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The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for pinoxaden are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Austria and presents EFSA's scientific views and conclusions on the individual comments received. [ABSTRACT FROM AUTHOR]

The article argues for broadening the role of alternatives in assessing dangerous products under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to end pesticide myopia. Topics discussed include pesticide risk assessment under FIFRA, history of NRDC v. EPA that led to the cancellation of tetrachlorvinphos pet collars, role of innovation in pesticides, consumer knowledge of products, and legal avenue to consider the presence of alternatives in registration and cancellations.

In August 2021, after years of delay, the U.S. Environmental Protection Agency revoked food-based "tolerances," or maximum allowable residues, for the neurotoxic pesticide chlorpyrifos. The new rule has been widely--and rightfully--heralded as a victory for children's, environmental, and labor advocates. The tolerance revocation ends many of the most popular and pervasive uses of the pesticide. However, chlorpyrifos remains legal for a variety of non-food uses, both agricultural and otherwise. Many agricultural workers remain vulnerable to the occupational health risks associated with these uses. Their children and neighbors, too, continue to endure spray drift, take-home contamination, and prenatal exposure. Importantly, this population is often pushed to the margins of dominant policy discourse--an outcome bound up with a history of U.S. "agricultural exceptionalism" and the challenges of tenuous immigration status and linguistic isolation. This Note posits that chlorpyrifos's persistent harm is attributable to and best described by the concept of "stranded" pesticide uses. Stranded pesticides linger, quietly evading regulation and harming an already environmentally burdened community. This Note traces the legal advocacy efforts that culminated in the 2021 chlorpyrifos rule; explores why agricultural workers and their communities remain vulnerable in its wake; discusses how federal pesticides law and policy exacerbates both worker vulnerability and the likelihood of future pesticide "strandings"; and finally, contemplates legal and policy adaptations to mitigate these risks to agricultural workers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tetraconazole. To assess the occurrence of tetraconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, as well as the import tolerances and European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and, with the exception of the MRL proposal for kaki, all MRL proposals derived by EFSA still require further consideration by risk managers. Regarding triazole derivative metabolites (TDMs), separate indicative exposure assessments were performed and no risk to consumers was identified for what regards these metabolites individually. However, TDMs may be generated by several pesticides belonging to the group of triazole fungicides, and a comprehensive risk assessment has thus to be performed that covers all existing European uses for all pesticides belonging to the class of triazole fungicides. EFSA recommended to elaborate together with risk managers a strategy to ensure that the required data are made available to finalise the overall risk assessment for triazole fungicides. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance isoxaben. To assess the occurrence of isoxaben residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance. Although this active substance is not authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States and the UK (including the supporting residues data). Considering that no toxicological reference values are currently established in Europe for novaluron because the peer review for the approval was terminated before an EFSA conclusion was issued, the toxicological profile of novaluron was also assessed, in order to be able to perform the consumer risk assessment in the framework of the art 12 MRL review. Based on the assessment of the available data, toxicological reference values were derived, and a consumer risk assessment was carried out for the existing CXLs and import tolerances. All CXLs and import tolerances were found to be supported by inadequate data and a possible chronic risk to consumers was identified. Hence, further consideration by risk managers is needed. [ABSTRACT FROM AUTHOR]

Following a request of the European Commission, EFSA and ANSES, beneficiary of the EFSA tasking grant on horizon scanning for plant pests (GP/EFSA/ALPHA/2017/02), developed a methodology to order by risk non‐regulated pests recently identified through the monitoring of media and scientific literature. The ranking methodology proposed at the end of the pilot phase was based on the scoring of pests under evaluation following 16 criteria related to the steps of the pest risk assessment scheme. The multicriteria matrix of scores obtained was then submitted to the multicriteria analysis method PROMETHEE. The pilot methodology was tested on a limited number of pests (14 pests identified during the monitoring activity, and 4 'control' pests whose well‐known risk should be reflected either in a positive or negative score), then applied on all non‐regulated pests identified through the media and scientific literature monitoring in the first 2 years of the project. After having collected feedback from the targeted final users (EU risk managers), the methodology underwent a few refinements: (i) implementation of the methodology to a set of already assessed reference pests from EFSA opinions, (ii) exclusions of three criteria from the scoring phase, (iii) identification of pests proposed for further action ('positive' pests), using a threshold defined after scoring the reference pests. [ABSTRACT FROM AUTHOR]

Scope: This Standard provides general guidance on the use of buffer zones to minimize the probability of spread of a pest into or out of delimited areas. It is intended to be used by risk assessors and risk managers when they are conducting pest risk analysis or designing phytosanitary measures, including for contingency plans. Specific approval: This Standard was first approved on 2021–09. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance spirodiclofen. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, as spirodiclofen is classified as carcinogenic 1B with threshold, all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metobromuron. To assess the occurrence of metobromuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the European authorisations reported by Member States and the United Kingdom (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substances Beta-cyfluthrin and Cyfluthrin. Although these active substances are no longer authorised for use on edible crops within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits (CXLs)) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. All CXLs were found to be sufficiently supported by data, whereas some import tolerances were not supported by adequate data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. Apart from a possible acute risk to consumers for a CXL higher than the existing MRL, no risk to consumers was identified. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance penthiopyrad. To assess the occurrence of penthiopyrad residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance isopyrazam. To assess the occurrence of isopyrazam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and one MRL proposal derived by EFSA still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance 1,4-dimethylnaphthalene. To assess the occurrence of 1,4-dimethylnaphthalene residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide valifenalate. To assess the occurrence of valifenalate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and one MRL proposal derived by EFSA still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pinoxaden. To assess the occurrence of pinoxaden residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyproconazole. Considering that no application was received to support the renewal of the approval of cyproconazole and considering the expiry date for its approval on 31 May 2021, and that the import tolerances identified were not supported by sufficient data, and are not forming the basis of any existing EU MRLs, but correspond to existing MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), the current assessment is limited to CXLs. To assess the occurrence of cyproconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the MRLs established by the Codex Alimentarius Commission. Based on the assessment of the available data, EFSA assessed the CXLs and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

A retrospective cumulative risk assessment of dietary exposure to pesticide residues was conducted for chronic inhibition of acetylcholinesterase. The pesticides considered in this assessment were identified and characterised in a previous scientific report on the establishment of cumulative assessment groups of pesticides for their effects on the nervous system. The exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2016, 2017 and 2018, and individual food consumption data from 10 populations of consumers from different countries and from different age groups. Exposure estimates were obtained by means of a two‐dimensional probabilistic model, which was implemented in SAS® software. The characterisation of cumulative risk was supported by an uncertainty analysis based on expert knowledge elicitation. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides contributing to the chronic inhibition of acetylcholinesterase does not exceed the threshold for regulatory consideration established by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance thiram. Although this active substance is no longer authorised within the European Union, MRLs based on the use of thiram were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the existing import tolerances, and a consumer risk assessment was carried out for thiram only. Although no apparent risk to consumers was identified, the import tolerances were not fully supported by data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC)No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for meptyldinocapare presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Spain and presents EFSA's scientific viewsand conclusions on the individual comments received. [ABSTRACT FROM AUTHOR]

Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing MRLs for that active substance. Article 12(2) of that Regulation stipulates that EFSA shall provide by 1 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC before 2 September 2008. Among the active substances that need to be reviewed under Article 12(1) or Article 12(2) of Regulation (EC) No 396/2005, EFSA identified 12 active substances for which a review of MRLs is no longer considered necessary, including five active substances that were already included temporarily in Annex IV of Regulation (EC) No 396/2005 by risk managers pending finalisation of their evaluation under Directive 91/414/EEC or Regulation (EC) No 1107/2009 and pending submission of EFSA's reasoned opinion in accordance with Article 12 of Regulation (EC) No 396/2005. EFSA prepared a statement explaining the reasons why a review of MRLs for these substances became obsolete. The relevant question numbers are considered addressed by this statement. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance oxyfluorfen. To assess the occurrence of oxyfluorfen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and one existing European MRL still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance quinmerac. To assess the occurrence of quinmerac residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

Rural Hoosier homemakers have long negotiated the tensions of competing priorities and demands on their farms: clean and pure households, robust and profitable fields, and the health of their families. Agricultural experts have stressed the benefits of using pesticides to help achieve all three of these aspects of farm life, while public health advocates have warned of the potentially dire health consequences of large-scale, long-term pesticide use—particularly for children. This article analyzes gendered perceptions of risk-assessment regarding chronic exposure to pesticide residues from the turn of the twentieth century to the present day in Indiana. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chlorantraniliprole. To assess the occurrence of chlorantraniliprole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance meptyldinocap (DE-126). To assess the occurrence of meptyldinocap residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, Commission Regulation (EU) No 188/2011 and the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance flubendiamide. To assess the occurrence of flubendiamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances (including the supporting residues data). No European authorisation was reported by Member States. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still requires further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metaflumizone. To assess the occurrence of metaflumizone residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission and the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC)No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for acibenzolar‐S‐methylare presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State France and presents EFSA's scientific viewsand conclusions on the individual comments received. [ABSTRACT FROM AUTHOR]

A retrospective chronic cumulative risk assessment of dietary exposure to pesticide residues, supported by an uncertainty analysis based on expert knowledge elicitation, was conducted for two effects on the thyroid, hypothyroidism and parafollicular cell (C‐cell) hypertrophy, hyperplasia and neoplasia. 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. Cumulative exposure assessments were conducted through probabilistic modelling by EFSA and the Dutch National Institute for Public Health and the Environment (RIVM) using two different software tools and reported separately. These exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual consumption data from 10 populations of consumers from different countries and different age groups. This report completes the characterisation of cumulative risk, taking account of the available data and the uncertainties involved. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides that have the chronic effects on the thyroid mentioned above does not exceed the threshold for regulatory consideration established by risk managers. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1836/fullhttp://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1835/full This publication is linked to the following EFSA Journal articles: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6087/full [ABSTRACT FROM AUTHOR]

A retrospective acute cumulative risk assessment of dietary exposure to pesticide residues, supported by an uncertainty analysis based on expert knowledge elicitation, was conducted for two effects on the nervous system: brain and/or erythrocyte acetylcholinesterase inhibition, and functional alterations of the motor division. 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. Cumulative exposure assessments were conducted through probabilistic modelling by EFSA and the Dutch National Institute for Public Health and the Environment (RIVM) using two different software tools and reported separately. These exposure assessments used monitoring data collected by Member States under their official pesticide monitoring programmes in 2014, 2015 and 2016 and individual consumption data from 10 populations of consumers from different countries and different age groups. This report completes the characterisation of cumulative risk, taking account of the available data and the uncertainties involved. For each of the 10 populations, it is concluded with varying degrees of certainty that cumulative exposure to pesticides that have the acute effects on the nervous system mentioned above does not exceed the threshold for regulatory consideration established by risk managers. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1836/fullhttp://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2020.EN-1835/full This publication is linked to the following EFSA Journal articles: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6088/full [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluopyram. To assess the occurrence of fluopyram residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible chronic risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

In various places in the world, aerial spraying of pesticides has met with resistance from local communities potentially endangered by toxic pesticide drift. Social movements, and the counter-expertise that they mobilise, often trigger changes in state regulations of the practice. This article describes such struggles over risk regulation in the Philippines, where aerial spraying is common in large monoculture banana plantations. It has provoked local activism contesting the socio-economic power of landed and business elites and has challenged the government's approach to managing pesticide risks. This article develops the argument that different types of counter-expertise must be recognised. The case shows that it can be difficult for movements to articulate these different types of counter-expertise. Furthermore, the weak state characteristics of the Philippine state has shaped the ambiguous responses of risk governance to multiple actors' divergent knowledge claims. The result is a legal impasse in which civil society has successfully pushed the issue of aerial spraying onto the national political arena, but the state has as yet been unable to develop a comprehensive pesticide risk regulation independent of powerful business interests. [ABSTRACT FROM AUTHOR]

BACKGROUND: With over 12 000 registered mixture formulations in China, environmental risk assessment of co‐formulated pesticide mixtures to aquatic ecosystems is of increasing interest to scientists, risk assessors, and risk managers. This study proposed a pragmatic approach based on widely accepted scientific concepts and strategies. RESULTS: The proposed approach has three tiers, a preliminary Tier 0 stage, a Tier 1 stage, and a refinement stage as Tier 2, which are demonstrated with one case study. Because of the large number of co‐formulated pesticide mixtures available in China, a unique Tier 0 stage is proposed with practicable criteria to identify mixtures requiring further evaluation. For Tier‐1 assessment, exposure is assessed based on the application scheme and local scenarios in China. Hazard is evaluated using the concentration addition model as the default approach, which was developed a century ago and was adopted by the majority of the regulators globally. Given the unique characteristics of mixtures in the environment, data variability and ratio changes of active ingredients are also evaluated for hazard assessment. More accurate assessments with decreased uncertainties can be achieved by higher tier refinements in Tier‐2, such as alternative models, consideration of co‐formulants, and higher tier effect and exposure analyses. CONCLUSION: Widely accepted concepts, methodologies, and criteria should be used for aquatic risk assessment for pesticide mixtures in China. To avoid unnecessary workload and a more accurate assessment, unique perspectives such as local agricultural practice, local scenarios and a preliminary screening stage (Tier 0) should be implemented. © 2019 Society of Chemical Industry [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance spirotetramat. To assess the occurrence of spirotetramat residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, Regulation (EC) No 1107/2009 and Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States (including the supporting residue data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance ipconazole. To assess the occurrence of ipconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009 as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived for ipconazole and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. Regarding triazole derivative metabolites (TDMs), separate indicative exposure assessments were performed for triazole alanine and triazole acetic acid and no risk to consumers was identified for what regards these two metabolites individually. However, TDMs may be generated by several pesticides belonging to the group of triazole fungicides, and a comprehensive risk assessment has thus to be performed that covers all existing European uses for all pesticides belonging to the class of triazole fungicides. EFSA recommended to elaborate together with risk managers a strategy to ensure that the required data are made available to finalise the overall risk assessment for triazole fungicides. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Agan Ltd submitted a request to the competent national authority in Italy to modify the existing maximum residue level (MRL) for the active substance imazamox in soyabeans to support the intended use in Europe. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for imazamox in soyabeans according to the existing and the revised enforcement residue definition. Adequate analytical methods for enforcement are available to control the residues of imazamox and CL 263284 in plant matrices at the individual validated limit of quantification (LOQ) of 0.01 mg/kg. The calculated livestock dietary burdens indicate no need to modify the existing EU MRLs in commodities of animal origin. EFSA proposes that the risk managers consider the modification of the existing enforcement and risk assessment residue definitions according to the conclusions of the EU pesticides peer review. Based on the risk assessment results, EFSA concluded that the proposed use of imazamox on soyabeans and the imazamox residues from the authorised uses will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a risk to consumers’ health. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tefluthrin. To assess the occurrence of tefluthrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance proquinazid. To assess the occurrence of proquinazid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance ametoctradin. To assess the occurrence of ametoctradin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and/or European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metamitron. To assess the occurrence of metamitron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the import tolerances and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance diclofop. To assess the occurrence of diclofop residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and the MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

Rice-crab (Chinese mitten crab, Eriocheir sinensis) coculture system has become one of the most important agricultural activities practiced in China. However, the effect of pesticide usage on the survival and edible safety of crab species living in the coculture system has not been investigated. In the present study, we created a field simulation experiment and discovered that the amount of pesticide chlorantraniliprole (CAP) entering the rice-crab coculture system accounted for 82.22% of the total CAP content present in the spray barrel. When CAP residues found in the soil leached into nearby areas, we observed an increase in the CAP concentration in the water and sediment. Specifically, peak CAP concentration (1.35 μg/L) was detected in water within 1 day, and a steady CAP concentration in the sediment (2.55 μg/kg) was detected within 3 days. Additionally, an extensive field sampling experiment conducted in the basin of the lower reaches of the Yangtze River revealed that CAP was routinely used in rice-crab coculture systems. Although detected CAP concentrations were below 1 μg/L in ditch water and below 1 μg/kg in ditch sediment, there was still a potential risk associated with the crab growth. Importantly, there was no risk associated with crab consumption, given the low detection frequency of CAP in the collected samples. Our analysis suggests that an increase in usage ratio and a decrease in the total CAP content will likely promote safe application of CAP in the rice-crab coculture systems. • A combination of simulation and field sampling experiments were conducted. • Chlorantraniliprole was posing a risk associated with the crab growth, but no risk associated with crab consumption. • An increase in usage ratio and a decrease in the total chlorantraniliprole content was suggested. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance benalaxyl-M. To assess the occurrence of benalaxyl-M residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the European authorisations for benalaxyl-M reported by Member States (including the supporting residues data) and also the authorised uses of benalaxyl reviewed by EFSA in the past (as they may generate common residues with benalaxyl-M) and the MRLs established for benalaxyl by the Codex Alimentarius Commission. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

• Effects of predation risk and chlorpyrifos on life history and physiology were tested. • Only chlorpyrifos was lethal, yet both stressors reduced growth. • Both stressors negatively affected the bioenergetics at organismal and cellular level. • Predation risk and chlorpyrifos consistently interacted in an additive way. Ignoring natural stressors such as predation risk may contribute to the failure of ecological risk assessment of pesticides to protect freshwater biodiversity. To better understand combined effects of multiple stressors, bioenergetic responses are important as these inform about the balance between energy input and consumption, and provide a unifying mechanism to integrate the impact of multiple stressors with different modes of action. We studied in Enallagma cyathigerum damselfly larvae the single and combined effects of exposure to the pesticide chlorpyrifos and predation risk on life history (survival and growth rate) and bioenergetic response variables at the organismal level (assimilation and conversion efficiency) and the cellular level (cellular energy allocation CEA, energy storage Ea, and energy consumption Ec). Chlorpyrifos exposure almost halved the survival of the damselfly larvae, while predation risk had no effect on survival. Both exposure to the pesticide and to predation risk reduced larval growth rates. This was caused by a reduced conversion efficiency under chlorpyrifos exposure, and by a reduced assimilation efficiency under predation risk. Both chlorpyrifos and predation risk reduced the CEA because of a decreased Ea, and for chlorpyrifos also an increased Ec. The lower Ea was driven by reductions in the fat and glycogen contents. Effects of the pesticide and predation risk were consistently additive and for most variables the strongest response was detected when both stressors were present. The absence of any synergisms may be explained by the high mortality and hypometabolism caused by the pesticide. Our results indicate that CEA can be a sensitive biomarker to evaluate effects of not only contaminants but also natural stressors, such as predation risk, and their combined impact on organisms. [ABSTRACT FROM AUTHOR]

Abstract The paradigm for all toxicological bioassays in the risk assessment of pesticide registration reflects the principle that experimental conditions should be controlled to avoid any other factors that may affect the endpoint measures. As honeybee colonies can be frequently exposed to bio-aggressors in real conditions, often concomitantly with pesticides, co-exposure to pesticide/bio-aggressors is becoming a concern for regulatory authorities. We investigated the effects of the neonicotinoid insecticide thiamethoxam on the homing performances of foragers emerging from colonies differentiated by health status (infestation with Varroa destructor mites, microsporidian parasite Nosema spp. and Deformed Wing Virus). We designed a homing test that has been recently identified to fill a regulatory gap in the field evaluations of sublethal doses of pesticides before their registration. We also assessed the effect of temperature as an environmental factor. Our results showed that the Varroa mite exacerbates homing failure (HF) caused by the insecticide, whereas high temperatures reduce insecticide-induced HF. Through an analytical Effective Dose (ED) approach, predictive modeling results showed that, for instance, ED level of an uninfested colony, can be divided by 3.3 when the colony is infested by 5 Varroa mites per 100 bees and at a temperature of 24 °C. Our results suggest that the health status of honeybee colonies and climatic context should be targeted for a thorough risk assessment. Graphical abstract Image 1 Highlights • Temperature and colony health modulate insecticide-induced homing failure in honeybee. • Varroa mites exacerbate homing failure caused by the insecticide thiamethoxam. • Low temperatures aggravate insecticide-induced homing failure. • Pesticide risk assessment should include temperature and Varroa mites as covariates. [ABSTRACT FROM AUTHOR]

Abstract The extensive use of pesticides in agriculture has become a very common practice in developing countries like India. Consequently, the increased concentration of residues of these hazardous pesticides in fruits and vegetables is manifested. The study aimed to assess the health hazards associated with the presence of pesticide residues in fruits and vegetables sampled from farms and markets of Kinnaur district of Himachal Pradesh (India). Residues of predominant pesticides used in the region, belonging to the group of organophosphates, pyrethroid and phthalimide, were analysed using gas chromatograph quadrupole mass spectrometer (GC-MS/MS). The pesticide extraction from the matrix was done following the modified QuEChERS method. Results indicated varying concentrations of pesticide residue in market and farm samples with farm samples more contaminated than market samples. Chronic health hazards prediction indicated that organophosphorus groups (methyl parathion and triazophos) posed health risk to children in the study area. Graphical abstract Image 1004 Highlights • Extensive use of pesticides, contaminate the food which can lead to serious health hazards. • Farm fruits and vegetables contained higher pesticide residues in comparison to market samples. • Residues of methyl parathion and triazophos in fruits and vegetables pose health risk. • Children are more vulnerable to health risk in the region. [ABSTRACT FROM AUTHOR]

Abstract We reviewed organophosphorus pesticide use in Japan between 1982 and 2016 using data from the National Institute of Environmental Studies. Organophosphorus pesticide concentrations in river water throughout Japan were taken from the literature, and risk assessments were performed for some organophosphorus pesticides based on risk quotients and hazard quotients. Assessments were performed for 20 common pesticides, including insecticides, fungicides, and herbicides. The amounts used decreased in the order: insecticides > herbicides > fungicides. Organophosphorus insecticide and fungicide use have decreased over the last four decades, but organophosphorus herbicide use has increased. During this period, annual organophosphorus pesticide use was the highest for chlorpyrifos (105,263 tons/year) and the lowest for glyphosate-sodium (8 tons/year). The ecotoxicological risk assessment indicated that diazinon and fenitrothion posed strong risks to the Japanese aquatic environment, and chlorpyrifos and malathion have moderate risks. None of the pesticides that were assessed posed significant risks to humans. Continued use of organophosphorus pesticides in Japan may cause strong risks to aquatic environments. These risks should be reassessed periodically. Graphical abstract Unlabelled Image [ABSTRACT FROM AUTHOR]

There is increasing concern that climate change may make organisms more sensitive to chemical pollution. Many pesticides are indeed more toxic at higher mean temperatures. Yet, we know next to nothing about the effect of another key component of climate change, the increase of daily temperature fluctuations (DTFs), on pesticide toxicity. Therefore, we tested the effect of the pesticide chlorpyrifos under different levels of DTF (constant = 0 °C, low = 5 °C (current maximum level) and high = 10 °C (predicted maximum level under global warming)) around the same mean temperature on key life history and physiological traits of Ischnura elegans damselfly larvae in a common-garden experiment. At all levels of DTF, chlorpyrifos exposure was stressful: it reduced energy storage (fat content) and the activity of its target enzyme acetylcholinesterase, while it increased the activity of the detoxification enzyme cytochrome P450 monooxygenase. Notably, chlorpyrifos did not cause mortality or reduced growth rate at the constant temperature (0 °C DTF), yet increased mortality 6x and reduced growth rate with ca. 115% in the presence of DTF. This indicates that daily short-term exposures to higher temperatures can increase pesticide toxicity. Our data suggest that when 5 °C DTF will become more common in the studied high-latitude populations, this will increase the toxicity of CPF, and that a further increase from 5° DTF to 10 °C DTF may not result in a further increase of pesticide toxicity. Our results highlight the biological importance of including daily temperature fluctuations in ecological risk assessment of pesticides and as an extra dimension in the climate-induced toxicant sensitivity concept. Image 1 • Daily temperature fluctuations (DTFs) increased chlorpyrifos toxicity. • Chlorpyrifos only induced mortality and reduced growth rate in the presence of DTFs. • Chlorpyrifos did not affect life history when the temperature was kept constant. • Current and future DTF increased toxicity to the same extent. Chlorpyrifos only induced mortality and reduced growth rate in the presence of daily temperature fluctuations and not when the temperature was kept constant. [ABSTRACT FROM AUTHOR]

A database of 1480 chemicals with 47 associated modes of action compiled from the literature encompasses a wide range of chemical classes (alkanes, polycyclic aromatic hydrocarbons, pesticides, and polar compounds) and includes toxicity data for 79 different aquatic genera. The data were split into a calibration group and a validation group (80/20) to apply k‐nearest neighbors (k‐NN) methodology to predict the toxic mode of action for the compound. Other approaches were tested (support vector machines and linear discriminant analysis) as well as variations in the k‐NN technique (distance weighting, feature weighting). Best‐prediction results were found with k = 3, in a voting platform with optimized feature weighting. Using the predicted mode of action, the appropriate polyparameter target site model for that mode of action is applied to calculate the 50% lethal concentration (LC50). Predicted LC50s for the validation database resulted in a root‐mean squared error (RMSE) of 0.752. This can be compared to an RMSE of 0.655 for the same validation set using the reference mode of action labels. The complete database resulted in an RMSE of 0.793 for reference mode of action labels. This confirms that the classification model has sufficient accuracy for predicting the mode of action and for determining toxicity using the target site model. Environ Toxicol Chem 2019;38:375–386. © 2018 SETAC [ABSTRACT FROM AUTHOR]