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Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products.

ABSTRACT: This guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs). It is based on the Scientific Opinion on 'Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders' developed by the EFSA Panel on Plant Protection Products and their Residue (PPR) in 2010. Highlighting some inconsistencies between the approaches adopted by regulatory authorities, the PPR Panel proposed a number of changes to the practices in use (i.e. use of deterministic methods for individual PPPs; need to perform an acute risk assessment for PPPs that are acutely toxic; use of appropriate percentile for acute or longer term risk assessments). In the first version of the guidance, issued in 2014, several scenarios for outdoor uses were included, with an annexed calculator, as well as recommendations for further research. The guidance has been updated in 2021 with the inclusion of additional scenarios and revision of default values, on the basis of the evaluation of additional evidence. To support users in performing the assessment of exposure and risk, an online calculator, reflecting the guidance content, has been further developed.

SUBMITTER: European Food Safety Authority (EFSA)

PROVIDER: S-EPMC8765091 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products.

Charistou Agathi A Coja Tamara T Craig Peter P Hamey Paul P Martin Sabine S Sanvido Olivier O Chiusolo Arianna A Colas Mathilde M Istace Frédérique F

EFSA journal. European Food Safety Authority 20220118 1

This guidance is designed to assist risk assessors and applicants when quantifying potential non-dietary, systemic exposures as part of regulatory risk assessment for plant protection products (PPPs). It is based on the Scientific Opinion on 'Preparation of a Guidance Document on Pesticide Exposure Assessment for Workers, Operators, Residents and Bystanders' developed by the EFSA Panel on Plant Protection Products and their Residue (PPR) in 2010. Highlighting some inconsistencies between the app ...[more]

PMID: 35079284

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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.

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.

Project description:BackgroundFemale workers who are pregnant or breastfeeding require adequate support to balance their roles as mothers and employees. This support comes in the form of Maternity Protection (MP). Low maternity protection among female workers is a major public health concern. Less research has been done on all the components of MP, especially among healthcare workers in Ghana.ObjectiveThe study aims to assess maternity protection as a whole (all the components of maternity protection) among female healthcare workers (HCWs) in health facilities in the Agona West District of Ghana.Study designA descriptive cross-sectional study involving 102 female workers in all the health facilities in the Agona West District of Ghana was conducted. A multistage sampling technique was employed. The International Labour Organization (ILO) standard questionnaire (adapted) was administered to assess all components of MP such as maternity leave, cash benefits, health protection at work, employment and discrimination, and childcare arrangements.ResultsAll (100%) participants stated that they had paid maternity leave but 7.8% received less than the 12-week statutory maternity leave. 23.5% felt that their health and that of their child were at risk due to work. Regarding employment and discrimination, none of them were dismissed due to pregnancy or childbirth. However, 2 % did not get their due promotion and 12.7% stated that they received unpleasant comments related to pregnancy or birth. Concerning breastfeeding, 82.4% of all the HCWs were able to breastfeed for at least 6 months whilst among all the HCWs, 17.6% were able to breastfeed whilst at work. 25% of the HCWs were somewhat satisfied with their childcare arrangements.ConclusionMaternity Protection among female healthcare workers in health facilities in Agona West District is moderate. The roles of pregnant or nursing mothers in the workplace should be adapted to their health needs, promoting a healthy work environment. This study recommends that the heads of the health facilities and all stakeholders ensure maternity protection through education, awareness, and review of workplace policies as well as establish control measures for those who flout this policy.

Dataset Information

Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products.

Publications

Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products.

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