EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on VTEC-seropathotype and scientific criteria regarding pathogenicity assessment

During 2007-2010, 13 545 confirmed human VTEC infections and 777 haemolytic uraemic syndrome (HUS) cases were reported in the EU; isolates from 85 % of cases were not fully serotyped and therefore could not be classified using the Karmali seropathotype concept. Seropathotype group D covered 5 % of isolates from fully serotyped cases; 14 cases (0.7 %) belonged to seropathotype group E, defined by Karmali et al. (2003) as non-human only. Isolates from around 27 % of cases could not be assigned. There were no HUS cases reported for the serotypes in groups D and E but 17 HUS cases could not be assigned. The health outcome was reported for only a fraction of confirmed cases. About 64 % of patients presented with only diarrhoea; VTEC infection resulted in HUS in around 10 % of cases. The new ISO/TS 13136:2012 standard improves the detection of VTEC in food. An alternative concept based on the detection of verocytotoxins alone or genes encoding such verocytotoxins does not provide a sound scientific basis on which to assess risk to the consumer because there is no single or combination of marker(s) that fully define a ‘pathogenic’ VTEC. Strains positive for verocytotoxin 2 gene(vtx2)- and eae (intimin production)- or [aaiC (secreted protein of EAEC) plus aggR (plasmid-encoded regulator)] genes are associated with higher risk of more severe illness than other virulence gene combinations. The 2011 O104:H4 outbreak demonstrated the difficulty of predicting the emergence of ‘new’ pathogenic VTEC types by screening only for the eae gene or by focusing on a restricted panel of serogroups. A molecular approach utilising genes encoding virulence characteristics additional to the presence of vtx genes has been proposed

GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations

In 2012, genetically engineered (GE) crops were grown by 17.3 million farmers on over 170 million hectares. Over 70% of harvested GE biomass is fed to food producing animals, making them the major consumers of GE crops for the past 15 plus years. Prior to commercialization, GE crops go through an extensive regulatory evaluation. Over one hundred regulatory submissions have shown compositional equivalence, and comparable levels of safety, between GE crops and their conventional counterparts. One component of regulatory compliance is whole GE food/feed animal feeding studies. Both regulatory studies and independent peer-reviewed studies have shown that GE crops can be safely used in animal feed, and rDNA fragments have never been detected in products (e.g. milk, meat, eggs) derived from animals that consumed GE feed. Despite the fact that the scientific weight of evidence from these hundreds of studies have not revealed unique risks associated with GE feed, some groups are calling for more animal feeding studies, including long-term rodent studies and studies in target livestock species for the approval of GE crops. It is an opportune time to review the results of such studies as have been done to date to evaluate the value of the additional information obtained. Requiring long-term and target animal feeding studies would sharply increase regulatory compliance costs and prolong the regulatory process associated with the commercialization of GE crops. Such costs may impede the development of feed crops with enhanced nutritional characteristics and durability, particularly in the local varieties in small and poor developing countries. More generally it is time for regulatory evaluations to more explicitly consider both the reasonable and unique risks and benefits associated with the use of both GE plants and animals in agricultural systems, and weigh them against those associated with existing systems, and those of regulatory inaction. This would represent a shift away from a GE evaluation process that currently focuses only on risk assessment and identifying ever diminishing marginal hazards, to a regulatory approach that more objectively evaluates and communicates the likely impact of approving a new GE plant or animal on agricultural production systems

Scientific Opinion on the risk to plant health posed by <em>Chrysanthemum stunt viroid</em> for the EU territory, with identification and evaluation of risk reduction options

The Panel on Plant Health conducted a pest risk assessment for Chrysanthemum stunt viroid (CSVd) and identified and evaluated risk reduction options, particularly those listed in Council Directive 2000/29/EC. Three entry pathways were identified, with plants for planting being the most important and rated as moderately likely. CSVd is recorded in some EU Member States with a limited distribution and is regulated on chrysanthemum; host plants are widely cultivated in greenhouses and outdoors. Therefore, establishment is very likely. Short-distance spread within a crop is likely, whereas short-distance spread between different species is unlikely to moderately likely. For vegetatively propagated species, in the absence of an efficient certification system, long-distance spread is very likely and a major impact would be expected on chrysanthemum, with associated yield and quality losses. However, under the existing certification scheme for chrysanthemum plant propagation material, the probability of spread through infected cuttings is largely reduced and the direct consequences of viroid outbreaks are expected to be minor. Minimal impact is predicted for other ornamental hosts and a minor impact for solanaceous vegetable crops. The indirect effects of CSVd are considered to be limited, with the exception of eradication. Risk reduction options addressing the sanitary status of the propagation material are likely to be the most effective and feasible. These include the current EU measures, as well as a statutory certification system with associated statutory import requirements or, failing that, but potentially less effective, the use of voluntary industry standards. It is difficult to disentangle the benefits of the current legislation from those of the industry-developed chrysanthemum certification system. The high efficacy of current measures is supported by the absence or limited presence of CSVd in the EU and by the limited number of interceptions and findings. Possible improvements to current measures are described and uncertainties discussed