Abstract: The present report is based on data from the 2010 EFSA Report on pesticide residues in food, the Norwegian monitoring programmes 2007-2012 and data from peer reviewed literature and governmental agencies. It is a challenge to perform quantitative estimates and comparative studies of residue levels due to large variation in the measured levels, and the large number of different pesticides present in the samples. Thus, the focus is on the frequency of observed contaminations in relation to regulatory limits and to present examples to illustrate the variation in residue values and number of detected substances.  Pesticide residues in conventional and organic products: Of the 12,168 samples (plant- and animal products) in the 2010 EU-coordinated programme, 1.6% exceeded the respective maximum residue level (MRL) values, and 47.7% had measurable residues above the limit of quantification (LOQ), but below or at the MRL. Of the 1168 samples analysed in Norway in 2012 (from both imported and domestic products), 1.9% exceeded MRL and 53% contained measurable pesticide residues. Direct comparison of these values is however not possible, since they contain different types of food samples, and are analysed for a different number of pesticides. When organic and conventional samples from fruit, vegetables and other plant products in the 2010 EU-coordinated programme were compared, 4.2% of the conventional and 1.0% of the organic samples exceeded the MRL values, while 43.2% of the conventional and 10.8% of the organic samples had measurable residues below or at the MRL value. Most of the pesticide residues detected in organic samples are not permitted for use in organic farming.  Of the 624 organic samples analysed in Norway 2007 - 2012, 0.2% (one sample) had residues exceeding MRL, while measurable residues were detected in 1.8% of the samples (11 samples). Conventional products were often found to contain different pesticides while most organic samples were found to contain few or only one type of pesticide.   Lack of data on pesticide residue levels of organic samples in the EU-coordinated programme, and few Norwegian samples do not allow for a quantitative comparison of pesticide residue levels in organic and conventional samples. Comparative estimation of pesticide residues faces a number of challenges and uncertainties. However, it seems unquestionable based on available data that organic plant products contain fewer and substantially lower amounts of pesticide residues than conventional products. Health risk associated with pesticide residues: The general level of pesticide residues in both conventional and organic food is low, and well below what is likely to result in adverse health effects. This conclusion is based on the comparison of estimated dietary exposure with toxicological reference values i.e. acceptable daily intake (ADI) for chronic effects, and acute reference dose (ARfD) for acute effects. The finding of pesticide residues that exceeds established regulatory limits in a minority of tested samples is not considered to represent a health risk. When dietary exposure that was estimated in six different food commodities in the 2010 EUcoordinated programme was compared with their relevant reference values, EFSA concluded that for 79 of 18243 conventionally grown fruit and vegetable samples, a short-term acute consumer health risk could not be excluded. The conclusion was based on the exceeding of ARfD. None of these 79 samples were organic. It is important to also consider that the exceeding of the acute reference value only occurred in 0.4% of the samples and that the scenario used for acute intake assessment is conservative, suggesting that the toxicological implications are limited. This is also reflected in the chronic exposure assessment, where none of the samples were found to exceed the toxicological reference value ADI.   Dietary exposure assessments on the basis of Norwegian samples of apples, tomatoes, carrots, strawberries and lettuce did not show an exceeding of any toxicological reference value.  Combined exposure and cumulative risk assessment of pesticide residues: No generally accepted methodology is at present established for cumulative risk assessment of combined exposure to pesticide residues. Available data suggest however that combined exposure is not likely to result in increased human health risk.

Abstract: In this report the following topic of pesticides and fate in Norway has been outlined covering: 1. Factors influencing degradation of pesticides. 2. Description and update of datasets on soil and climate in agricultural areas. 3. Normalization of field degradation data as input for modelling fate. 4. Use of degradation data from Norway in model scenarios. Norwegian laboratory degradation studies indicate that increased soil organic carbon content enhances degradation rates of pesticides that show low sorption (e.g. metalaxyl, bentazone) ,due to increased microbial activity. Whereas pesticides that sorb moderately to strongly to soil (e.g. boscalid, propiconazole), display reduced degradation as organic carbon increases as a consequence of sorption and reduced bioavailability. Recent DegT50 field studies display a large variation in fungicide degradation rates from Klepp in the south to Tromsø in the north. For the mobile herbicide bentazone, no effect of climate was observed, as degradation rates were coherent at all sites, probably due to rapid leaching. The climate (temperature) seems to be more determinate for fungicide degradation rates than the soil type. Fungicide degradation was slow at two northern sites having low soil temperatures, even though microbial biomass was hugely different at the sites. How soil temperature and moisture affects microbial activity and diversity in various soils, climates and crops is important for the understanding of degradation capacity in Norwegian soils and fields. Microbial activity could be related to both soil, climate and crops/cropping regime – as well as to the nature of the soil organic matter. The fact that DegT50 values are very much shorter than laboratory values at the same reference conditions, may point to some systematic error in the normalization procedure (e.g. the default simplifications in the Walker and Arrhenius equations), or that the parameters affecting degradation in the laboratory are different from the parameters that affect degradation in the field. Consequently, lab-derived and field-derived DegT50matrix values should be compared and interpreted with care. The large variations in normalized DegT50 values obtained in field studies in Norway as well as in other regions in Norway cannot be explained by differences in the associated parameters characterizing the soil and microbial community. It is therefore not possible to determine if a certain field study is more or less representative for “Norwegian conditions”. As a conservative approach, the highest, normalized DegT50 from the European field studies should be selected for the Norwegian risk assessment independent on geographic vicinity. As an alternative, when a sufficient number of data are available, a high percentile (e.g 80 or 90-percentile) should be used rather than the geomean. Each agricultural region in Norway is dominated by one specific soil type for each region. Albeluvisol, Cambisol, Umbrisol, Stagnosol and Histosol in respectively Eastern Norway south, Eastern Norway north, Rogaland, Trøndelag and North of Norway. New updates for Norway include especially Umbrisols and Histosols rich in organic matter. Albeluvisols, Cambisols and Stagnosols are representing the main soil types in the agricultural area in Norway. These are also included in the groundwater (Rustad and Heia) and surface water scenarios (Syverud) developed for Norway. Experience from pesticide fate in the organic rich soils on the south west coast and north of Norway is limited. Compared to the “normal” temperature and precipitation from 1961 to 1990 with a “new normal” from 1991 to 2014, the climate has changed. For the five described agricultural areas in Norway, annual temperature has increased in average 1 degrees for all five regions and seasons for the new normal. The rainfall has increased for all seasons and regions except for the Northern Norway (Holt in Tromsø) and summer season at Kvithamar (Trøndelag) with lower precipitation in June to September. Annually the precipitation has increased approximately 100 mm in average. The existing Norwegian scenarios in groundwater and surface water seem to be representative in the meaning of covering the main soil types in the central agricultural areas in South Eastern Norway. However there are no scenarios covering areas of South West and North of Norway containing soil with high organic content, slow degradation and heavy rainfall. Vulnerable areas are not included in these scenarios as the idea of the representativity of soil was to include the main soil types covering the most of the agricultural production areas. The vulnerable areas deals with smaller areas and has to be treated separately. Vulnerable areas are areas with high groundwater levels and sandy soil and mobile pesticides. Hilly areas with clay soil represent high risk of surface runoff with strongly sorbed pesticides. We are lacking experience from areas with high content of organic matter causing slow degradation, combined with heavy rainfall.  A database with representative soils and climates for various crops should be established in Norway and utilized in a targeted risk assessment approach. Then, the degradation of pesticides to be used in for example fruit/berry cropping, could be evaluated in respect to representative and vulnerable soils and climates in fruit/berry regions in Norway. A correct risk assessment of pesticide degradation in Norwegian agricultural soils should take the varying climatic zones, the diversity in agricultural soils and crops in Norway into consideration before formulated pesticides are approved. Risk assessment should be based on soils and climates most prevalent for the crop to which the pesticide is to be applied, in addition, vulnerable areas with slow degradation and/or high leaching/runoff risk should be recognized.

Abstract: Simplex is a new herbicide in Norway containing the active substances aminopyralid and fluroxypyr. Aminopyralid is a new active substance in Norway, but fluroxypyr is registered in several authorized products. The intended use of the plant protection product is in established grassland for forage, established ley and pasture and in grass at the first year of sowing.   During the spring of 2010, the Norwegian Scientific Committee for Food Safety (VKM) performed a human health risk assessment of the active substance aminopyralid and the product on request from the Norwegian Food Safety Authority. On further request from the Norwegian Food Safety Authority, VKM has performed a risk assessment on the fate and the behaviour in the environment and the environmental risk with regard to the properties of the active substance aminopyralid and the product Simplex, which was finalized at a meeting of VKM’s Scientific Panel on plant protection products (Panel 2) on November 25, 2010. VKM Panel 2’s conclusion is as follows: Aminopyralid is highly mobile in soil and the substance is very likely to reach ground water at concentrations above the threshold of 0.1 µg/L. Experimental data (watersediment studies) suggest that aminopyralid is persistent. However, aminopyralid concentrations in surface water are expected to decrease rapidly due to photolytic degradation. The overall risk for adverse effects on terrestrial and aquatic organisms following the proposed application of Simplex is considered to be minimal.

Abstract: Movento 100 SC is a new insecticide containing the active substance spirotetramat. The intended use is in stone fruit, pome fruit, vegetables and ornamentals outdoors, and lettuce, tomatoes and cucumbers in greenhouses. VKM was requested by the Norwegian Food Safety Authority to consider possible health risk for operators related to the properties of Movento 100 SC; in particular the relevance of the effects of spirotetramat on thyroid hormones, brain, thymus and body weight observed in dogs, and the reproductive effects of spirotetramat observed in rats. VKM was also asked to consider the fate and behaviour of Movento 100 SC with the active ingredient spirotetramat in the environment, and the ecotoxicological effects and risks related to its use. The risk assessment was finalized in a meeting on May 24. 2013, by VKM’s Scientific Panel on Plant Protection Products. VKM’s conclusions are as follows: Health: VKM concludes that spirotetramat shows toxic effects in dogs and rats that could be relevant for humans. Thyroid and thymus glands are target organs in the oral subchronic toxicity studies of spirotetramat in dogs, and effects are observed from 19 mg/kg bw/day (600 ppm). Decreases in circulating thyroid hormone levels were detected in all three studies carried out with dogs (28-, 90-days and 1-year) and should be considered toxicologically relevant. The opinion of the Panel is that it cannot be excluded that the observed brain dilatation in dogs is treatment-related, and relevant to humans. Furthermore, VKM concludes that the reproductive effect observed in rats could be relevant for humans. VKM proposes a NOAEL of 5 mg/kg bw/day (200 ppm) for spirotetramat based on a 1- year toxicity study in dogs, and a NOAEL of 100 mg/kg bw/day based on the acute neurotoxicity study in rats. VKM supports/proposes: ADI: 0.05 mg/kg bw/day. AOEL: 0.05 mg/kg bw/day. ARfD: 1 mg/kg bw/day. Risk calculations show minimal risk if personal protective equipment is used. Environment: VKM concludes that spirotetramat and its metabolites are not expected to accumulate in soil. It is not expected that spirotetramat or any of its metabolites will reach concentrations in groundwater above the threshold level of 0.1 μg/L when the formulation Movento 100 SC is applied according to the intended use. VKM concludes that use of Movento 100 SC with the active substance spirotetramat according to the proposed application scheme in Norway represents a minimal risk of adverse effects on terrestrial mammals, birds, earthworms, and soil microorganisms. However, in-field effects on sensitive species of predatory mites in the crop cannot be excluded. The risk of adverse effects on bees is minimal providing that spirotetramat is not used on crops during flowering or when bees are actively foraging. For aquatic organisms in surface water, the risk is considered minimal, provided that a 5 m buffer zone to open water is used.

Abstract: Gulløyelarver (green lacewing larvae, Chrysoperla carnea) is a product for biological control. The application is for use against aphids in green-houses and tunnels. Gulløyelarver was used in Norway from 1985-1993. An assessment in 2001 concluded however that the use of products with Chrysoperla carnea could represent an environmental risk since it was not known if the species in the products were the same as the ones with natural occurrence in Scandinavia. In this regard, The Norwegian Food Safety Authority would like VKM to perform an assessment of possible risks related to health and environment in light of possible new data. VKM’s conclusions are as follows: Health: The larvae of Chrysoperla carnea have hollow jaws through which they can inject digestive enzymes into their prey. In contact with humans, the larvae are capable of delivering painful bites which may cause local swelling. Such bites are however not considered dangerous, and can be avoided with preventive measures. Allergic asthma and rhino conjunctivitis has been reported in persons working in the production of biological agents with Chrysoperla carnea, but it is the opinion of VKM that such effects are not likely to be relevant for users of the agents. Environment: A previous assessment in 2001 concluded that the use of products with Chrysoperla carnea represented an environmental risk because of the risk of genetic interference with natural populations of the species in Norway. Lacewings belonging to the Chrysoperla carnea complex are considered established and indigenous in Norway, and a recent study by the Norwegian Institute for Agricultural and Environmental Research (Bioforsk) strongly suggests that the lacewings in the commercial products belong to the same cryptic species complex as individuals sampled in Norway. In case the species in the products is different from those present in Norway, any genetic interference with local populations in Norway is prevented by differences in duetting songs. If an invertebrate biological control agent is indigenous and has limited direct or indirect effect on the environment, it is the opinion of VKM that it could be authorized for release in greenhouses or plastic tunnels. Chrysoperla carnea is polyphagous and cannibalistic. They prefer aphids, but may also consume other insects and mites. It is however the opinion of VKM that the environmental risk from this will be minimized in greenhouses and tunnels where the release will be in a contained environment and directed against aphid colonies. Establishment, host range and dispersal ability should be carefully reviewed, even if the species is indigenous. Chrysoperla carnea may establish in the greenhouse and plastic tunnels and may also possess the ability to disperse and survive in the field. However, it is the opinion of VKM that the direct and indirect effects of this are at most moderate, although it cannot be completely excluded that Chrysoperla carnea species in the products might also have properties that have not been reviewed.

Abstract: Aviator Xpro EC 225 is a new fungicide for use in cereals, containing the new active substance bixafen and the already approved active substance prothioconazole. Prothioconazole was assessed by the Norwegian Scientific Committee for Food Safety in 2006, and is therefore not included in this report. VKM was requested by the Norwegian Food Safety Authority to consider the possible health risk for operators related to the properties of bixafen used in Aviator Xpro EC 225; in particular to evaluate the relevance of the effects of bixafen on liver and coagulation parameters observed in rats and mice, thyroid tumours and reproductive effects observed in rats, and the establishment of NOAELs and reference values. VKM was also asked to evaluate the fate and behaviour of bixafen in the environment, and the ecotoxicological effects and risks related to its use. The risk assessment was finalized in a meeting on May 24. 2013 by VKM’s Scientific Panel on Plant Protection Products. VKM’s conclusions are as follows: Health: VKM concluded that the liver effects reported in sub-chronic and chronic studies in rats, dogs and mice exposed to bixafen, as well as the effects on coagulating parameters, should be considered adverse and of relevance to humans. It is the opinion of VKM that the thyroid follicular cell tumours reported in female rats exposed to bixafen is not sufficient to suggest that bixafen has a tumour inducing potential. It is further the opinion of VKM that it cannot be excluded that the reduced pup weight during lactation in the two-generation study is mediated by bixafen via the milk, and that bixafen has a direct effect on the number of stillborn pups in the F1 and F2 generation. Finally, the pup developmental variants and anomalies reported in the teratogenicity study are considered treatment related, and not as secondary effects related to maternal toxicity. VKM proposes a NOAEL of 2.0 mg/kg bw/day based on a 2 year feeding study in rats. VKM support/propose: ADI: 0.02 mg/kg bw/day AOEL: 0.13 mg/kg bw/day ARfD: 0.2 mg/kg bw/day Risk calculations show minimal risk if personal protective equipment is used. Environment: Bixafen is shown to be persistent in soil. VKM considers the results from a field study on a German site and the Finnish PEC calculator to be relevant and concludes that repeated annual applications can cause accumulation in soil under Norwegian conditions. There is also a potential for groundwater contamination from leaching of the metabolite M44. VKM has concluded that the use of bixafen as an ingredient in Aviator Xpro EC 225 with the proposed application regime in Norway will represent a minimal risk for toxic effects to terrestrial organisms. The toxicity of bixafen to aquatic organisms is high, and minimal risk of effects in surface waters can be achieved only if risk mitigation measures with bufferzones of 10 m are applied.

Abstract: Plenum is a new insecticide containing the new active substance pymetrozine. Plenum is an insecticide against different pests in ornamentals, lettuce, cucumber and tomato in greenhouse and against pollen beetles in oilseed- and turnip rapes. The risk assessment was finalized at a meeting Mai 29, 2012, by VKM’s Scientific Panel on plant protection products (VKM). The Panel is in particular asked by the Norwegian Food Safety Authority to look at the following:  The human health risk for operators related to the properties of the active substance and the product. The Panel is in particular asked to look at the following: o The effects seen in studies on dog and if these effects warrant a classification for chronic toxicity. o The oncogenic effects in liver and lungs o The genotoxicity of metabolite CGA 300407. o The effects on reproduction and if the effects seen in teratology studies and developmental neurotoxicity study warrant a classification for developmental toxicity o The establishment of NOAELs and reference values (ADI, AOEL and ARfD). o The classification and labelling of the active substances and the product. VKM’s conclusion is as follows:  The effects reported in the repeated dose toxicity studies with dogs should be considered as adverse.   The increased incidence of liver and lung tumors should be considered as relevant for humans. It cannot be excluded that a genotoxic mechanism could be involved in the formation of the liver tumors, which would have implications for risk assessment. It should therefore be considered to test pymetrozine in more sensitive in vivo genotoxic endpoints in liver.  The effects reported in the teratogenicity studies in rats and rabbits and in the developmental neurotoxicity study in rats should be considered for a classification of pymetrozine for developmental toxicity.  Risk calculations with both the German model and the UK POEM show low risk if personal protection equipment is used. VKM propose: NOAEL of 0.6 mg/kg bw/day for pymetrozine based on the 1-year study in dogs.   AOEL of 0.006 mg/kg bw/day for pymetrozine based on the NOAEL value at 0.6 mg/kg bw/day from the one year study in dogs and an UF of 100.   ADI of 0.006 for pymetrozine based on the NOAEL value at 0.6 mg/kg bw/day from the one year study in dogs and an UF of 100.   ARfD of 0.02 mg/kg bw/day for pymetrozine based on the LOAEL value at 8.1 mg/kg bw/day from the developmental neurotoxicity study and an UF of 500 (10 x interspecies difference, 10 x intraspecies difference, 3 x due to the use of a LOAEL value and 2 x due to the adversity of the neurodevelopmental effects). VKM supports the classification proposal from Norwegian Food Safety Authority.