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Jean Lachaine,1,2 Jean-Nicolas Charron,2 Jean C Gregoire,3 Robert A Hegele,4 Lawrence A Leiter5 1University of Montreal, Montreal, QC, Canada; 2PeriPharm Inc., Montreal, QC, Canada; 3Institut de cardiologie de Montréal, Montreal, QC, Canada; 4Robarts Research Institute, London, ON, Canada; 5Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, Toronto, ON, CanadaCorrespondence: Jean Lachaine, Faculty of Pharmacy University of Montreal, 2900 Edouard-Montpetit Blvd, Montreal, Quebec, H3T 1J4, Canada, Email jean.lachaine@umontreal.caBackground: Despite the use of statins, many patients with cardiovascular disease (CVD) have persistent residual risk. In a large Phase III trial (REDUCE-IT), icosapent ethyl (IPE) was shown to reduce the first occurrence of the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina.Methods: We conducted a cost-utility analysis comparing IPE to placebo in statin-treated patients with elevated triglycerides, from a publicly funded, Canadian healthcare payer perspective, using a time-dependent Markov transition model over a 20-year time horizon. We obtained efficacy and safety data from REDUCE-IT, and costs and utilities from provincial formularies and databases, manufacturer sources, and Canadian literature sources.Results: In the probabilistic base-case analysis, IPE was associated with an incremental cost of $12,523 and an estimated 0.29 more quality-adjusted life years (QALYs), corresponding to an incremental cost-effectiveness ratio (ICER) of $42,797/QALY gained. At a willingness-to-pay of $50,000 and $100,000/QALY gained, there is a probability of 70.4% and 98.8%, respectively, that IPE is a cost-effective strategy over placebo. The deterministic model yielded similar results. In the deterministic sensitivity analyses, the ICER varied between $31,823-$70,427/QALY gained. Scenario analyses revealed that extending the timeframe of the model to a lifetime horizon resulted in an ICER of $32,925/QALY gained.Conclusion: IPE represents an important new treatment for the reduction of ischemic CV events in statin-treated patients with elevated triglycerides. Based on the clinical trial evidence, we found that IPE could be a cost-effective strategy for treating these patients in Canada.Keywords: cardiovascular diseases, icosapent ethyl, IPE, cost-effectiveness, cost per QALY

The EFSA Panel on Plant Health performed a group pest categorisation for the EU territory of non-EU Scolytinae (Coleoptera: Curculionidae) on non-coniferous hosts, which total 6495 known species. Most species attack apparently healthy, weakened or dead trees, either feeding on the phloem ('bark beetles' subgroup) or on fungi inoculated into the sapwood ('ambrosia beetles' subgroup). Smaller subgroups feed and reproduce in seeds and fruits, or in herbaceous plants. Some species are polygynous, the males initiate a gallery or a chamber on or in a new host and attract females. Others are monogamous, and the females initiate the new galleries. Many species respond to primary volatile attractants emitted by the hosts, and some produce aggregation pheromones that attract conspecifics of both sexes. The species attacking living hosts are often associated with fungi that contribute to weakening the host defences and provide nutrients to the insects. Some are inbreeding; the males in the offspring mate with their sisters and rarely leave their natal tree. The larvae of all species develop and pupate within their hosts. Based on catalogues and other published data, a database was constructed providing information on hosts, feeding and reproductive habits, geographic distribution and the Köppen-Geiger climate types in countries where species occur. The Scolytinae were screened to exclude species in the following categories: (i) 708 species attacking conifers; (ii) 127 species present in at least four EU Member States and (iii) 440 species occurring in areas with climatic conditions not occurring in the EU. Among the remaining 5220 species, 88 species known for their mobility, occupying at least two landmasses separated by geographical barriers and some of which had impact levels documented in literature, were extracted. They were grouped into four subcategories: (i) 12 species with high impact on plant health; (ii) 16 species with low or doubtful impact; (iii) 48 species with no impact; (iv) 12 species with no impact and which had never been recorded as 'introduced' in the consulted catalogues but occurring on at least two landmasses. All 88 species could enter the EU with wood or wood products, or with plants for planting, and could establish because host plants are available, and climate is suitable in parts of the EU. Control measures to inhibit introduction are available. There is considerable uncertainty regarding the potential impact of many species. Methods for the reliable identification of many species are lacking. For some species of non-EU Scolytinae on non-coniferous hosts, all criteria assessed by EFSA for consideration as potential quarantine pest are met. Nevertheless, the Panel was not able to develop a method to discriminate confidently between species that clearly meet the criteria for potential quarantine pest status and those that do not., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Matsucoccus matsumurae (Hemiptera: Matsucoccidae), the Massonian pine bast scale, for the EU territory. This pest categorisation was initiated following the commodity risk assessment of artificially dwarfed plants from China consisting of Pinus parviflora (Japanese white pine) grafted on P. thunbergii (Japanese black pine) performed by EFSA, in which M. matsumurae was identified as a pest of possible concern. However, its identity is not firmly established due to uncertainty regarding its taxonomic relationship with Matsucoccus pini (Green), a species widespread in Europe. M . matsumurae occurs in western China and has been reported as a pest of P. massoniana (Chinese red pine) and P. thunbergii . These hosts occur in the EU as ornamental/amenity trees. Other scales in the Matsucoccus genus feed on a variety of Pinus species and the host range of M . matsumurae could be wider than is currently recorded. The scale has one or two generations per year. All stages occur on the branches and stems of hosts with developing nymphs and adult females feeding through the bark on host phloem vessels. Symptoms include the yellowing/browning of host needles, early needle drop, desiccation of shoots and bark necrosis. The most serious infestations occur in hosts that are 8-25 years old and there can be some host mortality. In principle, host plants for planting and plant products such as cut branches and wood with bark could provide entry pathways into the EU. However, prohibitions on the import of Pinus from non-European third countries regulate these pathways. In China, M . matsumurae occurs in regions with temperate humid conditions and hot summers. These conditions are also found in parts of southern EU. Were M . matsumurae to establish in the EU, it is conceivable that it could expand its host range; however, this remains uncertain. Some uncertainty exists over the magnitude of potential impacts. M. matsumurae satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest, assuming M. pini is not a synonym, which is a key uncertainty., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

This study investigated the efficacy of various traps differing in colour (green or yellow), presence or absence of decoys (dead Agrilus planipennis) or design (commercial MULTz or multifunnel traps, and homemade bottle- or fan-traps) for monitoring European Buprestidae in deciduous forests and pear orchards. Over two years, we collected 2220 samples on a two-week basis from 382 traps across 46 sites in Belgium and France. None of the traps proved effective for monitoring Agrilus sinuatus in infested pear orchards (17 specimens captured in 2021, 0 in 2022). The decoys did not affect the catch rates whatever the trap model, colour, buprestid species or sex. The fluorescent yellow traps (MULTz and yellow fan-traps) tended to be more attractive than the green traps (green fan-traps and, to a lower extent, multifunnel green traps). Most Agrilus species showed similar patterns in mean trap catches, with the exception of Agrilus biguttatus, which had the largest catches in the green multifunnel traps. Finally, we observed a high variation in catch rates between localities: the site explained 64% of the catches variance, while the tree within the site and the type of trap explained only 6-8.5% each. In many sites, we captured very few specimens, despite the abundance of dying mature trees favourable to the development of Buprestidae. For the early detection of non-native Buprestidae, it therefore seems essential to maximise the number of monitoring sites. Due to their cost-effectiveness, lightweight design, and modularity, fan-traps emerged as promising tools for buprestid monitoring. The study's findings extend beyond European fauna, as a preliminary trial in Canada suggested that yellow fan-traps could also improve captures of non-European buprestid species and catch species of interest such as Agrilus bilineatus (a species on the EPPO A2 list of pests/pathogens recommended for regulation in the EU)., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Kuhn et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The EFSA Panel on Plant Health performed a pest categorisation of Monema flavescens (Lepidoptera, Limacodidae), following the commodity risk assessment of Acer palmatum plants grafted on A. davidii from China, in which M. flavescens was identified as a pest of possible concern to the European Union. This species can be identified by morphological taxonomic keys and by barcoding. The adults of the overwintering generation emerge from late June to late August. The eggs are laid in groups on the underside of the host-plant leaves, on which the larvae feed throughout their six to eight larval instars. Pupation occurs in ovoid cocoons at the junction between twigs and branches, or on the trunk. Overwintering occurs as fully grown larvae or prepupae in their cocoon. There are one or two generations per year. M. flavescens is polyphagous and feeds on broadleaves; it has been reported on 51 plant species belonging to 24 families. It mainly occurs in Asia (Bhutan, China, the Democratic People's Republic of Korea, Japan, Nepal, the Republic of Korea), Russia (Eastern Siberia) and Taiwan. It is also present in the USA (Massachusetts). The pest's flight capacities are unknown. The main pathway for entry and spread is plants for planting with cocoons attached. This is partially closed by prohibition of some hosts. In several EU member states climatic conditions are conducive for establishment and many host plants are widespread. Introduction of  M. flavescens may result in defoliations influencing tree health and forest diversity. The caterpillars also have urticating spines affecting human health. Phytosanitary measures are available to reduce the likelihood of entry, establishment and spread, and there is a definite potential for classical biological control. Recognising that natural enemies prevent M. flavescens being regarded as a pest in Asia, there is uncertainty regarding the magnitude of potential impact in EU depending on the influence of natural enemies. All criteria assessed by EFSA for consideration as a potential quarantine pest are met., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The European Commission requested the EFSA Panel on Plant Health to conduct a pest categorisation of Ceroplastes rubens Maskell (Hemiptera: Coccidae), following the commodity risk assessments of Acer palmatum plants grafted on A. davidii and Pinus parviflora bonsai plants grafted on P. thunbergii from China, in which C. rubens was identified as a pest of possible concern to the European Union (EU). The pest, which is commonly known as the pink, red or ruby wax scale, originates in Africa and is highly polyphagous attacking plants from more than 193 genera in 84 families. It has been present in Germany since 2010 in a single tropical glasshouse. It is known to attack primarily tropical and subtropical plants, but also other host plants commonly found in the EU, such as Malus sylvestris , Prunus spp., Pyrus spp. and ornamentals. It is considered an important pest of Citrus spp. The pink wax scale reproduces mainly parthenogenetically, and it has one or two generations per year. Fecundity ranges from 5 to 1178 eggs. Crawlers settle usually on young twigs and later stages are sessile. All life stages of C. rubens egest honeydew on which sooty mould grows. Host availability and climate suitability suggest that parts of the EU would be suitable for establishment. Plants for planting and cut branches provide the main pathways for entry. Crawlers could spread over short distances naturally through wind, animals, humans or machinery. C. rubens could be dispersed more rapidly and over long distances via infested plants for planting for trade. The introduction of C. rubens into the EU could lead to outbreaks causing damage to orchards, amenity ornamental trees and shrubs. Phytosanitary measures are available to inhibit the entry and spread of this species. C. rubens satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Popillia quadriguttata (Coleoptera: Scarabaeidae), following a commodity risk assessment of bonsai Pinus parviflora grafted onto P. thunbergii from China, in which P. quadriguttata was identified as a pest of possible concern for the territory of the European Union. This is a univoltine polyphagous pest that occurs in eastern Asia from Vietnam northwards through eastern China and Taiwan, South Korea and into Far East Russia. Hosts include species of fruit trees within the genera Malus and Prunus , trees of forestry and environmental importance such as Quercus and Ulmus , shrubs such as Wisteria , soft fruit such as Rubus , grasses, including amenity turf and field crops such as potatoes, maize and soybean. Adults feed on host leaves, tender stems, flower buds, flowers and fruits; larvae feed on host roots. In northern China P. quadriguttata is a major pest of soybean; in South Korea, P. quadriguttata is one of the most serious insect pests of golf course turf. P. quadriguttata could enter the EU on various pathways including infested soil and growing media accompanying host plants for planning. Biotic factors (host availability) and abiotic factors (climate suitability) suggest that large parts of the EU would be suitable for establishment. Local spread would be mainly via natural dispersal of adults. Long distance spread would be facilitated by the movement of eggs, larvae and pupae infesting soil especially with plants for planting; adults could spread on plants for planting without soil. Economic and or environmental impacts would be expected on a range of plants if P. quadriguttata were to establish in the EU. Phytosanitary measures are available to reduce the likelihood of its introduction. P. quadriguttata satisfies all of the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Cenopalpus irani (Trombidiformes: Tenuipalpidae), known as the Iranian false spider mite, following the commodity risk assessment of Malus domestica plants from Türkiye, in which C. irani was identified as a pest of possible concern for the territory of the European Union (EU). The pest is only known to be present in Iran and Türkiye and has not been reported from the EU. The mite primarily feeds on Rosaceae plants but is considered polyphagous. Important crops of the EU that are hosts of C. irani include apples ( Malus domestica ), pears ( Pyrus communis ) and figs ( Ficus carica ). Plants for planting and fruits provide potential pathways for entry into the EU. Host availability and climate suitability in southern EU countries would most probably allow this species to successfully establish and spread. This mite is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. Phytosanitary measures are available to reduce the likelihood of entry and spread of this species into the EU. The mite C. irani satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest, although there is a key uncertainty over the likelihood and magnitude of impact., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Diaphania indica (Lepidoptera: Crambidae), the cucumber moth for the territory of the European Union (EU), following the commodity risk assessment of Jasminum polyanthum from Uganda, in which D. indica was identified as a pest of possible concern to the European Union. D. indica is native to South Asian countries and is now distributed in tropical and subtropical areas of the Americas, Africa, Asia and Oceania. In the EU, D. indica occurs in Madeira (Portugal). It is a polyphagous pest, feeding on 16 genera in 6 plant families, primarily on plants of the Cucurbitaceae family. Important cucurbit hosts in the EU include cucumber ( Cucumis sativus ), melon ( Cucumis melo ), pumpkin ( Cucurbita moschata ), summer squash ( Cucurbita pepo ) and watermelon ( Citrullus lanatus ). Plants for planting, fruits and cut flowers provide potential pathways for entry into the EU. Climatic conditions and availability of host plants in southern EU countries would most probably allow this species to successfully establish and spread. Establishment could also occur in greenhouses in the northern parts of the EU. Economic impact in cultivated hosts, especially cucurbit crops is anticipated if establishment occurs. This insect is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. Phytosanitary measures are available to reduce the likelihood of entry and further spread . D. indica meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Bailey's rust mite, Calepitrimerus baileyi Keifer (Acariformes: Eriophyidae), following the commodity risk assessment of Malus domestica plants from Türkiye performed by EFSA, in which C. baileyi was identified as a pest of possible concern to the European Union. This mite is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. The eriophyid is known to occur in Africa, America, Asia, Europe (Greece and Serbia) and Oceania on Malus spp., which is the only confirmed host genus for C. baileyi . Plants for planting of Malus spp. are the main potential pathway for entry into the EU. However, plants for planting of the genus Malus Mill. are considered as high-risk plants (EU 2018/2019) and therefore prohibited from entering the EU unless granted a country-specific derogation. This is the case for the import of Malus spp. plants for planting from Serbia ((EU) 2020/1361 corrected by 2022/1309). Therefore, this derogation could provide a plausible entry pathway for C. baileyi into the EU. Climatic conditions and the ample availability of the host, Malus spp., in the EU are conducive for establishment, as proven by the occurrence of C. baileyi in Greece. However, the species is not reported as having an impact in Greece, despite reports of damage outside the EU. Measures to prevent further entry and spread of C. baileyi in the EU are available. C. baileyi satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. However, uncertainties about the distribution of C. baileyi within the EU and its impact on apples in the EU are considered key and affect the confidence of conclusions for this categorisation., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Shirahoshizo patruelis (Voss, 1937) (Coleoptera: Curculionidae), following the commodity risk assessment of bonsai plants from China consisting of Pinus parviflora grafted on P. thunbergii , in which S. patruelis was identified as a pest of possible concern to the European Union (EU). This categorisation refers to S. flavonotatus , which is the pest's current valid scientific name. It is native to China and has never been recorded in the EU. It completes from 2 to 3 generations per year. Eggs are laid in cracks and crevices of trunks and branches with bark thickness of approximately 0.6-1.2 cm. The pest overwinters as an adult or as a mature larva under the bark. Plants for planting, wood with bark and wood products provide pathways for entry. Although the weevil has been reported to carry the nematode Bursaphelenchus xylophilus, it is not considered a vector. Climatic conditions and availability of host plants in some EU countries would allow S. flavonotatus to establish and spread. Impact on Pinus spp. is anticipated. Recognising that the weevil is reported to attack both weakened and healthy trees, there is uncertainty on the magnitude of impact. Its recorded capacity to attack non-Asian Pinus species also indicates its ability to adapt and expand the range of trees it can utilise as hosts, which could include European Pinus species. Phytosanitary measures are available to reduce the likelihood of entry and spread. S. flavonotatus meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following the commodity risk assessments of Acer palmatum plants grafted on A. davidii from China, in which Crisicoccus matsumotoi (Hemiptera: Pseudococcidae) was identified as a pest of possible concern, the European Commission requested the EFSA Panel on Plant Health to conduct a pest categorisation of C. matsumotoi for the territory of the European Union. Recent taxonomic revision of the genus Crisisoccus concluded that C. matsumotoi is a synonym of C. seruratus ; therefore, the categorisation will use the current valid name C. seruratus . It is an insect pest native to Japan, feeding on species in 13 plant families. There are reports of its presence also in China and the Republic of Korea, but there is great uncertainty about the identity of the species for these records. Therefore, there is uncertainty about the species referred to as C. matsumotoi in the commodity risk assessments of A. palmatum. C. seruratus is a multivoltine species. It has three generations per year and overwinters as a nymph. The most important crops that may be affected by C. seruratus are figs ( Ficus carica ), grapes ( Vitis spp.), nashi pears ( Pyrus pyrifolia var. culta ), persimmons ( Diospyros kaki ) and walnuts ( Juglans regia ). Plants for planting and fruits provide potential pathways for entry into the EU. Host availability and climate suitability suggest that the central, northern and some areas of southern EU countries would be suitable for the establishment of C. seruratus . The introduction of this mealybug would likely have an economic impact in the EU through yield reduction and fruit downgrading because of honeydew deposition and the consequent growth of sooty moulds. This insect is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. Phytosanitary measures are available to reduce the likelihood of entry and spread of this species into the EU. C. seruratus satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Eulecanium giganteum (Hemiptera: Coccidae), the giant eulecanium scale, for the territory of the European Union, following the commodity risk assessment of Acer palmatum plants from China, in which E. giganteum came to attention as a pest of possible concern. The pest is only known to be present in Asia, where it has been reported from China, India, Iran, Japan and eastern Russia (Primorsky Krai). The pest has not been reported within the EU. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is polyphagous, feeding on broad-leaf trees and shrubs assigned to 41 genera in 22 plant families. Host plant species commonly found in the EU include apricot ( Prunus armeniaca ), elm ( Ulmus spp.), grapevine ( Vitis vinifera ), maple ( Acer spp.), oak ( Quercus spp.), oriental plane ( Platanus orientalis ), pomegranate ( Punica granatum ), quince ( Cydonia oblonga ), silkworm mulberry ( Morus alba ), walnut ( Juglans regia ), and several ornamentals. Climatic conditions and availability of host plants in southern EU countries would most probably allow this species to successfully establish and spread. However, EU native natural enemies are anticipated to provide biological control and therefore reduce potential impacts. Phytosanitary measures are available to reduce the likelihood of entry and spread. E. giganteum satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest, other than the criterion on impact which is a key uncertainty., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Lepidosaphes malicola (Hemiptera: Diaspididae), the Armenian mussel scale, for the territory of the European Union, following commodity risk assessments of Prunus persica and P. dulcis plants for planting from Türkiye, in which L. malicola was identified as a pest of possible concern. L. malicola is a polyphagous insect of temperate and arid areas, feeding on more than 60 plant species belonging to 26 families. Important crops significantly affected by L. malicola in parts of Asia include stone fruits ( Prunus armeniaca , P. persica ), pome fruits ( Malus domestica , Pyrus communis ), grapes ( Vitis vinifera ), pomegranate ( Punica granatum ), walnuts ( Juglans regia ) and ornamental plants ( Berberis spp. , Cornus spp. , Jasminum spp. , Ligustrum spp.). L. malicola has two generations annually. The overwintered eggs hatch from late May to early June. First-instar nymphs crawl on the host plant for a short period, then settle to feed. Nymphs reach maturity in late summer or early autumn. Plants for planting, fruits and cut flowers provide potential pathways for entry into the EU. Host availability and climate suitability suggest that southern, central and some parts of northern EU countries would be suitable for the establishment of L. malicola . Despite being a pest in Armenia, Iran and Tajikistan, there is no evidence of it being a pest in Türkiye. L. malicola was detected in Bulgaria and Greece over 30 years ago, but there have been no records since, and its status is uncertain. Its ability to cause an impact in the EU is also uncertain. It is not listed in Annex II of the Commission Implementing Regulation (EU) 2019/2072. Phytosanitary measures are available to reduce the likelihood of entry. Except for the criterion of having an economic or environmental impact, for which there is great uncertainty, L. malicola satisfies all other criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The European Commission requested the EFSA Panel on Plant Health to conduct a pest categorisation of Garella musculana (Erschov) (Lepidoptera: Nolidae), following a commodity risk assessment of Juglans regia plants for planting from Türkiye, in which G. musculana was identified as a pest of possible concern to the European Union (EU). Commonly known as the Asian walnut moth, this pest is native to Central Asia and develops on shoots, buds and fruits of Juglans species such as the English walnut, J. regia and the black walnut, J. nigra . Other reported host plants, such as Prunus dulcis and Populus spp., still require confirmation. The pest was first recorded in the EU (Bulgaria) in 2016 and was then reported in Romania in 2018 and Italy in 2021. This moth completes from one to four generations per year depending on environmental conditions (from valley to mountain forests and orchards up to an altitude of 2100 m). Eggs are laid in groups of 2-3 on young nuts or on buds of 1-year-old shoots. Neonate larvae usually enter the young nut through the peduncle. After fully exploiting one nut, the larva continues feeding in another one. Development takes 25-40 days. Larvae of the autumn generation do not enter the nuts, and so feed only in the pericarp. Larvae also often feed inside 1-year-old shoots or leaf axils. Larvae develop within the host but exit to pupate under loose bark or in deep cracks of bark. The pest overwinters at the larval or pupal stages. Plants for planting, cut branches and infested nuts provide pathways for entry. Climatic conditions and availability of host plants in southern and central EU MSs have allowed this species to establish and spread in Bulgaria, Romania and Italy. Adults can fly and the pest could spread naturally within the EU. Impact on Juglans spp. cultivated for fruit, timber and ornamental purposes is anticipated. Phytosanitary measures are available to reduce the likelihood of entry and further spread of G. musculana . This species meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Dendrolimus punctatus (Lepidoptera: Lasiocampidae), following a commodity risk assessment of bonsai Pinus parviflora grafted onto P. thunbergii from China, in which D. punctatus was identified as a pest of possible concern to the European Union (EU). D. punctatus , also known as the Masson pine caterpillar, is present in China, Taiwan, Vietnam, India and has recently spread to Japanese islands close to Taiwan. Larval feeding on the needles of Pinus elliottii , P. luchuensis , P. massoniana , P. merkusii and P. tabulaeformis causes important damage. D. punctatus larvae can also feed on P . armandii , P. echinata , P. latteri , P. parviflora , P. sylvestris var. mongolica , P. taeda , P. taiwanensis and P. thunbergii , but full development on these hosts is uncertain. The pest has three to five generations per year; winter is spent as larvae on branch tips, on tree trunks and in the soil. The females lay egg clusters on pine needles. Pupation occurs in cocoons attached to branches or needles. D. punctatus could enter the EU either as eggs, larvae or pupae in the foliage of plants for planting or cut branches, as larvae on wood with bark or as overwintering larvae in branches, crevices in the bark or in the litter of potted plants. However, Annex VI of 2019/2072 prohibits the introduction of D. punctatus hosts ( Pinus spp.) from countries and areas where the pest occurs. There are climate zones where the pest occurs in Asia that also occur in the EU, though they are limited, which constitutes an uncertainty regarding establishment. The pest's main hosts are not grown in the EU. However, the fact that it attacks the North American Pinus echinata , P. elliottii and P. taeda in its Asian native area suggests a potential capacity to shift to pine species occurring in the EU territory. D. punctatus satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. Whether the Pinus commonly found in Europe could act as hosts is unknown but is fundamental, affecting the criteria of establishment and magnitude of impact., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Objective: The cardiovascular benefits of low-dose colchicine have been demonstrated in patients with coronary disease. Its effects were evaluated in this prespecified analysis in patients with type 2 diabetes (T2D) from the Colchicine Cardiovascular Outcomes Trial (COLCOT)., Research Design and Methods: COLCOT was a randomized, double-blinded trial of colchicine, 0.5 mg daily, versus placebo initiated within 30 days after a myocardial infarction., Results: There were 959 patients with T2D enrolled and monitored for a median of 22.6 months. A primary end point event occurred in 8.7% of patients in the colchicine group and in 13.1% in the placebo group (hazard ratio 0.65; 95% CI 0.44-0.96; P = 0.03). Nausea was reported in 2.7% and 0.8% in the study groups (P = 0.03), and pneumonia occurred in 2.4% and 0.4% (P = 0.008)., Conclusions: Among patients with T2D and a recent myocardial infarction, colchicine, 0.5 mg daily, leads to a large reduction of cardiovascular events. These results support the conduct of the COLCOT-T2D trial in primary prevention., (© 2024 by the American Diabetes Association.)

The EFSA Panel on Plant Health performed a pest categorisation of Malacosoma parallela (Staudinger) (Lepidoptera: Lasiocampidae) for the territory of the European Union, following commodity risk assessments of Berberis thunbergii, Malus domestica , Prunus persica and P. dulcis plants for planting from Türkiye, in which M. parallela came to attention as of possible concern. M. parallela is commonly known as the mountain ring silk moth and is a polyphagous leaf-eating pest in west-central Asia, primarily feeding on deciduous trees and shrubs, and known to cause serious damage to Malus, Prunus, and Quercus species. It is found at a range of altitudes from 130 m to 3000 m although most common above 1000 m. It is a univoltine species. Eggs are laid in masses on twigs and branches in the summer and larvae hatch the following spring to feed on buds and fresh leaves. Host plants can be completely defoliated. Plants for planting and cut branches provide pathways for entry, especially if infested with egg masses. Host availability and climate suitability suggest that parts of the EU would be suitable for establishment. Adults can fly and the pest could spread naturally within the EU although adults only live for a few days. Faster and more extensive spread is therefore more likely via egg masses moved on plants for planting. The introduction of M. parallela into the EU could lead to outbreaks causing damage to deciduous trees and shrubs in forests and orchards. Phytosanitary measures are available to inhibit the entry and spread of this species. M. parallela satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Mimela testaceipes (Coleoptera: Scarabaeidae), the striated chafer, for the EU, following a commodity risk assessment of dwarfed Pinus parviflora grafted onto P. thunbergii from China in which M. testaceipes was identified as a pest of possible concern to the EU. M. testaceipes occurs in Japan, northeast China, Far East Russia, South Korea and very likely North Korea. Adults are recognised pests feeding on and damaging the needles of Japanese cedar ( Cryptomeria japonica ), Japanese cypress ( Chamaecyparis obtusa ) and Japanese larch ( Larix leptolepis ) which are important forestry trees where the pest currently occurs. It has adapted to feed on the needles of Pinus species introduced into its native area, such as P. taeda, which is native to southeastern USA although M. testaceipes is not regarded as a significant pest of pines. Larvae are reported to cause root damage to grasses, as well as conifers. Eggs are usually laid in grassy soils by females that develop on conifer species. Larvae develop in the soil feeding on the roots of grasses or conifer hosts. Larvae overwinter in the soil and take 2 or 3 years to develop. In principle soil, host plants for planting and cut branches with foliage could provide pathways into the EU. However, prohibitions on the import of soil and hosts such as Chamaecyparis , Larix and Pinus regulate such pathways into the EU. Nevertheless, certain dwarfed Pinus spp. from Japan are provided with a derogation for entry into the EU. In addition, the host C. japonica is unregulated and could also provide a pathway. Hosts occur in the EU in climate zones that match those where M. testaceipes occurs in Asia. If M. testaceipes were to enter the EU, conditions in central and northern EU are conducive to establishment. Following establishment, impacts on Japanese cedar, Japanese cypress and Japanese larch would be expected; it is possible that M. testaceipes could adapt to feed on Pinus and Larix species growing in Europe. M. testaceipes satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Lepidosaphes pineti Borchsenius the pine oyster scale, Lepidosaphes pini (Maskell) the Oriental pine scale and Lepidosaphes piniphila Borchsenius (Hemiptera: Diaspididae) for the EU, following a commodity risk assessment of dwarfed Pinus parviflora grafted onto P. thunbergii from China in which the three Lepidosaphes species were identified as pests of possible concern to the EU. All three species are native to Asia. L. pineti is only known from China; L. piniphila occurs in China, Japan and Malaysia; and L. pini is present in China, Japan, South Korea, Taiwan, and has been introduced to the USA. All three species feed primarily on Pinus spp., including several important forestry and ornamental trees, and L. pineti and L. pini have adapted to feed on North American species of pine. L. pineti also feeds on Torreya grandis ; L. pini on Abies sp., Cunninghamia lanceolata , Cycas spp., Podocarpus spp., Taxus sp. and Torreya sp.; and L. piniphila on Podocarpus spp. and T. grandis . All developmental stages occur on the foliage. Host plants for planting and cut branches with foliage could provide pathways into the EU. However, prohibitions on the import of Pinus close the main pathway. Certain dwarfed Pinus spp. from Japan are provided with a derogation for entry into the EU. The main hosts ( Pinus spp.) occur throughout the EU in climate zones that match those where the three Lepidosaphes species occur in Asia. If any of the three Lepidosaphes species were to enter the EU, conditions in most of the EU are conducive to establishment. Following establishment, impacts on pines by L. pineti and L. pini would be expected. There are no published reports of L. piniphila causing damage to pine. L. pineti and L. pini satisfy the criteria that are within the remit of EFSA to assess for them to be regarded as potential Union quarantine pests. L. piniphila does not satisfy the criteria, as there is no evidence that it is harmful; however, there is a key uncertainty regarding whether it is synonymous with a closely related species, L. pitysophila , which is recorded as a pest of pine in China., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of the citrus root weevil Diaprepes abbreviatus (L.) (Coleoptera: Curculionidae) for the European Union (EU) following the commodity risk assessment of Ligustrum delavayanum topiary grafted on L. japonicum plants from the UK in which D. abbreviatus was identified as a relevant non-regulated EU pest which could potentially enter the EU. This species is native to the Caribbean and was introduced to the continental USA in 1964, to Gran Canaria (Spain) in 2014 and to Madeira Island (Portugal) in 2018. It is a polyphagous insect, associated with more than 270 species in 60 plant families. Female D. abbreviatus can lay up to 5,000 eggs in clusters within leaves folded and glued together. Neonate larvae drop off the leaves onto the ground and enter the soil, where they feed on roots for several months. The mature larvae pupate in the soil. After emergence, adults usually stay on the first host plant they encounter and can move long distances on nursery stock. D. abbreviatus is not a regulated pest in the EU. It could enter and spread within the EU via the import and movement of host plants for planting, cut flowers and soil. Some host plants for planting (e.g. Vitis spp., Citrus spp.), and soil are prohibited from entering the EU from countries where this weevil is known to occur. The import of other host plants for planting and cut flowers is subject to phytosanitary certificate and that of soil attached to machinery is regulated. Host availability and climate suitability suggest that the southernmost coastal areas of southern EU MSs would be suitable for establishment of D. abbreviatus . Temporary establishment in greenhouses in other EU territories would be possible. The introduction of D. abbreviatus would likely cause impacts. Measures to prevent entry, spread and impact are available. D. abbreviatus satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Pochazia shantungensis (Hemiptera: Auchenorrhyncha: Ricaniidae) for the EU following commodity risk assessments of Malus domestica , Prunus persica , P. dulcis and Robinia pseudoacacia plants for planting from Türkiye in which P. shantungensis was identified as a pest that could potentially enter the EU. The native range of P. shantungensis is China (Shaanxi, Shandong and Zhejiang provinces), but around 2010, the species entered the Republic of Korea and rapidly spread. Small and localised populations were also recently found in Türkiye (Marmara) and southern Russia (Krasnodyarskiy kray). Within the EU, a few individuals have been recorded in Italy (Pistoia province, Tuscany), in one locality in southern France (Alpes-Maritimes), in the Netherlands (Western Netherlands) and in one garden in Germany (Baden-Württemberg) where it was eradicated. P. shantungensis is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is polyphagous, feeding on plants belonging to more than 200 species including many crop and ornamental plants. Economically important hosts in the EU include apple ( M. domestica ), citrus ( Citrus spp.), walnut ( Castanea sp.) and ornamentals such as hibiscus ( Hibiscus spp.) and camellia ( Camellia japonica ), as well as forest trees, mostly deciduous. In the Republic of Korea, the species has one generation per year. It overwinters as eggs and goes through five nymphal instars. Its impact is due to oviposition obstructing the vascular system of its hosts, depletion of the host resources and egestion of honeydew promoting the development of sooty moulds. Plants for planting constitute the main pathway for entry into the EU and for spread. Climatic conditions in southern EU countries and host plant availability in those areas would allow establishment and spread. The introduction of P. shantungensis is expected to have an economic impact in the EU through the reduction in yield, quality and commercial value of fruits and ornamental plants. Phytosanitary measures are available to reduce the likelihood of entry and further spread. P. shantungensis meets the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Didesmococcus unifasciatus (Hemiptera: Sternorrhyncha: Coccidae) for the EU following commodity risk assessments of Malus domestica (apple), Prunus dulcis (almond) and P. persica (peach) plants for planting from Türkiye in which D. unifasciatus was identified as a pest that could potentially enter the EU. It was first described in Uzbekistan and is widely distributed in Central and Western Asia, including Türkiye (where it was recently reported as limited to the Hakkari and Diyarbakir regions in the Asian part of the country). It has not been reported within the EU. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It completes one generation per year; a female lays between 1,500 and 2,400 eggs. It feeds on several important fruit trees of the family Rosaceae (e.g. P. dulcis , M. domestica ), as well as Ficus carica and Ulmus sp. Most of its hosts are widely cultivated in the EU. Woody plants for planting and cut branches are the main potential pathways for entry of D. unifasciatus into the EU. Climatic conditions and availability of host plants would likely allow this species to establish and spread in southern parts of the EU. Just as in other invaded areas, the presence of many of its natural enemies in the EU is likely to prevent the scale from becoming an economic or environmental pest. Nevertheless, phytosanitary measures are available to reduce the likelihood of entry and spread. Considering the weight of evidence, D. unifasciatus does not meet all the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Plant Health Panel performed a pest categorisation of Setoptus parviflorae (Acari: Eriophyoidea: Phytoptidae) for the European Union (EU). This mite is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is known to occur in the Nanjing Botanical Garden (China) on Pinus parviflora . This is its only known host plant and location. The mite occurs on the needles and in the needle sheaths. Details about its life cycle are mostly unknown. Plants for planting, including dwarfed plants, of P. parviflora are the main potential pathway for entry into the EU. However, plants of the genus Pinus other than fruit and seeds are mostly prohibited from entering the EU (Commission Implementing Regulation (EU) 2019/2072). The host, P. parviflora , can be found in temperate-zone gardens and arboreta, and is a popular tree for bonsai in the EU. Although the Köppen-Geiger climate type Cfa (humid subtropical), which occurs in Nanjing, can be found in the EU, the growing conditions of P. parviflora at the Nanjing Botanical Garden were not reported. This adds uncertainty about where in the EU this mite could establish, most probably on ornamental P. parviflora . There is no evidence of impact of S. parviflorae . Measures to prevent entry and spread are available. S. parviflorae does not satisfy all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest, as there is no evidence of impact., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Euzophera semifuneralis (Lepidoptera: Pyralidae), the American plum borer for the EU. This insect is native to North America, reported from the United States, Canada and Mexico. Out of its native range it is only present in Türkiye. It has not been reported in the EU and is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It can complete from one up to three generations per year in its native range and is polyphagous, feeding on 22 genera in 16 plant families. Host plant species commonly found in the EU include black walnut ( Juglans nigra ), mulberry ( Morus alba , M. nigra ), olive ( Olea europaea ), almond ( Prunus dulcis ), apricot ( P. armeniaca ), peach ( P. persica ), plum ( P. domestica ), sweet cherry ( P. avium ), apple ( Malus domestica ), pear ( Pyrus communis ) and pomegranate ( Punica granatum ). E. semifuneralis is generally known as pest of trees affected by mechanical injuries, frost or canker diseases. The pest is also known to vector the fungus Ceratocystis fimbriata which is not known to occur in the EU. Climatic conditions and availability of host plants in some EU countries would allow this species to establish and spread. Impact in cultivated hosts including apples, plums, mulberries, almond, olive and ornamental broadleaf trees is anticipated. Phytosanitary measures are available to reduce the likelihood of entry and spread. E. semifuneralis meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Blissus insularis (Hemiptera: Heteroptera: Blissidae) for the European Union (EU) territory. B. insularis , known in the US as the southern chinch bug, primarily feeds on St. Augustine grass ( Stenotaphrum secundatum , Poaceae, subfamily Panicoideae). This is a lawn grass grown in warm, tropical and subtropical regions of the world and which is widely grown in the southern US and also used in southern EU as a lawn and amenity grass. Adults and nymphs aggregate to feed at the base of the grass. B. insularis occurs in the southern continental US, Hawaii, Guam, Mexico, Central and South America, and across the Caribbean. In the EU, B. insularis was first detected in Portugal in 2019, where following a national survey, it has now been found in 10 municipalities across the central and southern parts of the country. The pathway for entry into Portugal is unknown. B. insularis is not a regulated pest in the EU. It could further enter and spread within the EU via the import and movement of host plants for planting. S. secundatum is vegetatively propagated because seed is largely sterile. Many Poaceae plants for planting are prohibited from entering the EU, other than some ornamental perennial grasses. Whether S. secundatum is considered an ornamental grass within phytosanitary legislation is not clear. Host availability and climate suitability suggest that southern EU regions extending from the Atlantic coast of Portugal through the Mediterranean would be suitable for B. insularis establishment. The introduction of B. insularis to such areas of the EU would likely cause impacts to St. Augustine grass, as already seen in Portugal. Measures to prevent further entry and spread are available. Options to reduce the impact of established populations are also available. B. insularis satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Background: It remains unclear whether racial and ethnic disparities for atherosclerotic cardiovascular disease (ASCVD) persist within universal health care systems. We aimed to explore long-term ASCVD outcomes within a single-payer health care system with extensive drug coverage in Québec, Canada., Methods: CARTaGENE (CaG) is a population-based prospective cohort study of individuals aged 40 to 69 years. We included only participants without previous ASCVD. The primary composite endpoint was time to the first ASCVD event (cardiovascular death, acute coronary syndrome, ischemic stroke-transient ischemic attack, or peripheral arterial vascular event)., Results: The study cohort included 18,880 participants followed for a median of 6.6 years (2009 to 2016). The mean age was 52 years, and 52.4% were female. After further adjustment for socioeconomic and cardiovascular factors, the increase in ASCVD risk for South Asians (SAs) was attenuated (hazard ratio [HR], 1.41; 95% confidence interval [CI], 0.75, 2.67), whereas Black participants' risk was lower (HR, 0.52; 95% CI, 0.29, 0.95) compared with White participants. After similar adjustments, there were no significant differences in ASCVD outcomes among the Middle Eastern, Hispanic, East-Southeast Asian, Indigenous, and mixed race-ethnicities participants and the White participants., Conclusions: After adjustment for CV risk factors, the risk of ASCVD was attenuated in the SA CaG participants. Intensive risk-factor modification may mitigate the ASCVD risk of the SAs. Within a universal health care context and comprehensive drug coverage, the ASCVD risk was lower among Black compared with White CaG participants. Future studies are needed to confirm whether universal and liberal access to health care and medications can reduce the rates of ASCVD among the Black population., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

The EFSA Panel on Plant Health performed a pest categorisation of Nilaparvata lugens (Hemiptera: Delphacidae), the brown planthopper, for the European Union. N. lugens is widespread in Asia where it is native; it also occurs in Oceania where it is naturalised. N. lugens is not known to be present in the EU and is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is a monophagous species and a major pest of rice (Oryza sativa ). High populations of planthoppers cause leaves to initially turn orange yellow before becoming brown and dry and this is a condition called 'hopperburn' that kills the plant. N. lugens can also transmit plant viruses. It can complete 12 generations per year in tropical areas, where it resides year-round. N. lugens can undertake long-distance migration of up to 500 km from tropical areas to form transient populations in sub-tropical and temperate areas but due to low temperatures and absence of rice plants during the winter it does not establish in such areas. Entry to the EU via migration is unlikely given the distance from tropical rice growing areas. A possible but unlikely potential pathway is the import of infested rice seedlings, although we have no evidence that such trade exists. In the EU, rice is mainly planted from seed; when transplanted, it is sourced locally. N. lugens is very unlikely to survive year-round in the EU due to unsuitable climate and lack of hosts during the winter. Consequently, the pest is very unlikely to become established in the EU territory. Nevertheless, there are measures available to further reduce the likelihood of entry, establishment and spread of N. lugens within the EU. N. lugens does not satisfy the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Solenopsis invicta Butler (Hymenoptera: Formicidae) the red imported fire ant, for the EU territory. S. invicta is native to central South America and has spread to North and Central America, East Asia and Australia where it is recognised as a major invasive species causing serious environmental impacts to biodiversity and harming horticultural crops such as cabbage, eggplant and potatoes. It can girdle and kill young citrus trees. S. invicta is not listed as a Union quarantine pest in Annex II of Commission Implementing Regulation (EU) 2019/2072. However, the European Scientific Forum on Invasive Alien Species lists S. invicta as a species of Union concern (Commission Implementing Regulation (EU) 2022/1203). Like other ant species, S. invicta is a social insect commonly creating colonies in the soil. Long-distance spread in the Americas has been attributed to nests being carried in soil accompanying plants for planting, or simply in soil alone. S. invicta could enter the EU via conveyances carrying a wide range of goods if the conveyance is contaminated with soil or has been in close contact with soil, and with plants for planting in soil or growing media. Climatic conditions in large parts of the southern EU are suitable for establishment and spread would occur when mated females disperse to form new colonies. If S. invicta established in the EU, losses to horticultural crops would be expected in addition to losses to biodiversity. The impacts of S. invicta go beyond plant health with the ant attacking new-born, hatching, weak or sick animals. Stings can cause allergic reactions in humans and are a public health issue. However, such factors are outside the scope of a pest categorisation. S. invicta satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Takahashia japonica (Hemiptera: Sternorrhyncha: Coccidae), the Asian string cottony scale, for the EU. This insect is native to Japan, and it is now established in many countries in Asia. It was first recorded in the EU (Italy) in 2017 and has also been found in Croatia. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is polyphagous, feeding on broad-leafed trees and shrubs assigned to 25 genera belonging to 17 families. Host plant species commonly found in EU include maple ( Acer spp.), alder ( Alnus japonica ), silkworm mulberry ( Morus alba ), black mulberry ( Morus nigra ), quince ( Cydonia oblonga ), walnut ( Juglans regia ), cherry plum ( Prunus cerasifera ), apple ( Malus domestica ) and citrus ( Citrus sp.). Climatic conditions and availability of host plants in southern and central EU countries have allowed this species to establish and spread. Impact in cultivated hosts including citrus, mulberries, quinces, apples, plums, forest trees, as well as ornamental plants, is anticipated. Phytosanitary measures are available to reduce the likelihood of entry and further spread. T. japonica meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Paracoccus marginatus (Hemiptera: Sternorrhyncha: Pseudococcidae), the papaya scale, for the EU. It is native to Central America and since the 1990s, it has spread rapidly in mainly tropical areas of the Caribbean, islands in the Indian and Pacific Oceans, Africa and southern Asia. Large populations were detected in northern Israel in 2016. It has not been reported within the EU. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It reproduces sexually and there are up to 11 generations per year in India. The estimated minimum, optimum and maximum temperature thresholds for the adult females are 13.9, 28.4 and 32.1°C, respectively. First-instar nymphs may move to neighbouring plants by crawling, or be passively dispersed by wind, or hitchhiking on clothing, equipment or animals. It is highly polyphagous, feeding on plants in 172 genera and 54 families. It is an important pest of custard apple ( Annona spp.), papaya ( Carica papaya ) and Hibiscus spp. It also feeds on a wide range of plants cultivated in the EU such as eggplant ( Solanum melongena ) , avocado ( Persea americana ) , citrus ( Citrus spp.), cotton ( Gossypium hirsutum ) , grapevine ( Vitis vinifera ), guava ( Psidium guajava ) , mango ( Mangifera indica ), passionfruit ( Passiflora edulis ) , pomegranate ( Punica granatum ) , pepper ( Capsicum annuum ) and tomato ( Solanum lycopersicum ). Plants for planting, fruits, vegetables and cut flowers are the main potential pathways for entry of P. marginatus into the EU. Climatic conditions in the warmest areas of Cyprus, Greece, Italy and Spain, where host plants occur, would likely allow this species to successfully establish and spread. Reductions in yield and quality of some cultivated hosts including Annona spp., Hibiscus spp. and papaya are anticipated if establishment occurs. Phytosanitary measures are available to reduce the likelihood of entry and spread. P. marginatus meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of  Urocerus albicornis (Hymenoptera: Siricidae), the black horntail sawfly, for the territory of the EU. U. albicornis is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. U. albicornis occurs throughout Canada and continental USA and has established in northern Spain, and probably in southern France (based on two specimens caught in two sites) and Japan (based on one individual caught in one site). It attacks mostly stumps or fallen or weakened trees of at least 20 species of Pinaceae ( Abies spp., Larix spp., Picea spp., Pinus spp., Pseudotsuga menziesii , Tsuga spp.) and of Cupressaceae ( Thuja plicata ). In Spain, the females fly between May and September with a peak in August and September. The eggs are deposited into the sapwood, together with mucus containing a venom and a white-rot wood-decay basidiomycete, either Amylostereum chailletii or A. areolatum. Each fungus is symbiotic with the insect. The larvae feed on wood infected by the fungus. All immature stages live in the host sapwood. In British Columbia, the lifecycle of the pest lasts 2 years but has not been fully characterised elsewhere. The wood of the host trees is impacted by decay due to the fungus, and structurally impaired by the larval galleries. U. albicornis can be carried in conifer wood, solid wood packaging material (SWPM) or plants for planting. Wood from North America is regulated by 2019/2072 (Annex VII) while SWPM is managed according to ISPM 15. The pathway plants for planting is largely closed by prohibition, with the exception of Thuja spp. Climatic conditions in several EU member states are conducive for establishment and the main host plants are widespread in those areas. Further spread and introduction of  U. albicornis is likely to decrease the quality of host wood and may influence forest diversity by selectively affecting conifers. Phytosanitary measures are available to reduce the likelihood of additional entry and further spread, and there is a potential for biological control. Despite uncertainty regarding potential damage, U. albicornis satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Milviscutulus mangiferae (Hemiptera: Sternorrhyncha: Coccidae), the mango shield scale, for the EU. The native range of M. mangiferae is uncertain. This species occurs widely in tropical and warmer subtropical regions throughout the world. Within the EU, the pest has been recorded in Italy in a greenhouse at the Botanical Garden of Padua on mango trees imported from Florida (USA); however, its establishment remains uncertain. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is polyphagous, feeding on plant species belonging to more than 86 genera in more than 43 families including many crop and ornamental plants. It can be a serious pest of mango ( Mangifera indica ) and an occasional pest of a range of ornamental plants. Economically important crops in the EU such as citrus ( Citrus spp.), avocado ( Persea americana ) and ornamentals such as hibiscus ( Hibiscus spp.) and myrtle ( Myrtus communis ), are included in the host list of M. mangiferae . Reproduction of M. mangiferae is generally parthenogenetic and it completes two to three generations annually. Plants for planting, cut flowers and fruits provide potential pathways for entry into the EU. Climatic conditions in southern EU countries and host plant availability in those areas are conducive for establishment and spread. Establishment could also occur in heated greenhouses in cooler areas of the EU. The introduction of the mango shield scale is expected to have an economic impact in the EU through the reduction in yield, quality and commercial value of fruits and ornamental plants. Phytosanitary measures are available to reduce the likelihood of entry and further spread. M. mangiferae meets the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Nipaecoccus viridis (Hemiptera: Sternorrhyncha: Pseudococcidae), the spherical scale, for the EU. It is of Asian origin and occurs widely in southern Asia, Africa and tropical Australia. It has been introduced to a few countries in the Americas. In the Mediterranean basin it is found in Algeria, Egypt, Israel, Syria and Turkey, where it is limited to the Marmara region. It has not been reported within the EU. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It reproduces sexually, has three generations each year in citrus orchards in South Africa, and all stages can overwinter. First instar nymphs may move to neighbouring plants by crawling or be passively dispersed by wind or hitchhiking on clothing, equipment or animals. It is highly polyphagous, feeding on plants in 115 genera and 46 families. It is an important pest of citrus ( Citrus spp.), cotton ( Gossypium spp.), mango ( Mangifera indica ), avocado ( Persea americana ) and stored potatoes ( Solanum tuberosum ). It also feeds on a wide range of other fruit (apple Malus domestica , olive Olea europea , pear Pyrus communis and grape Vitis vinifera ) and vegetable crops (tomato Solanum lycopersicum ), and ornamental plants (roses, Rosa spp.) that are widely grown in the EU. Plants for planting, fruits, vegetables, and cut flowers are the main potential pathways for entry of N. viridis into the EU. Climatic conditions and availability of host plants in southern parts of the EU where there are few days of frost each year would likely allow this species to successfully establish and spread. Reductions in yield and quality of cultivated hosts including avocado, citrus, cotton and mango is anticipated if establishment occurs. Phytosanitary measures are available to reduce the likelihood of entry and spread. N. viridis meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Resseliella maxima (Diptera: Cecidomyiidae), the soybean gall midge, for the EU. This midge was first described in 2018 and is widespread in north-western United States. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. Larvae feed on and develop in soybean ( Glycine max , Fabaceae), and possibly in two other Fabaceae, sweet clover ( Melilotus officinalis ) and alfalfa/lucerne ( Medicago sativa ). Feeding damage results in dark brown or black areas on the stems which become weak and can break near the soil; heavy infestations can cause plant death. R. maxima adults live only a few days and adult females lay eggs within 24 h after emergence. Larvae of R. maxima overwinter in the soil as third instars in silken cocoons. The main natural dispersal stage is the adult, which can fly. Freshly cut host plants for animal feed contaminated with larvae provide a potential pathway for entry into the EU. However, there is great uncertainty as to whether such plants are imported from USA states where R. maxima occurs. Climatic conditions and host availability in central-western EU MS are favourable for outdoor establishment. Phytosanitary measures are available to reduce the likelihood of entry and spread. Except for the uncertainty concerning the likelihood of entry, R. maxima satisfies the other criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Icerya aegyptiaca (Hemiptera: Sternorrhyncha: Monophlebidae), the Egyptian fluted scale, for the EU. This insect is established in several countries in tropical and subtropical regions of the world. Within the EU, the pest has not been reported. It is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is highly polyphagous, feeding on plants in 128 genera and 66 families, with some preference for avocado ( Persea americana ), banana ( Musa sp.), citrus ( Citrus spp.), coconut ( Coccos nucifera ), common pear ( Pyrus communis ), fig ( Ficus spp.), guava ( Psidium guajava ), maize ( Zea mays ), mango ( Mangifera indica ), white mulberry ( Morus alba ), and grapevine ( Vitis vinifera ). It has also been recorded feeding on tomato ( Solanum lycopersicum ), as well as on ornamental plants. Plants for planting and fruits, vegetables and cut flowers are the main potential pathways for entry of I. aegyptiaca into the EU. Climatic conditions and availability of host plants in parts of the EU where there are very few days of frost each year would likely allow this species to successfully establish and spread. Economic impact in cultivated hosts including citrus, grapes, maize, peppers, sunflowers, tomatoes and ornamental crops is anticipated if establishment occurs. Phytosanitary measures are available to reduce the likelihood of entry and spread. I. aegyptiaca meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of  Urocerus japonicus (Hymenoptera: Siricidae), the Japanese horntail, for the territory of the EU. U. japonicus is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072 but was identified as an actionable pest in a commodity risk assessment of Pinus thunbergii artificially dwarfed plants from Japan. U. japonicus occurs across Japan and on the Korean Peninsula. It attacks fallen or weakened Japanese cedars, Cryptomeria japonica and Japanese cypresses, Chamaecyparis obtusa . It has also been observed attacking Pinus spp., Abies spp., Larix kaempferi and Picea jezoensis . The females oviposit into the sapwood. Eggs are deposited together with a symbiotic basidiomycete fungus, Amylostereum laevigatum . The larvae feed on wood infected by the fungus. All immature stages live in the hosts sapwood. The lifecycle of the pest lasts 1 year, sometimes 2 years. The wood of the host trees is discoloured by the fungus and therefore loses much of its economic value. U. japonicus can be carried in conifer wood, solid wood packaging material (SWPM) or plants for planting. Wood from Japan is regulated by 2019/2072 (Annexes VII and XI) whilst SWPM is managed by ISPM 15. The pathway plants for planting is largely closed by prohibition, with the exception of Cryptomeria spp. and specified bonsai plants for planting. Climatic conditions in several EU Member States are conducive for establishment, but the main host plants are not very common in those areas, being only amenity trees, although the other hosts mentioned in the literature, Pinus spp., Abies spp., Picea spp. and Larix spp., are widespread. The introduction of  U. japonicus is likely to decrease the quality of host wood, as in Japan. Phytosanitary measures are available to reduce the likelihood of entry and further spread, and there is a potential for biological control. U. japonicus satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2023 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Monitoring is an important component in pest management, to prevent or mitigate outbreaks of native pests and to check for quarantine organisms. Surveys often rely on trapping, especially when the target species respond to semiochemicals. Many traps are available for this purpose, but they are bulky in most cases, which raises transportation and deployment issues, and they are expensive, which limits the size and accuracy of any network. To overcome these difficulties, entomologists have used recycled material, such as modified plastic bottles, producing cheap and reliable traps but at the cost of recurrent handywork, not necessarily possible for all end-users (e.g., for national plant-protection organizations). These bottle-traps have allowed very large surveys to be conducted, which would have been impossible with standard commercial traps, and we illustrate this approach with a few examples. Here, we present, under a Creative Commons BY-SA License, the blueprint for a fan-trap , a foldable model, laser cut from a sheet of polypropylene, which can rapidly be produced in large numbers in a Fab lab or by a commercial company and could be transported and deployed in the field with very little effort. Our first field comparisons show that fan-traps are as efficient as bottle-traps for some Scolytinae species and we describe two cases where they are being used for monitoring., Competing Interests: The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

The EFSA Panel on Plant Health performed a pest categorisation of Dendrolimus spectabilis (Lepidoptera: Lasiocampidae), a moth, also known as the Japanese pine caterpillar, for the European Union (EU). D . spectabilis is native to China, Japan and Korea. Its larvae primarily feed on the needles of Pinus densiflora and P . thunbergii and can also feed on P . strobus , P . rigida , P . taeda and P. tabuliformis . The pest can have one or two generations per year; winter is mostly spent as fifth instar larvae in the soil. Adults emerge in July and August and females lay egg masses of 200-300 eggs on coniferous host needles. Natural enemies are described as significant factors of population density changes in Japan and the Republic of Korea. The pest can be detected visually, and there are morphological keys as well as molecular markers allowing identification. D. spectabilis could enter the EU, either as eggs, larvae or pupae in the foliage of plants for planting or cut branches, as larvae on wood with bark or as overwintering larvae in the litter of potted plants. However, Annex VI of Regulation 2019/2072 prohibits the introduction of D. spectabilis hosts from countries and areas where the pest occurs. D. spectabilis occurs in climatic zones that are found in the EU, and the fact that it attacks the North American P. strobus, P. taeda and P. rigida in its Asian native area suggests a potential to shift to local conifer species in the EU territory. There is uncertainty regarding the magnitude of economic and environmental impact of D. spectabilis on conifer species commonly occurring in the EU. Notwithstanding this uncertainty, D. spectabilis satisfies all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Penthimiola bella (Hemiptera: Cicadellidae), the citrus leafhopper, for the European Union (EU). P. bella is native to the Afrotropical region; it has spread to Israel (first reported in 1974), Lebanon, and was reported from Morocco in 2018. Within the EU, P. bella is established in Portugal (Algarve) where it was first found on sweet oranges in 2012, and then in Spain in 2020, also on sweet oranges. P. bella is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is a polyphagous species reported, among cultivated hosts, on sweet orange, grapefruit and avocado. It is also described as being found on unspecified trees and bushes in savannahs, mountain forests and rain forests in Africa. Climatic conditions in some parts of southern EU countries are favourable and host plants are available in those areas to support establishment and spread. Despite being present in Portugal for over 10 years, there is a lack of evidence of impacts; hence, the magnitude of impact following introduction is uncertain. Nevertheless, in South Africa, P. bella was reported as being an economically important pest of citrus and to cause damage to avocado fruit during the early stages of development. Phytosanitary measures are available to reduce the likelihood of entry and further spread. Except for having uncertain economic or environmental impacts as a result of its introduction, P. bella satisfies all the other criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Neomaskellia andropogonis (Hemiptera: Aleyrodidae), the sugarcane whitefly, for the EU territory. N. andropogonis is a tropical and subtropical species that originates in south central Asia and has recently established in Iran and Iraq. N. andropogonis is not listed in Commission Implementing Regulation (EU) 2019/2072. It is oligophagous on Poaceae and most frequently reported on sugarcane ( Saccharum officinarum ), on which it has become an important emerging pest in western Iran. The larvae feed on the foliage and stalks and can cause a reduction of photosynthesis rate and growth. In heavy infestations, the sugar purity and content are greatly decreased. Honeydew egested by feeding N. andropogonis larvae can promote the growth of black sooty mould over the host. No evidence was found indicating economic damage to other grasses. The ornamental grass hosts Andropogon sp. and Imperata cylindrica are ornamental grasses in the subfamily Panicoideae and are exempt from a general prohibition on Poaceae entering the EU and together with fresh sugarcane, provide potential pathways for entry. An estimated threshold for development from egg to adult of 7.2°C with approximately 500 degree days required for a generation suggests that climatic conditions, together with the availability of grass hosts in the southern EU, would support establishment. Adults disperse naturally by flying and all stages can be moved over long distances by the trade of infested plant material. The pest has the potential to impact sugarcane production in Portugal and Spain. N. andropogonis satisfies all of the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. However, this conclusion has high uncertainties regarding the likelihood of entry and the magnitude of potential impact within the EU as the insect is only recorded as an economically important pest in Iran, and its host range is poorly known and understood., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Aims: In a retrospective analysis of dal-Outcomes, the effect of dalcetrapib on cardiovascular events was influenced by an adenylate cyclase type 9 (ADCY9) gene polymorphism. The dal-GenE study was conducted to test this pharmacogenetic hypothesis., Methods and Results: dal-GenE was a double-blind trial in patients with an acute coronary syndrome within 1-3 months and the AA genotype at variant rs1967309 in the ADCY9 gene. A total of 6147 patients were randomly assigned to receive dalcetrapib 600 mg or placebo daily. The primary endpoint was the time from randomization to first occurrence of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke. After a median follow-up of 39.9 months, the primary endpoint occurred in 292 (9.5%) of 3071 patients in the dalcetrapib group and 327 (10.6%) of 3076 patients in the placebo group [hazard ratio 0.88; 95% confidence interval (CI) 0.75-1.03; P = 0.12]. The hazard ratios for the components of the primary endpoint were 0.79 (95% CI 0.65-0.96) for myocardial infarction, 0.92 (95% CI 0.64-1.33) for stroke, 1.21 (95% CI 0.91-1.60) for death from cardiovascular causes, and 2.33 (95% CI 0.60-9.02) for resuscitated cardiac arrest. In a pre-specified on-treatment sensitivity analysis, the primary endpoint event rate was 7.8% (236/3015) in the dalcetrapib group and 9.3% (282/3031) in the placebo group (hazard ratio 0.83; 95% CI 0.70-0.98)., Conclusion: Dalcetrapib did not significantly reduce the risk of occurrence of the primary endpoint of ischaemic cardiovascular events at end of study. A new trial would be needed to test the pharmacogenetic hypothesis that dalcetrapib improves the prognosis of patients with the AA genotype., Clinical Trial Registration: Trial registration dal-GenE ClinicalTrials.gov Identifier: NCT02525939., Competing Interests: Conflict of interest: J.C.T. has received research grant and honoraria from Amarin; research grant from AstraZeneca; research grant, honoraria, and minor equity interest from DalCor; research grant from Esperion; research grant from Ionis; research grant and honoraria from Sanofi; research grant and honoraria from Servier; a patent on pharmacogenomics-guided CETP inhibition was obtained, and J.C.T. and M.P.D. are mentioned as authors. M.P.D. has a minor equity interest in DalCor and has received honoraria from DalCor. M.A.P. receives research support from Novartis; he serves as a consultant for AstraZeneca, Corvidia, DalCor, GlaxoSmithKline, Jazz, MyoKardia, Novartis, Novo Nordisk, Roche, Sanofi, Servier, and Takeda; and has equity in DalCor. D.D.W. has received remuneration for participation in clinical trial committees from CSL Ltd, Daiichi Sankyo, DalCor, the Medicines Company, Novo Nordisk, Regeneron, Resverlogix, and Sanofi, and honoraria for lectures from DalCor and Pfizer. W.K. reports personal fees (consulting) from DalCor and consulting fees from AstraZeneca, Novartis, Pfizer, The Medicines Company, Kowa, a Corvidia, Esperion, Genentech, Omeicos, Novo Nordisk, Daiichi Sankyo, and Amgen; personal fees (honorarium for lectures) from AstraZeneca, Novartis, Amgen, Sanofi, Bristol-Myers-Squibb, and Berlin-Chemie; grants and non-financial support (provision of reagents for biomarker measurements free of charge) from Roche Diagnostics, Beckmann, Singulex, and Abbott, outside the submitted work. A.P.M. has received personal fees for participation in study committee from DalCor, and personal fees for participation in study committees from AstraZeneca, Bayer, Novartis, and Fresenius. J.J.V.M. reports grants paid to his institution and fees as steering committee member from DalCor Pharma UK for the Dal-GenE study, during the conduct of the study; grants paid to his institution and fees as steering committee member from Oxford University and Bayer; grants paid to his institution from Theracos; grants paid to his institution and fees as steering committee from Abbvie; grants paid to his institution from Pfizer, Merck AstraZeneca, GlaxoSmithKline, and Novartis. J.W.J. and his department have received research grants from and/or was speaker (with or without lecture fees) in CME-accredited meetings sponsored by Amgen, Athera, Biotronik, Boston Scientific, Dalcor, Daiichi Sankyo, Lilly, Medtronic, Merck-Schering-Plough, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi-Aventis, The Medicine Company, The Netherlands Heart Foundation, CardioVascular Research The Netherlands (CVON), The Netherlands Heart Institute and the European Community Framework KP7 Programme. H.D.W. reports grants paid to his institution and fees as steering committee member from DalCor Pharma UK for the Dal-GenE study, during the conduct of the study; grants paid to his institution and fees as steering committee member from Sanofi-Aventis, Regeneron Pharmaceutics, National Institutes of Health (USA), CSL Behring, American Regent, Sanofi-Aventis Australia Pty Ltd, and Esperion Therapeutics Inc, outside the submitted work. F.L.T., T.H., and D.M.B. are employed by and have minor equity interest in DalCor. Other authors report no conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)

The EFSA Panel on Plant Health performed a pest categorisation of Pulvinaria psidii (Hemiptera: Coccidae), the green shield scale, for the EU. P. psidii was originally described from Hawaii on Psidium sp. and it is now established in many countries in tropical and subtropical regions of the world. Within the EU, the pest has been reported from mainland Spain and the Canary Islands. P. psidii is not listed in Annex II of Commission Implementing Regulation (EU) 2019/2072. It is highly polyphagous, feeding on 230 plant species belonging to more than 70 botanical families with preference for avocado ( Persea americana ), citrus ( Citrus spp.), coffee ( Coffea sp.), guava ( Psidium guajava ), litchi ( Litchi chinensis ), mango ( Mangifera indica ), mulberry ( Morus sp.) and pomegranate ( Punica granatum ). It has also been recorded feeding on some solanaceous plants: tomato ( Solanum lycopersicum ) and pepper ( Capsicum annuum ), as well as on ornamental plants. Climatic conditions and availability of host plants in southern EU countries would most probably allow this species to successfully establish and spread. Economic impact in cultivated hosts including citrus, mangoes, mulberries, as well as vegetable and ornamental crops is anticipated if establishment occurs. Indeed, P . psidii has already been reported causing damage to Melia azedarach , a widely used ornamental tree that lines streets in Valencia. There is contradictory information regarding impact in mangoes in Spain. This could be due to the relatively recent establishment of the pest. Phytosanitary measures are available to reduce the likelihood of entry and further spread. P. psidii meets the criteria that are within the remit of EFSA to assess for this species to be regarded as a potential Union quarantine pest., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed the pest categorisation of the ulluco weevil, Amathynetoides nitidiventris (Hustache), for the EU territory. This species is not included in EU Commission Implementing Regulation 2019/2072. However, its only substantiated host, ulluco ( Ullucus tuberosus ), is included in Annex I of Regulation EU 2018/2019 as a high risk plant prohibited from entering the EU, pending risk assessment. In its native Andean region, A. nitidiventris is univoltine, with a lifecycle highly synchronised with the phenology of its host, reproduction and development take place during the development of tubers. Oviposition occurs in the soil. Larvae feed by tunnelling into the tubers, which most of them abandon to pupate in the soil. A minority pupates in the tubers. Because adult A. nitidiventris are often found in other crops due to crop rotations and crop associations, this species has been mistakenly identified as a pest of other crops. In principle soil and tubers of ulluco could provide a pathway for A. nitidiventris into the EU. However, the soil pathway is closed and ulluco tubers are regulated as high risk plants. There are no EU records of interception. Should this weevil enter the EU, the rarity of its host, which is not known to be cultivated in EU MSs, would hamper establishment, spread, and impact. As a consequence, A. nitidiventris does not satisfy all the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. The criteria that are not met are the potential for establishment, spread, and economic or environmental consequences in the EU., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Tetraleurodes perseae (Hemiptera: Aleyrodidae), the red-banded whitefly, for the territory of the EU. T. perseae is a tropical and subtropical species that originated in the Neotropical region and has now spread and established in the USA (California and Florida), Israel and Lebanon. T . perseae is not listed in Commission Implementing Regulation (EU) 2019/2072. It is oligophagous on Lauraceae and most frequently reported on avocado ( Persea americana ), on which it is considered a minor or secondary pest. No evidence was found indicating damage to other plants. T. perseae larvae develop on the foliage and don't attack the fruit. The number of generations per year varies between one and ten. High populations may promote the growth of black sooty moulds on the foliage and fruit, and adults feeding on the buds can lead to deformed immature leaves and premature leaf drop. However, T. perseae populations are usually effectively controlled by hymenopteran parasitoids, at least one of which ( Cales noacki ) is widespread in the EU. The producers of organic avocados in the EU could encourage the use of C. noacki , although occasional outbreaks of T. perseae could temporarily impact the fruit quality. Adults disperse naturally by flying and all stages can be moved over long distances by the trade of infested plant material. Plants for planting provide potential pathways for entry and spread in the EU. Climatic conditions and availability of host plants in southern EU countries are conducive for establishment. Phytosanitary measures are available to reduce the risk. T. perseae satisfies all of the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest. However, this conclusion has a high uncertainty regarding magnitude of potential impact as the insect is a minor and sporadic pest in its current area of distribution., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Platypus apicalis (Coleoptera: Curculionidae: Platypodinae), an ambrosia beetle, also known as a pinhole borer, for the EU territory. P. apicalis is a polyphagous pest native to New Zealand. The majority of its life cycle is spent inside tree wood, but it does not directly feed on plant tissue, instead larvae and adults feed on a symbiotic fungus ( Sporothrix nothofagi which is pathogenic to Nothofagus spp.) vectored by adults and introduced when they bore tunnels into the host. P. apicalis feeds within a wide range of live, often stressed trees, in dead or dying hardwood and softwood trees, and fallen or felled trees. Successful reproduction can occur inside a number of living tree species including Castanea sativa, Pinus spp. and Ulmus spp. P. apicalis is not known to have established outside of New Zealand although findings have been reported in Australia. Whilst there are no records of interceptions of this species in the EU, platypodines are intercepted with solid wood packing material (SWPM) and Platypus species, but not P. apicalis , have been intercepted with wooden logs in Japan. Host plants for planting also provide a potential pathway. Hosts are grown widely across the EU in areas with climates comparable to those in New Zealand where the pest occurs suggesting that conditions in the EU are suitable for its establishment. If introduced into the EU, adults could disperse naturally by flight, perhaps tens or hundreds of metres. The movement of infested wood and host plants for planting within the EU could facilitate spread. Economic impacts in forestry and timber industries would result from the galleries created by P. apicalis and from wood staining caused by the symbiotic fungus. Phytosanitary measures are available to inhibit the entry of P. apicalis . P. apicalis satisfies the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Oligonychus perseae (Acari: Prostigmata: Tetranychidae), the persea mite, for the EU. O. perseae is a tropical species that originated in Mesoamerica and has now spread and established in California, Florida, Hawaii, Morocco, southern Europe and Israel. Within the EU, it is established in Italy, Portugal and Spain. O . perseae is not listed in Commission Implementing Regulation (EU) 2019/2072. It is polyphagous, feeding on plants in 20 genera in 17 families. It is most frequently reported on avocado ( Persea americana ), where it is considered a key pest. No evidence was found indicating damage to other crops. O. perseae live on leaves and do not attack the fruit. Populations usually grow exponentially at the beginning of summer and decline at the end of this season. High population densities can cause severe defoliation, resulting in downgrading of fruit through sunburn. However, this type of damage is common only if trees additionally suffer from water stress. The lack of additional avocado pests in the EU, which facilitates the production of organic avocados, is jeopardised by the occurrence of this mite, as it may require pesticide applications. This is why O. perseae is considered an important pest of avocados in Spain, where more than 80% of EU avocado production occurs. Natural dispersal is restricted to neighbouring trees. However, human-assisted movement can result in long-distance spread. Plants for planting provide potential pathways for further entry and spread, including O. perseae -free EU MS where avocados are grown (i.e. Cyprus, France, Greece). Climatic conditions and availability of host plants in southern EU countries are conducive for establishment. Phytosanitary measures are available to reduce the likelihood of further entry and spread. O. perseae satisfies with no key uncertainties the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

The EFSA Panel on Plant Health performed a pest categorisation of Russellaspis pustulans (Hemiptera: Asterolecaniidae), the oleander pit scale, for the EU. R . pustulans occurs widely in tropical and subtropical areas of the world and is restricted to indoor plantings in cooler temperate regions. Within the EU, it has been reported in some literature from Cyprus, Italy and Malta though not confirmed by the NPPOs. R. pustulans is not listed in Commission Implementing Regulation (EU) 2019/2072. It is very polyphagous, feeding on plants in 69 families and exhibits a preference for fig ( Ficus carica ) and oleander ( Nerium oleander ). R. pustulans was observed completing up to three generations per year in Egypt, with peaks of presence in June, October and December. The main natural dispersal stage is the first instar, which crawls over the host plant or may be dispersed further by wind and animals. Plants for planting, cut branches and fruits provide potential pathways for entry into the EU. Climatic conditions in some parts of southern EU countries are favourable and host plants are available in those areas to support establishment. However, the magnitude of impact following introduction is uncertain. Phytosanitary measures are available to reduce the likelihood of entry and further spread. R . pustulans does meet the criteria that are within the remit of EFSA to assess for it to be regarded as a potential Union quarantine pest., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)