Model Systems of Human Intestinal Flora, to Set Acceptable Daily Intakes of Antimicrobial Residues

The veterinary use of antimicrobial drugs in food producing animals may result in residues in food, that might modify the consumer gut flora. This review compares three model systems that maintain a complex flora of human origin: (i) human flora associated (HFA) continuous flow cultures in chemostats, (ii) HFA mice, and (iii) human volunteers. The "No Microbial Effect Level" of an antibiotic on human flora, measured in one of these models, is used to set the accept¬able daily intake (ADI) for human consumers. Human volunteers trials are most relevant to set microbio¬log¬ical ADI, and may be considered as the "gold standard". However, human trials are very expensive and unethical. HFA chemostats are controlled systems, but tetracycline ADI calculated from a chemostat study is far above result of a human study. HFA mice studies are less expensive and better controlled than human trials. The tetracycline ADI derived from HFA mice studies is close to the ADI directly obtained in human volunteers

Value addition to crop residues: An indigenous resource conserving and soil fertility enhancing technology of India

Not AvailableAbstract A two-year field experiment was conducted during the rainy seasons of 2004 and 2005 in the farmers' fields of Mahbubnagar district in Andhra Pradesh, India, to test the practice of cattle shed bedding with groundnut (Arachis hypogaea L.) shells by preparing Groundnut Shell Manure (GSM) and its application along with Farmers' practice (FP) and in comparison with five treatments namely, FP only, FP and GSM, FP and compost, regenerative (only organics) and Recommended Dose of Fertilizers (RDF), FP and RDF being the checks on rainy season rainfed groundnut and castor (Ricinus communis L.) crops. The results indicated that crops receiving GSM and compost performed well during the deficit rainfall year (2004) as well as during the normal rainfall year (2005) and recorded 12–16% higher yields of groundnut and 9–14% higher yields in castor over the FP. During 2004 which was a deficit rainfall year, GSM and compost application enhanced soil moisture by 14–40%, percentage of filled pods by 59–65% and 100 seed weight by 18% in groundnut while in castor 6–33% improved soil moisture enhanced capsules per plant from 45 to 57% without any significant effect on 100 seed weight. These treatments were followed by groundnut shell applied crop, RDF and regenerative (organics only) treatments. However, during 2005 the order in which higher yields achieved by treatments were GSM application, compost followed by RDF due to well-distributed rainfall. Therefore to sustain yields in rainfed groundnut and castor crops, present experimentation emphasized application of organics to improve soil fertility and drought management ability by recycling crop residues through a simple process of cattle shed bedding. This was an attempt to introduce the practice of cattle shed bedding as value addition to process other locally available crop residues to the practitioners of farming (especially parts of Africa and Latin America).Not Availabl

Summary Report on 2015 Residue Monitoring of Irish Farmed Finfish and 2015 Border Inspection Post Fishery and Fishery Product Sample Testing

On behalf of the Department of Agriculture, Food and Marine (DAFM), the Marine Institute carries out monitoring of chemical residues in finfish for aquaculture sector. This monitoring is set out in the annual National Residue Control Plan, which is approved by the European Commission, and is an important component of the DAFM food safety controls and is implemented under a service contract with the Food Safety Authority of Ireland. Since 1999, the Marine Institute has implemented the National Residues Monitoring Programme for aquaculture. This is carried out on behalf of the Sea Fisheries Protection Authority, which is the responsible organisation for residue controls on farmed finfish. The outcome for residues levels in farmed finfish during 2015 remains one of consistently low occurrence. In 2015, in excess of 676 tests and a total of 1,845 measurements were carried out on 128 samples (i.e. 124 target samples & 4 suspect samples) of farmed finfish for a range of chemical substances, including banned and unauthorised substances, various authorised veterinary treatments and environmental contaminants

Conclusion on the peer review of the pesticide risk assessment of the active substance metobromuron

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France, for the pesticide active substance metobromuron are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative use of metobromuron as a herbicide on potatoes. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. The consumer risk assessment should be considered provisional pending the outcome of the requested toxicological information on the metabolites included in the plant residue definitions. A high long-term risk to birds could not be excluded with the available data

Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance dimethoate

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State the United Kingdom, for the pesticide active substance dimethoate are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology, residues and ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of dimethoate as an insecticide on sugar beet and protected lettuce. Concerns are identified

Arrays on disc for screening and quantification of pollutants

A rapid compact disc based methodology for screening and quantification of organic pollutants in mandarin juices is presented. The assay is established on the coating conjugate indirect competitive principle and developed under disc-array configuration. The detection is based on the acquisition of attenuated reflective signals that were proportional to optical density of the immunoreaction product. The competitive assay is applied to quantify simultaneously, in a selective manner, non-systemic insecticides in mandarin juices. The detection limits were 0.2 and 0.1 ¿g L¿1 and the sensitivity 2.1 and 1.5 ¿g L¿1, for chlorpyrifos and fenthion, respectively. Pollutants were directly quantified after sample dilution in a total time of 40 min. Also, the implementation of positive and negative controls into the array configuration served as an automatic quality control test. The effect of thermal treatment on pesticide dissipation was studied and found that it was insignificant under the studied conditions. Recovery intervals ranged from 96¿105% to 94¿103%, for chlorpyrifos and fenthion, respectively and were similar to those obtained with gas chromatography coupled to mass spectrometry. In the current configuration, 64 samples can be simultaneously analyzed on a disc at a very competitive value, demonstrating its potential for high-throughput multiplexed screening applications for controlled monitoring programs in low-level labs or outside the lab settingThis work was funded by the projects FEDER CTQ2010-15943 (CICYT, Spain), and PROMETEO 2010/008 and ACOMP/2012/158 (Generalitat Valenciana).Navarro, P.; Morais Ezquerro, SB.; Gavaldón, JA.; Pérez, AJ.; Puchades Pla, R.; Maquieira Catala, Á. (2013). Arrays on disc for screening and quantification of pollutants. Analytica Chimica Acta. 784:59-64. https://doi.org/10.1016/j.aca.2013.04.041S596478

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Abstract The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quality of the data provided, the proposed fitting procedure of aged sorption experiments and the proposed method for combining results obtained from aged sorption studies and lower‐tier studies on degradation and adsorption. Aged sorption was a relevant process in all cases studied. The test revealed that the guidance could generally be well applied and resulted in robust and plausible results. The Panel considers the guidance suitable for use in the groundwater leaching assessment after the recommendations in this Scientific Opinion have been implemented, with the exception of the use of field data to derive aged sorption parameters. The Panel noted that the draft guidance could only be used by experienced users because there is no software tool that fully supports the work flow in the guidance document. It is therefore recommended that a user‐friendly software tool be developed. Aged sorption lowered the predicted concentration in groundwater. However, because aged sorption experiments may be conducted in different soils than lower‐tier degradation and adsorption experiments, it cannot be guaranteed that the higher tier predicts lower concentrations than the lower tier, while lower tiers should be more conservative than higher tiers. To mitigate this problem, the Panel recommends using all available higher‐ and lower‐tier data in the leaching assessment. The Panel further recommends that aged sorption parameters for metabolites be derived only from metabolite‐dosed studies. The formation fraction can be derived from parent‐dosed degradation studies, provided that the parent and metabolite are fitted with the best‐fit model, which is the double first‐order in parallel model in the case of aged sorption

International Frameworks Dealing with Human Risk Assessment of Combined Exposure to Multiple Chemicals

The development of harmonised terminology and frameworks for the human risk assessment of combined exposure to multiple chemicals (“chemical mixtures”) is an important area for EFSA and a number of activities have already been undertaken, i.e. in the fields of pesticides and contaminants. The first step prior to a risk assessment of combined exposure to multiple chemicals is problem formulation defining the relevant exposure, hazard and population to be considered. In practice, risk assessment of multiple chemicals is conducted using a tiered approach for exposure assessment, hazard assessment and risk characterisation. Higher tiers require increasing knowledge about the group of chemicals under assessment and the tiers can range from tier 0 (default values, data poor situation) to tier 3 (full probabilistic models). This scientific report reviews the terminology, methodologies and frameworks developed by national and international agencies for the human risk assessment of combined exposure to multiple chemicals and provides recommendations for future activities at EFSA in this area

Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment

Upon request of the European Commission, the Scientific Committee (SC) of the European Food Safety Authority reviewed existing information related to the testing and assessment of endocrine active substances (EASs) and endocrine disruptors (EDs). This work was conducted by a working group of experts in endocrinology, risk assessment and toxicology, together with observers from other EU agencies, namely EMA, ECHA and EEA. To distinguish between EDs and other groups of substances with different modes of action, it was concluded that an ED is defined by three criteria: the presence of i) an adverse effect in an intact organism or a (sub)population; ii) an endocrine activity; and iii) a plausible causal relationship between the two. As scientific criteria for adversity have not been generally defined, specific criteria for endocrine disrupting effects could not be identified. Hence, expert judgement is required to assess on a case-by-case basis the (eco)toxicological relevance of changes at the molecular to individual and/or (sub)population level following exposure to an EAS. The SC concluded that a reasonably complete suite of standardised assays for testing the effects of EASs is (or will soon be) available for the oestrogenic, androgenic, thyroid and steroidogenic modalities in mammals and fish, with fewer tests for birds and amphibians. Shortcomings in current tests and for other endocrine modalities and species were reviewed. Critical effect, severity, (ir)reversibility and potency aspects are part of the hazard characterisation of EDs. To inform on risk and level of concern for the purpose of risk management decisions, risk assessment (taking into account hazard and exposure data/predictions) makes best use of available information. Levels of concern are not determined exclusively by risk assessment but also by protection goals set by the risk management