Showing papers by "Philippe Berny published in 2021"

Statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protection products (PPP).

Abstract: The European Commission asked the European Food Safety Authority (EFSA) to prepare a statement on a framework for the environmental risk assessment (ERA) of transition metals (e.g. iron and copper) used as active substances in plant protection products (PPPs). Non-degradability, essentiality and specific conditions affecting fate and behaviour as well as their toxicity are distinctive characteristics possibly not covered in current guidance for PPPs. The proposed risk assessment framework starts with a preliminary phase, in which monitoring data on transition metals in relevant environmental compartments are provided. They deliver the metal natural background and anthropogenic residue levels to be considered in the exposure calculations. A first assessment step is then performed assuming fully bioavailable residues. Should the first step fail, refined ERA can, in principle, consider bioavailability issues; however, non-equilibrium conditions need to be taken into account. Simple models that are fit for purpose should be employed in order to avoid unnecessary complexity. Exposure models and scenarios would need to be adapted to address environmental processes and parameters relevant to the fate and behaviour of transition metals in water, sediment and soils (e.g. speciation). All developments should follow current EFSA guidance documents. If refined approaches have been used in the risk assessment of PPPs containing metals, post-registration monitoring and controlled long-term studies should be conducted and assessed. Utilisation of the same transition metal in other PPPs or for other uses will lead to accumulation in environmental compartments acting as sinks. In general, it has to be considered that the prospective risk assessment of metal-containing PPPs can only cover a defined period as there are limitations in the long-term hazard assessment due to issues of non-degradability. It is therefore recommended to consider these aspects in any risk management decisions and to align the ERA with the goals of other overarching legislative frameworks.

Are severe adverse events commonly observed in dogs during cancer chemotherapy? A retrospective study on 155 dogs.

Abstract: Overall prevalence of severe adverse events (sAE) has been poorly studied in veterinary medicine and peer-reviewed studies mostly focused on a single protocol, making it difficult to have a general overview. The aim of this retrospective study was to assess the frequency and risk factors of sAE secondary to various protocols of chemotherapy in dogs. Medical records of 155 dogs receiving chemotherapy between January 2013 and December 2018 were reviewed. Adverse events (AE) were graded according to Veterinary Comparative Oncology Group-common terminology criteria for AE (VCOG-CTCAE) grading system. Statistical analyses were performed to determine whether demographic, cancer type and chemotherapy protocol were associated with development of sAE and their consequences. AE were reported at least once in 124 (80%) dogs and sAE were observed in 50 (32.3%) dogs. Among them, 23 (14.8%) had gastro-intestinal and 31 (20.0%) had myelotoxic events. sAE led to hospitalisation in 37 (23.9%) dogs, to chemotherapy arrest in 12 (7.7%) dogs and to euthanasia or death in 9 (5.8%) dogs. Haematopoietic tumours were statistically associated with a higher frequency of sAE (p = .004), gastrointestinal sAE (p = .009) and hospitalisation (p = .004). A body weight over 10 kg was associated with less haematological sAE (p < .001). The use of a multi-agent protocol was highlighted as a risk factor for sAE (p = .038) and haematological sAE (p < .001). sAE following chemotherapy and leading to hospitalisation, chemo arrest or death were relatively common. A special attention during chemotherapy follow-up should be given to small dogs and those receiving multi-agent protocol or treated for haematopoietic tumours.

Risk of Anticoagulant Rodenticide Exposure for Mammals and Birds in Parc National des Pyrénées, France

Abstract: The extensive use of anticoagulant rodenticides (ARs) to control rodent populations poses intoxication risks for wildlife: persistence of ARs in rodents can cause secondary exposure and poisoning of predators or scavengers. We investigated risk factors for wildlife exposure to ARs in the Parc National des Pyrenees (PNP), France, using a multivariable logistic regression analysis. A total of 157 liver samples were collected from carcasses of 10 mammal and three bird species found in the PNP between 2010 and 2018 and screened for presence of AR residues. First- and second-generation ARs were detected in more than 60% of red fox (Vulpes vulpes) and stone marten (Martes foina) samples and in around 40% of wild cat (Felis silvestris), European pine marten (Martes martes), American mink (Neovison vison), and Eurasian Buzzard (Buteo buteo) samples. Wildlife exposure to ARs was significantly associated with species having a regular consumption of small mammals (odds ratio [OR]: 2.5, 95% confidence interval [CI]: 1.1–5.8) being collected in the Ossau valley (OR: 2.5, 95% CI: 1.1–6.1) and between 2013 and 2015 (OR: 4.8, 95% CI: 2.0–11.7). We identified wild species that could be targeted for risk-based surveillance program for AR secondary exposure and determined high risk areas in which alternative measures should be applied for rodent control.