Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products.
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ABSTRACT:
SUBMITTER: European Food Safety Authority (EFSA)
PROVIDER: S-EPMC8765091 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSubstances used as co-formulants in plant protection products (PPP) may require registration under Regulation (EC) No. 1907/2006 (REACH), and additionally where an exposure assessment is required, this must take into consideration the specifics of the PPP use.ObjectivesThis work reports a customized screening level model developed to support human health risk assessment of operators, workers, and bystanders (OWB) for co-formulants used in PPP. The OWB model was designed to closely integrate with REACH generic exposure scenarios (GES) for PPP developed by the European Crop Protection Association (ECPA). The use of these tools in combination is expected to lead to a more standardized and hence efficient risk assessment of co-formulants. This study describes the basis for OWB exposure predictions as well as benchmarking against relevant REACH exposure models for equivalent tasks. The benchmarking was carried out to gain some insight into the initial assumption that the most commonly used tier 1 REACH model would be more conservative than the specific PPP models used for regulatory risk assessments under PPP legislation.MethodExisting exposure models with regulatory acceptance for the most common types of PPP and their professional and consumer uses were selected. The German BBA model was used to assess spray applications. Granule and seed dispersal was assessed using the US Environmental Protection Agency (EPA) Pesticide Handlers Exposure Database (PHED). ECETOC TRA was employed to assess exposure during certain tasks performed in seed treatment, not covered by these PPP models. Where the underlying models featured multiple exposure determinants, the exposure was calculated for all permutations, and the worst-case exposure selected and reported for use in risk assessment. The PPP models are based on measured data collected during actual application of PPP; hence, the worst-case exposure predicted was expected to reflect a realistic worst case for these tasks.ResultsOWB was implemented as an Excel spreadsheet. Exposure models, parameters, and exposure and risk estimates are reported in a REACH-compliant output format to facilitate the registration of co-formulant uses. As would be expected, benchmarking OWB against the PPP-specific exposure models demonstrated equivalence with the worst-case prediction from these underlying PPP models. For the scenarios modelled, the tier 1 ECETOC TRA gave more conservative predictions than OWB. The reduction in conservatism is attributed to the underlying PPP models being based on measured data collected specifically during the use of PPP, compared to the data underlying ECETOC TRA, based mainly on industrial workplace uses.ConclusionsOWB provides inhalation and dermal exposure estimates for co-formulants used in PPP which are equivalent to the worst-case estimates from existing specialized PPP exposure models based on measured data. OWB has simplified information requirements in comparison to higher-tier REACH or PPP models. Use of OWB in combination with the defined ECPA GES facilitates an efficient and standardized REACH risk assessment and registration of co-formulant uses in PPP. A defined assessment framework and default inputs potentially decreases the anticipated inter-user variability compared with the use of higher-tier PPP or REACH models in this screening level context.
| S-EPMC6356032 | biostudies-literature
Project description:For the authorization of plant protection products, a quantitative non-dietary exposure risk assessment relies on established dermal exposure models, measured mainly using passive dosimetry. Exposure to the hands is determined via hand washing or using cotton gloves as a surrogate for skin. This study compared both methods using operator exposure data available from the Agricultural Operator Exposure Model (AOEM) project report. These data indicate that hand exposure determined using cotton gloves resulted in markedly higher exposure values for all exposure scenarios compared to those determined by hand washes. One explanation for this is that dermal uptake of the residues reduces the amount of residue that can be recovered by hand washing. Uncertainty due to dermal uptake can be addressed by either default assumptions or by specific dermal absorption data. However, this cannot solely account for the large difference observed between the values and is mainly likely to be due to the higher capacity of the cotton gloves vs. human skin to retain residues. The results further indicate that the variability between hand wash samples and cotton glove samples differs between the exposure scenarios. Hence, the level of conservatism related to the use of cotton gloves as surrogate skin remains unknown. In conclusion, this evaluation of the AOEM data indicates that the cotton glove method results in much higher levels of measured hand exposure than the hand wash method. It cannot be excluded that dermal uptake has contributed to that result. However, the findings suggest the higher retention capacity of cotton gloves vs. human skin to be the main impact parameter. The cotton glove method does not provide the results with regards to the protection level that can be expected from the use of protective gloves. Therefore, we believe that the application of the hand wash method is a more accurate measure of exposure levels, if either specific dermal absorption data or, in its absence, default assumptions are applied as adjustment factor.
| S-EPMC9798894 | biostudies-literature
Project description:BackgroundThe aim of this study was to update and refine an algorithm, originally developed in Canada, to assist care home staff to manage residents with suspected infection in the United Kingdom care home setting. The infections of interest were urinary tract infections, respiratory tract infections and skin and soft tissue infection.MethodWe used a multi-faceted process involving a literature review, consensus meeting [nominal group technique involving general practitioners (GPs) and specialists in geriatric medicine and clinical microbiology], focus groups (care home staff and resident family members) and interviews (GPs), alongside continual iterative internal review and analysis within the research team.ResultsSix publications were identified in the literature which met inclusion criteria. These were used to update the algorithm which was presented to a consensus meeting (four participants all with a medical background) which discussed and agreed to inclusion of signs and symptoms, and the algorithm format. Focus groups and interview participants could see the value in the algorithm, and staff often reported that it reflected their usual practice. There were also interesting contrasts between evidence and usual practice informed by experience. Through continual iterative review and analysis, the final algorithm was finally presented in a format which described management of the three infections in terms of initial assessment of the resident, observation of the resident and action by the care home staff.ConclusionsThis study has resulted in an updated algorithm targeting key infections in care home residents which should be considered for implementation into everyday practice.
| S-EPMC7023778 | biostudies-literature
Project description:This EFSA Guidance Document provides guidance for the exposure assessment of soil organisms to plant protection products (PPPs) and their transformation products in accordance with Regulation (EC) No. 1107/20091 of the European Parliament and the Council. This guidance was produced by EFSA in response to a question posed by the European Commission according to Article 31 of Regulation (EC) No. 178/20022 of the European Parliament and of the Council. Guidance is provided for all types of concentrations that are potentially needed for assessing ecotoxicological effects, i.e. the concentration in total soil and the concentration in pore water, both averaged over various depths and time windows. The current guidance considers both permanent crops and annual crops. The recommended exposure-assessment procedure consists of four tiers. To facilitate efficient use of the tiered approach in regulatory practice, user-friendly software tools have been developed. In higher tiers of the exposure assessment, crop interception and subsequent dissipation at the crop canopy may be included. The models that simulate these processes were harmonised. In addition, easy-to-use tables for the fraction of the dose intercepted by the canopy that is washed off have been developed, which should be used in combination with the simple analytical model. With respect to substance-specific model inputs, this guidance generally follows earlier documents; however, new guidance is included for some specific substance parameters.
| S-EPMC7010114 | biostudies-literature
Project description:BackgroundIn July of 2013, a pipeline connecting an offshore oil platform to a tanker caused crude oil to spill into the Sea of Rayong off the coast of Thailand. The resulting oil slick, estimated to be between 50 and 190 cubic meters (336-1,200 barrels), washed ashore one day later on the island of Samet. We conducted a study to quantify internal dose of polycyclic aromatic hydrocarbons (PAHs) and benzene in 1,262 oil spill cleanup workers, and to examine factors related to their dose.MethodsFrozen stored urine samples (n=1343) collected from the workers during the one month cleanup period were used to measure the concentration of 1-hydroxypyrene-glucuronide (1-OHPG), cotinine and creatinine. Data from questionnaires and urinary trans,trans-muconic acid (t,t-MA), a benzene metabolite, measured previously as part of a worker health surveillance plan, were linked with the laboratory data.ResultsThe internal dose of urinary 1-OHPG was highest in individuals who worked during the first 3 days of cleanup work (median: 0.97 pmol/ml) and was 66.7% lower (median: 0.32 pmol/ml) among individuals who worked in the final week of the study (days 21-28). After adjusting for age, cotinineand creatinine by regression analysis, the decline in urinary 1-OHPG concentration with days of cleanup remained significant (P-trend <0.001). A decreasing trend by days of cleanup was also observed for detectable urinary t,t-MA percentage (P-trend <0.001).ConclusionRayong oil spill cleanup workers exhibited evidence of elevated levels of PAH and benzene exposure during the early weeks of cleanup, compared to near background levels 4 weeks after cleanup began. Long-term health monitoring of oil spill cleanup workers is advised.
| S-EPMC6876312 | biostudies-literature
Project description:The concept of source-sink dynamics as a potentially important component of metapopulation dynamics was introduced in the 1980s. The objective of the present review was to review the considerable body of work that has been developed, to consider its theoretical implications as well as to understand how source-sink dynamics may manifest under field conditions in the specific case of nontarget arthropods in the agricultural environment. Our review concludes that metapopulation dynamics based on field observations are often far more complex than existing theoretical source-sink models would indicate, because they are dependent on numerous population processes and influencing factors. The difficulty in identifying and measuring these factors likely explains why empirical studies assessing source-sink dynamics are scarce. Furthermore, we highlight the importance of considering the spatial and temporal heterogeneity of agricultural landscapes when assessing the population dynamics of nontarget arthropods in the context of the risk from the use of plant protection products. A need is identified to further develop and thoroughly validate predictive population models, which can incorporate all factors relevant to a specific system. Once reliable predictive models for a number of representative nontarget arthropod species are available, they could provide a meaningful tool for refined risk evaluations (higher tier level risk assessment), addressing specific concerns identified at the initial evaluation stages (lower tier level risk assessment). Environ Toxicol Chem 2021;40:2667-2679. © 2021 ERM, FMC, Syngenta, Bayer AG, BASF SE, Corteva agriscience. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.
| S-EPMC9291833 | biostudies-literature
Project description:Heavy metal pollution in the air, water, and soil has attracted substantial interest recently; however, assessment of the total human environmental exposure remains limited. Therefore, determining the total human environmental exposure is imperative for the management and control of heavy metal pollution. This study assessed the total environmental exposure levels of heavy metals as well as the exposure contributions of air, water, and soil, focusing on Hg, Cd, As, Pb, and Cr. Data from 3,855 volunteers from the cities of Taiyuan, Dalian, Shanghai, Wuhan, Chengdu, and Lanzhou allowed for comparison of the exposures in urban and rural areas. The levels of total human environmental exposure of Hg, Cd, As, Pb, and Cr were 1.82 × 10-6 mg/(kg·d), 1.58 × 10-6 mg/(kg·d), 3.87 × 10-5 mg/(kg·d), 1.79 × 10-5 and 7.47 × 10-5 mg/(kg·d), respectively. There were regional, urban-rural, sex, and age differences in the levels of heavy metal exposure. Water pollution was determined to be the largest contributor to heavy metal exposure, accounting for 97.87%, 92.50%, 80.51%, 76.16% and 79.46% of the Hg, Cd, As, Pb, and Cr, followed by air and soil pollution. These results can provide data to inform environmental protection policies and identify the priority pollutants that can help identify and prevent health risks due to overexposure to these heavy metal pollutants.
| S-EPMC6841693 | biostudies-literature
Project description:The contamination of the eggs of farmland birds by currently used plant protection products (PPPs) is poorly documented despite a potential to adversely impact their breeding performance. In this context, 139 eggs of 52 grey partridge Perdix perdix clutches, collected on 12 intensively cultivated farmlands in France in 2010-2011, were analysed. Given the great diversity of PPPs applied on agricultural fields, we used exploratory GC/MS-MS and LC/MS-MS screenings measuring ca. 500 compounds. The limit of quantification was 0.01 mg/kg, a statutory reference. A total of 15 different compounds were detected in 24 clutches. Nine of them have been used by farmers to protect crops against fungi (difenoconazole, tebuconazole, cyproconazole, fenpropidin and prochloraz), insects (lambda-cyhalothrin and thiamethoxam/clothianidin) and weeds (bromoxynil and diflufenican). Some old PPPs were also detected (fipronil(+sulfone), HCH(?,?,? isomers), diphenylamine, heptachlor(+epoxyde), DDT(?isomers)), as well as PCBs(153, 180). Concentrations ranged between <0.01 and 0.05 mg/kg but reached 0.067 (thiamethoxam/clothianidin), 0.11 (heptachlor + epoxyde) and 0.34 (fenpropidin) mg/kg in some cases. These results testify an actual exposure of females and/or their eggs to PPPs in operational conditions, as well as to organochlorine pollutants or their residues, banned in France since several years if not several decades, that persistently contaminate the environment.Routes of exposure, probability to detect a contamination in the eggs, and effects on egg/embryo characteristics are discussed with regard to the scientific literature.
| S-EPMC4871908 | biostudies-other
Project description:This study investigated antimony exposure among employees in industries in Taiwan and evaluated whether their immunologic markers were associated with antimony exposure. We recruited 91 male workers and 42 male office administrators from 2 glass manufacturing plants, 1 antimony trioxide manufacturing plants, and 2 engineering plastic manufacturing plants. Air samples were collected at worksites and administrative offices, and each participant provided specimens of urine, blood, and hair to assay antimony levels. We also determined white blood cells, lymphocyte, and monocyte, IgA, IgE, and IgG in blood specimens. The mean antimony concentration in the air measured at worksites was much higher in the antimony trioxide plant (2.51 ± 0.57 mg/m³) than in plastic plants (0.21 ± 0.06 mg/m³) and glass plants (0.14 ± 0.01 mg/m³). Antimony levels in blood, urine, and hair measured for participants were correlated with worksites and were higher in workers than in administrators. The mean serum IgG, IgA, and IgE levels were lower in workers than in administrators (p < 0.001). Serum IgA and IgE levels in participants were negatively associated with antimony levels in air samples of workplaces, and in blood, urine, and hairs of participants. Serum IgG and IgE of all participants were also negatively associated with antimony levels in their hairs. In conclusion, the antimony exposure is greater for workers employed in the five industrial plants than for administrators. This study suggests serum IgG, IgA, and IgE levels are negatively associated with antimony exposure.
| S-EPMC5551127 | biostudies-other
Project description:Cadmium and its compounds are human carcinogens with severe organ toxicity, and their contamination of agricultural soil in China has been frequently reported; however, the dietary exposure to cadmium in residents and the relevant health risk have seldom been reported. In this study, the concentration of cadmium in various types of food collected from 2013 to 2015 were analyzed using graphite furnace atomic absorption spectrometry, and the dietary exposure to cadmium assessed based on a dietary survey in 2976 Guangzhou residents. In total, 3074 out of 4039 food samples had cadmium levels above the limit of detection. The mean ± standard deviation (50th, 95th percentile) cadmium content in all samples was 159.0 ± 112.7 (8.6, 392.4) μg/kg, with levels ranging from 1.0 to 7830 μg/kg. Using the mean cadmium concentrations, the average monthly dietary exposure of Guangzhou residents to cadmium was 14.4 (μg/kg body weight (BW), accounting for 57.6% of the provisional tolerable monthly intake (PTMI). Rice, laver, vegetables, and live aquatic products were the main sources of cadmium intake, on average accounting for 89% of the total value. The dietary cadmium exposure in high consumers (95th percentile food consumption) was 41.0 μg/kg·BW/month, accounting for 163% of the PTMI. Additionally, dietary cadmium exposure at mean consumption but high cadmium food concentration (95th percentile) was 32.3 μg/kg·BW/month, corresponding to 129% of the PTMI. The level of dietary exposure to cadmium in most Guangzhou residents was within the safety limit, thus increased health risk from dietary cadmium exposure is low at present. However, continued efforts by local governments to monitor the levels of cadmium in the four main food categories contributing to exposure are necessary.
| S-EPMC5877101 | biostudies-literature