Data collection initiatives of the crop protection industry - A mission to improve non-dietary risk assessment in Europe.

Plant protection products (PPPs) undergo rigorous safety assessments. In Europe, non-dietary risk assessments for operators, workers, bystanders and residents are highly conservative as this area of exposure science has historically been data poor. CropLife Europe (CLE) companies have collaborated to generate new data and pool existing data to refine the approaches prescribed by the European Food Safety Authority (EFSA) guidance on non-dietary exposure (2022).

Endocrine disruption assessment in aquatic vertebrates - Identification of substance-induced thyroid-mediated effect patterns.

According to the World Health Organisation and European Commission definitions, substances shall be considered as having endocrine disrupting properties if they show adverse effects, have endocrine activity and the adverse effects are a consequence of the endocrine activity (using a weight-of-evidence approach based on biological plausibility), unless the adverse effects are not relevant to humans or non-target organisms at the (sub)population level. To date, there is no decision logic on how to establish endocrine disruption via the thyroid modality in non-mammalian vertebrates. This paper describes an evidence-based decision logic compliant with the integrated approach to testing and assessment (IATA) concept, to identify thyroid-mediated effect patterns in aquatic vertebrates using amphibians as relevant models for thyroid disruption assessment.

The influence of crop type on pesticide wash-off parameters for use in environmental fate modelling.

Background: Wash-off of plant protection products from crops is represented in current European Union (EU) surface water models and future EU soil models by a coefficient that estimates its contribution to soil loadings following rainfall. Replacing the default coefficient with experimental data requires a harmonized protocol and this research forms part of the development of such a protocol. Following a successful test of the proposed protocol on a single crop across eight laboratories, a range of crops were tested in a single laboratory to assess the impact of crop type on the results.

Occurrence of common frog (Rana temporaria) and common toad (Bufo bufo) adults and metamorphs in agricultural fields in Germany: Potential for exposure to plant protection products.

To characterize the potential for exposure of amphibian terrestrial life stages to plant protection products (PPP), we studied the occurrence and habitat use of adult and metamorph common frogs (Rana temporaria) and common toads (Bufo bufo) in an agricultural landscape in Germany. The four selected study sites were breeding ponds with approximately 80% agricultural land within a 1-km radius. Adults were monitored by radio tracking for two years, and metamorph numbers were assessed for one summer using pitfall traps alongside drift fences.

Availability of pesticide-treated seeds on the soil surface in different crops and countries: A comprehensive data set reflecting modern agronomic practice.

For plant protection products applied as seed treatments, the risk to birds and mammals possibly feeding on such treated seeds needs to be addressed in the EU, in order to register these products for commercial use. For this purpose, the European Food Safety Food Authority (EFSA) has provided guidance on how to execute such a risk assessment. The risk assessment follows a tiered approach.

Ecotoxicological soil risk assessment under the new soil exposure framework - an impact assessment.

For the European risk assessment (RA) for soil organisms exposed to plant protection products (PPPs) endpoints from ecotoxicological laboratory studies are compared with predicted environmental concentrations in soil (PEC) at first tier. A safety margin must be met; otherwise, a higher tier RA is triggered (usually soil organism field studies). A new tiered exposure modeling guidance was published by EFSA to determine PEC.

CropLife Europe Crop Development Database: An open-source, pan-European, harmonized crop development database for use in regulatory pesticide exposure modeling and risk assessment.

There is a regulatory need for crop development dates to assess current default values used within chemical exposure assessments as well as to justify refinements within risk assessments. However, a readily available pan-European crop phenology database covering key FOrum for the Co-ordination of pesticide fate models and their USe (FOCUS) crops and scenarios to meet this need is not currently available. Therefore, we describe the development of a harmonized, pan-European, CropLife Europe Crop Development Database (C2D2), that is fully aligned with this regulatory requirement utilizing efficacy trials data generated for regulatory submissions when registering plant protection products under Regulation (EU)1107/2009.

An international cross-laboratory survey on fish vitellogenin analysis: Methodological challenges and opportunities for best practice.

Vitellogenin (VTG) is a biomarker for possible endocrine activity of chemicals acting via the estrogen, androgen, or steroidogenesis pathways. VTG is assessed in standardised fish guideline studies conducted for regulatory safety assessment of chemicals. VTG data can be highly variable leading to concerns for potential equivocal, false positive and/or negative outcomes.

Engineered coumarin accumulation reduces mycotoxin-induced oxidative stress and disease susceptibility.

Coumarins can fight pathogens and are thus promising for crop protection. Their biosynthesis, however, has not yet been engineered in crops. We tailored the constitutive accumulation of coumarins in transgenic Nicotiana benthamiana, Glycine max and Arabidopsis thaliana plants, as well as in Nicotiana tabacum BY-2 suspension cells.

EPPO ontology: a semantic-driven approach for plant and pest codes representation.

The agricultural industry and regulatory organizations define strategies and build tools and products for plant protection against pests. To identify different plants and their related pests and avoid inconsistencies between such organizations, an agreed and shared classification is necessary. In this regard, the European and Mediterranean Plant Protection Organization (EPPO) has been working on defining and maintaining a harmonized coding system (EPPO codes).

Decline of pesticide residue on treated crop seeds: An analysis of comprehensive industry data and implications of the current risk assessment scheme for plant protection products.

For plant protection products applied as seed treatments, the risk to birds and mammals possibly feeding on treated seeds must be addressed in the EU to register products for commercial use. One assumption of the Tier 1 long-term risk assessment of the European Food Safety Authority (EFSA) is that residues of pesticides on treated seeds do not decline over time after seeding. Consequently, a time-weighted average factor (f ) of 1 (i.

Standing genetic variation fuels rapid evolution of herbicide resistance in blackgrass.

Repeated herbicide applications in agricultural fields exert strong selection on weeds such as blackgrass (), which is a major threat for temperate climate cereal crops. This inadvertent selection pressure provides an opportunity for investigating the underlying genetic mechanisms and evolutionary processes of rapid adaptation, which can occur both through mutations in the direct targets of herbicides and through changes in other, often metabolic, pathways, known as non-target-site resistance. How much target-site resistance (TSR) relies on de novo mutations vs.

Development of a soil exposure assessment for plant protection products in Brazil: Requirements, options, and recommendations.

The Brazilian Environmental Authority (IBAMA) has recently identified soil organisms as a priority area for risk assessment development for plant protection products. This includes consideration of which species in soil fauna are important to be tested for risk assessment purposes, which ecotoxicological tests should be used, and which exposure models would be suitable, considering Brazilian soils, local agricultural practices, and local biodiversity. In this brief communication, we present proposals and recommendations for the selection of appropriate regulatory exposure assessment techniques to support initial or foundation tier assessment.

Involvement of glutamine synthetase 2 (GS2) amplification and overexpression in Amaranthus palmeri resistance to glufosinate.

Amplification and overexpression of the target site glutamine synthetase, specifically the plastid-located isoform, confers resistance to glufosinate in Amaranthus palmeri. This mechanism is novel among glufosinate-resistant weeds. Amaranthus palmeri has recently evolved resistance to glufosinate herbicide.

Predicted Dermal and Dietary Exposure of Bats to Pesticides.

Wild birds and mammals that feed in agricultural habitats are potentially exposed to pesticides through various routes. The European Food Safety Authority (EFSA) recently published a statement which concluded that the current EFSA risk assessment scheme for birds and mammals does not adequately cover bats (Chiroptera). In the present study, we take a more detailed look at the EFSA statement and assumptions made regarding direct (dermal) and indirect (dietary) exposure of bats to pesticides in terms of their realism and the potential implications for risk assessment outcomes.

Microencapsulation of High-Content Actives Using Biodegradable Silk Materials.

There is a compelling need across several industries to substitute non-degradable, intentionally added microplastics with biodegradable alternatives. Nonetheless, stringent performance criteria in actives' controlled release and manufacturing at scale of emerging materials hinder the replacement of polymers used for microplastics fabrication with circular ones. Here, the authors demonstrate that active microencapsulation in a structural protein such as silk fibroin can be achieved by modulating protein protonation and chain relaxation at the point of material assembly.

Are standard aquatic test species and methods adequate surrogates for use in environmental risk assessment of pesticides in tropical environments?

In regulatory risk assessment, surrogate species of fish, aquatic invertebrates, and primary producers are tested to assess toxicity and subsequently the risk of pesticides to freshwater biota. This study evaluates whether the standard, surrogate test species (mostly temperate in latitudinal distribution) used in many parts of the world are suitable surrogates for first-tier risk assessments involving tropical freshwater biota. Data for the toxicity of pesticides to tropical fish, invertebrates, and primary producer species were extracted from the USEPA ECOTOX database and peer-reviewed literature.

Disclosure of salicylic acid and jasmonic acid-responsive genes provides a molecular tool for deciphering stress responses in soybean.

Hormones orchestrate the physiology of organisms. Measuring the activity of defense hormone-responsive genes can help understanding immune signaling and facilitate breeding for plant health. However, different from model species like Arabidopsis, genes that respond to defense hormones salicylic acid (SA) and jasmonic acid (JA) have not been disclosed in the soybean crop.

Investigating endocrine-disrupting properties of chemicals in fish and amphibians: Opportunities to apply the 3Rs.

Many regulations are beginning to explicitly require investigation of a chemical's endocrine-disrupting properties as a part of the safety assessment process for substances already on or about to be placed on the market. Different jurisdictions are applying distinct approaches. However, all share a common theme requiring testing for endocrine activity and adverse effects, typically involving in vitro and in vivo assays on selected endocrine pathways.

The Extended Amphibian Metamorphosis Assay: A Thyroid-Specific and Less Animal-Intensive Alternative to the Larval Amphibian Growth and Development Assay.

The amphibian metamorphosis assay (AMA; US Environmental Protection Agency [USEPA] test guideline 890.1100 and Organisation for Economic Co-Operation and Development test guideline 231) has been used for more than a decade to assess the potential thyroid-mediated endocrine activity of chemicals. In 2013, in the context of the Endocrine Disruptor Screening Program of the USEPA, a Scientific Advisory Panel reviewed the results from 18 studies and recommended changes to the AMA test guideline, including a modification to a fixed-stage design rather than a fixed-time (i.

Key considerations to inform operational EU-specific protection goals: An example for non-target terrestrial plants.

This paper complements recent considerations of specific protection goals (SPG) to inform risk assessments for non-target terrestrial plants (NTTP) in the European Union. The SPG options in-field appear to be of the most disruptive potential from agronomic perspective and are therefore investigated in more detail. Overarching prerequisites have been identified that need to be accounted for to ensure that any of the potential SPG options remain operational in a sustainable agricultural context.

Rust expression browser: an open source database for simultaneous analysis of host and pathogen gene expression profiles with expVIP.

Background: Transcriptomics is being increasingly applied to generate new insight into the interactions between plants and their pathogens. For the wheat yellow (stripe) rust pathogen (Puccinia striiformis f. sp.

A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals.

Currently the only methods for non-genotoxic carcinogenic hazard assessment accepted by most regulatory authorities are lifetime carcinogenicity studies. However, these involve the use of large numbers of animals and the relevance of their predictive power and results has been scientifically challenged. With increased availability of innovative test methods and enhanced understanding of carcinogenic processes, it is believed that tumour formation can now be better predicted using mechanistic information.

Residue Levels of Pesticides on Fruits for Use in Wildlife Risk Assessments.

The guidance document on risk assessment for birds and mammals (GD) provides generic residue values of pesticides on potential diet items for use in wildlife risk assessments. For most diet items, these values are based on a large number of residue studies. However, the default residues per unit dose (RUD; standardized for application of 1 kg substance per hectare) values for fruits were taken from a few literature trials of unclear relevance for regulatory purposes.