Commodity risk assessment of bonsai plants from China consisting of Pinus parviflora grafted on Pinus thunbergii

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver a scientific opinion on the risk posed by bonsai plants from China consisting of Pinus parviflora grafted on Pinus thunbergii taking into account the available scientific information, including the technical information provided by China. All pests associated with P. parviflora and/or P. thunbergii were evaluated against specific criteria for their relevance for this Scientific Opinion. Forty-three pests that fulfilled all relevant criteria were selected for further evaluation. For 24 pests that are not quarantine in the EU, the risk mitigation measures described in the technical dossier from China were evaluated taking into account the possible limiting factors. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. While the estimated degree of pest freedom varied among pests, Setoptus parviflorae was the pest most frequently expected on the commodity. The Expert Knowledge Elicitation indicated, with 95% certainty, that 9,114 or more bonsai plants per 10,000 will be free from Setoptus parviflorae. For 19 pests that are quarantine in the EU, the implementation of specific measures defined in point 30 and 31 of Annex VII of Commission Implementing Regulation (EU) 2019/2072 was evaluated. The requirements of point 31 are met, whereas those of point 30 are not completely fulfilled

Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients

Background Patients with acute medical illnesses are at prolonged risk for venous thrombosis. However, the appropriate duration of thromboprophylaxis remains unknown. Methods Patients who were hospitalized for acute medical illnesses were randomly assigned to receive subcutaneous enoxaparin (at a dose of 40 mg once daily) for 10±4 days plus oral betrixaban placebo for 35 to 42 days or subcutaneous enoxaparin placebo for 10±4 days plus oral betrixaban (at a dose of 80 mg once daily) for 35 to 42 days. We performed sequential analyses in three prespecified, progressively inclusive cohorts: patients with an elevated d-dimer level (cohort 1), patients with an elevated d-dimer level or an age of at least 75 years (cohort 2), and all the enrolled patients (overall population cohort). The statistical analysis plan specified that if the between-group difference in any analysis in this sequence was not significant, the other analyses would be considered exploratory. The primary efficacy outcome was a composite of asymptomatic proximal deep-vein thrombosis and symptomatic venous thromboembolism. The principal safety outcome was major bleeding. Results A total of 7513 patients underwent randomization. In cohort 1, the primary efficacy outcome occurred in 6.9% of patients receiving betrixaban and 8.5% receiving enoxaparin (relative risk in the betrixaban group, 0.81; 95% confidence interval [CI], 0.65 to 1.00; P=0.054). The rates were 5.6% and 7.1%, respectively (relative risk, 0.80; 95% CI, 0.66 to 0.98; P=0.03) in cohort 2 and 5.3% and 7.0% (relative risk, 0.76; 95% CI, 0.63 to 0.92; P=0.006) in the overall population. (The last two analyses were considered to be exploratory owing to the result in cohort 1.) In the overall population, major bleeding occurred in 0.7% of the betrixaban group and 0.6% of the enoxaparin group (relative risk, 1.19; 95% CI, 0.67 to 2.12; P=0.55). Conclusions Among acutely ill medical patients with an elevated d-dimer level, there was no significant difference between extended-duration betrixaban and a standard regimen of enoxaparin in the prespecified primary efficacy outcome. However, prespecified exploratory analyses provided evidence suggesting a benefit for betrixaban in the two larger cohorts. (Funded by Portola Pharmaceuticals; APEX ClinicalTrials.gov number, NCT01583218. opens in new tab.

Commodity risk assessment of Acer palmatum plants from the UK

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by plants of Acer palmatum imported from the United Kingdom (UK) as: (a) 1- to 2-year-old bare root plants for planting and (b) 1- to 7-year-old plants in pots, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Six EU quarantine pests and four pests not regulated in the EU fulfilled all relevant criteria and were selected for further evaluation. For these pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For the selected pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Meloidogyne mali or M. fallax being the pest most frequently expected on the imported plants. The expert knowledge elicitation indicated with 95% certainty that 9,792 or more plants in pots per 10,000 will be free from Meloidogyne mali or M. fallax

Commodity risk assessment of ash logs from the US treated with sulfuryl fluoride to prevent the entry of the emerald ash borer Agrilus planipennis

The European Commission submitted to the EFSA Panel on Plant Health a dossier by USDA proposing to use sulfuryl fluoride on ash log shipments to treat Agrilus planipennis for phytosanitary certification. After collecting additional evidence from USDA APHIS, external experts and literature, the Panel performed a quantitative assessment on the likelihood of pest freedom from A. planipennis, at the point of entry in the EU, of two different commodities fumigated with sulfuryl fluoride: (a) ash logs with bark; and (b) debarked ash logs. An expert judgement is given on the likelihood of pest freedom taking into consideration the measures acting on the pest, including uncertainties associated with the assessment. The likelihood of pest freedom from A. planipennis is lower for ash logs with bark compared with debarked ash logs. With 95% certainty, the Panel concludes that between 9,740 and 10,000 containers of ash logs with bark per 10,000 and between 9,989 and 10,000 containers of debarked ash logs per 10,000 will be free from A. planipennis, when fumigated with sulfuryl fluoride at the specific treatment regime proposed by the USDA APHIS

Commodity risk assessment of Quercus robur plants from the UK

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High-risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by plants of Quercus robur imported from the UK as: (a) bundles of 1- to 2-year-old whips and seedlings, (b) 1- to 7-year-old bare root plants for planting and (c) less than 1- to 15-year-old plants in pots, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests, Cronartium quercuum and Phytophthora ramorum (non-EU isolates), two protected zone quarantine pests, Cryphonectria parasitica and Thaumetopoea processionea and four pests not regulated in the EU, Coniella castaneicola, Meloidogyne mali, Phytophthora kernoviae and Trinophylum cribratum, fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures included in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with C. castaneicola being the pest most frequently expected on the imported plants. The expert knowledge elicitation indicated with 95% certainty that between 9,711 and 10,000 per 10,000 less than 1- to 15-year-old plants in pots will be free from C. castaneicola

Commodity risk assessment of Acer palmatum plants grafted on Acer davidii from China

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by 2-year-old bare rooted plants for planting of Acer palmatum grafted on rootstocks of Acer davidii imported from China to the EU, taking into account the available scientific information, including the technical information provided by China. All pests associated with the commodity were evaluated against specific criteria for their relevance for this Scientific Opinion. Twenty-two pests that fulfilled all relevant criteria were selected for further evaluation. For 20 pests, the risk mitigation measures described in the technical dossier from China were evaluated taking into account the possible limiting factors. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. While the estimated degree of pest freedom varied among pests, Lopholeucaspis japonica was the pest most frequently expected on the commodity. The Expert Knowledge Elicitation indicated, with 95% certainty, that 9,336 or more bare rooted plants per 10,000 will be free from L. japonica. For Anoplophora chinensis and Anoplophora glabripennis, the Panel considers that China applies the relevant measures as specified in Commission Implementing Decision (EU) 2012/138 and Commission Implementing Decision (EU) 2015/893

Commodity risk assessment of Ligustrum delavayanum topiary plants grafted on Ligustrum japonicum from the UK

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by evergreen 3- to 20-year-old topiary plants of Ligustrum delavayanum grafted on L. japonicum in pots imported from the UK, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this Scientific Opinion. One EU quarantine pest (Scirtothrips dorsalis), one EU protected zone quarantine pest [(Bemisia tabaci (European populations)] and two EU non-regulated pests (Diaprepes abbreviatus and Epiphyas postvittana) fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures described in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. While the estimated degree of pest freedom varied among pests, E. postvittana was the pest most frequently expected on the commodity. The Expert Knowledge Elicitation indicated, with 95% certainty, that 9,724 or more living sculptures per 10,000 would be free from E. postvittana

Commodity risk assessment of Acer pseudoplatanus plants from the UK

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by plants of Acer pseudoplatanus imported from the United Kingdom (UK) as: (a) 1- to 7-year-old bare root plants for planting, (b) 1- to 7-year-old plants in pots and (c) bundles of 1- to 2-year-old whips and seedlings, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Six EU quarantine pests and four pests not regulated in the EU fulfilled all relevant criteria and were selected for further evaluation. For these pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For the selected pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Meloidogyne mali or M. fallax being the pest most frequently expected on the imported plants. The Expert Knowledge Elicitation indicated with 95% certainty that 9,792 or more plants in pots per 10,000 will be free from Meloidogyne mali or M. fallax

Commodity risk assessment of Fagus sylvatica plants from the UK

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by plants of Fagus sylvatica imported from the United Kingdom (UK) as: (a) 1- to 7-year-old bare root plants for planting, (b) < 1- to 15-year-old plants in pots and (c) bundles of 1- to 2-year-old whips and seedlings, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. Two EU quarantine pests, Phytophthora ramorum (non-EU isolates) and Thaumetopoea processionea, and two pests not regulated in the EU, Meloidogyne mali and Phytophthora kernoviae, fulfilled all relevant criteria and were selected for further evaluation. For the selected pests, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. For these pests an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. In the assessment of risk, the age of the plants was considered, reasoning that older trees are more likely to be infested mainly due to longer exposure time and larger size. The degree of pest freedom varies among the pests evaluated, with M. mali being the pest most frequently expected on the imported plants. The expert knowledge elicitation (EKE) indicated with 95% certainty that between 9,793 and 10,000 plants in pots up to 15 years old per 10,000 will be free from M. mali