Statement on a study proposal prepared by the UC to support a future derogation request from the EU import requirements for wood packaging material originating in the US and used to pack and transport military ammunition. Scientific Opinion.

Following a request from the European Commission, the EFSA Panel on Plant Health was asked to deliver a statement on a study proposal prepared by the US to support a future derogation request from the Community import requirements for wood packaging material (WPM) originating in the US and used to pack and transport military ammunition. The Panel reviewed the submitted study proposal and based its conclusions on the shortcomings identified in the study proposal. It was concluded that, due to these shortcomings, the evaluation of the methodological approach described in this study proposal with regard to: 1.the determination of the likelihood that live pinewood nematode (Bursaphelenchus xylophilus) and other harmful organisms relevant for the Community are present in the WPM used by the US Department of Defense to pack and transport military ammunition (Pest survey component), 2. the assessment of the likelihood that harmful organisms may be introduced into the Community through the WPM pathway (Pathway Risk Analysis component) cannot be conducted

Statement on the dossier for a derogation request for the US authorities concerning cold-treated strawberry plants intended for planting.

Following a request from the European Commission, the EFSA Panel on Plant Health examined the report “Evaluation of Strawberry Nursery Plant Cold Treatments on Survival of the Whitefly, Bemisia tabaci”, submitted to the European Commission by the United States Department of Agriculture (USDA). The report serves as technical justification for a derogation from requirements listed in Annex IV, Part A, Section 1, point 46 of the Council Directive 2000/29/EC. The Panel concluded that due to shortcomings in the report itself and in the experimental design of the study, this report does not demonstrate the effectiveness of the cold treatment proposed for the elimination of B. tabaci from strawberry plant consignments prepared for shipment to the EU. In addition, the Panel conducted a preliminary review of the available literature on viruses of strawberry and concluded that no B. tabaci‐transmitted viruses are currently known to infect strawberry and that no viruses of Fragaria listed in European Council Directive 2000/29/EC are known to be transmitted by B. tabaci. However, adult whiteflies of B. tabaci on strawberry consignments can carry plant viruses irrespective of whether strawberry is a host plant for these viruses and thus represent a pathway for the introduction of non‐European viruses. There is also some uncertainty concerning the extent to which known or unknown B. tabaci‐transmitted viruses could infect strawberry. Irrespective of the presence of B. tabaci, strawberry transplants from the US may represent a pathway for the introduction of any non‐European virus (and other potentially harmful organisms) of Fragaria

Scientific Opinion on the assessment of the risk of solanaceous pospiviroids for the EU territory and the identification and evaluation of risk management options.

Following a request from the EU Commission, the EFSA PLH Panel conducted a risk assessment for the EU territory of pospiviroids affecting solanaceous crops, identified and evaluated risk reduction options and evaluated the EU provisional emergency measures targeting Potato spindle tuber viroid (PSTVd). The risk assessment included PSTVd, Citrus exocortis viroid, Columnea latent viroid, Mexican papita viroid, Tomato apical stunt viroid, Tomato chlorotic dwarf viroid, Tomato planta macho viroid, Chrysanthemum stunt viroid and Pepper chat fruit viroid. Four entry pathways were identified, three involving plant propagation material, with moderate probability of entry, and one involving plant products for human consumption, with low probability of entry. The probability of establishment was considered very high. Spread was considered likely within a crop and moderately likely between crop species, with exception of spread to potato, rated as unlikely. The probability of long distance spread within vegetatively propagated crops was estimated as likely/very likely. The direct consequences were expected to be major in potato and tomato, moderate in pepper, minimal/minor in other vegetables and minimal in ornamentals. Main risk assessment uncertainties derive from limited knowledge on pospiviroids other than PSTVd, although all pospiviroids are expected to have similar biological properties. Management options to reduce risk of entry, spread and consequences were identified and evaluated. No management options can prevent establishment. Examples of successful PSTVd eradication are linked to timely and strict implementation of measures. Uncertainty exists on the effectiveness of risk reduction strategies targeting only one pathway. The EU provisional emergency measures appeared to have significantly reduced PSTVd incidence in Solanum jasminoides and Brugmansia sp., even though eradication from the EU is so far incomplete. The low PSTVd incidence in food crops did not permit to conclude whether the reduction in PSTVd prevalence in ornamentals led to a reduction in outbreaks in food crops

Scientific Opinion on a technical file submitted by the US Authorities to support a request to list a new opinion among the EU import requirements for wood of Agrilus planipennis host plants.

This document presents the scientific opinion of the Panel on Plant Health on the technical file submitted by the US Authorities to support a request to list a new option among the EU import requirements for wood of Agrilus planipennis host plants. The option under consideration is a heat treatment at 60 °C for 60 min to liminate possible infestations of the wood by the emerald ash borer (EAB). The experiments leading the US Authorities to propose this option are presented in a scientific peer reviewed publication, Myers et al. (2009). The analysis of the aggregated data published by Myers et al. (2009) and based on a Probit regression model showed that the proposed treatment cannot guarantee a control level of 99 % or higher. The analysis of the individual data either from the original measurements or from a corrected dataset, using a Probit regression model, showed that it is likely to observe one live EAB out of an infestation of 100 after the proposed heat treatment of 60 °C /60 min. To ensure a control level of 99 % the temperature of the heat treatment of 60 min should be higher than 70 °C. Results obtained with a Poisson log linear model based on individual data showed that the estimated probability that one insect or more per m2 survive the proposed heat treatment was higher than 0.6 and that there is a 0.1 probability that three insects or more per m2 survive the proposed heat treatment. Based on these results, the Panel concludes that A. planipennis is likely to survive the proposed heat treatment of 60 °C/60 min with a low uncertainty, and that the alternative option proposed in the technical file submitted by the US Authorities for wood does not guarantee the wood to be free of A. planipennis

Scientific Opinion on the effect on public or animal health or on the environment on the presence of seeds of Ambrosia spp. in animal feed

The European Commission requested EFSA to provide a scientific opinion on the effect on public or animal health or on the environment on the further distribution of Ambrosia spp. in the European Union and on the importance of feed materials, in particular bird feed, in the dispersion of Ambrosia spp. The genus Ambrosia (Asteraceae family) is distributed worldwide. Ambrosia artemisiifolia (common ragweed) has heavily colonised several areas of South-East Europe. Ambrosia spp., both in their native range and in invaded areas, are of public health concern due to the allergenic properties of their pollen. The NDA Panel concluded that inhalation of the plant pollen causes rhino-conjunctivitis and asthma, with skin allergies and food allergy playing minor roles. Ambrosia may cross-sensitize patients to other allergens, including food allergens. There is some evidence for allergenicity of Ambrosia pollen in animals. With regard to the effects on the environment of the further distribution of Ambrosia spp. in the European Union, the PLH Panel concluded that there is no direct evidence that Ambrosia spp. cause extinction of plant species. However, there are some indications that A. artemisiifolia could become highly invasive in certain environmentally-valuable habitats and might be linked to an impoverishment of species richness, therefore further ecological studies are needed. The CONTAM Panel focused on the relative importance of animal feed, bird feed in particular, on the dispersion of Ambrosia. Ambrosia seeds may contaminate feed. However, animal feed materials compounded for use in livestock are extensively processed. This processing destroys Ambrosia seeds and hence the contribution of compounded feed to the dispersion of Ambrosia is considered to be negligible. Bird feed often contains significant quantities of Ambrosia seeds and remains unprocessed. Therefore, bird feed seems to play an important role in introducing Ambrosia to new, previously not infested areas

Scientific opinion on a quantitative pathway analysis of the likelihood of Tilletia indica M. introduction into EU with importation of US wheat

The European Commission requested EFSA to provide a scientific opinion on the USDA APHIS quantitative pathway analysis on likelihood of Karnal bunt introduction with importation of US wheat for grain into EU and desert durum wheat for grain into Italy. EFSA was also requested to indicate whether the US bunted kernel standard would provide equivalent protection against introduction of Tilletia indica into EU, compared to the existing EU import requirement. The Panel on Plant Health reviewed pathway scenarios, model and parameters and found several shortcomings regarding model equations and parameter values, particularly a lack of scientific evidence for the infection threshold. Simulations were computed, for importations of US wheat into EU and desert durum wheat into Italy, based on original model and an updated model with revised parameter values. Model output was teliospores number per hectare on soil surface of each EU country. Simulated teliospores numbers entering EU were lower with the updated than with the original model. These results showed a high uncertainty, underestimated with the original model, over the number of teliospores entering each EU country. Sensitivity analysis showed several key parameters (proportion of bunted kernels in Arizona regulated counties, number of Arizona positive hectares and number of teliospores per bunted kernel) strongly influencing number of teliospores entering the EU. In addition, high sensitivity indices were obtained with the updated wheat model for several parameters related to EU country characteristics. Further research is needed to refine parameter values, to reduce uncertainty and to determine relationship between teliospores number on soil surface and number of bunted kernels resulting from infection of a wheat plant. The Panel concluded that the US bunted kernel standard does not provide a level of protection equivalent to EU requirements and that such level of protection could only be warranted by measures which include testing at harvest and before shipment to detect T. indica teliospores

Guidance on the environmental risk assessment of plant pests

The European Food Safety Authority (EFSA) requested the Panel on Plant Health to develop a methodology for assessing the environmental risks posed by harmful organisms that may enter, establish and spread in the European Union. To do so, the Panel first reviewed the methods for assessing the environmental risks of plant pests that have previously been used in pest risk assessment. The limitations identified by the review led the Panel to define the new methodology for environmental risk assessment which is described in this guidance document. The guidance is primarily addressed to the EFSA PLH Panel and has been conceived as an enhancement of the relevant parts of the “Guidance on a harmonised framework for pest risk assessment and the identification and evaluation of pest risk management options by EFSA”. Emphasizing the importance of assessing the consequences on both the structural (biodiversity) and the functional (ecosystem services) aspects of the environment, this new approach includes methods for assessing both aspects for the first time in a pest risk assessment scheme. A list of questions has been developed for the assessor to evaluate the consequences for structural biodiversity and for ecosystem services in the current area of invasion and in the risk assessment area. To ensure the consistency and transparency of the assessment, a rating system has also been developed based on a probabilistic approach with an evaluation of the degree of uncertainty. Finally, an overview of the available risk reduction options for pests in natural environments is presented, minimum data requirements are described, and a glossary to support the common understanding of the principles of this opinion is provided

Statement on a heat treatment to control Agrilus planipennis

In 2011, the EFSA Panel on Plant Health was asked by the European Commission to provide an opinion on a technical file submitted by the US Authorities to support a request to list a new heat treatment (60 °C/60 min) among the EU import requirements for wood of Agrilus planipennis host plants. After a thorough analysis of the documents provided the Panel concluded that, with a low uncertainty, A. planipennis is likely to survive the proposed heat treatment of 60 °C/60 min, and that, to ensure a control level of 99 % the temperature of the heat treatment of 60 min should be higher than 70 °C. Following the publication of this scientific opinion, the US Authorities submitted a new proposal to the European Commission, consisting in a new heat treatment (71.1 °C/60 min). The EFSA Panel on Plant Health was asked to consider whether this new proposal was within the scope of the published opinion and, if not, to clarify its conclusion and indicate what data would be needed to assess the effectiveness of the new treatment. The Panel concluded that the new proposal is not within the scope of the opinion as the data provided by the US Authorities cannot be used to evaluate the effectiveness of the new proposed heat treatment. An accurate assessment of the new proposed heat treatment (71.1 °C/60 min) would require an experiment including several temperatures higher than 70 °C (one corresponding to the proposed treatment). Regarding the data requirements for assessing the effectiveness of the new treatment, the Panel lists the information required in the checklist presented in the Panel’s draft guidance document on methodology for evaluation of the effectiveness of options to reduce the risk of introduction and spread of organisms harmful to plant health in the EU territory, currently under public consultation on EFSA website

Scientific Opinion on the phytosanitary risk associated with some coniferous species and genera for the spread of pine wood nematode

The European Commission requested the Panel on Plant Health to deliver a scientific opinion on the phytosanitary risk of plants (other than fruits and seeds) of Pinus pinea and of the genera Chamaecyparis, Cryptomeria and Juniperus for the spread of pine wood nematode (PWN) via movement of infested plants or untreated plant products or by supporting natural spread of PWN in conjunction with European species of the vector. The Panel analysed the data submitted by Portugal regarding surveys on the Tróia Peninsula where P. pinaster and P. pinea co-occur, and the related laboratory results of Naves et al. (2006) on feeding and oviposition preferences of Monochamus galloprovincialis. The Panel also undertook a comprehensive review of the literature. The zero infestation of PWN recorded on P. pinea on the Tróia Peninsula was not significantly different from the result for P. pinaster, because of the small P. pinea sample. Hence, the conclusion that P. pinea is not a host plant for PWN is not supported by the data submitted, principally because of low statistical confidence arising from the few P. pinea trees present. Moreover, the limited presence of P. pinea in the study areas means that the results are representative neither of the Tróia Peninsula nor of other parts of Portugal. Naves et al. (2006) recorded some oviposition by M. galloprovincialis on P. pinea, but less than on other hosts. No differences in feeding of M. galloprovincialis on P. pinaster and P. pinea were detected, thus potentially allowing PWN transmission to trees by this route. The available information regarding the genera Chamaecyparis, Cryptomeria and Juniperus as potential hosts of Monochamus spp. and PWN suggests overall a low susceptibility to PWN or its vectors; the uncertainty concerning PWN is high and would require supplementary research

Scientific Opinion on the evaluation of the pest risk analysis on Pomacea insularum, the island apple snail, prepared by the Spanish Ministry of Environment and Rural and Marine Affairs

The Panel considers the Spanish pest risk analysis (PRA) to be clear and to provide appropriate supporting evidence. However, (i) the environmental impact assessment is incomplete and (ii) the estimates for the potentially endangered area are too limited. The Panel points out that large areas of the European Union have climatic conditions, that are very similar to those of the areas of native distribution of Pomacea spp. snails, and suitable host plants are available. The Panel agrees with the Spanish PRA on the following points with regard to the risk assessment area: (i) the potential consequences of the organism for rice crops are major; (ii) the probability for establishment of the organism is very likely and (iii) the probability of spread is estimated as likely. The Panel disagrees with the Spanish PRA on the following points and considers (i) the effects on the environment to be massive under suitable environmental conditions in the PRA area and (ii) the probability of entry of the organism to be high. Regarding risk reduction options the Panel agrees with the Spanish PRA that no single risk reduction method is sufficient to halt the introduction and spread of Pomacea spp. snails in the PRA area. However, a legislative ban on import of Pomacea spp. is the only risk reduction option identified that can reduce the probability of entry. The many other risk reduction options listed will help to reduce the probability of spread within the PRA area. The Panel considers that the risk reduction options should target the canaliculata complex, as Pomacea insularum and P. canaliculata, as well as other species from the complex, are almost indistinguishable. This is of particular importance for risk reduction options addressing both breeding and trade of the organism