prokaryotes and eukaryotes. Alpha-amylase enzymes are present in plants, including maize. Alpha-amylase enzymes are also found in human saliva. There is an enormous diversity of alpha-amylases in soil microorganisms, including many heat-stable alpha-amylases. Therefore, it is likely that mammals, birds, insects and microorganisms exposed to AMY797E protein expressed in Event 3272 have had prior exposure to alpha-amylases. No harmful effects of such exposure is known.</p>\n\n<p style="text-align: justify;">Furthermore, as the AMY797E protein is not detectable in pollen of Event 3272, this maize poses no risk to pollinators and non-target pollen consumers. The kernel-specific expression of the protein in Event 3272, the lack of detectable mammalian toxicity of AMY797E, and the weight of evidence that alpha-amylases are not toxic to other wildlife, indicates minimal risk to non-target organisms resulting from exposure to AMY797E protein in Event 3272.</p>\n\n<p style="text-align: justify;">Phosphomannose isomerase is a ubiquitous enzyme involved in carbohydrate metabolism. Phosphomannose isomerases of varying degrees of amino acid homology to PMI expressed in Event 3272 occur widely in nature and have been detected in some crop species, mammals, humans, yeast, fungi and bacteria. Species that will be exposed to PMI from Event 3272 tissues are highly likely to have prior exposure to similar PMI proteins. No harmful effects of such exposure are known or expected. The PMI protein expressed in Event 3272 is not homologous to any known toxins and the bacterially-expressed PMI protein showed a lack of acute toxicity to the mouse at a single oral dose of 3,080 mg PMI/kg body weight. Based on this evidence, no adverse effects on organisms exposed to the PMI protein expressed in Event 3272 are anticipated.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">Event 3272 has no novel phenotypic characteristics that would extend its range beyond the current geographic range of maize production. Event 3272 is not more weedy or invasive than conventional maize and, since maize has no wild relatives with which it can outcross in the United States and Canada, there will be no transfer of the novel traits to other species in unmanaged environments. In addition, the novel traits were determined to pose minimal risk to non-target organisms and no changes to agronomic practices typically applied in management of conventional maize are required for Event 3272. Specifically, no increases in pesticides and fertilizers are required as well as no changes in cultivation, planting, harvesting or volunteer control. Thus, potential impacts on biodiversity are not expected to be different to the cultivation of conventional maize hybrids.</p>\n', NULL, '2013-08-30 00:53:01'),
(82, 136, '<p style="text-align: justify;"><b>Field Trial Evaluations</b></p>\n\n<p style="text-align: justify;">Agronomic data were collected in a series of three experiments (A, B, and C) from confined field trials of 98140 and non-transgenic control maize conducted at up to 15 locations in 2006. The trial locations provided a range of environmental and agronomic conditions representative of the major corn growing regions in the U.S. and Canada, where commercial production of event 98140 is expected. Agronomic practices used to prepare and maintain each field site were characteristic of each respective region.</p>\n\n<p style="text-align: justify;"><b>Experiment A:</b> Comprised seven locations in the major corn growing regions of the Midwest during the 2006 growing season and measured the following parameters: time to silking, time to pollen shed, plant height, ear height, final population, percent moisture, test weight and yield. For all characteristics measured, no statistical differences in mean values were seen between 98140 and control maize across locations (adjusted P-value &gt; 0.05).</p>\n\n<p style="text-align: justify;"><b>Experiment B:</b> Comprised nine locations in the major corn growing region of North America during the 2006 growing season and measured the following parameters: early population, final population, seedling vigor, time to silking, time to pollen shed, stalk lodging, root lodging, stay green, disease incidence, insect damage, yield, plant height and ear height. For all characteristics measured, no statistical differences in mean values were seen between 98140 and control maize across locations (adjusted P-value &gt; 0.05).</p>\n\n<p style="text-align: justify;"><b>Experiment C:</b> Comprised six locations in the major corn growing regions of North America during the 2006 growing season and measured the following parameters: early population, final population, seedling vigor, time to silking, time to pollen shed, stalk lodging, root lodging, stay green, disease incidence, insect damage, plant height, ear height and pollen viability (shape &amp; color) over time. For all characteristics measured, no statistical differences in mean values were seen between 98140 and control maize across locations (adjusted P-value &gt; 0.05).</p>\n\n<p style="text-align: justify;"><b>Ecological Observations</b></p>\n\n<p style="text-align: justify;">Ecological observations (plant interactions with insects and diseases) were recorded for all USDA-APHIS permitted field trials of 98140 maize during the 2005 and 2006 growing seasons. Plant breeders and field staff familiar with plant pathology and entomology observed event 98140 and control lines at least every four weeks for insect and disease pressure and recorded the severity of any stressor seen. In every case, the severity of insect or disease stress on event 98140 was not qualitatively different from various control lines growing at the same location. These results support the conclusion that the ecological interactions for event 98140 were comparable to control maize lines with similar genetics or to conventional maize lines.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Commercial maize varieties are not effective in invading established ecosystems (CFIA, 1994). Maize hybrids have been domesticated for such a long period of time that the seeds cannot be disseminated without human intervention, nor can corn seed readily survive in the U.S. and Canadian environments from one growing season to the next because of the poor dormancy. Any volunteer corn plants are easily identified and controlled through manual or chemical means.</p>\n\n<p style="text-align: justify;">There is little probability that event 98140 maize could become a problem weed. Various characteristics that might impart weediness potential were evaluated for 98140 and control maize in comparative studies, and no differences were seen in characteristics such as seed germination, emergence, seedling vigor, yield, and disease/insect susceptibility. Assessment of these data detected no biologically significant differences between event 98140 and control maize indicative of a selective advantage that would result in increased weediness potential. Furthermore, postharvest monitoring of field trial plots containing 98140 maize have shown no differences in survivability or persistence of event 98140 as compared to conventional maize.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Maize is an open pollinated monoecious plant that produces abundant pollen. Maize pollen is among the largest and heaviest of the wind-dispersed pollen grains, thus limiting the distance it can travel. The potential transfer of traits in pollen to other corn plants is sometimes called pollen-mediated gene flow. There are many factors that affect pollen-mediated gene flow in maize including isolation distance between pollen source and recipient field, size of pollen source and recipient field, shape and orientation of pollen source and recipient field, wind direction and velocity, rain, temperature and humidity, pollen viability, silk receptivity, synchrony of flowering between source and recipient fields, pollen competition and physical barriers. Event 98140 is unchanged with respect to pollen characteristics.</p>\n\n<p style="text-align: justify;">Maize freely hybridizes with annual teosinte (<i>Zea mays</i> ssp. <i>Mexicana</i>) when in close proximity. These wild maize relatives are native to Central America and are not present in the United States or Canada, except for special plantings. Tripsacum, another genus related to Zea, contains sixteen species, of which twelve are native to Mexico and Guatemala. Three species of Tripsacum have been reported in the continental United States: <i>T. dactyloides, T. floridanum</i> and <i>T. lanceolatum</i>. Of these, <i>T. dactyloides</i>, Eastern Gama Grass, is the only species of widespread occurrence and of any agricultural importance. It is commonly grown as a forage grass and has been the subject of some agronomic improvement (i.e., selection and classical breeding). <i>T. floridanum</i> is known from southern Florida and <i>T. lanceolatum</i> is present in the Mule Mountains of Arizona and possibly southern New Mexico. Even though some Tripsacum species occur in areas where maize is cultivated, gene introgression from maize under natural conditions is highly unlikely, if not impossible. Hybrids of Tripsacum species with <i>Zea mays</i> are difficult to obtain outside of the controlled conditions of laboratory and greenhouse. Seed obtained from such crosses are often sterile or progeny have greatly reduced fertility.</p>\n\n<p style="text-align: justify;"><b>Potential Impact on Farming Practices</b></p>\n\n<p style="text-align: justify;"><b>Cultivation and Management Practices:</b> No negative impact is expected from the introduction of 98140 maize on current cultivation and management practices for maize. Event 98140 has been shown to be comparable to conventional maize in phenotypic, ecological and compositional characteristics. Event 98140 maize is expected to be similar in its agronomic characteristics and have the same levels of resistance to insects and diseases as other commercially available maize.</p>\n\n<p style="text-align: justify;"><b>Weed Control:</b> The commercialization of herbicide tolerant 98140 maize is expected to have a beneficial impact on weed control practices, as growers will have more herbicide options available to address their regional weed problems. Event 98140 maize will enable growers to choose an optimal combination of glyphosate, ALS-inhibiting herbicides, and other complementary herbicides to best manage their individual weed populations. Growers value the glyphosate-resistant crop trait and the utility of glyphosate. The availability of event 98140 maize will enable growers to proactively manage weed populations while delaying population shifts to troublesome weeds or the evolution of resistant weeds. Alternating herbicides with different modes of actions to control weeds generally is recommended to help delay the evolution of herbicide-resistant weeds. Therefore, incorporating tolerance to two herbicides with different modes of action in maize, as in event 98140, will be useful.</p>\n\n<p style="text-align: justify;"><b>Potential Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">Event 98140 maize does not have an increased weediness potential, and unconfined cultivation of 98140 maize hybrids should not lead to increased weediness of other sexually compatible relatives, as non cultivated <i>Zea mays</i> species are not found in the United States or Canada. Therefore, it is unlikely to have effects on non-target organisms common to the agricultural ecosystem or threatened or endangered species, and there is no apparent potential for significant impact to biodiversity.</p>\n', NULL, '2013-08-30 01:01:45'),
(83, 137, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">The genetic modification resulting in transgenic maize event MIR162 was not intended to affect a specific agronomic or phenotypic characteristic except to confer resistance to certain lepidopteran insect pests. Grain yield and agronomic performance of MIR162 maize (field corn) hybrids were evaluated in a series of trials across a total of 16 locations over two years. In addition to inspections for disease and insect damage, qualitative and quantitative comparisons for a number of morphological and agronomic traits were made between MIR162 hybrids and non-transgenic control hybrids. The traits chosen for agronomic comparison were those typically observed by professional maize breeders and agronomists, covering a broad range of characteristics that encompass the entire life cycle of the maize plant. The agronomic performance and phenotypic data generated for MIR162-derived hybrids and their corresponding near isogenic non-transgenic control hybrids suggest that the genetic modification resulting in event MIR162 did not have any unintended effect on plant growth habit and general morphology, lifespan, vegetative vigour, flowering and pollination, grain yield, or disease susceptibility.</p>\n\n<p style="text-align: justify;"><b>Potential for Increased Weediness or Invasiveness</b></p>\n\n<p style="text-align: justify;">Maize has lost the ability to survive in the wild due to its long process of domestication, and needs human intervention to disseminate its seed. Although maize from the previous crop year can over-winter and germinate the following year, it cannot persist as a weed. In contrast to weedy plants, maize has a pistillate inflorescence (ear) with a cob enclosed with husks. Consequently seed dispersal of individual kernels does not occur naturally. The phenotypic comparison of event MIR162-derived hybrids and non-transgenic hybrids did not reveal any consistent biologically meaningful differences in vegetative vigour, time to maturity and seed production. These data support the conclusion that event MIR162-derived hybrids are unlikely to form feral persistent populations, or to be more invasive or weedy than conventional maize hybrids.</p>\n\n<p style="text-align: justify;"><b>Altered Plant Pest Potential</b></p>\n\n<p style="text-align: justify;">The intended effects of expression of the Vip3Aa20 and PMI proteins are unrelated to plant pest potential, and maize itself is not a plant pest in the United States or Canada. In addition, agronomic characteristics of MIR162-derived hybrids were not consistently significantly different than near-isogenic non-transgenic hybrids and indicated that growth habit of maize had not been unintentionally altered as a result of the genetic modification. Field observations did not indicate modifications to disease and pest susceptibilities.</p>\n\n<p style="text-align: justify;"><b>Potential Impacts on Non-target Organisms</b></p>\n\n<p style="text-align: justify;">An assessment of risk for nontarget organisms and endangered species that might be exposed to the Vip3Aa20 protein in MIR162 maize was performed. Extensive nontarget organism studies were performed with 12 different species representative of wild birds, wild mammals, pollinators, above ground arthropods, soil-swelling arthropods, aquatic organisms and farmed fish. No adverse effects were observed in any study that exposed representative nontarget organisms to Vip3Aa proteins. The concentration of Vip3Aa tested in the studies was sufficient to achieve margins of exposure of ? 1 for all but one species based on realistic expected environmental concentrations.</p>\n\n<p style="text-align: justify;">There is a weight of evidence that at concentrations in MIR162 maize, the toxicity of Vip3Aa20 will be limited to certain species of Lepidoptera. Its receptor-mediated mechanism of action and absence of activity in bioassays with multiple species outside of the order Lepidoptera support this conclusion. The comparison of hazard and exposure data corroborate the hypothesis that Vip3Aa20 is not harmful to nontarget organisms at concentrations likely to result from cultivation of MIR162, and provide a weight of evidence that Vip3Aa20 in MIR162 maize will have no harmful effects on populations of potentially exposed nontarget organisms.</p>\n\n<p style="text-align: justify;">The only endangered lepidopteran with potential for exposure to insecticidal proteins in maize is the Karner blue butterfly (<i>Lycaeides melissa samuelis</i>), which is listed as extirpated (a wildlife species that no longer exists in the wild in Canada, but exists elsewhere in the wild) in Schedule 1 of the Species at Risk Act. Even should Karner blue butterfly populations be recovered in the wild in Canada, exposure to maize pollen from MIR162 would be minimal because of the large separation between populations of its food plant (wild lupine; <i>Lupinus perennis</i>) and cultivated maize, and because maize anthesis usually occurs after the Karner blue has finished feeding.</p>\n\n<p style="text-align: justify;"><b>Potential Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">Event MIR162 has no novel phenotypic characteristics which would extend its use beyond the current geographic range of maize production in the United States and Canada. Since maize does not out cross to wild relatives in the United States or Canada, there will be no transfer of novel traits to unmanaged environments. MIR162 maize provides excellent protection against feeding damage caused by <i>A. ipsilon, H. zea, S. albicosta</i>, and <i>S. frugiperda</i>. For this reason, its introduction will impact current maize insect control practices in a very positive way, having the potential to displace conventional insecticide applications for control of these pests. Therefore, the potential impact on biodiversity of MIR162 is equivalent to its unmodified counterparts.</p>\n', NULL, '2013-08-30 01:03:38'),
(84, 141, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">Field studies were designed to compare agronomic performance of the transformed GlyTol cotton event GHB614, with the non-transformed Coker 312 counterpart. Data from agronomic trials were taken from 17 locations in 5 states over the 2004 and 2005 growing seasons. Studies were conducted in geographic regions of the southern United States representative of the regions in which nearly 94% of the total upland cotton production occurs. A comparison of 18 agronomic characteristics across eight locations in 2004 and nine locations in 2005 compared plant growth and plant mapping data taken by field agronomists to evaluate the growth and development of the plant. Plant mapping data was taken to evaluate the potential reproductive success of the cotton plant. The number of bolls, first position bolls, plant height, and total number of nodes are all key parameters for cotton production as it impacts the value, maturity, and development of the cotton fiber. Plant height and height to node ratio was calculated from these parameters as it is used as an indication of insufficient herbicide tolerance. These parameters are also used to determine the application timing of plant growth regulators (PGR) used to manage the height of the cotton plant which improves mechanical harvesting efficiency. Morphology ratings were taken to monitor for irregular plant development in key portions of the plant such as the leaves, flowers, and bolls. Fertility of the plant was measured in rating the number of embryos (seed) in the boll, their weight and the size of the fruit developed to house them. Fertility ratings were also taken to evaluate the fertility of the flower by the amount of pollen present and dehiscence.</p>\n\n<p style="text-align: justify;">Evaluation of plant mapping data and crop development data showed no significant differences in the GlyTol cotton event GHB614 and the non-transgenic Coker 312 counterpart. Findings across locations show that GlyTol cotton is similar for maturity and yield to the nontransformed counterpart in both Coker 312 and commercial cotton varieties. No differences were noted in the morphology of the plants when compared across testing locations. All plants with the GlyTol cotton event GHB614 and their non-transgenic Coker 312 counterparts appeared to develop normally, with no abnormalities noted in field observations.</p>\n\n<p style="text-align: justify;"><b>Seed Dormancy</b></p>\n\n<p style="text-align: justify;">Seed dormancy was evaluated in the GlyTol cotton event GHB614 to ensure that seed dormancy was not affected by the transformation of the Coker 312 germplasm or the production of the 2mEPSPS protein. Seeds were collected from the 2005 efficacy trials of transformation event GHB614 in six locations to test for effects to the seed dormancy. No significant differences were seen in germination between the transgenic and nontransgenic seed produced from the 2005 plot sites. Normal variation was detected between those which were planted immediately after harvest, and those which were stored for six months. This indicates that transformation event GHB614 does not increase seed dormancy and therefore does not contribute to the weediness of the transformed cotton plant through increased seed dormancy.</p>\n\n<p style="text-align: justify;"><b>Potential Plant Pest Risk</b></p>\n\n<p style="text-align: justify;">In addition to agronomic performance composition of the seed was evaluated for any potential plant pest risks to current cotton production in the United States. Composition data provided information on gossypol, antinutrient levels, and other toxicant contents. The overall conclusion is that there are no agronomically meaningful differences between the transformed GlyTol cotton event GHB614 and non-transformed cotton varieties evaluated. The resulting conclusion is that there are no new agronomic plant pest risks from the introduction of GlyTol cotton.</p>\n\n<p style="text-align: justify;"><b>Potential for Increased Weediness</b></p>\n\n<p style="text-align: justify;">In the United States, cotton (<i>G. hirsutum</i>) is not a weed pest and has no sexually compatible weedy relatives except perhaps <i>G. tomentosum</i> in Hawaii where there is no commercial cotton production. There is limited probability that Glytol cotton event GHB614 or any <i>Gossypium</i> species containing GlyTol cotton event GHB614 would become a weed problem. From the agronomic and phenotypic data, there were no consistent significant differences in germination, dormancy, phenotypic or plant morphological characteristics between the transgenic GlyTol cotton event GHB614 and the conventional near isogenic line Coker 312 that would impact plant pest or noxious weed potential. Based on these data there was no evidence to suggest that GlyTol cotton has a higher likelihood to become a weed than conventional cotton. There were no instances in which volunteer monitoring after harvest revealed any differences in survival or persistence relative to other cotton varieties.</p>\n\n<p style="text-align: justify;"><b>Potential Impact on Non-Target Organisms</b></p>\n\n<p style="text-align: justify;">Compositional analysis on the plants containing 2mEPSPS protein indicated no significant changes in the overall gossypol content of the plants or antinutrient levels between GlyTol cotton event GHB614 and the non-transgenic counterpart. This indicates that the transformed cotton is no more toxic than its non-transgenic counterpart. Composition findings are reinforced by visual field observations made by cooperators conducting field evaluations of the GlyTol cotton plants. Cooperators visually monitored all plots for differences in beneficial insect populations and types for each trial, as well as birds, pollinators, and other wildlife species. No reports of differences in populations for any of these non-target organisms were made by cooperators making these observations.</p>\n', NULL, '2013-08-30 01:10:28'),
(85, 142, '<p style="text-align: justify;"><b>Growth Habit and Ability to Overwinter</b></p>\n\n<p style="text-align: justify;">Leaf, stem, and fruit morphologies of X17-2 plants were normal throughout the year. X17-2 plants continuously grow throughout the year; more vigorously when ambient temperatures are above 65F and more slowly during cool weather (i.e., temperatures 50-65F). Once warm temperatures commence in the spring X17-2 papayas resume vigorous growth whereas PRSV-infected non-transgenic papaya only slowly resume growth; not growing vigorously until high temperatures in mid-summer.</p>\n\n<p style="text-align: justify;"><b>Life-Span and Vegetative Vigor</b></p>\n\n<p style="text-align: justify;">Papaya plants may live up to 20 years, however, typically, viral infection, other diseases, or natural disasters reduce their life-span to 4-5 years; commercial plants are replaced after 2-3 years. The fifth generation of the X17-2 has been grown for over two years with some losses due to 4 hurricanes in 2005.</p>\n\n<p style="text-align: justify;"><b>Days to Flowering and Fruit Maturity</b></p>\n\n<p style="text-align: justify;">The days from planting to first flowering and the rate of fruit development is influenced by genetics, environmental conditions (mostly temperature), and cultural practices. During the summer, there were no observed differences in the days to flowering or rate of fruit maturity between X17-2 papayas and PRSV-tolerant papaya cultivars (e.g., &lsquo;Red Lady&rsquo;). During spring, fall, and winter, fruit development was slower for non-transgenic plants compared to X17-2 papayas, most likely due to the effect of the PRSV on leaf area and health.</p>\n\n<p style="text-align: justify;"><b>Seed Parameters</b></p>\n\n<p style="text-align: justify;">No differences among X17-2 line papayas and non-transgenic papayas in seed production, dormancy, percent germination, seedling survival, or seedling emergence.</p>\n\n<p style="text-align: justify;"><b>Pollination and Reproduction</b></p>\n\n<p style="text-align: justify;">After X17-2 seedling field establishment and once plants begin to flower (usually 4-5 months post planting), female plants are generally eliminated from the field since only hermaphrodites have the ability to self-pollinate (thus reducing the need for male plants) and possess the desired fruit characteristics. The X17-2 line papayas are self-compatible as are all hermaphroditic papaya plants, and there were no observed changes in flower morphology or potential pollinator species in the field plots. There were no observed differences in the fertility of the X17-2 line papayas compared to other commercial papaya cultivars. Papaya seeds do not shatter even if the fruit is damaged.</p>\n\n<p style="text-align: justify;"><b>Weediness</b></p>\n\n<p style="text-align: justify;">No Carica species is considered a weed, and there is no evidence in the scientific literature to suggest that susceptibility to PRSV is the factor that prevents these plants from being weed pests. Therefore, it seems likely that even if the PRSV-resistance trait could be transferred from line X17-2 to another Carica species, the resultant offspring would not be weed pests.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">It was concluded that the genes inserted into the transgenic papaya line X17-2 would not result in any deleterious effects or significant impacts on non-target organisms, including threatened and endangered species or beneficial organisms. The PRSV coat protein expressed in these papaya lines is found in all PRSV-infected plants, and there are no reports of this protein having any toxic effects. In fact, this viral coat protein is routinely ingested by virtually all animals, including humans, when papaya is consumed. Naturally occurring infections of susceptible papaya varieties result in concentrations of coat proteins far higher than those that occur in the tissues of the transgenic papaya line X17-2. No direct pathogenic properties, nor any hypothetical mechanisms for pathogenesis toward beneficial organisms, such as bees and earthworms, were identified for papaya line X17-2.</p>\n', NULL, '2013-08-30 01:12:37'),
(86, 143, '<p style="text-align: justify;"><b>Gene Flow</b></p>\n\n<p style="text-align: justify;">The pollen flow / out crossing study conducted in 2003 using Bt Event-1 revealed that out-crossing occurred only upto 2 meters, and only 1% of the pollen reached a distance of 2 meters and beyond 2mt distance no plants were out crossed with transgenic pollen. As the cotton pollen is heavy and sticky, the range of pollen transfer is limited because it was observed that the pollen out crossing taken place upto the distance of 1 mt in East and North direction and 2mt in west direction of experimental site. Since the Bt gene is incorporated into tetraploid species and the native Indian cottons are of diploids and are not crossable to tetroploids, there is no chance that the Bt gene will transfer from cultivated tetraploid species to near relatives such as traditionally cultivated diploid species.</p>\n\n<p style="text-align: justify;"><b>Potential Weediness</b></p>\n\n<p style="text-align: justify;">The potential weediness of JK Bt Cotton Event-1 was assessed in comparison with non transgenic line of same by testing its vigor and the rate of germination in laboratory test as well in soil. The results demonstrated that there are no significant differences observed between Bt and non-Bt cotton for germination and vigor. This indicates that the Bt and non-Bt cotton are not different in regard to their weediness potential. In general the cotton plants are not having the potential weediness characteristics such as seed dormancy, soil persistence, germination under diverse environmental conditions, rapid vegetative growth, short life cycle or high seed out put and dispersal.</p>\n\n<p style="text-align: justify;"><b>Potential Impacts on Non-Target Organisms</b></p>\n\n<p style="text-align: justify;">The studies conducted on non-target organisms and beneficial insects during the multi-location and large scale field trials of JK- Bt Cotton Event &ndash;1 revealed that the Bt cotton hybrids do not have any toxic effects on the non-target species, namely sucking pests (aphids, jassids, white fly and mites). The population of secondary lepidopteran pests (<i>Spodoptera litura</i>) remained negligible during the study period in both Bt and non-Bt hybrids. The movement of beneficial insects populations (Chrysopa, Coccinellids, Syrphids and Spider) are equal and remained active over both Bt and non Bt cotton plots.</p>\n\n<p style="text-align: justify;"><b>Environmental Fate</b></p>\n\n<p style="text-align: justify;">Studies were conducted to assess the possible risk of accumulation of Bt protein in the soil as exudates from the roots of Bt Cotton. The soil samples from the Bt plots of different locations were subjected to quantify the Bt protein and the results showed that it was not detected in soil samples. This indicates that Bt protein is rapidly degraded in the soil on which Bt cotton is grown. This study showed that the Cry 1AC protein was rapidly degraded in the soil in both the purified form of the protein and as part of the cotton plant tissue. The half-life for the purified protein was less than 20 days. The half-life of the Cry 1AC protein in plant tissue was calculated to 41 days which is comparable to the degradation rates reported for microbial formulations of Bt.</p>\n\n<p style="text-align: justify;"><b>Potential Impacts on Soil Microflora</b></p>\n\n<p style="text-align: justify;">This Study was conducted in 2004 and 2005 to evaluate any impact of Bt protein exudated by roots of Bt cotton on the soil micro-flora. There was no significant difference in population of microbes and soil invertebrates like earthworm and Gllembola between Bt and non-Bt plant rhizosphere soil samples.</p>\n', NULL, '2013-08-30 01:14:23'),
(87, 85, '<p style="text-align: justify;">There were no identified significant adverse effects of the Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, or Cry34Ab1/35Ab1 proteins on the abundance of non-target organisms in any field population, whether expressed individually or as MON89034 x TC1507 x MON88017 x DAS-59122-7 combined stacked maize hybrid. The potential for synergistic effects was evaluated and the data that were reviewed for the individual parental events can be bridged to support the authorization of MON89034 x TC1507 x MON88017 x DAS-59122-7.</p>\n\n<p style="text-align: justify;">It is unlikely that direct or indirect harmful effects to non-target organisms, including threatened or endangered species, would result from the insecticidal proteins Cry1A.105, Cry2Ab2, Cry1F, Cry3Bb1, or Cry34/35Ab as a result of the authorized environmental release of this stacked maize hybrid. There is no expectation that full commercial cultivation would result in a hazard to the environment.</p>\n', NULL, '2013-08-29 23:56:16'),
(88, 133, '<p style="text-align: justify;"><strong>Field Testing</strong></p>\n\n<p style="text-align: justify;">Soybean event 356043 has been field-tested in the United States, Canada, and Japan. During the field tests, several phenotypic characteristics were evaluated, including early population, seedling vigor, days to maturity, plant height, lodging, pod shattering, final population, and yield. The statistical analysis of these observations showed no biologically meaningful differences between soybean 356043 and the control plant and supports a conclusion of phenotypic equivalence to currently commercialized soybean lines. The seed dormancy and germination of soybean event 356043 were compared with the control, and no significant differences were detected in percent germinated seed, percent dead seed, and percent viable firm, swollen seed and viable hard seed. Viable hard seed was not observed in seed germination and seed viability tests of soybean event 356043. Data on the susceptibility to a range of insect pests and diseases, and response to abiotic stressors were also recorded. No increase or decrease outside of the reference range was observed in any insect or abiotic stressor in soybean event 356043.</p>\n\n<p style="text-align: justify;"><strong>Outcrossing</strong></p>\n\n<p style="text-align: justify;">Pollen-mediated gene flow and introgression from transformed soybean line 356043 is extremely unlikely as there are no relatives of cultivated soybean in the continental United States and Canada, and soybean plants are almost completely self-pollinated. Furthermore, the reproductive characteristics such as pollen production and viability were unchanged by the genetic modification resulting in 356043 soybean.</p>\n\n<p style="text-align: justify;">Cultivated soybean, Glycine max, naturally hybridizes with the wild annual species G. soja. However, G. soja is only found naturally occurring in China, Korea, Japan, Taiwan and the former USSR, and is not naturalized in North America, although it may possibly be grown in research plots. It was concluded that the potential for transfer of the herbicide tolerance traits from the transgenic line to soybean relatives through gene flow was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada and the continental United States.</p>\n\n<p style="text-align: justify;"><strong>Weediness Potential</strong></p>\n\n<p style="text-align: justify;">Soybean (G. max) is not considered a weed and it does not persist in unmanaged ecosystems. In the United States, soybean is not listed as a weed in the major weed references and has been grown throughout the world without any report that it is a serious weed. Agronomic and phenotypic data collected from 16 field trial locations in North America over the 2004 and 2005 growing seasons indicated that 356043 was not different in any fitness characteristics from its parent that might cause 356043 to become invasive. There were no data indicating that the presence of the gat4601 or gm-hra genes improved the ability of this soybean line to survive without human intervention, nor is there any foreseeable reason to conclude that these genes would affect this line&rsquo;s survival in the wild. The combination of phenotypic data and ecological observations supported a conclusion of agronomic and phenotypic comparability of 356043 soybean to conventional soybean varieties with respect to the lack of increased weed or plant pest potential.</p>\n\n<p style="text-align: justify;"><strong>Secondary and Non-Target Adverse Effects</strong></p>\n\n<p style="text-align: justify;">Considering that GAT4601 and GM-HRA proteins lack the properties of known toxins or allergens, there should be no significant impacts to the environment or to non-target organisms, including threatened and endangered species from the introduction of 356043 soybean.</p>\n\n<p style="text-align: justify;"><strong>Impact on Biodiversity</strong></p>\n\n<p style="text-align: justify;">Analysis of available information demonstrates that 356043 does not exhibit any traits that should cause increased weediness, and that its unconfined cultivation should not lead to increased weediness of other sexually compatible relatives, of which there are none in North America. Soybean event 356043 has no effect on non-target organisms common to the agricultural ecosystem. Glyphosate use and crop production practices are not expected to change significantly, therefore there should be no indirect or cumulative effect on biodiversity related to these practices. Use of ALS-inhibitor herbicides will likely increase in order to manage glyphosate-tolerant weed populations, but the use of glyphosate and ALS-inhibitors on 356043 soybean according to product labels is not expected to cause significant impacts on biodiversity outside the agroecosystem based on the chemical and toxicological properties of these products.</p>\n', NULL, '2013-08-30 00:58:01');
INSERT INTO `gmcropdatabase_events_esafeties` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(89, 146, '<p style="text-align: justify;"><b>Field Testing</b></p>\n\n<p style="text-align: justify;">The agronomic and compositional characteristics of EH92-527-1 were compared with those of the parental cultivar Prevalent in field trials carried out over multiple growing seasons in multiple locations in Sweden. Trial site locations were representative of the typical areas for cultivation of conventional starch potatoes. Data on agronomic characteristics were obtained from field trials during 1994-1996 and variety trials during 1996-1997. Compositional data were obtained from field trials during 1996-1998. No significant differences in growth characteristics between EH92-527-1 and Prevalent were observed nor were there any differences in susceptibility to herbicide, late blight fungal disease, and frost. Additionally, EH92-527-1 did not display altered susceptibility to insects, bacteria, other fungi, nematodes, and plant viruses.</p>\n\n<p style="text-align: justify;"><b>Outcrossing</b></p>\n\n<p style="text-align: justify;">Potato is largely propagated vegetatively via tubers, but certain varieties can also form seeds. With regard to plant-to-plant gene transfer, the natural exchange of genetic material is only possible with other varieties of <i>Solanum tuberosum</i>. No natural genetic exchange has been detected with the potato&#39;s wild relatives in Europe, i.e., <i>Solanum nigrum</i> (deadly nightshade) and <i>Solanum ducamara</i> (woody nightshade). Efficient incompatibility barriers prevent hybridization between these species and <i>Solanum tuberosum</i>. Therefore, the chances of successful hybridization between transformed potatoes and other Solanum species under field conditions are considered extremely remote.</p>\n\n<p style="text-align: justify;">Any genetic spread is assessed as limited to cross-pollination with other potatoes. However, no changes in flower morphology have been observed for EH92-527-1 that could indicate a change in the ability to produce and release pollen. Therefore, no changes compared to conventional starch potatotes concerning the transfer of genetic material to other potato varieties is expected. The pollen production of flowers of EH92-527-1 is low and most of the flowers are shed before the pollen is ready. EH92-527-1 and Prevalent abort most flowers prematurely, and the stamen produce almost no pollen. This makes the probability of dispersal through pollen very low. Because the chance of any successful transfer is considered to be remote and would convey no selective advantage to any hybrid, the potential risk is considered to be extremely low. Therefore, the plant-to-plant gene transfer of the nptII and the antisense gbss genes is considered unlikely to be of environmental concern. Outside arable land, potato has a very low competitivelness, particularly in northern Europe, where the EH92-527-1 potatoes are intended to be cultivated.</p>\n\n<p style="text-align: justify;">With respect to plant-to-bacteria gene transfer, potato EH92-527-1 contains an nptII gene for kanamycin resistance that could theoretically be transferred from plant material to microbes in the soil. However, it is likely that cell DNA will be degraded by autolysis in any plant material left in the soil. Secondly, kanamycin resistance already occurs naturally in soil bacteria. Consequently, any additional contribution from potential transfer of nptII to soil microbes is considered insignificant.</p>\n\n<p style="text-align: justify;">Furthermore, studies show that a very large degree of homology is required between the plant&#39;s and the bacteria&#39;s DNA in order for horizontal gene transfer to take place at all in targeted studies. Under natural conditions, several other factors become important and these factors further limit the possibility for horizontal gene transfer that would result in a population of resistant bacteria. These factors include the absence of prokaryotic regulation sequences linked to <i>nptII</i> in the genetic construct in question and the need for selection pressure at the time of the gene transfer.<br />\nIn addition, gene transfer of the antisense gbss construct is not considered to pose an environmental risk. Furthermore, as demonstrated by Southern analysis, no genetic elements outside of the right and left border region of the T-DNA in construct pHoxwG that could affect the mobility of DNA have been inserted into potato event EH92-527-1. Therefore, no changes as compared to conventional starch potatoes are expected in the ability of EH92-527-1 to transfer genetic material to bacteria.</p>\n\n<p style="text-align: justify;"><b>Weediness Potential</b></p>\n\n<p style="text-align: justify;">Potato does not compete well outside the cultivated environment, but can survive mild winter temperatures as tubers in soil. The experimental data indicated that potato EH92-527-1 does not differ from its parent cultivar Prevalent with respect to frost tolerance, sensitivity to chemical treatment, and susceptibility to diseases and pests. No evidence was seen of increased competitiveness or over-winter survival that would indicate enhanced weediness or invasiveness of potato EH92-527-1. Outside the field, potato seedlings have difficulty becoming established, as they are at a competitive disadvantage relative to other plants. In general, the potato is not known as a colonizer of unmanaged ecosystems. It is not able to compete effectively with other species such as grasses, trees, and shrubs.<br />\nThe potato&#39;s low competitiveness outside arable land is especially true in northern Europe where EH92-527-1 is planned to be grown. EG92-527-1 and Prevalent can be assumed to have even less long-term competitive ability, because they shed most flowers prematurely and produce very little pollen. In order for the potato to establish itself and spread outside the field in northern Europe, its competitive ability would have to increase significantly.</p>\n\n<p style="text-align: justify;"><b>Secondary and Non-Target Adverse Effects</b></p>\n\n<p style="text-align: justify;">Data from field studies conducted in Sweden, Germany, and the Netherlands showed neither greater susceptibility nor greater resistance to pests (e.g., aphids, leafhoppers, potato cyst nematodes (sp. Globodera) and diseases (e.g., late blight (<i>Phytophthora infestans</i>), potato early blight (<i>Alternaria solani</i>), Erwinia rots) in potato EH92-527-1 versus non-GM potato lines. In addition, there was no evidence of changes in sensitivity to the plant-associated viruses PVY, PLRV, PMTV, and TRV.</p>\n\n<p style="text-align: justify;">It is believed that altered starch composition may have an effect on certain microorganisms, and that increased sugar content and reduced glycoalkaloid content might result in pests (e.g., insects) attacking the potato to a larger extent. However, several years of field trials on large areas under production conditions have not indicated any such differences. Furthermore, the levels of these substances are within the variation for conventional potatoes.<br />\nAlso, the antibiotics resistance and the increased amounts of vitamin C content should not be able to affect non-target organisms.</p>\n\n<p style="text-align: justify;">While, theoretically, event EH92-527-1 could have effects on other organisms if it were to establish itself within natural plant populations, the parent cultivar Prevalent, which has not shown spreading ability significantly different from that of EH92-527-1, has not been able to establish itself outside arable land. In addition, factors that provide for low competitive ability in the long term are that both Prevantent and EH92-527-1 shed most of their flowers prematurely, and produce almost no pollen.</p>\n\n<p style="text-align: justify;">In view of these results and the equivalent composition of the GM potato plant, it is considered that no adverse effects on plant-associated organisms would be expected from cultivation of the potato EH92-527-1. Furthermore, due to the nature of the modified trait and to the equivalence of the agronomic traits of the GM potato relative to those of the non-GM parental line, it is considered that no adverse effects on the abiotic environment would be likely from cultivation of EH92-527-1.</p>\n\n<p style="text-align: justify;"><b>Impact on Biodiversity</b></p>\n\n<p style="text-align: justify;">EH92-527-1 will be grown in the same regions of Europe in which starch potatoes are presently grown and it will be farmed using identical techniques. The demonstrated equivalency of the EH92-527-1 event to the parental variety Prevalent suggests that the growing of EH92-527-1 represents no greater risks to biodiversity than does the parental variety or do other starch potatoes. As noted earlier, cultivated starch potatoes do not grow well outside of the immediate cultivated area. Pollen movement from EH92-527-1 is like that of the parental variety and moves only very short distances, if at all. Considering this, together with the equivalency of EH92-527-1 to the parental variety, the effects on biodiversity in other habitats should be no different from those of other starch potatoes. In particular, both the starch component amylopectin and the NPTII protein have a safe history of use and do not engender any alteration in the interactions with the biotic environment as compared to the parental cultivar Prevalent.</p>\n', NULL, '2013-08-30 01:17:29'),
(105, 98, '', '2013-08-23 12:52:24', '2013-08-30 15:20:01'),
(102, 166, '<p><span style="color: rgb(89, 89, 89); font-family: Verdana, Helvetica, Arial, ''Sans Serif''; font-size: 11px; line-height: 14px; text-align: justify;">Agronomic and phenotypic evaluations of 4114 maize were conducted in order to support a conclusion of &ldquo;familiarity&rdquo; based on the similarity of phenotypic characteristics with conventional and/or control maize. The phenotypic evaluations were based on laboratory experiments, to examine seed dormancy and germination, and replicated, multi-location field trials to collect data on representative characteristics that influence reproductive and survival biology. In each of these assessments, 4114 maize was compared to a near?isogenic control (i.e.,&nbsp;</span><i style="color: rgb(89, 89, 89); font-family: Verdana, Helvetica, Arial, ''Sans Serif''; font-size: 11px; line-height: 14px; text-align: justify;">ca</i><span style="color: rgb(89, 89, 89); font-family: Verdana, Helvetica, Arial, ''Sans Serif''; font-size: 11px; line-height: 14px; text-align: justify;">. 98 percent similar) that did not go through the transformation process, and/or to commercial maize hybrids.</span><br style="color: rgb(89, 89, 89); font-family: Verdana, Helvetica, Arial, ''Sans Serif''; font-size: 11px; line-height: 14px; text-align: justify;" /><br><span style="color: rgb(89, 89, 89); font-family: Verdana, Helvetica, Arial, ''Sans Serif''; font-size: 11px; line-height: 14px; text-align: justify;">Germination rates of 4114 maize seed under warm, cold, and diurnal conditions were comparable to those of control maize under corresponding conditions. No potentially dormant seed were identified using a standard tetrazolium chloride test, which was applied to any non-germinated seed that were classified as hard or imbibed. Maize line 4114 can therefore be considered comparable to conventional maize with respect to seed germination and potential dormancy.</span><br><span style="color: rgb(89, 89, 89); font-family: Verdana, Helvetica, Arial, ''Sans Serif''; font-size: 11px; line-height: 14px; text-align: justify;">Comparisons of emergence and vegetative growth parameters between 4114 and control maize were based on assessments of early plant population, seedling vigour, plant height, ear height, stalk lodging, root lodging, final plant population, and stay green. There were no statistically significant differences in any of these parameters between 4114 and control maize.</span><br><span style="color: rgb(89, 89, 89); font-family: Verdana, Helvetica, Arial, ''Sans Serif''; font-size: 11px; line-height: 14px; text-align: justify;">Potential changes to the reproductive characteristics of 4114 maize were assessed through a combination of laboratory evaluations of seed germination and dormancy (previously described); evaluation of pollen viability, as correlated to pollen shape and colour; and collection of relevant field data on time to silking, time to pollen shed, and yield. In addition, visual estimates of foliar disease incidence and insect damage were collected for both 4114 and control maize at each location. There were no statistically significant differences in any of the parameters related to reproductive biology or disease and pest susceptibility between 4114 and control maize.</span></p><br>', '2013-08-09 12:49:40', '2013-08-23 00:19:19'),
(107, 107, '', '2013-08-30 16:46:53', '2013-08-30 16:46:53'),
(108, 108, '', '2013-09-02 13:10:02', '2013-09-02 13:13:42'),
(109, 119, '', '2013-09-02 13:41:41', '2013-09-02 13:41:41');

-- --------------------------------------------------------

INSERT INTO `gmcropdatabase_events_execsummaries` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(1, 21, '<p style="text-align: justify;">Soybean (<i>Glycine max</i>) is grown primarily for its seed, which has many uses in the food and industrial sectors, and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use. The major producers of soybeans were the United States, Brazil, Argentina, China, India, Paraguay and Canada.<br />\nA major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock.</p>\n\n<p style="text-align: justify;">Weeds are a major production problem in soybean cultivation. Typically, weeds are managed using a combination of cultural (<i>e.g.</i> seed bed preparation, using clean seed, variety selection, and planting date) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be applied before planting (<i>e.g.</i> pendimethalin, trifluralin, metribuzin), after planting but before emergence (<i>e.g.</i> pendimethalin, linuron, imazethapyr), and/or after emergence (<i>e.g.</i> bentazon, acifluorfen, fomesafen). Commonly, several different herbicides are required to adequately control weeds in soybean fields.</p>\n\n<p style="text-align: justify;">The soybean line GTS 40-3-2 was developed to allow for the use of glyphosate, the active ingredient in the herbicide Roundup&reg;, as a weed control option. This genetically engineered soybean line contains a form of the plant enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that allows GTS 40-3-2 to survive the otherwise lethal application of glyphosate. The EPSPS gene put into GTS 40-3-2 was isolated from a strain of the common soil bacterium <i>Agrobacterium tumefaciens</i> called CP4 and the form of EPSPS enzyme produced by this gene is tolerant to glyphosate.</p>\n\n<p style="text-align: justify;">The EPSPS enzyme is part of an important biochemical pathway in plants called the shikimate pathway, that is involved in the production of aromatic amino acids and other aromatic compounds. When conventional plants are treated with glyphosate, the plants cannot produce the aromatic amino acids needed to grow and survive. EPSPS is present in all plants, bacteria, and fungi. It is not present in animals, which do not synthesize their own aromatic amino acids. Because the aromatic amino acid biosynthetic pathway is not present in mammals, birds or aquatic life forms, glyphosate has little if any toxicity for these organisms. The EPSPS enzyme is naturally present in foods derived from plant and microbial sources.</p>\n\n<p style="text-align: justify;">GTS 40-3-2 was developed by introducing the CP4 EPSPS gene into a commercial soybean variety using particle-acceleration (biolistic) transformation. The glyphosate tolerance trait expressed in GTS 40-3-2 has since been transferred into more than one thousand commercial soybean varieties by traditional breeding techniques.<br />\nGTS 40-3-2 has been tested in field trials in the United States, Central and South America, Europe, Central Europe and Canada since 1991. Data collected from over 150 field trials conducted over a three-year period prior to commercialization in the United States demonstrated that GTS 40-3-2 did not differ significantly from conventional soybeans in morphology, seed production (yield), agronomic characteristics (such as time to flowering and pod set, or vigor) and tendency to weediness. GTS 40-3-2 did not negatively affect beneficial or nontarget organisms, and was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Soybean does not have any weedy relatives with which it can crossbreed in the continental United States and Canada. Cultivated soybean can naturally cross with the wild annual species <i>G. soja</i>, however <i>G. soja</i>, which occurs naturally in China, Korea, Japan, Taiwan and the former USSR, is not naturalized in North America. Additionally, soybean plants are almost completely self-pollinated and reproductive characteristics such as pollen production and viability were unchanged by the genetic modification resulting in GTS 40-3-2. It was therefore concluded that the potential for transfer of the glyphosate tolerance trait from the transgenic line to soybean relatives through gene flow (outcrossing) was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada and the continental United States.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of GTS 40-3-2 soybean was established based on: the evaluation of the similarity of the structure and function of CP4 EPSPS protein to this same enzyme naturally present in foods and livestock feeds; the fact that CP4 EPSPS protein constitutes a small amount of the protein in GTS-40-3-2 soybeans so there is little dietary exposure; the lack of toxicity or allergenicity of EPSPS proteins from plants, bacteria and fungi; and by direct laboratory studies of the CP4 EPSPS protein. The nutritional equivalence and wholesomeness of GTS 40-3-2 soybeans compared to conventional (non-GM) soybeans was demonstrated by the analysis of key nutrients, including proximates (<i>e.g.</i> protein, fat, fibre, ash, and carbohydrates), amino acid and fatty acid composition, as well as anti-nutrients. A number of these parameters were also measured in glyphosate-treated soybeans. The equivalence of GTS 40-3-2 soybeans to conventional soybeans was confirmed in numerous feeding studies with rats, fish, broiler chickens, quail, and cows.</p>\n', NULL, '2013-08-30 11:14:08'),
(2, 41, '<p style="text-align: justify;">Soybean (<i>Glycine max</i>) is grown primarily for its seed, which has many uses in the food and industrial sectors, and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use. The major producers of soybeans were the United States, Brazil, Argentina, China, India, Paraguay and Canada.</p>\n\n<p style="text-align: justify;">A major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock.</p>\n\n<p style="text-align: justify;">Soybean oil is rich in polyunsaturated fatty acids and is considered a &ldquo;healthy&rdquo; oil due to its effects on decreasing blood cholesterol levels. However, polyunsaturated fatty acids will oxidize and are unstable at high temperatures, which makes them unsuitable for high temperature cooking. For many food applications, soybean oil requires additional processing, such as hydrogenation, before it can be used in margarines, shortening, and deep fat frying products. The hydrogenation process changes the fatty acid profile of soybean oil by converting the polyunsaturates into monounsaturated fatty acids or saturated fats depending on the use of the final product. Chemical hydrogenation also generates trans-isomers of oleic acid and other trans-fatty acids reported to have negative health effects by raising blood cholesterol levels.</p>\n\n<p style="text-align: justify;">Soybean lines G94-1, G94-19 and G168 were developed through a specific genetic modification to produce a soybean oil that contains high levels of oleic acid, a monounsaturated fatty acid. These high oleic soybeans contain a second copy of fatty acid desaturase gene (<i>fad2</i>), which is naturally present in soybeans. The <i>fad2</i> gene codes for the enzyme, delta-12 desaturase, which is involved in fatty acid synthesis. Unlike conventional soybeans, the presence of a second copy of the <i>fad2</i> gene in the high oleic soybeans G94-1, G94-19 and G168 causes a phenomenon known as &quot;gene silencing&quot; which results in both copies of the fatty acid desaturase gene being &quot;switched off&quot;. This blocks the fatty acid biosynthetic pathway and results in the accumulation of oleic acid. As a consequence, polyunsaturated fatty acids (linoleic acid and linolenic acid) are only produced in very small amounts.</p>\n\n<p style="text-align: justify;">The transgenic <i>fad2</i> gene in G94-1, G94-19 and G168 was isolated from <i>G. max</i> and introduced into a commercial soybean variety using particle acceleration (biolistic) transformation. The genetic modification affects only the seed, allowing fatty acid biosynthesis to function normally in other plant parts such as the leaves.</p>\n\n<p style="text-align: justify;">High oleic soybean oil contains levels of oleic acid exceeding 80%, higher than the levels found in olive oil and rapeseed oil. This oil is lower in saturated fat, contains no trans-fatty acids, and remains in a user-friendly liquid form. The high levels of oleic acid make the oil more heat-stable for cooking and edible spray applications.</p>\n\n<p style="text-align: justify;">G94-1, G94-19 and G168 were tested in field trials in the United States and Canada. Data collected from these trials demonstrated that G94-1, G94-19 and G168 did not differ from conventional soybeans in agronomic characteristics including seed production and susceptibility to diseases and insects. These tests also demonstrated that the transformed lines did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms, and were not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Soybean does not have any weedy relatives with which it can crossbreed in the continental United States and Canada. Cultivated soybean can naturally cross with the wild annual species <i>G. soja</i>, however <i>G. soja</i>, which occurs naturally in China, Korea, Japan, Taiwan and the former USSR, is not naturalized in North America. Additionally, soybean plants are almost completely self-pollinated, and reproductive and growth characteristics were unchanged by the genetic modification resulting in G94-1, G94-19 and G168. It was therefore concluded that the potential for transfer of the trait for high oleic acid from the transgenic line to soybean relatives through gene flow (outcrossing) was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada and the continental United States.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of high oleic soybean lines G94-1, G94-19 and G168 was established based largely on the fact that there were no new proteins present in these soybean lines. It was determined that the allergenic potential of the high oleic soybeans was the same as for conventional soybeans. The nutritional equivalence of soybeans compared to conventional (non-GM) soybeans was demonstrated by the analyses of key nutrients, including proximates (<i>e.g.</i>, protein, fat, fibre, ash, and carbohydrates), amino acid and fatty acid composition, as well as anti-nutrients. High oleic soybean oil contains approximately 10% saturated fats, greater than 80% oleic acid, and low levels of polyunsaturated fatty acids (approximately 2% linoleic acid and 3.5% linolenic acid). Trace amounts (0.5%) of a linoleic acid 9,15 isomer were also detected, which while absent from non-hydrogenated soybean oil, is present at similar levels in butterfat, and is often found at considerably higher levels (typically 1-3%) in partially hydrogenated vegetable oils. The equivalence of high oleic soybeans to conventional soybeans was confirmed in feeding studies with pigs and broiler chickens. Soybean meal from high oleic soybeans was nutritionally equivalent to processed soybean meal derived from the conventional soybeans.</p>\n\n<p style="text-align: justify;">High oleic soybeans are a value-added commodity. These premium soybeans are grown under contract to preserve the identity of high oleic soybeans from the point of planting through to delivery of seed to the processing plant. Other than this, management and production practices for growing high oleic soybeans are much the same as growing any regular variety of soybean.</p>\n', NULL, '2013-08-30 11:59:39'),
(3, 60, '<p style="text-align: justify;">Soybean (<i>Glycine max</i>) is grown primarily for its seed, which has many uses in the food and industrial sectors, and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use. The major producers of soybeans were the United States, Brazil, Argentina, China, India, Paraguay and Canada.</p>\n\n<p style="text-align: justify;">A major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock.</p>\n\n<p style="text-align: justify;">Weeds are a major production problem in soybean cultivation. Typically, weeds are managed using a combination of cultural (<i>e.g.</i> seed bed preparation, using clean seed, variety selection, and planting date) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be applied before planting (<i>e.g.</i> pendimethalin, trifluralin, metribuzin), after planting but before emergence (<i>e.g.</i> pendimethalin, linuron, imazethapyr), and/or after emergence (<i>e.g.</i> bentazon, acifluorfen, fomesafen). Commonly, several different herbicides are required to adequately control weeds in soybean fields.</p>\n\n<p style="text-align: justify;">The soybean lines A2704-12, A2704-21, and A5547-35 were developed to allow for the use of glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg; , Ignite&reg; , Rely&reg; , Liberty&reg; , Harvest&reg; , and Finale&reg;) as a weed control option. These genetically engineered soybean lines contain the fungal enzyme phosphinothricin-N-acetyltransferase (PAT) that allows these plants to survive the otherwise lethal application of glufosinate. The <i>pat</i> gene inserted into A2704-12, A2704-21, and A5547-35 was isolated from a common soil fungus, <i>Streptomyces viridochromogenes</i>, and introduced into the soybean genome by particle acceleration (biolistic) transformation.</p>\n\n<p style="text-align: justify;">The PAT enzyme in soybean lines A2704-12, A2704-21, and A5547-35 converts L-phosphinothricin (PPT), the active ingredient in glufosinate ammonium, to an inactive form thereby conferring resistance to the herbicide. In absence of PAT, application of glufosinate leads to reduced production of the amino acid glutamine and increased ammonia levels in the plant tissues which are lethal to the plant. The PAT enzyme is not known to have any toxic properties.</p>\n\n<p style="text-align: justify;">Glufosinate-tolerant soybean lines A2704-12, A2704-21, and A5547-35 were tested in field trials in the United States (1990-1993) and line A2704-12 was field tested in Canada and Japan. These tests demonstrated that the transformed lines did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms, and were not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Soybean does not have any weedy relatives with which it can crossbreed in the continental United States or Canada. Cultivated soybean can naturally cross with the wild annual species <i>G. soja</i>, however <i>G. soja</i>, which occurs naturally in China, Korea, Japan, Taiwan and the former USSR, is not naturalized in North America. Additionally, soybean plants are almost completely self-pollinated and reproductive and growth characteristics remained unchanged by the genetic modification resulting in glufosinate-tolerant soybean lines. It was therefore concluded that the potential for transfer of the glufosinate tolerance trait from the transgenic line to soybean relatives through gene flow (outcrossing) was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada and the continental United States.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of glufosinate-tolerant soybean lines A2704-12, A2704-21, and A5547-35 was established based on the lack of toxicity or allergenicity of the PAT protein and by direct laboratory analyses. The nutritional equivalence and wholesomeness of these soybeans compared to conventional (non-GM) soybeans was demonstrated by the analysis of key nutrients, including proximates (<i> e.g.</i>, moisture, crude protein, crude fat, ash, acid detergent fibre, neutral detergent fibre, carbohydrate), fatty acid analysis, amino acid analysis, and analyses of minerals (calcium, phosphorous, and potassium). This equivalence of glufosinate-tolerant soybeans to conventional soybeans was further confirmed in feeding studies with rats and broiler chickens.</p>\n', NULL, '2013-08-30 12:11:29'),
(4, 9, '<p style="text-align: justify;">Maize, or corn (<i>Zea mays</i> L.) is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods. Maize is a raw material for the manufacture of starch, the majority of which is converted by a complex refining process into sweeteners, syrups and fermentation products, including ethanol. Maize oil is extracted from the germ of the maize kernel. Only a small proportion of the whole kernel is consumed by humans, while refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum. In the United States and Canada, maize is typically used as animal feed with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep and goats, fish and companion animals. Industrial uses for maize products include recycled paper, paints, cosmetics and car parts. Refined maize products are also used in bioproducts such as antibiotics. The European corn borer (ECB),<i> Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada with losses resulting from ECB damage and control costs exceeding $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second generation larvae, with annual yield losses estimated at 5 to 10 %. Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in managing ECB in maize crops: ECB larval damage is hidden; heavy infestations are unpredictable; insecticides are costly; timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control. The transgenic maize line MON810 was genetically engineered to resist ECB by producing its own insecticide. This line was developed by introducing the <i>cry1Ab</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into the maize cultivar Hi-II by particle acceleration (biolistic) transformation. The <i>cry1Ab</i> gene produces the insect control protein Cry1Ab, a delta-endotoxin. MON810 expressed Cry1Ab at an effective dosage over the growing season as indicated by its efficacy in controlling both first and second generation infestations of ECB, however, protein expression declined over the growing season as indicated by declining Cry1Ab protein concentrations in assayed leaves. The insecticidally active portion of the Cry1Ab protein produced by the <i>Bt</i> maize is identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry1Ab is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow causing gut paralysis and eventual death due to bacterial sepsis. Cry1Ab is insecticidal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins. MON810 was tested in field trials in the United States and Canada. Data collected from these trials demonstrated that MON810 was not different from conventional maize varieties. MON810 grew normally and exhibited the expected morphology, reproductive and physiological characteristics of maize. Furthermore, MON810 was shown not to have unexpected pest or disease susceptibility compared to conventional maize. Maize does not have any closely related species growing in the wild in continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in Canada or the United States. Additionally, reproductive characteristics such as pollen production, viability, and dispersal were unchanged in MON810. Gene exchange between MON810 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States. Maize inbreds and hybrids expressing the Cry1Ab protein were compared to their non-transformed counterpart for relative abundance of beneficial arthropods. Field studies demonstrated that Cry1Ab had neither a direct nor an indirect effect on the beneficial arthropod populations. In summary, it was determined that when compared with currently commercialized maize varieties, MON810 maize did not present an increased risk to or impact on interacting organisms, including humans, with the exception of specific lepidopteran insect species. Regulatory authorities in Canada and United States have mandatory requirements for developers of <i>Bt</i> maize to implement specific Insect Resistant Management (IRM) Programs. The potential exists for <i>Bt</i>-resistant ECB populations to develop as acreages planted with transgenic <i>Bt</i> hybrids expand. Hence, these IRM programs are designed to reduce this potential and prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial <i>Bt</i> spray formulations that contain these same toxins. The food and livestock feed safety of MON810 maize was established based on several standard criteria. As part of the safety assessment, the nutritional composition of MON810 grain was found to be equivalent to conventional maize as shown by the analyses of key nutrients including proximates (<i>e.g.</i> moisture, protein, fat, fibre, ash and carbohydrate), amino acid composition, fatty acid profiles, and minerals (calcium and phosphorus). Similar compositional analyses were conducted on MON810 green chop silage forage. The nutritional equivalence of MON810 and conventional maize was confirmed in feeding trials with bobwhite quail. The low potential for toxicity of plant-expressed Cry1Ab protein was demonstrated by the lack of amino acid sequence homology with known protein toxins and by laboratory studies showing that the protein was rapidly degraded in simulated gastric fluids and that it did not display any acute toxicity when administered to laboratory mice. In the latter study, mice were fed high doses of Cry1Ab protein that were 200-1000 fold greater than humans would be exposed to based on consumption of MON810 grain with no negative consequences. The potential allergenicity of Cry1Ab was assessed by examining: physiochemical characteristics; amino acid sequence homology to known protein allergens; and digestibility. The Cry1Ab protein has a history of safe use, demonstrated by its use in microbial <i>Bt</i> spray formulations in agriculture and forestry for more than 30 years with no evidence of adverse effects. This fact, combined with the lack of amino acid sequence homology between Cry1Ab protein and known allergens, and the rapid degradation of Cry1Ab protein in acidic gastric fluids, were sufficient to provide with reasonable certainty that Cry1Ab has no allergenic potential.</p>\r\n\r\n<p>&nbsp;</p>\r\n', NULL, '2013-09-02 14:27:02'),
(5, 16, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, car parts and pharmaceuticals.</p>\n\n<p style="text-align: justify;">The European corn borer (ECB), <i>Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada; losses resulting from ECB damage and control costs exceed $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second generation larvae, with annual yield losses estimated at 5 to 10 %.</p>\n\n<p style="text-align: justify;">Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in identifying and managing ECB in maize crops: ECB larval damage is hidden, heavy infestations are unpredictable, insecticides are costly, timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control.</p>\n\n<p style="text-align: justify;">Weeds are also a major production problem in maize cultivation. Even a light infestation of weeds can reduce yields by 10 to 15%; severe infestations can reduce yields by 50% or more. Typically, weeds are managed using a combination of cultural (<i>e.g.</i>, seed bed preparation, clean seed, variety selection) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be incorporated into the soil before planting (pre-plant), applied after planting but before emergence (pre-emergence), or applied after the maize plants emerge (post-emergence). Ideally, for maize production, weeds should be controlled for the full season. However, the most critical period for weed control is usually about six to eight weeks after crop emergence, during the 4th to 10th leaf stages. This critical period in the life cycle of maize must be kept weed free in order to prevent yield loss.</p>\n\n<p style="text-align: justify;">Maize line Bt11 was genetically modified to contain two novel genes, <i>cry1Ab</i> and <i>pat</i>, for insect and herbicide tolerance respectively. Both genes were introduced into a maize line by particle acceleration (biolistic) transformation.</p>\n\n<p style="text-align: justify;">Bt11 was developed to resist ECB by producing its own insecticide. This event was genetically engineered through introduction of the <i>cry1Ab</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>). The <i>cry1Ab</i> gene produces the insect control protein Cry1Ab, a delta-endotoxin. The Cry1Ab protein expressed in Bt11 is identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry1Ab is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death from bacterial sepsis. Cry1Ab is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.</p>\n\n<p style="text-align: justify;">In addition to insect resistance, Bt11 was developed to allow for the use of glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Liberty&reg;, and Finale&reg;) as a weed control option, and as a breeding tool for selecting plants containing the <i>cry1Ab</i> gene. Bt11 contains the <i>pat</i> gene, isolated from a common soil actinomycete <i>Streptomyces viridochromogenes</i>. This gene allows for the production of the enzyme phosphinothricin N-acetyltransferase (PAT) which confers tolerance to glufosinate. The PAT enzyme in maize line Bt11 converts L-phosphinothricin (PPT), the active ingredient in glufosinate ammonium, to an inactive form. In the absence of PAT, application of glufosinate leads to reduced production of the amino acid glutamine and increased ammonia levels in the plant tissues, resulting in the death of the plant. The PAT enzyme is not known to have any toxic properties.</p>\n\n<p style="text-align: justify;">Bt11 maize was tested in field trials in the United States, beginning in 1992, and in Canada, beginning in 1993. Data collected from these trials demonstrated that Bt11 was not different from conventional maize varieties. Agronomic characteristics such as vegetative vigour, fertility, time to maturity, seed yield, and kernel size, were within the expected range of expression reported for commercial maize hybrids. Bt11 was comparable to conventional maize lines and did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Bt11 maize was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States or Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in maize line Bt11. Gene exchange between Bt11 maize and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">Regulatory authorities in Canada and the United States have mandatory requirements for developers of Bt maize to implement specific Insect Resistant Management (IRM) Programs. The potential for ECB populations to develop tolerance or become resistant to the <i>Bt</i> toxin is expected to increase as more maize acreage is planted with <i>Bt</i> hybrids. These IRM programs are designed to reduce the potential development of <i>Bt</i>-resistant insect populations, as well as prolonging the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial <i>Bt</i> spray formulations of these same toxins.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of maize line Bt11 was established based on several standard criteria. As part of the safety assessment, the nutritional composition of grain from Bt11 maize was analyzed in order to determine protein, oil, starch and crude fibre content, and was found to be equivalent to conventional maize. Silage samples from the ECB resistant maize hybrids had significantly higher levels of acid detergent fibre and neutral detergent fibre than samples from the conventional lines, however the values were well within the normal range for corn silage. All other nutrients tested (protein, calcium, magnesium, phosphorus and potassium) were shown to be equivalent to non-transgenic maize lines.</p>\n\n<p style="text-align: justify;">The wholesomeness of maize line Bt11, as compared to conventional maize, was confirmed in feeding studies with quail, hens, and dairy and beef cattle. These trials demonstrated that there were no unintended effects experienced by these organisms when fed Bt11 maize feed and detected no novel proteins in milk or egg products produced by animals fed diets containing Bt11 maize.</p>\n\n<p style="text-align: justify;">The potential for toxicity and allergenicity of the Bt11-expressed Cry1Ab and PAT proteins was demonstrated by examining their physiochemical characteristics and amino acid sequence homologies to known protein toxins and allergens. Digestibility and acute oral toxicity studies were also conducted. The Cry1Ab protein has a history of safe use, as demonstrated by its use in microbial <i>Bt</i> spray formulations in agriculture for more than 30 years with no evidence of adverse effects. Similarly, PAT has a very specific enzymatic activity and does not possess proteolytic or heat stability, and does not affect plant metabolism. Acetyltransferases such as PAT are common enzymes in bacteria, plants and animals and no toxic or allergic effects were expected. These facts, combined with the lack of amino acid sequence homologies between Cry1Ab and PAT proteins, and known allergens and toxins, and the rapid degradation of the novel proteins in acidic gastric fluids, was sufficient to provide with reasonable certainty a lack of toxicity and allergenic potential.</p>\n', NULL, '2013-08-30 01:31:14'),
(6, 40, '<p style="text-align: justify;">Soybean (<i>Glycine max</i>) is grown primarily for its seed, which has many uses in the food and industrial sectors, and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use. The major producers of soybeans were the United States, Brazil, Argentina, China, India, Paraguay and Canada.</p>\n\n<p style="text-align: justify;">A major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock.</p>\n\n<p style="text-align: justify;">Weeds are a major production problem in soybean cultivation. Typically, weeds are managed using a combination of cultural (<i>e.g.</i>, seed bed preparation, use of clean seed, variety selection, and planting date) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be applied before planting (<i>e.g.</i>, pendimethalin, trifluralin, metribuzin), after planting but before emergence (e.g. pendimethalin, linuron, imazethapyr), and/or after emergence (<i>e.g.</i>, bentazon, acifluorfen, fomesafen). Commonly, several different herbicides are required to adequately control weeds in soybean fields.</p>\n\n<p style="text-align: justify;">The soybean line A5547-127 was developed to allow for the use of glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Ignite&reg;, Rely&reg;, Liberty&reg;, Harvest&reg;, and Finale&reg;) as a weed control option. This genetically engineered soybean line contains the fungal enzyme phosphinothricin-N-acetyltransferase (PAT), which allows these plants to survive the otherwise lethal application of glufosinate. The <i>pat</i> gene inserted into A5547-127 was isolated from a common soil fungus, <i>Streptomyces viridochromogenes</i>, and introduced into the soybean genome by particle acceleration (biolistic) transformation.</p>\n\n<p style="text-align: justify;">The PAT enzyme in soybean line A5547-127 converts L-phosphinothricin (PPT), the active ingredient in glufosinate ammonium, to an inactive form thereby conferring resistance to the herbicide. In the absence of PAT, application of glufosinate leads to reduced production of the amino acid glutamine and increased ammonia levels in the plant tissues, which are lethal to the plant. The PAT enzyme is not known to have any toxic properties.</p>\n\n<p style="text-align: justify;">Glufosinate-tolerant soybean line A5547-127 was tested in field trials in the United States (1996-1997). It was demonstrated that the transformed line did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms. A5547-127 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Soybean does not have any weedy relatives with which it can crossbreed in the continental United States or Canada. Cultivated soybean can naturally cross with the wild annual species <i>G. soja</i>, however <i>G. soja</i>, which occurs naturally in China, Korea, Japan, Taiwan and the former USSR, is not naturalized in North America. Additionally, soybean plants are almost completely self-pollinated, and reproductive and growth characteristics were unchanged by the genetic modification resulting in A5547-127. It was therefore concluded that the potential for transfer of the glufosinate tolerance trait from the transgenic line to soybean relatives through gene flow (outcrossing) was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada and the continental United States.</p>\n\n<p style="text-align: justify;">In order to establish the nutritional equivalence of A5547-127 to conventional soybean, samples of forage, seed, hulls, and toasted and non-toasted defatted soy meal from the transgenic event were subjected to proximate analyses (moisture, crude protein, crude fat, ash, acid detergent fibre, neutral detergent fibre, carbohydrate). As well, seed samples were subjected to fatty acid analysis, amino acid analysis, and analyses of minerals (calcium, phosphorous, and potassium). In all cases, there were no statistically significant differences between the values determined for A5547-127 and corresponding samples obtained from non-transgenic control plants.</p>\n\n<p style="text-align: justify;">The toxicity potential of A5547-127 was established from samples of seed analyzed for the naturally occurring anti-nutrients stachyose, raffinose, phytic acid, trypsin inhibitor and lectins. The concentrations of phytoestrogens, such as daidzein, genistein, and glycitein, were determined for samples of seed, and toasted and non-toasted soy meal. The levels of these compounds were not statistically different between samples from A5547-127 and non-transgenic soybeans.</p>\n\n<p style="text-align: justify;">The low potential for allergenicity of the PAT protein has previously been established through amino acid sequence comparisons with known protein allergens and digestibility studies using simulated gastric and intestinal fluids. Additionally, soybean seed extracts from line A5547-127 and from non-transgenic control plants were screened against a panel of sera from 16 soy-allergic individuals using the radioallergosorbent test (RAST). The results of this study did not reveal any qualitative or quantitative difference in endogenous soybean allergen content between transgenic and non-transgenic soybean.</p>\n', NULL, '2013-08-30 11:56:42');
INSERT INTO `gmcropdatabase_events_execsummaries` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(7, 49, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, car parts and pharmaceuticals.</p>\n\n<p style="text-align: justify;">The European corn borer (ECB), <i>Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada; losses resulting from ECB damage and control costs exceed $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second generation larvae, with annual yield losses estimated at 5 to 10 %.</p>\n\n<p style="text-align: justify;">Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in identifying and managing ECB in maize crops: ECB larval damage is hidden, heavy infestations are unpredictable, insecticides are costly, timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control.</p>\n\n<p style="text-align: justify;">Weeds are also a major production problem in maize cultivation. Even a light infestation of weeds can reduce yields by 10 to 15%; severe infestations can reduce yields by 50% or more. Typically, weeds are managed using a combination of cultural (<i>e.g.</i>, seed bed preparation, clean seed, variety selection) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be incorporated into the soil before planting (pre-plant), applied after planting but before emergence (pre-emergence), or applied after the maize plants emerge (post-emergence). Ideally, for maize production, weeds should be controlled for the full season. However, the most critical period for weed control is usually about six to eight weeks after crop emergence, during the 4th to 10th leaf stages. This critical period in the life cycle of maize must be kept weed free in order to prevent yield loss.</p>\n\n<p style="text-align: justify;">Maize line CBH-351 was genetically modified to contain two novel genes, <i>cry9C</i> and <i>bar</i>, for insect and herbicide tolerance respectively. Both genes were introduced into a maize line by particle acceleration (biolistic) transformation.<br />\nThe transgenic maize line CBH-351 was developed to resist ECB by producing its own insecticide. This event was genetically engineered by introducing the <i>cry9C</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into a maize line by particle acceleration (biolistic) transformation. The <i>cry9C</i> gene produces the insect control protein Cry9C, a delta-endotoxin. Cry proteins, of which Cry9C is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry9C is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for the delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.</p>\n\n<p style="text-align: justify;">In addition to the <i>cry9c</i> gene, CBH-351 was developed to allow for the use of glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Liberty&reg;, and Finale&reg;), as a weed control option, and as a breeding tool for selecting plants containing the <i>cry9c</i> gene. CBH-351 contains the <i>bar</i> gene isolated from a common soil actinomycete, <i>Streptomyces hygroscopicus</i>. This gene allows for the production of the enzyme phosphinothricin N-acetyltransferase (PAT) which confers tolerance to glufosinate.</p>\n\n<p style="text-align: justify;">The PAT enzyme in maize line CBH-351 converts L-phosphinothricin (PPT), the active ingredient in glufosinate ammonium, to an inactive form, thereby conferring resistance to the herbicide. In the absence of PAT, application of glufosinate leads to reduced production of the amino acid glutamine and increased ammonia levels in the plant tissues, resulting in the death of the plant. The PAT enzyme is not known to have any toxic properties.</p>\n\n<p style="text-align: justify;">Maize line CBH-351 was tested in field trials in the United States and Canada, beginning in 1995. Data collected from these trials demonstrated that CBH-351 was not different from conventional maize varieties. Agronomic characteristics and kernel traits were within the expected range of expression reported for commercial maize hybrids. Maize line CBH-351 was comparable to conventional maize lines and did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms. CBH-351 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States or Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in maize line CBH-351. Gene exchange between CBH-351 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">Regulatory authorities in Canada and the United States have mandatory requirements for developers of <i>Bt</i> maize to implement specific Insect Resistant Management (IRM) Programs. The potential for ECB populations to develop tolerance or become resistant to the <i>Bt</i> toxin is expected to increase as more maize acreage is planted with <i>Bt</i> hybrids. These IRM programs are designed to reduce the potential development of <i>Bt</i>-resistant insect populations, as well as prolonging the effectiveness of plant-expressed Bt toxins, and the microbial Bt spray formulations of these same toxins.</p>\n\n<p style="text-align: justify;">Kernel composition, quality and other characteristics of CBH-351 maize were not significantly different from non-transgenic maize.</p>\n\n<p style="text-align: justify;">CBH-351 maize has been approved in the United States only for livestock feed use. The safety for use in animal feed was supported by the lack of toxicity of bacterial-expressed Cry9C protein in high oral dose feeding studies with laboratory animals and the low potential for toxicity of plant-expressed Cry9C protein demonstrated by a lack of amino acid sequence homology with known protein toxins.</p>\n\n<p style="text-align: justify;">The allergenic potential of the Cry9C protein was assessed by examining the amino acid sequence homology between the Cry9C protein and known protein allergens. A database search determined that there were no significant similarities in the amino acid sequences for the Cry9C protein and known protein allergens. A pepsin digestibility study determined that the Cry9C protein was stable to digestion for up to 4 hours and was heat stable when incubated at 90C for 10 minutes.</p>\n\n<p style="text-align: justify;">The Environmental Protection Agency (EPA) ruled, in the pesticide assessment of Cry9C in maize line CBH-351, that the use of maize line CBH-351 be restricted to animal feed only. The EPA also established that it was acceptable to find the Cry9C protein in meat, poultry, milk, or eggs derived from animals fed CBH-351 maize feed. Following authorization of CBH-351 for use in animal feed, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) was tasked with reviewing scientific information concerning the allergenic potential of the Cry9C protein. In the SAP Report (December 2000) it was concluded that there was a medium likelihood that the Cry9C protein was a potential allergen.</p>\n', NULL, '2013-08-30 12:06:31'),
(8, 7, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\r\n\r\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.</p>\r\n\r\n<p style="text-align: justify;">In the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used forthe production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\r\n\r\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, car parts and pharmaceuticals.<br />\r\nThe European corn borer (ECB), <i>Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada; losses resulting from ECB damage and control costs exceed $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second generation larvae, with annual yield losses estimated at 5 to 10 %.</p>\r\n\r\n<p style="text-align: justify;">Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in identifying and managing ECB in maize crops: ECB larval damage is hidden, heavy infestations are unpredictable, insecticides are costly, timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control.</p>\r\n\r\n<p style="text-align: justify;">Weeds are also a major production problem in maize cultivation. Even a light infestation of weeds can reduce yields by 10 to 15%; severe infestations can reduce yields by 50% or more. Typically, weeds are managed using a combination of cultural (<i>e.g.</i>, seed bed preparation, clean seed, variety selection) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be incorporated into the soil before planting (pre-plant), applied after planting but before emergence (pre-emergence), or applied after the maize plants emerge (post-emergence). Ideally, for maize production, weeds should be controlled for the full season. However, the most critical period for weed control is usually about six to eight weeks after crop emergence, during the 4th to 10th leaf stages. This critical period in the life cycle of maize must be kept weed free in order to prevent yield loss.</p>\r\n\r\n<p style="text-align: justify;">Maize line DBT418 was genetically modified to contain two novel genes, <i>cry1Ac</i> and <i>bar</i>, for insect and herbicide tolerance respectively. Both genes were introduced into a maize line by particle acceleration (biolistic) transformation.<br />\r\nThe transgenic maize line DBT418 was developed to resist ECB by producing its own insecticide. This event was genetically engineered by introducing the <i>cry1Ac</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into the maize line AT824. The <i>cry1Ac</i> gene produces the insect control protein Cry1Ac, a delta-endotoxin. Cry proteins, of which Cry1Ac is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry1Ac is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for the delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.</p>\r\n\r\n<p style="text-align: justify;">In addition to the <i>cry1Ac</i> gene, DBT418 was developed to allow for the use of glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Liberty&reg;, and Finale&reg;), as a weed control option, and as a breeding tool for selecting plants containing the <i>cry1Ac</i> gene. DBT418 contains the <i>bar</i> gene isolated from a common soil actinomycete, <i>Streptomyces hygroscopicus</i>. This gene allows for the production of the enzyme phosphinothricin N-acetyltransferase (PAT) which confers tolerance to glufosinate.</p>\r\n\r\n<p style="text-align: justify;">The PAT enzyme in maize line DBT418 converts L-phosphinothricin (PPT), the active ingredient in glufosinate ammonium, to an inactive form, thereby conferring resistance to the herbicide. In the absence of PAT, application of glufosinate leads to reduced production of the amino acid glutamine and increased ammonia levels in the plant tissues, resulting in the death of the plant. The PAT enzyme is not known to have any toxic properties.<br />\r\nExpression of the Cry1Ac protein and PAT occurred in most, but not all, tissues of the maize plant with levels highest in leaves, and lower levels in roots, prop roots, stalk, tassel, cob, husk, and kernels. No Cry1Ac or PAT proteins were detected in silk or pollen.</p>\r\n\r\n<p style="text-align: justify;">Maize line DBT418 was tested in field trials in the United States, beginning in 1993, and in Canada, beginning in 1995. Data collected from these trials demonstrated that DBT418 was not different from conventional maize varieties. Agronomic characteristics such as seedling vigor and yield were within the expected range of expression reported for commercial maize hybrids. The transgenic line DBT418 provided significant protection from feeding damage caused by the European corn borer (<i>Ostrinia nubilalis</i>) and Southwestern corn borer (<i>Diatraea grandiosella</i>). Maize line DBT418 was comparable to conventional maize lines in all other respects and did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms. DBT418 was not expected to impact on threatened or endangered species.</p>\r\n\r\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States or Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in maize line DBT418. Gene exchange between DBT418 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\r\n\r\n<p style="text-align: justify;">Regulatory authorities in Canada and the United States have mandatory requirements for developers of <i>Bt</i> maize to implement specific Insect Resistant Management (IRM) Programs. The potential for ECB populations to develop tolerance or become resistant to the <i>Bt</i> toxin is expected to increase as more maize acreage is planted with <i>Bt</i> hybrids. These IRM programs are designed to reduce the potential development of <i>Bt</i>-resistant insect populations, as well as prolonging the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial <i>Bt</i> spray formulations of these same toxins.</p>\r\n\r\n<p style="text-align: justify;">The food and livestock feed safety of maize line DBT418 was established based on several standard criteria. As part of the safety assessment, the nutritional composition of the grain and forage of DBT418 were analyzed in order to determine protein, oil, fibre, ash, moisture, and starch content, and were found to be equivalent to conventional maize. The grain&rsquo;s amino acid composition was also analyzed and found to be identical to that of conventional maize hybrids.</p>\r\n\r\n<p style="text-align: justify;">The potential for toxicity and allergenicity of the DBT418-expressed Cry1Ac and PAT proteins was demonstrated by examining their physiochemical characteristics and amino acid sequence homologies to known protein toxins and allergens. Stability to acid and/or proteolytic digestion, heat stability, glycosylation, and molecular weight were determined and digestibility and acute oral toxicity studies were also conducted. The Cry1Ac protein has a history of safe use, as demonstrated by its use in microbial <i>Bt</i> spray formulations in agriculture for more than 30 years with no evidence of adverse effects. Similarly, PAT has a very specific enzymatic activity and does not possess proteolytic or heat stability, and does not affect plant metabolism. Acetyltransferases such as PAT are common enzymes in bacteria, plants and animals and no toxic or allergic effects were expected. These facts, combined with the lack of amino acid sequence homologies between Cry1Ac and PAT proteins, and known allergens and toxins, and the rapid degradation of the novel proteins in acidic gastric fluids, was sufficient to provide with reasonable certainty a lack of toxicity and allergenic potential.</p>\r\n', NULL, '2013-09-02 14:23:30'),
(9, 23, '<p style="text-align: justify;">Argentine or oilseed rape (<i>Brassica napus</i>) was grown as a commercial crop in over 50 countries, with a combined harvest of 48.9 million metric tonnes in 2006. The major producers of rapeseed are China, Canada, India, Germany, France, the United Kingdom and Australia. Canola is a genetic variation of <i>B. napus</i> that was developed through conventional breeding to contain low levels of the natural rapeseed toxins, glucosinolate and erucic acid. Canola is grown for its seed, which represents a major source of edible vegetable oil and is also used in livestock feeds.</p>\n\n<p style="text-align: justify;">The only food use of canola is as a refined oil. Typically, canola oil is used by itself as a salad oil or cooking oil, or blended with other vegetable oils in the manufacture of margarine, shortenings, cooking and salad oils. Canola meal, a byproduct of the oil production process, is added to livestock feed rations. An increasing amount of oil is being used for biodiesel production, especially in Europe.</p>\n\n<p style="text-align: justify;">The removal of weeds early in the growing season is extremely important in canola production. Young canola seedlings are not very competitive and early weed pressure has detrimental effects on final yield. Precautions such as preplant tillage or herbicide application are common approaches for reducing weed competition. Once established, canola forms a dense canopy and is very competitive, making weed control less of a concern.</p>\n\n<p style="text-align: justify;">At present, it is expensive, but possible, to control annual grassy weeds (wild oats, volunteer cereals), perennial weeds (Canada thistle, perennial sow thistle, quackgrass), and certain annual broadleaf weeds in canola. The broadleaves are the most difficult to control because there are few herbicide options available. Many producers will use as many as four herbicides per year in an effort to control weeds.</p>\n\n<p style="text-align: justify;">Traditionally, it has been difficult to manage weeds in canola rotations because of the need to use Group 1 herbicides (Assure&reg;, Fusion&reg;, Poast&reg;, Select&reg;, Venture DG&reg;) that are also commonly used to control weeds in flax, wheat and other cereals. Growers favour these herbicides because they are easy to work with, are extremely effective, and may be applied over a period of time. However, the constant use of Group 1 herbicides has placed large acreages of cultivated land at high risk of developing Group 1 weed resistance. The establishment of several herbicide-tolerant weed populations demonstrates this problem.</p>\n\n<p style="text-align: justify;">The herbicide-tolerant canola line GT73 (synonym RT73) was developed to allow for the use of glyphosate, the active ingredient in the herbicide Roundup&reg;, as a weed control option. In order to obtain field tolerance to glyphosate herbicide, two genes, CP4 EPSPS and <i>goxv</i>247, were introduced into <i>B. napus</i> cv. Westar by <i>Agrobacterium</i>-mediated transformation</p>\n\n<p style="text-align: justify;">The EPSPS gene codes for the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that is present in all plants, bacteria and fungi. The EPSPS gene put into GT73 was isolated from strain CP4 of the common soil bacterium <i>Agrobacterium tumefaciens</i> and is a glyphosate tolerant form of EPSPS. The EPSPS enzyme is part of an important biochemical pathway in plants called the shikimate pathway, which is involved in the production of aromatic amino acids and other aromatic compounds. When conventional canola plants are treated with glyphosate, the plants cannot produce the aromatic amino acids needed to grow and survive. EPSPS is not present in mammals, birds or aquatic life forms, which do not synthesize their own aromatic amino acids. For this reason, glyphosate has little toxicity to these organisms. The EPSPS enzyme is naturally present in foods derived from plant and microbial sources.</p>\n\n<p style="text-align: justify;">The canola line GT73 contains a second gene that codes for a modified version of glyphosate oxidase (GOX) enzyme that is ubiquitous in nature. The <i>goxv</i>247 gene inserted into GT73 was isolated from strain LBAA of the bacterium <i>Ochrobactrum anthropi</i>. Glyphosate oxidase (GOX) enzyme accelerates the normal breakdown of the herbicide glyphosate into two non-toxic compounds, aminomethylphosphonic acid (AMPA) and glyoxylate. AMPA is the principal breakdown product of glyphosate and is degraded by several microorganisms, while glyoxylate is commonly found in plant cells and is broken down by the glyoxylic pathway for lipid metabolism.</p>\n\n<p style="text-align: justify;">GT73 has been tested in field trials in Canada since 1992 and the United States since 1995. Agronomic and adaptation characteristics such as germination, vegetative vigour, overwintering capacity, seed production (yield), agronomic characteristics (such as time to flowering, maturity) and disease and insect resistance were all found to be within the normal range when compared to conventional canola. GT73 did not pose a plant pest risk, negatively affect beneficial or nontarget organisms, exhibit enhanced weediness potential, and was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;"><i>B. napus</i> may outcross (up to 30% of the time) with plants of the same species, and potentially with plants of related species <i>B. rapa</i>, <i>B. juncea</i>, <i>B. carinata</i>, <i>B. nigra</i>, <i>Diplotaxis muralis</i>, <i>Raphanus raphanistrum</i>, and <i>Erucastrum gallicum</i>. Previous studies have demonstrated that cross breeding is most likely to occur with <i>B. rapa</i>. Because of the ability of canola to outcross with related plants, the formation of glyphosate tolerant hybrids is possible. However, the glyphosate-tolerance trait is not expected to provide a competitive advantage to hybrid plants unless grown in managed environments routinely subjected to glyphosate applications. In the event that a glyphosate tolerant hybrid survived, the herbicide-tolerant individual could be easily controlled using mechanical and/or other available chemical means.</p>\n\n<p style="text-align: justify;">The human consumption of canola products is limited to the purified oil. Refined edible canola oil consists of purified triglycerides (96-97%) and does not contain any detectable protein, hence no amounts of CP4 EPSPS or GOX proteins were detected in the refined oil of GT73 canola. The fatty acid composition of GT73 was within the normal range for canola oil. GT73 contained less than 2% erucic acid and less than 30 micromoles/g glucosinolates in the oil-free meal, meeting published standards for canola oil.</p>\n\n<p style="text-align: justify;">The livestock feed safety of GT73 was established based on several standard criteria. The analysis of nutrients from GT73 and non-transgenic canola did not reveal any significant differences in the levels of crude protein, crude fat, crude fibre, ash and gross energy in either whole seed or processed meal. Levels of the shikimate pathway aromatic amino acids phenylalanine, tyrosine and tryptophan extracted from both transgenic GT73 and non-transgenic canola were statistically the same. These results demonstrated that the introduction of the novel genes in GT73 do not result in any secondary effects impacting on composition or nutritional quality.</p>\n\n<p style="text-align: justify;">Animal feeding studies included a four-week rat study on processed and unprocessed meal, a ten-week trout study on processed meal, and a five-day quail study on unprocessed meal. The studies all supported the wholesomeness of meal from glyphosate-tolerant canola as a component in animal feed.</p>\n\n<p style="text-align: justify;">It was determined that there were no toxicity and allergenicity concerns with GT73. There is no dietary exposure to CP4 EPSPS and GOX since these proteins are not present in the refined canola oil consumed by humans. Furthermore, the structure and function of CP4 EPSPS protein was determined to be similar to the same enzyme naturally present in foods and livestock feeds. Neither CP4 EPSPS nor GOX were found to have any amino acid sequence similarities with known toxins or allergens, and there are no known reports of toxicity or allergenicity of CP4 EPSPS or GOX proteins from plants, bacteria and fungi. Direct laboratory studies of the CP4 EPSPS and GOX proteins provided further evidence supporting the lack of toxicity or allergenicity concerns with GT73.</p>\n', NULL, '2013-08-30 11:15:47'),
(10, 51, '', NULL, NULL),
(11, 74, '<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">Corn line NK603 was developed to allow the use of the herbicide glyphosate as a weed control option in corn. The gene conferring tolerance to glyphosate was introduced via genetic engineering techniques. These techniques enable the developer to express in the corn plant the 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene, which is involved in the synthesis of aromatic amino acids. This gene, isolated from Agrobacterium tumefaciens strain CP4 (CP4 EPSPS), encodes a version of the enzyme that is tolerant to concentrations of glyphosate that would normally inhibit the activity of the endogenous corn enzyme. The CP4 EPSPS gene and regulatory sequences controlling its expression were introduced via biolistic particle bombardment.</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">Line NK603 was produced from a proprietary inbred line designated as AW x CW using particle acceleration. NK603 contains two plant expression cassettes each containing a single copy of the CP4 EPSPS gene and respective regulatory sequences as follows:</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">CP4 EPSPS Cassette 1 contains the CP4 EPSPS gene under the control of the rice actin 1 promoter (McElroy et al. 1990) and the CTP2 chloroplast transit peptide leader sequence from Arabidopsis thaliana (Klee and Rogers 1987). The purpose of this latter sequence is to direct CP4 EPSPS protein to the chloroplast, which is the site of aromatic amino acid synthesis. The CP4 EPSPS gene sequence was modified slightly, but retains greater than 99.4% homology to the native Agrobacterium gene. The NOS 3&rsquo; nontranslated region of the nopaline synthase gene from Agrobacterium tumefaciens T-DNA was used to provide the polyadenylation signal.</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">CP4 EPSPS Cassette 2 contains the CP4 EPSPS gene under the control of the enhanced cauliflower mosaic virus (CaMV) 35S promoter (Kay et al. 1985). The Zmhsp70 intron from the corn hsp70 heat shock protein was included to stabilize the level of transcription (Rochester et al. 1986) and the CTP2 chloroplast transit peptide leader sequence was used to direct the CP4 EPSPS protein to the chloroplast. The NOS 3&rsquo; nontranslated region of the nopaline synthase gene from Agrobacterium tumefaciens T-DNA was used to provide the polyadenylation signal.</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">Roundup ready corn line GA21 was designated as the antecedent organism for NK603, which was not judged to have any characteristics that would pose a greater impact on the environment or non-target organisms.</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">References:</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">Kay, R., Chan, A., Daly, M. &amp; McPherson, J. (1985). Duplication of the CaMV 35S promoter sequences creates a strong enhancer for plant genes. Science 236: 1299-1302.</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">Klee, H.J. &amp; Rogers, S.G. (1987). Cloning of an Arabidopsis gene encoding 5-enolpyruvlyshikimate-3-phosphate synthase: sequence analysis and manipulation to obtain glyphosate-tolerant plants. Mol. Gen. Genet. 210: 437-442.</font></font></font></p>\r\n\r\n<p><font color="#333333"><font face="sans-serif, Arial, Verdana, Trebuchet MS"><font style="font-size: 9pt">McElroy, D., Zhang, W., Cao, J. &amp; Wu, R. (1990). Isolation of an efficient actin promoter for use in rice transformation. Plant Cell 2: 163-171.</font></font></font></p>\r\n', NULL, '2013-09-02 17:06:58'),
(12, 72, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for ethanol production. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.<br />\nThe MON832 line of maize was developed to allow the use of glyphosate, the active ingredient in the herbicide Roundup&reg;, as a weed control option. In order to obtain field tolerance to glyphosate herbicide, two novel genes, EPSPS and <i>goxv</i>247, were introduced maize by particle acceleration (biolistic) transformation.</p>\n\n<p style="text-align: justify;">The EPSPS gene codes for the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that is present in all plants, bacteria and fungi. The EPSPS gene put into MON832 was isolated from strain CP4 of the common soil bacterium <i>Agrobacterium tumefaciens</i> and is a glyphosate tolerant form of EPSPS. The EPSPS enzyme is part of an important biochemical pathway in plants called the shikimate pathway that is involved in the production of aromatic amino acids and other aromatic compounds. When conventional maize plants are treated with glyphosate, they cannot produce the aromatic amino acids needed to grow and survive. EPSPS is not present in mammals, birds or aquatic life forms, which do not synthesize their own aromatic amino acids. For this reason, glyphosate has little toxicity to these organisms. The EPSPS enzyme is naturally present in foods derived from plant and microbial sources.</p>\n\n<p style="text-align: justify;">MON832 contains a second gene that codes for a modified version of glyphosate oxidase (GOX) enzyme that is ubiquitous in nature. The <i>goxv</i>247 gene inserted into MON832 was isolated from strain LBAA of the bacterium <i>Ochrobactrum anthropi</i>. The GOX enzyme accelerates the normal breakdown of the herbicide glyphosate into two non-toxic compounds, aminomethylphosphonic acid (AMPA) and glyoxylate. AMPA is the principal breakdown product of glyphosate and is degraded by several microorganisms, while glyoxylate is commonly found in plant cells and is broken down by the glyoxylic pathway for lipid metabolism.</p>\n\n<p style="text-align: justify;">The major components of grain and forage from MON832 maize were analyzed in order to determine their safety for use as food and as livestock feed. Proximate analysis determined that MON832 grain was comparable to that of the non-transgenic control line in its protein, fat, ash, carbohydrate, fibre, moisture and caloric content. Additionally, the amino acid and fatty acid composition of MON832 grain was comparable to that of a non-transgenic line. Based on this data, it was concluded that there was no significant difference between the forage from MON832 maize and the control line.</p>\n\n<p style="text-align: justify;">The low potential for toxicity of the transgenic maize line MON832 was demonstrated by examining the amino acid sequence homology and protein characterization of the line. The CP4 EPSPS and GOX proteins did not show meaningful amino acid sequence homology with known allergens or protein toxins. Further assessment of the allergenic potential of these proteins consisted of digestibility studies and an acute oral toxicity study involving mice. Results of the digestibility studies indicated that, unlike known protein allergens, the CP4 EPSPS and GOX proteins are rapidly degraded and their enzymatic activity lost under conditions that simulate mammalian digestion. The mouse toxicity study indicated that there were no toxic effects caused by consumption of the CP4 EPSPS or GOX proteins, as measured by the absence of treatment-related adverse effects in the mice. It was therefore concluded that the CP4 EPSPS and GOX proteins are not likely to pose any toxicity or allergenicity concerns.</p>\n', NULL, '2013-08-30 16:57:15'),
(13, 12, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods. Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum. In the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for ethanol production. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals. Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts. The European corn borer (ECB), <i>Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada; losses resulting from ECB damage and control costs exceed $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second generation larvae, with annual yield losses estimated at 5 to 10 %. Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in identifying and managing ECB in maize crops: ECB larval damage is hidden, heavy infestations are unpredictable, insecticides are costly, timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control. The transgenic maize line MON809 was genetically engineered to resist ECB by producing its own insecticide. This line was developed by introducing the <i>cry1Ab</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into the maize line by particle acceleration (biolistic) transformation. The <i>cry1Ab</i> gene produces the insect control protein Cry1Ab, a delta-endotoxin. The Cry1Ab protein produced by the <i>Bt</i> maize is identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry1Ab is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry1Ab is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for the delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins. MON809 expressed the Cry1Ab protein at an effective dosage over the growing season, as indicated by its efficacy in controlling both first and second generation infestations of ECB. Protein expression was found to decrease over the growing season, as evidenced by declining Cry1Ab protein concentrations in assayed leaves. MON809 was tested in field trials in Canada from 1994 to 1996. Data collected from these trials demonstrated that MON809 was not different from conventional maize lines; agronomic characteristics, including vegetative vigour, time to maturity, seed production, and disease and pest susceptibilities, were within the normal range reported for conventional maize lines. It was demonstrated that the transformed maize line did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms. MON809 was not expected to impact on threatened or endangered species. Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in MON809. Gene exchange between MON809 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States. Regulatory authorities in Canada and the United States have mandatory requirements for developers of <i>Bt</i> maize to implement specific Insect Resistant Management (IRM) Programs. The potential for ECB populations to develop tolerance or become resistant to the <i>Bt</i> toxin is expected to increase as more maize acreage is planted with <i>Bt</i> hybrids. These IRM programs are designed to reduce the potential development of <i>Bt</i>-resistant insect populations, as well as prolonging the effectiveness of plant-expressed Bt toxins, and the microbial <i>Bt</i> spray formulations of these same toxins. The food and livestock feed safety of MON809 maize was established based on several standard criteria. Analyses determined that MON809 grain was nutritionally equivalent to non-transgenic grain, posing no health risks to either humans or livestock. Proximate analysis (ash, crude fat, crude protein, and moisture content), and fatty acid and amino acid composition of MON809 grain revealed only minor differences from the levels reported for non-transgenic maize. These differences were within the normal range of variation for maize and were attributed to normal genotypic variation rather than to the presence of the introduced genes. The toxicity and allergenicity potential of the Cry1Ab protein in MON809 was assessed by examining its physiochemical characteristics, degree of amino acid sequence homology to known protein allergens, and digestibility. The Cry1Ab protein has a history of safe use, demonstrated by its use in microbial <i>Bt</i> spray formulations in agriculture for more than 40 years with no evidence of adverse effects. This fact, combined with the lack of amino acid sequence homology between the Cry1Ab protein and known allergens and toxins, and the rapid degradation of the Cry1Ab protein in acidic gastric fluids, was sufficient to provide with reasonable certainty a lack of toxicity and allergenic potential.</p>\n', NULL, '2013-08-30 01:28:31'),
(14, 1, '', NULL, NULL),
(15, 15, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for ethanol production. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.</p>\n\n<p style="text-align: justify;">The maize line 3751IR was developed to express tolerance to imidazolinone herbicides, a class of herbicides which target and bind to the acetolactate synthase (ALS) enzyme in plants. ALS catalyzes the first reaction in the biosynthesis of branched-chain amino acids. Imidazolinone inhibits the production of these essential amino acids (valine, leucine and isoleucine), resulting in a decrease in protein synthesis and the eventual death of the plant. ALS is also active in the glycolytic pathway of plant metabolism, by which sugars are broken down to produce acids and release energy.</p>\n\n<p style="text-align: justify;">Imidazolinones applied at rates recommended for effective weed control are toxic to currently cultivated maize varieties. Imidazolinone tolerance in 3751IR maize results from a mutation in the ALS enzyme. The mutant form of ALS in 3751IR prevents the binding of imidazolinone herbicides to the enzyme, allowing the 3751IR maize plants to survive application of the herbicide. The mutant form of ALS is not otherwise altered, and its ability to regulate the levels of the branched-chain amino acids via feedback inhibition is equivalent to that of unaltered ALS.</p>\n\n<p style="text-align: justify;">The maize line 3751IR was developed from a mutant line (XA17) selected from somatic (non-reproductive) maize embryos grown on imidazolinone-enriched media under conditions designed to induce mutation. The imidazolinone-enriched media selects for those mutants expressing tolerance to imidazolinone. The chosen mutant cell line XA17 was regenerated to a whole plant and crossed to the inbred maize line B73. A further series of crosses involving this XA17/B73 line resulted in the production of the hybrid 3751IR.</p>\n\n<p style="text-align: justify;">As the development of 3751IR did not employ recombinant DNA technologies, this product was not subject to regulation in any jurisdiction except Canada, where it was regulated as a plant with novel trait under the Seeds Act, a novel feed under the Feeds Act, and as a novel food under the Food and Drug Regulations. Specific environmental, livestock feed, and food safety assessment of this product was only required for Canada.</p>\n', NULL, '2013-08-30 01:30:31');
INSERT INTO `gmcropdatabase_events_execsummaries` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(16, 45, '<p style="text-align: justify;">Sugar beet (<i>Beta vulgaris</i> L. ssp. <i>vulgaris</i> var.<i> altissima</i>) is a botanical variety of <i>B. vulgaris</i> ssp.<i> vulgaris</i>, as are other comestible and fodder beets, and is a member of the goosefoot (Chenopodiaceae) family. It is an important source of sugar (sucrose), accounting for approximately 40 percent of global production.</p>\n\n<p style="text-align: justify;">Sucrose is present in limited quantities in many plants, including various palms and the sugar maple, but sugar beet and sugarcane are the only commercially important sources. More than half of the world sugar supply is obtained from sugarcane, which is grown in tropical and subtropical climates. The rest is supplied by the sugar beet, which is grown in temperate countries. Sugar is manufactured from the roots of the sugar beet; the leaves and tops are removed after harvesting and used as livestock feed. The roots are cut into cossettes, or chips, from which the juice is extracted. The juice is processed to yield sugar and beet molasses, and the remaining pulp is used for domestic animal feed. Beet molasses is also fed to livestock; table molasses is not made from beets because of difficulties in purification. The sugar that is produced from the sugar beet is identical to the sugar that is derived from sugarcane. It is widely used as a sweetener for foods, in preserves, and in the manufacture of candies, baked goods, and soft and alcoholic beverages. Sugar is also used as the raw material for fermentation products such as ethyl alcohol, butyl alcohol, glycerin, citric acid, and levulinic acid. Sugar is an ingredient in some transparent soaps, and it can be converted to esters and ethers, some of which yield tough, insoluble, and infusible resins.</p>\n\n<p style="text-align: justify;">Effective weed management is critical to sugar beet production. Weeds cause significant losses in sugar beet yield and crop quality, and also cause harvesting problems. The low growth habit of the sugar beet plant renders it more susceptible to competition from weeds compared to other crops, such as corn or soybean. Many weed species grow taller than sugar beet and thus aggressively compete for light, water and nutrients. The economic threshold for weed control in sugar beet production is therefore quite low, given the high value of the crop, and the significant losses caused by the presence of weeds. Weeds control strategies include the use of herbicides alone, and herbicides in combination with hand weeding. Sugar beet herbicides can be applied prior to crop emergence (<i>e.g.</i>, triallate, EPTC, ethofumesate), and post-emergence (<i>e.g.</i>, ethofumesate, triflusulfuron, desmedipham, phenimedipham, sethoxydim).<br />\nThe sugar beet line T120-7 was genetically engineered to express tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate ammonium acts by inhibiting the plant enzyme glutamine synthetase, a key enzyme that detoxifies ammonia by incorporating it into glutamine. Inhibition of this enzyme leads to an accumulation of ammonia in the plant tissues, which kills the plant within hours of application. Phosphinothricin herbicides applied at rates recommended for effective weed control are toxic to conventional sugar beet varieties. The modified T120-7 line permits growers to use phosphinothricin-containing herbicides for weed control in the cultivation of sugar beet.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in T120-7 sugar beet is the result of the introduction of the <i>pat</i> gene into the beet genome via <i>Agrobacterium</i>-mediated transformation. The <i>pat</i> gene was isolated from the common soil fungus, <i>Streptomyces viridochromogenes</i>, and encodes the enzyme phosphinothricin-N-acetyltransferase (PAT). PAT catalyses the acetylation of phosphinothricin which detoxifies it into an inactive compound.</p>\n\n<p style="text-align: justify;">The transgenic sugar beet line T120-7 was field tested in the United States from 1994 to 1997, as well as in Canada, Western and Eastern Europe, and in the former Soviet Union. T120-7 was evaluated extensively and no differences were found in agronomic characteristics, plant emergence and seedling vigour when compared to standard commercial sugar beet varieties growing in nearby fields. It was demonstrated that the transformed sugar beet line did not negatively affect beneficial or non-target organisms, and it was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Sugar beet is an outcrossing species, and is mainly wind pollinated. It is a biennial, developing a rosette of leaves and a large taproot in the first year, and bolting (<i>i.e.</i>, forming an inflorescence bearing stem) in the second year. Bolting is induced only after the plant has undergone vernalization at the end of the first season. Certain environmental conditions, such as low temperatures and longer daylength, may induce bolting in the first year. Sugar beet is also very sensitive to frost, and is a poor competitor with other plants. Large amounts of pollen are produced during the reproductive phase, which is carried by wind over long distances.</p>\n\n<p style="text-align: justify;">The genus Beta is comprised of four sections: i) Beta, to which sugar beet belongs; ii) Corollinae; iii) Nanae; and iv) Procumbentes. All species within the Beta section (<i>e.g.</i>, <i>B. vulgaris</i> ssp.<i> maritima</i>,<i> B. macrocarpa</i>) are cross-compatible and produce fertile progeny. Hybrids between sugar beet and members of the other three sections do not occur naturally, and cross-breeding with other members of the Chenopodiaceae is unlikely. As with conventional sugar beet cultivars, T120-7 plants are harvested prior to the initiation of the bolting phase. Since sugar beets are usually not allowed to bolt, except in fields or plots grown for seed production, there is little opportunity for uncontrolled pollen flow. Sugar beets grown for seed production are also isolated from other sugar beet fields to minimize pollen flow. This is usually acheived by the use of isolation distances enforced by seed certification agencies.</p>\n\n<p style="text-align: justify;">The development of glufosinate-tolerant hybrids is possible due to the ability of sugar beet to outcross with related plants. However, the glufosinate-tolerance trait is not expected to provide a competitive advantage to hybrid plants unless grown in managed environments routinely subjected to glufosinate applications. In the event that a glufosinate-tolerant hybrid survived, the herbicide-tolerant individual could be controlled using mechanical and/or other available chemical means. T120-7 is considered unlikely to increase the weediness potential of any other cultivated plant or native wild species with which it may interbreed. T120-7 also does not possess growth and reproductive characteristics that would render it weedier than conventional sugar beet.</p>\n\n<p style="text-align: justify;">Sugar beet intended for human consumption is generally converted directly to refined white sugar through extensive purification processes. The PAT protein in T120-7 sugar beet was expressed at low levels in the sugar beet roots and tops, and was not detected in refined sugar or molasses derived from T120-7. Consequently there will be no human exposure to PAT protein as a result of consumption of refined sugar derived from T120-7 sugar beet.</p>\n\n<p style="text-align: justify;">Sugar beet pulp is a by-product of the refining process and is normally dried and pelleted for use as a livestock feed. In recent years, it has been purified and used as an additive, at levels of less than 1%, in some specific foods, such as food fibre for breakfast cereals. The PAT protein was not detected in the pulp produced from T120-7 sugar beet.</p>\n\n<p style="text-align: justify;">T120-7 line was compared with non-transgenic sugar beets in analyses of numerous compositional components, including crude fat, crude protein, fibre, ash, carbohydrate, calories, calcium, magnesium, phosphorus, potassium, and sodium. With the exception of fibre content, no statistically significant differences were observed. The differences in fibre content were ascribed to environmental factors associated with different growing locations and conditions. The process fractions, refined sugar, molasses and dried pulp produced from T120-7 sugar beet were assessed by proximate analysis (fatty acids, amino acids, minerals and sugar profiles). The dried pulp fraction revealed differences in ash content and some amino acids. It was determined that these differences in nutrient content would not impact on animal nutrition, as dried pulp comprises less than 25% of the content of livestock feed. The molasses fraction revealed differences in fat, protein, calcium, and some amino acids. These differences were small and not expected to impact the nutritional content of animal feed. Analysis of the refined sugar fraction showed a difference in tryptophan levels. Importantly, there were no significant differences in carbohydrate content, which is the major nutrient in refined sugar (98%).</p>\n\n<p style="text-align: justify;">Potential toxicity and allergenicity of the transformed sugar beet line was investigated through examination of the amino acid sequence and physiochemical characteristics of the introduced PAT protein. It was determined that the PAT enzyme has a very low potential for toxic or allergenic effects. No significant homologies with the amino acid sequences of known protein toxins or allergens were detected, the PAT enzyme did not display the heat stability characteristic of allergenic compounds, and was rapidly degraded under conditions simulating mammalian digestion. The low concentrations of the PAT enzyme found in T120-7 tissues, and so in the food or livestock feed products derived from them, further supported the conclusion that the PAT enzyme possessed little or no potential for allergenicity or toxicity.</p>\n', NULL, '2013-08-30 12:04:44'),
(17, 14, '<p style="text-align: justify;">Cotton (<i>Gossypium hirsutum</i> L.) is primarily grown for its seed bolls that produce fibres used in numerous textile products. The major producers of cotton seed and lint are China, the United States, India, Pakistan, Brazil, Uzbekistan and Turkey.</p>\n\n<p style="text-align: justify;">About two thirds of the harvested cotton crop is seed, which is separated from the lint during ginning. The cotton seed is crushed to produce cottonseed oil, cottonseed cake (meal), and hulls. Cottonseed oil is used primarily as a cooking oil, in shortening and salad dressing, and is used extensively in the preparation of snack foods such as crackers, cookies and chips. The meal and hulls are an important protein concentrate for livestock, and may also serve as bedding and fuel. Linters, or fuzz, which are not removed in ginning, are used in felts, upholstery, mattresses, twine, wicks, carpets, surgical cottons, and in industrial products such as rayon, film, shatterproof glass, plastics, sausage skins, lacquers, and cellulose explosives.</p>\n\n<p style="text-align: justify;">Tobacco budworm (<i>Heliothis virescens</i>), pink bollworm (<i>Pectinophora gossypiella</i>), and cotton bollworm (<i>Helicoverpa zea</i>) are three of the most destructive pests of cotton. In the United States alone, the combined costs of costs of control and yield loss attributed to these pests is up to $476 million per year. In Egypt, China and Brazil, pink bollworm commonly causes cotton losses of up to 20 percent.</p>\n\n<p style="text-align: justify;">More insecticides are applied to conventionally grown cotton than any other single crop. Each year cotton producers around the world use nearly $2.6 billion worth of pesticides such as aldicarb, phorate, methamidophos and endosulfan. Cotton pests, such as the tobacco budworm, have developed some resistance to many of the insecticides used to control them. In regions where insecticide-resistant populations have developed, budworm damage can reduce yields by 29%, despite an average of six insecticide applications each growing season.</p>\n\n<p style="text-align: justify;">Cotton lines MON531, MON757, and MON1076 were genetically engineered to resist cotton bollworm, tobacco budworm and pink bollworm by producing their own insecticide. These lines were developed by introducing the <i>cry1Ac</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into a cotton line by <i>Agrobacterium</i>-mediated transformation. The <i>cry1Ac</i> gene produces the insect control protein Cry1Ac, a delta-endotoxin. The Cry1Ac protein produced in lines MON531, MON757, and MON1076 is almost identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry1Ac is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry1Ac is insecticidal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.</p>\n\n<p style="text-align: justify;">Cotton lines MON531, MON757, and MON1076 were tested in field trials in the United States beginning in 1990. Agronomic characteristics such as yield, boll size, plant vigour, growth, morphology, germination and flowering were found to be within the range for commercial cotton lines. Disease susceptibility remained unchanged in the transgenic lines, and the processing qualities of cotton lint, such as fibre length and strength, were also within the norms for conventional cotton varieties. It was demonstrated that MON531, MON757, and MON1076 did not exhibit weedy characteristics and had no effect on non-target organisms or the general environment. The transformed lines were not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Cotton plants are primarily self-pollinating, but insects, especially bumblebees and honeybees, also distribute cotton pollen. Cotton can cross-pollinate with compatible species including <i>G. hirsutum</i> (wild or under cultivation), <i>G. barbadense</i> (cultivated Pima cotton), and <i>G. tomentosum</i>. Overall, the probability of gene transfer to wild species in unmanaged ecosystems is low due to the relatively isolated distribution of Gossypium species, different breeding systems, and genome incompatibility. Assuming proximity, synchronicity of flowering and availability of insects, MON531, MON757, and MON1076 may freely hybridize with other <i>G. hirsutum</i> varieties.</p>\n\n<p style="text-align: justify;">Regulatory authorities in the United States have mandatory requirements for developers of <i>Bt</i> cotton to implement specific Insect Resistant Management (IRM) Programs. The potential for <i>Bt</i>-resistant insect populations to develop increases as acreages planted with transgenic <i>Bt</i> cotton hybrids expand. Hence, these IRM programs are designed to reduce this potential and prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial <i>Bt</i> spray formulations that contain these same toxins.</p>\n\n<p style="text-align: justify;">The livestock feed safety of MON531, MON757, and MON1076 was established based on several standard criteria. As part of the safety assessment, the nutritional composition of cottonseed was tested and found to be equivalent to conventional cotton, as shown by analyses of key nutrients, including proximates (crude protein, crude fat, crude fibre, ash and gross energy), tocopherols, and amino acid and fatty acid composition. Assays were completed to determine levels of anti-nutritional factors such as aflatoxins, gossypol, and dihydrosterculic fatty acids and there were no differences in cottonseed samples from the transgenic and conventional cotton lines. Cottonseed products (raw meal, toasted meal, kernel, refined oil) were analyzed and found to be similar in composition to conventional cotton. The nutritional equivalence of MON531, MON757, and MON1076 to conventional cotton was confirmed in feeding trials with rats and quail, which did not experience any deleterious effects when fed raw cottonseed meal from cotton line 531.</p>\n\n<p style="text-align: justify;">Refined cottonseed oil and cellulose from processed linters of cottonseed are the only cotton products consumed by humans, and are subjected to processing treatments that would be expected to remove and/or destroy DNA and protein. Nevertheless, toxicity of MON531, MON757, and MON1076 was assessed by analysis of the naturally occurring toxins gossypol and cyclopropenoid fatty acids (sterculic and malvalic acid) in cottonseed and refined oil. The deduced amino acid sequences of Cry1Ac was compared to the amino acid sequence of known protein toxins and no significant similarities were found.</p>\n\n<p style="text-align: justify;">Refined cottonseed oil and cellulose from linters are devoid of protein and, given that most allergens are proteins, consumption of oil and cellulose is unlikely to provoke an allergic reaction. The potential for allergenicity was assessed based on studies that included digestive degradation, sequence similarity to known allergens, and lack of protein in food derived from cotton. Cry1Ac showed no significant protein sequence homology to a database of known allergens and, unlike known allergenic proteins, Cry1Ac is rapidly degraded when exposed to simulated gastric fluids.</p>\n', NULL, '2013-08-30 01:29:57'),
(18, 18, '<p style="text-align: justify;">Argentine or oilseed rape (<i>Brassica napus</i>) was grown as a commercial crop in over 50 countries, with a combined harvest of 48.9 million metric tonnes in 2006. The major producers of rapeseed are China, Canada, India, Germany, France, the United Kingdom and Australia. Canola is a genetic variation of <i>B. napus</i> that was developed through conventional breeding to contain low levels of the natural rapeseed toxins, glucosinolate and erucic acid. Canola is grown for its seed, which represents a major source of edible vegetable oil and is also used in livestock feeds. The only food use of canola is as a refined oil. Typically, canola oil is used by itself as a salad oil or cooking oil, or blended with other vegetable oils in the manufacture of margarine, shortenings, cooking and salad oils. Canola meal, a byproduct of the oil production process, is added to livestock feed rations. An increasing amount of oil is being used for biodiesel production, especially in Europe. The canola lines 23-18-17 and 23-198 were genetically engineered to express modified seed fatty acid content, specifically high levels of lauric acid and myristic acid. The increased levels of lauric acid in oil from the modified canola lines allow for its use as a replacement for other lauric acid oils, such as coconut and palm kernel oil, in products such as confectionery coatings and fillings, margarines, spreads, shortenings and commercial frying oils. The modified fatty acid content of the canola lines 23-18-17 and 23-198 is a result of the insertion of a thioesterase (TE) encoding gene from the California bay tree,<i>Umbellularia californica</i>, which is an alternative source of the spice &ldquo;bay leaf&rdquo; that is harvested commercially from <i>Lauris nobilis</i>. The introduced thioesterase enzyme is active in the fatty acid biosynthetic pathway of the developing seed and causes the accumulation of triacylglycerides containing esterified lauric acid and, to a lesser extent, myristic acid. The canola lines 23-198 and 23-18-17 were field tested in the United States from 1991 to 1992, and in Canada from 1993 to 1995. Agronomic and adaptation characteristics such as seed germination, seed yield, seedling growth, and flowering and maturity dates were within the normal range of expression found in conventional canola varieties. The laurate canola lines were generally taller, later maturing and lower yielding, reflecting characteristics of the parent line. Disease incidence and insect susceptibilities were shown to the same as those of unmodified counterparts. The only significant difference between high laurate canola and the parent variety was the modified laurate content. Overall the field data reports demonstrated that the transformed canola lines did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Canola lines 23-18-17 and 23-198 were not expected to impact on threatened or endangered species. <i>Brassica napus</i> may outcross (up to 30% of the time) with plants of the same species, and potentially with plants of related species <i>B. rapa</i>, <i>B. juncea</i>, <i>B. carinata</i>, <i>B. nigra</i>, <i>Diplotaxis muralis</i>, <i>Raphanus raphanistrum</i>, and <i>Erucastrum gallicum</i>. Previous studies have demonstrated that cross breeding is most likely to occur with <i>B. rapa</i>. The ability of rapeseed to outcross with related plants makes the formation of high laurate content hybrids possible. However, the high laurate content trait is not expected to provide a competitive advantage to hybrid plants, and the high laurate <i>B. napus</i> lines are grown under contract to preserve their identity and prevent mixing with conventional canola. Any hybrids that do arise would be found in managed environments and could easily be controlled using mechanical and/or chemical means. The human consumption of canola products is limited to the refined oil. The level and composition of laurate produced by lines 23-18-17 and 23-198 was no different from that found in common food sources, such as coconut and palm oil. The modified fatty acid composition of the oil from transgenic canola lines 23-198 and 23-18-17 does not raise any nutritional concerns regarding its intended use. The analysis of levels of erucic acid and glucosinolates, as well as the quality and quantity of seed protein, were within acceptable levels for canola. The fatty acid profile of high laurate canola was different from all control varieties, with increased levels of lauric acid (up to 40%) and myristic acid, and lower levels of oleic acid and linoleic acid, as well as less palmitic, stearic, linoleic, arachidic, and gadoleic acids, and slightly more behenic acid. Nevertheless, the overall lipid content of the seed remained unchanged. It was concluded that the consumption of products formulated with this oil would have no significant impact on the nutritional quality of the food supply in North America and Canada. No statistical differences in crude protein, crude fibre, gross energy content, or amino acids were noted between the processed meal of high laurate lines and control <i>B. napus</i> cultivars. The levels of both laurate and myristate oils were within the accepted ranges for canola meal used in livestock feed. It was determined that canola meal derived from lines 23-18-17 and 23-198 was equivalent to meal from traditional B. napus varieties in terms of nutritional composition and safety. Potential toxicity and allergenicity of the Bay TE enzyme expressed in the transgenic canola lines 23-18-17 and 23-198 was investigated by searching for amino acid sequence homologies with known toxins and allergens, and by examining their physiochemical properties. No homologies between the amino acid sequences of the Bay TE enzyme and the sequences of known toxins or allergens were detected. Bay TE does not possess the proteolytic or heat stability characteristic of toxic compounds, and was readily digested under conditions simulating mammalian digestion. Thioesterase enzymes like Bay TE are widespread in nature and no toxic or allergenic effects have ever been reported. Based on these properties, it was concluded that Bay TE enzyme possessed little or no potential for allergenicity or toxicity.</p>\n\n<p>&nbsp;</p>\n', NULL, '2013-08-30 01:32:09'),
(19, 25, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amont is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals, and car parts.</p>\n\n<p style="text-align: justify;">The European corn borer (ECB), <i>Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada; losses resulting from ECB damage and control costs exceed $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second generation larvae, with annual yield losses estimated at 5 to 10 %.</p>\n\n<p style="text-align: justify;">Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in identifying and managing ECB in maize crops: ECB larval damage is hidden, heavy infestations are unpredictable, insecticides are costly, timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control.</p>\n\n<p style="text-align: justify;">The transgenic maize Event 176 was genetically engineered to resist ECB by producing its own insecticide. This line was developed by introducing the <i>cry1Ab</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into a maize line by particle acceleration (biolistic) transformation. The <i>cry1Ab</i> gene produces the insect control protein Cry1Ab, a delta-endotoxin. The Cry1Ab protein produced by the <i>Bt</i> maize is identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry1Ab is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry1Ab is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for the delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.</p>\n\n<p style="text-align: justify;">Maize Event 176 expressed the Cry1Ab protein at levels effective against first generation infestations of ECB. Protein expression declined as the growing season progressed, and was less effective against later generations of ECB. Event 176 was tested in field trials in the United States beginning in 1992. Data collected from these trials demonstrated that Event 176 was not different from conventional maize lines; agronomic characteristics, including seed germination rates, yield characteristics, and disease and pest susceptibilities, were within the normal range reported for conventional maize lines. It was demonstrated that the transformed maize line did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Event 176 maize was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive characteristics such as pollen production, viability and dispersal were unchanged in Event 176. Gene exchange between maize Event 176 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">Regulatory authorities in Canada and the United States have mandatory requirements for developers of <i>Bt</i> maize to implement specific Insect Resistant Management (IRM) Programs. The potential for ECB populations to develop tolerance or become resistant to the <i>Bt</i> toxin is expected to increase as more maize acreage is planted with <i>Bt</i> hybrids. These IRM programs are designed to reduce the potential development of <i>Bt</i>-resistant insect populations, as well as prolonging the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial <i>Bt</i> spray formulations of these same toxins.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of maize Event 176 was established based on several standard criteria. As part of the safety assessment, the nutritional composition of grain from Event 176 was analyzed in order to determine protein, fat, total ash, crude fibre, moisture, protein, starch, and carotenoid content. Amino acid composition was established and a fatty acid profile was completed. Maize Event 176 was found to be nutritionally equivalent to conventional maize and minor differences detected were all within the normal established ranges for maize.</p>\n\n<p style="text-align: justify;">The wholesomeness of maize Event 176, as compared to conventional maize, was confirmed in feeding studies in which mice and bobwhite quail were fed Cry1Ab protein prepared from maize leaves. These trials also demonstrated that there were no unintended effects experienced by these organisms when fed Event 176 grain.</p>\n\n<p style="text-align: justify;">The toxicity and allergenicity potential of the Cry1Ab protein in Event 176 maize was demonstrated by examining its physiochemical characteristics and amino acid sequence homology with known protein allergens. Digestibility studies and an acute oral toxicity study were also conducted. In the latter study, mice were fed high doses of native Cry1Ab protein with no negative consequences, demonstrating the protein&rsquo;s lack of toxicity. The Cry1Ab protein has a history of safe use, demonstrated by its use in microbial Bt spray formulations in agriculture for more than 30 years with no evidence of adverse effects. This fact, combined with the lack of amino acid sequence homology between the Cry1Ab protein and known allergens and toxins, and the rapid degradation of the Cry1Ab protein in acidic gastric fluids, was sufficient to provide with reasonable certainty a lack of toxicity and allergenic potential.</p>\n', NULL, '2013-08-30 11:16:35'),
(20, 20, '<p style="text-align: justify;">Potato (<i>Solanum tuberosum</i> L.) is grown commercially in over 150 countries with a combined harvest of over 315 million metric tonnes in 2006. The major producers of potatoes are China, Russia, India, the United States, Ukraine, Poland and Germany. Potatoes are the fourth most important food crop in the world, providing more edible food than the combined world output of fish and meat. They are grown for the fresh and processed food industries, especially the frozen food sector. In North America, potato tubers are used primarily for French fries, chips, and dehydrated flakes. Other food uses of the crop include consumption of fresh tubers, and in the production of flour, starch and alcohol.</p>\n\n<p style="text-align: justify;">Colorado potato beetle (CPB; <i>Leptinotarsa decemlineata</i> [Say]) is the most destructive insect pest of potatoes in North America. The adult and all larval stages feed primarily on foliage and occasionally on stems. When the population of beetles is high, plants can be completely defoliated. Extensive feeding at any time during the growing season can reduce yield, as a reduction in leaf surface area decreases the plant&rsquo;s ability to produce and store nutrients, which affects tuber size and number.</p>\n\n<p style="text-align: justify;">Commercial production of potatoes is nearly impossible without using insecticides to control CPB. Thirty-four percent of total insecticide use on potatoes is for control of CPB, more than used on any other insect potato pest. There are several insecticide classes that are available for Colorado potato beetle control including organophosphates, carbamates, pyrethroids, chlorinated hydrocarbons, insect growth regulators, chloronicotinyl, spinosads and abamectins. Colorado potato beetle has shown a tremendous ability to develop resistance to insecticides, including the arsenicals, organochlorines, carbamates, organophosphates, and pyrethroids. Cross-resistance to organophosphates and carbamates, and multiple resistance to organophosphates, carbamates, and pyrethroids has also been reported.<br />\nThe transgenic potato lines BT6, BT10, BT12, BT16, BT17, BT18, and BT23 were genetically engineered to resist CPB by producing their own insecticide. These lines were developed by introducing the <i>cry3A</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> subspecies tenebrionis (Btt), into the potato cultivar &lsquo;Russet Burbank&rsquo; by <i>Agrobacterium</i>-mediated transformation. The <i>cry3A</i> gene produces the insect control protein Cry3A, a delta-endotoxin.<br />\nThe Cry3A protein produced by BT6, BT10, BT12, BT16, BT17, BT18, and BT23 is identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry3A is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow causing gut paralysis and eventual death due to bacterial sepsis. Cry3A is insecticidal only when eaten by the larvae of coleopteran insects such as Colorado potato beetle and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.</p>\n\n<p style="text-align: justify;">Transgenic potato lines BT6, BT10, BT12, BT16, BT17, BT18, and BT23 were tested in field trials in the United States (1991-1994) and Canada (1992-1995). Data collected from these trials demonstrated these potato lines were not different from conventional Russet Burbank. They grew normally and exhibited the expected morphology, reproductive and physiological characteristics of potatoes. Susceptibility to diseases and insects, other than CPB, remained unchanged and the transgenic potato lines did not exhibit enhanced weediness potential.</p>\n\n<p style="text-align: justify;">Dietary toxicity studies were performed using the Cry3A protein on four beneficial insects (honeybee, ladybird beetle, green lacewing and parasitic wasp), and eight non-target insect species (southern corn rootworm, yellow fever mosquito, green peach aphid, European corn borer, tobacco hornworm, corn earworm, tobacco budworm and German cockroach). No negative effects were observed, except for slightly higher mortality and reduced honeydew production of green peach aphids, which as vectors of damaging potato viruses, are normally controlled in potato fields by chemical means. BT6, BT10, BT12, BT16, BT17, BT18, and BT23 were not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Generally, varieties of <i>S. tuberosum</i> are capable of cross-breeding with each other, but genetic exchange with other Solanum species is usually unsuccessful. In Canada there are no tuber producing wild relatives of Solanum. In the United States, tuber-bearing Solanum species include <i>S. jamesii</i>, <i>S. fendleri</i>, and <i>S. pinnatisectum</i>, however, the possibility of cultivated potato crossing with these species is remote because of geographical isolation and other biological barriers to natural hybridization. No natural hybrids have been observed between these species and cultivated <i>S. tuberosum</i>.</p>\n\n<p style="text-align: justify;">Gene transfer from BT6, BT10, BT12, BT16, BT17, BT18, and BT23 to other potato cultivars is unlikely. Multiple barriers, such as male sterility, prevent pollen production in the CPB-resistant potato lines as the transgenic lines are derived from the male sterile cultivar &#39;Russet Burbank&#39;. Cross-pollination between BT6, BT10, BT12, BT16, BT17, BT18, and BT23 and male-fertile potato cultivars and subsequent seed production is restricted due to limited pollen dispersal in potatoes.</p>\n\n<p style="text-align: justify;">Regulatory authorities in Canada and the United States have mandatory requirements for developers of <i>Bt</i> potatoes to implement specific Insect Resistant Management (IRM) Programs. The potential exists for <i>Bt</i>-resistant CPB populations to develop as acreages planted with transgenic CPB-resistant potatoes expand. Hence, these IRM programs are designed to reduce this potential and prolong the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial <i>Bt</i> spray formulations that contain these same toxins.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of transformed potato lines BT6, BT10, BT12, BT16, BT17, BT18, and BT23 was established based on several standard criteria. As part of the safety assessment, the nutritional composition of the seven CPB-resistant lines was found to be equivalent to conventional potatoes as shown by the analyses of key nutritional parameters including protein, fat, ash, total dietary fibre, carbohydrates, calories, and micronutrients and trace elements (<i>e.g.</i>, thiamine, niacin, riboflavin, vitamin C, calcium, iron and zinc). There were significant differences in carbohydrate, fat and fibre although in each case the measured concentration was within the range normally reported for potatoes. It was concluded that the consumption of products from BT6, BT10, BT12, BT16, BT17, BT18, and BT23 potatoes has no significant impact on the nutritional quality of the Canadian and American food supply.</p>\n\n<p style="text-align: justify;">The glycoalkaloids, solanine and chaconine, are naturally occurring toxicants found in potato tubers, particularly green tubers that have been exposed to sunlight. Analyses of total glycoalkaloid levels in each of the transgenic lines demonstrated that in each case the levels were within the standards previously established for potatoes. The potential toxicity of the Cry3A protein was also examined: in acute oral toxicity studies with mice Cry3A was found to have no negative effects, and the amino acid sequence of Cry3A was not homologous with those of known mammalian protein toxins.</p>\n\n<p style="text-align: justify;">The potential for allergenicity of the Cry3A protein was assessed based upon the physiochemical properties of known food allergens, such as stability to acid and/or proteolytic digestion, heat stability, and glycosylation. Cry3A did not demonstrate any characteristics normally associated with food allergens. Unlike known protein allergens, which are normally resistant to digestion, Cry3A was rapidly inactivated and degraded when subjected to typical mammalian acidic stomach conditions. Additionally, the Cry3A protein has a history of safe use as demonstrated by its application in microbial <i>Bt</i> spray formulations in agriculture and forestry for more than 30 years with no evidence of adverse effects. These facts, combined with the lack of amino acid sequence homology between Cry3A protein and known allergens, were sufficient to provide with reasonable certainty that Cry3A has no allergenic potential.</p>\n', NULL, '2013-08-30 01:33:39'),
(21, 42, '<p style="text-align: justify;">Soybean (<i>Glycine max</i>) is grown primarily for its seed, which has many uses in the food and industrial sectors, and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use. The major producers of soybeans were the United States, Brazil, Argentina, China, India, Paraguay and Canada.</p>\n\n<p style="text-align: justify;">A major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock.</p>\n\n<p style="text-align: justify;">Weeds are a major production problem in soybean cultivation. Typically, weeds are managed using a combination of cultural (<i>e.g.</i>, seed bed preparation, using clean seed, variety selection, and planting date) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be applied before planting (<i>e.g.</i>, pendimethalin, trifluralin, metribuzin), after planting but before emergence (<i>e.g.</i>, pendimethalin, linuron, imazethapyr), and/or after emergence (<i>e.g.</i>, bentazon, acifluorfen, fomesafen). Commonly, several different herbicides are required to adequately control weeds in soybean fields.</p>\n\n<p style="text-align: justify;">The soybean line GU262 was genetically engineered to express tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in GU262 soybean is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces viridochromogenes</i>, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties. The <i>pat</i> gene was introduced into the soybean genome by micro-particle acceleration (biolistic) transformation, and the resulting soybean line, GU262, displayed field tolerance to phosphinothricin-containing herbicides, thereby permitting farmers to use this herbicide for weed control in soybean cultivation.</p>\n\n<p style="text-align: justify;">The transgenic soybean line GU262 was field tested in the United States from 1996 to 1998, and field trial reports indicated that this line did not exhibit weedy characteristics, and had no effect on non-target organisms or the general environment. In the United States, the transgenic soybean lines A2704-12, A2704-21, and A5547-35 were designated as the antecedent organisms to GU262 for the purposes of conducting an environmental safety assessment. The soybean line GU262 and its progeny were similar to the antecedent organisms as they were genetically engineered to express the same pat gene, and they all exhibited similar agronomic characteristics. Based on the similarity between GU262 and the antecedent organisms A2704-12, A2704-21, and A5547-35, and on an analysis of scientific data and field tests, the soybean line GU262 was judged not to have any characteristics that would have a significant impact on any beneficial organisms in the environment or on any threatened or endangered species.</p>\n\n<p style="text-align: justify;">Soybean does not have any weedy relatives with which it can crossbreed in the continental United States or Canada. Additionally, soybean plants are almost completely self-pollinated, and the reproductive and growth characteristics of GU262 were unchanged by the genetic modification resulting in glufosinate-tolerance. It was therefore concluded that the potential for transfer of the glufosinate-tolerance trait from the transgenic line to soybean relatives through gene flow (outcrossing) was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada or the continental United States.</p>\n', NULL, '2013-08-30 12:00:07');
INSERT INTO `gmcropdatabase_events_execsummaries` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(22, 133, '<p style="text-align: justify;">Soybean (<i>Glycine max</i> L. Merr.), is grown primarily for its seed which has many uses in the food and industrial sectors and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use. A major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock. The major producers of soybeans are the United States, Brazil, Argentina, China, India, Paraguay and Canada.</p>\n\n<p style="text-align: justify;">Weeds are a major production problem in soybean cultivation. Typically, weeds are managed using a combination of cultural (<i>e.g.</i> seed bed preparation, using clean seed, variety selection, and planting date) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be applied before planting (<i>e.g.</i> pendimethalin, trifluralin, metribuzin), after planting but before emergence (<i>e.g.</i> pendimethalin, linuron, imazethapyr), and/or after emergence (<i>e.g.</i> bentazon, acifluorfen, fomesafen). Commonly, several different herbicides are required to adequately control weeds in soybean fields.</p>\n\n<p style="text-align: justify;">DP356043 has been transformed to express two novel genes, providing tolerance to two different classes of herbicide. The line contains two genes; <i>gat4601</i> which provides tolerance to glyphosate by detoxifying the compound, while <i>gm-hra</i> encodes for a modified acetolactate synthase (ALS) enzyme which is not affected by the imidazolinone class of ALS inhibiting herbicides. The <i>gat4601</i> gene is based on the sequences of three <i>gat</i> genes from the common soil bacterium <i>Bacillus licheniformis</i>. <i>B. licheniformis</i> is widespread in the environment; therefore, animals and humans are regularly exposed without adverse consequences to this organism and its components, such as the glyphosate N-acetyltransferase (GAT) protein. The GAT4601 protein is 84% homologous to each of the three native GAT proteins from which it was derived. In DP356043, the expression of the <i>gat4601</i> gene is driven by the constitutive synthetic core promoter SCP1.</p>\n\n<p style="text-align: justify;">The GM-HRA protein in DP356043 is a modified version of the soybean GM-ALS protein. GM-ALS is involved in branched chain amino acid (leucine, isoleucine and valine) biosynthesis in the plastid. The herbicide tolerant gm-hra gene was made by isolating the herbicide sensitive soybean <i>gm-als</i> gene and introducing two specific amino acid changes, known to confer herbicide tolerance to tobacco ALS. The GM-HRA protein is &gt;99% homologous to the native GM-ALS protein from which it was derived. In DP356043, the expression of the <i>gm-hra</i> gene is driven by the soybean constitutive S-adenosyl-L-methionine synthetase (SAMS) promoter.</p>\n\n<p style="text-align: justify;">There was no evidence of acute toxicity in mice for either GAT4601 or GM-HRA at doses of 1680 or 582 mg protein per kg of body weight, respectively. Based on the GAT4601 and GM-HRA protein levels in DP356043, exposure levels would be well below the tested doses. These data support the food and feed safety of the GAT4601 and GM-HRA proteins. The allergenic potential of the GAT4601 and GM-HRA proteins was assessed using a step-wise, weight-of-the evidence approach. Bioinformatic analyses revealed no identities to known or putative protein allergens or toxins for either the GAT4601 or GM-HRA amino acid sequences. Both the GAT4601 and GM-HRA proteins were non-glycosylated and heat labile. Both proteins hydrolyzed rapidly (within 30 seconds) in simulated gastric fluid. In simulated intestinal fluid the GAT4601 protein hydrolyzed within 2 minutes and the GMHRA protein hydrolyzed within 30 seconds.</p>\n', NULL, '2013-08-30 17:33:35'),
(23, 39, '<p style="text-align: justify;">Soybean (<i>Glycine max</i>) is grown primarily for its seed, which has many uses in the food and industrial sectors, and represents one of the major sources of edible vegetable oil and of proteins for livestock feed use. The major producers of soybeans were the United States, Brazil, Argentina, China, India, Paraguay and Canada.</p>\n\n<p style="text-align: justify;">A major food use of soybean in North America and Europe is as purified oil, used in margarines, shortenings, and cooking and salad oils. It is also a major ingredient in food products such as tofu, tempeh, soya sauce, simulated milk and meat products, and is a minor ingredient in many processed foods. Soybean meal is used as a supplement in feed rations for livestock.</p>\n\n<p style="text-align: justify;">Weeds are a major production problem in soybean cultivation. Typically, weeds are managed using a combination of cultural (<i>e.g.</i>, seed bed preparation, using clean seed, variety selection, and planting date) and chemical controls. Depending on the production area and the prevalent weed species, herbicides may be applied before planting (<i>e.g.</i>, pendimethalin, trifluralin, metribuzin), after planting but before emergence (<i>e.g.</i>, pendimethalin, linuron, imazethapyr), and/or after emergence (<i>e.g.</i>, bentazon, acifluorfen, fomesafen). Commonly, several different herbicides are required to adequately control weeds in soybean fields.</p>\n\n<p style="text-align: justify;">The soybean lines W62 and W98 were genetically engineered to express tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in W62 and W98 soybean lines is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces hygroscopicus</i>, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties. The PAT encoding gene (<i>bar</i>) was introduced into the soybean genome by micro-particle acceleration (biolistic) transformation, and the resulting soybean lines displayed field tolerance to phosphinothricin-containing herbicides, thereby permitting farmers to use this herbicide for weed control in soybean cultivation.</p>\n\n<p style="text-align: justify;">The soybean lines W62 and W98 were field tested in the United States from 1990-1993, and field trial reports indicated that these lines did not exhibit weedy characteristics, and had no effect on non-target organisms or the general environment. Soybean does not have any weedy relatives with which it can crossbreed in the continental United States or Canada. Additionally, soybean plants are almost completely self-pollinated, and the reproductive and growth characteristics of these transgenic lines were unchanged by the genetic modification resulting in glufosinate-tolerance. It was therefore concluded that the potential for transfer of the glufosinate-tolerance trait from W62 and W68 lines to soybean relatives through gene flow (outcrossing) was negligible in managed ecosystems, and that there was no potential for transfer to wild species in Canada or the continental United States.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of glufosinate-tolerant soybean lines W62 and W98 was established based on the lack of toxicity or allergenicity of the PAT enzyme and by direct laboratory analyses. The nutritional equivalence and wholesomeness of these soybeans compared to conventional (non-transgenic) soybeans was demonstrated by the analysis of key nutrients, including proximates (<i>e.g.</i>, moisture, crude protein, crude fat, ash, acid detergent fibre, neutral detergent fibre, carbohydrate), fatty acid analysis, amino acid analysis, and analyses of minerals (calcium, phosphorous, and potassium). The values for each of these parameters were found to be within the normal range of expression found in unmodified soybean varieties.</p>\n\n<p style="text-align: justify;">Samples of seed from the transgenic lines were analyzed to determine concentrations of known antinutrients found in soybean (<i>e.g.</i>, trypsin inhibitors, lectins, stachyose, raffinose, and phytic acid), as well as concentrations of phytoestrogens. The levels of these substances were found to be within the normal range of expression of currently cultivated varieties of soybean.</p>\n\n<p style="text-align: justify;">The low potential toxicity and allergenicity of the PAT protein expressed in the transgenic soybean lines W62 and W98 was supported by previous studies demonstrating a lack of amino acid sequence homology between the PAT protein and known protein allergens and toxins, and through examination of the protein&rsquo;s physiochemical characteristics (<i>e.g.</i>, susceptibility to pepsin degradation in simulated gastric fluids, heat instability).</p>\n', NULL, '2013-08-30 11:56:04'),
(24, 48, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production od ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.</p>\n\n<p style="text-align: justify;">The maize line DLL25 (synonym B16) was genetically engineered to express tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in this maize line is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces hygroscopicus</i>, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties. The PAT encoding gene (<i>bar</i>) was introduced into the soybean genome by micro-particle acceleration (biolistic) transformation, and the resulting maize line displayed field tolerance to phosphinothricin-containing herbicides, thereby permitting farmers to use this herbicide for weed control in maize cultivation.</p>\n\n<p style="text-align: justify;">The maize line DLL25 was field tested in the major maize growing regions of the United States starting in 1991, in Canada beginning 1994, and in Argentina. DLL25 has been evaluated extensively in the laboratory and greenhouse, and in field experiments. The transgenic maize was compared to its non-transgenic counterparts, assessing agronomic characteristics such as vegetative vigour, flowering period, time to maturity, seed production, and disease and insect susceptibilities. Field data determined that the values observed for DLL25 maize were within the normal range of expression currently displayed by commercial maize hybrids. Overall the field data reports and data on agronomic traits showed that maize line DLL25 did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. DLL25 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in DLL25. Gene exchange between DLL25 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">In an assessment of food and livestock feed safety forage and grain from DLL25 maize hybrids were analyzed for nutritional composition and compared to the nutritional composition of non-transgenic versions of the same maize hybrids. Proximate and amino acid analyses were performed. Small differences between DLL25 plants and their non-transgenic counterparts were occasionally observed. However, the nutrient composition of DLL25 maize fell within the range of variability for the relevant nutrients reported for maize. The use of maize products derived from DLL25 was not anticipated to have any significant impact on the nutritional quality of the food supply.</p>\n\n<p style="text-align: justify;">Potential toxicity and allergenicity of the PAT protein expressed in the transgenic maize line DLL25 was investigated by searching for amino acid sequence homology with known toxins and allergens, by examining its physiochemical properties, and by acute oral toxicity testing in mice. No homologies between the deduced amino acid sequence of the PAT protein and the sequences of known toxins or allergens were detected. The PAT enzyme does not possess the proteolytic or heat stability characteristic of toxic compounds, and was readily digested under conditions simulating mammalian digestion. In the acute mouse toxicity study, mice were fed high doses of the PAT protein, with no observable adverse effects. Based on these properties, it was concluded that the PAT protein, and thus DLL25 maize, possessed little or no potential for allergenicity or toxicity.</p>\n', NULL, '2013-08-30 12:05:51'),
(25, 6, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.<br />\nThe maize lines T14 and T25 were genetically engineered to express tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in T14 and T25 maize is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces viridochromogenes</i>, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties.</p>\n\n<p style="text-align: justify;">Cultured protoplasts obtained from a yellow dent corn line were transformed using a chemically mediated direct DNA introduction method. Transformed cell colonies were selected for the presence of the <i>pat</i> gene by regeneration on medium containing glufosinate ammonium. The primary transformants, T14 and T25, were then backcrossed with parental lines of the yellow dent corn type. The resulting lines displayed field tolerance to phosphinothricin-containing herbicides, thereby permitting farmers to use this herbicide for weed control in maize cultivation.</p>\n\n<p style="text-align: justify;">The maize events T14 and T25 have been field tested in the major maize growing regions of the United States since 1992 and in Canada since 1993. Field reports on T14 and T25 were compared to those of their non-transgenic counterparts, and it was determined that agronomic characteristics such as yield, plant height, over-wintering capacity, flowering period, and disease susceptibility were within the normal range of expression currently displayed by commercial maize hybrids. Overall the field data reports indicated that the transformed maize lines did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms, and were not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in T14 and T25. Gene exchange between the modified lines and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">Compositional analyses of T14 and T25 maize grain and of current commercial maize varieties were compared for a number of parameters, including moisture, crude fat, crude protein, crude fibre, ash, carbohydrates, mineral content (calcium and phosphorous), amino acid profile, phytates and oil composition. Overall protein content in the grain and whole plant was significantly higher in the transgenic lines than in the unmodified controls. It was determined that this variation arose from genetic differences unrelated to the transformation event. In all cases protein content and nutrient values were within the normal published range for maize. The use of grain from T14- and T25-derived maize lines was determined not to have a significant impact on the nutritional quality of the North American food supply.</p>\n\n<p style="text-align: justify;">Potential toxicity and allergenicity of the PAT protein expressed in the transgenic maize lines T14 and T25 was investigated by searching for amino acid sequence homologies with known toxins and allergens, by examining its physiochemical properties, and by acute oral toxicity testing in mice. No homologies between the deduced amino acid sequence of the PAT protein and the sequences of known toxins or allergens were detected. The PAT enzyme does not possess the stability to digestive enzymes or heat stability characteristic of toxic compounds, and was readily degraded under conditions simulating mammalian digestion. In the acute mouse toxicity study mice were fed high doses of the PAT protein, with no observable adverse effects. Based on these properties, it was concluded that the PAT protein, and thus T14 and T25 maize, possessed little or no potential for allergenicity or toxicity.</p>\n', NULL, '2013-08-30 01:25:00'),
(26, 5, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.<br />\nThe European corn borer (ECB), <i>Ostrinia nubilalis</i>, is the most damaging insect pest of maize in the United States and Canada; losses resulting from ECB damage and control costs exceed $1 billion each year. An average of one ECB cavity per maize stalk across an entire field can reduce yield by as much as 5% when caused by first generation larvae, and 2.5% when caused by second-generation larvae, with annual yield losses estimated at 5 to 10 %.</p>\n\n<p style="text-align: justify;">Despite consistent losses to ECB, chemical insecticides are utilized on a relatively small acreage (less than 20%). Historically, this reluctance stems from the difficulties in identifying and managing ECB in maize crops: ECB larval damage is hidden, heavy infestations are unpredictable, insecticides are costly, timing of insecticide application is difficult and multiple applications may be required to guarantee ECB control.</p>\n\n<p style="text-align: justify;">The transgenic maize line MON802 was genetically engineered to resist ECB by producing its own insecticide. This line was developed by introducing the <i>cry1Ab</i> gene, isolated from the common soil bacterium <i>Bacillus thuringiensis</i> (<i>Bt</i>), into the maize line by particle acceleration (biolistic) transformation. MON802 was further engineered to express resistance to glyphosate, the active ingredient in the herbicide Roundup&reg;, allowing for its use as a weed control option. In order to obtain field tolerance to glyphosate herbicide, two novel genes, CP4 EPSPS and <i>goxv247</i>, were introduced maize by particle acceleration (biolistic) transformation.</p>\n\n<p style="text-align: justify;">The <i>cry1Ab</i> gene produces the insect control protein Cry1Ab, a delta-endotoxin. The Cry1Ab protein produced by the <i>Bt</i> maize is identical to that found in nature and in commercial <i>Bt</i> spray formulations. Cry proteins, of which Cry1Ab is only one, act by selectively binding to specific sites localized on the lining of the midgut of susceptible insect species. Following binding, pores are formed that disrupt midgut ion flow, causing gut paralysis and eventual death due to bacterial sepsis. Cry1Ab is lethal only when eaten by the larvae of lepidopteran insects (moths and butterflies), and its specificity of action is directly attributable to the presence of specific binding sites in the target insects. There are no binding sites for the delta-endotoxins of <i>B. thuringiensis</i> on the surface of mammalian intestinal cells, therefore, livestock animals and humans are not susceptible to these proteins.</p>\n\n<p style="text-align: justify;">In plants, the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (abbreviated EPSPS) plays a key role in the biochemical pathway that results in the synthesis of the aromatic amino acids phenylalanine, tyrosine, and tryptophan. This enzyme is only present in plants and microorganisms, such as bacteria and fungi, and is not present in animals and humans. In the early 1970s, it was discovered that the simple amino acid analogue, glyphosate, could selectively inhibit the activity of the EPSPS enzyme, thus shutting off aromatic amino acid synthesis. Because these amino acids are needed for protein synthesis, which is required for plant growth and maintenance, the application of glyphosate quickly results in plant death. EPSPS is not present in mammals, birds or aquatic life forms, which do not synthesize their own aromatic amino acids. For this reason, glyphosate has little toxicity to these organisms.</p>\n\n<p style="text-align: justify;">A gene encoding a glyphosate-tolerant form of the EPSPS enzyme was isolated from the CP4 strain of <i>Agrobacterium tumefaciens</i>, a common soil bacterium, and introduced into the maize genome using micro-particle bombardment. MON802 contains a third gene that codes for a modified version of the enzyme glyphosate oxidase (GOX), which accelerates the normal breakdown of glyphosate into two non-toxic products, aminomethylphosphonic acid (AMPA) and glyoxylate. AMPA is the principal breakdown product of glyphosate and is degraded by several microorganisms, while glyoxylate is commonly found in plant cells and is broken down by the glyoxylic pathway for lipid metabolism. The GOX encoding gene (<i>goxv247</i> was isolated from the bacterium <i>Ochrobactrum anthropi</i> strain LBAA.<br />\n<br />\nMON802 expressed the Cry1Ab protein at an effective dosage over the growing season, as indicated by its efficacy in controlling both first and second-generation infestations of ECB. Protein expression was found to decrease over the growing season, as evidenced by declining Cry1Ab protein concentrations in assayed leaves. MON802 maize has been field tested since 1993 in the major maize growing regions of the United States and Puerto Rico, as well as in Canada (1995, 1996), Chile, Argentina, France, Italy, South Africa, and Costa Rica. The studies demonstrated that MON802 maize retained the agronomic characteristics of the parental line. The transgenic line provided significant protection from feeding damage from ECB throughout the season, while some protection was noted from Southwestern corn borer (Diatraea grandiosella) and corn earworm (Heliothis zea). No significant differences were observed in resistance to a number of other significant insect pests or diseases compared to non-transgenic controls. It was demonstrated that the transformed maize line did not exhibit weedy characteristics, or negatively affect beneficial or nontarget organisms. MON802 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in MON802. Gene exchange between MON802 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">Regulatory authorities in Canada and the United States have mandatory requirements for developers of <i>Bt</i> maize to implement specific Insect Resistant Management (IRM) Programs. The potential for ECB populations to develop tolerance or become resistant to the <i>Bt</i> toxin is expected to increase as more maize acreage is planted with <i>Bt</i> hybrids. These IRM programs are designed to reduce the potential development of <i>Bt</i>-resistant insect populations, as well as prolonging the effectiveness of plant-expressed <i>Bt</i> toxins, and the microbial <i>Bt</i> spray formulations of these same toxins.</p>\n\n<p style="text-align: justify;">The food and livestock feed safety of MON802 maize was established based on several standard criteria. Analyses determined that MON802 grain was nutritionally equivalent to non-transgenic grain, posing no health risks to either humans or livestock. Proximate analysis (ash, crude fat, crude protein, and moisture content), and fatty acid and amino acid composition of MON802 grain revealed only minor differences from the levels reported for non-transgenic maize. These differences were within the normal range of variation for maize and were not linked to the presence of the introduced genes.</p>\n\n<p style="text-align: justify;">The toxicity and allergenicity potential of the Cry1Ab, CP4 EPSPS and GOX proteins expressed in MON802 was assessed by examining their physiochemical characteristics, degree of amino acid sequence homology to known protein allergens, and digestibility. An acute oral gavage feeding study was conducted in which mice were fed high doses of each of the three novel proteins, and did not exhibit any toxic effects. The Cry1Ab protein has a history of safe use, demonstrated by its use in microbial <i>Bt</i> spray formulations in agriculture for more than 40 years with no evidence of adverse effects. No significant amino acid sequence homologies were observed between the Cry1Ab, CP4 EPSPS or GOX proteins and known allergens and toxins. Neither Cry1Ab, CP4 EPSPS, nor GOX possess the characteristics of stability to digestion, heat stability, and glycosylation commonly associated with allergenic proteins.</p>\n', NULL, '2013-08-30 01:24:17'),
(27, 50, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), or corn, is is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock although an increasing amount is being used for the production ot ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.</p>\n\n<p style="text-align: justify;">The maize lines 676, 678, and 680 were genetically engineered to express male sterility and tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in these maize lines is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces viridochromogenes</i>, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties.<br />\nThe male-sterile trait was introduced by inserting a bacterial gene encoding the enzyme DNA adenine methylase (DAM). Expression of the <i>Escherichia coli dam</i> gene in specific plant tissues results in the inability of the transformed plants to produce anthers or pollen, resulting in a male-sterile plant. The PAT enzyme was used as a selectable marker enabling identification of transformed plants during tissue culture regeneration, and as a field selection method to identify the male-sterile lines prior to flowering. Under field conditions, plants that were not male-sterile could be eliminated by application of the herbicide glufosinate ammonium. The novel hybrid system provided an efficient and effective way to identify male-sterile plants for use in hybrid seed production.</p>\n\n<p style="text-align: justify;">The maize lines 676, 678, and 680 have been field tested in the major maize growing regions of the United States since 1995. Field data regarding seed germination rates, yield characteristics, disease and pest susceptibilities, compositional analyses, and numerous other reports supported the conclusion that maize lines 676, 678, and 680 were as safe to grow as any other male sterile maize and would not present a plant pest risk. It was demonstrated that the transformed maize lines did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Maize lines 676, 678, and 680 were not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, multiple barriers, including sterility of the maize lines 676, 678, and 680, ensured that gene flow from these transformed lines into wild or cultivated sexually-compatible plants was extremely unlikely. Gene exchange between maize lines 676, 678, and 680 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">In an assessment of food and livestock feed safety, forage and grain from these male-sterile lines were analyzed for nutritional composition and compared to the nutritional composition of non-transgenic inbred parental lines. Proximate, fatty acid, and amino acid analyses were performed and in each case there were no significant differences noted between the transgenic and non-transgenic control lines. The use of maize products derived from lines 676, 678, and 680 was not anticipated to have any significant impact on the nutritional quality of the food supply.</p>\n\n<p style="text-align: justify;">Previous studies have demonstrated that the PAT protein has a very low potential to be toxic or allergenic. The enzyme possesses none of the physiochemical characteristics commonly associated with known toxins or allergens, such as resistance to thermal or proteolytic degradation, and its amino acid sequence does not show homology with the sequences of known protein toxins and allergens.</p>\n', NULL, '2013-08-30 12:07:02'),
(28, 66, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.) is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.</p>\n\n<p style="text-align: justify;">The maize line MS6 was genetically engineered to express male sterility and tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in this maize line is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces hygroscopicus</i>. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties.</p>\n\n<p style="text-align: justify;">The male-sterile trait was introduced by inserting the <i>barnase</i> gene, isolated from <i>Bacillus amyloliquefaciens</i>, a common soil bacterium that is frequently used as a source for industrial enzymes. The <i>barnase</i> gene encodes for a ribonuclease enzyme (RNAse) that is expressed only in the tapetum cells of the pollen sac during anther development. The RNAse affects RNA production, disrupting normal cell functioning and arresting early anther development, thus leading to male sterility. The PAT enzyme was used as a selectable marker enabling identification of transformed plants during tissue culture regeneration, and as a field selection method to identify the male-sterile lines prior to flowering. Under field conditions, plants that were not male-sterile could be eliminated by application of the herbicide glufosinate ammonium. The novel hybrid system provided an efficient and effective way to identify male-sterile plants for use in hybrid seed production.</p>\n\n<p style="text-align: justify;">In the United States, the male-sterile line MS3 was designated as the antecedent organism for MS6 for the purposes of conducting the environmental safety assessment. Maize lines MS3 and MS6 were genetically modified using the same transformation technique and the same genetic elements. Based on the similarity between MS6 and the antecedent organism MS3, and on an analysis of scientific data and field tests of MS6, the maize line MS6 was judged not to have any characteristics that would pose a greater impact on the environment or on non-target organisms.</p>\n\n<p style="text-align: justify;">For additional information related to either the environmental or food safety assessment of the antecedent organism, MS3, the reader is referred to the description for that product.</p>\n', NULL, '2013-08-30 16:55:45');
INSERT INTO `gmcropdatabase_events_execsummaries` (`id`, `eventId`, `description`, `created`, `updated`) VALUES
(29, 13, '<p style="text-align: justify;">Maize (<i>Zea mays</i> L.), is grown primarily for its kernel, which is largely refined into products used in a wide range of food, medical, and industrial goods.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.</p>\n\n<p style="text-align: justify;">The maize line MS3 was genetically engineered to express male sterility and tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in this maize line is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces hygroscopicus</i>. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties.</p>\n\n<p style="text-align: justify;">The male-sterile trait was introduced by inserting the barnase gene, isolated from <i>Bacillus amyloliquefaciens</i>, a common soil bacterium that is frequently used as a source for industrial enzymes. The barnase gene encodes for a ribonuclease enzyme (RNAse) that is expressed only in the tapetum cells of the pollen sac during anther development. The RNAse affects RNA production, disrupting normal cell functioning and arresting early anther development, thus leading to male sterility. The PAT enzyme was used as a selectable marker enabling identification of transformed plants during tissue culture regeneration, and as a field selection method to identify the male-sterile lines prior to flowering. Under field conditions, plants that were not male-sterile could be eliminated by application of the herbicide glufosinate ammonium. The novel hybrid system provided an efficient and effective way to identify male-sterile plants for use in hybrid seed production.</p>\n\n<p style="text-align: justify;">The male sterile maize line MS3 has been tested in the major maize growing regions of the United States since 1992 and has been extensively evaluated in laboratory, greenhouse, and field experiments. Agronomic characteristics such as seed germination, vegetative vigour, time to maturity, time to tassel emergence, time to and process of silk extrusion, male and female fertility, yield parameters, and disease and pest susceptibilities were compared to those of non-transgenic Zea mays counterparts and found to be within the normal range for commercial maize hybrids. Overall the field data reports and data on agronomic traits demonstrated that MS3 maize was as safe to grow as any other male sterile maize and had no potential to pose a plant pest risk. It was demonstrated that the transformed maize line did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Maize line MS3 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in the continental United States and Canada. Cultivated maize can naturally cross with annual teosinte (<i>Zea mays</i> ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, multiple barriers, including sterility of the maize line MS3, ensured that gene flow from this transformed line into wild or cultivated sexually-compatible plants was extremely unlikely. Gene exchange between maize line MS3 and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada and the United States.</p>\n\n<p style="text-align: justify;">In an assessment of food and livestock feed safety the composition of grain from MS3-derived hybrid maize was compared to grain from non-transgenic maize. Parameters such as moisture, fibre, fat, protein, ash, starch, oil, and the fatty acid and amino acid composition were compared with no significant differences observed. It was therefore concluded that the use of grain from MS3-derived maize hybrids would have no significant impact on the nutritional quality of the food supply.</p>\n\n<p style="text-align: justify;">Potential toxicity and allergenicity of the PAT protein and the barnase RNase expressed in the transgenic maize line MS3 were investigated by searching for amino acid sequence homology with known toxins and allergens, and by examining their physiochemical properties. No significant homologies between the deduced amino acid sequence of the PAT protein or the barnase RNase and the sequences of known toxins or allergens were detected. Neither the PAT enzyme nor the RNase possess the proteolytic or heat stability characteristic of toxic compounds, and the PAT enzyme was readily digested under conditions simulating mammalian digestion. In summary, the barnase RNAse and PAT enzyme were not derived from allergenic sources, do not share amino acid sequence homology with known allergens, and do not possess the physiochemical properties (heat and proteolytic digestion stability) normally associated with allergens. Based on these properties, it was concluded that the RNase and the PAT protein, and thus MS3 maize, possessed little or no potential for allergenicity or toxicity.</p>\n', NULL, '2013-08-30 01:29:12'),
(30, 17, '<p style="text-align: justify;">As the development of DK404SR did not employ recombinant DNA technologies, this product was not subject to regulation in any jurisdiction except Canada, where it was regulated as a plant with novel trait under the <i>Seeds Act</i>, a novel feed under the <i>Feeds Act</i>, and as a novel food under the Food and Drug Regulations. Specific environmental, livestock feed, and food safety assessment of this product was only required for Canada.</p>\n\n<p style="text-align: justify;">Only a small amount of whole maize kernel is consumed by humans. Maize oil is extracted from the germ of the maize kernel and maize is also a raw material in the manufacture of starch. A complex refining process converts the majority of this starch into sweeteners, syrups and fermentation products, including ethanol. Refined maize products, sweeteners, starch, and oil are abundant in processed foods such as breakfast cereals, dairy goods, and chewing gum.<br />\nIn the United States and Canada maize is typically used as animal feed, with roughly 70% of the crop fed to livestock, although an increasing amount is being used for the production of ethanol. The entire maize plant, the kernels, and several refined products such as glutens and steep liquor, are used in animal feeds. Silage made from the whole maize plant makes up 10-12% of the annual corn acreage, and is a major ruminant feedstuff. Livestock that feed on maize include cattle, pigs, poultry, sheep, goats, fish and companion animals.</p>\n\n<p style="text-align: justify;">Industrial uses for maize products include recycled paper, paints, cosmetics, pharmaceuticals and car parts.</p>\n\n<p style="text-align: justify;">The maize hybrid DK404SR was developed to allow the use of sethoxydim, the active ingredient in the herbicide Poast&reg;, for the control of annual and perennial grasses in maize crops. The original sethoxydim-tolerant mutant line (S2), which was the source of the sethoxydim tolerance trait in hybrid DK404SR, was selected as a somaclonal variant from maize embryo tissue grown under sethoxydim-selective pressure. The process involved growing somatic embryos on sethoxydim-enriched media in the presence of mutagenic agents. The somaclonal variant cell line S2 was selected from the resulting mutant cells and subsequently regenerated. This S2 line was backcrossed at least six times with both parental lines of the hybrid DK404SR to transfer the herbicide tolerance trait.</p>\n\n<p style="text-align: justify;">Sethoxydim and other cyclohexanedione herbicides act by inhibiting the enzyme acetyl-CoA-carboxylase (ACCase), a key enzyme in the fatty acid biosynthesis pathway necessary for the synthesis and maintenance of membranes and for the incorporation of fatty acids into triacylglycerides. Inhibition of this enzyme results in a lethal disruption of lipid biosynthesis. Cyclohexanedione herbicides applied at rates recommended for effective weed control are toxic to conventional maize varieties. The ACCase present in DK404SR contains a mutation within the sethoxydim binding site that reduces the herbicide&rsquo;s affinity for the enzyme, and thus its inhibitory activity, while retaining the normal catalytic properties of the enzyme. The modified maize plants also demonstrated some level of cross-tolerance to the related herbicides, aryloxyphenoxypropionates, including haloxyfop (not registered in Canada), fluazifop (Venture&reg;) and quizalofop (Assure&reg;). These herbicides all have the same mode of action through ACCase inhibition. Natural tolerance to sethoxydim herbicide is found in several broad-leaved plants and grasses, including annual ryegrass, green foxtail and red fescue.</p>\n\n<p style="text-align: justify;">As the development of DK404SR did not employ recombinant DNA technologies, this product was not subject to regulation in any jurisdiction except Canada, where it was regulated as a plant with novel trait under the Seeds Act, a novel feed under the Feeds Act, and as a novel food under the Food and Drug Regulations. Specific environmental, livestock feed, and food safety assessment of this product was only required for Canada.</p>\n\n<p style="text-align: justify;">Field testing of DK404SR maize hybrids demonstrated that agronomic characteristics such as plant size and vigour, growth, male and female fertility, time to maturity, flowering period, and seed yield were within the range of values displayed by currently commercialized hybrids. It was determined that the growing habit of the modified maize plants was not inadvertently altered and that they did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. DK404SR was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;">Maize does not have any closely related species growing in the wild in Canada. Cultivated maize can naturally cross with annual teosinte (Zea mays ssp. mexicana) when grown in close proximity, however, these wild maize relatives are native to Central America and are not naturalized in North America. Additionally, reproductive and growth characteristics were unchanged in DK404SR. Gene exchange between DK404SR and maize relatives was determined to be negligible in managed ecosystems, with no potential for transfer to wild species in Canada.</p>\n\n<p style="text-align: justify;">A food and livestock feed safety assessment of DK404SR compared the nutritional composition of the modified maize line to that of its unmodified counterparts, revealing no significant differences. The selection of the DK404SR maize hybrid through somaclonal variation had no meaningful effect on the maize plant nutrient levels. It was therefore determined that the use of maize products derived from the DK404SR maize hybrid would have no significant impact on the nutritional quality of the food supply in Canada.<br />\n<br />\nThe novel trait in the DK404SR maize hybrid results from modifications of a single maize enzyme, altering the sethoxydim binding site without modifying the metabolic abilities of the ACCase enzyme. Potential toxicity of this enzyme was therefore not a concern. No new genetic material was introduced into the maize genome during the modification process, minimizing potential toxicity and allergenicity concerns.</p>\n', NULL, '2013-08-30 01:31:50'),
(31, 134, '<p style="text-align: justify;">MON89034 X MON88017 (OECD identifier: MON-89&Oslash;34-3 X MON-88&Oslash;17-3) maize is an F1 hybrid resulting from the hybridization of maize inbred MON89034 (MON-89&Oslash;34-3) with MON88017 (MON-88&Oslash;17-3). This stacked maize hybrid is a product of traditional plant breeding, and therefore is not automatically subject to regulation in all jurisdictions as are transgenic plants resulting from recombinant DNA technologies. Certain jurisdictions may request notification in advance of the release of a stacked hybrid, or may request information to conduct an environmental and food safety assessment. Examples of jurisdictions that require either notification or information about stacked hybrids prior to their release into the environment, and for use in human food and livestock feed are Canada and Japan.</p>\n\n<p style="text-align: justify;">The stacked hybrid MON89034 X MON88017 expresses three novel insecticidal proteins and a protein providing tolerance to the herbicide glyphosate. MON 89034 produces the Cry1A.105 and Cry2Ab2 proteins, which are active against lepidopteran insect pests and MON88017 produces Cry3Bb1 which confers resistance to Corn Rootworm. All of these proteins are derived from <i>Bacillus thuringiensis</i>. Tolerance to glyphosate is provided by the CP4 EPSPS protein, produced by the <i>cp4 epsps</i> gene from MON88017. The novel traits of each parent line have been combined, through traditional plant breeding, to produce this new hybrid. For a full description of each parent line please refer to the individual product descriptions in the crop database for MON89034 and MON88017.</p>\n\n<p style="text-align: justify;">The inserted genes and their gene products have a history of safe use, and have undergone review and approval by several regulatory agencies. No interactions among the gene products or negative synergistic effects are expected in the stacked hybrid. The Cry1A.105, Cry2Ab2 and Cry3Bb1 proteins are not enzymes and therefore do not affect plant metabolism. The CP4 EPSPS has high affinity for its substrates phosphoenolpyruvate (PEP) and shikimate-3-phosphate, which are part of the shikimate metabolic pathway. These proteins are therefore not expected to interact within, nor affect the metabolism of the stacked hybrid.</p>\n', NULL, '2013-08-30 17:34:00'),
(32, 22, '<p style="text-align: justify;">Argentine or oilseed rape (<i>Brassica napus</i>) was grown as a commercial crop in over 50 countries, with a combined harvest of 48.9 million metric tonnes in 2006. The major producers of rapeseed are China, Canada, India, Germany, France, the United Kingdom and Australia. Canola is a genetic variation of <i>B. napus</i> that was developed through conventional breeding to contain low levels of the natural rapeseed toxins, glucosinolate and erucic acid. Canola is grown for its seed, which represents a major source of edible vegetable oil and is also used in livestock feeds.<br />\nThe only food use of canola is as a refined oil. Typically, canola oil is used by itself as a salad oil or cooking oil, or blended with other vegetable oils in the manufacture of margarine, shortenings, cooking and salad oils. Canola meal, a byproduct of the oil production process, is added to livestock feed rations. An increasing amount of oil is being used for biodiesel production, especially in Europe.</p>\n\n<p style="text-align: justify;">The removal of weeds early in the growing season is extremely important in canola production. Young canola seedlings are not very competitive and early weed pressure has detrimental effects on final yield. Precautions such as pre-plant tillage or herbicide application are common approaches for reducing weed competition. Once established, canola forms a dense canopy and is very competitive, making weed control less of a concern.</p>\n\n<p style="text-align: justify;">At present, it is expensive, but possible, to control annual grassy weeds (wild oats, volunteer cereals), perennial weeds (Canada thistle, perennial sow thistle, quackgrass), and certain annual broadleaf weeds in canola. The broadleaves are the most difficult to control because there are few herbicide options available. Many producers will use as many as four herbicides per year in an effort to control weeds.</p>\n\n<p style="text-align: justify;">Traditionally, it has been difficult to manage weeds in canola rotations because of the need to use Group 1 herbicides (Assure&reg;, Fusion&reg;, Poast&reg;, Select&reg;, Venture DG&reg;) that are also commonly used to control weeds in flax, wheat and other cereals. Growers favour these herbicides because they are easy to work with, are extremely effective, and may be applied over a period of time. However, the constant use of Group 1 herbicides has placed large acreages of cultivated land at high risk of developing Group 1 weed resistance. The establishment of several herbicide-tolerant weed populations demonstrates this problem.</p>\n\n<p style="text-align: justify;">The canola line HCN92 was genetically engineered to express tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in HCN92 is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces viridochromogenes</i>, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties.<br />\nThe canola line HCN92 was field tested in Canada from 1990 to 1994. Agronomic and adaptation characteristics such as vegetative vigour, seed production and dormancy were compared to unmodified canola counterparts and determined to be within the normal range of expression found in commercial canola cultivars. The only significant difference between HCN92 canola and the parental non-transformed variety was its resistance to glufosinate ammonium. It was demonstrated that the transformed canola line did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Canola line HCN92 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;"><i>Brassica napus</i> may outcross (up to 30% of the time) with plants of the same species, and potentially with plants of related species <i>B. rapa</i>, <i>B. juncea</i>, <i>B. carinata</i>, <i>B. nigra</i>, <i>Diplotaxis muralis</i>, <i>Raphanus raphanistrum</i>, and <i>Erucastrum gallicum</i>. Previous studies have demonstrated that cross hybridization is most likely to occur with <i>B. rapa</i>. Because of the ability of canola to outcross with related plants, the formation of glufosinate-tolerant hybrids is possible. However, the glufosinate-tolerance trait is not expected to provide a competitive advantage to hybrid plants unless grown in managed environments routinely subjected to glufosinate applications. In the event that a glufosinate-tolerant hybrid survived, the herbicide-tolerant individual could be easily controlled using mechanical and/or other available chemical means.</p>\n\n<p style="text-align: justify;">The human consumption of canola products is limited to the refined oil. Refined edible canola oil consists of purified triglycerides (96-97%) and does not contain any detectable protein, and hence no PAT protein was detected in the refined oil of HCN92 canola. As such, there will be no human exposure to this novel protein as a result of the consumption of refined oil from line HCN92.</p>\n\n<p style="text-align: justify;">A comparative analysis of nutrients from transgenic HCN92 canola and non-transgenic canola did not reveal any significant differences in the levels crude protein, crude fat, crude fibre, ash and gross energy in either the whole seed or processed meal. Compositional analysis of processed canola oil indicated that no statistically significant differences existed between HCN92 and current commercial canola cultivars in fatty acid, chlorophyll, phytosterol, glucosinolate and erucic acid content. These results collectively demonstrated that the novel herbicide-tolerant genes introduced into HCN92 had no observable secondary effects on nutritional composition or quality. The use of refined oil from line HCN92 was judged to be equivalent to that of traditional canola varieties and would therefore have no significant impact on the nutritional quality of the food supply.</p>\n\n<p style="text-align: justify;">Canola meal from HCN92 canola was also assessed to determine its safety for use in animal feed. In vivo tests performed on broiler chickens fed diets containing transgenic canola confirmed the safety previously established with purified PAT protein. It was also determined that PAT protein represented only 0.005% of protein in finished canola meal and enzyme activity was always destroyed in toasted canola meal. The overall results lead to the conclusion that there were no significant risks to livestock consuming transgenic HCN92 canola meal.</p>\n\n<p style="text-align: justify;">It was determined that there were no toxicity and allergenicity concerns with HCN92. There is no dietary exposure to PAT since this protein is not present in the refined canola oil consumed by humans. PAT was not found to have any amino acid sequence similarities with known toxins or allergens. An acute oral toxicity study revealed that no negative effects were experienced by mice fed high doses of the PAT protein, providing further evidence supporting the lack of toxicity or allergenicity concerns related to the expression of PAT protein in HCN92 canola.</p>\n', NULL, '2013-08-30 11:14:58'),
(33, 32, '<p style="text-align: justify;">Argentine or oilseed rape (<i>Brassica napus</i>) was grown as a commercial crop in over 50 countries, with a combined harvest of 48.9 million metric tonnes in 2006. The major producers of rapeseed are China, Canada, India, Germany, France, the United Kingdom and Australia. Canola is a genetic variation of <i>B. napus</i> that was developed through conventional breeding to contain low levels of the natural rapeseed toxins, glucosinolate and erucic acid. Canola is grown for its seed, which represents a major source of edible vegetable oil and is also used in livestock feeds.</p>\n\n<p style="text-align: justify;">The only food use of canola is as a refined oil. Typically, canola oil is used by itself as a salad oil or cooking oil, or blended with other vegetable oils in the manufacture of margarine, shortenings, cooking and salad oils. Canola meal, a byproduct of the oil production process, is added to livestock feed rations. An increasing amount of oil is being used for biodiesel production, especially in Europe.</p>\n\n<p style="text-align: justify;">The removal of weeds early in the growing season is extremely important in canola production. Young canola seedlings are not very competitive and early weed pressure has detrimental effects on final yield. Precautions such as pre-plant tillage or herbicide application are common approaches for reducing weed competition. Once established, canola forms a dense canopy and is very competitive, making weed control less of a concern.</p>\n\n<p style="text-align: justify;">At present, it is expensive, but possible, to control annual grassy weeds (wild oats, volunteer cereals), perennial weeds (Canada thistle, perennial sow thistle, quackgrass), and certain annual broadleaf weeds in canola. The broadleaves are the most difficult to control because there are few herbicide options available. Many producers will use as many as four herbicides per year in an effort to control weeds.</p>\n\n<p style="text-align: justify;">Traditionally, it has been difficult to manage weeds in canola rotations because of the need to use Group 1 herbicides (Assure&reg;, Fusion&reg;, Poast&reg;, Select&reg;, Venture DG&reg;) that are also commonly used to control weeds in flax, wheat and other cereals. Growers favour these herbicides because they are easy to work with, are extremely effective, and may be applied over a period of time. However, the constant use of Group 1 herbicides has placed large acreages of cultivated land at high risk of developing Group 1 weed resistance. The establishment of several herbicide-tolerant weed populations demonstrates this problem.</p>\n\n<p style="text-align: justify;">The canola line T45 was genetically engineered to express tolerance to glufosinate ammonium, the active ingredient in phosphinothricin herbicides (Basta&reg;, Rely&reg;, Finale&reg;, and Liberty&reg;). Glufosinate chemically resembles the amino acid glutamate and acts to inhibit an enzyme, called glutamine synthetase, which is involved in the synthesis of glutamine. Essentially, glufosinate acts enough like glutamate, the molecule used by glutamine synthetase to make glutamine, that it blocks the enzyme&#39;s usual activity. Glutamine synthetase is also involved in ammonia detoxification. The action of glufosinate results in reduced glutamine levels and a corresponding increase in concentrations of ammonia in plant tissues, leading to cell membrane disruption and cessation of photosynthesis resulting in plant withering and death.</p>\n\n<p style="text-align: justify;">Glufosinate tolerance in T45 is the result of introducing a gene encoding the enzyme phosphinothricin-N-acetyltransferase (PAT) isolated from the common aerobic soil actinomycete, <i>Streptomyces viridochromogenes</i>, the same organism from which glufosinate was originally isolated. The PAT enzyme catalyzes the acetylation of phosphinothricin, detoxifying it into an inactive compound. The PAT enzyme is not known to have any toxic properties.<br />\nLine HCN28, which was derived from T45, was field tested in Canada (1993 - 1995), in the United States (1996, 1997) and in Chile, Japan, the United Kingdom, and Australia. Agronomic characteristics such as cotyledon width, pod and leaf length, flowering period, time to maturity, plant height, lodging score, seed yield and thousand seed weight were compared to those of unmodified canola. The only significant difference between HCN28 canola and the parental non-transformed variety was its tolerance of glufosinate ammonium. It was demonstrated that the transformed canola line did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Canola line HCN28 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;"><i>Brassica napus</i> may outcross (up to 30% of the time) with plants of the same species, and potentially with plants of related species <i>B. rapa, B. juncea, B. carinata, B. nigra, Diplotaxis muralis, Raphanus raphanistrum</i>, and <i>Erucastrum gallicum</i>. Previous studies have demonstrated that cross hybridization is most likely to occur with <i>B. rapa</i>. Because of the ability of canola to outcross with related plants, the formation of glufosinate-tolerant hybrids is possible. However, the glufosinate-tolerance trait is not expected to provide a competitive advantage to hybrid plants unless grown in managed environments routinely subjected to glufosinate applications. In the event that a glufosinate-tolerant hybrid survived, the herbicide-tolerant individual could be easily controlled using mechanical and/or other available chemical means.</p>\n\n<p style="text-align: justify;">The human consumption of canola products is limited to the refined oil. Refined edible canola oil consists of purified triglycerides (96-97%) and does not contain any detectable protein, and hence no PAT protein was detected in the refined oil of HCN28 canola. As such, there will be no human exposure to this novel protein as a result of the consumption of refined oil from line HCN28. Compositional analyses of processed canola oil from HCN28 and current commercial canola cultivars were compared for fatty acids, glucosinolates, chlorophyll and phytosterol content. These comparisons indicated no statistically significant differences for the components analyzed. The use of refined oil from HCN28 would therefore have no significant impact on the nutritional quality of the food supply.</p>\n\n<p style="text-align: justify;">Canola meal from line HCN28 was also assessed to determine its safety for use in animal feed. Additional compositional studies were conducted, revealing no significant differences in the moisture, oil, protein, crude fibre, ash, phytosterol and gross energy content between HCN28 and other commercially available canola lines, thus supporting the safety of the inclusion of HCN28 canola in animal feed.</p>\n\n<p style="text-align: justify;">It was determined that there were no toxicity and allergenicity concerns with HCN28. There is no dietary exposure to PAT since this protein is not present in the refined canola oil consumed by humans. PAT was not found to have any amino acid sequence similarities with known toxins or allergens. The PAT enzyme does not possess the proteolytic or heat stability characteristic of toxic compounds, and was readily digested under conditions simulating mammalian digestion. An acute oral toxicity study revealed that no negative effects were experienced by rats fed high doses of the PAT protein (up to 50,000 ppm for a period of 14 days), providing further evidence supporting the lack of toxicity or allergenicity concerns related to the expression of PAT protein in HCN28 canola.</p>\n', NULL, '2013-08-30 11:54:04'),
(34, 19, '<p style="text-align: justify;">Argentine or oilseed rape (<i>Brassica napus</i>) was grown as a commercial crop in over 50 countries, with a combined harvest of 48.9 million metric tonnes in 2006. The major producers of rapeseed are China, Canada, India, Germany, France, the United Kingdom and Australia. Canola is a genetic variation of <i>B. napus</i> that was developed through conventional breeding to contain low levels of the natural rapeseed toxins, glucosinolate and erucic acid. Canola is grown for its seed, which represents a major source of edible vegetable oil and is also used in livestock feeds.</p>\n\n<p style="text-align: justify;">The only food use of canola is as a refined oil. Typically, canola oil is used by itself as a salad oil or cooking oil, or blended with other vegetable oils in the manufacture of margarine, shortenings, cooking and salad oils. Canola meal, a byproduct of the oil production process, is added to livestock feed rations. An increasing amount of oil is being used for biodiesel production, especially in Europe.</p>\n\n<p style="text-align: justify;">The removal of weeds early in the growing season is extremely important in canola production. Young canola seedlings are not very competitive and early weed pressure has detrimental effects on final yield. Precautions such as pre-plant tillage or herbicide application are common approaches for reducing weed competition. Once established, canola forms a dense canopy and is very competitive, making weed control less of a concern.</p>\n\n<p style="text-align: justify;">At present, it is expensive, but possible, to control annual grassy weeds (wild oats, volunteer cereals), perennial weeds (Canada thistle, perennial sow thistle, quackgrass), and certain annual broadleaf weeds in canola. The broadleaves are the most difficult to control because there are few herbicide options available. Many producers will use as many as four herbicides per year in an effort to control weeds.</p>\n\n<p style="text-align: justify;">Traditionally, it has been difficult to manage weeds in canola rotations because of the need to use Group 1 herbicides (Assure&reg;, Fusion&reg;, Poast&reg;, Select&reg;, Venture DG&reg;) that are also commonly used to control weeds in flax, wheat and other cereals. Growers favour these herbicides because they are easy to work with, are extremely effective, and may be applied over a period of time. However, the constant use of Group 1 herbicides has placed large acreages of cultivated land at high risk of developing Group 1 weed resistance. The establishment of several herbicide-tolerant weed populations demonstrates this problem.</p>\n\n<p style="text-align: justify;">The herbicide-tolerant canola line GT200 was developed to allow for the use of glyphosate, the active ingredient in the herbicide Roundup&reg;, as a weed control option. In order to obtain field tolerance to glyphosate herbicide, two novel genes, CP4 EPSPS and goxv247, were introduced into <i>B. napus</i> cv. Westar by <i>Agrobacterium</i>-mediated transformation.<br />\nThe CP4 EPSPS gene codes for the enzyme 5-enolpyruvylshikimate-3-phosphate synthase that is present in all plants, bacteria and fungi. The EPSPS gene put into GT200 was isolated from strain CP4 of the common soil bacterium <i>Agrobacterium tumefaciens</i> and is a glyphosate tolerant form of EPSPS. The EPSPS enzyme is part of an important biochemical pathway in plants called the shikimate pathway that is involved in the production of aromatic amino acids and other aromatic compounds. When conventional canola plants are treated with glyphosate, the plants cannot produce the aromatic amino acids needed to grow and survive. EPSPS is not present in mammals, birds or aquatic life forms, which do not synthesize their own aromatic amino acids. For this reason, glyphosate has little toxicity to these organisms. The EPSPS enzyme is naturally present in foods derived from plant and microbial sources.</p>\n\n<p style="text-align: justify;">The canola line GT200 contains a second gene that codes for a modified version of glyphosate oxidase (GOX) enzyme that is ubiquitous in nature. The <i>goxv247</i> gene inserted into GT200 was isolated from strain LBAA of the bacterium <i>Ochrobactrum anthropi</i>. Glyphosate oxidase (GOX) enzyme accelerates the normal breakdown of the herbicide glyphosate into two non-toxic compounds, aminomethylphosphonic acid (AMPA) and glyoxylate. AMPA is the principal breakdown product of glyphosate and is degraded by several microorganisms, while glyoxylate is commonly found in plant cells and is broken down by the glyoxylic pathway for lipid metabolism.</p>\n\n<p style="text-align: justify;">The canola line GT200 was field tested in Canada from 1992 to 1994. Agronomic characteristics such as vegetative vigor, overwintering capacity, time to maturity, seed production and yield of the transformed line GT200 were compared to unmodified canola counterparts and determined to be within the normal range of expression found in commercial canola cultivars. The only significant difference between GT200 canola and the parental non-transformed variety was tolerance to glyphosate. It was demonstrated that the transformed canola line did not exhibit weedy characteristics, or negatively affect beneficial or non-target organisms. Canola line GT200 was not expected to impact on threatened or endangered species.</p>\n\n<p style="text-align: justify;"><i>Brassica napus</i> may outcross (up to 30% of the time) with plants of the same species, and potentially with plants of related species <i>B. rapa, B. juncea, B. carinata, B. nigra, Diplotaxis muralis, Raphanus raphanistrum</i>, and <i>Erucastrum gallicum</i>. Previous studies have demonstrated that cross hybridization is most likely to occur with <i>B. rapa</i>. Because of the ability of canola to outcross with related plants, the formation of glyphosate tolerant hybrids is possible. However, the glyphosate-tolerance trait is not expected to provide a competitive advantage to hybrid plants unless grown in managed environments routinely subjected to glyphosate applications. In the event that a glyphosate tolerant hybrid survived, the herbicide-tolerant individual could be easily controlled using mechanical and/or other available chemical means.</p>\n\n<p style="text-align: justify;">The human consumption of canola products is limited to the purified oil. Refined edible canola oil consists of purified triglycerides (96-97%) and does not contain any detectable protein, hence no amounts of CP4 EPSPS or GOX proteins were detected in the refined oil of GT200 canola. As the introduced gene products are not detectable in the refined oil produced from transgenic canola, there will be no human exposure to these proteins and the consumption of refined oil from GT200 was judged to have no significant impact on the nutritional quality of the food supply.</p>\n\n<p style="text-align: justify;">The livestock feed safety of GT200 canola was established based on several standard criteria. The analysis of nutrients from transgenic GT200 canola and non-transgenic canola did not reveal any significant differences in the levels of crude protein, crude fat, crude fibre, ash and gross energy in either the whole seed or processed meal. Raw seeds of GT200 were shown to have the same levels of glucosinolates and erucic acid as commercial canola varieties. Seed protein profiles, amino acid and fatty acid compositions were all within the range of the unmodified counterparts.</p>\n\n<p style="text-align: justify;">Several animal feeding studies were conducted to demonstrate the wholesomeness of glyphosate-tolerant canola meal. Canola meal is used only for animal feed and is not considered a human food fraction. These studies included a four-week rat study on processed and unprocessed meal, a five-day quail (Northern Bobwhite) study on unprocessed meal, and a ten-week trout study on processed meal. The studies all supported the safety of the inclusion of GT200 canola in animal feed.</p>\n\n<p style="text-align: justify;">It was determined that there were no toxicity and allergenicity concerns with GT200. There is no dietary exposure to CP4 EPSPS and GOX since these proteins are not present in the refined canola oil consumed by humans. Furthermore, the structure and function of CP4 EPSPS protein was determined to be similar to the same enzyme naturally present in foods. Neither CP4 EPSPS nor GOX were found to have any amino acid sequence similarities with known toxins or allergens, and there are no known reports of toxicity or allergenicity of EPSPS or GOX proteins derived from plants, bacteria and fungi. Direct laboratory studies of the CP4 EPSPS and GOX proteins revealed the ready digestibility of both proteins under conditions simulating mammalian digestion, providing further evidence supporting the lack of toxicity or allergenicity concerns with GT200.</p>\n', NULL, '2013-08-30 01:32:48');
