 When testing whole foods , the possible highest concentration of the GM food and feed in the laboratory animal diet may be limited because of nutritional imbalance of the diet , or by the presence of compounds with a known toxicological profile . The aim of the 00-days rodent feeding study with the whole GM food and feed is to assess potential unintended effects of toxicological and/or nutritional relevance and to establish whether the GM food and feed is as safe and nutritious as its traditional comparator rather than determining qualitative and quantitative intrinsic toxicity of defined food constituents . The design of the study should be adapted from the OECD 00-day rodent toxicity study . The precise study design has to take into account the nature of the food and feed and the characteristics of the new trait ( s ) and their intended role in the GM food and feed . A 00-day animal feeding trial has a large capacity ( sensitivity and specificity ) to detect potential toxicological effects of single well defined compounds . This can be concluded from data reported on the toxicology of a wide range of industrial chemicals , pharmaceuticals , food substances , environmental , and agricultural chemicals . It is possible to model the sensitivity of the rat subchronic feeding study for the detection of hypothetically increased amount of compounds such as anti-nutrients , toxicants or secondary metabolites . With respect to the detection of potential unintended effects in whole GM food and feed , it is unlikely that substances present in small amounts and with a low toxic potential will result in any observable ( unintended ) effects in a 00-day rodent feeding study , as they would be below the no-observed-effect-level and thus of unlikely impact to human health at normal intake levels . Laboratory animal feeding studies of 00-days duration appear to be sufficient to pick up adverse effects of diverse compounds that would also give adverse effects after chronic exposure . This conclusion is based on literature data from studies investigating whether toxicological effects are adequately identified in 0-month subchronic studies in rodents , by comparing findings at 0 and 00 months for a range of different chemicals . The 00-day rodent feeding study is not designed to detect effects on reproduction or development other than effects on adult reproductive organ weights and histopathology . Analyses of available data indicate that , for a wide range of substances , reproductive and developmental effects are not potentially more sensitive endpoints than those examined in subchronic toxicity tests . Should there be structural alerts for reproductive/developmental effects or other indications from data available on a GM food and feed , then these tests should be considered . By relating the estimated daily intake , or theoretical maximum daily intake per capita for a given whole food ( or the sum of its individual commercial constituents ) to that consumed on average per rat per day in the subchronic 00-day feeding study , it is possible to establish the margin of exposure ( safety margin ) for consumers . Results obtained from testing GM food and feed in rodents indicate that large ( at least 000-fold ) safety margins exist between animal exposure levels without observed adverse effects and estimated human daily intake . Results of feeding studies with feed derived from GM plants with improved agronomic properties , carried out in a wide range of livestock species , are discussed . The studies did not show any biologically relevant differences in the parameters tested between control and test animals . ( ABSTRACT TRUNCATED ) [ Sen. 00, subscore: 0.00 ]: The design of the study should be adapted from the OECD 00-day rodent toxicity study . The precise study design has to take into account the nature of the food and feed and the characteristics of the new trait ( s ) and their intended role in the GM food and feed . A 00-day animal feeding trial has a large capacity ( sensitivity and specificity ) to detect potential toxicological effects of single well defined compounds . This can be concluded from data reported on the toxicology of a wide range of industrial chemicals , pharmaceuticals , food substances , environmental , and agricultural chemicals . It is possible to model the sensitivity of the rat subchronic feeding study for the detection of hypothetically increased amount of compounds such as anti-nutrients , toxicants or secondary metabolites . With respect to the detection of potential unintended effects in whole GM food and feed , it is unlikely that substances present in small amounts and with a low toxic potential will result in any observable ( unintended ) effects in a 00-day rodent feeding study , as they would be below the no-observed-effect-level and thus of unlikely impact to human health at normal intake levels . Laboratory animal feeding studies of 00-days duration appear to be sufficient to pick up adverse effects of diverse compounds that would also give adverse effects after chronic exposure . This conclusion is based on literature data from studies investigating whether toxicological effects are adequately identified in 0-month subchronic studies in rodents , by comparing findings at 0 and 00 months for a range of different chemicals . The 00-day rodent feeding study is not designed to detect effects on reproduction or development other than effects on adult reproductive organ weights and histopathology . Analyses of available data indicate that , for a wide range of substances , reproductive and developmental effects are not potentially more sensitive endpoints than those examined in subchronic toxicity tests . Should there be structural alerts for reproductive/developmental effects or other indications from data available on a GM food and feed , then these tests should be considered . By relating the estimated daily intake , or theoretical maximum daily intake per capita for a given whole food ( or the sum of its individual commercial constituents ) to that consumed on average per rat per day in the subchronic 00-day feeding study , it is possible to establish the margin of exposure ( safety margin ) for consumers . Results obtained from testing GM food and feed in rodents indicate that large ( at least 000-fold ) safety margins exist between animal exposure levels without observed adverse effects and estimated human daily intake . Results of feeding studies with feed derived from GM plants with improved agronomic properties , carried out in a wide range of livestock species , are discussed . The studies did not show any biologically relevant differences in the parameters tested between control and test animals . ( ABSTRACT TRUNCATED ) [ Sen. 00, subscore: 0.00 ]: The precise study design has to take into account the nature of the food and feed and the characteristics of the new trait ( s ) and their intended role in the GM food and feed . A 00-day animal feeding trial has a large capacity ( sensitivity and specificity ) to detect potential toxicological effects of single well defined compounds . This can be concluded from data reported on the toxicology of a wide range of industrial chemicals , pharmaceuticals , food substances , environmental , and agricultural chemicals . It is possible to model the sensitivity of the rat subchronic feeding study for the detection of hypothetically increased amount of compounds such as anti-nutrients , toxicants or secondary metabolites . With respect to the detection of potential unintended effects in whole GM food and feed , it is unlikely that substances present in small amounts and with a low toxic potential will result in any observable ( unintended ) effects in a 00-day rodent feeding study , as they would be below the no-observed-effect-level and thus of unlikely impact to human health at normal intake levels . Laboratory animal feeding studies of 00-days duration appear to be sufficient to pick up adverse effects of diverse compounds that would also give adverse effects after chronic exposure . This conclusion is based on literature data from studies investigating whether toxicological effects are adequately identified in 0-month subchronic studies in rodents , by comparing findings at 0 and 00 months for a range of different chemicals . The 00-day rodent feeding study is not designed to detect effects on reproduction or development other than effects on adult reproductive organ weights and histopathology . Analyses of available data indicate that , for a wide range of substances , reproductive and developmental effects are not potentially more sensitive endpoints than those examined in subchronic toxicity tests . Should there be structural alerts for reproductive/developmental effects or other indications from data available on a GM food and feed , then these tests should be considered . By relating the estimated daily intake , or theoretical maximum daily intake per capita for a given whole food ( or the sum of its individual commercial constituents ) to that consumed on average per rat per day in the subchronic 00-day feeding study , it is possible to establish the margin of exposure ( safety margin ) for consumers . Results obtained from testing GM food and feed in rodents indicate that large ( at least 000-fold ) safety margins exist between animal exposure levels without observed adverse effects and estimated human daily intake . Results of feeding studies with feed derived from GM plants with improved agronomic properties , carried out in a wide range of livestock species , are discussed . The studies did not show any biologically relevant differences in the parameters tested between control and test animals . ( ABSTRACT TRUNCATED ) [ Sen. 00, subscore: 0.00 ]: This can be concluded from data reported on the toxicology of a wide range of industrial chemicals , pharmaceuticals , food substances , environmental , and agricultural chemicals . It is possible to model the sensitivity of the rat subchronic feeding study for the detection of hypothetically increased amount of compounds such as anti-nutrients , toxicants or secondary metabolites . With respect to the detection of potential unintended effects in whole GM food and feed , it is unlikely that substances present in small amounts and with a low toxic potential will result in any observable ( unintended ) effects in a 00-day rodent feeding study , as they would be below the no-observed-effect-level and thus of unlikely impact to human health at normal intake levels . Laboratory animal feeding studies of 00-days duration appear to be sufficient to pick up adverse effects of diverse compounds that would also give adverse effects after chronic exposure . This conclusion is based on literature data from studies investigating whether toxicological effects are adequately identified in 0-month subchronic studies in rodents , by comparing findings at 0 and 00 months for a range of different chemicals . The 00-day rodent feeding study is not designed to detect effects on reproduction or development other than effects on adult reproductive organ weights and histopathology . Analyses of available data indicate that , for a wide range of substances , reproductive and developmental effects are not potentially more sensitive endpoints than those examined in subchronic toxicity tests . Should there be structural alerts for reproductive/developmental effects or other indications from data available on a GM food and feed , then these tests should be considered . By relating the estimated daily intake , or theoretical maximum daily intake per capita for a given whole food ( or the sum of its individual commercial constituents ) to that consumed on average per rat per day in the subchronic 00-day feeding study , it is possible to establish the margin of exposure ( safety margin ) for consumers . Results obtained from testing GM food and feed in rodents indicate that large ( at least 000-fold ) safety margins exist between animal exposure levels without observed adverse effects and estimated human daily intake . Results of feeding studies with feed derived from GM plants with improved agronomic properties , carried out in a wide range of livestock species , are discussed . The studies did not show any biologically relevant differences in the parameters tested between control and test animals . ( ABSTRACT TRUNCATED ) Supplemental links/files: reference in endnote online text related articles pubmed citation Score: 00.00 Author: 