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7 results for “Cumulative exposure”
Annexes to the external scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software - Input and output data sets
<p>Retrospective dietary exposure assessments were conducted for two groups of pesticides that have acute effects on the nervous system: </p> <ol> <li>brain and/or erythrocyte acetylcholinesterase inhibition (CAG-NAN);</li> <li>functional alterations of the motor division (CAG-NAM).</li> </ol> <p>The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system (<a href="https://doi.org/10.2903/j.efsa.2019.5800">here</a>).</p> <p>The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe.</p> <p>Exposure estimates were obtained with Monte Carlo Risk Assessment (MCRA) software using a 2-dimensional Monte Carlo simulation, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data).</p> <p>Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile.</p> <p>The input and output data for the exposure assessment are reported in the following annexes:</p> <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-NAN</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-NAM</li> <li>Annex B.1 – Output data from the Tier II exposure assessment of CAG-NAN</li> <li>Annex B.2 – Output data from the Tier II exposure assessment of CAG-NAM</li> </ul> <p>Further information on the data, methodologies and interpretation of the results are provided in the external scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software (<a href="https://doi.org/10.2903/sp.efsa.2019.en-1708">here</a>).</p> <p>The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the nervous system (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.</p>
Annexes to the external scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using MCRA software - Input and output data sets
<p>Retrospective dietary exposure assessments were conducted for two groups of pesticides that have chronic effects on the thyroid: </p> <ol> <li>hypertrophy, hyperplasia and neoplasia of C-cells, i.e. affecting the parafollicular cells or the calcitonin system of the thyroid (CAG-TCP);</li> <li>hypothyroidism, i.e. affecting the follicular cells and/or the hormone system of the thyroid (CAG-TCF).</li> </ol> <p>The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the thyroid (<a href="https://doi.org/10.2903/j.efsa.2019.5801">here</a>).</p> <p>The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe.</p> <p>Exposure estimates were obtained with Monte Carlo Risk Assessment (MCRA) software using a 2-dimensional probabilistic method, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data).</p> <p>Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile.</p> <p>The input and output data for the exposure assessment are reported in the following annexes:</p> <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-TCP</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-TCF</li> <li>Annex B.1 – Output data from the Tier II exposure assessment of CAG-TCP</li> <li>Annex B.2 – Output data from the Tier II exposure assessment of CAG-TCF</li> </ul> <p>Further information on the data, methodologies and interpretation of the results are provided in the external scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using MCRA software (<a href="https://doi.org/10.2903/sp.efsa.2019.en-1707">here</a>).</p> <p>The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the thyroid (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.</p>
Annexes to the scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS® software - Input and output data sets
<p>Retrospective dietary exposure assessments were conducted for two groups of pesticides that have chronic effects on the thyroid: </p> <ol> <li>hypertrophy, hyperplasia and neoplasia of C-cells, i.e. affecting the parafollicular cells or the calcitonin system of the thyroid (CAG-TCP);</li> <li>hypothyroidism, i.e. affecting the follicular cells and/or the hormone system of the thyroid (CAG-TCF).</li> </ol> <p>The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the thyroid (<a href="https://doi.org/10.2903/j.efsa.2019.5801">here</a>).</p> <p>The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe.</p> <p>Exposure estimates were obtained with SAS<sup>®</sup> software using a 2-dimensional probabilistic method, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data).</p> <p>Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile.</p> <p>The input and output data for the exposure assessment are reported in the following annexes:</p> <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-TCP</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-TCF</li> <li>Annex B.1 – Output data from the Tier I exposure assessment of CAG-TCP</li> <li>Annex B.2 – Output data from the Tier I exposure assessment of CAG-TCF</li> <li>Annex C.1 – Output data from the Tier II exposure assessment of CAG-TCP</li> <li>Annex C.2 – Output data from the Tier II exposure assessment of CAG-TCF</li> </ul> <p>Further information on the data, methodologies and interpretation of the results are provided in the scientific report on the cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS<sup>®</sup> software (<a href="https://doi.org/10.2903/j.efsa.2019.5763">here</a>).</p> <p>The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the thyroid (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.</p>
Annexes to the scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS® software - Input and output data sets
<p>Retrospective dietary exposure assessments were conducted for two groups of pesticides that have acute effects on the nervous system: </p> <ol> <li>brain and/or erythrocyte acetylcholinesterase inhibition (CAG-NAN);</li> <li>functional alterations of the motor division (CAG-NAM).</li> </ol> <p>The pesticides considered in this assessment were identified and characterised in the scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system (<a href="https://doi.org/10.2903/j.efsa.2019.5800">here</a>).</p> <p>The exposure calculations used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual food consumption data from ten populations of consumers from different countries and from different age groups. Regarding the selection of relevant food commodities, the assessment included water, foods for infants and young children and 30 raw primary commodities of plant origin that are widely consumed within Europe.</p> <p>Exposure estimates were obtained with SAS<sup>®</sup> software using a 2-dimensional Monte Carlo simulation, which is composed of an inner-loop execution and an outer-loop execution. Variability within the population is modelled through the inner-loop execution and is expressed as a percentile of the exposure distribution. The outer-loop execution is used to derive 95% confidence intervals around those percentiles (reflecting the sampling uncertainty of the input data).</p> <p>Furthermore, calculations were carried out according to a tiered approach. While the first-tier calculations (Tier I) use very conservative assumptions for an efficient screening of the exposure with low risk for underestimation, the second-tier assessment (Tier II) includes assumptions that are more refined but still conservative. For each scenario, exposure estimates were obtained for different percentiles of the exposure distribution and the total margin of exposure (MOET, i.e. the ratio of the toxicological reference dose to the estimated exposure) was calculated at each percentile.</p> <p>The input and output data for the exposure assessment are reported in the following annexes:</p> <ul> <li>Annex A.1 – Input data for the exposure assessment of CAG-NAN</li> <li>Annex A.2 – Input data for the exposure assessment of CAG-NAM</li> <li>Annex B.1 – Output data from the Tier I exposure assessment of CAG-NAN</li> <li>Annex B.2 – Output data from the Tier I exposure assessment of CAG-NAM</li> <li>Annex C.1 – Output data from the Tier II exposure assessment of CAG-NAN</li> <li>Annex C.2 – Output data from the Tier II exposure assessment of CAG-NAM</li> </ul> <p>Further information on the data, methodologies and interpretation of the results are provided in the scientific report on the cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS<sup>®</sup> software (<a href="https://doi.org/10.2903/j.efsa.2019.5764">here</a>).</p> <p>The results reported in this assessment only refer to the exposure and are not an estimation of the actual risks. These exposure estimates should therefore be considered as documentation for the final scientific report on the cumulative risk assessment of dietary exposure to pesticides for their effects on the nervous system (<a href="https://www.efsa.europa.eu/en/consultations/call/public-consultation-scientific-report-cumulative">here</a>). The latter combines the hazard assessment and exposure assessment into a consolidated risk characterisation, including all related uncertainties.</p>
Data from: Risk of cancer with angiotensin-receptor blockers increases with increasing cumulative exposure: Meta-regression analysis of randomized trials
<p>Angiotensin-receptor blockers (ARBs) are a class of drugs approved for the treatment of several common conditions, such as hypertension and heart failure. Recently, regulatory agencies have started to identify possibly carcinogenic nitrosamines and azido compounds in a multitude of formulations of several ARBs, resulting in progressive recalls. Furthermore, data from several randomized controlled trials suggested that there is also a clinically increased risk of cancer and specifically lung cancer with ARBs; whereas other trials suggested no increased risk. The purpose of this analysis was to provide additional insight into the ARB-cancer link by examining whether there is a relationship between degree of cumulative exposure to ARBs and risk of cancer in randomized trials. Trial-level data from ARB Trialists Collaboration including 15 randomized controlled trials was extracted and entered into meta-regression analyses. The two co-primary outcomes were the relationship between cumulative exposure to ARBs and risk of all cancers combined and the relationship between cumulative exposure and risk of lung cancer. A total of 74,021 patients were randomized to an ARB resulting in a total cumulative exposure of 172,389 person-years of exposure to daily high dose (or equivalent). 61,197 patients were randomized to control. There was a highly significant correlation between the degree of cumulative exposure to ARBs and risk of all cancers combined (slope=0.07 [95% CI 0.03 to 0.11], p<0.001), and also lung cancer (slope=0.16 [95% CI 0.05 to 0.27], p=0.003). Accordingly, in trials where the cumulative exposure was greater than 3 years of exposure to daily high dose, there was a statistically significant increase in risk of all cancers combined (I<sup>2</sup>=31.4%, RR 1.11 [95% CI 1.03 to 1.19], p=0.006). There was a statistically significant increase in risk of lung cancers in trials where the cumulative exposure was greater than 2.5 years (I<sup>2</sup>=0%, RR 1.21 [95% CI 1.02 to 1.44], p=0.03). In trials with lower cumulative exposure to ARBs, there was no increased risk of all cancers combined or lung cancer. Cumulative exposure-risk relationship with ARBs was independent of background angiotensin-converting enzyme inhibitor treatment or the type of control (i.e. placebo or non-placebo control). Since this is a trial-level analysis. the effects of patient characteristics such as age and smoking status could not be examined due to lack of patient-level data. In conclusion, this analysis, for the first time, reveals that risk of cancer with ARBs (and specifically lung cancer) increases with increasing cumulative exposure to these drugs. The excess risk of cancer with long-term ARB use has public health implications.</p>
Data from: Risk of cancer with angiotensin-receptor blockers increases with increasing cumulative exposure: Meta-regression analysis of randomized trials
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Supplementary material to: Demonstration of a tool to assess cumulative risks from combined exposure to multiple pesticide residues in fruits and vegetables
<p>Supplementary material to: Kruisselbrink, J.W., van der Voet, H., van Lenthe, M.S., de Boer, W.J., Bakker, R. (2023). Demonstration of a tool to assess cumulative risks from combined exposure to multiple pesticide residues in fruits and vegetables. Wageningen University & Research Biometris report 48.01.23. https://doi.org/10.18174/584369. Catalogues and secondary data for the cumulative risk calculations.</p>
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